Gantrisin Pediatric

Generic Name: sulfisoxazole (Oral route)

sul-fi-SOX-a-zole

Commonly used brand name(s)

In the U.S.

• Gantrisin Pediatric


• Truxazole

Available Dosage Forms:

• Tablet


• Syrup


• Suspension

Therapeutic Class: Antibiotic

Chemical Class: Sulfonamide

Uses For Gantrisin Pediatric

Sulfisoxazole is used to treat or prevent infections in many different parts of the body. It belongs to the group of medicines known as sulfonamide antibiotics. It works by preventing the growth of bacteria. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Before Using Gantrisin Pediatric

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Because of sulfisoxazole's toxicity, use in infants younger than 2 months of age is not recommended.

Geriatric

No information is available on the relationship of age to the effects of sulfisoxazole in geriatric patients. However, elderly patients are more likely to have age-related kidney and liver problems, which may require caution in patients receiving sulfadiazine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Methotrexate


• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetohexamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or


• Blood problems (e.g., agranulocytosis, aplastic anemia) or


• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem) or


• Kidney disease or


• Liver disease—Use with caution. May have an increased chance of side effects.

Proper Use of sulfisoxazole

This section provides information on the proper use of a number of products that contain sulfisoxazole. It may not be specific to Gantrisin Pediatric. Please read with care.

This medicine should not be given to infants younger than 2 months of age unless directed by your child's doctor. Sulfisoxazole may cause serious unwanted effects in this age group.

Take this medicine with a full glass (8 ounces) of water. Several additional glasses of water should be taken during the day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects.

This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times during the day. If you need help in planning the best times to take your medicine, check with your doctor.

To help clear up your infection completely, keep using this medicine for the full treatment time, even if you feel better after the first few doses. If you stop taking this medicine too soon, your symptoms may return.

Shake the oral suspension well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (suspension, tablets):
  
  • For treatment of infections:
    
    • Adults—4000 to 8000 milligrams (mg) per day, divided and given in 4 to 6 doses per day.
    
    
    • Children and infants 2 months of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 75 milligrams (mg) per kilogram (kg) of body weight per day (mg/kg/day), divided and given in 4 to 6 doses per day. Your doctor may increase your dose to 150 mg/kg/day, but the total dose is usually not more than 6000 mg per day.
    
    
    • Infants younger than 2 months of age—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Gantrisin Pediatric

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have any of the following symptoms: a skin rash; blistering, peeling, or loosening of the skin; cough; diarrhea; itching; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Check with your doctor right away if you have fever; chills; joint or muscle pain; pale skin; pinpoint red or purple spots on the skin; shortness of breath; sore throat; pain in the upper stomach; or yellow eyes or skin. These may be symptoms of a serious blood problem.

Sulfisoxazole may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without checking first with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If mild diarrhea continues or gets worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Gantrisin Pediatric Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Anxiety


• blurred vision


• changes in menstrual periods


• chills


• cold sweats


• coma


• confusion


• cool, pale skin


• decreased sexual ability in males


• depression


• dizziness


• dry, puffy skin


• fast heartbeat


• feeling cold


• headache


• increased hunger


• nausea


• nervousness


• nightmares


• seizures


• shakiness


• slurred speech


• swelling of the front part of the neck


• unusual tiredness or weakness


• weight gain

Incidence not known

• Abdominal or stomach pain, cramps, or tenderness


• agitation


• back, leg, or stomach pains


• bleeding gums


• bleeding under the skin


• blindness or vision changes


• blistering, peeling, or loosening of the skin


• bloating


• bloody or cloudy urine


• bloody, black, or tarry stools


• bluish color of the fingernails, lips, skin, palms, or nail beds


• burning of the face or mouth


• burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings


• change in the ability to see colors, especially blue or yellow


• chest pain


• chills


• clay-colored stools


• clumsiness or unsteadiness


• constipation


• continuing ringing or buzzing or other unexplained noise in the ears


• cough or hoarseness


• cracks in the skin


• dark urine


• decrease in frequency of urination


• decrease in the amount of urine


• diarrhea


• diarrhea, watery and severe, which may also be bloody


• difficult or painful urination


• difficulty in passing urine (dribbling)


• difficulty with breathing


• difficulty with swallowing


• dizziness or lightheadedness


• drowsiness


• enlarged salivary glands


• fainting


• fast, pounding, or irregular heartbeat or pulse


• feeling of discomfort


• feeling unusually cold


• fever with or without chills


• general body swelling


• general feeling of discomfort or illness


• general feeling of tiredness or weakness


• hair loss


• headache


• hearing loss


• hives or welts


• hostility


• increased sensitivity of the skin to sunlight


• increased thirst


• indigestion


• inflammation of the joints


• irritability


• itching


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lethargy


• light-colored stools


• loss of appetite and weight


• loss of heat from the body


• loss of strength or energy


• lower back or side pain


• muscle aches


• muscle pain or weakness


• muscle twitching


• nosebleeds


• not able to pass urine


• pain


• pain or burning while urinating


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale skin


• pinpoint red or purple spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rapid heart rate


• rapid weight gain


• rash


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• redness of the white part of the eyes


• redness, soreness or itching skin


• scaly skin


• severe sunburn


• shakiness and unsteady walk


• shivering


• shortness of breath


• skin rash


• sore throat


• soreness of the muscles


• sores, ulcers, or white spots on the lips or in the mouth


• sores, welting, or blisters


• stupor


• swelling around the eyes


• swelling of face, ankles, hands, feet, or lower legs


• swelling or inflammation of the mouth


• swollen lymph glands


• swollen or painful glands


• thickening of bronchial secretions


• tightness in the chest


• troubled breathing


• troubled breathing with exertion


• unpleasant breath odor


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual bleeding or bruising


• unusual weak feeling


• unusual weight gain


• unusual weight loss


• upper right abdominal pain


• vomiting


• vomiting of blood or material that looks like coffee grounds


• weakness in the hands or feet


• weight loss


• wheezing


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Confusion about identity, place, and time


• difficulty with moving


• excess air or gas in the stomach or intestines


• fear


• feeling of constant movement of self or surroundings


• feeling that others are watching you or controlling your behavior


• feeling that others can hear your thoughts


• feeling, seeing, or hearing things that are not there


• full feeling


• lack of feeling or emotion


• passing gas


• redness, swelling, or soreness of the tongue


• sensation of spinning


• severe mood or mental changes


• sleeplessness


• trouble with sleeping


• unable to sleep


• uncaring


• unusual behavior

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Gantrisin Pediatric side effects (in more detail)

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More Gantrisin Pediatric resources

• Gantrisin Pediatric Side Effects (in more detail)
• Gantrisin Pediatric Use in Pregnancy & Breastfeeding
• Gantrisin Pediatric Drug Interactions
• Gantrisin Pediatric Support Group
• 0 Reviews for Gantrisin Pediatric - Add your own review/rating

• Gantrisin Pediatric Concise Consumer Information (Cerner Multum)


• Gantrisin Prescribing Information (FDA)


• Gantrisin Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Sulfisoxazole Professional Patient Advice (Wolters Kluwer)


• Sulfisoxazole MedFacts Consumer Leaflet (Wolters Kluwer)


• sulfisoxazole Concise Consumer Information (Cerner Multum)

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Phenylephrine/Brompheniramine/Dextromethorphan

Pronunciation: FEN-il-EF-rin/BROME-fen-IR-a-meen/DEX-troe-meth-OR-fan
Generic Name: Phenylephrine/Brompheniramine/Dextromethorphan
Brand Name: BroveX PB DM

Phenylephrine/Brompheniramine/Dextromethorphan is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Phenylephrine/Brompheniramine/Dextromethorphan is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Phenylephrine/Brompheniramine/Dextromethorphan if:

• you are allergic to any ingredient in Phenylephrine/Brompheniramine/Dextromethorphan


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, stomach ulcer, or narrow-angle glaucoma


• you are unable to urinate or are having an asthma attack


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Phenylephrine/Brompheniramine/Dextromethorphan:

Some medical conditions may interact with Phenylephrine/Brompheniramine/Dextromethorphan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; mental or mood problems (eg, depression); or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you are in poor health or if you are very overweight

Some MEDICINES MAY INTERACT with Phenylephrine/Brompheniramine/Dextromethorphan. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Phenylephrine/Brompheniramine/Dextromethorphan's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Phenylephrine/Brompheniramine/Dextromethorphan


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Phenylephrine/Brompheniramine/Dextromethorphan

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenylephrine/Brompheniramine/Dextromethorphan may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Phenylephrine/Brompheniramine/Dextromethorphan:

Use Phenylephrine/Brompheniramine/Dextromethorphan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Phenylephrine/Brompheniramine/Dextromethorphan by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take Phenylephrine/Brompheniramine/Dextromethorphan with a full glass of water (8 oz/240 mL).


• Drink plenty of water while taking Phenylephrine/Brompheniramine/Dextromethorphan.


• If you miss a dose of Phenylephrine/Brompheniramine/Dextromethorphan, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Phenylephrine/Brompheniramine/Dextromethorphan.

Important safety information:

• Phenylephrine/Brompheniramine/Dextromethorphan may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Phenylephrine/Brompheniramine/Dextromethorphan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Phenylephrine/Brompheniramine/Dextromethorphan; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you take Phenylephrine/Brompheniramine/Dextromethorphan without checking with your doctor.


• Phenylephrine/Brompheniramine/Dextromethorphan has phenylephrine, brompheniramine, and dextromethorphan in it. Before you start any new medicine, check the label to see if it has phenylephrine, brompheniramine, and dextromethorphan in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not use Phenylephrine/Brompheniramine/Dextromethorphan for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 days, if they get worse, or if they occur along with a fever, check with your doctor.


• Phenylephrine/Brompheniramine/Dextromethorphan may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Phenylephrine/Brompheniramine/Dextromethorphan. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Phenylephrine/Brompheniramine/Dextromethorphan may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Phenylephrine/Brompheniramine/Dextromethorphan for a few days before the tests.


• Tell your doctor or dentist that you take Phenylephrine/Brompheniramine/Dextromethorphan before you receive any medical or dental care, emergency care, or surgery.


• Use Phenylephrine/Brompheniramine/Dextromethorphan with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using Phenylephrine/Brompheniramine/Dextromethorphan in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Phenylephrine/Brompheniramine/Dextromethorphan should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Phenylephrine/Brompheniramine/Dextromethorphan while you are pregnant. Do not take Phenylephrine/Brompheniramine/Dextromethorphan in the third trimester of pregnancy. It is not known if Phenylephrine/Brompheniramine/Dextromethorphan is found in breast milk. Do not breast-feed while taking Phenylephrine/Brompheniramine/Dextromethorphan.

Possible side effects of Phenylephrine/Brompheniramine/Dextromethorphan:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; increased sweating; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest tightness; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or sore throat; flushing or redness of the face; hallucinations; mental or mood changes; numbness or tingling; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe dryness of mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Phenylephrine/Brompheniramine/Dextromethorphan side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; muscle spasms; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusual eye movements; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Phenylephrine/Brompheniramine/Dextromethorphan:

Store Phenylephrine/Brompheniramine/Dextromethorphan at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Phenylephrine/Brompheniramine/Dextromethorphan out of the reach of children and away from pets.

General information:

• If you have any questions about Phenylephrine/Brompheniramine/Dextromethorphan, please talk with your doctor, pharmacist, or other health care provider.


• Phenylephrine/Brompheniramine/Dextromethorphan is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Phenylephrine/Brompheniramine/Dextromethorphan. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Phenylephrine/Brompheniramine/Dextromethorphan resources

• Phenylephrine/Brompheniramine/Dextromethorphan Side Effects (in more detail)
• Phenylephrine/Brompheniramine/Dextromethorphan Use in Pregnancy & Breastfeeding
• Phenylephrine/Brompheniramine/Dextromethorphan Drug Interactions
• Phenylephrine/Brompheniramine/Dextromethorphan Support Group
• 1 Review for Phenylephrine/Brompheniramine/Dextromethorphan - Add your own review/rating

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• Cough and Nasal Congestion

Nuelin SA 250 mg Tablets

1. Name Of The Medicinal Product

Nuelin SA 250 mg Tablets

2. Qualitative And Quantitative Composition

Theophylline 250mg

3. Pharmaceutical Form

Prolonged release tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Nuelin SA are indicated for the prophylaxis and treatment of reversible bronchospasm associated with asthma and chronic obstructive pulmonary disease.

Because effective plasma levels are maintained for up to twelve hours from a single dose, less frequent dosing is required than with conventional theophylline preparations.

4.2 Posology And Method Of Administration

ADULTS: One tablet twice daily, preferably after food, increasing to two tablets twice daily, if necessary.

CHILDREN: 6 TO 12 YEARS: One tablet twice daily, preferably after food.

ELDERLY: Elderly patients may require lower doses due to reduced theophylline clearance.

Nuelin SA-250 are not recommended for children under six years.

Nuelin SA-250 tablets are scored and may be halved but should not be crushed or chewed.

The dosage should be titrated for each individual and adjusted with caution. Serum theophylline levels should be monitored to ensure that they remain within the therapeutic range.

4.3 Contraindications

Porphyria

Hypersensitivity to any constituent or to xanthines.

Concomitant use with ephedrine in children.

4.4 Special Warnings And Precautions For Use

The patients response to therapy should be carefully monitored. Worsening of asthma symptoms requires urgent medical attention.

Use with caution in patients with cardiac arrhythmias, peptic ulcer, hyperthyroidism, severe hypertension, acute porphyria, hepatic dysfunction, chronic alcoholism, acute febrile illness and chronic lung disease.

Smoking and alcohol consumption may increase theophylline clearance and increased doses of theophylline are therefore required. In patients with cardiac failure, hepatic dysfunction/disease and fever the reverse is true and these patients may require a reduced dosage.

Alternative bronchodilator therapy should be used in patients with a history of seizures.

It is not recommended that the product be used concurrently with other preparations containing xanthine derivatives.

WARNINGS: Xanthines can potentiate hypokalaemia resulting from beta-2-agonist therapy steroids, diuretics and hypoxia. Particular caution is advised in severe asthma. It is recommended that serum potassium levels are monitored in such situations.

PRECAUTIONS: In the case of an acute asthmatic attack in a patient receiving a sustained action theophylline preparation, great caution should be taken when administering intravenous aminophylline. Half the recommended loading dose of aminophylline (generally 6 mg/kg) should be given, i.e. 3 mg/kg, cautiously.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Cimetidine, allopurinol, corticosteroids, frusemide, isoprenaline, oral contraceptives, thiobendazole, ciprofloxacin, erythromycin or other macrolide antibiotics and the calcium channel blockers, diltiazem and verapamil, nizatidine, norfloxacin, isoniazid, fluconazole, carbimazole, mexiletine, propafenone, oxpentifylline, disulfiram, viloxazine, interferon alfa, and influenza vaccine increase plasma theophylline concentrations. A reduction of the theophylline dosage is recommended.

Phenytoin, carbamazepine, barbiturates, rifampicin, sulphinpyrazone, ritonavir, primidone and aminoglutethimide may reduce plasma theophylline concentrations and therefore the theophylline dosage may need to be increased.

Theophylline can increase lithium excretion.

The concomitant use of theophylline and fluvoxamine should usually be avoided. Where this is not possible, patients should have their theophylline dose halved and plasma theophylline should be monitored closely.

Warnings about the concurrent use of xanthines and xanthine derivatives are shown in Section 4, Special Warnings.

Plasma concentrations of theophylline can be reduced by concomitant use of the herbal remedy St John's wort (Hypericum perforatum).

Other interactions:

β-Blockers: antagonism of bronchodilation.

Ketamine: reduced convulsive threshold.

Doxapram: increased CNS stimulation.

Also see Warnings.

4.6 Pregnancy And Lactation

Administration of theophylline drugs during pregnancy should only be considered if there is no safe alternative and the benefits of treatment outweigh the risks.

Theophylline is excreted in breast milk and should not therefore be routinely administered to nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

No effect.

4.8 Undesirable Effects

The side-effects commonly associated with xanthine derivatives such as nausea, gastric irritation, palpitations, tachycardia, arrhythmias, convulsions, headache, CNS stimulation and insomnia are much diminished when a sustained action preparation such as Nuelin SA is used. These side-effects are mild and infrequent when the plasma concentration is maintained at less than 20 microgrammes/ml.

4.9 Overdose

Over 3 g could be serious in an adult (40 mg/kg in a child). The fatal dose may be as little as 4.5 g in an adult (60 mg/kg in a child), but is generally higher.

SYMPTOMS

Warning: Serious features may develop as long as 12 hours after overdosage with sustained release formulations.

Alimentary features:

Nausea, vomiting (which is often severe). epigastric pain and haematernesis. Consider pancreatitis if abdominal pain persists.

Neurological features:

Restlessness, hypertonia. exaggerated limb reflexes and convulsions.

Coma may develop in very severe cases.

Cardiovascular features:

Sinus tachycardia is common. Ectopic beats and supraventricular and ventricular tachycardia may follow.

Metabolic features:

Hypokalaemia due to shift of potassium from plasma into cells is common, can develop rapidly and may be severe. Hyperglycaemia. hypomagnesaemia and metabolic acidosis may also occur. Rhabdomyolysis may also occur.

MANAGEMENT

Activated charcoal or gastric lavage should be considered if a significant overdose has been ingested within 1-2 hours. Repeated doses of activated charcoal given by mouth can enhance theophylline elimination. Measure the plasma potassium concentration urgently, repeat frequently and correct hypokalaemia. BEWARE! If large amounts of potassium have been given, serious hyperkalaemia may develop during recovery. If plasma potassium is low then the plasma magnesium concentration should be measured as soon as possible.

In the treatment of ventricular arrhythmias, proconvulsant antiarrhythmic agents such as lignocaine (lidocaine) should be avoided because of the risk of causing or exacerbating seizures.

Measure the plasma theophylline concentration regularly when severe poisoning is suspected, until concentrations are falling. Vomiting should be treated with an antiemetic such as metoclopramide or ondansetron.

Tachycardia with an adequate cardiac output is best left untreated. Beta-blockers may be given in extreme cases but not if the patient is asthmatic.

Control isolated convulsions with intravenous diazepam. Exclude hypokalaemia as a cause.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Theophylline directly relaxes smooth muscle thus acting mainly as a bronchodilator and vasodilator. The drug also possesses other action typical of the xanthines derivatives - coronary vasodilator, diuretic, cardiac stimulant, cerebral stimulant and skeletal muscle stimulant.

5.2 Pharmacokinetic Properties

It has been established that the xanthines, which include theophylline, are readily absorbed after oral, rectal or parenteral administration and this is well documented in published literature.

Theophylline is excreted in the urine as metabolites, mainly 1,3-dimethyluric acid and 3-methylxanthine, and about 10% is excreted unchanged.

Plasma half-lives ranging from 3 to 9 hours and therapeutic plasma concentrations from about 5 to 20 μg per ml have been reported.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose Ph Eur

Cellulose Acetate Phthalate Ph Eur

Magnesium Stearate Ph Eur

6.2 Incompatibilities

None known

6.3 Shelf Life

3 Years

6.4 Special Precautions For Storage

Store below 30°C.

6.5 Nature And Contents Of Container

Bottle or Blister packs of 60

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Meda Pharmaceuticals Ltd

249 West George Street

Glasgow

G2 4RB

Trading as:

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

8. Marketing Authorisation Number(S)

PL 15142/0114

9. Date Of First Authorisation/Renewal Of The Authorisation

22 January 1980/21 August 2004

10. Date Of Revision Of The Text

2^nd February 2010

Navane

Generic Name: thioxanthene (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

• Navane

Available Dosage Forms:

• Liquid


• Capsule


• Tablet


• Solution

Uses For Navane

The family of medicines known as thioxanthenes are used in the treatment of nervous, mental, and emotional conditions. Improvement in such conditions is thought to result from the effect of these medicines on nerve pathways in specific areas of the brain.

Thioxanthene medicines are available only with your doctor's prescription.

Before Using Navane

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Certain side effects, such as muscle spasms of the face, neck, and back, tic-like or twitching movements, inability to move the eyes, twisting of the body, or weakness of the arms and legs, are more likely to occur in children, who are usually more sensitive than adults to the side effects of thioxanthenes.

Geriatric

Constipation, dizziness or fainting, drowsiness, dryness of mouth, trembling of the hands and fingers, and symptoms of tardive dyskinesia (such as rapid, worm-like movements of the tongue or any other uncontrolled movements of the mouth, tongue, or jaw, and/or arms and legs) are especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of thioxanthenes.

Pregnancy

Studies have not been done in pregnant women. Although animal studies have not shown that thioxanthenes cause birth defects, the studies have shown that these medicines cause a decrease in fertility and fewer successful pregnancies.

Breast Feeding

It is not known if thioxanthenes pass into the breast milk. However, similar medicines for nervous, mental, or emotional conditions do pass into breast milk and may cause drowsiness and increase the risk of other problems in the nursing baby. Be sure you have discussed the risks and benefits of this medicine with your doctor.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Metoclopramide

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Hydromorphone


• Lithium


• Milnacipran


• Tramadol


• Zotepine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse—Drinking alcohol will add to the central nervous system (CNS) depressant effects of thioxanthenes.

• Blood disease or


• Enlarged prostate or


• Glaucoma or


• Heart or blood vessel disease or


• Lung disease or


• Parkinson's disease or


• Stomach ulcers or


• Urination problems—Thioxanthenes may make the condition worse.

• Liver disease—Higher blood levels of thioxanthenes may occur, increasing the chance of side effects.

• Reye's syndrome—The risk of liver problems may be increased.

• Seizure disorders—The risk of seizures may be increased.

Proper Use of Navane

This medicine may be taken with food or a full glass (8 ounces) of water or milk to reduce stomach irritation.

For patients taking thiothixene oral solution:

• This medicine must be diluted before you take it. Just before taking, measure the dose with the specially marked dropper. Mix the medicine with a full glass of water, milk, tomato or fruit juice, soup, or carbonated beverage.

Do not take more of this medicine or take it more often than your doctor ordered. This is particularly important when this medicine is given to children, since they may react very strongly to its effects.

Sometimes this medicine must be taken for several weeks before its full effect is reached.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For chlorprothixene


• For treatment of psychosis:
  
  • For oral dosage forms (suspension or tablets):
    
    • Adults and teenagers—25 to 50 milligrams (mg) three or four times a day.
    
    
    • Children 6 to 12 years of age—10 to 25 mg three or four times a day.
    
    
    • Children up to 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For injection dosage form:
    
    • Adults and teenagers—25 to 50 mg, injected into a muscle, three or four times a day.
    
    
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  

• For flupenthixol


• For treatment of psychosis:
  
  • For oral dosage form (tablets):
    
    • Adults—To start, 1 milligram (mg) three times a day. Your doctor may increase your dose if needed, depending on your condition.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For long-acting injection dosage form:
    
    • Adults—To start, 20 to 40 milligrams (mg) injected into a muscle. Your doctor will determine whether your dose needs to be changed, depending on your condition.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For thiothixene


• For treatment of psychosis:
  
  • For oral dosage forms (capsules and solution):
    
    • Adults and teenagers—To start, 2 milligrams (mg) three times a day, or 5 mg two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 60 mg a day.
    
    
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For injection dosage form:
    
    • Adults and teenagers—4 milligrams (mg), injected into a muscle, two to four times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 30 mg a day.
    
    
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Navane

Your doctor should check your progress at regular visits. This will allow the dosage of the medicine to be adjusted when necessary and also will reduce the possibility of side effects.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. This is to prevent side effects and to prevent your condition from becoming worse.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any such depressants while you are using this medicine.

Do not take this medicine within an hour of taking antacids or medicine for diarrhea. Taking them too close together may make this medicine less effective.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking thioxanthenes together with medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects.

This medicine may cause some people to become drowsy or less alert than they are normally, especially during the first few weeks the medicine is being taken. Even if you take this medicine only at bedtime, you may feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur while you are taking this medicine, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Thioxanthenes may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat. Also, wear sunglasses.


• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.


• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.


• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If you are taking a liquid form of this medicine, try to avoid spilling it on your skin or clothing. Skin rash and irritation have been caused by similar medicines.

If you are receiving this medicine by injection:

• The effects of the long-acting injection form of this medicine may last for up to 3 weeks. The precautions and side effects information for this medicine applies during this period of time.

Navane Side Effects

Along with their needed effects, thioxanthenes can sometimes cause serious side effects. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects may also occur. Some of these side effects, including severe muscle stiffness, fever, unusual tiredness or weakness, fast heartbeat, difficult breathing, increased sweating, loss of bladder control, and seizures, may be the sign of a condition called neuroleptic malignant syndrome. You and your doctor should discuss the good this medicine will do as well as the risks of taking it.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

• Convulsions (seizures)


• difficulty in breathing


• fast heartbeat


• high fever


• high or low (irregular) blood pressure


• increased sweating


• loss of bladder control


• muscle stiffness (severe)


• unusually pale skin


• unusual tiredness

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Difficulty in talking or swallowing


• inability to move eyes


• lip smacking or puckering


• loss of balance control


• mask-like face


• muscle spasms, especially of the neck and back


• puffing of cheeks


• rapid or worm-like movements of tongue


• restlessness or need to keep moving (severe)


• shuffling walk


• stiffness of arms and legs


• trembling and shaking of fingers and hands


• twisting movements of body


• uncontrolled chewing movements


• uncontrolled movements of the arms and legs

Less common

• Blurred vision or other eye problems


• difficult urination


• fainting


• skin discoloration


• skin rash

Rare

• Hot, dry skin or lack of sweating


• increased blinking or spasms of eyelid


• muscle weakness


• sore throat and fever


• uncontrolled twisting movements of neck, trunk, arms, or legs


• unusual bleeding or bruising


• unusual facial expressions or body positions


• yellow eyes or skin

Symptoms of overdose

• Difficulty in breathing (severe)


• dizziness (severe)


• drowsiness (severe)


• muscle trembling, jerking, stiffness, or uncontrolled movements (severe)


• small pupils


• unusual excitement


• unusual tiredness or weakness (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation


• decreased sweating


• dizziness, lightheadedness, or fainting


• drowsiness (mild)


• dryness of mouth


• increased appetite and weight


• increased sensitivity of skin to sunlight (skin rash, itching, redness or other discoloration of skin, or severe sunburn)


• stuffy nose

Less common

• Changes in menstrual period


• decreased sexual ability


• swelling of breasts (in males and females)


• unusual secretion of milk

After you stop taking this medicine your body may need time to adjust, especially if you took this medicine in high doses or for a long time. If you stop taking it too quickly, the following withdrawal effects may occur and should be reported to your doctor:

• Dizziness


• nausea and vomiting


• stomach pain


• trembling of fingers and hands


• uncontrolled, continuing movements of mouth, tongue, or jaw

Although not all of the side effects listed above have been reported for all thioxanthenes, they have been reported for at least one of them. However, since these medicines are very similar, any of the above side effects may occur with any of them.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Fleet Relief Ointment

Pronunciation: pra-MOX-een
Generic Name: Pramoxine
Brand Name: Examples include Fleet Relief and Tucks Hemorrhoidal

Fleet Relief Ointment is used for:

Treating pain, soreness, burning, and itching of the anal area due to hemorrhoids and other anorectal disorders.

Fleet Relief Ointment is a topical anesthetic. It works by blocking pain signals from the nerve endings in the skin, which helps relieve discomfort.

Do NOT use Fleet Relief Ointment if:

• you are allergic to any ingredient in Fleet Relief Ointment

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fleet Relief Ointment:

Some medical conditions may interact with Fleet Relief Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Fleet Relief Ointment. Because little, if any, of Fleet Relief Ointment is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fleet Relief Ointment may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fleet Relief Ointment:

Use Fleet Relief Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fleet Relief Ointment is for use around the rectal area only.


• Wash your hands immediately after using Fleet Relief Ointment.


• Wash the affected area with soap and water, and gently pat dry.


• Apply Fleet Relief Ointment according to the instructions on the container unless directed otherwise by your doctor.


• If you miss a dose of Fleet Relief Ointment, apply it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fleet Relief Ointment.

Important safety information:

• If your symptoms do not improve within 7 days, or if they become worse, check with your doctor.


• Avoid getting Fleet Relief Ointment in your eyes. If you get Fleet Relief Ointment in your eyes, immediately flush them with cool tap water.


• Fleet Relief Ointment is not recommended for use in CHILDREN younger than 12 years of age, except under the advice of a doctor. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Fleet Relief Ointment during pregnancy. It is unknown if Fleet Relief Ointment is excreted in breast milk after topical use. If you are or will be breast-feeding while you are using Fleet Relief Ointment, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Fleet Relief Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding from the rectum; new or increasing redness, pain, swelling, irritation, or other symptoms.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Fleet Relief side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Fleet Relief Ointment may be harmful if swallowed.

Proper storage of Fleet Relief Ointment:

Store in an upright position at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fleet Relief Ointment out of the reach of children and away from pets.

General information:

• If you have any questions about Fleet Relief Ointment, please talk with your doctor, pharmacist, or other health care provider.


• Fleet Relief Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fleet Relief Ointment. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Fleet Relief resources

• Fleet Relief Side Effects (in more detail)
• Fleet Relief Use in Pregnancy & Breastfeeding
• Fleet Relief Support Group
• 1 Review for Fleet Relief - Add your own review/rating

Compare Fleet Relief with other medications

• Hemorrhoids

Fludara

Pronunciation: floo-DAYR-a-been
Generic Name: Fludarabine
Brand Name: Fludara

Some patients who received high doses of Fludara to treat acute leukemia developed severe nervous system side effects, including blindness, coma, and death. Similar nervous system side effects, including coma, seizures, agitation, and confusion, have occurred in patients at doses recommended for the treatment of chronic lymphocytic leukemia. Discuss any questions or concerns with your doctor. Contact your doctor right away if any of these effects occur.

Fludara may severely decrease bone marrow function. This can lower your body's ability to fight infection and reduce the ability of your blood to clot properly. Some patients have developed severe and sometimes fatal blood problems (eg, hemolytic anemia, autoimmune thrombocytopenia, hemophilia) while using Fludara. Your doctor will need to monitor you closely for these conditions. Tell your doctor right away if you develop signs or symptoms of an infection (eg, swollen glands, sore throat, fever, chills), bleeding problems (eg, easy bruising; black, tarry stools; bleeding from the gums), or hemolytic anemia (eg, yellowing of the eyes or skin, dark urine, severe tiredness or weakness). Be sure to keep all doctor and laboratory appointments.

Fatal lung problems have been reported in patients receiving Fludara along with pentostatin. Fludara is not recommended for use with pentostatin.

Fludara is used for:

Treating patients with certain types of leukemia who have not responded to other therapy or whose disease has progressed during treatment with other medicines. It may also be used for other conditions as determined by your doctor.

Fludara is an antimetabolite. It works by preventing the cancer cell from reproducing, which results in death of the cell.

Do NOT use Fludara if:

• you are allergic to any ingredient in Fludara


• you are taking pentostatin


• you have severely decreased kidney function

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fludara:

Some medical conditions may interact with Fludara. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of bone marrow problems (eg, low blood platelet levels, anemia), blood or bleeding problems, kidney problems, immune system problems, nervous system problems, infections, skin cancer, autoimmune hemolytic anemia, or a positive Coombs test


• if you receive other chemotherapy, radiation therapy, or you have received radiation or chemotherapy in the past


• if you have developed an autoimmune reaction (eg, hemolytic anemia) after receiving Fludara


• if you will be having a blood transfusion

Some MEDICINES MAY INTERACT with Fludara. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Pentostatin because the risk of fatal lung problems may be increased


• Digoxin because its effectiveness may be decreased by Fludara

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fludara may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fludara:

Use Fludara as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fludara is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Fludara at home, a health care provider will teach you how to use it. Be sure you understand how to use Fludara. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Avoid contact with skin and mucous membranes (eg, mouth, nose). If Fludara accidentally spills on your skin, wash it off immediately with soap and water. If it gets in your eyes, rinse thoroughly with plain tap water.


• Do not use Fludara if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• If you miss a dose of Fludara, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Fludara.

Important safety information:

• Fludara may cause drowsiness, dizziness, tiredness, weakness, vision problems, confusion, agitation, or seizures. Some of these effects may be worse if you use it with alcohol or certain medicines. Use Fludara with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.


• Fludara may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Fludara may lower the ability of your body to fight infection and may increase the risk of severe and sometimes fatal infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Do not receive a live vaccine (eg, measles, mumps) during or after treatment with Fludara. Talk with your doctor before you receive any vaccine.


• New or worsening skin cancer has been reported with Fludara. Tell your doctor if you have a history of skin cancer. Contact your doctor right away if you notice a change in the appearance of a mole, new growth on the skin, or any unusual skin change.


• Serious bone marrow problems (myelodysplastic syndrome [MDS]) and a type of leukemia (acute myeloid leukemia [AML]) have been reported with Fludara. Most reports were in patients who had also been treated with certain other chemotherapy medicines or radiation. Tell your doctor if you have ever received other chemotherapy or radiation treatments. Contact your doctor if you have questions about this information.


• A severe and possibly fatal nervous system problem (progressive multifocal leukoencephalopathy [PML]) has been reported in patients who use Fludara. This has been reported to develop between a few weeks and as long as about 1 year after starting treatment. Many of these patients were also taking other chemotherapy or had received other chemotherapy in the past. Contact your doctor right away if you develop signs of PML, such as trouble walking or talking, confusion, vision problems, or vision loss.


• Men who may father a child and women who may become pregnant must use an effective form of birth control (eg, condoms) while using Fludara and for 6 months after stopping treatment. If you have questions about effective birth control, talk with your doctor.


• Fludara may cause infertility in men that is sometimes permanent. Discuss any questions or concerns with your doctor.


• Lab tests, including complete blood cell counts, may be performed while you use Fludara. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Fludara with caution in the ELDERLY; they may be more sensitive to its effects.


• Fludara should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Fludara has been shown to cause harm to the fetus. Avoid becoming pregnant while you use it and for 6 months after you stop treatment. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fludara while you are pregnant. It is not known if Fludara is found in breast milk. Do not breast-feed while using Fludara.

Possible side effects of Fludara:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; general body discomfort; loss of appetite; muscle pain; nausea; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; black, tarry, or bloody stools; bloody or dark urine; changes in strength or the way you walk; chest pain; confusion; coughing or vomiting blood; difficult, decreased, or painful urination; fainting; hearing loss; irregular heartbeat; lower back or side pain; mental or mood changes (eg, agitation); muscle weakness or cramps; numbness or tingling in the hands or feet; red, swollen, blistered, or peeling skin; seizures; severe or persistent tiredness or weakness; shortness of breath; signs of infection (eg, fever, chills, cough, or sore throat); skin changes; swelling of the fingers, hands, or feet; swelling or sores of the mouth, lips, or tongue; unusual bruising or bleeding; vision changes or blindness; vomit that looks like coffee grounds; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Fludara side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bleeding; blindness; coma; infection.

Proper storage of Fludara:

Fludara is usually handled and stored by a health care provider. If you are using Fludara at home, store Fludara as directed by your pharmacist or health care provider. Keep Fludara out of the reach of children and away from pets.

General information:

• If you have any questions about Fludara, please talk with your doctor, pharmacist, or other health care provider.


• Fludara is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fludara. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Fludara resources

• Fludara Side Effects (in more detail)
• Fludara Use in Pregnancy & Breastfeeding
• Fludara Drug Interactions
• Fludara Support Group
• 1 Review for Fludara - Add your own review/rating

• Fludara Prescribing Information (FDA)


• Fludara Monograph (AHFS DI)


• Fludara Advanced Consumer (Micromedex) - Includes Dosage Information


• Fludarabine Prescribing Information (FDA)


• fludarabine Advanced Consumer (Micromedex) - Includes Dosage Information


• Oforta Prescribing Information (FDA)


• Oforta Consumer Overview

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itraconazole

it-ra-KON-a-zole

Oral route(Capsule)

Itraconazole capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. If signs or symptoms of CHF occur during administration of itraconazole capsules, discontinue administration. Coadministration of cisapride, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl) with itraconazole is contraindicated. Itraconazole, a potent CYP3A4 inhibitor, may increase plasma concentrations of drugs metabolized by this pathway. Serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death have occurred in patients using cisapride, pimozide, levacetylmethadol (levomethadyl), or quinidine concomitantly with itraconazole and/or other CYP3A4 inhibitors .

Oral route(Solution)

If signs or symptoms of congestive heart failure occur during administration of itraconazole, continued itraconazole use should be reassessed. Coadministration of cisapride, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl) with itraconazole is contraindicated. Itraconazole, a potent CYP3A4 inhibitor, may increase plasma concentrations of drugs metabolized by this pathway. Serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death have occurred in patients using cisapride, pimozide, levacetylmethadol (levomethadyl), or quinidine concomitantly with itraconazole and/or other CYP3A4 inhibitors .

Commonly used brand name(s)

In the U.S.

• Sporanox

Available Dosage Forms:

• Solution


• Capsule

Therapeutic Class: Antifungal

Chemical Class: Triazole

Uses For itraconazole

Itraconazole is used to treat serious fungal or yeast infections, such as oropharyngeal candidiasis (thrush, oral thrush), esophageal candidiasis (candida esophagitis), blastomycosis (Gilchrist’s disease), aspergillosis (fungal infection in the lungs), histoplasmosis (Darling’s disease), or onychomycosis (fungal infection in the fingernails or toenails). itraconazole works by killing the fungus or yeast and preventing its growth.

itraconazole is available only with your doctor's prescription.

Before Using itraconazole

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For itraconazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to itraconazole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of itraconazole have not been performed in the pediatric population. Safety and efficacy have not been established. However, pediatric-specific problems that would limit the usefulness of itraconazole in children are not expected.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of itraconazole in the elderly. However, elderly patients are more likely to have temporary or permanent hearing loss, which may require caution in patients receiving itraconazole.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking itraconazole, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using itraconazole with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin


• Alprazolam


• Astemizole


• Cisapride


• Colchicine


• Conivaptan


• Dihydroergotamine


• Dofetilide


• Dronedarone


• Eplerenone


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Levomethadyl


• Lovastatin


• Methylergonovine


• Methysergide


• Midazolam


• Nisoldipine


• Pimozide


• Quinidine


• Ranolazine


• Silodosin


• Simvastatin


• Terfenadine


• Tolvaptan


• Triazolam

Using itraconazole with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone


• Aliskiren


• Amiodarone


• Aprepitant


• Atorvastatin


• Boceprevir


• Brentuximab Vedotin


• Bretylium


• Cabazitaxel


• Cerivastatin


• Clozapine


• Crizotinib


• Cyclosporine


• Dasatinib


• Diazepam


• Digoxin


• Disopyramide


• Docetaxel


• Efavirenz


• Erythromycin


• Etravirine


• Everolimus


• Fentanyl


• Fluticasone


• Halofantrine


• Ibutilide


• Iloperidone


• Isoniazid


• Ixabepilone


• Lapatinib


• Nevirapine


• Nilotinib


• Oxycodone


• Pazopanib


• Repaglinide


• Rifabutin


• Rifampin


• Rivaroxaban


• Romidepsin


• Ruxolitinib


• Salmeterol


• Sirolimus


• Sotalol


• Sunitinib


• Tacrolimus


• Tadalafil


• Tamsulosin


• Temsirolimus


• Ticagrelor


• Toremifene


• Vemurafenib


• Venlafaxine


• Vinblastine


• Vincamine


• Vincristine


• Vincristine Liposome


• Vindesine


• Vinorelbine

Using itraconazole with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Alfentanil


• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Amlodipine


• Anisindione


• Betamethasone


• Bexarotene


• Bortezomib


• Budesonide


• Buspirone


• Busulfan


• Calcium


• Cinacalcet


• Ciprofloxacin


• Clarithromycin


• Conjugated Estrogens


• Corticotropin


• Cosyntropin


• Dexamethasone


• Dicumarol


• Didanosine


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Esterified Estrogens


• Estradiol


• Estriol


• Estrone


• Estropipate


• Famotidine


• Felodipine


• Fesoterodine


• Fludrocortisone


• Fosphenytoin


• Gefitinib


• Hydrocortisone


• Indinavir


• Isradipine


• Loperamide


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Meloxicam


• Methadone


• Methylprednisolone


• Micafungin


• Nicardipine


• Nifedipine


• Nimodipine


• Pantoprazole


• Phenobarbital


• Phenprocoumon


• Phenytoin


• Prednisolone


• Prednisone


• Rabeprazole


• Ranitidine


• Ranitidine Bismuth Citrate


• Rifapentine


• Risperidone


• Ritonavir


• Rosuvastatin


• Saquinavir


• Sildenafil


• Sodium Bicarbonate


• Telithromycin


• Tolterodine


• Trazodone


• Triamcinolone


• Trimetrexate


• Vardenafil


• Verapamil


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using itraconazole with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use itraconazole, or give you special instructions about the use of food, alcohol, or tobacco.

• food


• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of itraconazole. Make sure you tell your doctor if you have any other medical problems, especially:

• Chronic obstructive pulmonary disease (COPD), history of or


• Congestive heart failure, history of or


• Heart problems (e.g., heart attack history, valve problem), history of or


• Kidney disease, history of—Use with caution. May increase the risk for side effects.

• Cystic fibrosis or


• Hypochlorhydria (low level of acid in the stomach)—Absorption from the stomach may change.

• Liver disease—Use with caution. The effects of itraconazole may be increased because of slower removal from the body.

• Liver disease, severe—Use with caution. May make this condition worse.

Proper Use of itraconazole

Itraconazole oral solution works differently than itraconazole capsules, even at the same dose (number of milligrams). Do not switch from the capsules to the oral solution unless your doctor tells you to.

Keep using itraconazole for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

itraconazole comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Talk with your doctor if you have any questions.

Itraconazole capsules should be taken with a full meal. The oral solution is best taken on an empty stomach.

Measure the oral solution with a marked measuring spoon or medicine cup. If you have thrush in the mouth or throat, place 10 milliliters (mL) of the liquid in your mouth, swish it in the mouth for several seconds, and then swallow it. Repeat these steps if your total dose is more than 10 mL. If you do not have oral thrush, the liquid should be swallowed without swishing as a single dose.

If you are using antacids (e.g., Maalox®, Mylanta®, Pepcid® Complete, Rolaids®, or Tums®), take the antacid at least 1 hour before or 2 hours after taking itraconazole.

Dosing

The dose of itraconazole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of itraconazole. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  • For aspergillosis:
    
    • Adults—200 to 400 milligrams (mg) per day, given as a single dose once a day or divided in two doses.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For blastomycosis or histoplasmosis:
    
    • Adults—200 milligrams (mg) once a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 400 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For onychomycosis of the fingernails:
    
    • Adults—200 milligrams (mg) two times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For onychomycosis of the toenails:
    
    • Adults—200 milligrams (mg) once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (solution):
  
  • For esophageal candidiasis:
    
    • Adults—At first, 100 milligrams (mg) or 10 milliliters (mL) once a day. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For serious fungal infections:
    
    • Adults—200 milligrams (mg) or 20 milliliters (mL) two times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oropharyngeal candidiasis:
    
    • Adults—200 milligrams (mg) or 20 milliliters (mL) once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of itraconazole, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using itraconazole

It is very important that your doctor check your progress at regular visits to make sure that itraconazole is working properly and to check for unwanted effects.

If your symptoms do not improve, or if they become worse, check with your doctor. You may need to take itraconazole for several weeks or months before your infection gets better.

Stop using itraconazole and check with your doctor right away if you are having chest pain; decreased urine output; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; tightness in the chest; troubled breathing; weight gain; or wheezing. These could be symptoms of a side effect called congestive heart failure.

Itraconazole should not be taken with cisapride (Propulsid®), dofetilide (Tikosyn™), oral midazolam (Versed®), nisoldipine (Sular®), pimozide (Orap®), quinidine (Quinaglute®), triazolam (Halcion®), or levomethadyl (Orlaam®). You should not use itraconazole if you are also using lovastatin (Mevacor®), simvastatin (Zocor®), or an ergot medicine such as dihydroergotamine (Migranal®), ergometrine or ergonovine (Ergotrate Maleate®), ergotamine (Ergomar®), or methylergometrine or methylergonovine (Methergine®). Doing so may increase the risk of serious side effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Make sure your doctor knows if you are pregnant or planning to get pregnant before you start using itraconazole for a fingernail or toenail infection. The oral capsule should not be used to treat onychomycosis in pregnant women or those who are planning to get pregnant. Use an effective form of birth control while you are using itraconazole and for 2 months after you stop using it. If you think you have become pregnant while using the medicine, tell your doctor right away.

Liver problems may occur while you are taking itraconazole. Check with your doctor right away if you are having more than one of these symptoms: stomach pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Stop using itraconazole and call your doctor right away if your skin feels like it is burning, crawling, itching, or if you have numbness, prickling, "pins and needles", or a tingling feeling after taking itraconazole.

Temporary or permanent hearing loss may occur while you are taking itraconazole. Stop using itraconazole and check with your doctor right away if you have any changes in your hearing.

itraconazole Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Convulsions


• decreased urine


• dry mouth


• fever


• increased thirst


• irregular heartbeat


• loss of appetite


• mood changes


• muscle pain or cramps


• nausea or vomiting


• numbness or tingling in the hands, feet, or lips


• shortness of breath


• unusual tiredness or weakness

Less common

• Abdominal or stomach cramps


• abdominal or stomach pain


• blurred vision


• chest pain


• chills


• clay-colored stools


• cloudy urine


• cold sweats


• confusion


• cough


• dark urine


• decrease in urine output or decrease in urine-concentrating ability


• diarrhea


• difficult or labored breathing


• dizziness


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• drowsiness


• feeling unusually cold


• headache


• itching


• large amount of triglyceride in the blood


• light-colored stools


• mental changes


• muscle cramps in the hands, arms, feet, legs, or face


• muscle spasms (tetany) or twitching


• nervousness


• noisy, rattling breathing


• numbness and tingling around the mouth or fingertips


• pounding in the ears


• rash


• seizures


• shivering


• slow, fast, or pounding heartbeat or pulse


• sneezing


• sore throat


• sweating


• swelling of the fingers, hands, feet, or lower legs


• tightness in the chest


• trembling


• troubled breathing at rest


• unpleasant breath odor


• vomiting of blood


• weight gain


• wheezing


• yellow eyes or skin

Rare

• Abdominal or stomach tenderness


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating or swelling of the face, arms, hands, lower legs, or feet


• blood in the urine or stools


• blue lips and fingernails


• burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings


• continuing ringing or buzzing or other unexplained noise in the ears


• coughing that sometimes produces a pink frothy sputum


• cracks in the skin


• decreased appetite


• difficulty swallowing


• dilated neck veins


• disturbed color perception


• double vision


• extreme fatigue


• fast or irregular breathing


• feeling of discomfort


• general feeling of tiredness or weakness


• halos around lights


• hearing loss


• hives or welts


• increased sweating


• inflammation of the joints


• joint pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• loss of heat from the body


• loss of vision


• lower back or side pain


• night blindness


• overbright appearance of lights


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rapid weight gain


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• scaly skin


• sores, ulcers, or white spots on the lips or in the mouth


• stomach pain, continuing


• swollen lymph glands


• tingling of the hands or feet


• tunnel vision


• unsteadiness or awkwardness


• unusual bleeding or bruising


• unusual weight gain or loss


• upper right abdominal pain


• weakness in the arms, hands, legs, or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Decreased interest in sexual intercourse


• difficulty having a bowel movement (stool)


• difficulty in moving


• discouragement


• feeling of constant movement of self or surroundings


• feeling sad or empty


• inability to have or keep an erection


• indigestion


• irritability


• loss in sexual ability, desire, drive, or performance


• loss of interest or pleasure


• muscle aching or stiffness


• pain or tenderness around eyes and cheekbones


• passing of gas


• sensation of spinning


• sleepiness or unusual drowsiness


• soreness of the skin


• stomach fullness or discomfort


• stuffy or runny nose


• swollen joints


• tiredness


• trouble concentrating


• trouble sleeping

Rare

• Acid or sour stomach


• belching


• change in taste


• hair loss or thinning of the hair


• heartburn


• increased need to urinate


• increased sensitivity of the eyes to sunlight


• increased sensitivity of the skin to sunlight


• loss of bladder control


• loss of taste


• menstrual changes


• passing urine more often


• redness or other discoloration of the skin


• severe sunburn


• stomach fullness, discomfort, or upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: itraconazole side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More itraconazole resources

• Itraconazole Side Effects (in more detail)
• Itraconazole Use in Pregnancy & Breastfeeding
• Drug Images
• Itraconazole Drug Interactions
• Itraconazole Support Group
• 11 Reviews for Itraconazole - Add your own review/rating

• Itraconazole Prescribing Information (FDA)


• Itraconazole Professional Patient Advice (Wolters Kluwer)


• Itraconazole Monograph (AHFS DI)


• Itraconazole MedFacts Consumer Leaflet (Wolters Kluwer)


• Sporanox Consumer Overview


• Sporanox Prescribing Information (FDA)


• Sporanox PulsePak MedFacts Consumer Leaflet (Wolters Kluwer)

Compare itraconazole with other medications

• Aspergillosis, Aspergilloma
• Blastomycosis
• Candida Infections, Systemic
• Candida Urinary Tract Infection
• Coccidioidomycosis
• Cryptococcosis
• Dermatophytosis
• Esophageal Candidiasis
• Febrile Neutropenia
• Histoplasmosis
• Onychomycosis, Fingernail
• Onychomycosis, Toenail
• Oral Thrush
• Paracoccidioidomycosis
• Sporotrichosis
• Tinea Capitis
• Tinea Versicolor
• Vaginal Yeast Infection