Sporagin

Sporagin10mg/ml

Type:100ml bot

Generic Name:Itraconazole

Manufacturer:The Ibn Sina Pharmaceutical Ind. Ltd.

Price:400.00

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Indication

Candidiasis, Fungal infections, Tinea pedis, Tinea cruris, Tinea corporis, Pityriasis versicolor

Administration

Should be taken with food. Take immediately after a full meal.

Adult Dose

Oral Adult: PO: Oropharyngeal candidiasis As cap: 100 mg/day for 15 days. Vulvovaginal candidiasis As cap: 200 mg twice daily for 1 day. Pityriasis versicolor As cap: 200 mg/day for 7 days. Tinea corporis; Tinea cruris As cap: 100 mg/day for 15 days. Fungal nail infections As cap: 200 mg/day for 3 mth. Systemic fungal infections As cap: 100-200 mg once daily, up to 200 mg twice daily for invasive or disseminated infections. Prophylaxis of infections in neutropenic or AIDS patients As cap: 200 mg/day, up to 200 mg twice daily if needed. Tinea pedis; Tinea manuum As cap: 100 mg/day for 30 days or 200 mg bid for 7 days.

Child Dose

Child: PO 10 mg/kg/day, max 200 mg/day q12h 5 mg/kg/day for chronic mucocutaneous Candida q24h <3 years: Safety and efficacy not established

Contraindication

Hypersensitivity to azole antifungals; pregnancy and lactation; hepatic disease. IV: CrCl: <30 ml/min.

Mode of Action

Itraconazole decreases ergosterol synthesis by interfering w/ cytochrome P450 activity. This inhibits cell membrane function of susceptible fungi including Microsporum spp., Trichophyton spp., Candida spp., Aspergillus spp., Epidermophyton spp., Cryptococcus neoformans, Histoplasma capsulatum, Blastomyces dermatitidis, sporothrix schenckii, Malassezia furfur, Coccidioides immitis and Paracoccidiodes brasiliensis. It also has antiprotozoal activity against Leishmania spp.

Precaution

Renal insufficiency; CHF, history of CHF, COPD; monitor liver function. Lactation: Drug enters breast milk; weigh risk against benefit

Side Effect

>10% Nausea (11%) 1-10% Rash (9%),Vomiting (5%),Edema (4%),Headache (4%),Abnormal liver function test results (3%),Diarrhea (3%),Fever (3%),Hypertension (3%),Pruritus (3%),Fatigue (2-3%),Abdominal pain (2%),Dizziness (2%),Hypertriglyceridemia (2%),Hypokalemia (2%),Albuminuria (1%),Anorexia (1%),Decreased libido (1%),Hepatitis (1%),Malaise (1%) Potentially Fatal: Liver failure; heart failure; pulmonary oedema; CV disease.

Interaction

May increase the plasma concentrations of oral anticoagulants, digoxin, cilostazol, alprazolam, midazolam (IV), repaglinide, corticosteroids (e.g. budesonide, dexamethasone, fluticasone, methylprednisolone). May increase plasma concentration w/ HIV protease inhibitors (e.g. ritonavir, indinavir, saquinavir), erythromycin, clarithromycin. May reduce plasma concentration w/ isoniazid, carbamazepine, nevirapine, phenytoin, Phenobarbital, rifampicin, rifabutin. May reduce absorption w/ PPIs, antacids, antimuscarinics, histamine H2 receptor antagonists. Concomitant use w/ dihydropyridines may cause oedema. May increase negative inotropic effects of verapamil. May increase risk of potentially fatal resp depression w/ fentanyl. Potentially Fatal: May increase risk of QT prolongation or torsades de pointes w/ astemizole, bepridil, cisapride, dofetilide, levacetylmethadol (levomethadyl), mizolastine, pimozide, quinidine, sertindole, terfenadine, methadone, ranolazine, dronedarone, halofantrine. May increase risk of myopathy including rhabdomyolysis w/ HMG-CoA reductase inhibitors (e.g. atorvastatin, lovastatin, simvastatin). May increase risk of ergotism w/ ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergometrine, methylergometrine). May potentiate hypnotic and sedative effect of triazolam and oral midazolam. May increase plasma concentration of eletriptan, nisoldipine, felodipine, disopyramide, irinotecan, lurasidone; colchicine (patient w/ renal or hepatic failure). May increase risk of hypotension and hyperkalaemia w/ eplerenone.

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