Rx Item-Amethia Lo 100 20(84) Dpk 2X91 By Method Pharma

AMETHIA- levonorgestrel and ethinyl estradiol and ethinyl estradiol
Watson Pharma, Inc.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (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 should not be used by women who are over 35 years of age and smoke


INDICATIONS AND USAGE
AMETHIA tablets are indicated for use by women to prevent pregnancy.
DESCRIPTION
AMETHIATM tablets are an extended-cycle oral contraceptive consisting of 84 white tablets each containing 0.15 mg of levonorgestrel, synthetic progestogen and 0.03 mg of ethinyl estradiol, and light blue tablets containing 0.01 mg of ethinyl estradiol.

Mechanism of action
COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

2. DOSAGE AND ADMINISTRATION
Take one tablet by mouth at the same time every day. The dosage of AMETHIA tablets is one white tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one light blue ethinyl estradiol tablet for days. To achieve maximum contraceptive effectiveness, AMETHIA tablets must be taken exactly as directed and at intervals not exceeding 24 hours.
Instruct the patient to begin taking AMETHIA tablets on the first Sunday after the onset of menstruation. If menstruation begins on Sunday, the first white tablet is taken that day. One white tablet should be taken daily for 84 consecutive days, followed by one light blue tablet for consecutive days. non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until white tablet has been taken daily for consecutive days. scheduled period should occur during the days that the light blue tablets are taken.
Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of AMETHIA tablets, following the same schedule: 84 days taking white tablet followed by days taking blue tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using non-hormonal back-up method of contraception until she has taken white tablet daily for consecutive days. If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.
AMETHIA tablets are available in Extended-Cycle Tablet Dispensers, each containing 13-week supply of tablets: 84 white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and light blue tablets each containing 0.01 mg of ethinyl estradiol. The white tablets are round, flat face beveled edge, unscored tablets with WATSON on one side and 268 on the other side. The light blue tablets are round, flat face beveled edge, unscored tablets with WATSON on one side and 270 on the other side.

Rx Item-Amethia Lo 100 20(84) Dpk 2X91 B
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