Backaid Max

Backaid Max

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Newly Diagnosed Glioblastoma Multiforme

Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.

1.2 Refractory Anaplastic Astrocytoma

Temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

History

There is currently no drug history available for this drug.

Other Information

Temozolomide capsules contain temozolomide, an imidazotetrazine derivative. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1d]-as-tetrazine-8-carboxamide. The structural formula is:

f696f63e-figure-02

The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence temozolomide can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH.

TemozolomideCapsules:

Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide.

The inactive ingredients for temozolomide capsules are as follows: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid.

The body of the capsules are made of gelatin and titanium dioxide, and are white opaque color. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac.

Temozolomide Capsules 5 mg: The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide.

Temozolomide Capsules 20 mg: The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide.

Temozolomide Capsules 100 mg: The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide.

Temozolomide Capsules 140 mg: The blue cap contains FD&C Blue #1, gelatin and titanium dioxide.

Temozolomide Capsules 180 mg: The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide.

Temozolomide Capsules 250 mg: The white cap contains gelatin and titanium dioxide.

Backaid Max Manufacturers


  • Alva-amco Pharmacal Companies, Inc.
    Backaid Max (Acetaminophen, Pamabrom) Tablet, Film Coated [Alva-amco Pharmacal Companies, Inc.]

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