UR N-C Urinary Antiseptic

Dosage Form: tablet
UR N-C Urinary Antiseptic

Each tablet for oral administration contains:
Hyoscyamine sulfate	0.12 mg
Methenamine	81.6 mg
Methylene blue	10.8 mg
Phenyl salicylate	36.2 mg
Sodium phosphate, monobasic	40.8 mg

Inactive ingredients: calcium sulfate, carbopol 934P, D &C #27, FD &C Blue #2, FD& C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, purified water, starch 1500, talc and titanium dioxide.

Hyoscyamine sulfate. [620-61-1] [3(S)-endo]-α-(Hydroxymethyl)-benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester sulfate(2:1)(salt); 1αH,5α H-tropan-3α-ol(-)-tropate (ester) sulfate(2:1)(salt); 3α-tropanyl S-(-)-tropate; I-tropic acid ester with tropine; I-tropine tropate. C34H48N2O10S. Hyoscyamine sulfate is an alkaloid of belladonna. Exists as a white crystalline powder. Its solutions are alkaline to litmus. Affected by light, it is slightly soluble in water; freely soluble in alcohol; sparingly soluble in ether.

Methenamine. [100-97-0] 1,3,5,7- Tetraazatricyclo [3.3.1.13•7] decane; hexamethylenetetramine; HMT; HMTA; hexamine; 1,3,5,7- tetraazaadamantane hexamethylenemine; Uritone; Urotropin. C6H12N4; mol wt 140.19; C 51.40%, H 8.63%, N 39.96%. Methenamine (hexamethylenetetramine)exists as colorless, lustrous crystals or white crystalline powder. Its solutions are alkaline to litmus. Freely soluble in water, soluble in alcohol and in chloroform.

Phenyl salicylate. [118-55-8] 2-Hydroxybenzoic acid phenyl ester; Salol. C13H10O3 ; mol wt 214.22, C 72.89%, H 4.71%, O 22.41%. Made by the action of phosphorus oxy-chloride on a mixture of phenol and salicylic acid. Phenyl salicylate exists as white crystals with a melting point of 41°-43° C. It is very slightly soluble in water and freely soluble in alcohol.

Sodium phosphate, monobasic. [7558-80-7] Phosphoric acid sodium salt (1:1); Sodium biphosphate; sodium dihydrogen phosphate; acid sodium phosphate; monosodium orthophosphate; primary sodium phosphate; [H2NaO4P:] mol wt 119.98, H 1.68%, Na 19.16%, O 53.34%, P 25.82%. Monohydrate, white, odorless slightly deliquesce crystals or granules. At 100°C loses all its water; when ignited it converts to metaphosphate. It is freely soluble in water and practically insoluble in alcohol. The aqueous solution is acid. pH of 0.1 molar aqueous solution at 25°C: 4.5.

Methylene blue. [61-73-4] 3,7-Bis(dimethylamino) phenothiazin-5-ium chloride; C.I. Basic Blue 9; methylthioninium chloride; tetramethylthionine chloride; 3,7-bis(dimethylamino) phenazathionium chloride. C16H18CIN3S; mol wt 319.85, C 60.08%, H 5.67%, Cl 11.08%, N 13.14%, S 10.03%. Methylene blue (Methylthionine chloride) exists as dark green crystals. It is soluble in water and in chloroform; sparingly soluble in alcohol.

INDICATIONS AND USAGE:

UR N-C is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

DOSAGE AND ADMINISTRATION:

FOR ORAL USE ONLY

Adults: One tablet 4 times per day by mouth, followed by liberal fluid intake. Older Children: Dosage must be individualized by physician. Not recommended for use in children younger than six years.

CONTRAINDICATIONS:

UR N-C is contraindicated in patients hypersensitive to any of its ingredients. Risk benefits should be carefully considered when the following medical problems exist: achalasia of esophagus, atony of colon, diseases of cardiovascular system, gastrointestinal hemorrhage; glaucoma; hemolytic anemia from pyruvate kinase and G6PD deficiencies, infected urolithiasis, myasthenia gravis, paralytic ileus, severe ulcerative colitis, toxic megacolon; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

WARNINGS AND PRECAUTIONS:

Do not exceed recommended dosage. This drug may make you dizzy or drowsy or cause blurred vision; use caution while driving, using machinery, or doing any activity that requires alertness or clear vision. Limit alcohol consumption. Cross sensitivity and/or related problems – patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers. There have been no studies to establish the safety of prolonged use of this product in humans. No known long-term animal studies have been performed to evaluate carcinogenic potential.

Pregnancy: Teratogenic Effects. Pregnancy Category C:

Hyoscyamine sulfate and methenamine cross the placenta. Studies have not been done in animals or humans. It is not known whether UR N-C tablets cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. UR N-C tablets should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

Problems in humans have not been documented; however, methenamine and traces of hyoscyamine sulfate are excreted in breast milk. Accordingly, UR N-C tablets should be given to a lactating woman only if clearly needed. Discuss the risks and benefits with your doctor.

Pediatric Use:

Infants and young children are especially susceptible to the toxic effect of the belladonna alkaloids (hyoscyamine sulfate). This product contains salicylate, which is related to aspirin. Children and teenagers should not take aspirin, aspirin-containing or aspirin-related medications if they have chickenpox, influenza, or any undiagnosed illness without first consulting a doctor. A rare but serious illness known as Reye’s syndrome may occur. This medication is not recommended for children younger than 6 years.

Geriatric Use:

Kidney function becomes impaired with age. This medication is removed by the kidneys. Therefore, use with caution in elderly patients as they may respond to usual doses of hyoscyamine sulfate with excitement, agitation, drowsiness or confusion.

ADVERSE REACTIONS:

Cardiovascular: rapid heartbeat, flushing Central Nervous System: blurred vision, dizziness, drowsiness Genitourinary: difficulty micturition, acute urinary retention Gastrointestinal: dry mouth, nausea and vomiting Respiratory: shortness of breath or trouble breathing

Serious allergic reactions to this drug are rare. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including itching, rash, severe dizziness, swelling or trouble breathing.

This medication can cause urine and sometimes stools to turn blue-green. This effect is harmless and will subside after medication is stopped.

Call your doctor or physician for medical advice about side effects. The following number does not provide medical advice, but in the U.S. you may report suspected side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

This drug should not be used with the following medications because very serious interactions may occur: live influenza virus vaccine, pramlintide. Because of this product’s effect on gastrointestinal motility and gastric emptying, it may decrease the absorption of other oral medications during concurrent use such as: urinary alkalizers; thiazide diuretics (may cause the urine to become alkaline reducing the effectiveness of methenamine by inhibiting its conversion to formaldehyde); antimuscarinics (concurrent use may intensify antimuscarinic effects of hyoscyamine sulfate because of secondary antimuscarinic activities of these medications); antacids/antidiarrheals (may reduce absorption of hyoscyamine sulfate, concurrent use with antacids may cause urine to become alkaline, reducing effectiveness of methenamine by inhibiting its conversion to formaldehyde). Doses of these medications should be spaced 1 hour apart from doses of hyoscyamine sulfate; antimyasthenics (concurrent use with hyoscyamine sulfate may further reduce intestinal motility); ketoconazole (patients should be advised to take this combination at least 2 hours after ketoconazole); monoamine oxidase (MAO) inhibitors (concurrent use may intensify antimuscarinic side effects), opioid (narcotic analgesics may result in increased risk of severe constipation); sulfonamides (these drugs may precipitate with formaldehyde in the urine, increasing the danger of crystalluria). This is not a complete list of all drug interactions. Tell your doctor or pharmacist of all prescription medications prior to use.

DRUG ABUSE AND DEPENDENCE:

A dependence on the use of UR N-C has not been reported nor expected based on the pharmacology of the ingredients contained in UR N-C.

OVERDOSAGE:

By exceeding the recommended dosage of UR N-C, symptomology related to the overdose of its individual active ingredients may be expected as follows:

Hyoscyamine sulfate: Symptoms associated with overdosage of UR N-C will most probably be manifested in the symptoms related to overdosage of alkaloid hyoscyamine sulfate. Such symptoms as dryness of mucous membranes; dilation of pupils, hot, dry, flushed skin; hyperpyrexia; tachycardia; palpitations; elevated blood pressure; coma; circulatory collapse and death from respiratory failure can occur due to overdosage of these alkaloids.

Methenamine: If large amounts of the drug (2-8 g daily) are used over extended periods (3-4 weeks), bladder and gastrointestinal irritation, painful and frequent micturition, albuminuria and gross hematuria may be expected.

Phenyl salicylate: Symptoms of phenyl salicylate overdosage include burning pain in throat and mouth, white necrotic lesions in the mouth, abdominal pain, vomiting, bloody diarrhea, pallor, sweating, weakness, headache, dizziness and tinnitus. The symptoms, however, are not expected to be discernible from those associated with the other active ingredients in UR N-C.

Sodium phosphate, monobasic: Symptoms of sodium biphosphate overdosage may include diarrhea, dehydration, and electrolyte imbalances.

Methylene blue: Symptoms of methylene blue overdosage associated with the overdosage of UR N-C are not expected to be discernible from those associated with other active ingredients in UR N-C.

Treatment: Emesis or gastric lavage. Slow intravenous administration of physostigmine in doses of 1 to 4 mg (0.5 to 1 mg in children), repeated as needed in one to two hours to reverse severe antimuscarinic symptoms. Administration of small doses of diazepam or baclofen to control excitement and seizures. Artificial respiration with oxygen if needed for respiratory depression. Adequate re-hydration is required. Symptomatic treatment as determined by a doctor.

If overdose is suspected, contact your local poison center or emergency room immediately. US residents can contact the US National Poison Hotline at 1-800-222-1222.

CLINICAL PHARMACOLOGY:

Hyoscyamine sulfate: Hyoscyamine sulfate is a parasympatholytic which relaxes smooth muscles and thus produces an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout the body tissues. Following oral administration, the drug has an onset of action of 20 to 30 minutes. The half-life is 3.5 hours. Hyoscyamine is distributed throughout the body, crosses the blood-brain barrier, and is approximately 50% bound to plasma proteins. It is metabolized in the liver to tropic acid, tropine, and hyoscyamine glucuronide. Hyoscyamine is excreted primarily unchanged in the urine within 12 hours. Its biotransformation is hepatic.

Methenamine: Methenamine, after oral administration, undergoes hydrolysis and generates formaldehyde, which provides bactericidal or bacteriostatic action. Methenamine is rapidly absorbed from the intestinal tract and is excreted, for the most part, unchanged in the urine at which point it is hydrolyzed if the urine is acidic. It is almost completely excreted (90%) in the urine within 24 hours; of this at a pH of 5, approximately 10-30% is converted to formaldehyde in the stomach.

Phenyl salicylate: Phenyl salicylate, a form of salicylic acid, is a mild analgesic for pain relief.

Sodium phosphate, monobasic: Sodium phosphate, monobasic increases urinary acidity helping to maintain an acid pH necessary for the degradation of methenamine.

Methylene blue: Methylene blue is a monoamine oxidase inhibitor with weak antiseptic properties. It is well absorbed by the intestinal tract and rapidly reduced to leukomethylene blue, which is stabilized in the urine. Approximately 70-80% is excreted unchanged in the urine.

HOW SUPPLIED:

UR N-C is available as a purple tablet, imprinted “293”: bottles of 100 tablets, NDC 51862-175-01. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at controlled room temperature 15°-30°C (59°- 86°F). Keep in a cool, dry place.

WARNING: Keep this and all drugs out of reach of children. Caution: Rx Only

Manufactured for:

Libertas Pharma, Inc.

Lawrenceville, GA 30043

Iss. 04/11 175-01

1000412

Container Label

NDC 51862-175-01

UR N-C

Urinary Antiseptic

Each tablet for oral administration contains:

Hyoscyamine sulfate……...12 mg

Methenamine.....81.6 mg

Methylene blue.....10.8 mg

Phenyl salicylate.....36.2 mg

Sodium phosphate monobasic…..40.8 mg

Rx Only

100 TABLETS

Libertas

Pharma, Inc.

UR N-C Urinary Antiseptic  hyoscyamine sulfate, methenamine, phenyl salicylate, sodium phosphate monobasic, methylene blue   tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51862-175 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.12 mg SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (PHOSPHORIC ACID) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 40.8 mg PHENYL SALICYLATE (PHENYL SALICYLATE) PHENYL SALICYLATE 36.2 mg METHENAMINE (METHENAMINE) METHENAMINE 81.6 mg METHYLENE BLUE (METHYLENE BLUE) METHYLENE BLUE 10.8 mg

Inactive Ingredients Ingredient Name Strength CALCIUM SULFATE   CARBOMER HOMOPOLYMER TYPE B   D&C RED NO. 27   FD&C BLUE NO. 2   FD&C RED NO. 40   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   POLYVINYL ALCOHOL   WATER   STARCH, CORN   TALC   TITANIUM DIOXIDE

Product Characteristics Color PURPLE Score no score Shape ROUND Size 10mm Flavor Imprint Code 293 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51862-175-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		05/21/2011

Labeler - Libertas Pharma, Inc. (962128943)

Revised: 05/2011Libertas Pharma, Inc.

More UR N-C Urinary Antiseptic resources

• UR N-C Urinary Antiseptic Use in Pregnancy & Breastfeeding
• UR N-C Urinary Antiseptic Drug Interactions
• UR N-C Urinary Antiseptic Support Group
• 16 Reviews for UR N-C Urinary Antiseptic - Add your own review/rating

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• Urinary Tract Infection

Calcijex Solution

Pronunciation: KAL-si-TRYE-ol
Generic Name: Calcitriol
Brand Name: Calcijex

Calcijex Solution is used for:

Treating low calcium levels in the blood of patients undergoing chronic kidney dialysis. It may also be used for other conditions as determined by your doctor.

Calcijex Solution is a form of vitamin D. It works by promoting proper absorption and use of calcium and phosphate by the body in normal bone development and maintenance.

Do NOT use Calcijex Solution if:

• you are allergic to any ingredient in Calcijex Solution


• you have high levels of vitamin D or calcium in the blood

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

Before using Calcijex Solution:

Some medical conditions may interact with Calcijex Solution. 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 heart disease, kidney disease or kidney stones, hardening of the arteries or other blood vessel problems, or a high phosphate level in the blood


• if you are dehydrated, have recently had surgery, or will be confined to a bed or chair for a long period of time


• if you take a phosphate-binding medicine (eg, calcium acetate)

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

• Thiazide diuretics (eg, hydrochlorothiazide) because the risk of high blood calcium levels may be increased


• Digoxin because the risk of irregular heartbeat may be increased


• Antacids that contain magnesium because high blood magnesium levels may occur


• Barbiturates (eg, phenobarbital), cholestyramine, corticosteroids (eg, prednisone), hydantoins (eg, phenytoin), or ketoconazole because they may decrease Calcijex Solution's effectiveness

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

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

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


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


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Calcijex Solution and you are using 1 dose every other day, use the missed dose if you remember the same day. If you do not remember the dose until the next day, use the missed dose, and then skip a day. Return to your every other day schedule.

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

Important safety information:

• Calcijex Solution may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Calcijex Solution. Using Calcijex Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


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


• Carefully follow the diet plan provided by your doctor.


• Check with your doctor before taking any vitamins or mineral supplements containing vitamin D or calcium, phosphorus, or antacids containing calcium or magnesium.


• You will need to take care to not become dehydrated while you take Calcijex Solution. If you have normal kidney function, be sure to drink plenty of fluids. If you have kidney problems or are on dialysis, talk with your doctor about how much fluid you should drink each day. Discuss any questions with your doctor.


• Tell your doctor you take Calcijex Solution if you will be having surgery or will be confined to a bed or chair for a long period of time. The risk of high blood calcium levels may be increased.


• Lab tests, including calcium, phosphorus, magnesium, and alkaline phosphate levels, may be performed while you use Calcijex Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Calcijex Solution should be used with extreme caution in CHILDREN younger than 13 year old and in CHILDREN who are on dialysis; safety and effectiveness in these children have not been confirmed.


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

Possible side effects of Calcijex Solution:

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; bone pain; constipation; decreased sex drive; diarrhea; difficult or painful urination; dizziness; drowsiness; dry mouth; eye redness or irritation; fever; flushing; frequent urination; headache; increased body temperature; increased thirst; irregular heartbeat; loss of appetite; mental or mood changes; metallic taste; muscle pain; nausea; runny nose; sensitivity of the eyes to sunlight; stomach pain or cramps; unexplained weight loss; unusual thinking; vomiting; weakness.

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: Calcijex 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 dizziness; headache; irregular heartbeat; loss of appetite; mental or mood changes; nausea; stomach pain or cramps; vomiting; weakness.

Proper storage of Calcijex Solution:

Store Calcijex Solution as directed on the prescription label. Keep Calcijex Solution out of the reach of children and away from pets.

General information:

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


• Calcijex Solution 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 Calcijex Solution. 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 Calcijex resources

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

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• Hypocalcemia
• Hypoparathyroidism
• Renal Osteodystrophy
• Rickets
• Secondary Hyperparathyroidism

Co-Gesic

Generic Name: acetaminophen and hydrocodone (a SEET a MIN oh fen and hye droe KOE done)

Brand Names: Anexsia, Co-Gesic, Hycet, Liquicet, Lorcet 10/650, Lorcet Plus, Lortab 10/500, Lortab 2.5/500, Lortab 5/500, Lortab 7.5/500, Lortab Elixir, Maxidone, Norco, Polygesic, Stagesic, Vicodin, Vicodin ES, Vicodin HP, Xodol, Zamicet, Zolvit, Zydone

What is Co-Gesic (acetaminophen and hydrocodone)?

Hydrocodone is in a group of drugs called narcotic pain relievers.

Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.

The combination of acetaminophen and hydrocodone is used to relieve moderate to severe pain.

Acetaminophen and hydrocodone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Co-Gesic (acetaminophen and hydrocodone)?

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

What should I discuss with my healthcare provider before taking Co-Gesic (acetaminophen and hydrocodone)?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or hydrocodone. Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

To make sure you can safely take acetaminophen and hydrocodone, tell your doctor if you have any of these other conditions:

• 
  

  asthma, COPD, sleep apnea, or other breathing disorders;

  
  


• 
  

  liver or kidney disease;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  a stomach or intestinal disorder;

  
  


• 
  

  underactive thyroid;

  
  


• 
  

  Addison's disease or other adrenal gland disorder;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  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 acetaminophen and 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 this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Acetaminophen and hydrocodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Co-Gesic (acetaminophen and hydrocodone)?

Take exactly as prescribed. Never take acetaminophen and hydrocodone in larger amounts, or for longer than recommended by your doctor. An overdose of acetaminophen can damage your liver or cause death.

One acetaminophen and hydrocodone tablet may contain up to 750 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and hydrocodone. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor. Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and hydrocodone.

Acetaminophen can cause false results with certain lab tests for glucose (sugar) in the urine. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and hydrocodone. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

What happens if I miss a dose?

Since acetaminophen and hydrocodone is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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 use 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 acetaminophen and hydrocodone can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include extreme drowsiness, pinpoint pupils, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing

What should I avoid while taking Co-Gesic (acetaminophen and hydrocodone)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Co-Gesic (acetaminophen and hydrocodone) 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 any of these serious side effects:

• 
  

  shallow breathing, slow heartbeat;

  
  


• 
  

  feeling light-headed, fainting;

  
  


• 
  

  confusion, fear, unusual thoughts or behavior;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  problems with urination; or

  
  


• 
  

  nausea, 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:

• 
  

  anxiety, dizziness, drowsiness;

  
  


• 
  

  mild nausea, vomiting, upset stomach, constipation;

  
  


• 
  

  headache, mood changes;

  
  


• 
  

  blurred vision;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  dry mouth.

  
  

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 Co-Gesic (acetaminophen and hydrocodone)?

Do not take acetaminophen and hydrocodone with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

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

• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;

  
  


• 
  

  an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);

  
  


• 
  

  atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  
  


• 
  

  a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

  
  

This list is not complete and other drugs may interact with acetaminophen and hydrocodone. 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 Co-Gesic resources

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

• Co-Gesic Advanced Consumer (Micromedex) - Includes Dosage Information


• Co-gesic Prescribing Information (FDA)


• Dolacet MedFacts Consumer Leaflet (Wolters Kluwer)


• Hycet Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Hycet Prescribing Information (FDA)


• Liquicet Prescribing Information (FDA)


• Lorcet Plus Prescribing Information (FDA)


• Lortab Consumer Overview


• Lortab MedFacts Consumer Leaflet (Wolters Kluwer)


• Lortab Prescribing Information (FDA)


• Maxidone Prescribing Information (FDA)


• Norco Prescribing Information (FDA)


• Norco Consumer Overview


• Vicodin Prescribing Information (FDA)


• Vicodin Consumer Overview


• Vicodin ES Prescribing Information (FDA)


• Vicodin HP Prescribing Information (FDA)


• Xodol Prescribing Information (FDA)


• Zolvit Prescribing Information (FDA)


• Zydone Prescribing Information (FDA)

Compare Co-Gesic with other medications

• Back Pain
• Cough
• Pain
• Rheumatoid Arthritis

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen and hydrocodone.

See also: Co-Gesic side effects (in more detail)

Vetscription Hydocortisone Spray

Dosage Form: FOR ANIMAL USE ONLY
Vetscription Hydocortisone Spray for Dogs & Cats

INDICATIONS & USAGE:

Hydrocortisone Spray provides quick relief from itching and rashes and other minor skin irritations.

DIRECTIONS:

Apply directly to affected skin areas twice a day to relieve irritation.

CAUTION:

For external pet use only.  Avoid contact with eyes and mouth.  If no noticeable improvement in 7 days or if irritation worsens, discontinue use and consult your veterinarian.

KEEP OUT OF REACH OF CHILDREN

ACTIVE INGREDIENT

0.5% Hydrocortisone

INACTIVE INGREDIENTS:

Propylene Glycol, Ethyl Alcohol, Lactic Acid, Menthol, PCMX, FD and C Blue No. 1.

RECOMMENDED STORAGE:

STORE BELOW 30 DEGREES C (86 DEGREES F)

How is Vetscription Hydocortisone Spray Supplied

Net Contents:  4 fl oz (118 mL)

QUESTIONS AND/OR COMMENTS

Sergeant's is committed to providing high quality products.  If you have questions or comments about this product, please write:  Sergeant's Consumer Response, P.O. Box 540399. 


In case of an Emergency call:  1-800-781-4738.

Non-Emergency call:  1-800 224-PETS (7387).

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Distributed by:  Sergeant's Pet Care Products, Inc., Omaha, NE 68130


MADE IN USA


P995112-3

VETSCRIPTION HYDROCORTISONE   hydrocortisone  spray

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 21091-423 Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 0.59 mL  in 118 mL

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL   ALCOHOL   LACTIC ACID   MENTHOL   CHLOROXYLENOL   FD&C BLUE NO. 1

Product Characteristics Color blue Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 21091-423-04 118 mL In 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/14/2006

Labeler - Sergeant's Pet Care Products, Inc. (876995171)

Establishment
Name	Address	ID/FEI	Operations
ABS Corporation		048022727	manufacture

Revised: 09/2010Sergeant's Pet Care Products, Inc.

DHC Continus prolonged release tablets 60mg, 90mg and 120 mg

1. Name Of The Medicinal Product

DHC^® Continus^® prolonged release tablets 60 mg, 90 mg, 120 mg.

2. Qualitative And Quantitative Composition

Dihydrocodeine tartrate 60 mg, 90 mg, 120 mg.

3. Pharmaceutical Form

Prolonged release tablet.

White capsule shaped tablets, 60 mg are marked DHC 60, 90 mg are marked DHC 90 and 120 mg are marked DHC 120.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of severe pain in cancer and other chronic conditions.

4.2 Posology And Method Of Administration

Adults and children over 12 years: 60 mg - 120 mg every 12 hours.

Elderly: Dosage should be reduced.

Children 12 years or under: Not recommended.

Method of administration

Oral.

4.3 Contraindications

Hypersensitivity to dihydrocodeine or any of the tablet constituents; respiratory depression; obstructive airways disease; paralytic ileus; head injury; raised intracranial pressure; acute alcoholism. As dihydrocodeine may cause the release of histamine, it should not be given during an asthma attack and should be given with caution to asthmatics.

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

4.4 Special Warnings And Precautions For Use

Dosage should be reduced in the elderly, in hypothyroidism, chronic hepatic disease and renal insufficiency.

Dihydrocodeine should be administered with caution to patients with a history of opioid abuse, biliary tract disorders, prostatic hypertrophy, pancreatitis, constipation, obstructive bowel disorder and severe cor pulmonale.

Dihydrocodeine has a recognised abuse and addiction profile similar to other opioids. Tolerance to analgesic effects may develop upon repeated administration.

The risk-benefit of continued use should be assessed regularly by the prescriber, and in particular the prescriber should take care to avoid any unnecessary increase in dosage especially where there is evidence of a previous history of drug dependence or abuse.

DHC Continus tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed tablets may lead to a rapid release and absorption of a potential overdose of dihydrocodeine (see Section 4.9).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Other central nervous system depressants, including sedatives or hypnotics, phenothiazines, other tranquillisers and alcohol, may result in respiratory depression or sedation. Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors or within two weeks of such therapy.

4.6 Pregnancy And Lactation

There is little published evidence on safety in human pregnancy but dihydrocodeine has been used for many years without apparent ill effects. Dihydrocodeine has not been reported to be excreted in breast milk. However, it is advisable that dihydrocodeine only be administered to breast-feeding mothers if considered essential.

4.7 Effects On Ability To Drive And Use Machines

Dihydrocodeine may cause drowsiness and, if affected, patients should not drive or operate machinery.

4.8 Undesirable Effects

Common adverse drug reactions seen during therapy are constipation, nausea, vomiting, headache, somnolence, pruritus and rash.

Uncommon adverse reactions are urinary retention, ureteric or biliary spasm, dry mouth, mood changes, blurred vision, sweating, decreased libido, flushing, abdominal pain, hypotension, paraesthesia, confusion, dizziness, hallucinations, urticaria, paralytic ileus and respiratory depression.

Dependence may occur. Regular prolonged use of dihydrocodeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is stopped.

Prolonged use of a painkiller for headaches can make them worse.

4.9 Overdose

Acute overdosage with dihydrocodeine can be manifested by somnolence progressing to stupor or coma, miotic pupils, rhabdomyolysis, non-cardiac pulmonary oedema, bradycardia, hypotension and respiratory depression or apnoea.

Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.

In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children) if the patient is in a coma or respiratory depression is present. Repeat the dose at 2 minute intervals if there is no response, or by an infusion. An infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient's clinical state. Intramuscular naloxone is an alternative in the event that IV access is not possible.

As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients. For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.

Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to dihydrocodeine overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on dihydrocodeine. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.

Additional/other considerations:

• Consider activated charcoal (50 g for adults, 10-15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. It may be reasonable to assume that late administration of activated charcoal may be beneficial for prolonged release preparations but there is no evidence to support this.

•DHC Continus tablets will continue to release and add to the dihydrocodeine load for up to 12 hours after administration and the management of overdosage should be modified accordingly. Gastric contents may therefore need to be emptied, as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Dihydrocodeine is a semisynthetic narcotic analgesic with a potency between morphine and codeine. It acts on opioid receptors in the brain to reduce the patient's perception of pain and improve the psychological reaction to pain by reducing the associated anxiety.

5.2 Pharmacokinetic Properties

Dihydrocodeine is well absorbed from the gastrointestinal tract following administration of DHC Continus tablets and plasma levels are maintained throughout the twelve hour dosing interval.

Like other phenanthrene derivatives, dihydrocodeine is mainly metabolised in the liver with the resultant metabolites being excreted mainly in the urine. Metabolism of dihydrocodeine includes o-demethylation, n-demethylation and 6-keto reduction.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose (anhydrous)

Hydroxyethylcellulose

Cetostearyl alcohol

Magnesium stearate

Purified talc

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Polypropylene containers with polyethylene lids (56 tablets)

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge

CB4 0GW

8. Marketing Authorisation Number(S)

PL 16950/0019 - 0021

9. Date Of First Authorisation/Renewal Of The Authorisation

60 mg	5 November 1986 / 5 March 2001
90 mg and 120 mg	12 July 1990 / 5 March 2001

10. Date Of Revision Of The Text

February 2007

Legal Category

POM

^® The Napp device, DHC and DHC CONTINUS are Registered Trade Marks

^© Napp Pharmaceuticals Ltd 2007.

Pentasa Rectal

Generic Name: mesalamine (Rectal route)

me-SAL-a-meen

Commonly used brand name(s)

In the U.S.

• Canasa


• Rowasa


• sfRowasa

In Canada

• Mesasal


• Pentasa


• Salofalk

Available Dosage Forms:

• Suppository


• Enema

Therapeutic Class: Gastrointestinal Agent

Chemical Class: Salicylate, Non-Aspirin

Uses For Pentasa

Mesalamine is used to treat inflammatory bowel disease, such as ulcerative colitis. This medicine works inside the bowel by helping to reduce inflammation and other symptoms.

Mesalamine 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 this use is not included in product labeling, mesalamine is used in certain patients with the following medical condition:

• Ulcerative colitis, history of—prevent it from occurring again

Before Using Pentasa

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of mesalamine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mesalamine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 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.

• Varicella Virus Vaccine

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.

• Ardeparin


• Certoparin


• Dalteparin


• Danaparoid


• Enoxaparin


• Nadroparin


• Parnaparin


• Reviparin


• Tamarind


• Tinzaparin


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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:

• Kidney disease—The use of mesalamine may make this condition worse.

Proper Use of mesalamine

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

For best results, empty your bowel just before using the rectal enema or suppository.

Keep using this medicine for the full time of treatment even if you begin to feel better after a few days. Do not miss any doses.

For patients using the enema form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Remove the bottles from the protective foil pouch, being careful not to squeeze or puncture them. The enema is an off-white to tan color. Contents of the enemas removed from the foil pouch may darken with time. Slight darkening will not affect the potency of the contents. However, enemas with dark brown contents should be discarded.


• Shake the bottle well to make sure that the medication is thoroughly mixed. Remove the protective cover from the applicator tip. Hold bottle at the neck so that no medicine spills out.


• Lie on your left side with your left leg straight and your right knee bent in front of you for balance. You can also lie in the knee-chest position, on your knees with your chest touching the bed.


• Gently insert the rectal tip of the enema applicator pointed slightly toward your naval to prevent damage to the rectal wall. Tilt the nozzle slightly toward the back and squeeze slowly to cause the enema to flow into your rectum. Steady pressure will discharge most of the medicine. After administering, withdraw and discard the bottle.


• Remain in position for at least 30 minutes to allow the medicine to distribute thoroughly. Retain the medicine all night if possible.

For patients using the suppository form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Detach one suppository from strip of suppositories. Hold suppository upright and carefully remove the foil wrapper.


• Avoid excessive handling of the suppository, which is designed to melt at body temperature.


• Insert suppository (pointed end first) completely into rectum with gentle pressure. Retain the suppository for 3 hours or longer, if possible, to achieve the best result.

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 inflammatory bowel disease:
  
  • For enema dosage form:
    
    • Adults and teenagers—4 grams (1 unit), used as directed, every night for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For suppository dosage form:
    
    • Adults and teenagers—500 milligrams (mg), inserted into your rectum, two or three times a day for three to six weeks or 1000 mg, inserted into your rectum, one time a day at bedtime for three to six weeks.
    
    
    • 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.

Precautions While Using Pentasa

It is important that your doctor check your progress at regular visits.

Contact your doctor if you develop cramping, acute abdominal pain, bloody diarrhea, fever, headache or rash. These may be symptoms of a serious condition.

Tell your doctor right away if you experience chest pain or shortness of breath.

Check with your doctor if you notice rectal bleeding, blistering, pain, burning, itching, or other sign of irritation not present before you started using this medicine.

Mesalamine rectal enema may stain clothing, fabrics, painted surfaces, marble, granite, vinyl, or other surfaces it touches.

Pentasa 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 as soon as possible if any of the following side effects occur:

Less common or rare

• Abdominal or stomach cramps or pain (severe)


• anxiety


• back pain (severe)


• bloody, black, or tarry stools


• blue or pale skin


• bright red blood in the stool


• chest pain, possibly moving to the left arm, neck, or shoulder


• chills


• diarrhea (severe)


• fast heartbeat


• fever


• headache (severe)


• nausea or vomiting


• shortness of breath


• skin rash


• stomach cramps, tenderness, pain


• swelling of the stomach


• unusual tiredness or weakness


• watery or bloody diarrhea


• yellow eyes or skin

Incidence not known

• Blood in urine


• change in frequency of urination or amount of urine


• cough


• difficulty in breathing


• drowsiness


• high fever


• increased thirst


• loss of appetite


• lower back or side pain


• painful or difficult urination


• pale skin


• sore throat


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


• swelling of feet or lower legs


• swollen glands


• troubled breathing


• unexplained or unusual bleeding or bruising


• weakness

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

• Abdominal or stomach cramps or pain (mild)


• gas or flatulence


• headache (mild)


• nausea

Less common or rare

• Acne


• diarrhea


• dizziness


• leg or joint pain


• loss of hair


• rectal pain or irritation

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: Pentasa Rectal 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 Pentasa Rectal resources

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

Compare Pentasa Rectal with other medications

• Crohn's Disease
• Crohn's Disease, Maintenance
• Inflammatory Bowel Disease
• Ulcerative Colitis
• Ulcerative Colitis, Active
• Ulcerative Proctitis

Azathioprine

Pronunciation: AY-za-THYE-oh-preen
Generic Name: Azathioprine
Brand Name: Examples include Azasan and Imuran

Long-term use of Azathioprine increases the risk of developing certain types of cancers (eg, leukemia, lymphoma, skin cancer). A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has been reported in patients treated with Azathioprine. These cases have been fatal. Most of these cases occurred in teenagers and young adults who had Crohn disease or ulcerative colitis. Some patients who developed this cancer were using Azathioprine along with certain other medicines called TNF blockers (eg, infliximab). Tell your doctor if you have or have ever had any type of cancer.

Azathioprine may also cause serious blood disorders (eg, anemias, low white blood cell or platelet levels). Discuss any questions or concerns with your doctor.

Contact your doctor at once if you develop changes in the appearance or size of a mole; easy bruising or bleeding; unusual growths; unusual lumps or swelling (eg, in your neck, armpit, groin); persistent, unexplained itching; night sweats; signs of infection (eg, fever, chills, persistent sore throat); stomach pain or tenderness; unusual tiredness or weakness; or unexplained weight loss.

Azathioprine is used for:

Preventing kidney transplant rejection when used along with other medicines. It may also be used to reduce signs and symptoms of active rheumatoid arthritis. It may also be used for other conditions as determined by your doctor.

Azathioprine is an antimetabolite. It works by decreasing the effects of certain cells in the body's immune system.

Do NOT use Azathioprine if:

• you are allergic to any ingredient in Azathioprine


• you have rheumatoid arthritis and are pregnant


• you have rheumatoid arthritis and have used alkylating agents (eg, cyclophosphamide, chlorambucil, melphalan) in the past


• you are taking mercaptopurine

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

Before using Azathioprine:

Some medical conditions may interact with Azathioprine. 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


• if you have certain bowel problems (eg, Crohn disease, ulcerative colitis)


• if you have an infection; a history of frequent, recurrent, or prolonged infections; or you have recently had or are scheduled to receive a vaccination


• if you have a history of cancer, bone marrow problems, anemia, low white blood cell or platelet levels, or unusual bruising or bleeding


• if you have certain enzyme deficiencies (thiopurine methyltransferase [TPMT] or xanthine oxidase) or you have recently had a blood transfusion


• if you are taking a disease-modifying antirheumatic drug (DMARD) (eg, methotrexate, adalimumab)

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

• Alkylating agents (eg, cyclophosphamide, chlorambucil, melphalan) or TNF blockers (eg, certolizumab, etanercept) because the risk of developing certain types of cancer may be increased


• Mercaptopurine because the risk of severe toxic effects, including severe bone marrow suppression or death, may be increased


• Allopurinol, aminosalicylates (eg, mesalazine, olsalazine, sulfasalazine), angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), doxorubicin, febuxostat, ribavirin, or trimethoprim/sulfamethoxazole because they may increase the risk of Azathioprine's side effects


• Anticoagulants (eg, warfarin) or hydantoins (eg, phenytoin) because their effectiveness may be decreased by Azathioprine

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

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

• Take Azathioprine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Ask your doctor if you should follow any special guidelines for handling Azathioprine.


• If you miss a dose of Azathioprine, 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 Azathioprine.

Important safety information:

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


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


• Tell your doctor or dentist that you take Azathioprine before you receive any medical or dental care, emergency care, or surgery.


• Talk with your doctor before you receive any vaccine while you are taking Azathioprine.


• Contact your doctor at once if you develop severe nausea and vomiting. This may occur with or without diarrhea, rash, fever, muscle pain, dizziness, fainting, or unusual tiredness. If this reaction occurs, it usually happens within the first several weeks of therapy.


• Azathioprine may increase your risk of developing a tumor or other cancer. Contact your doctor at once if you notice any unusual growths or lumps. To decrease your risk of developing skin cancer, avoid the sun, sunlamps, or tanning booths. Use a sunscreen with a high protection factor and wear protective clothing if you must be outside for more than a short time. Discuss any questions or concerns with your doctor.


• An enzyme called TPMT helps to break Azathioprine down in the body. Infrequently, some patients may have decreased TPMT enzyme activity. This may increase the risk of developing serious side effects (eg, severe bone marrow problems). Patients with decreased TPMT enzyme activity may need a lower dose of Azathioprine. Discuss any questions or concerns with your doctor.


• If you are able to become pregnant, talk with your doctor or pharmacist about the use of effective birth control while taking Azathioprine.


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


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


• PREGNANCY and BREAST-FEEDING: Azathioprine has been shown to cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Azathioprine while you are pregnant. Azathioprine is found in breast milk. Do not breast-feed while taking Azathioprine.

Possible side effects of Azathioprine:

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:

Mild nausea or vomiting.

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

Severe allergic reactions (rash; itching; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or tightness; dizziness; fatty stools; fever, chills, or persistent sore throat; increased or painful urination; muscle pain or aches; painful, red bumps or blisters on the arms, face, neck, or back; severe or persistent nausea, vomiting, or diarrhea; shortness of breath; stomach pain; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, right-sided stomach pain, yellowing of the eyes or skin); unusual bleeding or bruising; unusual growths or lumps; unusual weakness or tiredness.

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: Azathioprine 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 severe or persistent diarrhea, nausea, or vomiting; unusual bruising or bleeding.

Proper storage of Azathioprine:

Store Azathioprine at room temperature, between 59 and 77 degrees F (15 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. If you no longer need Azathioprine, ask your doctor how to properly dispose of it. Keep Azathioprine out of the reach of children and away from pets.

General information:

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


• Azathioprine 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 Azathioprine. 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 Azathioprine resources

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

• Azathioprine Professional Patient Advice (Wolters Kluwer)


• Azathioprine Prescribing Information (FDA)


• Azathioprine Monograph (AHFS DI)


• Azasan Advanced Consumer (Micromedex) - Includes Dosage Information


• Azasan Prescribing Information (FDA)


• Imuran Prescribing Information (FDA)


• azathioprine Concise Consumer Information (Cerner Multum)


• azathioprine Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

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