5 Pill — GREEN;WHITE CAPSULE, 16mm — Temozolomide

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Imprint5
ColourGREEN;WHITE
ShapeCAPSULE
Size16
StrengthTemozolomide 5 mg;Anhydrous Lactose 132.8 mg;Silicon Dioxide 0.2 mg;Sodium Starch Glycolate Type A Potato 7.5 mg;Tartaric Acid 1.5 mg;Stearic Acid 3 mg
Dosage formCapsule
ManufacturerChemi Pharma LLC
NDC42737-101
Schedule—
Availability—
IngredientsTemozolomide[Temozolomide];Anhydrous Lactose[];Silicon Dioxide[];Sodium Starch Glycolate Type A Potato[];Tartaric Acid[];Stearic Acid[]

What does this imprint mean?

The imprint "5" 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

Temozolomide

Uses and warnings

BOXED WARNING: Myelosuppression - "Myelosuppression, including pancytopenia, leukopenia...and anemia, some with fatal outcomes, have occurred," with approximately 10% of patients requiring hospitalization or transfusion; blood counts must be monitored, with nadirs typically around day 26-28. Hepatotoxicity - "Fatal and severe hepatotoxicity have been reported" and liver function should be checked at baseline, mid-cycle, and after each cycle. Secondary malignancies, including myelodysplastic syndrome and secondary leukemias, have been observed. Contraindicated in patients with prior serious hypersensitivity to temozolomide or dacarbazine (shared metabolite). Also warns of Pneumocystis pneumonia risk, especially with concurrent steroid use, and embryo-fetal toxicity.

Indicated for adults with "newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment," and for "adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma" as well as "treatment of adults with refractory anaplastic astrocytoma."

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file b46735bd-5244-440e-96bb-b8cfef80533c.xml