Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
NORETHINDRONE (UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Glenmark Pharmaceuticals Inc., USA
NORETHINDRONE
NORETHINDRONE 0.5 mg
PRESCRIPTION DRUG
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:
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.
Abbreviated New Drug Application
ALYACEN 7/7/7- NORETHINDRONE AND ETHINYL ESTRADIOL ALYACEN 1/35- NORETHINDRONE AND ETHINYL ESTRADIOL GLENMARK PHARMACEUTICALS INC., USA ---------- 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 Leggi il documento completo