Rokin®

Therapeutic Area:

Generic Name:

Drospirenone/ethinyl estradiol

Dosage Form:

3mg drospirenone and 0.03 mg ethinyl estradiol tablets

Drug Dose

Therapeutic Indications:

  • Prevent pregnancy
  • Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception.
  • Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control.

Mechanism of Action:

Inhibition of ovulation, other alterations include changes in the cervical mucus (which increases the difficulty of sperm entry into the uterus) and the endometrium (which reduces the likelihood of implantation).

Method of Administration:

Rokin® consists of 21 film-coated tablets

  • Take one tablet daily by mouth at the same time every day.

Notes

Contraindications:

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.

Interactions:

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.

Pregnancy and Lactation:

PREGNANCY: Rokin® should not be taken by pregnant women. There is no evidence, however, that the birth control pill can damage a developing child. You should check with your doctor about risks to your unborn child from any medication taken during pregnancy.

LACTATION: Not recommended; can decrease milk production.

Warning and Precaution:

Vascular risks: Stop Rokin® 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 Rokin® 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 Rokin® if jaundice occurs. High blood pressure: Do not prescribe Rokin® for women with uncontrolled hypertension or hypertension with vascular disease. Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Rokin®. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. Headache: Evaluate significant change in headaches and discontinue Rokin® if indicated. Uterine bleeding: Evaluate irregular bleeding or amenorrhea.

Adverse Reactions:

The most frequent adverse reactions (≥ 2%) in contraception and acne clinical trials were: headache/migraine (6.7%), menstrual irregularities (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4.0%) and mood changes (2.2%). The most frequent adverse reactions (≥ 2%) in PMDD clinical trials were: 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%).

Storage:

Store below 30 and protect from light and moisture.