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Dienogest + Estradiol ValerateDienogest + Estradiol Valerate

Indications

This is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. The efficacy of this tablet in women with a body mass index (BMI) of >30 kg/m 2 has not been evaluated. Treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception.

Pharmacology

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.

Dosage & Administration

Take one tablet daily by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Do not skip or delay intake by more than 12 hours. 

Interaction

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.

Contraindications

  • A high risk of arterial or venous thrombotic diseases
  • Undiagnosed abnormal uterine bleeding
  • Breast cancer or other estrogens- or progestin-sensitive cancer

Side Effects

The most common adverse reactions (≥2%) in clinical trials for Natazia are headache (including migraines) 13%, breast pain 7%, menstrual disorders 7%, nausea or vomiting 6%, acne 4%, mood changes (3%) and increased weight 3%.

Precautions & Warnings

  • Vascular risks: Stop this tablet if a thrombotic event occurs. Stop this tablet at least 4 weeks before and through 2 weeks after major surgery. Start this tablet no earlier than 4 weeks after delivery, in women who are not breastfeeding.
  • Liver disease: Discontinue this tablet if jaundice occurs.
  • High blood pressure: Do not prescribe this tablet for women with uncontrolled hypertension or hypertension with vascular disease.
  • Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking this tablet. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
  • Headache: Evaluate significant change in headaches and discontinue this tablet if indicated.
  • Uterine bleeding: Evaluate irregular bleeding or amenorrhea.
  • CYP3A4 induction: Women taking strong CYP3A4 inducers (for example, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should not choose this tablet as their oral contraceptive due to the possibility of decreased contraceptive efficacy.

Therapeutic Class

Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

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