5412 150 Pill — PINK OVAL, 11mm — Fluconazole

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Imprint5412 / 150
ColourPINK
ShapeOVAL
Size11
StrengthFLUCONAZOLE 150 mg
Dosage formTablet
ManufacturerClinical Solutions Wholesale
NDC58118-5027
Schedule—
Availability—
IngredientsFLUCONAZOLE[FLUCONAZOLE]

What does this imprint mean?

The imprint "5412 150" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Fluconazole

Uses and warnings

No boxed warning. Contraindicated with concomitant cisapride, terfenadine (with high-dose fluconazole), or other drugs such as quinidine and pimozide whose QT-prolonging effects can be increased through CYP3A4 inhibition. Key warnings include hepatotoxicity, including rare fatal hepatic failure, requiring liver function monitoring; "exfoliative skin disorders" (including Stevens-Johnson syndrome and toxic epidermal necrolysis) that have been fatal in seriously ill patients; QT prolongation with rare torsade de pointes; anaphylaxis; and potential fetal harm, as high-dose, long-duration use in pregnancy has been linked to a pattern of congenital anomalies.

Fluconazole is indicated for treatment of vaginal candidiasis, oropharyngeal and esophageal candidiasis, and cryptococcal meningitis, and for prophylaxis of candidiasis in patients undergoing bone marrow transplantation who are receiving cytotoxic chemotherapy and/or radiation therapy; other labeled uses include candidemia/disseminated candidiasis and urinary tract or peritoneal Candida infections.

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file be5faf00-77d0-4b85-b1ea-fb2392bb837e.xml