DINOPROSTONE insert

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Ferring Pharmaceuticals Inc.

INN (International Name):

DINOPROSTONE

Sammensetning:

DINOPROSTONE 10 mg in 241 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

New Drug Application

Preparatomtale

DINOPROSTONE- DINOPROSTONE INSERT
FERRING PHARMACEUTICALS INC.
----------
DINOPROSTONE
_VAGINAL INSERT_
Rev. 08/2013
R ONLY
6765-01
DESCRIPTION
Dinoprostone Vaginal Insert is a thin, flat, polymeric slab which is
rectangular in shape with rounded
corners contained within the pouch of an off-white knitted polyester
retrieval system. Each slab is buff
colored, semitransparent and contains 10 mg of dinoprostone in a
hydrogel insert. An integral part of the
knitted polyester retrieval system is a long tape designed to aid
retrieval at the end of the dosing interval
or earlier if clinically indicated. The finished product is a
controlled release formulation which has
been found to release dinoprostone in vivo at a rate of approximately
0.3 mg/hr.
The chemical name for dinoprostone (commonly known as prostaglandin E
or PGE ) is 11α,15S-
dihydroxy-9-oxo-prosta-5Z,13E-dien-1-oic acid and the structural
formula is represented below:
The molecular formula is C
H O and its molecular weight is 352.5. Dinoprostone occurs as a white
to off-white crystalline powder. It has a melting point within the
range of 65° to 69°C. Dinoprostone is
soluble in ethanol and in 25% ethanol in water. Each insert contains
10 mg of dinoprostone in 241 mg of
a cross-linked polyethylene oxide/urethane polymer which is a
semiopaque, beige colored, flat
rectangular slab measuring 29 mm by 9.5 mm and 0.8 mm in thickness.
The insert and its retrieval system,
made of polyester yarn, are nontoxic and when placed in a moist
environment, absorb water, swell, and
release dinoprostone.
CLINICAL PHARMACOLOGY
Dinoprostone (PGE ) is a naturally-occurring biomolecule. It is found
in low concentrations in most
tissues of the body and functions as a local hormone (1-3). As with
any local hormone, it is very rapidly
metabolized in the tissues of synthesis (the half-life estimated to be
2.5-5 minutes). The rate limiting
step for inactivation is regulated by the enzyme
15-hydroxyprostaglandin dehydrogenase (PGDH) (1,4).
Any PGE that escapes local inactivation is r