Monday, December 26, 2011

Proking




Proking may be available in the countries listed below.


Ingredient matches for Proking



Clobutinol

Clobutinol hydrochloride (a derivative of Clobutinol) is reported as an ingredient of Proking in the following countries:


  • Argentina

International Drug Name Search

Sunday, December 25, 2011

Sapofen




Sapofen may be available in the countries listed below.


Ingredient matches for Sapofen



Ibuprofen

Ibuprofen is reported as an ingredient of Sapofen in the following countries:


  • Oman

Pseudoephedrine

Pseudoephedrine hydrochloride (a derivative of Pseudoephedrine) is reported as an ingredient of Sapofen in the following countries:


  • Oman

International Drug Name Search

Saturday, December 24, 2011

Carpilo




Carpilo may be available in the countries listed below.


Ingredient matches for Carpilo



Carteolol

Carteolol hydrochloride (a derivative of Carteolol) is reported as an ingredient of Carpilo in the following countries:


  • France

Pilocarpine

Pilocarpine hydrochloride (a derivative of Pilocarpine) is reported as an ingredient of Carpilo in the following countries:


  • France

International Drug Name Search

Friday, December 23, 2011

Carnitor




In the US, Carnitor (levocarnitine systemic) is a member of the drug class nutraceutical products and is used to treat Carnitine Deficiency and Peripheral Neuropathy.

US matches:

  • Carnitor

  • Carnitor SF Solution

  • Carnitor Solution

  • Carnitor Injection

  • Carnitor Oral Solution

  • Carnitor Sugar-Free Solution

  • Carnitor Tablets

UK matches:

  • Carnitor 1 g Solution for Injection (SPC)
  • Carnitor 30% Paediatric Oral Solution (SPC)
  • Carnitor 330 mg Tablets (SPC)
  • Carnitor Oral Single Dose 1g (SPC)

Ingredient matches for Carnitor



Levocarnitine

Levocarnitine is reported as an ingredient of Carnitor in the following countries:


  • Canada

  • Hong Kong

  • India

  • United Kingdom

  • United States

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)

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

Tuesday, December 20, 2011

Crofed




Crofed may be available in the countries listed below.


Ingredient matches for Crofed



Pseudoephedrine

Pseudoephedrine hydrochloride (a derivative of Pseudoephedrine) is reported as an ingredient of Crofed in the following countries:


  • Indonesia

Triprolidine

Triprolidine hydrochloride monohydrate (a derivative of Triprolidine) is reported as an ingredient of Crofed in the following countries:


  • Indonesia

International Drug Name Search

Thursday, December 15, 2011

Benylin Descongestivo




Benylin Descongestivo may be available in the countries listed below.


Ingredient matches for Benylin Descongestivo



Dextromethorphan

Dextromethorphan hydrobromide (a derivative of Dextromethorphan) is reported as an ingredient of Benylin Descongestivo in the following countries:


  • Spain

Pseudoephedrine

Pseudoephedrine hydrochloride (a derivative of Pseudoephedrine) is reported as an ingredient of Benylin Descongestivo in the following countries:


  • Spain

International Drug Name Search

Wednesday, December 7, 2011

Synrelina




Synrelina may be available in the countries listed below.


Ingredient matches for Synrelina



Nafarelin

Nafarelin acetate (a derivative of Nafarelin) is reported as an ingredient of Synrelina in the following countries:


  • Switzerland

International Drug Name Search

Sunday, December 4, 2011

Carnidose




Carnidose may be available in the countries listed below.


Ingredient matches for Carnidose



Levocarnitine

Levocarnitine is reported as an ingredient of Carnidose in the following countries:


  • Greece

International Drug Name Search

Saturday, December 3, 2011

demecarium bromide ophthalmic


Generic Name: demecarium bromide ophthalmic (deh meh KARE ee um)

Brand Names: Humorsol Ocumeter


What is demecarium bromide ophthalmic?

Demecarium bromide ophthalmic reduces pressure in the eye by increasing the amount of fluid that drains from the eye. Demecarium bromide ophthalmic also causes the pupil to become smaller and reduces its response to light or dark conditions.


Demecarium bromide ophthalmic is used to treat glaucoma by lowering the pressure inside the eye. Demecarium bromide ophthalmic is also used for other conditions that require increased fluid outflow from the eye, after surgical iridectomy, and for certain eye disorders involving eye accommodation (focusing).


Demecarium bromide ophthalmic may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about demecarium bromide ophthalmic?


Contact your doctor immediately if you notice any decrease in vision or an increase in "floaters" in your visual field. Rarely, demecarium bromide ophthalmic may cause retinal detachment. Retinal detachment can lead to blind spots, floaters in the visual field, and even blindness. Your doctor will want to check your retina before you use this medication to determine if you have an increased risk of retinal detachment.


Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

Apply light pressure to the inside corner of the eye (near the nose) after each application to prevent the medicine from draining down the tear duct.


Use caution when driving, operating machinery, or performing other hazardous activities. Demecarium bromide ophthalmic may cause decreased vision at night. If you experience decreased vision, avoid these activities.

What should I discuss with my healthcare provider before using demecarium bromide ophthalmic?


Rarely, demecarium bromide ophthalmic may cause retinal detachment. Tell your doctor if you have any type of retinal disease, if you have had a retinal tear, if you are nearsighted, or if you have had cataract surgery. These conditions may increase the risk of retinal detachment.


Before using this medication, tell your doctor if you



  • have heart failure,




  • have high or low blood pressure,




  • have ever had a heart attack,




  • have asthma,




  • have a stomach ulcer or stomach spasms,




  • have epilepsy,




  • have hyperthyroidism (an overactive thyroid),




  • have blockage of your urinary tract or difficulty urinating, or




  • have Parkinson's disease.



You may not be able to use demecarium bromide ophthalmic, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


If you wear contact lenses, remove them before applying demecarium bromide ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication.


Demecarium bromide ophthalmic is in the FDA pregnancy category X. This means that it is known to cause birth defects in an unborn baby. Do not use demecarium bromide ophthalmic if you are pregnant or could become pregnant during treatment. It is not known whether demecarium bromide passes into breast milk. Do not use demecarium bromide ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use demecarium bromide ophthalmic?


Use demecarium bromide ophthalmic eye drops exactly as directed by your doctor. If you do not understand the instructions, ask your doctor, pharmacist, or nurse to explain them to you.


Wash your hands immediately before using the eye drops.

If you wear contact lenses, remove them before applying demecarium bromide ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication.


To apply the eye drops:



  • Tilt the head back slightly and pull down on the lower eyelid. Position the dropper above the eye. Look up and away from the dropper. Squeeze out a drop and close the eye. Apply gentle pressure to the inside corner of the eye (near the nose) for about 1 minute to prevent the liquid from draining down the tear duct. If you are using more than one drop in the same eye, repeat the process with about 5 minutes between drops. If you are using drops in both eyes, repeat the process in the other eye.




Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye. Do not use any eyedrop that is discolored or has particles in it. Store demecarium bromide ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?


Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.


What happens if I overdose?


Flush the eye with water and seek emergency medical attention.

Symptoms of a demecarium bromide ophthalmic overdose may include sweating, nausea, vomiting, diarrhea, watering mouth, tearing eyes, fainting, difficulty breathing, and an irregular heartbeat.


What should I avoid while using demecarium bromide ophthalmic?


Use caution when driving, operating machinery, or performing other hazardous activities. Demecarium bromide ophthalmic may cause decreased vision at night. If you experience decreased vision, avoid these activities. Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

If you wear contact lenses, remove them before applying demecarium bromide ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication.


Do not use other eye medications during treatment with demecarium bromide ophthalmic except under the direction of your doctor.


Demecarium bromide ophthalmic side effects


Contact your doctor immediately if you notice any decrease in vision or an increase in "floaters" in your visual field. Rarely, demecarium bromide ophthalmic may cause retinal detachment. Retinal detachment can lead to blind spots, floaters in the visual field, and even blindness. Your doctor will want to check your retina before you use this medication to determine if you have an increased risk of retinal detachment.


If you experience any of the following serious side effects, stop using demecarium bromide ophthalmic and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives);




  • abdominal cramps or diarrhea;




  • watering mouth;




  • excessive sweating;




  • urinary incontinence;




  • muscle weakness;




  • difficulty breathing; or




  • an irregular heart beat.



Other, less serious side effects may be more likely to occur. Continue to use demecarium bromide ophthalmic and talk to your doctor if you experience



  • burning, stinging, red, or tearing eyes;




  • eyelid muscle twitches;




  • headache or brow ache; or




  • decreased vision in poor light.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect demecarium bromide ophthalmic?


Do not use other eye medications during treatment with demecarium bromide ophthalmic except under the direction of your doctor.


Organophosphates may increase the effects of demecarium bromide ophthalmic. If you are a gardener, an organophosphate plant or warehouse worker, or a farmer, you may be exposed to organophosphates. Follow the directions of your doctor and workplace safety guides regarding respiratory masks and the washing and changing of clothes.


Drugs other than those listed here may also interact with demecarium bromide ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.



More demecarium bromide ophthalmic resources


  • Demecarium bromide ophthalmic Drug Interactions
  • Demecarium bromide ophthalmic Support Group
  • 0 Reviews for Demecarium bromide - Add your own review/rating


Compare demecarium bromide ophthalmic with other medications


  • Eye Conditions
  • Glaucoma


Where can I get more information?


  • Your pharmacist has additional information about demecarium bromide ophthalmic written for health professionals that you may read.

What does my medication look like?


Demecarium bromide ophthalmic is available with a prescription under the brand name Humorsol in 0.125% and in 0.25% solutions. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.



Thursday, December 1, 2011

Azatioprina Rontag




Azatioprina Rontag may be available in the countries listed below.


Ingredient matches for Azatioprina Rontag



Azathioprine

Azathioprine is reported as an ingredient of Azatioprina Rontag in the following countries:


  • Argentina

International Drug Name Search

Sunday, November 27, 2011

LĂ©visole




LĂ©visole may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for LĂ©visole



Levamisole

Levamisole is reported as an ingredient of LĂ©visole in the following countries:


  • France

Levamisole hydrochloride (a derivative of Levamisole) is reported as an ingredient of LĂ©visole in the following countries:


  • France

International Drug Name Search

Friday, November 25, 2011

Bivicetyl




Bivicetyl may be available in the countries listed below.


Ingredient matches for Bivicetyl



Acetylcysteine

Acetylcysteine is reported as an ingredient of Bivicetyl in the following countries:


  • Vietnam

International Drug Name Search

Thursday, November 24, 2011

Apiguard




Apiguard may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Apiguard



Thymol

Thymol is reported as an ingredient of Apiguard in the following countries:


  • France

  • Luxembourg

  • Netherlands

  • Switzerland

  • United Kingdom

International Drug Name Search

Oxcarbazepine



Pronunciation: OX-kar-BAZ-e-peen
Generic Name: Oxcarbazepine
Brand Name: Trileptal


Oxcarbazepine is used for:

Treating certain types of seizures in patients with epilepsy. It may be used alone or in combination with other medicines. It may also be used for other conditions as determined by your doctor.


Oxcarbazepine is an anticonvulsant. It works by slowing abnormal nerve impulses in the brain.


Do NOT use Oxcarbazepine if:


  • you are allergic to any ingredient in Oxcarbazepine

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



Before using Oxcarbazepine:


Some medical conditions may interact with Oxcarbazepine. 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 are allergic to carbamazepine

  • if you have kidney or liver problems or low blood sodium levels

  • if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions

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


  • HIV protease inhibitors (eg, ritonavir), monoamine oxidase inhibitors (MAOIs) (eg, selegiline), quetiapine, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Oxcarbazepine's side effects

  • Carbamazepine or valproic acid because they may decrease Oxcarbazepine's effectiveness

  • Hydantoins (eg, phenytoin) or phenobarbital because they may decrease Oxcarbazepine's effectiveness. The risk of their side effects may also be increased by Oxcarbazepine

  • Aripiprazole, aromatase inhibitors (eg, exemestane), cyclosporine, epothilones (eg, ixabepilone), felodipine, HIV protease inhibitors (eg, ritonavir), hormonal contraceptives (eg, birth control pills), kinase inhibitors (eg, sunitinib), maraviroc, nonnucleoside reverse transcriptase inhibitors (NNRTIs) (eg, etravirine), quetiapine, tramadol, or tricyclic antidepressants (eg, amitriptyline) because their effectiveness may be decreased by Oxcarbazepine

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


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


  • Oxcarbazepine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Oxcarbazepine refilled.

  • Take Oxcarbazepine by mouth with or without food.

  • It is important to take all doses on time to keep the level of medicine in your blood constant. Take doses at evenly spaced intervals. Do not skip doses.

  • Taking Oxcarbazepine at the same times each day will help you remember to take it.

  • Continue to take Oxcarbazepine even if you feel well. Do not miss any doses. Oxcarbazepine works best when there is a constant level of it in your body.

  • If Oxcarbazepine is stopped, it should be done gradually as directed by your doctor. The risk of seizures may be increased if Oxcarbazepine is suddenly stopped.

  • If you miss a dose of Oxcarbazepine, 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 Oxcarbazepine.



Important safety information:


  • Oxcarbazepine may cause drowsiness, dizziness, changes in vision, or difficulty with coordination. These effects may be worse if you take it with alcohol or certain medicines. Use Oxcarbazepine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Oxcarbazepine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Patients who take Oxcarbazepine may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Oxcarbazepine closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.

  • Carry identification (eg, MedicAlert) if Oxcarbazepine is used for seizures. Carry an ID card at all times that says you take Oxcarbazepine.

  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Oxcarbazepine. To prevent pregnancy, use an extra form of birth control (eg, condoms).

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

  • Do not suddenly stop taking Oxcarbazepine. Oxcarbazepine must be gradually decreased when discontinued. Talk to your doctor about the proper way to stop taking Oxcarbazepine.

  • Notify your doctor if seizure control worsens.

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

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

  • Oxcarbazepine should be used with extreme caution in CHILDREN younger than 2 years; safety and effectiveness in these children have not been confirmed.

  • Oxcarbazepine may become less effective if used during pregnancy. Your doctor will closely monitor your condition. Discuss any questions or concerns with your doctor. If you think you may be pregnant, contact your doctor.

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


Possible side effects of Oxcarbazepine:


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



Constipation; diarrhea; dizziness; drowsiness; headache; indigestion; mild stomach pain; nausea; tiredness; vomiting.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, eyes, face, lips, or tongue; unusual hoarseness); blood in the stool; chest pain; decreased coordination; decreased urination; difficulty concentrating or speaking; double vision, changes in vision, or involuntary eye movement; dulled sense of touch; fast, slow, or irregular heartbeat; fever, chills, or sore throat; joint or muscle pain, swelling, or weakness; new or worsening mental or mood changes (eg, depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness, behavior changes, suicidal thoughts or actions); new or worsening seizures; nosebleed; painful sores in the mouth or around the eyes; red, swollen, blistered, or peeling skin; severe or persistent stomach pain; shortness of breath; swollen lymph nodes; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); symptoms of low sodium levels (nausea, general body discomfort, headache, lack of energy, confusion, decreased consciousness, increased frequency or severity of seizures); tremor; trouble sleeping; trouble walking; uncontrolled muscle movements; unusual bruising or bleeding; unusual tiredness or 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: Oxcarbazepine 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 Oxcarbazepine:

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


General information:


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

  • Oxcarbazepine 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 Oxcarbazepine. 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 Oxcarbazepine resources


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


  • Oxcarbazepine Prescribing Information (FDA)

  • Oxcarbazepine Professional Patient Advice (Wolters Kluwer)

  • Oxcarbazepine Monograph (AHFS DI)

  • Trileptal Consumer Overview

  • Trileptal Prescribing Information (FDA)

  • oxcarbazepine Advanced Consumer (Micromedex) - Includes Dosage Information



Compare Oxcarbazepine with other medications


  • Anxiety
  • Bipolar Disorder
  • Seizures
  • Trigeminal Neuralgia

Tuesday, November 22, 2011

Disopyramide Sustained-Release Capsules


Pronunciation: dye-soe-PEER-a-mide
Generic Name: Disopyramide
Brand Name: Norpace CR

Disopyramide Sustained-Release Capsules sometimes produces new irregular heartbeats (arrhythmias). Therefore, it should be used in carefully selected patients. Consult your doctor or pharmacist for more information.





Disopyramide Sustained-Release Capsules are used for:

Correcting or preventing various types of life-threatening irregular heartbeats and heart rhythm disturbances.


Disopyramide Sustained-Release Capsules are an antiarrhythmic. It works by stabilizing the heart rhythm in conditions in which the heart is beating too fast or in an irregular rhythm (antiarrhythmic effect).


Do NOT use Disopyramide Sustained-Release Capsules if:


  • you are allergic to any ingredient in Disopyramide Sustained-Release Capsules

  • you have second- or third-degree heart block and do not have a pacemaker, you were born with an irregular heartbeat due to QT prolongation, or your heart is in shock

  • you are taking astemizole, cisapride, a class III antiarrhythmic (eg, amiodarone, sotalol), a phenothiazine (eg, thioridazine), pimozide, or a quinolone (eg, grepafloxacin, sparfloxacin), or terfenadine

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



Before using Disopyramide Sustained-Release Capsules:


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


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

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

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

  • if you have a history of certain heart conditions or irregular heart rhythms (eg, enlargement or inflammation of the heart, heart block, heart failure, heart attack, Wolff-Parkinson-White syndrome), diabetes, glaucoma, severe muscle weakness, high or low levels of potassium in the blood, or kidney or liver disease

  • if you have difficulty urinating due to an obstruction of the bladder neck or prostate problems

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


  • Astemizole, beta-blockers (eg, propranolol), cisapride, class III antiarrhythmics (eg, amiodarone, sotalol), dofetilide, droperidol, ketolides (eg, telithromycin), macrolides (eg, erythromycin), phenothiazine (eg, thioridazine), pimozide, quinolones (eg, sparfloxacin, grepafloxacin), terfenadine, verapamil, or ziprasidone because side effects, such as life threatening irregular heartbeats, may be increased

  • Hydantoins (eg, phenytoin) because the effectiveness of Disopyramide Sustained-Release Capsules may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Disopyramide Sustained-Release Capsules 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 Disopyramide Sustained-Release Capsules:


Use Disopyramide Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Disopyramide Sustained-Release Capsules may be taken with or without food.

  • Swallow Disopyramide Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.

  • Disopyramide Sustained-Release Capsules works best if it is taken at the same time each day.

  • If you miss a dose of Disopyramide Sustained-Release Capsules, 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 Disopyramide Sustained-Release Capsules.



Important safety information:


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

  • Do not become overheated in hot weather or during exercise or other activities; heatstroke may occur.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Disopyramide Sustained-Release Capsules.

  • Use Disopyramide Sustained-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects.

  • Use Disopyramide Sustained-Release Capsules with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

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


Possible side effects of Disopyramide Sustained-Release Capsules:


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:



Aches or pain; bloating; blurred vision; constipation; difficulty urinating; dizziness; dryness of the eyes, mouth, nose, or throat; fatigue; frequent and urgent urination; gas; general body discomfort; headache; muscle weakness; nausea; tiredness.



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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or slow heartbeat; fever; lightheadedness; heart rhythm problems; severe difficulty urinating; shortness of breath; sore throat; swelling.



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: Disopyramide 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 difficulty breathing; change in heart rhythm; loss of consciousness.


Proper storage of Disopyramide Sustained-Release Capsules:

Store Disopyramide Sustained-Release Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Disopyramide Sustained-Release Capsules out of the reach of children and away from pets.


General information:


  • If you have any questions about Disopyramide Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.

  • Disopyramide Sustained-Release Capsules 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 Disopyramide Sustained-Release Capsules. 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 Disopyramide resources


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


Compare Disopyramide with other medications


  • Arrhythmia

Chlorsuccillin




Chlorsuccillin may be available in the countries listed below.


Ingredient matches for Chlorsuccillin



Suxamethonium Chloride

Suxamethonium Chloride is reported as an ingredient of Chlorsuccillin in the following countries:


  • Poland

International Drug Name Search

Monday, November 21, 2011

FML Forte Liquifilm


FML Forte Liquifilm is a brand name of fluorometholone ophthalmic, approved by the FDA in the following formulation(s):


FML FORTE (fluorometholone - suspension/drops; ophthalmic)



  • Manufacturer: ALLERGAN

    Approval date: April 23, 1986

    Strength(s): 0.25%

Has a generic version of FML Forte Liquifilm been approved?


No. There is currently no therapeutically equivalent version of FML Forte Liquifilm available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of FML Forte Liquifilm. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with FML Forte Liquifilm.

See also...

  • FML Forte Consumer Information (Wolters Kluwer)
  • FML Forte Liquifilm Consumer Information (Cerner Multum)
  • Fluorometholone Consumer Information (Wolters Kluwer)
  • Fluorometholone Acetate Suspension Consumer Information (Wolters Kluwer)
  • Fluorometholone Ointment Consumer Information (Wolters Kluwer)
  • Fluorometholone ophthalmic Consumer Information (Cerner Multum)
  • Fluorometholone AHFS DI Monographs (ASHP)

Evothyl




Evothyl may be available in the countries listed below.


Ingredient matches for Evothyl



Fenofibrate

Fenofibrate is reported as an ingredient of Evothyl in the following countries:


  • Indonesia

International Drug Name Search

Saturday, November 19, 2011

Kezole




Kezole may be available in the countries listed below.


Ingredient matches for Kezole



Ketoconazole

Ketoconazole is reported as an ingredient of Kezole in the following countries:


  • Ethiopia

  • Georgia

  • Peru

International Drug Name Search

Cefuracet




Cefuracet may be available in the countries listed below.


Ingredient matches for Cefuracet



Cefuroxime

Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Cefuracet in the following countries:


  • Mexico

International Drug Name Search

Thursday, November 17, 2011

Ciprofloxacin Heumann




Ciprofloxacin Heumann may be available in the countries listed below.


Ingredient matches for Ciprofloxacin Heumann



Ciprofloxacin

Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Ciprofloxacin Heumann in the following countries:


  • Germany

International Drug Name Search

Saturday, November 12, 2011

Genbexil




Genbexil may be available in the countries listed below.


Ingredient matches for Genbexil



Gentamicin

Gentamicin is reported as an ingredient of Genbexil in the following countries:


  • Ecuador

International Drug Name Search

Thursday, November 10, 2011

Amlodipina Hexal




Amlodipina Hexal may be available in the countries listed below.


Ingredient matches for Amlodipina Hexal



Amlodipine

Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Amlodipina Hexal in the following countries:


  • Italy

International Drug Name Search

Pontocaine




In the US, Pontocaine (tetracaine topical) is a member of the drug class topical anesthetics and is used to treat Allergic Urticaria, Cold Sores, Local Anesthesia, Skin Rash and Urticaria.

US matches:

  • Pontocaine

Ingredient matches for Pontocaine



Tetracaine

Tetracaine hydrochloride (a derivative of Tetracaine) is reported as an ingredient of Pontocaine in the following countries:


  • Canada

  • United States

International Drug Name Search

Monday, November 7, 2011

Vitaminum B6




Vitaminum B6 may be available in the countries listed below.


Ingredient matches for Vitaminum B6



Pyridoxine

Pyridoxine hydrochloride (a derivative of Pyridoxine) is reported as an ingredient of Vitaminum B6 in the following countries:


  • Poland

International Drug Name Search

Sunday, November 6, 2011

Masticlav




Masticlav may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Masticlav



Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Masticlav in the following countries:


  • Switzerland

Clavulanate

Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Masticlav in the following countries:


  • Switzerland

International Drug Name Search

Wednesday, November 2, 2011

Propranolol Stada




Propranolol Stada may be available in the countries listed below.


Ingredient matches for Propranolol Stada



Propranolol

Propranolol hydrochloride (a derivative of Propranolol) is reported as an ingredient of Propranolol Stada in the following countries:


  • Germany

International Drug Name Search

Monday, October 31, 2011

Cefonicid ratiopharm




Cefonicid ratiopharm may be available in the countries listed below.


Ingredient matches for Cefonicid ratiopharm



Cefonicid

Cefonicid disodium salt (a derivative of Cefonicid) is reported as an ingredient of Cefonicid ratiopharm in the following countries:


  • Italy

International Drug Name Search

Thursday, October 27, 2011

Brompheniramine/Pseudoephedrine Suspension


Pronunciation: brome-fen-EER-ah-meen/soo-doe-eh-FED-rin
Generic Name: Brompheniramine/Pseudoephedrine
Brand Name: Lodrane D


Brompheniramine/Pseudoephedrine Suspension is used for:

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


Brompheniramine/Pseudoephedrine Suspension is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure.


Do NOT use Brompheniramine/Pseudoephedrine Suspension if:


  • you are allergic to any ingredient in Brompheniramine/Pseudoephedrine Suspension

  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

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

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



Before using Brompheniramine/Pseudoephedrine Suspension:


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


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

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

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

  • if you have a fast, slow, or irregular heartbeat; heart blood vessel problems; or other heart problems

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

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


  • Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Brompheniramine/Pseudoephedrine Suspension may be increased

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

  • Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Brompheniramine/Pseudoephedrine Suspension

  • Guanadrel, guanethidine, methyldopa, mecamylamine, or reserpine because effectiveness may be decreased by Brompheniramine/Pseudoephedrine Suspension

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


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


  • Brompheniramine/Pseudoephedrine Suspension may be taken with or without food.

  • Shake well before each use.

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

  • If you miss a dose of Brompheniramine/Pseudoephedrine Suspension, 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 Brompheniramine/Pseudoephedrine Suspension.



Important safety information:


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

  • Do not take diet or appetite control medicines while you are taking Brompheniramine/Pseudoephedrine Suspension without checking with your doctor.

  • Brompheniramine/Pseudoephedrine Suspension contains brompheniramine and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains brompheniramine or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.

  • Do NOT exceed the recommended dose or take Brompheniramine/Pseudoephedrine Suspension for longer than prescribed without checking with your doctor.

  • If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.

  • Brompheniramine/Pseudoephedrine Suspension may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Brompheniramine/Pseudoephedrine Suspension. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

  • If you are scheduled for allergy skin testing, do not take Brompheniramine/Pseudoephedrine Suspension for several days before the test because it may decrease your response to the skin tests.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Brompheniramine/Pseudoephedrine Suspension.

  • Use Brompheniramine/Pseudoephedrine Suspension with caution in the ELDERLY because they may be more sensitive to its effects.

  • Caution is advised when using Brompheniramine/Pseudoephedrine Suspension in CHILDREN because they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Brompheniramine/Pseudoephedrine Suspension, discuss with your doctor the benefits and risks of using Brompheniramine/Pseudoephedrine Suspension during pregnancy. It is unknown if Brompheniramine/Pseudoephedrine Suspension is excreted in breast milk. Do not breast-feed while taking Brompheniramine/Pseudoephedrine Suspension.


Possible side effects of Brompheniramine/Pseudoephedrine Suspension:


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



Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.



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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.



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


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


If OVERDOSE is suspected:


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


Proper storage of Brompheniramine/Pseudoephedrine Suspension:

Store Brompheniramine/Pseudoephedrine Suspension 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 Brompheniramine/Pseudoephedrine Suspension out of the reach of children and away from pets.


General information:


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

  • Brompheniramine/Pseudoephedrine Suspension 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 Brompheniramine/Pseudoephedrine Suspension. 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 Brompheniramine/Pseudoephedrine resources


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


Compare Brompheniramine/Pseudoephedrine with other medications


  • Hay Fever
  • Nasal Congestion

Sunday, October 16, 2011

Sodate Ointment




Sodate Ointment may be available in the countries listed below.


Ingredient matches for Sodate Ointment



Fusidic Acid

Fusidic Acid is reported as an ingredient of Sodate Ointment in the following countries:


  • Bangladesh

International Drug Name Search

Friday, October 14, 2011

Acido Alendronico Ratiopharm




Acido Alendronico Ratiopharm may be available in the countries listed below.


Ingredient matches for Acido Alendronico Ratiopharm



Alendronic Acid

Alendronic Acid is reported as an ingredient of Acido Alendronico Ratiopharm in the following countries:


  • Portugal

International Drug Name Search

Sunday, October 9, 2011

Ranitidine Tablets




Generic Name: ranitidine hydrochloride

Dosage Form: tablet
PRESCRIBING INFORMATION


Ranitidine Tablets USP, 150 mg and 300 mg

Ranitidine Tablets Description


The active ingredient in Ranitidine Tablets 150 mg and 300 mg is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5- [(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:

The empirical formula is C13H22N4O3S•HCl, representing a molecular weight of 350.87.

Ranitidine HCl is a white to pale yellow, crystalline practically odorless powder, very soluble in water, sparingly soluble in alcohol.


Each ranitidine tablet 150 mg for oral administration contains 168 mg of ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, hypromellose, titanium dioxide, diethyl phthalate, FD&C yellow # 6 and iron oxide red.


Each Ranitidine Tablet 300 mg for oral administration contains 336 mg of ranitidine HCl equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, hypromellose, titanium dioxide, and diethyl phthalate.

Ranitidine Tablets - Clinical Pharmacology


Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H2-receptors, including receptors on the gastric cells. Ranitidine does not lower serum Ca++ in hypercalcemic states. Ranitidine is not an anticholinergic agent.

Pharmacokinetics:


Absorption: Ranitidine is 50% absorbed after oral administration, compared to an intravenous (IV) injection with mean peak levels of 440 to 545 ng/mL occurring 2 to 3 hours after a 150-mg dose. Absorption is not significantly impaired by the administration of food or antacids. Propantheline slightly delays and increases peak blood levels of ranitidine, probably by delaying gastric emptying and transit time. In one study, simultaneous administration of high-potency antacid (150 mmol) in fasting subjects has been reported to decrease the absorption of ranitidine.


Distribution: The volume of distribution is about 1.4 L/kg. Serum protein binding averages 15%.


Metabolism: In humans, the N-oxide is the principal metabolite in the urine; however, this amounts to <4% of the dose. Other metabolites are the S-oxide (1%) and the desmethyl ranitidine (1%). The remainder of the administered dose is found in the stool. Studies in patients with hepatic dysfunction (compensated cirrhosis) indicate that there are minor, but clinically insignificant, alterations in ranitidine half-life, distribution, clearance, and bioavailability.


Excretion: The principal route of excretion is the urine, with approximately 30% of the orally administered dose collected in the urine as unchanged drug in 24 hours. Renal clearance is about 410 mL/min, indicating active tubular excretion. The elimination half-life is 2.5 to 3 hours. Four patients with clinically significant renal function impairment (creatinine clearance 25 to 35 mL/min) administered 50 mg of ranitidine intravenously had an average plasma half-life of 4.8 hours, a ranitidine clearance of 29 mL/min, and a volume of distribution of 1.76 L/kg. In general, these parameters appear to be altered in proportion to creatinine clearance (see DOSAGE AND ADMINISTRATION).


Geriatrics: The plasma half-life is prolonged and total clearance is reduced in the elderly population due to a decrease in renal function. The elimination half-life is 3 to 4 hours. Peak levels average 526 ng/mL following a 150-mg twice daily dose and occur in about 3 hours (see PRECAUTIONS: Geriatric Use and DOSAGE AND ADMINISTRATION: Dosage Adjustment for Patients With Impaired Renal Function).


Pediatrics: There are no significant differences in the pharmacokinetic parameter values for ranitidine in pediatric patients (from 1 month up to 16 years of age) and healthy adults when correction is made for body weight. The average bioavailability of ranitidine given orally to pediatric patients is 48% which is comparable to the bioavailability of ranitidine in the adult population. All other pharmacokinetic parameter values (t1/2, Vd, and CL) are similar to those observed with intravenous ranitidine use in pediatric patients. Estimates of Cmax and Tmax are displayed in Table 1.























Table 1. Ranitidine Pharmacokinetics in Pediatric Patients Following Oral Dosing
Population (age)nDosage Form

(dose)
Cmax

(ng/mL)
Tmax

(hours)
Gastric or duodenal ulcer

(3.5 to 16 years)
12Tablets

(1 to 2 mg/kg)
54 to 4922.0
Otherwise healthy requiring ranitidine

(0.7 to 14 years, Single dose)
10Syrup

(2 mg/kg)
2441.61
Otherwise healthy requiring ranitidine

(0.7 to 14 years, Multiple dose)
10Syrup

(2 mg/kg)
3201.66

Plasma clearance measured in 2 neonatal patients (less than 1 month of age) was considerably lower (3 mL/min/kg) than children or adults and is likely due to reduced renal function observed in this population (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION: Pediatric Use).


Pharmacodynamics: Serum concentrations necessary to inhibit 50% of stimulated gastric acid secretion are estimated to be 36 to 94 ng/mL. Following a single oral dose of 150 mg, serum concentrations of ranitidine are in this range up to 12 hours. However, blood levels bear no consistent relationship to dose or degree of acid inhibition.


Antisecretory Activity: 1. Effects on Acid Secretion: Ranitidine inhibits both daytime and nocturnal basal gastric acid secretions as well as gastric acid secretion stimulated by food, betazole, and pentagastrin, as shown in Table 2.








































Table 2. Effect of Oral Ranitidine on Gastric Acid Secretion
Time After

Dose, hours
% Inhibition of Gastric Acid Output by Dose, mg
75-80100150200
BasalUp to 49995
NocturnalUp to 13959692
BetazoleUp to 39799
PentagastinUp to 558727280
MealUp to 3737995

It appears that basal-, nocturnal-, and betazole-stimulated secretions are most sensitive to inhibition by ranitidine, responding almost completely to doses of 100 mg or less, while pentagastrin- and food-stimulated secretions are more difficult to suppress.


2. Effects on Other Gastrointestinal Secretions:


Pepsin: Oral ranitidine does not affect pepsin secretion. Total pepsin output is reduced in proportion to the decrease in volume of gastric juice.


Intrinsic Factor: Oral ranitidine has no significant effect on pentagastrin-stimulated intrinsic factor secretion.


Serum Gastrin: Ranitidine has little or no effect on fasting or postprandial serum gastrin.


Other Pharmacologic Actions:
  1. Gastric bacterial flora—increase in nitrate-reducing organisms, significance not known.

  2. Prolactin levels—no effect in recommended oral or IV dosage, but small, transient, dose-related increases in serum prolactin have been reported after IV bolus injections of 100 mg or more.

  3. Other pituitary hormones—no effect on serum gonadotropins, TSH, or GH. Possible impairment of vasopressin release.

  4. No change in cortisol, aldosterone, androgen, or estrogen levels.

  5. No antiandrogenic action.

  6. No effect on count, motility, or morphology of sperm.



Pediatrics: Oral doses of 6 to 10 mg/kg/day in 2 or 3 divided doses maintain gastric pH>4 throughout most of the dosing interval.


Clinical Trials: Active Duodenal Ulcer: In a multicenter, double-blind, controlled, US study of endoscopically diagnosed duodenal ulcers, earlier healing was seen in the patients treated with ranitidine as shown in Table 3.

























Table 3. Duodenal Ulcer Patient Healing Rates
Ranitidine*Placebo*
Number

Entered
Healed /

Evaluable
Number

Entered
Healed /

Evaluable
Outpatients195

69/182

(38%) †
188

31/164

(19%)
Week 2    
Week 4137/187

(73%) †
76/168

(45%)
  

* All patients were permitted antacids as needed for relief of pain.

†P<0.0001.


In these studies, patients treated with ranitidine reported a reduction in both daytime and nocturnal pain, and they also consumed less antacid than the placebo-treated patients.












Table 4. Mean Daily Doses of Antacid
Ulcer HealedUlcer Not Healed
Ranitidine0.060.71
Placebo0.711.43

Foreign studies have shown that patients heal equally well with 150 mg twice daily and 300 mg at bedtime (85% versus 84%, respectively) during a usual 4-week course of therapy. If patients require extended therapy of 8 weeks, the healing rate may be higher for 150 mg twice daily as compared to 300 mg at bedtime (92% versus 87%, respectively).


Studies have been limited to short-term treatment of acute duodenal ulcer. Patients whose ulcers healed during therapy had recurrences of ulcers at the usual rates.


Maintenance Therapy in Duodenal Ulcer: Ranitidine has been found to be effective as maintenance therapy for patients following healing of acute duodenal ulcers. In 2 independent, double-blind, multicenter, controlled trials, the number of duodenal ulcers observed was significantly less in patients treated with ranitidine (150 mg at bedtime) than in patients treated with placebo over a 12-month period.






































Table 5. Duodenal Ulcer Prevalence
Double-Blind, Multicenter, Placebo-Controlled Trials
Multicenter

Trial
DrugDuodenal Ulcer PrevalenceNo. Of Patients
0-4

Months
0-8

Months
0-12

Months
USARAN20%*24%*35%*138
PLC44%54%59%139 
ForeignRAN12%*21%*28%*174
PLC56%64%68%165 

% = Life table estimate.

* = P<0.05 (ranitidine versus comparator).

RAN = ranitidine.

PLC = placebo.


As with other H2-antagonists, the factors responsible for the significant reduction in the prevalence of duodenal ulcers include prevention of recurrence of ulcers, more rapid healing of ulcers that may occur during maintenance therapy, or both.


Gastric Ulcer: In a multicenter, double-blind, controlled, US study of endoscopically diagnosed gastric ulcers, earlier healing was seen in the patients treated with ranitidine as shown in Table 6.

























Table 6. Gastric Ulcer Patient Healing Rates
Ranitidine*Placebo*
Number

Entered
Healed /

Evaluable
Number

Entered
Healed /

Evaluable
Outpatients92

16/83

(19%)
94

10/83

(12%)
Week 2    
Week 650/73

(68%)†
35/69

(51%)
  

* All patients were permitted antacids as needed for relief of pain.

†P = 0.009.


In this multicenter trial, significantly more patients treated with ranitidine became pain free during therapy.


Maintenance of Healing of Gastric Ulcers: In 2 multicenter, double-blind, randomized, placebo-controlled, 12-month trials conducted in patients whose gastric ulcers had been previously healed, ranitidine 150 mg at bedtime was significantly more effective than placebo in maintaining healing of gastric ulcers.


Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome): Ranitidine inhibits gastric acid secretion and reduces occurrence of diarrhea, anorexia, and pain in patients with pathological hypersecretion associated with Zollinger-Ellison syndrome, systemic mastocytosis, and other pathological hypersecretory conditions (e.g., postoperative, "short-gut" syndrome, idiopathic). Use of ranitidine was followed by healing of ulcers in 8 of 19 (42%) patients who were intractable to previous therapy.


Gastroesophageal Reflux Disease (GERD): In 2 multicenter, double-blind, placebo-controlled, 6-week trials performed in the United States and Europe, ranitidine 150 mg twice daily was more effective than placebo for the relief of heartburn and other symptoms associated with GERD. Ranitidine-treated patients consumed significantly less antacid than did placebo-treated patients.


The US trial indicated that ranitidine 150 mg twice daily significantly reduced the frequency of heartburn attacks and severity of heartburn pain within 1 to 2 weeks after starting therapy. The improvement was maintained throughout the 6-week trial period. Moreover, patient response rates demonstrated that the effect on heartburn extends through both the day and night time periods.


In 2 additional US multicenter, double-blind, placebo-controlled, 2-week trials, ranitidine 150 mg twice daily was shown to provide relief of heartburn pain within 24 hours of initiating therapy and a reduction in the frequency of severity of heartburn.


Erosive Esophagitis: In 2 multicenter, double-blind, randomized, placebo-controlled, 12-week trials performed in the United States, ranitidine 150 mg 4 times daily was significantly more effective than placebo in healing endoscopically diagnosed erosive esophagitis and in relieving associated heartburn. The erosive esophagitis healing rates were as follows:

















Table 7. Erosive Esophagitis Patient Healing Rates
Healed / Evaluable
Placebo*

n=229
Ranitidine HCl

150 mg 4 times daily*

n=215
Week 443/198 (22%)96/206 (47%) †
Week 863/176 (36%)142/200 (71%) †
Week 1292/159 (58%)162/192 (84%) †

* All patients were permitted antacids as needed for relief of pain.

†P<0.001 versus placebo.


No additional benefit in healing of esophagitis or in relief of heartburn was seen with a ranitidine dose of 300 mg 4 times daily.


Maintenance of Healing of Erosive Esophagitis: In 2 multicenter, double-blind, randomized, placebo-controlled, 48-week trials conducted in patients whose erosive esophagitis had been previously healed, ranitidine 150 mg twice daily was significantly more effective than placebo in maintaining healing of erosive esophagitis.

Indications and Usage for Ranitidine Tablets


Ranitidine Tablets are indicated in:
  1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks.  Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.

  2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.

  3. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).

  4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated.  Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.

  5. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.

  6. Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily.

  7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily.

  8. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.  


Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.

Contraindications


Ranitidine is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS).

Precautions


General:
  1. Symptomatic response to therapy with ranitidine does not preclude the presence of gastric malignancy.

  2. Since ranitidine is excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function (see DOSAGE AND ADMINISTRATION).  Caution should be observed in patients with hepatic dysfunction since ranitidine is metabolized in the liver.

  3. Rare reports suggest that ranitidine may precipitate acute porphyric attacks in patients with acute porphyria. Ranitidine should therefore be avoided in patients with a history of acute porphyria.


Laboratory Tests: False-positive tests for urine protein with MULTISTIX® may occur during therapy with ranitidine, and therefore testing with sulfosalicylic acid is recommended.


Drug Interactions: Ranitidine has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.


Procainamide: Ranitidine, a substrate of the renal organic cation transport system, may affect the clearance of other drugs eliminated by this route. High doses of ranitidine (e.g., such as those used in the treatment of Zollinger-Ellison syndrome) have been shown to reduce the renal excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs. Although this interaction is unlikely to be clinically relevant at usual ranitidine doses, it may be prudent to monitor for procainamide toxicity when administered with oral ranitidine at a dose exceeding 300 mg per day.


Warfarin: There have been reports of altered prothrombin time among patients on concomitant warfarin and ranitidine therapy. Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.


Ranitidine may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability. This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in absorption (e.g., ketoconazole, atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is recommended.


Atazanavir: Atazanavir absorption may be impaired based on known interactions with other agents that increase gastric pH. Use with caution. See atazanavir label for specific recommendations.


Delavirdine: Delavirdine absorption may be impaired based on known interactions with other agents that increase gastric pH. Chronic use of H2-receptor antagonists with delavirdine is not recommended.


Gefitinib: Gefitinib exposure was reduced by 44% with the coadministration of ranitidine and sodium bicarbonate (dosed to maintain gastric pH above 5.0). Use with caution.


Glipizide: In diabetic patients, glipizide exposure was increased by 34% following a single 150-mg dose of oral ranitidine. Use appropriate clinical monitoring when initiating or discontinuing ranitidine.


Ketoconazole: Oral ketoconazole exposure was reduced by up to 95% when oral ranitidine was coadministered in a regimen to maintain a gastric pH of 6 or above. The degree of interaction with usual dose of ranitidine (150 mg twice daily) is unknown.


Midazolam: Oral midazolam exposure in 5 healthy volunteers was increased by up to 65% when administered with oral ranitidine at a dose of 150 mg twice daily. However, in another interaction study in 8 volunteers receiving IV midazolam, a 300 mg oral dose of ranitidine increased midazolam exposure by about 9%. Monitor patients for excessive or prolonged sedation when ranitidine is coadministered with oral midazolam.


Triazolam: Triazolam exposure in healthy volunteers was increased by approximately 30% when administered with oral ranitidine at a dose of 150 mg twice daily. Monitor patients for excessive or prolonged sedation.


Carcinogenesis, Mutagenesis, Impairment of Fertility: There was no indication of tumorigenic or carcinogenic effects in life-span studies in mice and rats at dosages up to 2,000 mg/kg/day.

Ranitidine was not mutagenic in standard bacterial tests (Salmonella, Escherichia coli) for mutagenicity at concentrations up to the maximum recommended for these assays.

In a dominant lethal assay, a single oral dose of 1,000 mg/kg to male rats was without effect on the outcome of 2 matings per week for the next 9 weeks.


Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 160 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ranitidine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.


Nursing Mothers: Ranitidine is secreted in human milk. Caution should be exercised when ranitidine is administered to a nursing mother.


Pediatric Use: The safety and effectiveness of ranitidine have been established in the age-group of 1 month to 16 years for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease and erosive esophagitis, and the maintenance of healed duodenal and gastric ulcer. Use of ranitidine in this age-group is supported by adequate and well-controlled studies in adults, as well as additional pharmacokinetic data in pediatric patients and an analysis of the published literature (see CLINICAL PHARMACOLOGY: Pediatrics and DOSAGE AND ADMINISTRATION: Pediatric Use).

Safety and effectiveness in pediatric patients for the treatment of pathological hypersecretory conditions or the maintenance of healing of erosive esophagitis have not been established.

Safety and effectiveness in neonates (less than 1 month of age) have not been established (see CLINICAL PHARMACOLOGY: Pediatrics).


Geriatric Use: Of the total number of subjects enrolled in US and foreign controlled clinical trials of oral formulations of ranitidine, for which there were subgroup analyses, 4,197 were 65 and over, while 899 were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics and DOSAGE AND ADMINISTRATION: Dosage Adjustment for Patients With Impaired Renal Function).


Adverse Reactions


The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine. The relationship to therapy with ranitidine has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ranitidine.


Central Nervous System: Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received.


Cardiovascular: As with other H2-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.


Gastrointestinal: Constipation, diarrhea, nausea/vomiting, abdominal discomfort/ pain, and rare reports of pancreatitis.


Hepatic: There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, ranitidine should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred. Rare cases of hepatic failure have also been reported. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intravenously 4 times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously 4 times daily for 5 days.


Musculoskeletal: Rare reports of arthralgias and myalgias.


Hematologic: Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.


Endocrine: Controlled studies in animals and man have shown no stimulation of any pituitary hormone by ranitidine and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when ranitidine has been substituted. However, occasional cases of impotence and loss of libido have been reported in male patients receiving ranitidine, but the incidence did not differ from that in the general population. Rare cases of breast symptoms and conditions, including galactorrhea and gynecomastia, have been reported in both males and females.


Integumentary: Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis.


Respiratory: A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H2RAs) compared to patients who had stopped H2RA treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07- 2.48). However, a causal relationship between use of H2RAs and pneumonia has not been established.


Other: Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine.

Overdosage


There has been limited experience with overdosage. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience (see ADVERSE REACTIONS). In addition, abnormalities of gait and hypotension have been reported.

When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.


Studies in dogs receiving dosages of ranitidine in excess of 225 mg/kg/day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal. Intravenous LD50 values in mice and rats were 77 and 83 mg/kg, respectively.

Ranitidine Tablets Dosage and Administration


Active Duodenal Ulcer: The current recommended adult oral dosage of ranitidine for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared to the other in a particular patient population have yet to be demonstrated (see Clinical Trials: Active Duodenal Ulcer).  Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US studies, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.


Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).


Maintenance of Healing of Duodenal Ulcers: The current recommended adult oral dosage is 150 mg at bedtime.


Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome): The current recommended adult oral dosage is 150 mg twice daily. In some patients it may be necessary to administer ranitidine 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease.


Benign Gastric Ulcer: The current recommended adult oral dosage is 150 mg twice daily.


Maintenance of Healing of Gastric Ulcers: The current recommended adult oral dosage is 150 mg at bedtime.


GERD: The current recommended adult oral dosage is 150 mg twice daily.


Erosive Esophagitis: The current recommended adult oral dosage is 150 mg 4 times daily.


Maintenance of Healing of Erosive Esophagitis: The current recommended adult oral dosage is 150 mg twice daily.


Pediatric Use: The safety and effectiveness of ranitidine have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of ranitidine in neonatal patients (less than 1 month of age) to make dosing recommendations.


The following 3 subsections provide dosing information for each of the pediatric indications.


Treatment of Duodenal and Gastric Ulcers: The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.


Maintenance of Healing of Duodenal and Gastric Ulcers: The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients.


Treatment of GERD and Erosive Esophagitis: Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg/day, usually given as 2 divided doses.


Dosage Adjustment for Patients With Impaired Renal Function: On the basis of experience with a group of subjects with severely impaired renal function treated with ranitidine, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg or 10 mL of syrup (2 teaspoonfuls of syrup equivalent to 150 mg of ranitidine) every 24 hours. Should the patient's condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.

Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics and PRECAUTIONS: Geriatric Use).

How is Ranitidine Tablets Supplied


Ranitidine Tablets USP 150 mg (ranitidine HCl equivalent to 150 mg of ranitidine) are orange colored, film-coated, irregular hexagonal-shaped tablets debossed with "W" on one side and plain on other side.                                                                                                                                                                                     447

They are available in following packs.


PACKS                                NDC NUMBER

10 Tablets                                     64679-447-01

60 Tablets                                     64679-447-04

100 Tablets                                   64679-447-02

10 X 10’s Blister Pack                  64679-447-03

500 Tablets                                   64679-447-06


Ranitidine Tablets USP 300 mg (ranitidine HCl equivalent to 300 mg of ranitidine) are white to off white, film-coated, capsule-shaped tablets debossed with "W742" on one side and plain on other side.

They are available in following packs.


PACKS                                NDC NUMBER

30 Tablets                                     64679-742-01

100 Tablets                                   64679-742-04

250 Tablets                                   64679-742-02

10 X 10’s Blister Pack                64679-742-03


Store between 20° and 25°C (68°and 77°F) in a dry place. Protect from light. Replace cap securely after each opening.


Bottle contains desiccant.


Rx only


MULTISTIX is a registered trademark of Bayer Healthcare LLC.


Manufactured By:

Wockhardt Limited

Mumbai, India.


Distributed By:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.


Iss.210711













RANITIDINE 
ranitidine hydrochloride  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)64679-447
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (RANITIDINE)RANITIDINE150 mg






















Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
COLLOIDAL SILICON DIOXIDE 
HYPROMELLOSES 
TITANIUM DIOXIDE 
DIETHYL PHTHALATE 
FD&C YELLOW NO. 6 
FERRIC OXIDE RED 


















Product Characteristics
Colororange (Orange)Scoreno score
ShapeHEXAGON (6 sided) (irregular hexagonal-shaped)Size10mm
FlavorImprint CodeW;447
Contains      

































Packaging
#NDCPackage DescriptionMultilevel Packaging
164679-447-0110 TABLET In 1 BOTTLENone
264679-447-0460 TABLET In 1 BOTTLENone
364679-447-02100 TABLET In 1 BOTTLENone
464679-447-0310 BLISTER In 1 CARTONcontains a BLISTER PACK
410 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (64679-447-03)
564679-447-0515000 TABLET In 1 DRUMNone
664679-447-06500 TABLET In 1 BOTTLENon