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SIGMADERM: |
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Composition |
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Each tube of SIGMADERM Cream contains:
Clotrimazole … 1% w/w
Beclomethasone dipropionate … 0.025% w/w
Neomycin sulphate
Equivalent to neomycin … 0.5% w/w
Chlorocresol … 0.1% w/w
Bronopol … 0.02% w/w |
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Therapeutic Indications & Usage |
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SIGMADERM is advocated for infected atopic dermatitis, infected excoriations, intertrigo, bacterial
superinfection of chronic superficial mycoses, otitis externa and other infected (mixed / suspected)
steroid-responsive dermatoses.
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Contraindications |
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SIGMADERM is not advocated for those allergic to its ingredients, history of hypersensitivity to
aspirin or other NSAIDs, aspirin-induced nasal polyps or bronchospasm, active peptic ulceration and in severe renal dysfunction.
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Precautions & Warnings |
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SIGMADERM is to be advocated with caution in liver & kidney damage, elderly, patients requiring
surgery, anemia, bronchial asthma, stomatitis, compromised cardiac function, heart failure,
pre-existing edema, systemic lupus erythematosus.
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Safe use of SIGMADERM in pregnancy and lactation has not been established. SIGMADERM should
not be preferably coadministered with other NSAIDs, corticosteroids, hypoglycemics, digoxin, lithium,
methotrexate, cyclosporine, coagulants & anticoagulants, bone marrow suppressants as well as
probenecid. |
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The use of SIGMADERM is not advisable for more than 4 weeks, unless prescribed. Its use in
pregnancy & lactation, and in children, must be advocated only if strictly required. |
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Adverse Reactions |
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Adverse reactions reported with the use of clotrimazole (in SIGMADERM) are as follows: erythema, s
tinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin. |
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The following local adverse reactions are reported infrequently when topical corticosteroids
[beclomethasone (in SIGMADERM)] are used as recommended. These reactions are listed in an a
pproximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis,
hypertrichosis, acneiform eruptions, hypopigmentation, perioral ermatitis, allergic contact dermatitis,
maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. |
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Serum neomycin concentrations up to 4 mcg per mL or more can occur with SIGMADERM topical
administration. Nephrotoxicity and moderate to severe ototoxicity may occur, especially if renal
function is impaired and systemic nephrotoxic and/or ototoxic drugs are given concurrently (with
SIGMADERM). |
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Use of topical neomycin (in SIGMADERM) may lead to skin sensitization resulting in hypersensitivity
reactions. |
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Drug Interaction |
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Synergism or antagonism between clotrimazole (in SIGMADERM) and nystatin or amphotericin B or
fluocytosine can occur.
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Nephrotoxicity and moderate to severe ototoxicity may occur, especially if renal function is impaired
and systemic nephrotoxic and / or ototoxic drugs are given concurrently (with SIGMADERM). |
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Recommended Dosage & Administration |
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SIGMADERM Cream is to be applied as a thin layer 2-4 times daily on the affected skin site.
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Presentations |
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SIGMADERM Cream: Tubes of 5, 10 gms. |
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