SIMLIYA- desogestrel and ethinyl estradiol and ethinyl estradiol kit

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

DESOGESTREL (UNII: 81K9V7M3A3) (DESOGESTREL - UNII:81K9V7M3A3), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Доступна з:

Aurobindo Pharma Limited

ІПН (Міжнародна Ім'я):

DESOGESTREL

Склад:

DESOGESTREL 0.15 mg

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

SIMLIYATM (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. a) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b) Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. c) Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectl

Огляд продуктів:

SIMLIYATM (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) 0.15 mg/0.02 mg and 0.01 mg are available in a carton of 3 pouches and 6 pouches, each containing 28 tablets: 21 white to off-white active tablets: White to off-white, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “51” on other side. 2 green inert tablets: Green, round, mottled, biconvex, beveled-edge uncoated tablets, debossed with “S” on one side and “61” on other side of the tablet. 5 light blue active tablets: Light blue, mottled, round, biconvex, beveled-edge tablets, debossed with “S” on one side and “45” on other side. Carton of 3 Pouches                                          NDC 65862-886-88 Carton of 6 Pouches                                          NDC 65862-886-92 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

SIMLIYA- DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
AUROBINDO PHARMA LIMITED
----------
SIMLIYA
(DESOGESTREL AND ETHINYL ESTRADIOL TABLETS, USP AND ETHINYL ESTRADIOL
TABLETS,
USP) 0.15 MG/0.02 MG AND 0.01 MG
RX ONLY
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR
EVENTS
Cigarette smoking increases the risk of serious cardiovascular events
from
combination oral contraceptive (COC) use. This risk increases with
age, particularly
in women over 35 years of age, and with the number of cigarettes
smoked. For
this reason, COCs, including SIMLIYA
, are contraindicated in women who are
over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS).
DESCRIPTION
SIMLIYA
(desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol
tablets,
USP) provide an oral contraceptive regimen of 21 white to off-white
round tablets each
containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17
alpha-pregn- 4-
en- 20-yn-17-ol), 0.02 mg ethinyl estradiol USP (19-nor- 17
alpha-pregna-1,3,5 (10)-
trien-20-yne-3,17-diol), and inactive ingredients which include
colloidal silicon dioxide,
lactose monohydrate, potato starch, povidone, stearic acid and vitamin
E, followed by 2
inert green round tablets with the following inactive ingredients:
anhydrous lactose,
croscarmellose sodium, FD&C blue no. 2 aluminum lake, ferric oxide
yellow, magnesium
stearate, microcrystalline cellulose and povidone. SIMLIYA
also contains 5 light blue
round tablets containing 0.01 mg ethinyl estradiol USP (19-nor-17
alpha-pregna-1,3,5
(10)-trien-20-yne-3,17-diol) and inactive ingredients which include
colloidal silicon dioxide,
FD&C blue no. 1, lactose monohydrate, povidone, pregelatinized starch
(maize), stearic
acid and vitamin E. The molecular weights for desogestrel and ethinyl
estradiol are
310.48 and 296.40 respectively. The structural formulas are as
follows:
TM
TM
TM
TM
SIMLIYA
meets USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotropins.
Although the
primar