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:

Dispensing Solutions, Inc.

DCI (Denominação Comum Internacional):

METHYLERGONOVINE MALEATE

Composição:

METHYLERGONOVINE MALEATE 0.2 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

For routine management after delivery of the placenta; postpartum atony and hemorrhage; subinvolution. Under full obstetric supervision, it may be given 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.

Status de autorização:

New Drug Application

Características técnicas

METHERGINE - METHYLERGONOVINE MALEATE TABLET, COATED
DISPENSING SOLUTIONS, INC.
----------
METHERGINE
T2006-91 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
d