METHYLERGONOVINE MALEATE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

METHYLERGONOVINE MALEATE (UNII: IR84JPZ1RK) (METHYLERGONOVINE - UNII:W53L6FE61V)

可用日期:

West-Ward Pharmaceuticals Corp

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder. Hypertension; toxemia; pregnancy; and hypersensitivity. Methylergonovine maleate has not been associated with drug abuse or dependence of either a physical or psychological nature.

產品總結:

White, round, biconvex compressed tablets debossed with “G 786” on one side and plain on the other side. Available in bottles of 7, 12, 28 and 100 tablets. Bottles of 7 Tablets............................................... NDC 0054-0639-03 Bottles of 12 Tablets............................................. NDC 0054-0639-05 Bottles of 28 Tablets............................................. NDC 0054-0639-13 Bottles of 100 Tablets........................................... NDC 0054-0639-25 Store and Dispense Tablets: Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature] Dispense in tight, light-resistant container. Manufactured by: Granules Pharmaceuticals, Inc . Chantilly VA 20151 Distr. by: West-Ward Pharmaceuticals Corp . Eatontown, NJ 07724 Revised July 2018

授权状态:

Abbreviated New Drug Application

产品特点

METHYLERGONOVINE MALEATE- METHYLERGONOVINE MALEATE TABLET
WEST-WARD PHARMACEUTICALS CORP
----------
METHYLERGONOVINE MALEATE TABLETS, USP
RX ONLY
DESCRIPTION
Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot
alkaloid used for the
prevention and control of postpartum hemorrhage.
Methylergonovine Maleate Tablets, USP is available in tablets for oral
ingestion containing
0.2 mg methylergonovine maleate.
TABLETS
_Active ingredient:_ Methylergonovine maleate, USP, 0.2 mg.
_Inactive ingredients:_ acacia, corn starch, gelatin, lactose
monohydrate, methylparaben,
microcrystalline cellulose, povidone, propylparaben, stearic acid, and
tartaric acid.
Chemically, methylergonovine maleate is designated as
ergoline-8-carboxamide, 9, 10-
didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-,
(Z)-2-butenedioate (1:1)
(salt). Its structural formula is:
C
H
N
O
•C
H
O
Mol Wt: 455.51
CLINICAL PHARMACOLOGY
Methylergonovine maleate acts directly on the smooth muscle of the
uterus and
increases the tone, rate, and amplitude of rhythmic contractions.
Thus, it induces a
rapid and sustained tetanic uterotonic effect which shortens the third
stage of labor and
reduces blood loss. The onset of action after I.V. administration is
immediate; after I.M.
administration, 2 to 5 minutes, and after oral administration, 5 to 10
minutes.
20
25
3
2
4
4
4
Pharmacokinetic studies following an I.V. injection have shown that
methylergonovine is
rapidly distributed from plasma to peripheral tissues within 2 to 3
minutes or less. The
bioavailability after oral administration was reported to be about 60%
with no
accumulation after repeated doses. During delivery, with intramuscular
injection,
bioavailability increased to 78 %. Ergot alkaloids are mostly
eliminated by hepatic
metabolism and excretion, and the decrease in bioavailability
following oral administration
is probably a result of first-pass metabolism in the liver.
Bioavailability studies conducted in fasting healthy female volunteers
have shown that
oral absorption of a 0.2