TRINESSA norgestimate and ethinyl estradiol

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

norgestimate (UNII: C291HFX4DY) (norgestimate - UNII:C291HFX4DY)

Dostępny od:

Actavis Pharma, Inc

INN (International Nazwa):

norgestimate

Skład:

norgestimate 0.18 mg

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

New Drug Application

Charakterystyka produktu

TRINESSA- NORGESTIMATE AND ETHINYL ESTRADIOL
ACTAVIS PHARMA, INC
----------
TRINES S A
TABLETS
(NORGESTIMATE AND ETHINYL ESTRADIOL)
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
TriNessa
, should not be used by women who are over 35 years of age and smoke.
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
The following product is a combination oral contraceptive containing
the progestational compound
norgestimate and the estrogenic compound ethinyl estradiol.
TRINES S A
TABLETS
Each white tablet contains 0.180 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 carnauba wax, croscarmellose sodium, hypromellose, lactose,
magnesium stearate,
microcrystalline cellulose, polyethylene glycol, purified water and
titanium dioxide.
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. 2 Aluminum Lake, carnauba wax, croscarmellose
sodium, hypromellose,
lactose, magnesium stearate, microcrystalline cellulose, polyethylene
glycol, purified water and
titanium dioxide.
Each blue tablet contains 0.250 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 estrog