Generic medicine

Ethinyl Estradiol + Drospirenone + Levomefolate

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 ... Read moreOral 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.

Brands

2

Categories

1

Browse brands Open class

Clinical notes

Applications:

N/A

Indication Notes:
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 ... Read moreOral 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.
Avoid In:

N/A

Contraindication Notes:
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
Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.
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%)
Nursing mothers: Not recommended; can decrease milk production.
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.