18 . August , 2018 - Saturday
Check todays hot topics or new products

Find a Drug: Advanced

Please Sign in or Register

All about: Ocufen

Big Image
Generic Name: flurbiprofen sodium
Dosage Form: Ophthalmic solution, usp

sterile

Ocufen Description

Ocufen® (flurbiprofen sodium ophthalmic solution, USP) 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use.

Chemical Name:

Sodium (±)-2-(2-fluoro-4-biphenylyl)-propionate dihydrate.

Structural Formula:

Contains: Active: flurbiprofen sodium 0.03% (0.3 mg/mL). Preservative: thimerosal 0.005%. Inactives: citric acid; edetate disodium; polyvinyl alcohol 1.4%; potassium chloride; purified water; sodium chloride; and sodium citrate. May also contain hydrochloric acid and/or sodium hydroxide to adjust the pH. The pH of Ocufen® ophthalmic solution is 6.0 to 7.0. It has an osmolality of 260 - 330 mOsm/kg.

Ocufen - Clinical Pharmacology

Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic, and anti-inflammatory activity in animal inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclo-oxygenase enzyme that is essential in the biosynthesis of prostaglandins.

Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilatation, increased vascular permeability, leukocytosis, and increased intraocular pressure.

Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In clinical studies, Ocufen® ophthalmic solution has been shown to inhibit the miosis induced during the course of cataract surgery. Results from clinical studies indicate that flurbiprofen sodium has no significant effect upon intraocular pressure.

Indications and Usage for Ocufen

Ocufen® ophthalmic solution is indicated for the inhibition of intraoperative miosis.

Contraindications

Ocufen® ophthalmic solution is contraindicated in individuals who are hypersensitive to any components of the medication.

Warnings

With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding due to interference with thrombocyte aggregation. There have been reports that Ocufen® ophthalmic solution may cause increased bleeding of ocular tissues including hyphemas in conjunction with ocular surgery.

There exists the potential for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

Precautions

General:

Wound healing may be delayed with the use of Ocufen® (flurbiprofen sodium ophthalmic solution, USP) 0.03%.

It is recommended that Ocufen® ophthalmic solution be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

Drug interactions:

Interaction of Ocufen® ophthalmic solution with other topical ophthalmic medications has not been fully investigated.

Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with Ocufen® ophthalmic solution.

Carcinogenesis, Mutagenesis, Impairment of fertility:

Long-term studies in mice and/or rats have shown no evidence of carcinogenicity with flurbiprofen. Long-term mutagenicity studies in animals have not been performed.

Pregnancy:

Pregnancy category C. Flurbiprofen has been shown to be embryocidal, delay parturition, prolong gestation, reduce weight, and/or slightly retard growth of fetuses when given to rats in daily oral doses of 0.4 mg/kg (approximately 300 times the human daily topical dose) and above.

There are no adequate and well-controlled studies in pregnant women. Ocufen® ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from flurbiprofen sodium, 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 efffectiveness have been observed between elderly and younger patients.

Adverse Reactions

Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of Ocufen® ophthalmic solution. Other adverse reactions reported with the use of Ocufen® ophthalmic solution include: fibrosis, miosis, and mydriasis.

Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported.

Overdosage

Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.

Ocufen Dosage and Administration

A total of four (4) drops of Ocufen® ophthalmic solution should be administered by instilling one (1) drop approximately every 1/2 hour beginning 2 hours before surgery.

How is Ocufen Supplied

Ocufen® (flurbiprofen sodium ophthalmic solution, USP) is available for topical ophthalmic administration as a 0.03% sterile solution, and is supplied in a white opaque low density polyethylene bottle with a controlled dropper tip and a gray high impact polystyrene cap in the following size:

 
2.5 mL in 5 mL bottle - NDC 11980-801-03.

Note: Store at 15° - 25°C (59°-79°F).
Rx Only

Revised May 2004
© 2004 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® Marks owned by Allergan, Inc.

5827X
71587US12P


Ocufen (flurbiprofen sodium)
PRODUCT INFO
Product Code 11980-801 Dosage Form SOLUTION
Route Of Administration OPHTHALMIC DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
flurbiprofen sodium (flurbiprofen) Active 0.3 MILLIGRAM  In 1 MILLILITER
citric acid Inactive  
edetate disodium Inactive  
polyvinyl alcohol Inactive  
potassium chloride Inactive  
water Inactive  
sodium chloride Inactive  
sodium citrate Inactive  
hydrochloric acid Inactive  
sodium hydroxide Inactive  
thimerosal 0.005% Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 11980-801-03 2.5 MILLILITER In 1 BOTTLE, PLASTIC None

Revised: 03/2007

Recent Drug Updates at DrugIndexOnline:





Clotrimazole Lozenge Clotrimazole Lozenge
FOR TOPICAL ORAL ADMINISTRATION Clotrimazole Lozenge Description Each Clotrimazole Lozenge contains 10 mg clotrimazole [1-(o-chloro-α, α-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth. Structural Formula: Chemical Formula: C22H17ClN2 The loze more...

Elocon Topical Elocon Topical
Some commonly used brand names are: In the U.S.— Alphatrex 3 Aristocort 20 Aristocort A 20 Betatrex 3 Beta-Val 3 Bio-Syn 9 Cordran 11 Cordran SP 11 Cormax 4 Cutivate 12 Cyclocort 1 Delta-Tritex 20 Dermabet 3 Dermatop 19 Diprolene 3 Diprolene AF 3 Diprosone 3 Elocon 18 Florone 7 Florone E more...

Ethacrynic Acid (Ethacrynate) Ethacrynic Acid (Ethacrynate)
( Ethacrynate ) Pronouncation: (eth-uh-KRIN-ik acid) Class: Loop diuretic Trade Names: Edecrin - Tablets 25 mg - Tablets 50 mg Trade Names: Edecrin Sodium - Powder for injection 50 mg (as ethacrynate sodium) per vial Mechanism of Action Pharmacology Inhibits reabsorption of sodium and chloride in p more...

Liothyronine Sodium (T3; triiodothyronine) Liothyronine Sodium (T3; triiodothyronine)
( T 3 ; triiodothyronine ) Pronouncation: (lie-oh-THIGH-row-neen SO-deeuhm) Class: Thyroid hormone Trade Names: Cytomel - Tablets 5 mcg - Tablets 25 mcg - Tablets 50 mcg Trade Names: Triostat - Injection 10 mcg/mL Mechanism of Action Pharmacology Increases metabolic rate of body tissues; is needed more...

Montelukast Montelukast
Generic Name: Montelukast Tablets (mon-te-LOO-kast) Brand Name: SingulairMontelukast is used for:Prevention and long-term treatment of asthma. It is also used to relieve allergy symptoms. It may also be used for other conditions as determined by your doctor. Montelukast is a leukotriene recept more...

Nicotine Nicotine
Pronouncation: (NIK-oh-TEEN) Class: Smoking deterrent Trade Names: Commit - Lozenges 2 mg - Lozenges 4 mg Trade Names: Habitrol - Transdermal system 17.5 mg - Transdermal system 35 mg - Transdermal system 52.5 mg Trade Names: Nicoderm - Transdermal system 36 mg - Transdermal system 78 mg - T more...

Ophthetic Ophthalmic Ophthetic Ophthalmic
Some commonly used brand names are: In the U.S.— Ak-Taine 1 Ak-T-Caine 2 Alcaine 1 Ocu-Caine 1 Ophthaine 1 Ophthetic 1 Opticaine 2 Pontocaine 2 Spectro-Caine 1 In Canada— Alcaine 1 Diocaine 1 Minims Tetracaine 2 Ophthetic 1 Pontocaine 2 Other commonly used names are: Amethocaine more...

Pepto-Bismol Pepto-Bismol
Some commonly used brand names are: In the U.S.— Bismatrol Bismatrol Extra Strength Extra Strength Kaopectate Kaopectate Note: Prior to 2003, Kaopectate contained attapulgite. It was reformulated to contain bismuth subsalicylate as the active ingredient. Pepto-Bismol Pepto-Bismo more...