Soframycin (Framycetin Sulfate)

SOFRAMYCIN® Ointment

SOFRAMYCIN®

Ophthalmic Hoechst Marion Roussel

Framycetin Sulfate-Gramicidin Framycetin Sulfate

Antibiotic

Action and Clinical

Framycetin, a broad spectrum aminoglycoside antibiotic, is usually bactericidal in action. Although the exact mechanism of action has not been fully elucidated, the drug appears to inhibit protein synthesis in susceptible bacteria by binding to ribosomal subunits. In general, framycetin is active against many aerobic gram-negative bacteria and some aerobic gram-positive bacteria. The drug is inactive against fungi, viruses, and most anaerobic bacteria.IndicationsIndications:

Indications And Clinical Uses:

For local use in the treatment of infections caused by pyogenic organisms, in particular S. aureus, the proteus group of bacteria, coliforms and P. aeruginosa.

Ointment: The treatment of bacterial infections of the skin and mucous membrane caused by susceptible bacteria. These include such conditions as pyoderma, folliculitis, paronychia, sycosis barbae, and impetigo. Also useful in controlling secondary bacterial infections in skin carcinoma, burns, eczemas, contact dermatitis, seborrhea, acne, psoriasis, varicose ulcers, and neurodermatitis.

Ophthalmic Drops and Ointment: Treatment of bacterial blepharitis, conjunctivitis, styes, corneal abrasions and burns; prophylactically following removal of foreign bodies; corneal ulcers (sole treatment or as an adjunct to subconjunctival injection of framycetin).

Contra-Indications:

Sensitivity to framycetin.

Framycetin should never be administered either i.v. or i.m. in view of the risk of irreversible ototoxicity or reversible nephrotoxicity.

Precautions:

Cross sensitization may occur among the group of Streptomyces derived antibiotics (neomycin, paromomycin, kanamycin) of which framycetin is a member, but this is not invariable. Prolonged use of antibiotics may result in the overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.DosageDosage:

Dosage And Administration:

Ointment: Apply locally 2 to 4 times a day as prescribed.

Ophthalmic Drops and Ointment: Drops for rapid action: 1 or 2 drops every 1 or 2 hours in acute conditions (generally for 2 or 3 days), reducing to 1 or 2 drops, 3 or 4 times daily.

Ointment for continued effect: 2 or 3 applications daily, or at bedtime if drops have been used during the day.

Availability And Storage:

Ointment: Each g of ointment contains: framycetin sulfate BP 15 mg (1.5%), gramicidin 50 g (0.005%) and anhydrous lanolin 10%. Tubes of 15 g.

Ophthalmic Drops and Ointment: Each mL of drops (pH is 5.8 to 6.8) or g of ointment contains: framycetin sulfate BP 5 mg in a sterile, buffered, isotonic aqueous solution or sterile, greasy ointment base, respectively. The ointment base is Plastibase 30W. Drops, bottles of 8 mL. Ointment, tubes of 5 g.

Store all Soframycin products at controlled room temperature.

SOFRAMYCIN® Ointment SOFRAMYCIN® Ophthalmic Hoechst Marion Roussel Framycetin Sulfate–Gramicidin Framycetin Sulfate Antibiotic

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Bacterial Infections

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Burns

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Conjunctivitis

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Blepharitis

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