| CICATRIN® |
|Glaxo Wellcome |
|Bacitracin - Neomycin Sulfate - Amino Acids |
|Antibiotic - Tissue Healant |
|Indications And Clinical Uses: As a prophylactic or treatment and healing agent for surface wounds, minor burns, and stasis ulcers. Not recommended for the treatment of superficial fungal infections. The use of the powder does not exclude concomitant systemic therapy with antibiotics where appropriate.
Contra-Indications: Patients who have demonstrated allergic hypersensitivity to the product or any of its constituents, or to cross-sensitizing substances such as framycetin, kanamycin, gentamicin and other related antibiotics.
The presence of preexisting nerve deafness is a contraindication to the use of powder in circumstances in which significant systemic absorption could occur.
The concurrent use of other aminoglycoside antibiotics in circumstances where significant systemic absorption of neomycin sulfate could occur is contraindicated.
A possibility of increased absorption of neomycin exists in neonates and infants, thus Cicatrin is not recommended for use in neonates and should be used at reduced dosages in infants.
Cicatrin powder should not be applied to the eyes.
Precautions: General: Ototoxicity and nephrotoxicity have been reported in association with large or prolonged doses of neomycin and nephrotoxicity has also been reported with inappropriate dosing with bacitracin. While these effects are normally reversible on cessation of therapy, the ototoxicity of neomycin is not. In consequence, the application of three 15 g insufflators of powder daily for 4 weeks should not be exceeded in adults. After such a course, treatment should not be repeated for at least 3 months.
As with any antibiotic product, overgrowth by nonsusceptible organisms may occur. If this occurs, institute appropriate measures. The possibility of allergies to neomycin in patients with stasis ulcers or eczema should be borne in mind. Following the application of powder to substantial areas of burnt or broken skin, significant systemic absorption of active ingredients may occur.
Geriatrics: Maximum dose should be reduced especially where decreased renal function exists.
Infants and Children: In neonates and infants, absorption of neomycin by immature skin may be enhanced. Immaturity of renal functions may predispose these patients to decreased elimination and increased blood levels of neomycin (see Contraindications). In children, the maximum dosage should be reduced in proportion to body weight.
Fertility: There is insufficient information available to determine whether any of the active ingredients can affect fertility.
Pregnancy and Lactation: 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 fetal toxicity thus use of Cicatrin powder is not recommended. No information is available regarding the excretion of the active ingredients in human milk.
Teratogenicity: There is insufficient information available to determine whether the active ingredients have teratogenic potential. Neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of fetal ototoxicity.
Patients with Special Diseases and Conditions: In renal impairment the plasma clearance of neomycin is reduced; therefore, a reduction in dose should be made that relates to the degree of renal impairment.
Drug Interactions: Following significant systemic absorption, neomycin sulfate can intensify and prolong the respiratory depressant effect of neuromuscular blocking agents.
Adverse Reactions: Allergic hypersensitivity to active ingredients has been reported. Anaphylactic reactions are rare.
Allergic hypersensitivity to neomycin following topical application may manifest itself 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.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: No specific symptoms or signs have been associated with excessive use of Cicatrin powder. However, consideration should be given to significant systemic absorption (see Precautions).
In the event of signs of toxicity developing following significant absorption of the active ingredients, the patient's general status, hearing acuity and renal function should be monitored and blood levels of neomycin and zinc bacitracin determined. Serum levels of neomycin can be reduced by hemodialysis.
Dosage And Administration: Adults: Before use, the area of application should be cleaned gently. Debris such as pus or crusts should be removed from the affected area.
A light dusting of powder should be applied to affected area twice daily or as directed by a physician. Treatment should not be continued for more than 7 days without medical supervision (see Precautions).
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 Contraindications and Precautions).
A possibility of increased absorption exists in neonates and infants thus Cicatrin powder is not recommended for use in neonates and should be used at reduced dosages in infants. Follow administration instructions as per adults.
Geriatrics: Cicatrin powder is suitable for use in the elderly (see Renal Impairment and Precautions).
Renal Impairment: Dosage should be reduced in patients with reduced renal function (see Precautions).
Availability And Storage: Each g of white, free-flowing powder contains: zinc bacitracin 250 units, neomycin sulfate equivalent to 3.3 mg of neomycin base, l-cysteine 2 mg, glycine 10 mg, dl-threonine 1 mg and cornstarch. Polyethylene insufflators of 15 g. Store between 15 to 30°C and keep dry.