1) COMPANY NAME
ARAB COMPANY FOR PHARMACEUTICAL & MEDICINAL PLANTS (MEPACO-
MEDIFOOD)-EGYPT
2) TRADE NAME
Tineapirox 1% topical cream
3) GENERIC NAME
Ciclopirox olamine
4) COMPOSITION
Each tube of Tineapirox 1% topical cream (10gm) contains:
Active ingredients:
0.1gm Ciclopiroxolamine
Inactive ingredients:
Stearyl alcohol, cetyl alcohol, stearic acid, Isopropyl myristate, span 60, heavy liquid paraffin, tween 60, tween 80, benzyl alcohol and purified water.
5) PHARMACEUTICAL FORM:
Topical cream
6) PHARMACOLOGICAL ACTION
Ciclopirox is a broad spectrum topical antifungal agent that belongs to pyridone family active in vitro to candida albicans , Trichophyton , Epidermophyton .
It also processes antibacterial action against gram positive (staphylococci, streptococci) and gram negative (E. coli, proteus and pseudomonas).
7) PHARMACOKINETICS :
The absorption of tineapirox is very weak only 1.1% to 1.6% of the dose is detected in urine. The maximum plasma concentration is (0.2 to 0.3 microgram
/ml) . Ciclopirox penetrates into the hair and through the epidermis and hair follicles into the sebaceous glands and dermis with a portion of the drug remains in the stratum corneum.
Systemic distribution on tineapirox is negligible.
INDICATIONS 8)
Tineapirox cream is indicated for the topical treatment of the following dermal complicated or uncomplicated infections: due to Trichophyton , Epidermophyton
,candidiasis(moniliasis)
Pytiriasis versicolor.
Mild to moderate seborrheic dermatitis
9) DOSAGE & ADMINISTRATION:
Gently massage Tineapirox cream into the affected and surrounding skin areas twice daily in the morning and evening.
10) CONTRAINDICATIONS:
Tineapirox cream is contraindicated in individuals who have shown hypersensitivity to any of its components

11) SIDE EFFECTS:
No undesirable systemic side effects have been reported, this may only be considered in cases of treatment of large skin areas including mucus membrane and for prolonged periods.
Rarely at the beginning of treatment (2.8% of cases) local manifestation in the form of burning sensation, erythema, pruritis , this does not require to stop the treatment .
12) DRUG INTERACTION:
No Information provided.
13) PREGNANCY & LACTATION
Pregnancy: This drug should be used during pregnancy only if clearly needed.
Nursing mothers: No Information provided.
14) PRECAUTIONS & WARNING
Avoid contact with eyes.
It is not recommended to use acid PH soap during the use of tineapirox.
15) PATIENT INFORMATION:
Patients shouldn't use Tineapirox without consulting their doctor.
16) PACKAGE& STORAGE
Tube of 10gm topical cream
Store at temperature not exceeding 30 o C.
Produced by MEDIZEN FOR PHARMACEUTICAL INDUSTRIES for
ARAB COMPANY FOR PHARMACEUTICAL & MEDICINAL
PLANTS
(MEPACO-MEDIFOOD)-EGYPT