COMPOSITION:
1g contains
Econazole Nitrate…………………………………..….. 10.0mg
Triamcinolone Acetonide………………………………. 1.0mg
Gentamicin Sulphate…………………………………… 1.0mg
CLINICAL PHARMACOLOGY:
Pharmacodynamic:
Econazole is an imidazole antifungal agent which alters fungal cell wall membrane permeability, may interfere with Ribonucleic Acid, protein synthesis and lipid metabolism.
Triamcinolone Acetonide is a potent corticosteroid with anti-inflammatory, antipruritic and antiallergic activity.
Gentamicin is an aminoglycoside antibiotic which interferes with bacterial protein synthesis. It is active against a wide variety of pathogenic gram-positive and gram-negative microorganisms. Gentamicin is indicated for the topical treatment of the primary and secondary bacterial infections of the skin caused by the organisms sensitive to Gentamicin. Gentamicin may clear infections that have not responded to other topical antibiotics.
INDICATIONS
Drunalog® Cream is indicated for the topical treatment of:
-Inflammatory dermatoses responsive to steroids
-Inflammatory skin conditions complicated by bacterial or fungal skin infection
-Tinea pedis (athlete’s foot), tinea cruris (jock itch), tinea corporis (ringworm), tinea versicolor and cutaneous candidiasis.
-Allergic inflammatory dermatoses (eczema, dermatitis, diaper dermatitis and intertrigo).
CONTRAINDICATIONS
-Hypersensitivity to Econazole, Triamcinolone Acetonide, Gentamicin sulphate (other aminoglycoside) or any component of the formulation.
-Patients with tuberculosis cutis, herpes simplex, varicella, herpes zoster, vaccinia and syphilis.
-Eczematous otitis external with perforated ear drum.
WARNINGS & PRECAUTIONS
-Discontinue drug if sensitivity or chemical irritation occurs.
-Long-term continuous therapy particularly occlusive dressings should be avoided since it may cause side effects same as systemic administration of corticosteroid. PREGNANCY AND LACTATION
No specific precautions apply. Systemic absorption is likely to be negligible.
CHILDREN: In infants, long-term, continuous, topical steroid therapy should be avoided, courses should be limited to 5 days and occulusion should not be used.
ADVERSE REACTIONS/SIDE EFFECTS
-Local reactions including burning sensations and irritation may occur when Econazole nitrate is applied topically. Contact dermatitis has been reported rarely.
-Hypersensitivity reactions have occurred, especially after local use and cross sensitivity between aminoglycosides may occur. Very rarely anaphylactic reactions to Gentamicin have occurred.
-When applied topically particularly to large areas, when the skin is broken or under occlusive dressings, corticosteroids may be absorbed in sufficient amounts to cause systemic effect.
-Itching, allergic contact dermatitis, erythema, dryness papular rashes, folliculitis, furunculosis, pustules, pyoderma, vesiculation, hyperesthesia and skin infection (secondary).
-Burning and irritation.
KEEP OUT OF THE REACH OF THE CHILDREN

SYMPTOMS OF OVERDOSAGE AND ANTIDOTE
Topically applied corticosteroid can be absorbed in sufficient amounts to produce systemic effects such as thinning of the skin, increased sweating, purpura, striae, hirsutism, lupus erythematosus-like lesions and suppressed reactions to skin tests. In the event of accidental ingestion, the patient should be observed and treated symptomatically.
DOSAGE AND ADMINISTRATION
To be applied to the affected area two to four times daily.
PRESENTATION
Available in tubes of 20g
STORAGE CONDITION
Store at room temperature. Avoid freezing.