Tuesday, October 27, 2009

Orasorbil




Orasorbil may be available in the countries listed below.


Ingredient matches for Orasorbil



Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of Orasorbil in the following countries:


  • Portugal

International Drug Name Search

DSS


Generic Name: docusate (DOK ue sate)

Brand Names: Calcium Stool Softener, Colace, Correctol Softgel Extra Gentle, D-S Caps, Diocto, Doc-Q-Lace, Docu, Docu Soft, Doculase, Docusoft S, DocuSol, DOK, DOS, DSS, Dulcolax Stool Softener, Enemeez Mini, Fleet Sof-Lax, Kao-Tin, Kaopectate Stool Softener, Kasof, Phillips Stool Softener, Silace, Sur-Q-Lax


What is DSS (docusate)?

Docusate is a stool softener. It makes bowel movements softer and easier to pass.


Docusate is used to treat or prevent constipation, and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements.


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


What is the most important information I should know about DSS (docusate)?


You should not use docusate if you are allergic to it, or if you have a blockage in your intestines. Do not use docusate while you are sick with nausea, vomiting, or stomach pain. Do not take mineral oil while using docusate, unless your doctor tells you to.

Ask a doctor or pharmacist before using docusate if you are on a low-salt diet, if you are pregnant or breast-feeding, or if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.


What should I discuss with my healthcare provider before using DSS (docusate)?


You should not use docusate if you are allergic to it, or if you have a blockage in your intestines. Do not use docusate while you are sick with nausea, vomiting, or stomach pain. Do not take mineral oil while using docusate, unless your doctor tells you to.

Ask a doctor or pharmacist if it is safe for you to take docusate:



  • if you are on a low-salt diet; or




  • if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.




It is not known whether docusate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether docusate 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. Do not give this medication to a child younger than 2 years old without the advice of a doctor.

How should I use DSS (docusate)?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.


Take docusate tablets or capsules with a full glass of water. Drink plenty of liquids while you are taking docusate. Do not crush, chew, or break a docusate capsule. Swallow it whole.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Mix the liquid with 6 to 8 ounces of milk, fruit juice, or infant formula and drink the mixture right away.


Do not take docusate rectal enema by mouth. It is for use only in your rectum. Wash your hands before and after using docusate rectal enema.

Try to empty your bowel and bladder just before using the enema.


Twist off the applicator tip. Lie down on your left side with your knees bent, and gently insert the tip of the enema applicator into the rectum. Squeeze the tube to empty the entire contents into the rectum. Throw away the tube, even if there is still some medicine left in it.


After using docusate, you should have a bowel movement within 12 to 72 hours. Call your doctor if you have not had a bowel movement within 1 to 3 days.


Do not use docusate for longer than 7 days unless your doctor has told you to. Overuse of a stool softener can lead to serious medical problems. Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Since docusate is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting or stomach pain.


What should I avoid while using DSS (docusate)?


Avoid using laxatives or other stool softeners unless your doctor has told you to.

Avoid using the bathroom just after using docusate enema.


DSS (docusate) side effects


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

  • rectal bleeding or irritation;




  • numbness or a rash around your rectum;




  • severe diarrhea or stomach cramps; or




  • continued constipation.



Less serious side effects may include:



  • mild diarrhea; or




  • mild nausea.



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


What other drugs will affect DSS (docusate)?


There may be other drugs that can interact with docusate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More DSS resources


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


  • Docusate Professional Patient Advice (Wolters Kluwer)

  • Colace MedFacts Consumer Leaflet (Wolters Kluwer)

  • Diocto Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Docusate Salts Monograph (AHFS DI)

  • Dostinex Monograph (AHFS DI)

  • Enemeez Mini Enema MedFacts Consumer Leaflet (Wolters Kluwer)



Compare DSS with other medications


  • Constipation


Where can I get more information?


  • Your pharmacist can provide more information about docusate.

See also: DSS side effects (in more detail)


Sunday, October 25, 2009

Alendronato Teva




Alendronato Teva may be available in the countries listed below.


Ingredient matches for Alendronato Teva



Alendronic Acid

Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Alendronato Teva in the following countries:


  • Italy

International Drug Name Search

Saturday, October 24, 2009

Epidemac




Epidemac may be available in the countries listed below.


Ingredient matches for Epidemac



Epirubicin

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


  • Slovakia

International Drug Name Search

Friday, October 23, 2009

Eliprim Balsámico




Eliprim Balsámico may be available in the countries listed below.


Ingredient matches for Eliprim Balsámico



Guaifenesin

Guaifenesin is reported as an ingredient of Eliprim Balsámico in the following countries:


  • Peru

Sulfamethoxazole

Sulfamethoxazole is reported as an ingredient of Eliprim Balsámico in the following countries:


  • Peru

Trimethoprim

Trimethoprim is reported as an ingredient of Eliprim Balsámico in the following countries:


  • Peru

International Drug Name Search

Thursday, October 22, 2009

Nalgesin




Nalgesin may be available in the countries listed below.


Ingredient matches for Nalgesin



Naproxen

Naproxen is reported as an ingredient of Nalgesin in the following countries:


  • Bosnia & Herzegowina

  • Croatia (Hrvatska)

  • Georgia

  • Lithuania

  • Serbia

  • Slovenia

Naproxen sodium salt (a derivative of Naproxen) is reported as an ingredient of Nalgesin in the following countries:


  • Czech Republic

  • Estonia

  • Poland

  • Russian Federation

  • Slovakia

International Drug Name Search

Monday, October 19, 2009

Spironolactone RPG




Spironolactone RPG may be available in the countries listed below.


Ingredient matches for Spironolactone RPG



Spironolactone

Spironolactone is reported as an ingredient of Spironolactone RPG in the following countries:


  • France

International Drug Name Search

Tuesday, October 13, 2009

Brexin L.A.


Generic Name: chlorpheniramine and pseudoephedrine (klor fen EER a meen and soo doe e FED rin)

Brand Names: AccuHist Drops, Allerest Maximum Strength, Brexin L.A., Colfed-A, D-Amine-SR, Dayquil Allergy, Deconamine, Dicel, Dicel Chewables, Dura-Tap/PD, Durafed, Duratuss DA, Dynahist-ER Pediatric, Genaphed Plus, Histade, Histex, Kronofed-A, Kronofed-A-Jr, LoHist-D, Mintex, Neutrahist Drops, Re2+30, Rescon-Ed, Suclor, SudaHist, Sudal-12 Chewable, Sudal-12 Tannate, Sudogest Cold & Allergy, SudoGest Sinus & Allergy, Tavist-DA, Triaminic Cold and Allergy, Triaminic Softchew Cold and Allergy, Triaminic Softchews Allergy Runny Nose and Congestion


What is Brexin L.A. (chlorpheniramine and pseudoephedrine)?

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


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


The combination of chlorpheniramine and pseudoephedrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.


Chlorpheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Brexin L.A. (chlorpheniramine and pseudoephedrine)?


There are many brands and forms of this medication available and not all brands are listed on this leaflet.


Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.


What should I discuss with my healthcare provider before taking Brexin L.A. (chlorpheniramine and pseudoephedrine)?


Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have:

  • severe or uncontrolled high blood pressure;




  • severe coronary artery disease;




  • narrow angle glaucoma;




  • a stomach ulcer;




  • if you are unable to urinate; or




  • if you are having an asthma attack.



Ask a doctor or pharmacist if it is safe for you to take this medication if you have:


  • kidney disease;

  • liver disease;


  • diabetes;




  • glaucoma;




  • circulation problems;




  • heart disease or high blood pressure;




  • overactive thyroid;




  • a seizure disorder such as epilepsy;




  • asthma, emphysema or chronic bronchitis; or




  • urination problems or an enlarged prostate.




FDA pregnancy category C. It is not known whether chlorpheniramine and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether chlorpheniramine and pseudoephedrine 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. Older adults may be more likely to have side effects from this medicine.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.


How should I take Brexin L.A. (chlorpheniramine and pseudoephedrine)?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.


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


Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.


This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.


If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Since cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.


What should I avoid while taking Brexin L.A. (chlorpheniramine and pseudoephedrine)?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Chlorpheniramine and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Brexin L.A. (chlorpheniramine and pseudoephedrine) side effects


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

  • fast or pounding heartbeats;




  • confusion, hallucinations, unusual thoughts or behavior;




  • severe dizziness, anxiety, restless feeling, nervousness;




  • urinating less than usual or not at all;




  • easy bruising or bleeding, unusual weakness; or




  • seizure (black-out or convulsions).



Less serious side effects may include:



  • blurred vision;




  • dry nose or mouth;




  • nausea, stomach pain, constipation, loss of appetite;




  • dizziness, drowsiness;




  • problems with memory or concentration;




  • ringing in your ears; or




  • feeling restless or excited (especially in children).



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


What other drugs will affect Brexin L.A. (chlorpheniramine and pseudoephedrine)?


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

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



  • mecamylamine (Inversine);




  • methyldopa (Aldomet);




  • reserpine;




  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;




  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or




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



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



More Brexin L.A. resources


  • Brexin L.A. Use in Pregnancy & Breastfeeding
  • Drug Images
  • Brexin L.A. Drug Interactions
  • Brexin L.A. Support Group
  • 0 Reviews for Brexin L.A. - Add your own review/rating


  • AccuHist Drops Prescribing Information (FDA)

  • Biohist LA Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Deconamine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Deconamine SR Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Duotan Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • QDALL 24-Hour Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Brexin L.A. with other medications


  • Hay Fever
  • Sinusitis


Where can I get more information?


  • Your pharmacist can provide more information about chlorpheniramine and pseudoephedrine.


Saturday, October 10, 2009

Omnipred



prednisolone acetate

Dosage Form: ophthalmic suspension
Omnipred® (prednisolone acetate ophthalmic suspension)

DESCRIPTION


Omnipred® (prednisolone acetate ophthalmic suspension) is an adrenocortical steroid product prepared as sterile ophthalmic suspension. The active ingredient is represented by the chemical structure:



Established name: Prednisolone Acetate


Chemical name: Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-,(11β)-.


Each mL contains: Active: prednisolone acetate 1.0%. Preservative: benzalkonium chloride 0.01%.


Vehicle: hypromellose. Inactives: dibasic sodium phosphate, polysorbate 80, edetate disodium, glycerin, citric acid and/or sodium hydroxide (to adjust pH), purified water.



CLINICAL PHARMACOLOGY


Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.


Corticosteroids are capable of producing a rise in intraocular pressure.



INDICATIONS AND USAGE


Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.



CONTRAINDICATIONS


Omnipred® (prednisolone acetate ophthalmic suspension) is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Omnipred® (prednisolone acetate ophthalmic suspension) is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.



WARNINGS


FOR TOPICAL OPHTHALMIC USE ONLY. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma.


Intraocular pressure should be checked frequently.


The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.


Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.


Corticosteroids are not effective in mustard gas keratitis and Sjogren's keratoconjunctivitis.



PRECAUTIONS



General


The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.


As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.


If this product is used for 10 days or longer, intraocular pressure should be monitored (SEE WARNINGS).



Information for Patients


If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.


This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children.



Carcinogenesis, Mutagenesis, Impairment of Fertility


No studies have been conducted in animals or in humans to evaluate the potential of these effects.



Pregnancy



Teratogenic effects


Pregnancy Category C. Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 times the human dose.


Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate and well controlled studies in pregnant women. Omnipred® (prednisolone acetate ophthalmic suspension) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.



Nursing Mothers


It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from prednisolone acetate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.



Pediatric Use


Safety and effectiveness in pediatric patients have not been established.



Geriatric Use


No overall differences in safety or effectiveness have been observed between elderly and younger patients.



ADVERSE REACTIONS


Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.


Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids.


Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe.


Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.


The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (SEE WARNINGS).



DOSAGE AND ADMINISTRATION


SHAKE WELL BEFORE USING. Two drops topically in the eye(s) four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is mandatory. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (SEE PRECAUTIONS).


The dosing of Omnipred® suspension may be reduced, but care should be taken not to discontinue therapy prematurely.


In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.



HOW SUPPLIED


Omnipred® (prednisolone acetate ophthalmic suspension) is supplied in a white, round low density polyethylene DROP-TAINER® dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.


Omnipred® suspension:


5 mL NDC 0065-0638-27


10 mL NDC 0065-0638-25


STORAGE: STORE at 8° - 24°C (46° - 75°F) in an UPRIGHT position.


Rx Only



ALCON LABORATORIES, INC.


Fort Worth, Texas 76134 USA


Printed in USA


©2006-2008 Alcon, Inc.


Revised: October 2007


9004078-1008



PRINCIPAL DISPLAY PANEL


NDC 0065-0638-27        STERILE


Omnipred®


(prednisolone


acetate ophthalmic


suspension) 1%


5 mL                    Alcon®











Omnipred 
prednisolone acetate  suspension










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0065-0638
Route of AdministrationOPHTHALMICDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PREDNISOLONE ACETATE (PREDNISOLONE)PREDNISOLONE ACETATE10 mg  in 1 mL




















Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
POLYSORBATE 80 
EDETATE DISODIUM 
GLYCERIN 
CITRIC ACID MONOHYDRATE 
SODIUM HYDROXIDE 
WATER 
HYPROMELLOSES 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10065-0638-275 mL In 1 BOTTLE, PLASTICNone
20065-0638-2510 mL In 1 BOTTLE, PLASTICNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01746911/06/2007


Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)









Establishment
NameAddressID/FEIOperations
Alcon Laboratories, Inc.008018525MANUFACTURE
Revised: 07/2011Alcon Laboratories, Inc.

More Omnipred resources


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


  • Omnipred Concise Consumer Information (Cerner Multum)

  • Omnipred Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • AK-Pred Concise Consumer Information (Cerner Multum)

  • AK-Pred Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Prednisolone Monograph (AHFS DI)

  • Prednisolone Acetate eent Monograph (AHFS DI)



Compare Omnipred with other medications


  • Postoperative Ocular Inflammation

Sunday, October 4, 2009

Vinces




Vinces may be available in the countries listed below.


Ingredient matches for Vinces



Vincristine

Vincristine sulfate (a derivative of Vincristine) is reported as an ingredient of Vinces in the following countries:


  • Argentina

  • Peru

International Drug Name Search

Thursday, October 1, 2009

Atenolol Merck




Atenolol Merck may be available in the countries listed below.


Ingredient matches for Atenolol Merck



Atenolol

Atenolol is reported as an ingredient of Atenolol Merck in the following countries:


  • Netherlands

  • Portugal

International Drug Name Search