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Cicatrin (Bacitracin Zinc Neomycin Sulfate AminoAcids)
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Pharmacology
When used topically, bacitracin zinc and neomycin sulfate are rarely irritating and not absorbed systemically in significant amounts through intact skin or mucous membrane, but the possibility of significant absorption exists when extensive raw areas are being treated. The incidence of skin sensitization to this combination has been shown to be low on normal skin. Since these antibiotics are seldom used systemically, the patient is spared sensitization to those antibiotics which might later be required systemically.
When used topically, bacitracin zinc and neomycin sulfate are rarely irritating and not absorbed systemically in significant amounts through intact skin or mucous membrane, but the possibility of significant absorption exists when extensive raw areas are being treated. The incidence of skin sensitization to this combination has been shown to be low on normal skin. Since these antibiotics are seldom used systemically, the patient is spared sensitization to those antibiotics which might later be required systemically.
Indications
When Used Topically, Bacitracin Zinc And Neomycin Sulfate Are Rarely Irritating And Not Absorbed Systemically In Significant Amounts Through Intact Skin Or Mucous Membrane, But The Possibility Of Significant Absorption Exists When Extensive Raw Areas Are Being Treated. The Incidence Of Skin Sensitization To This Combination Has Been Shown To Be Low On Normal Skin. Since These Antibiotics Are Seldom Used Systemically, The Patient Is Spared Sensitization To Those Antibiotics Which Might Later Be Required Systemically.
When Used Topically, Bacitracin Zinc And Neomycin Sulfate Are Rarely Irritating And Not Absorbed Systemically In Significant Amounts Through Intact Skin Or Mucous Membrane, But The Possibility Of Significant Absorption Exists When Extensive Raw Areas Are Being Treated. The Incidence Of Skin Sensitization To This Combination Has Been Shown To Be Low On Normal Skin. Since These Antibiotics Are Seldom Used Systemically, The Patient Is Spared Sensitization To Those Antibiotics Which Might Later Be Required Systemically.
Contraindications
In patients who have demonstrated allergic hypersensitivity to the product or any of its constituents, or to cross-sensitizing substances such as aminoglycosides and other related antibiotics.
The presence of pre-existing nerve deafness is a contraindication to the use of Cicatrin cutaneous 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 neomycin absorption exists in very young children, thus Cicatrin cutaneous powder is not recommended for use in neonates and infants (up to 2 years). In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature.
Cicatrin cutaneous powder should not be applied to the eyes.
Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, the use of Cicatrin cutaneous powder in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.
In patients who have demonstrated allergic hypersensitivity to the product or any of its constituents, or to cross-sensitizing substances such as aminoglycosides and other related antibiotics.
The presence of pre-existing nerve deafness is a contraindication to the use of Cicatrin cutaneous 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 neomycin absorption exists in very young children, thus Cicatrin cutaneous powder is not recommended for use in neonates and infants (up to 2 years). In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature.
Cicatrin cutaneous powder should not be applied to the eyes.
Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, the use of Cicatrin cutaneous powder in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.
Safety Information / Warning
Caution should be exercised so that the recommended dosage is not exceeded (see Contraindications and Dosage).
Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known.
When using neomycin-containing products to control secondary infection in the chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than is normal skin to become sensitized to many substances including neomycin.
The manifestation of sensitization to neomycin is usually a low-grade reddening with swelling, dry scaling and itching; it may be manifested simply as a failure to heal. Periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. These symptoms regress quickly on withdrawing the medication. Neomycin-containing applications should be avoided for the patient thereafter.
Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity, and both neomycin sulfate and bacitracin zinc have nephrotoxic potential.
Caution should be exercised so that the recommended dosage is not exceeded (see Contraindications and Dosage).
Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known.
When using neomycin-containing products to control secondary infection in the chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than is normal skin to become sensitized to many substances including neomycin.
The manifestation of sensitization to neomycin is usually a low-grade reddening with swelling, dry scaling and itching; it may be manifested simply as a failure to heal. Periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. These symptoms regress quickly on withdrawing the medication. Neomycin-containing applications should be avoided for the patient thereafter.
Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity, and both neomycin sulfate and bacitracin zinc have nephrotoxic potential.
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.
Following the application of powder to substantial areas of burnt or broken skin, significant systemic absorption of active ingredients may occur.
As with any antibiotic preparation, prolonged use may result in the overgrowth of nonsusceptible organisms, including fungi.
The use of Cicatrin cutaneous powder should not be continued for more than 7 days without medical supervision.
The possibility of allergies to neomycin in patients with stasis ulcers or eczema should be borne in mind.
Allergic cross-reactions may occur which could prevent the use of any or all of the aminoglycoside antibiotics for the treatment of future infections.
Geriatrics: Cicatrin cutaneous powder is suitable for use in elderly patients. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulfate may occur (see Dosage).
Children: Cicatrin cutaneous powder is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Cicatrin cutaneous powder is not recommended for use in neonates and infants (<2 years) (see Contraindications and Dosage).
Fertility: There is insufficient information available to determine whether any of the active ingredients can affect fertility.
Pregnancy: There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy. However, neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of fetal toxicity, thus use of Cicatrin cutaneous powder is not recommended in pregnancy.
Lactation: There is little information to demonstrate the possible effect of topically applied neomycin in lactation. Thus use of Cicatrin cutaneous powder is not recommended in nursing mothers.
Patients with Special Diseases and Conditions: In renal impairment the plasma clearance of neomycin is reduced (see Dosage).
Drug Interactions : Following significant systemic absorption, neomycin sulfate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.
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.
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.
Following the application of powder to substantial areas of burnt or broken skin, significant systemic absorption of active ingredients may occur.
As with any antibiotic preparation, prolonged use may result in the overgrowth of nonsusceptible organisms, including fungi.
The use of Cicatrin cutaneous powder should not be continued for more than 7 days without medical supervision.
The possibility of allergies to neomycin in patients with stasis ulcers or eczema should be borne in mind.
Allergic cross-reactions may occur which could prevent the use of any or all of the aminoglycoside antibiotics for the treatment of future infections.
Geriatrics: Cicatrin cutaneous powder is suitable for use in elderly patients. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulfate may occur (see Dosage).
Children: Cicatrin cutaneous powder is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Cicatrin cutaneous powder is not recommended for use in neonates and infants (<2 years) (see Contraindications and Dosage).
Fertility: There is insufficient information available to determine whether any of the active ingredients can affect fertility.
Pregnancy: There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy. However, neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of fetal toxicity, thus use of Cicatrin cutaneous powder is not recommended in pregnancy.
Lactation: There is little information to demonstrate the possible effect of topically applied neomycin in lactation. Thus use of Cicatrin cutaneous powder is not recommended in nursing mothers.
Patients with Special Diseases and Conditions: In renal impairment the plasma clearance of neomycin is reduced (see Dosage).
Drug Interactions : Following significant systemic absorption, neomycin sulfate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.
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.
Side Effects / Adverse Effects
Neomycin occasionally causes skin sensitization. There is, however, an increased incidence of hypersensitivity to neomycin sulfate in certain selected groups of patients in dermatological practice, particularly those with venous stasis eczema and ulceration.
Allergic hypersensitivity to neomycin following topical use may manifest itself as an eczematous exacerbation with reddening, scaling, swelling and itching of the affected skin, or as a failure of the lesion to heal.
Allergic hypersensitivity reactions following the topical administration of bacitracin zinc has been reported but is rare.
Anaphylactic reactions following the topical administration of bacitracin zinc have been reported but are rare.
Neomycin occasionally causes skin sensitization. There is, however, an increased incidence of hypersensitivity to neomycin sulfate in certain selected groups of patients in dermatological practice, particularly those with venous stasis eczema and ulceration.
Allergic hypersensitivity to neomycin following topical use may manifest itself as an eczematous exacerbation with reddening, scaling, swelling and itching of the affected skin, or as a failure of the lesion to heal.
Allergic hypersensitivity reactions following the topical administration of bacitracin zinc has been reported but is rare.
Anaphylactic reactions following the topical administration of bacitracin zinc have been reported but are rare.
Overdose
Symptoms: No specific symptoms or signs have been associated with excessive use of Cicatrin cutaneous powder. However, consideration should be given to significant systemic absorption (see Warnings and Precautions).
Treatment: 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 sulfate and bacitracin zinc should be determined. Hemodialysis may reduce the serum level of neomycin sulfate.
Symptoms: No specific symptoms or signs have been associated with excessive use of Cicatrin cutaneous powder. However, consideration should be given to significant systemic absorption (see Warnings and Precautions).
Treatment: 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 sulfate and bacitracin zinc should be determined. Hemodialysis may reduce the serum level of neomycin sulfate.
Recommended Dosage
Before use, the area of application should be cleaned gently. Debris such as pus or crusts should be removed from the affected area.
Adults: A light dusting of Cicatrin cutaneous 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.
Children: Cicatrin cutaneous powder is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Cicatrin cutaneous powder is not recommended for use in neonates and infants (<2 years).
Geriatrics: Cicatrin cutaneous powder is suitable for use in elderly patients. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulfate may occur.
Renal Impairment: Dosage should be reduced in patients with reduced renal function.
Before use, the area of application should be cleaned gently. Debris such as pus or crusts should be removed from the affected area.
Adults: A light dusting of Cicatrin cutaneous 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.
Children: Cicatrin cutaneous powder is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Cicatrin cutaneous powder is not recommended for use in neonates and infants (<2 years).
Geriatrics: Cicatrin cutaneous powder is suitable for use in elderly patients. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulfate may occur.
Renal Impairment: Dosage should be reduced in patients with reduced renal function.
Supplied / Packaging
Each g of white, free-flowing powder contains: bacitracin zinc 250units, neomycin sulfate equivalent to 3.3mg neomycin base, l-cysteine 2mg, glycine 10mg, dl-threonine 1mg and cornstarch. Polyethylene insufflators of 15g. Store between 15to 30°C and keep dry.
Each g of white, free-flowing powder contains: bacitracin zinc 250units, neomycin sulfate equivalent to 3.3mg neomycin base, l-cysteine 2mg, glycine 10mg, dl-threonine 1mg and cornstarch. Polyethylene insufflators of 15g. Store between 15to 30°C and keep dry.
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Brand Name
Cicatrin
Cicatrin
Generic Name
Bacitracin Zinc Neomycin Sulfate AminoAcids
Bacitracin Zinc Neomycin Sulfate AminoAcids
General Indications
Antibiotic Tissue Healant
Antibiotic Tissue Healant
