Polysporib (Polymyxin B Sulfate)

POLYSPORIN® Preparations

Warner-Lambert Consumer Healthcare

Polymyxin B Sulfate – Gramicidin or Bacitracin

Antibiotic

Indications And Clinical Uses: Cream: Infection in dermatologic disorders particularly where the lesions are moist or weeping. Prophylactically, against bacterial contamination in burns, skin grafts, incisions and other clean lesions. For abrasions, minor cuts and wounds, the cream may prevent infection and permit normal healing.

Eye/Ear Drops: For external infections of the eye and ear when due to susceptible organisms. Used in situations in which drops may be preferred to an ointment, as in preoperative and postoperative use in surgery.

Ointment/Triple Antibiotic Ointment: For treating local infections due to susceptible organisms and amenable to local treatment; these include infected wounds, burns and skin grafts; pyodermas; folliculitis; infections of external ear.

Ophthalmic Ointment: For treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to polymyxin B sulfate and bacitracin zinc.

Contra-Indications: Hypersensitivity to any of the components.

Eye/Ear Drops: Should not be given subconjunctivally or intraocularly, nor should it be used for the irrigation of fistulous tracts in or about the eye or its socket.

Precautions: As with any antibiotic containing medication, prolonged use may result in the overgrowth of nonsusceptible organisms, including fungi. Should superinfection occur, the preparation should be discontinued and/or appropriate therapy instituted.

Ophthalmic ointments may retard corneal healing.

Geriatrics: No specific information is available regarding the use of Polysporin in the elderly; however, the maximum dosage should be reduced in cases where a decrease in renal function may exist.

Pregnancy: Polysporin has been used for several years without any evidence of untoward effects in pregnancy. The clinical benefit of treatment to the patient must be balanced against any possible, but unknown hazards to the fetus.

Following application to extensive areas of raw skin, the possibility of systemic absorption of the active ingredients exists.

Allergic hypersensitivity following topical application of polymyxin B sulfate and bacitracin zinc is rare but has been reported. Rarely anaphylactic reactions following topical administration of bacitracin zinc have been reported. Following significant systemic absorption, polymyxin B can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: If toxic symptoms develop following significant systemic absorption, treatment with Polysporin should be stopped and the patient’s general status, renal function and neuromuscular function should be monitored and blood levels of polymyxin B sulfate and bacitracin zinc determined.

Dosage And Administration: Cream: Apply a small quantity 2 to 5 times daily, as required, rub in gently if condition permits.

Eye/Ear Drops: 1 or 2 drops in the affected eye or ear, 2 to 4 times daily, or more frequently as required.

Ointment: To be applied over the infected area 2 to 5 times a day. May be covered with a dressing or left exposed.

Ophthalmic Ointment: Apply every 3 or 4 hours, depending on the severity of the disease.

Triple Antibiotic Ointment: To be applied to the affected area 1 to 3 times daily. May be covered with a bandage or gauze or left uncovered.

Availability And Storage: Cream: Each g contains: polymyxin B sulfate 10 000 units, gramicidin 250 g (0.25 mg) in a white vanishing cream base, pH of 5. Nonmedicinal ingredients: mineral oil, paraben, petrolatum, poloxamer, propylene glycol, sodium hydroxide, water and wax. Tubes of 15 and 30 g.

Eye/Ear Drops: Each mL contains: polymyxin B sulfate 10 000 units, gramicidin 25 g (0.025 mg). Nonmedicinal ingredients: alcohol, benzalkonium chloride, poloxamer, propylene glycol and water. Plastic dropper bottles of 10 mL.

Ointment: Each g contains: polymyxin B sulfate 10 000 units (equivalent to 1 mg polymyxin standard) and bacitracin 500 units. Nonmedicinal ingredients: BHT and petrolatum. Tubes of 15 and 30 g. Sterile ophthalmic in tubes of 3.5 g.

Triple Antibiotic Ointment: Each g contains: polymyxin B sulfate 10 000 units (equivalent to 1 mg polymyxin standard), bacitracin 500 units and gramicidin 0.25 mg. Nonmedicinal ingredients: BHT and petrolatum. Tubes of 15 and 30 g.

Store at 15 to 25┬░C.

POLYSPORIN┬« Preparations Warner-Lambert Consumer Healthcare Polymyxin B Sulfate – Gramicidin or Bacitracin Antibiotic

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