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Fulcover

Fulcover

itraconazole

Manufacturer:

Saga Lab

Distributor:

KTZ
Concise Prescribing Info
Contents
Itraconazole
Indications/Uses
Persistent vulvovag candidiasis & dermatomycosis; fungal keratitis; onychomycosis caused by dermatophytes &/or yeasts; systemic aspergillosis & candidiasis, histoplasmosis, sporotrichosis, paracoccidioidomycosis & blastomycosis.
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Dosage/Direction for Use
Adult Oropharyngeal candidiasis 100 mg daily for 15 days. Vulvovag candidiasis 200 mg bd for 1 day. Pityriasis versicolor 200 mg daily for 7 days. Tinea corporis & tinea cruris 100 mg daily for 15 days or 200 mg daily for 7 days. Fungal nail infection 200 mg daily for 3 mth. Systemic fungal infection 100-200 mg once daily, increased to 200 mg bd for invasive or disseminated infection. Prophylaxis of primary or secondary infection in neutropenic or AIDS patient 200 mg daily increased to 200 mg bd if necessary. Tinea pedis or tinea manuum 100 mg daily for 30 days or 200 mg bd for 7 days.
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Overdosage
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Administration
Should be taken with food: Take immediately after a full meal.
Contraindications
Hypersensitivity. Concomitant use w/ terfenadine, astemizole, mizolastine, cisapride, dofetilide, quinidine, pimozide, CYP3A4 metabolised HMG-CoA reductase inhibitors (eg, simvastatin & lovastatin), triazolam & oral midazolam cap. Women of childbearing potential should use adequate contraception. Pregnancy.
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Special Precautions
Hypersensitivity to other azoles. Not to be used in patients w/ or history of CHF. Decreased gastric acidity. Concomitant use w/ Ca-channel blockers. Administration w/ cola beverage in achlorhydria eg, certain AIDS patients & patients on acid secretion suppressors (eg, H2-antagonists, proton-pump inhibitors). Hepatic & renal impairment. Pregnancy & lactation.
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Adverse Reactions
Dyspepsia, abdominal pain, nausea, vomiting, diarrhoea, menstrual disorders, constipation, rash, pruritus, urticaria; angioedema, anaphylaxis. Increased liver enzyme values, jaundice, Stevens-Johnson syndrome, hypokalaemia.
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Drug Interactions
Decreased bioavailability w/ rifampicin, rifabutin, phenytoin; carbamazepine, phenobarb & isoniazid. Increased &/or prolonged effects including side effects w/ terfenadine, astemizole, mizolastine, cisapride, triazolam, oral midazolam, dofetilide, quinidine, pimozide, CYP3A4-metabolised HMG-CoA reductase inhibitors (eg, simvastatin & lovastatin). Negative inotropic effects w/ Ca-channel blockers. Reduce dose during co-administration w/ oral anticoagulants; HIV PIs eg, ritonavir, indinavir, saquinavir; certain antineoplastic (eg, vinca alkaloids, busulphan, docetaxel & trimetrexate) & immunosuppressive agents (eg, cyclosporin, tacrolimus, sirolimus); CYP3A4-metabolised Ca-channel blockers eg, dihydropyridines & verapamil.
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Storage
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Description
View Fulcover description for details of the chemical structure and excipients (inactive components).
Action
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MIMS Class
Antifungals
ATC Classification
J02AC02 - itraconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Fulcover cap 100 mg
Packing/Price
10 × 4's
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