Tums Chewable Tablets

Pronunciation: KAL-see-um KAR-bo-nate
Generic Name: Calcium Carbonate
Brand Name: Examples include Tums and Tums Kids

Tums Chewable Tablets are used for:

Treating heartburn, sour stomach, acid indigestion, and upset stomach caused by these conditions. It is also used to treat or prevent calcium deficiency. It may also be used for other conditions as determined by your doctor.

Tums Chewable Tablets are an antacid. It works by neutralizing acid in the stomach. It also works to treat or prevent calcium deficiency by providing extra calcium to the body.

Do NOT use Tums Chewable Tablets if:

• you are allergic to any ingredient in Tums Chewable Tablets


• you have high blood calcium levels

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

Before using Tums Chewable Tablets:

Some medical conditions may interact with Tums Chewable 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 high blood phosphate levels or high calcium levels


• if you have appendicitis, heart problems, parathyroid problems, hardening of the arteries, kidney problems, kidney stones, stomach or bowel problems (eg, blockage of your bowel, stomach bleeding), or inflammatory problems (eg, sarcoidosis)


• if you take digoxin or if you are dehydrated

Some MEDICINES MAY INTERACT with Tums Chewable Tablets. Tell your health care provider if you are taking any other medicines.

Ask your health care provider if Tums Chewable 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 Tums Chewable Tablets:

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

• Take Tums Chewable Tablets by mouth with or without food.


• Chew Tums Chewable Tablets well before you swallow it.


• If you take an azole antifungal (eg, ketoconazole), a bisphosphonate (eg, alendronate), certain cephalosporins (eg, cefpodoxime), iron, mycophenolate, a quinolone antibiotic (eg, ciprofloxacin), a cation exchange resin (eg, sodium polystyrene sulfonate), a tetracycline antibiotic (eg, doxycycline), or a thyroid hormone, ask your doctor or pharmacist how to take them with Tums Chewable Tablets.


• If you miss a dose of Tums Chewable Tablets, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Tums Chewable Tablets.

Important safety information:

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


• This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.


• Different brands of Tums Chewable Tablets may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tums Chewable Tablets while you are pregnant. It is not known if Tums Chewable Tablets are found in breast milk. If you are or will be breast-feeding while you use Tums Chewable Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Tums Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Tums Chewable Tablets. 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).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

See also: Tums 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.

Proper storage of Tums Chewable Tablets:

Store Tums Chewable Tablets at room temperature, below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tums Chewable Tablets out of the reach of children and away from pets.

General information:

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


• Tums Chewable 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 Tums Chewable 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 Tums resources

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

Compare Tums with other medications

• Duodenal Ulcer
• Erosive Esophagitis
• GERD
• Indigestion
• Stomach Ulcer

Mysoline

Generic Name: Primidone
Class: Barbiturates
VA Class: CN400
Chemical Name: 5-ethyldihydro-5-phenyl-4,6(1H, 5H)-pyrimidinedione
CAS Number: 125-33-7

REMS:

FDA approved a REMS for primidone to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Anticonvulsant; a structural analog of phenobarbital; related to barbiturate-derivative anticonvulsants.^{a b c d}

Uses for Mysoline

Used alone or with other anticonvulsants (e.g., phenytoin, phenobarbital); ^{a c d} however, some clinicians do not recommend concurrent use of primidone and phenobarbital because of possible increased sedation.^a

Generalized Seizures

Prophylactic management of tonic-clonic (grand mal) seizures, particularly those refractory to other anticonvulsant therapy.^{a c d}

Prophylactic management of other partial seizures (e.g., those with autonomic symptoms), including atonic (also known as akinetic) seizures.^{a b}

Partial Seizures

Prophylactic management of partial seizures with complex symptomatology (psychomotor seizures).^{a c d}

Prophylactic management of other partial seizures, including focal seizures.^{a b c d}

Mysoline Dosage and Administration

General

• 
  

  Closely monitor patients receiving anticonvulsant therapy for notable changes in behavior that could indicate emergence or worsening of suicidal thoughts or behavior or depression.^{d g h i} (See Suicidality Risk under Cautions.)

  
  


• 
  

  When primidone therapy is discontinued, withdraw the drug slowly to avoid precipitating seizures or status epilepticus.^{a b c d}

  
  


• 
  

  When a patient is transferred to primidone from another anticonvulsant, gradually increase primidone dosage over a period of at least 2 weeks while gradually decreasing dosage of the other anticonvulsant, to maintain adequate seizure control.^{a c}

  
  

Administration

Oral Administration

Administer orally.^{a c d}

Dosage

Adjust dosage carefully according to individual requirements and response.^{a c d} In some cases, determination of blood concentrations of the drug may be needed to achieve optimal dosage adjustment.^{c d}

May require several weeks of therapy before therapeutic efficacy can be assessed.^{c d}

Pediatric Patients

Generalized and Partial Seizures

Oral

Anticonvulsant-naive children <8 years of age: Initially, 50 mg at bedtime (days 1–3), increase to 50 mg twice daily (days 4–6), then increase to 100 mg twice daily (days 7–9).^{a c d} Follow with a maintenance dosage of 125–250 mg 3 times daily or 10–25 mg/kg daily given in divided doses.^{a c d} Alternatively, some clinicians recommend 1.25 g/m² daily in 2–4 divided doses.^a

Anticonvulsant-naive children ≥8 years of age: Initially, 100–125 mg at bedtime (days 1–3), increase to 100–125 mg twice daily (days 4–6), then increase to 100–125 mg 3 times daily (days 7–9).^{a c d} Follow with a maintenance dosage of 250 mg 3 or 4 times daily.^{a c d} Do not exceed 500 mg 4 times daily.^{a c d}

Children ≥8 years of age receiving other anticonvulsants: Initially, 100–125 mg (primidone) at bedtime; increase dosage (primidone) slowly to maintenance level while gradually decreasing dosage of other anticonvulsant.^{c d} Continue this regimen until satisfactory dosage achieved with the combination, or the other drug is withdrawn.^{c d} If primidone monotherapy is the objective, gradually increase primidone dosage while decreasing dosage of the drug being discontinued over a period of at least 2 weeks.^{a c d}

Adults

Generalized and Partial Seizures

Oral

Anticonvulsant therapy-naive adults: Initially, 100–125 mg at bedtime (days 1–3), increase to 100–125 mg twice daily (days 4–6), then increase to 100–125 mg 3 times daily (days 7–9).^{a c d} Follow with a maintenance dosage of 250 mg 3 or 4 times daily.^{a c d} Do not exceed 500 mg 4 times daily.^{a c d}

Adults receiving other anticonvulsants: Initially, 100–125 mg (primidone) at bedtime; increase dosage (primidone) slowly to maintenance level while gradually decreasing dosage of other anticonvulsant.^{c d} Continue this regimen until satisfactory dosage is achieved with the combination, or the other drug is withdrawn.^{c d} If primidone monotherapy is the objective, gradually increase primidone dosage while decreasing dosage of the drug being discontinued over a period of at least 2 weeks.^{a c d}

Prescribing Limits

Pediatric Patients

Generalized and Partial Seizures

Oral

Children ≥8 years of age: Maximum 2 g daily given in divided doses (e.g., 500 mg 4 times daily).^{a c d}

Adults

Generalized and Partial Seizures

Oral

Maximum 2 g daily given in divided doses (e.g., 500 mg 4 times daily).^{a c d}

Special Populations

No special population dosage recommendations at this time.^{c d}

Cautions for Mysoline

Contraindications

• 
  

  Porphyria.^{c d}

  
  


• 
  

  Known hypersensitivity to phenobarbital.^{c d}

  
  

Warnings/Precautions

Warnings

Shares the toxic potentials of the barbiturate-derivative anticonvulsants; observe the usual precautions of anticonvulsant therapy.^a

Suicidality Risk

Increased risk of suicidality (suicidal ideation or behavior) observed in an analysis of studies using various anticonvulsants in patients with epilepsy, psychiatric disorders (e.g., bipolar disorder, depression, anxiety), and other conditions (e.g., migraine, neuropathic pain); risk in patients receiving anticonvulsants (0.43%) was approximately twice that in patients receiving placebo (0.24%).^{d g h i j} Increased suicidality risk was observed ≥1 week after initiation of anticonvulsant therapy and continued through 24 weeks.^{d g h j} Risk was higher for patients with epilepsy compared with those receiving anticonvulsants for other conditions.^{d g h j}

Closely monitor all patients currently receiving or beginning anticonvulsant therapy for changes in behavior that may indicate emergence or worsening of suicidal thoughts or behavior or depression.^{d g h i j} Anxiety, agitation, hostility, hypomania, and mania may be precursors to emerging suicidality.^g

Balance risk of suicidality with the risk of untreated illness.^{d g} Epilepsy and other illnesses treated with anticonvulsants are themselves associated with morbidity and mortality and an increased risk of suicidality.^{d g} If suicidal thoughts or behavior emerge during anticonvulsant therapy, consider whether these symptoms may be related to the illness itself.^{d i} (See Advice to Patients.)

Withdrawal Effects

Abrupt withdrawal may result in increased seizure frequency or status epilepticus.^{a b c d}

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.^{c d}

Reports suggest an association between use of anticonvulsants in pregnant, epileptic women and an increased incidence of birth defects in children born to these women; however, causal relationship to many anticonvulsants not established.^{c d f}

Neurologic manifestations (overactivity, tumors) reported in neonates whose mothers received primidone during pregnancy.^f

Do not discontinue anticonvulsants in pregnant women in whom the drugs are administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.^{c d}

Carefully weigh these considerations when treating or counseling epileptic women of childbearing potential.^{c d}

Neonatal hemorrhage (with a coagulation defect resembling vitamin K deficiency) reported in newborns whose mothers were receiving primidone during pregnancy.^{b c d f} Administer prophylactic vitamin K to pregnant women taking primidone for one month prior to and during delivery.^{b c d} Additionally, administer vitamin K to the neonate immediately after birth.^{b f}

General Precautions

Laboratory Monitoring

Perform baseline CBC and a sequential multiple analysis-12 (SMA-12) test every 6 months during primidone therapy.^{a c d}

Hematologic Effects

Granulocytopenia, agranulocytosis, red-cell hypoplasia and aplasia rarely reported; may require discontinuance of primidone.^{c d}

Megaloblastic anemia may occur as a rare idiosyncrasy.^{c d} Administer folic acid.^{c d}

Specific Populations

Pregnancy

Category D.^f Safety during pregnancy not established.^{a c d} (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

North American Antiepileptic Drug (NAAED) Pregnancy Registry at 888-233-2334 (for patients); registry information also available on the website .^d

Lactation

Distributed into milk.^{a c d f} Discontinue nursing or drug if excessive somnolence or drowsiness is observed in nursing infants of women receiving the drug.^{a c d}

Pediatric Use

Safety and efficacy established in pediatric patients.^{c d}

Possible paradoxical excitement and hyperactivity or an exacerbation of existing hyperactivity in children.^b

Geriatric Use

Possible excitement, confusion, or depression.^b

Common Adverse Effects

Drowsiness, ataxia, vertigo, lethargy, anorexia, nausea, vomiting.^{a c d}

Interactions for Mysoline

Specific Drugs

Drug	Interaction	Comments
Contraceptives (oral)	Possible increased metabolism of both the estrogenic and progestinic components of oral contraceptivesb	Consider alternate methods of contraceptionb
Phenobarbital	Possible increased sedationa b	Use with caution,a if at all b
Phenytoin	Possible increase in amount of primidone converted to phenobarbital and increased sedationb
Valproic acid	Increased plasma phenobarbital concentrations and excessive somnolenceb	Observe patient for possible neurologic toxicity and monitor plasma concentrations of phenobarbital; decrease dosage of primidone if neededb

Mysoline Pharmacokinetics

Absorption

Bioavailability

Approximately 60–80% absorbed from GI tract.^a

Onset

Following oral administration, peak serum concentrations are reached in about 4 hours.^a

Plasma Concentrations

Limited data indicate that serum primidone concentrations should be maintained at 5–12 mcg/mL to adequately control seizures and minimize risk of adverse effects.^{a c d}

Distribution

Extent

Distributed into milk in substantial quantities.^{a c d}

Elimination

Metabolism

Slowly metabolized by the liver.^a Approximately 15–25% of an oral dose metabolized to phenobarbital.^a

Elimination Route

Slowly excreted in urine as phenylethylmalonamide (PEMA), phenobarbital, and p-hydroxyphenobarbital.^a

During chronic therapy, approximately 15–25% excreted in urine unchanged and approximately 50–70% excreted as PEMA.^a

Half-life

Primidone: One manufacturer stated 21 hours; other clinicians suggested 10–12 hours.^a

PEMA: 24–48 hours.^a

Special Populations

Removed by hemodialysis.^a

Stability

Storage

Oral

Tablets

Tight, light-resistant containers at 20–25°C.^{c d}

Actions

• 
  

  Shares the actions of barbiturate-derivative anticonvulsants and has sedative properties similar to phenobarbital.^a

  
  


• 
  

  Exact mechanism of antiepileptic action is unknown; primidone and its metabolites (phenobarbital and PEMA) have anticonvulsant activity.^{c d}

  
  


• 
  

  Effective in subhypnotic doses.^a

  
  

Advice to Patients

• 
  

  Risk of suicidality (anticonvulsants may increase risk of suicidal thoughts or actions in about 1 in 500 people).^{d g h i j} Importance of patients, family, and caregivers being alert to day-to-day changes in mood, behavior, and actions and immediately informing clinician of any new or worrisome behaviors (e.g., talking or thinking about wanting to hurt oneself or end one’s life, withdrawing from friends and family, becoming depressed or experiencing worsening of existing depression, becoming preoccupied with death and dying, giving away prized possessions).^{d g h j}

  
  


• 
  

  Importance of informing patients that several weeks of therapy may be required before therapeutic efficacy can be assessed.^{c d}

  
  


• 
  

  Importance of informing patients not to stop primidone therapy abruptly; may precipitate seizures or status epilepticus.^{a b c d}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products, as well as any concomitant illnesses.^c

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed; advise pregnant women of possible risk to fetus.^{a d f} Importance of clinicians informing women about the existence of and encouraging enrollment in pregnancy registries (see Pregnancy under Cautions).^d

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{c d} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Primidone

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	50 mg*	Mysoline (scored)	Valeant
			Primidone Tablets
		250 mg*	Mysoline (scored)	Valeant
			Primidone Tablets

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Mysoline 250MG Tablets (VALEANT): 30/$209.99 or 90/$602.66

Mysoline 50MG Tablets (VALEANT): 90/$194.24 or 270/$551.20

Primidone 250MG Tablets (AMNEAL PHARMACEUTICALS): 90/$69.99 or 270/$191.98

Primidone 50MG Tablets (LANNETT): 90/$39.99 or 270/$109.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2007. McEvoy GK, ed. Primidone. Bethesda, MD: American Society of Health-System Pharmacists; 2008.

b. AHFS drug information 2007. McEvoy GK, ed. Anticonvulsants General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2254-8.

c. Mutual Pharmaceuticals. Primidone tablets prescribing information. Philadelphia, PA; 2006 Nov.

d. Valeant Pharmaceuticals North America. Mysoline (primidone) tablets prescribing information. Aliso Viejo, CA; 2009 May.

e. Food and Drug Administration. Drugs or vaccines used in registries for specific diseases. From the FDA web site. Rockville, MD; Undated. Accessed 2008 Mar 20.

f. Primidone. In: Briggs GG, Freeman RK, Yaffe SJ. Drug in pregnancy and lactation: a reference guide to fetal and neonatal risk. 8th ed. Philadelphia: Lippincott Williams & Wilkins; 2008;1525-8.

g. US Food and Drug Administration. Information for healthcare professionals: suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA web site.

h. US Food and Drug Administration. FDA News: FDA alerts health care providers to risk of suicidal thoughts and behavior with antiepileptic medications. Rockville, MD; 2008 Jan 31. From the FDA website.

i. US Food and Drug Administration. Suicidal behavior and ideation and antiepileptic drugs: update 5/5/2009. Rockville, MD; 2009 May 5. From the FDA website. Accessed 2009 Oct 21.

j. US Food and Drug Administration. FDA Alert: Suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA website.

More Mysoline resources

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

• Mysoline Prescribing Information (FDA)


• Mysoline MedFacts Consumer Leaflet (Wolters Kluwer)


• Mysoline Concise Consumer Information (Cerner Multum)


• Mysoline Advanced Consumer (Micromedex) - Includes Dosage Information


• Primidone Prescribing Information (FDA)


• Primidone Professional Patient Advice (Wolters Kluwer)

Compare Mysoline with other medications

• Seizures

Lipram

Generic Name: pancrelipase (oral) (pan kre LYE pace)

Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancrelipase may also be used following surgical removal of the pancreas.

Pancrelipase may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

• kidney disease;


• 
  

  gout;

  
  


• 
  

  a history of blockage in your intestines;

  
  


• 
  

  a sudden onset of pancreatitis; or

  
  


• 
  

  worsening of chronic pancreatic disease.

  
  

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase 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 pancrelipase?

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.

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F.

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.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pancrelipase 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. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

• 
  

  nausea or vomiting;

  
  


• 
  

  mild stomach pain or upset;

  
  


• 
  

  diarrhea or constipation;

  
  


• 
  

  bloating or gas.

  
  


• 
  

  greasy stools;

  
  


• 
  

  rectal irritation;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  cough; or

  
  


• 
  

  weight loss.

  
  

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 pancrelipase?

There may be other drugs that can interact with pancrelipase. 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 Lipram resources

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

• Pancrelipase Professional Patient Advice (Wolters Kluwer)


• Pancrelipase Prescribing Information (FDA)


• Pancrelipase Monograph (AHFS DI)


• Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer)


• Creon Prescribing Information (FDA)


• Creon Advanced Consumer (Micromedex) - Includes Dosage Information


• Creon MedFacts Consumer Leaflet (Wolters Kluwer)


• Creon Consumer Overview


• Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Dygase MedFacts Consumer Leaflet (Wolters Kluwer)


• Pancreaze Consumer Overview


• Pancreaze Prescribing Information (FDA)


• Zenpep Prescribing Information (FDA)


• Zenpep Consumer Overview

Compare Lipram with other medications

• Chronic Pancreatitis
• Cystic Fibrosis
• Pancreatic Exocrine Dysfunction

Where can I get more information?

• Your pharmacist can provide more information about pancrelipase.

See also: Lipram side effects (in more detail)

Guaifenesin Liquid

Pronunciation: gwye-FEN-eh-sin
Generic Name: Guaifenesin
Brand Name: Examples include Guaituss and Robitussin Maximum Strength

Guaifenesin Liquid is used for:

Relieving symptoms of an unproductive cough and mucus in the chest due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Guaifenesin Liquid is an expectorant. It works by thinning mucus (phlegm) in the lungs and making it less sticky and easier to cough up. This reduces chest congestion by making coughs more productive.

Do NOT use Guaifenesin Liquid if:

• you are allergic to any ingredient in Guaifenesin Liquid

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

Before using Guaifenesin Liquid:

Some medical conditions may interact with Guaifenesin Liquid. 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 chronic cough that occurs with smoking, asthma, chronic bronchitis, or emphysema, or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Guaifenesin Liquid. Tell your health care provider if you are taking any other medicines. However, no specific interactions with Guaifenesin Liquid are known at this time.

Ask your health care provider if Guaifenesin Liquid 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 Guaifenesin Liquid:

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

• Take Guaifenesin Liquid 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 this dose.


• Drinking extra fluids while you are taking Guaifenesin Liquid is recommended. Check with your doctor for instructions.


• If you miss a dose of Guaifenesin Liquid and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. 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 Guaifenesin Liquid.

Important safety information:

• If cough persists for more than 1 week or is accompanied by a fever, contact your health care provider. A persistent cough could be a sign of a serious condition.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Different brands of Guaifenesin Liquid may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Guaifenesin Liquid while pregnant. It is not known if Guaifenesin Liquid is found in breast milk. If you are or will be breast-feeding while you are using Guaifenesin Liquid, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Guaifenesin Liquid:

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:

Nausea; 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).

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: Guaifenesin 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.

Proper storage of Guaifenesin Liquid:

Store Guaifenesin Liquid 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 Guaifenesin Liquid out of the reach of children and away from pets.

General information:

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


• Guaifenesin Liquid 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 Guaifenesin Liquid. 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 Guaifenesin resources

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

Compare Guaifenesin with other medications

• Bronchitis
• Cough
• Fibromyalgia

Panadol Night

1. Name Of The Medicinal Product

Panadol Night or Panadol NightPain

2. Qualitative And Quantitative Composition

Each tablet contains Paracetamol Ph Eur 500.0 mg and Diphenhydramine hydrochloride Ph Eur 25.0 mg.

Also contains lactose monohydrate.

3. Pharmaceutical Form

Film-coated tablets

Blue film coated capsule shaped tablets embossed 'PM' on one face.

4. Clinical Particulars

4.1 Therapeutic Indications

For the short term treatment of bedtime pain, for example rheumatic and muscle pain, backache, neuralgia, toothache, migraine, headache and period pain which is causing difficulty in getting to sleep.

4.2 Posology And Method Of Administration

Oral administration only.

Do not exceed the stated dose or frequency of dosing.

Children:	Not recommended for children under 12 years of age except on medical advice.
Adults and Elderly:	2 tablets to be taken 20 minutes before bedtime. Maximum daily dose: Two tablets (1000 mg paracetamol, 50 mg diphenhydramine hydrochloride) in 24 hours. Other products containing paracetamol may be taken for daytime pain relief but at a reduced maximum dose of 6 tablets in 24 hours. The dose should not be repeated more frequently than every four hours.

Patients should not take the tablets for more than 7 consecutive nights without consulting their doctor.

4.3 Contraindications

Hypersensitivity to paracetamol, diphenhydramine hydrochloride or other constituents. Closed angle glaucoma. Porphyria. Acute asthma. Antihistamines are contraindicated in premature infants or neonates who have increased susceptibility to antimuscarinic effects.

4.4 Special Warnings And Precautions For Use

Antihistamines should be used with caution in conditions such as epilepsy, prostatic hypertrophy, glaucoma, urinary retention, pyloroduodenal obstruction, or myasthenia gravis. Care is advised in the administration to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the recommended dose.

Patients should be advised to consult their doctor if their headaches become persistent.

Patients should be advised not to take other paracetamol containing products, other products containing antihistamines, other drugs with sedating properties, or alcohol concurrently.

May cause drowsiness.

Keep out of the reach of children.

If symptoms persist for more than 7 days medical advice should be sought. Antihistamines should be used with caution in the elderly as they may be more susceptible to adverse effects, in those with severe cardiovascular disease and patients with asthma or chronic pulmonary disease.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsoprtion should not take this medicine.

Pack Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with any other paracetamol-containing products.

Patient Information Leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Diphenhydramine hydrochloride may enhance the sedative action of central nervous system depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and neuroleptics. MAOIs may enhance the antimuscarinic effects of antihistamines. Antihistamines may have an additive antimuscarinic action with other antimuscarinic drugs such as atropine and tricyclic antidepressants.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding. There is inadequate evidence for the safety of diphenhydramine hydrochloride in human pregnancy. Diphenhydramine has been detected in breast milk. Because of the higher risks of antihistamines for infants diphenhydramine is not recommended in nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised not to drive or operate machinery if affected by drowsiness.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol. Adverse effects of diphenhydramine hydrochloride may include sedation. Antimuscarinic effects include dry mouth, urinary retention, blurred vision, thickened respiratory tract secretions and chest tightness. In high doses transient bradycardia followed by tachycardia may occur. Other side effects that may occur occasionally are headache, rashes, cross sensitivity to related drugs, photosensitivity, gastrointestinal disturbance and psychomotor impairment. Blood disorders including agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia and jaundice though rare have been reported with antihistamines. Paradoxical stimulation may rarely occur especially in high doses or in children.

4.9 Overdose

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

• Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

• Regularly consumes ethanol in excess of recommended amounts.

Or

• Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

Mild cases of overdose with antihistamines are mainly characterised by prominent anticholinergic effects including dry mouth, headache, nausea, tachycardia and urinary retention. Larger overdoses will have additional antihistamine effects which may depress or stimulate the CNS. In small children, the stimulatory effects predominate and clinical features include hallucinations, ataxia and convulsions. The child may be hot, flushed and have dilated pupils. Cardiorespiratory depression and coma can subsequently develop followed by rapid death. Overdosing diphenhydramine in adults usually results in drowsiness followed by convulsions and coma. Fever and flushing are uncommon. Overdosed patients are best treated by gastric lavage and supportive measures. Administration of activated charcoal may be useful. Convulsions can be controlled with diazepam. Peripheral anticholinergic effects can be controlled with subcutaneous neostigmine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol has analgesic and antipyretic effects. It is only a weak inhibitor of prostaglandin biosynthesis, although there is some evidence to suggest that it may be more effective against enzymes in the CNS than those in the periphery. This fact may partly account for its ability to reduce fever (a central action) and to induce analgesia. Diphenhydramine is an ethanolamine class antihistamine that acts predominantly as a competitive but reversible inhibitor of histamine at the H₁ receptor sites. However, like most H₁ antihistamines it has additional sedative anticholinergic (antimuscarinic) and local anaesthetic properties.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration in plasma generally reaches a peak in 30-120 minutes; plasma half-life is 1-4 hours. Paracetamol is relatively uniformly distributed throughout most body fluids. Plasma binding is variable. Excretion is almost exclusively renal in the form of conjugates. Diphenhydramine is well absorbed from the gastrointestinal tract following oral administration. Peak plasma concentrations are achieved in 2 to 3 hours and the effects usually last 4 to 6 hours. Diphenhydramine is extensively metabolised mainly in the liver, and excreted usually as metabolites in the urine.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet cores:

Maize starch

starch pre-gelatinised

potassium sorbate

povidone

purified talc

stearic acid

Film coating:

hypromellose (E 464)

titanium dioxide (E 171)

lactose monohydrate

macrogol 400

triacetin

brilliant blue FCF (E 133)

indigo carmine (E 132)

carnauba wax.

6.2 Incompatibilities

None.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store below 25°C in a dry place.

6.5 Nature And Contents Of Container

White PVDC coated PVC (250µm) and aluminium foil (30µm) child-resistant blister packed into outer cardboard cartons, containing 10 or 20 tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

SmithKline Beecham (SWG) Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as Sterling Health

or as GlaxoSmithKline Consumer Healthcare

or as SmithKline Beecham International

Brentford

TW8 9GS

8. Marketing Authorisation Number(S)

PL 00071/0423

9. Date Of First Authorisation/Renewal Of The Authorisation

19/01/1996 / 09/06/2005

10. Date Of Revision Of The Text

11/12/2009

Prelone

Generic Name: prednisolone (Oral route)

pred-NIS-oh-lone

Commonly used brand name(s)

In the U.S.

• Bubbli-Pred


• Cotolone


• Flo-Pred


• Millipred


• Millipred DP


• Orapred


• Orapred ODT


• Pediapred


• Prelone


• Veripred 20

In Canada

• Pms-Prednisolone

Available Dosage Forms:

• Solution


• Tablet


• Syrup


• Suspension


• Liquid


• Tablet, Disintegrating

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Prelone

Prednisolone provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, eye or vision problems, lupus, skin conditions, kidney problems, ulcerative colitis, and flare-ups of multiple sclerosis. Prednisolone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.

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

Before Using Prelone

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of prednisolone in children. However, pediatric patients are more likely to have slower growth and bone problems if prednisolone is used for a long time. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prednisolone in the elderly. However, elderly patients are more likely to have age-related kidney and bone problems, which may require caution and an adjustment in the dose for elderly patients receiving prednisolone.

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

• Rotavirus Vaccine, Live

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.

• Aldesleukin


• Asparaginase


• Bupropion


• Quetiapine

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.

• Alatrofloxacin


• Alcuronium


• Amobarbital


• Aspirin


• Atracurium


• Balofloxacin


• Cinoxacin


• Ciprofloxacin


• Clinafloxacin


• Desogestrel


• Dienogest


• Drospirenone


• Enoxacin


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Fleroxacin


• Flumequine


• Fosphenytoin


• Gallamine


• Gemifloxacin


• Grepafloxacin


• Hexafluorenium


• Itraconazole


• Levofloxacin


• Levonorgestrel


• Licorice


• Lomefloxacin


• Medroxyprogesterone Acetate


• Mestranol


• Metocurine


• Moxifloxacin


• Norelgestromin


• Norethindrone


• Norfloxacin


• Norgestimate


• Norgestrel


• Ofloxacin


• Pefloxacin


• Phenytoin


• Primidone


• Prulifloxacin


• Rifampin


• Rosoxacin


• Rufloxacin


• Saiboku-To


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate


• Vecuronium

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:

• Cataracts or


• Congestive heart failure or


• Cushing's syndrome (adrenal gland problem) or


• Diabetes or


• Eye infection or


• Glaucoma or


• Hyperglycemia (high blood sugar) or


• Hypertension (high blood pressure) or


• Infection (e.g., bacterial, virus, or fungus) or


• Mood changes, including depression or


• Myasthenia gravis (severe muscle weakness) or


• Osteoporosis (weak bones) or


• Peptic ulcer, active or history of or


• Personality changes or


• Stomach or intestinal problems (e.g., diverticulitis, ulcerative colitis) or


• Tuberculosis, inactive—Use with caution. May make these conditions worse.

• Fungal infections or


• Herpes simplex eye infection—Should not be used in patients with these conditions.

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

Proper Use of prednisolone

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

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.

This medicine comes with a patient instruction insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

This medicine should be taken with food to avoid stomach irritation.

Measure the oral liquid with the special oral syringe that comes with the package. The average household teaspoon may not hold the right amount of liquid.

If you use this medicine for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.

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 (solution, suspension, syrup, tablets):
  
  • Dose depends on medical condition:
    
    • Adults—At first, 5 to 60 milligrams (mg) per day. Your doctor may adjust your dose as needed.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.14 to 2 mg per kilogram (kg) of body weight per day, divided and taken 3 or 4 times a day. Your doctor may adjust your dose as needed.
    
    
  
  

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 Prelone

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be caused by this medicine. Blood or urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

This medicine may cause you to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away. If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.

This medicine may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression; mood swings; a false or unusual sense of well-being; trouble with sleeping; or personality changes while taking this medicine.

This medicine might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly.

If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of this medicine might need to be changed for a short time while you have extra stress.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

While you are being treated with prednisolone, do not have any immunizations (vaccines) without your doctor's approval. Prednisolone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain skin tests.

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.

Prelone 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

• Aggression


• agitation


• anxiety


• blurred vision


• decrease in the amount of urine


• dizziness


• fast, slow, pounding, or irregular heartbeat or pulse


• headache


• irritability


• mental depression


• mood changes


• nervousness


• noisy, rattling breathing


• numbness or tingling in the arms or legs


• pounding in the ears


• shortness of breath


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


• trouble thinking, speaking, or walking


• troubled breathing at rest


• weight gain

Incidence not known

• Abdominal cramping and/or burning (severe)


• abdominal pain


• backache


• bloody, black, or tarry stools


• cough or hoarseness


• darkening of skin


• decrease in height


• decreased vision


• diarrhea


• dry mouth


• eye pain


• eye tearing


• facial hair growth in females


• fainting


• fatigue


• fever or chills


• flushed, dry skin


• fractures


• fruit-like breath odor


• full or round face, neck, or trunk


• heartburn and/or indigestion (severe and continuous)


• increased hunger


• increased thirst


• increased urination


• loss of appetite


• loss of sexual desire or ability


• lower back or side pain


• menstrual irregularities


• muscle pain or tenderness


• muscle wasting or weakness


• nausea


• pain in back, ribs, arms, or legs


• painful or difficult urination


• skin rash


• sleeplessness


• sweating


• trouble healing


• trouble sleeping


• unexplained weight loss


• unusual tiredness or weakness


• vision changes


• vomiting


• vomiting of material that looks like coffee grounds

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

• Increased appetite

Incidence not known

• Abnormal fat deposits on the face, neck, and trunk


• acne


• dry scalp


• lightening of normal skin color


• red face


• reddish purple lines on the arms, face, legs, trunk, or groin


• swelling of the stomach area


• thinning of the scalp hair

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.

Indivina

Indivina may be available in the countries listed below.

UK matches:

• Indivina
• Indivina (SPC)

Ingredient matches for Indivina

Estradiol

Estradiol 17ß-valerate (a derivative of Estradiol) is reported as an ingredient of Indivina in the following countries:

• Denmark


• Germany


• Hungary


• Lithuania


• Norway


• Slovakia


• Sweden


• Switzerland


• Taiwan


• Thailand


• United Kingdom

Medroxyprogesterone

Medroxyprogesterone 17α-acetate (a derivative of Medroxyprogesterone) is reported as an ingredient of Indivina in the following countries:

• Denmark


• Germany


• Hungary


• Lithuania


• Norway


• Slovakia


• Sweden


• Switzerland


• Taiwan


• Thailand


• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Entecavir

Pronunciation: en-TEK-a-vir
Generic Name: Entecavir
Brand Name: Baraclude

Entecavir may increase the risk of severe and sometimes fatal lactic acidosis (buildup of lactic acid in the blood) or liver problems when used alone or with other medicines. The risk may be greater in women, in patients who are very overweight, or in patients who have been on Entecavir or similar medicines for a prolonged period of time. Patients with certain serious liver problems may also have a higher risk of developing lactic acidosis. Contact your doctor right away if you experience muscle pain, fast or irregular heartbeat, stomach pain, trouble breathing, an unusually cold feeling in the arms or legs, unusual tiredness or fatigue, yellowing of the skin or eyes, dark urine, pale stools, or persistent loss of appetite.

A severe worsening of your condition may occur if you stop taking Entecavir. Do not change your dose or stop taking Entecavir without first talking to your doctor. Lab tests, including liver function tests, may be performed for at least several months after you stop taking Entecavir.

Entecavir should not be used in patients who also have HIV infection and are not receiving highly active antiretroviral therapy (HAART). If you have HIV infection or think that you may have been exposed to HIV, talk with your doctor before you begin to take Entecavir.

Entecavir is used for:

Treating hepatitis B virus infection in certain patients.

Entecavir is a nucleoside analogue. It works by reducing the amount of hepatitis B virus in the blood. It also helps prevent the hepatitis B virus from multiplying and infecting new liver cells.

Do NOT use Entecavir if:

• you are allergic to any ingredient in Entecavir


• you have HIV infection and you are not receiving HAART

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

Before using Entecavir:

Some medical conditions may interact with Entecavir. 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 HIV infection or kidney problems, or if you are on dialysis


• if you have a history of liver problems or you have had a liver transplant


• if you are very overweight


• if you have received medicine to treat hepatitis B in the past or if you have been taking nucleoside analogues for a long time

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

• Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because they may increase the risk of Entecavir's side effects. Ask your doctor if you are unsure if any of your medicines may harm the kidneys.

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

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

• An extra patient leaflet is available with Entecavir. Talk to your pharmacist if you have questions about this information.


• Take Entecavir on an empty stomach, at least 2 hours after a meal and at least 2 hours before the next meal.


• Entecavir works best if it is taken at the same time each day.


• Continue to take Entecavir even if you feel well. Do not miss any doses.


• If you miss a dose of Entecavir, 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 Entecavir.

Important safety information:

• Entecavir may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Entecavir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Entecavir does not stop you from spreading hepatitis B virus to others through sexual contact, sharing needles, or being exposed to your blood. Use barrier methods of birth control (eg, condoms) if you have hepatitis B virus infection. Talk with your doctor about safe sexual practices that protect your partner. Never share needles or other injection supplies. Do not share personal items that may have blood or body fluids on them, like toothbrushes or razors. A vaccine is available to protect people at risk from becoming infected with hepatitis B virus.


• Do not change your dose without checking with your doctor.


• Entecavir is not a cure for hepatitis B virus infection. Remain under the care of your doctor.


• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Entecavir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.


• Lab tests, including liver and kidney function and HIV and hepatitis B virus antibody, may be performed while you use Entecavir and for several months after you stop Entecavir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


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


• Entecavir should be used with extreme caution in CHILDREN younger than 16 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 taking Entecavir while you are pregnant. It is not known if Entecavir is found in breast milk. Do not breast-feed while taking Entecavir.

Possible side effects of Entecavir:

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; dizziness; drowsiness; headache; indigestion; nausea; tiredness; trouble sleeping; 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-colored urine; difficulty breathing; fast or irregular heartbeat; feeling cold, especially in the arms or legs; light-colored bowel movements; loss of appetite for several days; muscle pain; severe dizziness or lightheadedness; severe or prolonged nausea or vomiting; severe tiredness; stomach pain (with or without nausea or vomiting); weakness; 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: Entecavir 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.

Proper storage of Entecavir:

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

General information:

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


• Entecavir 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 Entecavir. 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 Entecavir resources

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

• Entecavir Professional Patient Advice (Wolters Kluwer)


• Entecavir Monograph (AHFS DI)


• entecavir Advanced Consumer (Micromedex) - Includes Dosage Information


• Baraclude Prescribing Information (FDA)


• Baraclude Consumer Overview

Compare Entecavir with other medications

• Hepatitis B