Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Actavis Pharma, Inc.
ETHINYL ESTRADIOL
ETHINYL ESTRADIOL 0.03 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
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) Прочитајте комплетан документ