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Gemcitabine for Injection USP in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
Gemcitabine for Injection USP in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
Gemcitabine for Injection USP is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer.
Gemcitabine for Injection USP is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine for Injection USP is indicated for patients previously treated with 5-FU.
There is currently no drug history available for this drug.
Gemcitabine for Injection USP is a nucleoside metabolic inhibitor that exhibits antitumor activity. Gemcitabine hydrochloride, USP is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer).
The structural formula is as follows:
The molecular formula for gemcitabine hydrochloride, USP is C9H11F2N3O4 • HCl. It has a molecular weight of 299.66.
Gemcitabine hydrochloride, USP is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents.
Gemcitabine for Injection USP is supplied in a sterile form for intravenous use only. Vials of Gemcitabine for Injection USP contain either 200 mg or 1 g of gemcitabine hydrochloride, USP (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Sodium hydroxide may have been added for pH adjustment.