ALYACEN 7/7/7- norethindrone and ethinyl estradiol kit ALYACEN 1/35- norethindrone and ethinyl estradiol kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Disponível em:

Glenmark Pharmaceuticals Inc., USA

DCI (Denominação Comum Internacional):

NORETHINDRONE

Composição:

NORETHINDRONE 0.5 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

ALYACEN 7/7/7 and ALYACEN 1/35 Tabletsare 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 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT® System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Chance# 85 85 SpermicidesÞ 26 6 40 Periodic abstinence 25 63   Calendar 9   Ovulation Method 3   Sympto-Thermalß 2   Post-Ovulation 1 Capà   Parous Women 40 26 42   Nulliparous Women 20 9 56 Sponge   Parous Women 40 20 42   Nulliparous Women 20 9 56 Diaphragmà 20 6 56 Withdrawal 19 4 Condomè   Female (Reality® ) 21 5 56   Male 14 3 61 Pill 5 71   Progestin Only 0.5   Combined 0.1 IUD   Progesterone T 2 1.5 81   Copper T380A 0.8 0.6 78   LNg 20 0.1 0.1 81 Depo-Provera® 0.3 0.3 70 Norplant® and Norplant-2® 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 ALYACEN 7/7/7 and ALYACEN 1/35 have not been studied for and are not indicated for use in emergency contraception. Oral contraceptives should not be used in women who currently have the following conditions:

Resumo do produto:

ALYACEN 7/7/7 Tablets are available in blister packs containing 28 tablets, as follows: NDC 68462-556-29 1 carton containing 3 blister cards of 28 tablets ALYACEN 1/35 Tablets are available in blister packs containing 28 tablets, as follows: NDC 68462-394-29 1 carton containing 3 blister cards of 28 tablets Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Trademarks are the property of their respective owners.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ALYACEN 7/7/7- NORETHINDRONE AND ETHINYL ESTRADIOL
ALYACEN 1/35- NORETHINDRONE AND ETHINYL ESTRADIOL
GLENMARK PHARMACEUTICALS INC., USA
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ALYACEN 7/7/7(NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP, 0.5
MG/0.035 MG, 0.75
MG/0.035 MG, 1 MG/0.035 MG)
ALYACEN 1/35(NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP, 1
MG/0.035 MG)
WARNING: 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 ALYACEN 7/7/7 AND ALYACEN 1/35, 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.
COMBINED ORAL CONTRACEPTIVES
Each of the following products is a combined oral contraceptive
containing the progestational
compound norethindrone and the estrogenic compound ethinyl estradiol.
ALYACEN 7/7/7 TABLETS:
Each white to off-white tablet contains 0.5 mg of norethindrone, USP
and 0.035 mg of ethinyl estradiol,
USP. Inactive ingredients include colloidal silicon dioxide, anhydrous
lactose, lactose monohydrate,
magnesium stearate, pregelatinized starch and talc. Each light peach
tablet contains 0.75 mg of
norethindrone, USP and 0.035 mg of ethinyl estradiol, USP. Inactive
ingredients include colloidal
silicon dioxide, FD&C Yellow No. 6, anhydrous lactose, lactose
monohydrate, magnesium stearate,
pregelatinized starch and talc. Each peach tablet contains 1 mg of
norethindrone, USP and 0.035 mg of
ethinyl estradiol, USP. Inactive ingredients include colloidal silicon
dioxide, FD&C Yellow No. 6,
anhydrous lactose, lactose monohydrate, magnesium stearate,
pregelatinized starch and talc. Each light
green tablet contains only inert ingredients, as follows: D&C Yellow
No. 10, FD&C Blue No. 2,
lactose monohydrate, magnesi