Neozine

Neozine1%

Cream

Silver Sulfadiazine

Opsonin Pharma Ltd.

Product Code : 11599
MRP 30.11
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Medicine overview

Indications of Neozine 1%

Neozine 1% cream is indicated in- The topical prophylaxis against bacterial colonization and infection in burn wounds. The topical antibacterial management of certain contaminated or infection-prone wounds, other than burns.

Theropeutic Class

Topical Antibiotic preparations

Pharmacology

The mechanism of Neozine 1%'s antibacterial action has not been fully elucidated. After exposure to the drug, structural changes in the bacterial cell membrane occur, including distortion and enlargement of the cell and a weakening of the cell wall membrane. This is accompanied by reduced viability in sensitive strains. The Neozine 1% molecule dissociates and the silver moiety is bound to the bacterial cells. It is believed that, after penetrating the cell wall, the silver moiety is attached to deoxyribonucleic acid (DNA) and prevents bacterial cell proliferation. There is approximately 100 times more DNA in mammalian cells than in bacterial cells. It is thought that the ratio of Neozine 1% to bacterial DNA is sufficiently high to prevent bacterial division but the corresponding ratio to epithelial DNA is low enough not to block epithelial cell regeneration. The sulfadiazine moiety also provides a bacteriostatic action against sensitive organisms. In adults, up to 10% of the sulfadiazine may be absorbed and 60 to 85% of the absorbed amount is excreted in the urine. In children with 13% body surface area burns, the urinary sulfadiazine concentration was 31.8 mg/L.

Dosage & Administration of Neozine 1%

The burn wounds are cleansed, and Neozine 1% is applied over the burn wound. The burn areas should be covered with Neozine 1% at all times. The cream should be applied once to twice daily to a thickness of approximately 1/16 inches or 1.5 mm. Whenever necessary; the cream should be reapplied to any areas from which it has been removed by patient activity. If individual patient requirements make dressings necessary, they may be used. Reapplication should be ensured immediately after hydrotherapy. Treatment with Neozine 1% should be continued until satisfactory healing is occurred, or until the burn site is ready for grafting. The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.

Dosage of Neozine 1%

The burn wounds are cleansed, and Neozine 1% is applied over the burn wound. The burn areas should be covered with Neozine 1% at all times. The cream should be applied once to twice daily to a thickness of approximately 1/16 inches or 1.5 mm. Whenever necessary; the cream should be reapplied to any areas from which it has been removed by patient activity. If individual patient requirements make dressings necessary, they may be used. Reapplication should be ensured immediately after hydrotherapy. Treatment with Neozine 1% should be continued until satisfactory healing is occurred, or until the burn site is ready for grafting. The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.

Interaction of Neozine 1%

Enzymatic debriding agents: Silver sulfadiazine may inactivate enzymatic debriding agents, thus the concomitant use of these compounds may be inappropriate. Oral hypoglycemic agents and phenytoin: In patients with large area burns where serum sulfadiazine levels may approach therapeutic levels, the action of oral hypoglycemic agents and phenytoin may be potentiated and it is recommended that blood levels be monitored. Cimetidine: In-patients with large area burns, it has been reported that co-administration of Cimetidine may increase the incidence of leukopenia.

Contraindications

It is contraindicated in-patients who are hypersensitive to it or any of the other ingredients in the preparation. It should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life

Side Effects of Neozine 1%

Several cases of transient leukopenia have been reported in-patients receiving Neozine 1% therapy. Other infrequently occurring events include skin necrosis, erythema multiform, skin discoloration, burning sensation, rashes, and interstitial nephritis.

Pregnancy & Lactation

Pregnancy Category B. This drug should be used during pregnancy only if clearly justified, especially in pregnant women approaching or at term. It is not known whether Neozine 1% is excreted in human milk. A decision should be made, whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Precautions & Warnings

General: If hepatic and renal functions become impaired and elimination of drug decreases, accumulation may occur and discontinuation of this should be weighed against the therapeutic benefit being achieved. In considering the use of topical proteolytic enzymes in conjunction with it, the possibility should be noted that silver might inactivate such enzymes. Laboratory Tests: In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 mg% to 12 mg%). Therefore, in these patients it would be advisable to monitor serum sulfa concentrations. Renal function should be carefully monitored and the urine should be checked for sulfa crystals.

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Drug Classes

Topical Antibiotic preparations

Mode Of Action

The mechanism of Neozine 1%'s antibacterial action has not been fully elucidated. After exposure to the drug, structural changes in the bacterial cell membrane occur, including distortion and enlargement of the cell and a weakening of the cell wall membrane. This is accompanied by reduced viability in sensitive strains. The Neozine 1% molecule dissociates and the silver moiety is bound to the bacterial cells. It is believed that, after penetrating the cell wall, the silver moiety is attached to deoxyribonucleic acid (DNA) and prevents bacterial cell proliferation. There is approximately 100 times more DNA in mammalian cells than in bacterial cells. It is thought that the ratio of Neozine 1% to bacterial DNA is sufficiently high to prevent bacterial division but the corresponding ratio to epithelial DNA is low enough not to block epithelial cell regeneration. The sulfadiazine moiety also provides a bacteriostatic action against sensitive organisms. In adults, up to 10% of the sulfadiazine may be absorbed and 60 to 85% of the absorbed amount is excreted in the urine. In children with 13% body surface area burns, the urinary sulfadiazine concentration was 31.8 mg/L.

Pregnancy

Pregnancy Category B. This drug should be used during pregnancy only if clearly justified, especially in pregnant women approaching or at term. It is not known whether Neozine 1% is excreted in human milk. A decision should be made, whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.