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Epiderm

Shalina Healthcare Nig. Ltd (Socomex Nig. Ltd)
3/4, Adewunmi Industrial Estate, John Holt Ventures compound, Kudirat Abiola Way, Oregun, Lagos
Tel: +234-1-818-3973
Website: http://shalinahealthcare.com

Brand Name

Epiderm

Manufacturer

SHALINA LABORATORIES PVT. LTD. 96, Maker Chambers VI, Nariman Point, Mumbai - India.

At / A / Em: Plot No. E - 2, M.I.D.C. Jejuri, Tal. Purandar, Dist. Pune, Maharashtra - India. www.shalina.com

Therapeutic Class

Anti-infective/Corticosteroid combinations, Skin

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Cream (NRN: A4-4676): Epiderm Cream: Each gram contains: Betamethasone Dipropionate USP 0.643 mg, Gentamicin sulphate BP equivalent to Gentamicin base 1mg, Tolnaflate USP 10 mg, lodochlorhydroxyquinoline 10 mg, Chlorocresol BP (preservative) 1 mg. Excipients: cetomacragol-1000 BP, Cetostearyl alcohol BP, White soft Paraffin BP, purified water BP, Propylene Glycol BP and Disodium Hydrogen Phosphate dihydrate BP.

Pack Size: Epiderm Cream: Pack of 15 g

EPIDERM CREAM 15g

Cream (NRN: A4-4676): Epiderm Cream: Each gram contains: Betamethasone Dipropionate USP 0.643 mg, Gentamicin sulphate BP equivalent to Gentamicin base 1mg, Tolnaflate USP 10 mg, lodochlorhydroxyquinoline 10 mg, Chlorocresol BP (preservative) 1 mg. Excipients: cetomacragol-1000 BP, Cetostearyl alcohol BP, White soft Paraffin BP, purified water BP, Propylene Glycol BP and Disodium Hydrogen Phosphate dihydrate BP.

Pack Size: Epiderm Cream: Pack of 30 g

EPIDERM CREAM 30g

Lotion (NRN:A4-6173): Epiderm Lotion: Each mL contains: Betamethasone Dipropionate USP 0.643 mg, Gentamicin sulphate BP equivalent to Gentamicin base 1 mg, Tolnaflate USP 10 mg, lodochlorhydroxyquinoline 10 mg, Chlorocresol BP (Preservative) 1 mg. in a suitable base q.s.
Excipients: Cetomacragol-1000 BP, Cetostearyl alcohol BP, White soft Paraffin BP, Purified water BP, Paraffin liquid heavy BP, Propylene Glycol BP and Disodium Hydrogen Phosphate dihydrate BP.

Pack Size: Epiderm Lotion: Pack of 30 mL

EPIDERM LOTION

 

Pharmacology

Pharmacological category:

Epiderm Cream / Lotion is a combination of anti-fungal, anti-bacterial & anti-inflammatory drugs, which provide synergetic action in treatment of mix bacterial & fungal infections.

Pharmacological action:

Corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.

Gentamicin is an aminoglycoside that binds to 30s and 50s ribosomal subunits of susceptible bacteria disrupting protein synthesis, thus rendering the bacterial cell membrane defective.

Tolnaflate is an antifungal which inhibits growth of dermatophytes. lodochlorhydroxyquinoline has antibacterial and antifungal activity.

Pharmacokinetics:

Epiderm Cream / Lotion:

Absorption: Percutaneous absorption

Elimination: Via urine.

Indications

Epiderm Cream / Lotion is indicated for the treatment of following: Mixed bacterial and fungal infections, Tinea Infections of the skin (Ringworm), Otitis externa, Seborrhoeic dermatitis, Contact dermatitis, Eczemas, psoriasis, Athlete's foot, Anal & vulval pruritis.

Contra-indications

Epiderm Cream / Lotion is contraindicated in patients who are hypersensitive to any of the component of the drug. It is also contraindicated in the treatment of herpes simplex, vaccina or varicella.

Precautions/Warnings

Paediatric Use:

HPA axis suppression, Cushing's syndrome and intracranial hypertension have been reported in paediatric patients receiving topical corticosteroids.

Usage in Pregnancy & Lactation:

Epiderm Cream / Lotion is not safe in pregnancy. Physician should be consulted before initiating therapy with Epiderm Cream / Lotion for nursing mothers.

Interactions

No interaction have been reported on local application with Epiderm Cream/Lotion. Avoid using other topical medications.

Adverse Effects

Epiderm Cream / Lotion is generally safe. Prolong, continuous treatment may cause atrophy skin changes leading to: thinning, loss of elasticity, dilatation of superficial blood vessels, telangiectasiae and ecchymoses. Systemic absorption of corticosteroid can cause hypothalamic-pituitary-adrenal axis suppression, manifestation of cushing's syndrome, hyperglycaemia and glucosuria.

Undesirable Effects:

Epiderm Cream / lotion is generally well tolerated. Some of the rarely reported side effects are burning sensation, itching, irritation, dryness, folliculitis, acneform eruptions, hypopigmentation, maceration of the skin, secondary infection, skin atrophy etc.

Dosage & Administration

Apply 2-3 times of Epiderm Cream / Lotion a day to the affected area or as directed by physician.

Symptoms of over dosage & Its treatment:

Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal functions resulting in secondary adrenal insufficiency which is usually reversible. In such cases appropriate symptomatic treatment is indicated. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, reduce the frequency of application, or to substitute a less potent steroid.

Storage/Handling Recommendations

Storage condition: Shake well before use. For External Use Only. Do not swallow. Do not store above 30

Review Date

2017-04-28 09:59:36