METHERGINE- methylergonovine maleate tablet, coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Bryant Ranch Prepack

DCI (Denominação Comum Internacional):

METHYLERGONOVINE MALEATE

Composição:

METHYLERGONOVINE MALEATE 0.2 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Following delivery of the 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. Methergine (methylergonovine maleate) has not been associated with drug abuse or dependence of either a physical or psychological nature.

Resumo do produto:

Tablets 0.2 mg round, coated, orchid, branded “78-54” one side, “SANDOZ” other side.       Bottles of 100…………………………………………………………..NDC 0078-0054-05 Ampuls 1 mL size       Boxes of 20…………………………………………………………….NDC 0078-0053-03 Tablets : Store below 25°C (77°F); in tight, light-resistant container. Ampuls: Store in refrigerator, 2ºC-8°C (36°F-46°F). Protect from light. Administer only if solution is clear and colorless. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis T2012-125 June 2012

Status de autorização:

New Drug Application

Características técnicas

METHERGINE- METHYLERGONOVINE MALEATE TABLET, COATED
BRYANT RANCH PREPACK
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METHERGINE
METHERGINE
_(METHYLERGONOVINE MALEATE)_
TABLETS, USP
_(METHYLERGONOVINE MALEATE)_
INJECTION, USP
RX ONLY
DESCRIPTION
Methergine
(methylergonovine maleate) is a semi-synthetic ergot alkaloid used for
the prevention and
control of postpartum hemorrhage.
Methergine is available in sterile ampuls of 1 mL, containing 0.2 mg
methylergonovine maleate for
intramuscular or intravenous injection and in tablets for oral
ingestion containing 0.2 mg
methylergonovine maleate.
TABLETS
Active Ingredient: methylergonovine maleate, USP, 0.2 mg.
Inactive Ingredients: acacia, carnauba wax, D&C Red #7, FD&C Blue #1,
gelatin special, lactose,
maleic acid, mixed parabens, povidone, sodium benzoate, sodium
hydroxide, starch, stearic acid,
sucrose, talc, and titanium dioxide.
AMPULS, 1 mL, clear, colorless solution.
Active Ingredient: methylergonovine maleate, USP, 0.2 mg.
Inactive Ingredients: maleic acid, 0.10 mg; sodium chloride, 7.0 mg;
water for injection, qs to 1 mL.
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
®
®
CLINICAL PHARMACOLOGY
Methergine (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, 2-5
minutes, and after oral administration,
5-10 minutes.
Pharmacokinetic studies following an I.V. injection have shown that
methylergonovine is rapidly
distributed from plasma to peripheral tissues within 2-3 minutes or
less. The bioavailability after oral
administration was reported to be about 60% with no accumulation after
repeated doses. During
delivery, with intramuscula