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DIFLUCAN ORAL SUSP
Fungal infections
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Drug Name:

DIFLUCAN ORAL SUSP Rx

Generic Name and Formulations:
Fluconazole 10mg/mL, 40mg/mL; pwd for oral susp; orange flavor; contains sucrose.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for DIFLUCAN ORAL SUSP:

Oropharyngeal, esophageal, systemic candidiasis. Bone marrow transplant prophylaxis. Cryptococcal meningitis. Candida urinary tract infection (UTI), peritonitis.

Adult:

Individualize. All doses are once daily. Oropharyngeal candidiasis: 200mg on Day 1, then 100mg/day for at least 2 weeks. Esophageal candidiasis: 200mg on Day 1, then 100mg/day for at least 3 weeks; treat for at least 2 weeks after symptoms resolve; max 400mg/day. Systemic candidiasis: doses of up to 400mg/day have been used. Prophylaxis of candidiasis in bone marrow transplantation: 400mg/day; if anticipated severe granulocytopenia: see full labeling. Cryptococcal meningitis: 400mg on Day 1, then 200–400mg/day for 10–12 weeks after spinal fluid negative; to suppress relapse in AIDS: 200mg/day. UTI, peritonitis: 50–200mg/day have been used. Renal impairment (CrCl ≤50mL/min): see full labeling.

Children:

Individualize. All doses are once daily. Neonates: see full labeling. Over 2 weeks of age: Oropharyngeal candidiasis: 6mg/kg on Day 1, then 3mg/kg/day for at least 2 weeks. Esophageal candidiasis: 6mg/kg on Day 1, then 3mg/kg/day for at least 3 weeks; treat for at least 2 weeks after symptoms resolve; max 12mg/kg/day. Systemic candidiasis: 6–12mg/kg/day have been used. Cryptococcal meningitis: 12mg/kg on Day 1, then 6mg/kg/day for 10–12 weeks after negative CSF cultures; max 12mg/kg/day; to suppress relapse in AIDS: 6mg/kg/day. Max for all: 600mg/day. Renal impairment (CrCl ≤50mL/min): see full labeling.

Contraindications:

Concomitant terfenadine at multiple doses of fluconazole ≥400mg. Concomitant drugs known to prolong the QT interval and metabolized by CYP3A4 (eg, cisapride, astemizole, erythromycin, pimozide, quinidine).

Warnings/Precautions:

Proarrhythmic conditions. Renal or hepatic impairment. Monitor liver function during therapy and for signs/symptoms of hepatic injury; discontinue if develop. Monitor closely for skin rashes; discontinue if lesions progress. Susp: hereditary fructose, glucose/galactose malabsorption, sucrose-isomaltase deficiency: not recommended. Elderly. Pregnancy (Cat.D); may cause rare congenital anomalies in infants exposed in-utero to high doses (400–800mg/day) during 1st trimester. Nursing mothers.

Interactions:

See Contraindications. Risk of cardiotoxicity with erythromycin; avoid. Avoid concomitant voriconazole; if needed, monitor closely esp. when given within 24hrs after fluconazole. Caution with other drugs metabolized by CYP2C9 and CYP3A4 with a narrow therapeutic window. Potentiates warfarin, oral hypoglycemics, oral midazolam, tofacitinib, alfentanil, amitriptyline, nortriptyline, calcium channel blockers, losartan, saquinavir; adjust dose as necessary. May increase serum levels of phenytoin, theophylline, halofantrine, rifabutin, tacrolimus, sirolimus, vinca alkaloids, triazolam, methadone, NSAIDs, cyclosporine, zidovudine, sulfonylureas, carbamazepine. Concomitant celecoxib: reduce celecoxib dose by half. Thiazides increase fluconazole levels. Monitor levels and/or effects of cyclosporine, phenytoin, sulfonylureas, rifabutin, tacrolimus, theophylline, warfarin, prednisone. Increased risk of myopathy/rhabdomyolysis with concomitant HMG-CoA reductase inhibitors; closely monitor. Cimetidine (oral), rifampin may decrease fluconazole levels. Oral contraceptives: see full labeling. Avoid other hepatotoxic drugs.

See Also:

DIFLUCAN

DIFLUCAN INJECTION

Pharmacological Class:

Azole antifungal.

Adverse Reactions:

Nausea, headache, rash, vomiting, abdominal pain, diarrhea, dizziness, seizures; hepatotoxicity; rare: exfoliative dermatitis, QT prolongation, Torsade de pointes.

How Supplied:

Tabs—30; Susp (35mL)—1; IV (200mg, 400mg)—6

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