Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
BUSULFAN (UNII: G1LN9045DK) (BUSULFAN - UNII:G1LN9045DK)
Aspen Global Inc.
BUSULFAN
BUSULFAN 2 mg
ORAL
PRESCRIPTION DRUG
MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia. MYLERAN is contraindicated in patients in whom a definitive diagnosis of chronic myelogenous leukemia has not been firmly established. MYLERAN is contraindicated in patients who have previously suffered a hypersensitivity reaction to busulfan or any other component of the preparation.
MYLERAN is supplied as white, film-coated, round, biconvex tablets containing 2 mg busulfan in amber glass bottles with child-resistant closures. One side is imprinted with "GX EF3" and the other side is imprinted with an "M.” Bottle of 25 (NDC 76388-713-25). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).
New Drug Application
MYLERAN- BUSULFAN TABLET, FILM COATED ASPEN GLOBAL INC. ---------- MYLERAN (BUSULFAN) TABLETS WARNING _MYLERAN is a potent drug. It should not be used unless a diagnosis of chronic_ _myelogenous leukemia has been adequately established and the responsible_ _physician is knowledgeable in assessing response to chemotherapy._ _MYLERAN can induce severe bone marrow hypoplasia. Reduce or discontinue the_ _dosage immediately at the first sign of any unusual depression of bone marrow_ _function as reflected by an abnormal decrease in any of the formed elements of the_ _blood. A bone marrow examination should be performed if the bone marrow status_ _is uncertain._ _SEE WARNINGS FOR INFORMATION REGARDING BUSULFAN-INDUCED_ _LEUKEMOGENESIS IN HUMANS._ DESCRIPTION MYLERAN (busulfan) is a bifunctional alkylating agent. Busulfan is known chemically as 1,4-butanediol dimethanesulfonate and has the following structural formula: CH SO O(CH ) OSO CH Busulfan is _not _a structural analog of the nitrogen mustards. MYLERAN is available in tablet form for oral administration. Each film-coated tablet contains 2 mg busulfan and the inactive ingredients hypromellose, lactose (anhydrous), magnesium stearate, pregelatinized starch, triacetin, and titanium dioxide. The activity of busulfan in chronic myelogenous leukemia was first reported by D.A.G. Galton in 1953. CLINICAL PHARMACOLOGY Busulfan is a small, highly lipophilic molecule that easily crosses the blood brain barrier. ® 3 2 2 4 2 3 Following absorption, 32% and 47% of busulfan are bound to plasma proteins and red blood cells, respectively. Busulfan absorption from the gastrointestinal tract is essentially complete. This has been demonstrated in radioactive studies after both intravenous and oral administration of S-busulfan, C-busulfan, and H-busulfan. Following intravenous administration of a single therapeutic dose of S-busulfan, there was rapid disappearance of radioactivity from the blood and 90% to 95% of the S-label disappeared within 3 to 5 minutes after injection. After e Citiți documentul complet