ALYACEN 7/7/7- norethindrone and ethinyl estradiol
ALYACEN 1/35- norethindrone and ethinyl estradiol
Glenmark Generics Inc., USA
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 ALYACEN 7/7/7 and ALYACEN 1/35, should not be used by women who are over 35 years of age and smoke.
COMBINED ORAL CONTRACEPTIVES
Each of the following products is combined oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol.
ALYACEN 7/7/7
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 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, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc.
ALYACEN 1/35
Each peach tablet contains 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, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc.
The chemical name for norethindrone USP is 17-Hydroxy-19-nor-17?-pregn-4-en-20-yn3-one, and for ethinyl estradiol USP is 19-Nor-17?-pregna-1,3,5(10)-trien-20-yne-3,17diol.
Combined Oral Contraceptives
Combined oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).
INDICATIONS AND USAGE
ALYACEN 7/7/7 and ALYACEN 1/35 are indicated for the prevention of pregnancy in women who elect to use this product as method of contraception.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, ALYACEN 7/7/7 and ALYACEN 1/35 tablets must be taken exactly as directed and at intervals not exceeding 24 hours. ALYACEN 7/7/7 and ALYACEN 1/35 tablets are available in blister pack which is preset for Sunday Start. Day Start is also available.
Sunday Start
When taking ALYACEN 7/7/7 and ALYACEN 1/35, the first ?active? tablet should be taken on the first Sunday after menstruation begins. If the period begins on Sunday, the first ?active? tablet should be taken that day. Take one active tablet daily for 21 days followed by one light green ?reminder? tablet daily for days. After 28 tablets have been taken, new course is started the next day (Sunday). For the first cycle of Sunday Start regimen, another method of contraception such as condom or spermicide should be used until after the first consecutive days of administration.
If the patient misses one ?active? tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two ?active? tablets in Week or Week 2, the patient should take two tablets the day she remembers and two tablets the next day; and then continue taking one tablet day until she finishes the pack. The patient should be instructed to use back-up method of birth control such as condom or spermicide if she has sex in the seven days after missing pills. If the patient misses two ?active? tablets in the third week or misses three or more ?active? tablets in row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start new pack that same day. The patient should be instructed to use back-up method of birth control if she has sex in the seven days after missing pills.
