LOW-OGESTREL norgestrel and ethinyl estradiol

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Mevcut itibaren:

Actavis Pharma, Inc.

INN (International Adı):

ETHINYL ESTRADIOL

Kompozisyon:

ETHINYL ESTRADIOL 0.03 mg

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

LOW-OGESTREL- NORGESTREL AND ETHINYL ESTRADIOL
ACTAVIS PHARMA, INC.
----------
_WATSON PHARMA_
PHYSICIAN LABELING
_LOW-OGESTREL_
(NORGESTREL AND ETHINYL ESTRADIOL TABLETS USP,
0.3 MG/0.03 MG)
RX ONLY
REVISED: MAY 2004
IN-
5186/S_ _
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
ORAL CONTRACEPTIVE AGENTS
DESCRIPTION
_LOW-OGESTREL _
Tablets (norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg)
provide an oral
contraceptive regimen consisting of 21 white tablets followed by 7
peach tablets.
Each white tablet, for oral administration contains 0.3 mg of
norgestrel and 0.03 mg ethinyl estradiol and
the following inactive ingredients: croscarmellose sodium, lactose,
magnesium stearate,
microcrystalline cellulose, and povidone.
Each inactive peach tablet, for oral administration, in the 28 day
regimen contains the following inactive
ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose
monohydrate, magnesium stearate,
and microcrystalline cellulose.
Norgestrel is a totally synthetic progestogen, insoluble in water,
freely soluble in chloroform,
sparingly soluble in alcohol with the chemical name
(±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-
4-en-20-yn-3-one. Ethinyl estradiol is an estrogen, insoluble in
water, soluble in alcohol, in
chloroform, in ether, in vegetable oils, and in solutions of fixed
alkali hydroxides with the chemical
name 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their
structural formulae follow:
Therapeutic class: Oral contraceptive.
CLINICAL PHARMACOLOGY
®
®
Combination oral contraceptives act by suppression of gonadotrophins.
Although the primary
mechanism of this action is inhibition of ovulation, other alterations
include changes in the cervical
mucus (which increase the difficulty of sperm entry into the uterus)
and the endometrium (which may
reduce the likelihood of implantation).
INDICATIONS AND USAGE
Low-Ogestrel
(norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg)