Friday, 27 April 2012

ControlRx Toothpaste





Dosage Form: oral paste, dentifrice
ControlRx™

1.1% Sodium Fluoride Prescription Toothpaste

DESCRIPTION:


ControlRx dentifrice is a prescription formulation for use in the prevention of dental caries. This formulation contains 1.1% sodium fluoride in a neutral pH base and a mild abrasive to help remove dental plaque, debris and stain.



ACTIVE INGREDIENT: Sodium Fluoride 1.1% w/w.



INACTIVE INGREDIENTS: Water, Sorbitol, Hydrated Silica, Glycerin, MICRODENT® 2.0% w/w - a patented ULTRAMULSION® of Dimethicone and Poloxamer 407, PEG 12, Flavor, Cellulose Gum, Sodium Lauryl Sulfate, Titanium Dioxide, Sodium Saccharin.



CLINICAL PHARMACOLOGY:


The use of higher-concentration fluoride products results in greater reductions in the incidence of dental caries. ControlRx dentifrice provides enhanced remineralization of demineralized enamel and enhanced protection against subsequent acid challenges, relative to over the counter fluoride products.



INDICATIONS AND USAGE:


ControlRx dentifrice is indicated for use as part of a professional program for the prevention and control of dental caries. ControlRx dentifrice is applied to the teeth using a toothbrush. ControlRx dentifrice should be used once daily in place of a conventional toothpaste, unless otherwise instructed by a dental professional.



CONTRAINDICATIONS:


Do not use in children less than 6 years of age unless recommended by a dental professional.



WARNINGS:


Do not swallow. Keep out of reach of children. Frequent ingestion may result in dental fluorosis in children less than 6 years of age, especially if community water fluoridation exceeds 0.6 ppm fluoride ion. Use in children less than 6 years of age requires special supervision to prevent swallowing. Carefully read all instructions before using this product.



ADVERSE REACTIONS:


Allergic reactions and other idiosyncrasies have been rarely reported.



OVERDOSAGE:


Medical attention should be sought if more than a thin ribbon or pea-sized amount is accidentally swallowed. A thin ribbon or pea-sized amount of ControlRx dentifrice weighs approximately 0.3g and contains approximately 1.5mg of fluoride ion. A 2 oz tube contains 282mg of fluoride ion.



DOSAGE AND ADMINISTRATION:


Follow these instructions unless otherwise instructed by a dental professional. Use once daily.


Apply a thin ribbon or pea-sized amount of ControlRx dentifrice to a soft-bristled toothbrush, and brush teeth for two minutes. After brushing, adults should expectorate. Children 6 to 16 years of age should expectorate and thoroughly rinse mouth with water.



HOW SUPPLIED:


2 oz (57g) net wt. of paste in laminate tubes.



STORAGE: Do not freeze or expose to extreme heat.


Rx Only


Refreshing Berry Flavor: 2 oz tube - NDC 48878-3101-6.


MICRODENT and ULTRAMULSION are registered trademarks of Whitehill Oral Technologies, Inc.



Principal Display Panel – Box Label


3M ESPE


NDC 48878-3101-6


ControlRx™


Berry


1.1% Sodium Fluoride


5000 ppm F- Prescription ToothpasteOMNI™


Rx Only


Contents: 1 Tube


NET WT 2oz (57g)




Principal Display Panel – Tube Label


3M ESPE


NDC 48878-3101-6


ControlRx™


Berry


1.1% Sodium Fluoride


5000 ppm F- Prescription Toothpaste


Rx Only


OMNI™


NET WT


2oz (57g)










CONTROLRX 
sodium fluoride  paste, dentifrice










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)48878-3101
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium fluoride (fluoride ion)sodium fluoride11 mg  in 1 g


























Inactive Ingredients
Ingredient NameStrength
Water 
Sorbitol 
Silicon Dioxide 
Glycerin 
Dimethicone 
Poloxamer 407 
Polyethylene Glycol 
Carboxymethylcellulose Sodium 
Sodium Lauryl Sulfate 
Titanium Dioxide 
Saccharin Sodium 


















Product Characteristics
Color    Score    
ShapeSize
FlavorBERRY (BERRY)Imprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
148878-3101-61 TUBE In 1 BOXcontains a TUBE
157 g In 1 TUBEThis package is contained within the BOX (48878-3101-6)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/2005


Labeler - 3M ESPE Dental Products (799975909)
Revised: 05/20103M ESPE Dental Products




More ControlRx Toothpaste resources


  • ControlRx Toothpaste Use in Pregnancy & Breastfeeding
  • ControlRx Toothpaste Support Group
  • 3 Reviews for ControlRx Toothpaste - Add your own review/rating


Compare ControlRx Toothpaste with other medications


  • Prevention of Dental Caries

Lumitene


Generic Name: beta carotene (Oral route)


bay-ta KAR-oh-teen


Commonly used brand name(s)

In the U.S.


  • A-Caro-25

  • Lumitene

Available Dosage Forms:


  • Capsule

  • Capsule, Liquid Filled

  • Liquid

  • Tablet

Therapeutic Class: Nutritive Agent


Pharmacologic Class: Vitamin A (class)


Uses For Lumitene


Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Beta-carotene is converted in the body to vitamin A, which is necessary for healthy eyes and skin.


A lack of vitamin A may cause a rare condition called night blindness (problems seeing in the dark). It may also cause dry eyes, eye infections, skin problems, and slowed growth. Your health care professional may treat these problems by prescribing either beta-carotene, which your body can change into vitamin A, or vitamin A for you.


Some conditions may increase your need for vitamin A. These include:


  • Cystic fibrosis

  • Diarrhea, continuing

  • Illness, long-term

  • Injury, serious

  • Liver disease

  • Malabsorption problems

  • Pancreas disease

Increased need for vitamin A should be determined by your health care professional.


Claims that beta-carotene is effective as a sunscreen have not been proven. Although beta-carotene supplements are being studied for their ability to reduce the risk of certain types of cancer and possibly heart disease, there is not enough information to show that this is effective.


Beta-carotene may be used to treat other conditions as determined by your doctor.


Beta-carotene is available without a prescription.


Once a product has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, beta-carotene is used in certain patients with the following medical conditions:


  • Polymorphous light eruption (a type of reaction to sun)

  • Erythropoietic protoporphyria photosensitivity reaction (a type of reaction to sun)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.


Importance of Diet


For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.


It is documented that people who consume diets high in fruits and vegetables have a reduced risk of heart disease and certain cancers. Fruits and vegetables are rich in beta-carotene and other nutrients that may be beneficial.


Beta-carotene is found in carrots; dark-green leafy vegetables, such as spinach and green leaf lettuce; sweet potatoes; broccoli; cantaloupe; and winter squash. The body converts beta-carotene into vitamin A. Ordinary cooking does not destroy beta-carotene.


Vitamins alone will not take the place of a good diet and will not provide energy. Your body needs other substances found in food, such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, some fat is needed so that beta-carotene can be absorbed into the body.


Before Using Lumitene


If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, 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


Problems in children have not been documented with intake of normal daily recommended amounts.


Geriatric


Problems in older adults have not been documented with intake of normal daily recommended amounts.


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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


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 dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:


  • Eating disorders or

  • Kidney disease or

  • Liver disease—These conditions may cause high blood levels of beta-carotene, which may increase the chance of side effects

Proper Use of beta carotene

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


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 use as a dietary supplement:


  • For oral dosage forms (capsules or chewable tablets):
    • Adults and teenagers: 6 to 15 milligrams (mg) of beta-carotene (the equivalent of 10,000 to 25,000 Units of vitamin A activity) per day.

    • Children: 3 to 6 mg of beta-carotene (the equivalent of 5,000 to 10,000 Units of vitamin A activity) per day.


For other uses:


  • For oral dosage forms (capsules or tablets):
    • To treat or prevent a reaction to sun in patients with erythropoietic protoporphyria:
      • Adults and teenagers—30 to 300 milligrams (mg) of beta-carotene (the equivalent of 50,000 to 500,000 Units of vitamin A activity) a day.

      • Children—30 to 150 mg of beta-carotene (the equivalent of 50,000 to 250,000 Units of vitamin A activity) a day.


    • To treat or prevent a reaction to sun in patients with polymorphous light eruption:
      • Adults and teenagers—75 to 180 mg of beta-carotene (the equivalent of 125,000 to 300,000 Units of vitamin A activity) a day.

      • Children—30 to 150 mg of beta-carotene (the equivalent of 50,000 to 250,000 Units of vitamin A activity) a day.



If you have high blood levels of vitamin A, your body will convert less beta-carotene to vitamin A.


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.


If you miss taking a vitamin for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins. However, if your health care professional has recommended that you take this vitamin, try to remember to take it as directed every day.


If you miss a dose and you are using it as 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. Do not refrigerate. Keep from freezing.


Store the dietary supplement 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.


Precautions While Using Lumitene


Use of beta-carotene has been associated with an increased risk of lung cancer in people who smoke or who have been exposed to asbestos. One study of 29,000 male smokers found an 18% increase in lung cancer in the group receiving 20 mg of beta-carotene a day for 5 to 8 years. Another study of 18,000 people found 28% more lung cancers in people with a history of smoking and/or asbestos exposure. These people took 30 mg of beta-carotene in addition to 25,000 Units of retinol (a form of vitamin A) a day for 4 years. However, one study of 22,000 male physicians, some of them smokers or former smokers, found no increase in lung cancer. These people took 50 mg of beta-carotene every other day for 12 years. If you smoke or have a history of smoking or asbestos exposure, you should not take large amounts of beta-carotene supplements for long periods of time. However, foods that are rich in beta-carotene are considered safe and appear to lower the risk of some types of cancer and possibly heart disease.


Lumitene 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.


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
  • Yellowing of palms, hands, or soles of feet, and to a lesser extent the face (this may be a sign that your dose of beta-carotene as a nutritional supplement is too high)

Rare
  • Diarrhea

  • dizziness

  • joint pain

  • unusual bleeding or bruising

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: Lumitene 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 Lumitene resources


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


Compare Lumitene with other medications


  • Vitamin A Deficiency

Coughtuss


Generic Name: chlorpheniramine, hydrocodone, and phenylephrine (KLOR fe NEER a meen, HYE droe KOE done, FEN il EFF rin)

Brand Names: B-Tuss, Coughtuss, Cytuss HC, De-Chlor HC, DroTuss-CP, Ed-TLC, Ed-Tuss HC, Endal-HD Plus, H-C Tussive, Histussin-HC, Hydro-PC II, Hydro-PC II Plus, Hydron CP, Liquicough HC, Maxi-Tuss HCX, Mintuss MS, Neo HC, Poly-Tussin, Poly-Tussin HD, Relacon-HC, Relacon-HC NR, Relasin-HC, Rindal HD Plus, Rindal-HD, Triant-HC, Tusana-D, Z-Cof HC


What is Coughtuss (chlorpheniramine, hydrocodone, and phenylephrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


Hydrocodone is a narcotic cough medicine.


Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of chlorpheniramine, hydrocodone, and phenylephrine is used to treat runny or stuffy nose, sinus congestion, and cough caused by the common cold or flu.


Chlorpheniramine, hydrocodone, and phenylephrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Coughtuss (chlorpheniramine, hydrocodone, and phenylephrine)?


Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use chlorpheniramine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body. Chlorpheniramine, hydrocodone, and phenylephrine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine, hydrocodone, and phenylephrine. Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, hydrocodone, and phenylephrine. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

What should I discuss with my healthcare provider before taking Coughtuss (chlorpheniramine, hydrocodone, and phenylephrine)?


Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use chlorpheniramine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body. You should not use chlorpheniramine, hydrocodone, and phenylephrine if you are allergic to it.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:



  • asthma, COPD, sleep apnea, or other breathing disorder;



  • liver or kidney disease;


  • heart disease or high blood pressure;




  • diabetes;




  • a thyroid disorder;




  • curvature of the spine;




  • a history of head injury or brain tumor;




  • epilepsy or other seizure disorder;




  • low blood pressure;




  • glaucoma;




  • gallbladder disease;




  • Addison's disease or other adrenal gland disorders;




  • enlarged prostate, urination problems;




  • mental illness; or




  • a history of drug or alcohol addiction.




Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether chlorpheniramine, hydrocodone, and phenylephrine will harm an unborn baby. Hydrocodone may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using chlorpheniramine, hydrocodone, and phenylephrine. It is not known whether chlorpheniramine, hydrocodone, and phenylephrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Coughtuss (chlorpheniramine, hydrocodone, and phenylephrine)?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


You may take this medication with or without food.


Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydrocodone can be fatal.

Overdose symptoms may include extreme drowsiness, feeling restless or nervous, vomiting, stomach pain, warmth or tingly feeling, seizure (convulsions), pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.


What should I avoid while taking Coughtuss (chlorpheniramine, hydrocodone, and phenylephrine)?


Chlorpheniramine, hydrocodone, and phenylephrine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine, hydrocodone, and phenylephrine.

Coughtuss (chlorpheniramine, hydrocodone, and phenylephrine) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • severe dizziness, anxiety, restless feeling, or nervousness;




  • fast, pounding, or uneven heartbeats;




  • shallow breathing, slow heartbeat;




  • confusion, hallucinations, unusual thoughts or behavior;




  • feeling like you might pass out;




  • urinating less than usual or not at all;




  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, seizure); or




  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects may include:



  • nausea, vomiting, upset stomach, constipation;




  • dry mouth;




  • blurred vision;




  • dizziness, drowsiness;




  • problems with memory or concentration;




  • sleep problems (insomnia);




  • ringing in your ears;




  • warmth, tingling, or redness under your skin; or




  • skin rash or itching.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Coughtuss (chlorpheniramine, hydrocodone, and phenylephrine)?


Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, hydrocodone, and phenylephrine.

Tell your doctor about all other medications you use, especially:



  • blood pressure medication;




  • cimetidine (Tagamet);




  • rifampin (Rifadin, Rifater, Rifamate, Rimactane);




  • zidovudine (Retrovir, AZT);




  • an antidepressant;




  • a diuretic (water pill);




  • medication to treat irritable bowel syndrome;




  • bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);




  • aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);




  • seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);




  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or




  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril).



This list is not complete and other drugs may interact with chlorpheniramine, hydrocodone, and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Coughtuss resources


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


  • Chlorpheniramine/Hydrocodone/Phenylephrine Liquid MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Coughtuss with other medications


  • Cough and Nasal Congestion


Where can I get more information?


  • Your pharmacist can provide more information about chlorpheniramine, hydrocodone, and phenylephrine.

See also: Coughtuss side effects (in more detail)


Wednesday, 25 April 2012

Zalcitabine


Pronunciation: zal-SITE-ah-been
Generic Name: Zalcitabine
Brand Name: Hivid

Zalcitabine may infrequently cause severe side effects, which could be fatal. Zalcitabine can cause severe nerve problems (peripheral neuropathy), and should be used with extreme caution in those who already suffer from this disorder. It may rarely cause swelling of the pancreas (pancreatitis). Tell your doctor immediately if vomiting, stomach/abdominal pain, or persistent nausea occur, as Zalcitabine may need to be stopped until you can be checked. Severe and sometimes fatal lactic acidosis or severe liver disease may also occur. Rarely, fatal liver failure has occurred in those with hepatitis B infection while using Zalcitabine. Zalcitabine should be used with caution if you have a hepatitis B infection. Tell your doctor immediately if tingling/numbness of the hands and feet, dark urine, yellowing of eyes/skin, rapid breathing, muscle aches, or unusual drowsiness occurs.





Zalcitabine is used for:

Treating HIV infection. It is used in combination with other medicines.


Zalcitabine in a nucleoside reverse transcriptase inhibitor. It works by blocking the growth of HIV.


Do NOT use Zalcitabine if:


  • you are allergic to any ingredient in Zalcitabine

  • you have lactic acidosis (a metabolic disorder) or certain liver problems (eg, enlarged liver, liver steatosis, abnormal liver function tests)

  • you are taking lamivudine or didanosine

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



Before using Zalcitabine:


Some medical conditions may interact with Zalcitabine. 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 nervous system disease (eg, peripheral neuropathy); a history of liver disease, including hepatitis B; kidney problems; diabetes; heart problems (eg, cardiomyopathy, congestive heart failure); AIDS; high triglyceride levels; or inflammation of the pancreas

  • if you have had unusual weight loss, are very overweight, have certain abnormal blood levels (eg, increased serum amylase, very low CD4 cell count), or if you regularly consume alcoholic beverages

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


  • Pentamidine or zidovudine because side effects, such as increased risk of swelling or irritation of the pancreas, may occur

  • Lamivudine because effectiveness of Zalcitabine may be decreased

  • Chloramphenicol, cisplatin, dapsone, disulfiram, ethionamide, glutethimide, gold-based medicines (eg, gold sodium thiomalate), other nucleoside analogs (eg, didanosine), phenytoin, ribavirin, vincristine, hydralazine, iodoquinol, isoniazid, metronidazole, or nitrofurantoin because risk of severe nerve problems may be increased

  • Aminoglycosides (eg, gentamicin), amphotericin, cimetidine, magnesium or aluminum-containing antacids, or probenecid because risk of side effects or toxic effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zalcitabine 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 Zalcitabine:


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


  • Take Zalcitabine on an empty stomach at least 1 hour before or 2 hours after eating.

  • Zalcitabine must be taken with other medicines that treat HIV infection to be effective.

  • Do not take Zalcitabine at the same time you take antacids containing magnesium or aluminum.

  • Continue to use Zalcitabine even if you feel well. Do not miss any doses.

  • If you miss a dose of Zalcitabine, take it as soon as you remember. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. It is important not to miss doses of Zalcitabine. Do not take 2 doses at once.

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



Important safety information:


  • Do not exceed the recommended dose without checking with your doctor. Exceeding the prescribed dose of Zalcitabine may not provide additional benefits, and may increase the risk of side effects.

  • When your medicine supply begins to run low, get more from your doctor or pharmacy as soon as possible. The virus may develop resistance to Zalcitabine if you stop taking it, even for a short period of time, and may become harder to treat.

  • If you experience numbness, tingling, or pain in the hands or feet, report these symptoms to your health care provider. Parents should closely watch their children for these symptoms if they are taking this medication. Inform your health care provider if your child has ever experienced any of these symptoms.

  • Contact your health care provider if severe nausea, vomiting, or stomach pain occurs.

  • Zalcitabine is not a cure for HIV infection and patients may continue to acquire illnesses/infections associated with HIV infection. Remain under the care of your health care provider.

  • Zalcitabine offers no protection from the transmission of HIV to others through sexual contact or blood contamination. Use barrier forms of contraception (eg, condoms) if you are infected with HIV.

  • Changes in body fat may occur while you are taking Zalcitabine (eg, increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

  • LAB TESTS will be performed to monitor your progress. Be sure to keep all doctor and lab appointments.

  • Use an effective form of birth control while taking Zalcitabine.

  • PREGNANCY AND BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Zalcitabine during pregnancy. It is unknown if Zalcitabine is excreted in breast milk. HIV-infected mothers should not breast-feed their infants because of the risk of transmitting the HIV infection or Zalcitabine to the baby.


Possible side effects of Zalcitabine:


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:



Constipation; diarrhea; fatigue; headache; itching; loss of appetite; nausea; shift in body fat to stomach and upper back; tiredness.



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); convulsions; fast, shallow breathing; feeling cold; heart problems; lactic acid imbalance (slow or irregular heartbeat; dizziness; lightheadedness); liver inflammation (liver tenderness; weakness; fatigue); numbness, tingling, burning, or sharp shooting pains in arms, hands, legs, and feet; pain on swallowing; persistent or severe nausea; severe muscle pain or cramping; sores in mouth or throat; stomach pain; swelling of the hands or feet; vomiting; weakness or exhaustion.



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: Zalcitabine 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 (http://www.aapcc.org ), or emergency room immediately.


Proper storage of Zalcitabine:

Store tablets at room temperature, 59 to 86 degrees F (15 to 30 degrees C), in a tightly-closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zalcitabine out of the reach of children and away from pets.


General information:


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

  • Zalcitabine 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 Zalcitabine. 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 Zalcitabine resources


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


  • Zalcitabine Monograph (AHFS DI)

  • zalcitabine Advanced Consumer (Micromedex) - Includes Dosage Information

  • zalcitabine Concise Consumer Information (Cerner Multum)

  • Hivid Prescribing Information (FDA)



Compare Zalcitabine with other medications


  • HIV Infection

Tuesday, 24 April 2012

Cetirizine Syrup


Pronunciation: se-TIR-i-zeen
Generic Name: Cetirizine
Brand Name: Zyrtec


Cetirizine Syrup is used for:

Preventing or treating symptoms of hay fever and other upper respiratory allergies such as stuffy nose, runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes. It is also used for preventing or treating chronic hives. It may also be used for other conditions as determined by your doctor.


Cetirizine Syrup is an antihistamine. It works by blocking the action of histamine, which reduces the symptoms of an allergic reaction.


Do NOT use Cetirizine Syrup if:


  • you are allergic to any ingredient in Cetirizine Syrup or to hydroxyzine

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



Before using Cetirizine Syrup:


Some medical conditions may interact with Cetirizine Syrup. 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 kidney or liver problems, or you are receiving dialysis

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


Theophylline because it may increase the risk of Cetirizine Syrup's side effects


How to use Cetirizine Syrup:


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


  • Take Cetirizine Syrup by mouth with or without food.

  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • If you miss a dose of Cetirizine Syrup, 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 Cetirizine Syrup.



Important safety information:


  • Cetirizine Syrup may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Cetirizine Syrup 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 Cetirizine Syrup; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

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

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

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

  • Caution is advised when using Cetirizine Syrup in CHILDREN; they may be more sensitive to its effects, especially stomach pain and trouble sleeping.

  • Cetirizine Syrup should be used with extreme caution in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: It is not known if Cetirizine Syrup can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cetirizine Syrup while you are pregnant. Cetirizine Syrup is found in breast milk. Do not breast-feed while taking Cetirizine Syrup.


Possible side effects of Cetirizine Syrup:


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:



Drowsiness; dry mouth; stomach pain (in children); tiredness; trouble sleeping (in children).



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; unusual hoarseness); dark urine; fainting; fast or irregular heartbeat; mental or mood changes; persistent fatigue; seizures; severe dizziness; unusual bruising or bleeding; yellowing of 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: Cetirizine 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 irritability; restlessness; severe drowsiness.


Proper storage of Cetirizine Syrup:

Store Cetirizine Syrup at 77 degrees F ( 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Cetirizine Syrup may be refrigerated at 36 to 46 degrees F (2 to 8 degrees C). Do not store in the bathroom. Keep Cetirizine Syrup out of the reach of children and away from pets.


General information:


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

  • Cetirizine Syrup 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 Cetirizine Syrup. 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 Cetirizine resources


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


Compare Cetirizine with other medications


  • Hay Fever
  • Urticaria

Monday, 23 April 2012

Exterol 5% w / w Ear Drops, Solution





1. Name Of The Medicinal Product



EXTEROL™ 5% w/w EAR DROPS, SOLUTION


2. Qualitative And Quantitative Composition



Urea Hydrogen Peroxide 5.0% w/w.



3. Pharmaceutical Form



Ear drops, solution.



Clear, straw-coloured, viscous ear drops.



4. Clinical Particulars



4.1 Therapeutic Indications



As an aid in the removal of hardened ear wax.



4.2 Posology And Method Of Administration



For adults, children and the elderly: Instil up to 5 drops into the ear. Retain drops in ear for several minutes by keeping the head tilted and then wipe away any surplus. Repeat once or twice daily for at least 3 to 4 days, or as required.



4.3 Contraindications



Do not use if the eardrum is known or suspected to be damaged, in cases of dizziness, or if there is any other ear disorder (such as pain, discharge, inflammation, infection or tinnitus). Do not use after ill-advised attempts to dislodge wax using fingernails, cotton buds or similar implements, as such mechanical efforts can cause the ear's delicate inner lining to become damaged, inflamed or infected, whereupon the use of ear drops can be painful. For similar reasons, it is inadvisable to use Exterol within 2 to 3 days of syringing. Do not use where there is a history of ear problems, unless under close medical supervision. Do not use if sensitive to any of the ingredients.



4.4 Special Warnings And Precautions For Use



Keep Exterol away from the eyes. For external use only. Replace cap after use, and return bottle to carton.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Exterol should not be used at the same time as anything else in the ear.



4.6 Pregnancy And Lactation



No known side-effects.



4.7 Effects On Ability To Drive And Use Machines



None known.



4.8 Undesirable Effects



Due to the release of oxygen, patients may experience a mild, temporary effervescence in the ear. Stop usage if irritation or pain occurs. Instillation of ear drops can aggravate the painful symptoms of excessive ear wax, including some loss of hearing, dizziness and tinnitus. Very rarely, unpleasant taste has been reported. If patients encounter any of these problems, or if their symptoms persist or worsen, they should discontinue treatment and consult a doctor.



4.9 Overdose



No adverse effects.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



After insertion of the drops into the ear, the urea hydrogen peroxide complex liberates oxygen which acts to break up the hardened wax. The hydrogen peroxide component is also an antiseptic, especially in sites with relative anaerobiosis. The glycerol assists in softening the wax, so that it may more easily be removed from the ear, either with or without syringing. The urea acts as a mild keratolytic, helping to reduce the keratin-load in the wax debris, thereby assisting penetration of the other components.



5.2 Pharmacokinetic Properties



Exterol is intended only for the treatment of impacted wax in the external auditory canal. The ingredients of the formulation are therefore readily available for intimate contact with the affected area, as the drops are instilled into the ear and retained therein for several minutes by tilting the head.



5.3 Preclinical Safety Data



No special information.



6. Pharmaceutical Particulars



6.1 List Of Excipients



8-Hydroxyquinoline; Glycerol.



6.2 Incompatibilities



None known.



6.3 Shelf Life



24 months. Discard 4 weeks after first opening.



6.4 Special Precautions For Storage



Store upright. Do not store above 25°C. Replace cap after use.



6.5 Nature And Contents Of Container



8 ml easy squeeze plastic dropper bottle with screw cap. This is supplied as an original pack (OP).



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



7. Marketing Authorisation Holder



Dermal Laboratories



Tatmore Place, Gosmore



Hitchin, Herts SG4 7QR, UK.



8. Marketing Authorisation Number(S)



00173/0037.



9. Date Of First Authorisation/Renewal Of The Authorisation



28 January 2007.



10. Date Of Revision Of The Text



July 2010.




Wednesday, 18 April 2012

Proamatine


Generic Name: midodrine (Oral route)

MYE-doe-dreen

Oral route(Tablet)

Can cause marked elevation of supine blood pressure and should be used only in patients whose lives are considerably impaired despite standard clinical care .



Commonly used brand name(s)

In the U.S.


  • Orvaten

  • Proamatine

Available Dosage Forms:


  • Tablet

Therapeutic Class: Vasopressor


Pharmacologic Class: Alpha-Adrenergic Agonist


Uses For Proamatine


Midodrine is used to treat low blood pressure (hypotension). It works by stimulating nerve endings in blood vessels, causing the blood vessels to tighten. As a result, blood pressure is increased.


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


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in product labeling, midodrine is used in certain patients with the following medical conditions:


  • Low blood pressure (hypotension) caused by kidney dialysis.

  • Low blood pressure caused by certain medicines used to treat mental illness.

  • Low blood pressure in children with an infection.

Before Using Proamatine


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


This medicine has been tested in a limited number of children 6 months to 12 years of age. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.


Geriatric


This medicine has been tested and has not been shown to cause different side effects or problems in older people than it dose in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal 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 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Dihydroergotamine

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.


  • Amitriptyline

  • Amoxapine

  • Clomipramine

  • Desipramine

  • Deslanoside

  • Digitoxin

  • Dothiepin

  • Doxepin

  • Ephedrine

  • Imipramine

  • Lofepramine

  • Nortriptyline

  • Opipramol

  • Phenylephrine

  • Phenylpropanolamine

  • Protriptyline

  • Pseudoephedrine

  • Trimipramine

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.


  • Perphenazine

  • Promethazine

  • Risperidone

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:


  • Heart disease, severe or

  • Hypertension (high blood pressure) or

  • Overactive thyroid or

  • Visual problems—Effects of midodrine on blood pressure may aggravate these problems.

  • Kidney disease or

  • Liver disease—The effects of midodrine may be increased because of slower removal of the medicine from the body.

  • Urinary retention—Effects of midodrine on the bladder may aggravate this condition.

Proper Use of midodrine

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


The last dose of midodrine should not be taken after the evening meal or less than 3 to 4 hours before bedtime because high blood pressure upon lying down (supine hypertension) can occur, which can cause blurred vision, headaches, and pounding in the ears while lying down after taking this medicine.


Also, midodrine should not be taken if you will be lying down for any length of time.


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 (tablets):
    • For low blood pressure:
      • Adults—10 milligrams (mg) three times a day in approximately 4-hour intervals during daytime hours: shortly before or upon rising in the morning, at midday, and in the late afternoon (not later than 6 p.m.). Your doctor may increase your dose if needed.

      • Children—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


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 Proamatine


Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hayfever, or sinus problems, since they may tend to increase your blood pressure.


Proamatine 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
  • Blurred vision

  • cardiac awareness

  • headache

  • pounding in the ears

Rare
  • Fainting

  • increased dizziness

  • slow pulse

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
  • Burning, itching, or prickling of the scalp

  • chills

  • goosebumps

  • urinary frequency, retention, or urgency

Less common
  • Anxiety or nervousness

  • confusion

  • dry mouth

  • flushing

  • headache or feeling of pressure in the head

  • skin rash

Rare
  • Backache

  • canker sores

  • dizziness

  • drowsiness

  • dry skin

  • leg cramps

  • pain or sensitivity of the skin to touch

  • stomach problems such as gas, heartburn, or nausea

  • trouble seeing

  • trouble with sleeping

  • weakness

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: Proamatine 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 Proamatine resources


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


  • Midodrine Prescribing Information (FDA)

  • Midodrine Hydrochloride Monograph (AHFS DI)

  • ProAmatine Prescribing Information (FDA)

  • ProAmatine Concise Consumer Information (Cerner Multum)

  • ProAmatine MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Proamatine with other medications


  • Dysautonomia
  • Hypotension
  • Postural Orthostatic Tachycardia Syndrome

Quinidine Gluconate Controlled-Release Tablets


Pronunciation: KWIN-ih-deen
Generic Name: Quinidine Gluconate
Brand Name: Generic only. No brands available.

Quinidine Gluconate Controlled-Release Tablets are associated with an increased risk of death when used to treat non-life-threatening irregular heartbeat. This risk may be greater if you have structural heart disease. Talk with your doctor for more information.





Quinidine Gluconate Controlled-Release Tablets are used for:

Treating and preventing abnormal heart rhythms.


Quinidine Gluconate Controlled-Release Tablets are an antiarrhythmic. It works by stabilizing the heart rhythm in conditions in which the heart is beating too fast or in an irregular rhythm (antiarrhythmic effect).


Do NOT use Quinidine Gluconate Controlled-Release Tablets if:


  • you are allergic to any ingredient in Quinidine Gluconate Controlled-Release Tablets

  • you have certain severe, uncontrolled abnormal heart rhythms or muscle weakness due to myasthenia gravis, or you have previously developed unusual bruising while using Quinidine Gluconate Controlled-Release Tablets or similar medications

  • you are currently taking astemizole, codeine, cisapride, a class III antiarrhythmic (eg, amiodarone), grepafloxacin, an H1 antagonist (eg, diphenhydramine), itraconazole, a ketolide (eg, telithromycin), a macrolide (eg, erythromycin), a nondepolarizing muscle relaxant (eg, pancuronium), a phenothiazine (eg, chlorpromazine), a phosphodiesterase type 5 inhibitor (eg, sildenafil), pimozide, a quinolone (eg, ciprofloxacin), ritonavir, sparfloxacin, succinylcholine, terfenadine, voriconazole, or medicine for myasthenia gravis

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



Before using Quinidine Gluconate Controlled-Release Tablets:


Some medical conditions may interact with Quinidine Gluconate Controlled-Release Tablets. 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 liver or kidney disease; congestive heart failure, a history of heart block, QT prolongation, or other heart problems; low blood pressure; high or low blood calcium levels; decreased blood platelets; or digitalis intoxication

Some MEDICINES MAY INTERACT with Quinidine Gluconate Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), nifedipine, or rifampin because the effectiveness of Quinidine Gluconate Controlled-Release Tablets may be decreased

  • Amiloride, amiodarone, carbonic anhydrase inhibitors (eg, acetazolamide), cimetidine, itraconazole, ketoconazole, thiazide diuretics (eg, hydrochlorothiazide), verapamil, or voriconazole because side effects, such as increased risk of low blood pressure or heart conduction disturbances and racing heart rate, dizziness, or fainting, may occur

  • Arsenic, cisapride, class III antiarrhythmics (eg, amiodarone), dofetilide, droperidol, H1 antagonists (eg, diphenhydramine), haloperidol, HIV protease inhibitors (eg, indinavir), ketolides (eg, telithromycin), macrolides (eg, erythromycin), phenothiazines (eg, chlorpromazine), phosphodiesterase type 5 inhibitors (eg, sildenafil), pimozide, quinolones, streptogramins (eg, pristinamycin), or ziprasidone because the actions and side effects of Quinidine Gluconate Controlled-Release Tablets and these medicines may be increased

  • Anticoagulants (eg, warfarin), aripiprazole, beta-adrenergic blockers (eg, metoprolol), digitoxin, digoxin, nondepolarizing muscle relaxants (eg, pancuronium), norepinephrine reuptake inhibitors (eg, atomoxetine), procainamide, propafenone, or succinylcholine because the actions or side effects of these medicines may be increased

  • Anticholinesterases (eg, pyridostigmine) or narcotic analgesics (eg, codeine) because the effectiveness of these medicines may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Quinidine Gluconate Controlled-Release Tablets 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 Quinidine Gluconate Controlled-Release Tablets:


Use Quinidine Gluconate Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Quinidine Gluconate Controlled-Release Tablets may be taken with or without food. Take Quinidine Gluconate Controlled-Release Tablets with a full glass of water.

  • Swallow whole. Do not crush or chew before swallowing.

  • Do not lie down for 30 minutes after taking Quinidine Gluconate Controlled-Release Tablets.

  • Do not drink grapefruit juice or eat grapefruit while taking Quinidine Gluconate Controlled-Release Tablets.

  • Use Quinidine Gluconate Controlled-Release Tablets on a regular schedule around the clock, unless otherwise directed by your doctor.

  • If you miss a dose of Quinidine Gluconate Controlled-Release Tablets, take it as soon as possible. If it is almost time for our 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 Quinidine Gluconate Controlled-Release Tablets.



Important safety information:


  • Quinidine Gluconate Controlled-Release Tablets may cause dizziness or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Quinidine Gluconate Controlled-Release Tablets.

  • Quinidine Gluconate Controlled-Release Tablets may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Quinidine Gluconate Controlled-Release Tablets. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

  • Do not suddenly stop taking Quinidine Gluconate Controlled-Release Tablets without checking with your doctor.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Quinidine Gluconate Controlled-Release Tablets.

  • LAB TESTS may be performed to check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Quinidine Gluconate Controlled-Release Tablets with extreme caution in CHILDREN; safety and effectiveness have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Quinidine Gluconate Controlled-Release Tablets during pregnancy. Quinidine Gluconate Controlled-Release Tablets are excreted in breast milk. Do not breast-feed while you are taking Quinidine Gluconate Controlled-Release Tablets.


Possible side effects of Quinidine Gluconate Controlled-Release Tablets:


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; diarrhea; heartburn; nausea; stomach discomfort; vomiting.



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); dark urine; deafness; dizziness; fainting; fast or slow heartbeat; headache; hearing loss; irregular heartbeat; lightheadedness; liver toxicity; pale stools; psychotic reactions; ringing in ears; yellowing of the skin or eyes.



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: Quinidine Gluconate 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 diarrhea; disturbed vision; fainting; fast or slow heartbeat; low blood pressure; ringing in the ears; trouble breathing; trouble walking.


Proper storage of Quinidine Gluconate Controlled-Release Tablets:

Store between 59 and 86 degrees F (15 and 30 degrees C). Keep Quinidine Gluconate Controlled-Release Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Quinidine Gluconate Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Quinidine Gluconate Controlled-Release Tablets are 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 Quinidine Gluconate Controlled-Release Tablets. 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 Quinidine Gluconate resources


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


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Drug List:

Sunday, 8 April 2012

Dioctyl 100 mg Capsules





1. Name Of The Medicinal Product



Dioctyl Capsules.



DulcoEase 100mg Capsules


2. Qualitative And Quantitative Composition



Docusate sodium 100 mg.



For excipients, see Section 6.1.



3. Pharmaceutical Form



Capsules



A two colour (opaque white and opaque yellow) soft, oval, gelatin capsule with a clear, colourless liquid fill.



4. Clinical Particulars



4.1 Therapeutic Indications



a) To prevent and treat chronic constipation.



(i) to soften hard, dry stools in order to ease defaecation and reduce straining at stool; and



(ii) in the presence of haemorrhoids and anal fissure, to prevent hard, dry stools and reduce straining.



b) As an adjunct in abdominal radiological procedures.



4.2 Posology And Method Of Administration



Route of administration: Oral



Adults and elderly:



Up to 500 mg should be taken daily in divided doses. Treatment should be commenced with large doses, which should be decreased as the condition of the patient improves.



For use with barium meals:



400 mg to be taken with the meal.



Children under 12 years:



Not recommended.



4.3 Contraindications



These capsules should not be administered when abdominal pain, nausea, vomiting or intestinal obstruction is present.



This product should not be given to patients with a known hypersensitivity to Dioctyl capsules or any of the components.



Patients with rare hereditary problems of fructose intolerance should not take this medicine.



4.4 Special Warnings And Precautions For Use



Organic disorders should be excluded prior to the administration of any laxative.



The treatment of constipation with any medicinal product is only adjuvant to a healthy lifestyle and diet, for example:



• Increased intake of fluids and dietary fibre.



• Advice on appropriate physical activity



If laxatives are needed every day, or if there is persistent abdominal pain, consult your doctor.



Contains sorbitol: do not use this medicine if you are intolerant to small quantities of sugar (sorbitol, fructose).



Contains colouring E110 which may cause allergic reactions.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



These capsules should not be taken concurrently with mineral oil.



4.6 Pregnancy And Lactation



There are no adequate data from the use of the drug in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryonic foetal development. The potential risk for humans is unknown. During wide use, no adverse consequences have been reported.



Use in pregnancy only if the benefits outweigh the risks.



Docusate sodium is excreted in breast milk and should therefore, be used with caution in lactating mothers.



4.7 Effects On Ability To Drive And Use Machines



None known



4.8 Undesirable Effects



Rarely, these capsules can cause diarrhoea, nausea, abdominal cramps or skin rash.



4.9 Overdose



In rare cases of overdose, excessive loss of water and electrolytes should be treated by encouraging the patient to drink plenty of fluid. Electrolyte loss should be replenished where appropriate.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



ATC code: A06A02 Laxatives, softeners, emollients



Docusate sodium is an anionic wetting agent, which acts as a faecal softener by lowering the surface tension and allowing penetration of accumulated hard dry faeces by water and salts.



Docusate Sodium also possesses stimulant activity.



5.2 Pharmacokinetic Properties



Docusate sodium exerts its clinical effect in the gastrointestinal tract. There is some evidence that docusate sodium is absorbed and is excreted in the bile. There is also evidence that docusate sodium is capable of enhancing absorption of certain compounds administered concomitantly.



5.3 Preclinical Safety Data



None stated



6. Pharmaceutical Particulars



6.1 List Of Excipients



Macrogol 400



Propylene glycol



Gelatin 195 bloom



Purified water



Sorbitol special



Glycerol



Titanium dioxide E171



Quinoline yellow E104



Sunset yellow E110



6.2 Incompatibilities



None



6.3 Shelf Life



PVC/PVdC blister packs with aluminium foil: 18 months



Polyethylene / polypropylene containers: 24 months



6.4 Special Precautions For Storage



Do not store above 25ÂșC. Store in the original package in order to protect from moisture.



6.5 Nature And Contents Of Container



PVC/PVdC blister packs with aluminium foil containing 10, 20, 30, 40 or 50 capsules.



Polyethylene / polypropylene containers, e.g.: securitainers / tampertainers containing 30, 100 and 250 capsules.



Not all pack sizes may be marketed.



6.6 Special Precautions For Disposal And Other Handling



None



7. Marketing Authorisation Holder



UCB Pharma Limited



208 Bath Road



Slough



Berkshire



SL1 3WE



United Kingdom



8. Marketing Authorisation Number(S)



PL 00039/0737



9. Date Of First Authorisation/Renewal Of The Authorisation



28 February 2008 / 17 June 2010



10. Date Of Revision Of The Text



August 2010