DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM — drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium
Lupin Pharmaceuticals, 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 [see Contraindications (4)].

1 INDICATIONS AND USAGE

1.1 Oral Contraceptive

Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for use by women to prevent pregnancy.

1.2 Premenstrual Dysphoric Disorder (PMDD)

Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets for PMDD when used for more than three menstrual cycles has not been evaluated.

The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.

Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has not been evaluated for the treatment of premenstrual syndrome (PMS).

1.3 Acne

Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

1.4 Folate Supplementation

Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

2 DOSAGE AND ADMINISTRATION

2.1 How to Take Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets

Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.

To achieve maximum contraceptive and PMDD effectiveness, drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets must be taken as directed, in the order directed on the blister. Single missed pills should be taken as soon as remembered.

2.2 How to Start Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets

Instruct the patient to begin taking drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

Day 1 Start

During the first cycle of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets use, instruct the patient to take one pink drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one pink drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets can be taken without regard to meals. If drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet is first taken later than the first day of the menstrual cycle, drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

Sunday Start

During the first cycle of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets use, instruct the patient to take one pink drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets can be taken without regard to meals. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should begin her next and all subsequent 28-day regimens of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her pink tablets on the next day after ingestion of the last light orange folate tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets is started later than the day following administration of the last light orange tablet, the patient should use another method of contraception until she has taken a pink drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet daily for seven consecutive days.

When Switching from a Different Birth Control Pill

When switching from another birth control pill, drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be started on the same day that a new pack of the previous oral contraceptive would have been started.

When Switching from a Method Other than a Birth Control Pill

When switching from a transdermal patch or vaginal ring, drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be started when the next application would have been due. When switching from an injection, drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be started on the day of removal.

Withdrawal bleeding usually occurs within 3 days following the last pink tablet. If spotting or breakthrough bleeding occurs while taking drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets, instruct the patient to continue taking drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider.

Although the occurrence of pregnancy is low if drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets if pregnancy is confirmed.

The risk of pregnancy increases with each active pink tablet missed. For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS ” section in the FDA Approved Patient Labeling. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more light orange tablets, she should still be protected against pregnancy provided she begins taking a new cycle of pink tablets on the proper day.

For postpartum women who do not breastfeed or after a second trimester abortion, start drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets for 7 consecutive days.

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