Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
GALLIUM NITRATE (UNII: VRA0C6810N) (Gallium cation - UNII:F7K5MP217W)
Genta Incorporated
GALLIUM NITRATE
GALLIUM NITRATE 25 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Ganite is indicated for the treatment of clearly symptomatic cancer-related hypercalcemia that has not responded to adequate hydration. In general, patients with a serum calcium (corrected for albumin) < 12 mg/dL would not be expected to be symptomatic. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without diuretics). In the treatment of cancer-related hypercalcemia, it is important first to establish adequate hydration, preferably with intravenous saline, in order to increase the renal excretion of calcium and correct dehydration caused by hypercalcemia. Ganite should not be administered to patients with severe renal impairment (serum creatinine > 2.5 mg/dL).
Ganite® (gallium nitrate injection) is supplied as a 5-unit carton, NDC 66657-301-05. Each carton contains 5 single-dose, flip-top vials (NDC 66657-301-01) each containing 500 mg of gallium nitrate (25 mg/mL) in 20 mL. Store at controlled room temperature 20°-25°C (68°-77°F). Contains no preservative. Discard unused portion. Rx only Ganite® is a trademark of Genta Incorporated. Manufactured for: Genta Incorporated Berkeley Heights, NJ 07922 1-888-TO-GENTA Revised: October 2006 30105902
New Drug Application
GANITE- GALLIUM NITRATE INJECTION, SOLUTION, CONCENTRATE GENTA INCORPORATED ---------- GANITE® (GALLIUM NITRATE INJECTION) WARNING Concurrent use of gallium nitrate with other potentially nephrotoxic drugs (e.g., aminoglycosides, amphotericin B) may increase the risk for developing severe renal insufficiency in patients with cancer-related hypercalcemia. If use of a potentially nephrotoxic drug is indicated during gallium nitrate therapy, gallium nitrate administration should be discontinued and it is recommended that hydration be continued for several days after administration of the potentially nephrotoxic drug. Serum creatinine and urine output should be closely monitored during and subsequent to this period. Ganite therapy should be discontinued if the serum creatinine level exceeds 2.5 mg/dL. DESCRIPTION Gallium nitrate injection is a clear, colorless, odorless, sterile solution of gallium nitrate, a hydrated nitrate salt of the group IIIa element, gallium. Gallium nitrate is formed by the reaction of elemental gallium with nitric acid, followed by crystallization of the drug from the solution. The stable, nonahydrate, Ga(N0 ) •9H O is a white, slightly hygroscopic, crystalline powder of molecular weight 417.87, that is readily soluble in water. Each mL of Ganite (gallium nitrate injection) contains gallium nitrate 25 mg (on an anhydrous basis) and sodium citrate dihydrate 28.75 mg. The solution may contain sodium hydroxide or hydrochloric acid for pH adjustment to 6.0-7.0. CLINICAL PHARMACOLOGY _MECHANISM OF ACTION_ Ganite exerts a hypocalcemic effect by inhibiting calcium resorption from bone, possibly by reducing increased bone turnover. Although _in vitro_ and animal studies have been performed to investigate the mechanism of action of gallium nitrate, the precise mechanism for inhibiting calcium resorption has not been determined. No cytotoxic effects were observed on bone cells in drug-treated animals. _PHARMACOKINETICS_ Gallium nitrate was infused at a daily dose of 200 mg/m for 5 (n=2) or 7 (n=10) Olvassa el a teljes dokumentumot