Oral Contraceptive: This is indicated for use by women to prevent pregnancy.

Premenstrual Dysphoric Disorder (PMDD): This contraceptive preparation is 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 This contraceptive preparation 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. This contraceptive preparation has not been evaluated for the treatment of premenstrual syndrome (PMS).

Acne: This is 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. This contraceptive preparation should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Folate Supplementation: This contraceptive preparation is 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.

How to Take this contraceptive pill: 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, this contraceptive pill must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.

How to Start this contraceptive pill: Instruct the patient to begin taking this contraceptive pill 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 this contraceptive pill use, instruct the patient to take one pink contraceptive pill daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one pink contraceptive pill daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. this contraceptive pill 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. this contraceptive pill can be taken without regard to meals. If this contraceptive pill is first taken later than the first day of the menstrual cycle, this contraceptive pill 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 backup 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 this contraceptive pill use, instruct the patient to take one pink contraceptive pill daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink contraceptive pill daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. this contraceptive pill 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. this contraceptive pill can be taken without regard to meals. this contraceptive pill 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 backup 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 this contraceptive pill 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 this contraceptive pill 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 contraceptive pill daily for seven consecutive days.

When switching from a different birth control pill: When switching from another birth control pill, this contraceptive pill should be started on the same day that a new pack of the previous oral contraceptive would have been started.

• Renal impairment
• Adrenal insufficiency
• A high risk of arterial or venous thrombotic diseases
• Undiagnosed abnormal uterine bleeding
• Breast cancer or other estrogen- or progestin-sensitive cancer
• Liver tumors or liver disease
• Pregnancy

The most frequent adverse reactions (≥ 2%) in contraception, acne and folate clinical trials are headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness (3.2%). The most frequent adverse reactions (≥ 2%) in PMDD clinical trials are menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%)

Vascular risks: Stop this contraceptive pill if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins. Before initiating this contraceptive pill in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE.

Hyperkalemia: DRSP has antimineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration.

Liver disease: Discontinue this contraceptive pill if jaundice occurs.

High blood pressure: Do not prescribe this contraceptive pill for women with uncontrolled hypertension or hypertension with vascular disease.

Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking this contraceptive pill. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.

Headache: Evaluate significant change in headaches and discontinue this contraceptive pill if indicated.

Uterine bleeding: Evaluate irregular bleeding or amenorrhea.

Pregnancy & Lactation

Nursing mothers: Not recommended; can decrease milk production.