Wednesday, 28 September 2016

Clinoril


Clinoril is a brand name of sulindac, approved by the FDA in the following formulation(s):


CLINORIL (sulindac - tablet; oral)



  • Manufacturer: MERCK

    Approved Prior to Jan 1, 1982

    Strength(s): 200MG [RLD][AB]

Has a generic version of Clinoril been approved?


Yes. The following products are equivalent to Clinoril:


sulindac tablet; oral



  • Manufacturer: EPIC PHARMA

    Approval date: March 25, 1991

    Strength(s): 200MG [AB]


  • Manufacturer: MUTUAL PHARM

    Approval date: April 17, 1991

    Strength(s): 200MG [AB]


  • Manufacturer: MYLAN

    Approval date: June 22, 1993

    Strength(s): 200MG [AB]


  • Manufacturer: WATSON LABS

    Approval date: April 3, 1990

    Strength(s): 200MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Clinoril. 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 Clinoril.

See also...

  • Clinoril Consumer Information (Wolters Kluwer)
  • Clinoril Consumer Information (Cerner Multum)
  • Clinoril Advanced Consumer Information (Micromedex)
  • Clinoril AHFS DI Monographs (ASHP)
  • Sulindac Consumer Information (Wolters Kluwer)
  • Sulindac Consumer Information (Cerner Multum)
  • Sulindac Advanced Consumer Information (Micromedex)
  • Sulindac AHFS DI Monographs (ASHP)

Serc-16mg





1. Name Of The Medicinal Product



Serc®-16/Betahistine Tablets 16 mg


2. Qualitative And Quantitative Composition



Each tablet contains 16 mg betahistine dihydrochloride.



3. Pharmaceutical Form



Tablet:



Round, biconvex, scored, white to almost white tablets imprinted '267' on one face and '



4. Clinical Particulars



4.1 Therapeutic Indications



Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.



4.2 Posology And Method Of Administration



Adults (including the elderly): initially 16 mg three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily.



Children: no dosage recommendations are made for children.



4.3 Contraindications



Phaeochromocytoma. Hypersensitivity to the active substance or to any of the excipients.



4.4 Special Warnings And Precautions For Use



Caution is advised in the treatment of patients with a history of peptic ulcer. Clinical intolerance to Serc in bronchial asthma patients has been shown in a relatively few patients. These patients need to be carefully monitored during the therapy.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



No in-vivo interaction studies have been performed. Based on in-vitro data no in-vivo inhibition on Cytochrome P450 enzymes is expected.



Although an antagonism between Serc and antihistamines could be expected on a theoretical basis, no such interactions have been reported.



4.6 Pregnancy And Lactation



Pregnancy:



There are no adequate data from the use of betahistine in pregnant women.



Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Betahistine should not be used during pregnancy unless clearly necessary.



Lactation:



It is not known whether betahistine is excreted in human milk. There are no animal studies on the excretion of betahistine in milk. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.



4.7 Effects On Ability To Drive And Use Machines



Betahistine is regarded to have no or negligible effects on the ability to drive and use machines as no effects potentially influencing this ability were found to be related to betahistine in clinical studies.



4.8 Undesirable Effects



The following undesirable effects have been experienced with the below indicated frequencies in betahistine-treated patients in placebo-controlled clinical trials [very common (



Gastrointestinal disorders



Common: nausea and dyspepsia



In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneously during post-marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as “not known”.



Immune System disorders



Hypersensitivity reactions, e.g. anaphylaxis have been reported.



Gastrointestinal disorders



Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating) have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.



Nervous System disorders



Headache



Skin and subcutaneous tissue disorders



Cutaneous and subcutaneous hypersensitivity reactions have been reported, in particular angioneurotic oedema, urticaria, rash, and pruritus.



4.9 Overdose



A few overdose cases have been reported. Some patients experienced mild to moderate symptoms with doses up to 640 mg (e.g. nausea, somnolence, abdominal pain). More serious complications (e.g. convulsion, pulmonary or cardiac complications) were observed in cases of intentional overdose of betahistine especially in combination with other overdosed drugs. Treatment of overdose should include standard supportive measures.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



The active ingredient is a specific histamine agonist with virtually no H2-activity. It appears to act on the precapillary sphincter in the stria vascularis of the inner ear, thus reducing the pressure in the endolymphatic space.



5.2 Pharmacokinetic Properties



Betahistine is rapidly and completely absorbed after oral administration of the drug in tablets. It is excreted almost quantitatively in urine as 2-pyridylacetic acid within 24 hours after administration. No unchanged betahistine has been detected.



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



Microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica and talc.



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



5 years.



6.4 Special Precautions For Storage



Do not store above 25°C. Store in the original package.



6.5 Nature And Contents Of Container



PVC/PVdC blister packs containing 84 tablets.



HDPE tablet containers containing 500 or 1000 tablets.



6.6 Special Precautions For Disposal And Other Handling



None.



7. Marketing Authorisation Holder



Solvay Healthcare Limited/Solvay Healthcare Limited T/A Mansbridge Pharmaceuticals Ltd



Mansbridge Road



West End



Southampton



SO18 3JD



8. Marketing Authorisation Number(S)



PL 00512/0088



9. Date Of First Authorisation/Renewal Of The Authorisation



15 October 1997/ 14 October 2002



10. Date Of Revision Of The Text



03/07/2009




Cholografin Meglumine


Cholografin Meglumine is a brand name of iodipamide, approved by the FDA in the following formulation(s):


CHOLOGRAFIN MEGLUMINE (iodipamide meglumine - injectable; injection)



  • Manufacturer: BRACCO

    Approved Prior to Jan 1, 1982

    Strength(s): 52% [RLD]

Has a generic version of Cholografin Meglumine been approved?


No. There is currently no therapeutically equivalent version of Cholografin Meglumine available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Cholografin Meglumine. 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 Cholografin Meglumine.

See also...

    Cryopyrin-Associated Periodic Syndromes Medications


    Drugs associated with Cryopyrin-Associated Periodic Syndromes

    The following drugs and medications are in some way related to, or used in the treatment of Cryopyrin-Associated Periodic Syndromes. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    Topics under Cryopyrin-Associated Periodic Syndromes

    • Familial Cold Autoinflammatory Syndrome (2 drugs)

    • Muckle Wells Syndrome (2 drugs)





    Drug List:

    Apo-Theo LA




    Apo-Theo LA may be available in the countries listed below.


    Ingredient matches for Apo-Theo LA



    Theophylline

    Theophylline is reported as an ingredient of Apo-Theo LA in the following countries:


    • Canada

    • Singapore

    International Drug Name Search

    brimonidine ophthalmic


    Generic Name: brimonidine ophthalmic (bri MO ni deen)

    Brand names: Alphagan P, Alphagan


    What is brimonidine ophthalmic?

    Brimonidine reduces the amount of fluid in the eye, which decreases pressure inside the eye.


    Brimonidine ophthalmic is used to treat open-angle glaucoma or ocular hypertension (high pressure inside the eye).

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


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


    Do not use brimonidine ophthalmic if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

    Before using brimonidine ophthalmic, tell your doctor if you have kidney or liver disease, heart disease, high blood pressure, circulation problems such as Raynaud's or Buerger's disease, or a history of fainting or low blood pressure.


    Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using brimonidine before putting your contact lenses in.

    Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.


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


    You should not use this medication if you are allergic to brimonidine.


    Do not use brimonidine ophthalmic if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

    Before using brimonidine ophthalmic, tell your doctor if you have:


    • kidney disease;

    • liver disease;


    • heart disease or high blood pressure;




    • circulation problems, such as Raynaud's syndrome or Buerger's disease; or




    • a history of fainting or low blood pressure.



    If you have any of these conditions, you may need a dose adjustment or special tests to safely use brimonidine ophthalmic.


    FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether brimonidine ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

    How should I use brimonidine ophthalmic?


    Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.


    Wash your hands before using the eye drops.


    Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using brimonidine before putting your contact lenses in.

    To apply the eye drops:



    • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.




    • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.




    • If you use any other eye medications, wait about 5 minutes after using brimonidine eye drops before using the other medication.




    • Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.



    Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.


    Store the drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.


    What happens if I miss a dose?


    Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.


    What happens if I overdose?


    Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of brimonidine ophthalmic is unlikely to cause life-threatening side effects.

    What should I avoid while using brimonidine ophthalmic?


    Brimonidine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid using any eye medications your doctor has not prescribed. Cold or allergy medicine, narcotic pain medicine, sleeping pills, sedatives, and medicine for seizures can add to sleepiness caused by brimonidine ophthalmic. Tell your doctor if you regularly use any of these medicines.

    Brimonidine ophthalmic side effects


    Stop using brimonidine and 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:

    • slow or uneven heart rate;




    • pounding heartbeats or fluttering in your chest;




    • shallow breathing, feeling like you might pass out;




    • severe swelling, redness, or discomfort in or around your eye;




    • eye pain or increased watering; or




    • numbness or tingly feeling in your hands or feet.



    Less serious side effects may include:



    • burning, stinging, or itching of your eyes;




    • feeling like something is in your eye;




    • blurred vision;




    • redness of the eye or eyelid;




    • mildly swollen or puffy eyes;




    • sensitivity to light;




    • nausea, upset stomach;




    • headache, dizziness;




    • muscle pain;




    • tired feeling;




    • sleep problems (insomnia);




    • dry nose or mouth; or




    • unusual or unpleasant taste in your mouth.



    This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


    Brimonidine ophthalmic Dosing Information


    Usual Adult Dose for Intraocular Hypertension:

    1 drop in the affected eye every 8 hours

    Usual Adult Dose for Glaucoma (Open Angle):

    1 drop in the affected eye every 8 hours

    Usual Pediatric Dose for Intraocular Hypertension:

    >= 2 years: 1 drop in the affected eye every 8 hours

    Usual Pediatric Dose for Glaucoma (Open Angle):

    >= 2 years: 1 drop in the affected eye every 8 hours


    What other drugs will affect brimonidine ophthalmic?


    Before using brimonidine ophthalmic, tell your doctor if you are using any of the following medications:



    • blood pressure medications;




    • digoxin (digitalis, Lanoxin);




    • a beta-blocker such as atenolol (Tenormin), betaxolol (Betoptic, Kerlone), bisoprolol (Zebeta), carteolol (Cartrol, Ocupress), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), timolol (Betimol, Blocadren, Cosopt, Timoptic, Istalol), and others; or




    • antidepressants such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.



    This list is not complete and there may be other drugs that can interact with brimonidine ophthalmic. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



    More brimonidine ophthalmic resources


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


    • Alphagan Consumer Overview

    • Alphagan P Prescribing Information (FDA)

    • Alphagan P Monograph (AHFS DI)

    • Alphagan P Advanced Consumer (Micromedex) - Includes Dosage Information

    • Alphagan P MedFacts Consumer Leaflet (Wolters Kluwer)



    Compare brimonidine ophthalmic with other medications


    • Glaucoma, Open Angle
    • Intraocular Hypertension


    Where can I get more information?


    • Your pharmacist can provide more information about brimonidine ophthalmic.

    See also: brimonidine side effects (in more detail)


    Potassion




    Potassion may be available in the countries listed below.


    Ingredient matches for Potassion



    Potassium

    Potassium mixture of several salts (a derivative of Potassium) is reported as an ingredient of Potassion in the following countries:


    • Italy

    International Drug Name Search