Prokanazol®
capsules
![ProkanazolRR](javascript:obrazek_big("http://promedcs.cz//en/../img/baleni/600_prokanazol(1).jpg", "en"); "ProkanazolRR")
- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Itraconazolum (itraconazole) 100 mg in 1 capsule.
- Indication group:
- antimycotic agent with systemic effect
The following information is for health professionals only.
READ CAREFULLY THIS NOTICE!
Characteristics:
Itraconazole is a wide-spectrum triazole derivative, effective against infections caused by dermatophytes, yeast fungi, and moulds. The mechanism of effect is the impairment of the synthesis of ergosterol, an important membrane component of micromycete cells.
Indications:
Gynecological - vulvovaginal candidosis; dermatological - pityriasis versicolor, dermatomycosis, onychomycosis, oral candidosis; ophthalmological - mycotic keratitis caused by dermatophytes and/or yeast fungi; systemic mycoses - systemic aspergillosis and candidosis, cryptococcosis, histoplasmosis, sporotrichosis, paracoccidioidomycosis, blastomycosis, chromomycosis, and other rarely occurring systemic mycoses. The preparation Prokanazol® capsules is intended for treatment of adults and children over 40 kg of body weight.
Contraindications:
Hypersensitivity to itraconazole. Concomitant treatment with terfenadine, astemizole, mizolastine, cisapride, dofetilide, quinidine, pimozide, triazolame, midazolame, simvastatin, and lovastatine. During gravidity and lactation it is necessary to carefully consider the ratio of benefit to risk. After termination of the therapy it is necessary to secure contraception till the next menstruation.
Undesirable effects:
Insignificant gastrointestinal complaints. Less frequently headaches, vertigoes, reversible increase in liver enzymes, disorders in menstruation, allergic reactions. Sporadically cases of peripheral neuropathy and Stevens-Johnson syndrome, edemas, congestive heart frailty and pulmonary edema. On long-term continuous therapy (about 1 month), cases of hypokalemia, hepatitis, and hair loss were observed.
Interactions:
On concomitant use with itraconazole, mutual intensification of the effects of some drugs, particularly CYP3A4 inhibitors (alprazolam, oral anticoagulants, HIV proteases inhibitors, calcium channel blockers, some immunosuppressive agents), can take place. The effect of itraconazole is decreased by enzyme inductors, e.g., phenytoin, carbamazepine, rifampicin. Drugs decreasing the acidity of the gastric content (antacids, inhibitors of acid gastric secretion) limit the absorption of itraconazole.
Caution:
Caution is necessary in patients with congestive heart frailty (also in the anamnesis), and in the impairment of the liver or kidney it is necessary to adjust dosage. Antacids are to be administered at least 2 hours after Prokanazol® administration. In achlorhydria or concomitant use of itraconazole with H2 antagonists or inhibitors of the proton pump it is advisable to wash it down with a drink of an acid character.
Dosage:
Vulvovaginal candidosis: 200 mg once daily for 3 days, or 200 mg 2 times daily for 1 day, pityriasis versicolor: 200 mg once daily for 7 days, dermatomycosis: 200 mg once daily for 7 days, or 100 mg once daily for 15 days, oral candidosis: 100 mg once daily for 15 days. In immunodeficient patients and in mycoses in highly keratinized regions it is necessary to increase doses. Onychomycoses: pulse therapy 200 mg 2 times daily for a period of one week with subsequent three-week break, pulse is repeated 2 times (fingernails), 3 times (toenails). The capsules Prokanazol® are swallowed whole immediately after meals.
Package:
4, 14, and 28 capsules.
Complete information about the preparation is included in the drug information sheet.
Date of the latest revision of the text: October 19, 2005.
The preparation is available on medical prescription only.