Class: Eye, Nose and Ear
Dosage Form: Eye Ointment
Polymyxin B………………………10000 Units/g
Mineral oil, White petrolatum
Oxytetracycline is a product of the metabolism of Streptomyces rimosus and is one of the family of tetracycline antibiotics. Oxytetracycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. Oxytetracycline is active against a wide range of gram-negative and gram-positive organisms.
There is no published information on the systemic absorption of oxytetracycline following dermal application. Polymyxin B is not absorbed to an appreciable extent through intact or denuded skin.
Terramycin with Polymyxin B Topical Preparations are indicated for the prophylaxis and topical treatment of localized cutaneous infections such as pyoderma, pustular dermatitis and infected minor wounds of burns due to susceptible microroganisms.
Contraindicated in persons who have shown hypersensitivity to any of its components.
Oxytetracycline is an antibiotic of low toxicity. Allergic reactions, including contact dermatitis, due to individual hypersensitivity have been reported. If such reactions occur, therapy should be discontinued.
Dosage and Administration:
Topical preparations should be kept in continuous contact with the infected area. Duration of the treatment will depend on the nature and severity of the infection and may vary from a few days to several weeks. Since the causative organism may reappear if therapy is interrupted too early, treatment should be continued until healing is complete.
Terramycin with Polymyxin B Sulfate Ointment should be applied only topically as follows: After the skin is cleansed gently and thoroughly, the preparation is applied directly to the involved area by means of a sterile gauze. This procedure should be repeated at least 2 or 3 times daily.
No case of overdosage with topical use of oxytetracylcine have been reported.
Pregnancy and Lactation:
There are no controlled studies to date using topical tetracylines in pregnant women. The use of systemic tetracylcines in pregnant women has resulted in retardation of skeleton development and bone growth in fetus. None the less, topical tetracyclines should be used during pregnancy only when the possible benefits outweigh the potential risks.
It is not known whether topically applied tetracylcines are distributed into the breast milk. Tetracylcines are distributed into breast milk following systemic administration. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
As with other antibiotic preparations, use of this drug may result in an overgrowth of nonsusceptible organisms, including fungi. Constant observation of the patient for this possibility is essential. If new infections due to nonsusceptible bacetria or fungi appear during therapy, appropriate measures should be taken.
Topical application of Terramycin with Polymyxin B should be supplemented with systemic therapy when cutaneous infecitons are severe or are likely to become systemic.
2. Use in Children:
Systemic administration of tetracyclines during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth, as well as, retardation in the development of the skeleton. Enamel hypoplasia has also been reported. Although these effects are unlikely following topical application of tetracyclines because of the low doses used, the possibility that these effects could occur should be considered.
14.2 g tube.
Store at room temperature, below 25°C.