METHERGINE methylergonovine maleate tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Avera McKennan Hospital

INN (nume internaţional):

METHYLERGONOVINE MALEATE

Compoziție:

METHYLERGONOVINE MALEATE 0.2 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

METHERGINE- METHYLERGONOVINE MALEATE TABLET
AVERA MCKENNAN HOSPITAL
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METHERGINE®
(METHYLERGONOVINE MALEATE) TABLETS, USP
RX ONLY
DESCRIPTION
Methergine
(methylergonovine maleate) is a semi-synthetic ergot alkaloid used for
the prevention and
control of postpartum hemorrhage.
Methergineis 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:
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 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 mg methylergonovine tablet was fairly rapid with a mean peak
plasma conc