Neomycin And Polymyxin B Sulfates And Gramicidin

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Neomycin And Polymyxin B Sulfates And Gramicidin Recall

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Side Effects & Adverse Reactions

NOT FOR INJECTION INTO THE EYE. This product should never be directly introduced into the anterior chamber of the eye or injected subconjunctivally.

Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known.

The manifestations of sensitization to topical antibiotics are usually itching, reddening and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication.

Applications of products containing these ingredients should be avoided for the patient thereafter. (See PRECAUTIONS, General)

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

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History

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Other Information

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP is a sterile antimicrobial solution for ophthalmic use.

EACH mL CONTAINS: ACTIVES: Neomycin Sulfate, (equivalent to 1.75 mg neomycin base), Polymyxin B Sulfate equal to 10,000 Polymyxin B units, Gramicidin, 0.025 mg; INACTIVES: Sodium Chloride, Alcohol (0.5%), Poloxamer 188, Propylene Glycol, Purified Water. Hydrochloric Acid and/ or Ammonium Hydroxide may be added to adjust pH (4.7- 6.0).

PRESERVATIVE ADDED: Thimerosal 0.001%.

Neomycin Sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis.

The structural formulae are:

Polymyxin B Sulfate is the sulfate salt of polymyxin Bl and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are:

Gramicidin (also called gramicidin D) is a mixture of three pairs of antibacterial substances (Gramicidin A, B and C) produced by the growth of Bacillusbrevis Dubos (Fam. Bacillaceae). It has a potency of not less than 900 mcg of standard gramicidin per mg. The structural formulae are:

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Neomycin And Polymyxin B Sulfates And Gramicidin Manufacturers

Rebel Distributors Corp

Neomycin And Polymyxin B Sulfates And Gramicidin | Rebel Distributors Corp

Instill one or two drops into the affected eye every 4 hours for 7 to 10 days. In severe infections, dosage may be increased to as much as two drops every hour.

DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW IS NOT INTACT.

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Physicians Total Care, Inc.

Neomycin And Polymyxin B Sulfates And Gramicidin | Physicians Total Care, Inc.

Instill one or two drops into the affected eye every 4 hours for 7 to 10 days. In severe infections, dosage may be increased to as much as two drops every hour.

DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW IS NOT INTACT.

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Dispensing Solutions, Inc.

Neomycin And Polymyxin B Sulfates And Gramicidin | Dispensing Solutions, Inc.

Instill one or two drops into the affected eye every 4 hours for 7 to 10 days. In severe infections, dosage may be increased to as much as two drops every hour.

DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW IS NOT INTACT.

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A-s Medication Solutions Llc

Neomycin And Polymyxin B Sulfates And Gramicidin | A-s Medication Solutions Llc

Instill one or two drops into the affected eye every 4 hours for 7 to 10 days. In severe infections, dosage may be increased to as much as two drops every hour.

DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW IS NOT INTACT.

No Recall
Bausch & Lomb Incorporated

Neomycin And Polymyxin B Sulfates And Gramicidin | Pd-rx Pharmaceuticals, Inc.

Cefadroxil is acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.
Adults
Urinary Tract Infections: For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a single (q.d.) or divided doses (b.i.d.).

For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d.).

Skin and Skin Structure Infections: For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d.).

Pharyngitis and Tonsillitis: Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis—1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days.
Children
For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours. For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of cefadroxil should be administered for at least 10 days.
Renal Impairment
In patients with renal impairment, the dosage of cefadroxil should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the initial dose is 1000 mg of cefadroxil and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 m2]) is 500 mg at the time intervals listed below.

Creatinine Clearances Dosage Interval 0 to 10 mL/min
36 hours
10 to 25 mL/min
24 hours
25 to 50 mL/min
12 hours

Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function.

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