Description

Each gram of Ointment contains: Neomycin Sulphate BP 3.5 mg Bacitracin Zinc BP 400 IU Polymyxin B Sulphate BP 5000 IU

This Ointment may be usedin the treatment of infected wounds, burns or skin grafts,andit is also of value in the preparation of donor sites for skin grafting and in the prevention of infection of extensive burnsand contaminated wounds. It is of value in the local treatment of chronic varicose or other indolent ulcers. The preparation is also of value, in the treatment of furuncles, carbuncles, pyoderma, sycosis barbae, impetigo and acne. It has also been used in dealing with secondary infected skin lesions of scabies, pediculosis, tinea pedis and contact and allergic dermatitis.

The combination of Polymyxin B sulfate with Neomycin and Bacitracin zinc most nearly meets the criteria for an ideal topical antibacterial preparation. The spectrum of action encompasses virtually all pathogenic bacteria found topically and the three antibiotics are bactericidal. When used topically Polymyxin B sulphate with Neomycin and Bacitracin zinc are rarely irritating, and absorption from the skin or mucous membrane is insignificant. Polymyxin B sulphate attacks gram-negative bacilli including clinically isolated strains of Pseudomonas aeruginosa. This organism is conspicuously absent from the spectra of most other antibiotic agents, but it is highly susceptible to polymyxin B sulphate, which is acknowledged to be the most effective agent known for the treatment and prophylaxis of Pseudomonas infections. Neomycin provides bactericidal action against various gram-positive organisms and gram-negative organisms including many strains of Proteus. Neomycin is considered by various authorities to be the most effective antibiotic against Staphylococcus aureus which is among the more common aetiological organisms in topical bacterial infections. Bacitracin zinc is highly active against gram-positive bacilli and cocci and extends the spectrum to include haemolytic streptococci, thus completing the anti-bacterial range of this Ointment. There is overlapping of the bactericidal spectra of these three antibiotics, thereby providing increased activity through combined antibiotic action.

Adult: This Ointment should be applied thinly over the affected area after cleaning it.1-3 daily applications should be continued until the infection is controlled and healing completely. Children and Infants: This Ointment is suitable for use in children at the same dose as adults, but the dose should be reduced in infants. This ointment is not recommended for use in neonates.

This ointment should not be used in individuals who have shown sensitivity to any of the components. A possibility of increased absorption exists in very young children, thus this ointment is not recommended for use in neonates.

Common side effects are Nausea; Vomiting; Pain, burning, or swelling; Skin rashes; Possible kidney problems; Hearing loss; Dizziness; Unusual numbness of the skin; Muscle twitching; Seizures; Pain; Redness; Swelling at the injection site.

There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy and lactation. However, neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of foetal toxicity, thus this ointment is not recommended in pregnancy and lactation.

It is to be noted that this Ointment is not intended for sterile use in surgical procedures such as those involving abdominal or thoracic cavities as there is evidence that neomycin, when in contact with peritoneal or pleural tissues, can potentiate neuromuscular block in patients under the influence of muscle relaxants, producing respiratory paralysis. As with other antibiotic preparations prolonged use may result in overgrowth of non-susceptible organisms. Ototoxicity to neomycin has been reported. In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature.

Topical Antibiotic preparations