PROSTIN E2- dinoprostone suppository

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

DINOPROSTONE (UNII: K7Q1JQR04M) (DINOPROSTONE - UNII:K7Q1JQR04M)

Disponible des:

Pharmacia and Upjohn Company LLC

Vía de administración:

VAGINAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

- PROSTIN E2 Vaginal Suppository is indicated for the termination of pregnancy from the 12th through the 20th gestational week as calculated from the first day of the last normal menstrual period. - PROSTIN E2 is also indicated for evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period. - PROSTIN E2 is indicated in the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole). - Hypersensitivity to dinoprostone [see WARNINGS and ADVERSE REACTIONS] - Acute pelvic inflammatory disease - Patients with active cardiac, pulmonary, renal, or hepatic disease

Resumen del producto:

PROSTIN E2 Vaginal Suppositories are available in foil strips of 5 individually sealed suppositories, NDC 0009-0827-03. Each suppository contains 20 mg of dinoprostone in a mixture of glycerides of fatty acids. STORE IN A FREEZER NOT ABOVE –20°C (–4°F).

Estat d'Autorització:

New Drug Application

Fitxa tècnica

PROSTIN E2- DINOPROSTONE SUPPOSITORY
PHARMACIA AND UPJOHN COMPANY LLC
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PROSTIN E2
DINOPROSTONE VAGINAL
S UPPOS ITORY
DESCRIPTION
PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as
the naturally occurring
prostaglandin E2 (PGE2).
Its chemical name is
(5Z,11_α_,13E,15S)-11,15-Dihydroxy-9-oxo-prosta-5,13-dien-1-oic acid
and the
structural formula is represented below:
The molecular formula is C
H O . The molecular weight of dinoprostone is 352.5. Dinoprostone
occurs as a white crystalline powder. It has a melting point within
the range of 64° to 71°C.
Dinoprostone is soluble in ethanol and in 25% ethanol in water. It is
soluble in water to the extent of 130
mg/100 mL.
Each suppository contains 20 mg of dinoprostone in a mixture of
glycerides of fatty acids.
CLINICAL PHARMACOLOGY
PROSTIN E2 Vaginal Suppository administered intravaginally stimulates
the myometrium of the gravid
uterus to contract in a manner that is similar to the contractions
seen in the term uterus during labor.
Whether or not this action results from a direct effect of
dinoprostone on the myometrium has not been
determined with certainty at this time. Nonetheless, the myometrial
contractions induced by the vaginal
administration of dinoprostone are sufficient to produce evacuation of
the products of conception from
the uterus in the majority of cases.
Dinoprostone is also capable of stimulating the smooth muscle of the
gastrointestinal tract of man. This
activity may be responsible for the vomiting and/or diarrhea that is
not uncommon when dinoprostone is
used to terminate pregnancy.
In laboratory animals, and also in man, large doses of dinoprostone
can lower blood pressure, probably
as a consequence of its effect on the smooth muscle of the vascular
system. With the doses of
dinoprostone used for terminating pregnancy this effect has not been
clinically significant. In laboratory
animals, and also in man, dinoprostone can elevate body temperature.
With the clinical doses of
dinoprostone used for the termination of