TRI PREVIFEM norgestimate and ethinyl estradiol

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY)

Disponível em:

Par Pharmaceutical

DCI (Denominação Comum Internacional):

NORGESTIMATE

Composição:

NORGESTIMATE 0.18 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Status de autorização:

Abbreviated New Drug Application

Características técnicas

TRI PREVIFEM- NORGESTIMATE AND ETHINYL ESTRADIOL
PAR PHARMACEUTICAL
----------
TRI-PREVIFEM
(NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
RX ONLY
WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION
ORAL CONTRACEPTIVE USE. THIS RISK INCREASES WITH AGE, PARTICULARLY IN
WOMEN OVER 35 YEARS OF
AGE, AND WITH THE NUMBER OF CIGARETTES SMOKED. FOR THIS REASON,
COMBINATION ORAL
CONTRACEPTIVES, INCLUDING TRIPREVIFEM (NORGESTIMATE AND ETHINYL
ESTRADIOL TABLETS USP),
SHOULD NOT BE USED BY WOMEN WHO ARE OVER 35 YEARS OF AGE AND SMOKE.
DESCRIPTION
Tri-Previfem (norgestimate and ethinyl estradiol tablets USP) is a
combination oral contraceptive
containing the progestational compound norgestimate and the estrogenic
compound ethinyl estradiol.
Each white tablet contains 0.18 mg of the progestational compound,
norgestimate (18,19-dinor-17-
pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and
0.035 mg of the estrogenic
compound, ethinyl estradiol (19-nor-17α-pregna,
1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients
include hypromellose, lactose monohydrate, magnesium stearate,
polyethylene glycol, and
pregelatinized starch.
Each light-blue tablet contains 0.215 mg of the progestational
compound norgestimate (18,19-dinor-17-
pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and
0.035 mg of the estrogenic
compound, ethinyl estradiol (19-nor-17α-pregna,
1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients
include FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose
monohydrate, magnesium stearate,
polyethylene glycol, and pregelatinized starch.
Each blue tablet contains 0.25 mg of the progestational compound
norgestimate (18,19-dinor- 17-pregn-
4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and 0.035
mg of the estrogenic compound,
ethinyl estradiol (19-n