Fungikem Capsules (Hard Gelatin)
Itraconazole
100mg
Alkem Laboratories Limited
| Pack size | 5's Blister |
|---|---|
| Dispensing mode | POM |
| Source | INDIA |
| Agent | AL MANARAH MEDICINE STORE L.L.C. |
| Retail Price | 3.50 AED |
Indications
Fungikem Capsules (Hard Gelatin) is used for:
Candidiasis, Fungal infections, Tinea pedis, Tinea cruris, Tinea corporis, Pityriasis versicolor
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
Renal Dose
Administration
Should be taken with food. Take immediately after a full meal.
Contra Indications
Hypersensitivity to azole antifungals; pregnancy and lactation; hepatic disease. IV: CrCl: <30 ml/min.
Precautions
Renal insufficiency; CHF, history of CHF, COPD; monitor liver function.
Lactation: Drug enters breast milk; weigh risk against benefit
Pregnancy-Lactation
Pregnancy
There are no data on exposure to itraconazole during pregnancy
Published epidemiologic studies of women exposed to short courses of treatment with itraconazole in the first trimester of pregnancy have reported no risk of major birth defects overall and inconclusive findings on the risk of miscarriage
Drug should be used for treatment of systemic fungal infections in pregnancy only if benefit outweighs potential risk; therapy should not be administered for treatment of onychomycosis to pregnant patients or to women contemplating pregnancy; drug should not be administered to women of childbearing potential for treatment of onychomycosis unless they are using effective measures to prevent pregnancy and they begin therapy on the second or third day following the onset of menses; highly effective contraception should be continued throughout therapy and for 2 months following the end of treatment
Animal
In animal reproduction studies, itraconazole was found to cause a dose-related increase in maternal toxicity, embryotoxicity, and teratogenicity in rats at dosage levels of approximately (6-25 times the maximum recommended human dose [MRHD] of 390 mg/day based on mg/kg comparisons), and in mice at dosage levels of ~80 mg/kg/day (12 times the MRHD).
Lactation
Itraconazole is excreted in human milk
No data on the amount of itraconazole in human milk, the effects on the breastfed child, or the effects on milk production
Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for itraconazole and any potential adverse effects on the breastfed child from itraconazole or from underlying maternal condition
Interactions
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.
Adverse Effects
Side effects of Itraconazole :
>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.
Mechanism 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.
Note
Fungikem 100mg Capsules (Hard Gelatin) manufactured by Alkem Laboratories Limited. Its generic name is Itraconazole. Fungikem is availble in United Arab Emirates.
Farmaco UAE drug index information on Fungikem Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.
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