(and dosage form):
CICATRIN Powder contains:
Neomycin sulphate 3300 Units per gram Bacitracin zinc 250 Units per gram in a dried modified-starch, dusting powder base containing the amino acids: Glycine 1.0% m/m; L-Cysteine 0.2% m/m and DL-Threonine 0.1% m/m.
Cicatrin is not widely used anymore as studies have shown basic OTC creams such as polysporin and neosporin work just as effectively.
A20.1.6 Topical antibiotics.
CICATRIN Powder is a broad-spectrum bactericidal preparation active against pathogens commonly found in infections of the skin.
CICATRIN Powder is indicated for:
Prophylaxis of superficial skin infections caused by susceptible organisms in minor abrasions, burns, and cuts.
The use of CICATRIN Powder does not exclude concomitant therapy with antibiotics where appropriate.
The use of CICATRIN Powder is contra-indicated in patients who have demonstrated allergic sensitivity to any of the ingredients of the products or cross-sensitising substances such as framycetin, kanamycin, gentamicin and other related antibiotics.
The use of CICATRIN Powder is contra-indicated in circumstances where significant systemic absorption could occur, e.g. application of large amounts, treatment of large areas or chronic wounds or prolonged treatment.
CICATRIN Powder should not be used on pre-term infants.
CICATRIN Powder should not be applied to the eyes.
Use in pregnancy and lactation:
Safety in pregnancy and lactation has not been established, therefore the use of CICATRIN Powder is not recommended.
Neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of foetal ototoxicity.
No information is available regarding the excretion of the active ingredients or their metabolites in human breast milk.
DOSAGE AND DIRECTIONS FOR USE:
Administration and dosage in adults:
Before use the area for application should be cleaned gently.
Debris such as pus or crusts should be removed from the affected area.
A light dusting of the powder or a thin film of the cream should be applied to the affected area one to four times daily, depending on the clinical condition. Treatment should not continue for more than seven days without medical supervision (see CONTRA-INDICATIONS and SIDE-EFFECTS AND SPECIAL PRECAUTIONS).
Dosage in children:
CICATRIN Powder is suitable for use in children. In older children, dosage is as for adults, but in infants dosage should be reduced (see SIDE-EFFECTS AND SPECIAL PRECAUTIONS).
A possibility of increased absorption exists in very young children, thus CICATRIN Powder is not recommended for use in neonates.
Dosage in the elderly:
CICATRIN Powder is suitable for use in the elderly (see Dosage in renal impairment and SIDE-EFFECTS AND SPECIAL PRECAUTIONS).
Dosage in patients with renal impairment:
Dosage should be reduced in patients with reduced renal function (see SIDE-EFFECTS AND SPECIAL PRECAUTIONS).
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Caution should be exercised so that the recommended dosage is not exceeded (see CONTRA-INDICATIONS and DOSAGE AND DIRECTIONS FOR USE).
Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity and both neomycin sulphate and bacitracin zinc have nephrotoxic potential. In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature (see CONTRA-INDICATIONS).
In renal impairment the plasma clearance of neomycin is reduced (see Dosage in renal impairment).
Prolonged use may result in overgrowth by non-susceptible organisms, including fungi.
Allergic hypersensitivity reactions to neomycin following topical application may manifest as a reddening and scaling of the affected skin, as an eczematous exacerbation of the lesion, or as a failure of the lesion to heal.
Allergic hypersensitivity and anaphylactic reactions following topical application of bacitracin zinc have been reported but are rare.
There is a possibility that CICATRIN could cause staining and users should take adequate precautions. Interactions:
Following significant systemic absorption, neomycin sulphate can intensify and prolong the respiratory depressant effect of neuromuscular blocking agents.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms and signs:
No specific symptoms or signs have been associated with excessive use of CICATRIN Powder. However, consideration should be given to significant systemic absorption (see SIDE-EFFECTS AND SPECIAL PRECAUTIONS).
Use of the product should be stopped and the patient’s general status, hearing acuity, renal and neuromuscular functions should be monitored. Blood levels of neomycin sulphate and bacitracin zinc should also be determined. Haemodialysis may reduce the serum level of neomycin sulphate.
A white to cream coloured powder with a faint odour.
Plastic puffer pack of 15 g.
Store below 25°C. Keep out of reach of children. Keep dry.
G2370 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pfizer Consumer Healthcare, division of
Warner-Lambert S.A. (Pty) Ltd.
241 Main Road,
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 April 2000