Endix

Endix

Manufacturer:

Dongkwang

Distributor:

Propharm
Full Prescribing Info
Contents
Econazole nitrate and triamcinolone acetonide.
Description
Each gram contains econazole nitrate 10 mg, triamcinolone acetonide 1 mg. It also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate as preservatives.
Action
Pharmacodynamics: Econazole nitrate is a broad spectrum antifungal and antibiotic agent, active against dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Malassezia furfur); pathogenic yeasts; Candida albicans and other Candida spp. It is also active against gram-positive bacteria.
Triamcinolone is a potent fluorinated corticosteroid with rapid anti-inflammatory, antipruritic and antiallergic actions.
Pharmacokinetics: Triamcinolone, when administered by topical application, is well absorbed from sites of local application.
Econazole's absorption is not significant when applied to the skin.
Indications/Uses
Dermatophytosis: Tinea pedis (Athlete's foot), tinea corporis (Ringworm), tinea capitis, tinea cruris, tinea barbae; tinea vesicolor, candidiasis, eczema, dermatitis, intertrigo.
Dosage/Direction for Use
Apply to the affected area once or twice daily.
Overdosage
If accidental ingestion of Endix cream occurs, an appropriate method of gastric emptying may be used if considered appropriate.
Contraindications
Hypersensitivity or history to econazole nitrate and triamcinolone acetonide, and to the ingredients of Endix. Bacterium (tuberculosis, syphilis), virus (herpes zoster, herpes simplex, chickenpox, vaccinia, etc) infection; eczematous otitis externa with perforated eardrum. Ulcer (excluding Behcet's disease), burn exceeding 2nd degree, chilblain; perioral dermatitis, acne vulgaris, rosacea patients; initial stage of skin inflammatory lesion.
Special Precautions
Cautiously administer to the patients with history of hypersensitivity or allergy to these propylene glycol.
General Precautions: Use according to the recommended dose. Long-term continuous therapy, particularly occlusive dressings, should be avoided since it may cause side effects same as systemic administration of corticosteroid. If the symptom does not improve or is aggravated, discontinue therapy. If the symptom has improved, change to other NSAIDs as soon as possible. Do not exceed 7 days of treatment.
Use in pregnancy & lactation: Administer carefully to pregnant patients or female of childbearing potential.
Embryonic toxicity may occur when econazole nitrate (10-40 times of skin dosage for men) is administered orally to rats. Similar results occur when econazole nitrate (40-80 times of skin dosage for men) is administered orally to mouse, rabbit and rats.
Safety for use of Endix in pregnancy has not yet been established. It should be given to women who are pregnant or potentially pregnant only when the expected benefits exceed the risks. Especially, do not use in pregnancy within 3 months.
It has not been reported that Endix is excreted in human milk but corticoids, which is absorbed, is systemically excreted in human milk.
Use in children: Administer carefully to infant and children.
Long-term therapy or occlusive dressing technique (ODT) may cause growth delay for infants and children. Using a napkin may cause a similar effect to ODT.
Use In Pregnancy & Lactation
Administer carefully to pregnant patients or female of childbearing potential.
Embryonic toxicity may occur when econazole nitrate (10-40 times of skin dosage for men) is administered orally to rats. Similar results occur when econazole nitrate (40-80 times of skin dosage for men) is administered orally to mouse, rabbit and rats.
Safety for use of Endix in pregnancy has not yet been established. It should be given to women who are pregnant or potentially pregnant only when the expected benefits exceed the risks. Especially, do not use in pregnancy within 3 months.
It has not been reported that Endix is excreted in human milk but corticoids, which is absorbed, is systemically excreted in human milk.
Adverse Reactions
Skin: Skin Infection: Bacterial (infectious impetigo, folliculitis, etc) and viral infections may occur.
Other Dermal Symptoms:
Folliculitis, skin irritation, rash-flare, itching, allergic contact dermatitis, pigmentation, urticaria, etc. Discontinue use once symptoms occur.
Long-Term Therapy:
Xeroderma, steroidal acne, steroidal skin (skin atropy, telangiectasis) and changes of the skin eg, thinning, purpura, hirsutism and hypopigmentation may occur. If these symptoms occur, discontinue therapy.
Endocrine System: Long-term therapy or occlusive dressing technique may cause hypothalamus-pituitary-adrenal axis suppression.
Eye: When Endix is used in eyelid skin, ocular hypertension and glaucoma may occur. Cataract and glaucoma might result from long-term continuous therapy or occlusive dressings.
Others: Inhibition of endogenous corticoid synthesis, hyperadrenalism with edema, diabetes mellitus, osteoporosis, growth delay for children.
Caution For Usage
Do not use for the opthalmological field.
Storage
Store in hermetic container at room temperature (1-30°C).
ATC Classification
D01AE - Other antifungals for topical use ; Used in the topical treatment of fungal infection.
Presentation/Packing
Cream (white) 10 g.
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