Estradiol valerate/Dienogest

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[edit] BRAND NAMES

[edit] STRUCTURE

[edit] MECHANISM OF ACTION

Combination oral contraceptives, containing both estrogen and progestins, act by suppression of gonadotropins (FSH and LH). Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

Dienogest has high progestational and significant antiandrogenic activity, so it may improve androgenic symptoms (including hirsutism, seborrhoea, alopecia, acne vulgaris and hair and skin greasiness).

[edit] INDICATIONS

Estradiol valerate/Dienogest combination is indicated for use by women to prevent pregnancy. The efficacy of Estradiol valerate/Dienogest pill, in women with a body mass index (BMI) of >30 kg/m2has not been evaluated

Estradiol valerate/Dienogest combination is also indicated for treatment of heavy menstrual bleeding.

[edit] DOSAGE

28 film tablets box

  • 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

[edit] CONTRAINDICATIONS

Oral contraceptives should not be used in women who currently have the following conditions:

  • Cigarette smoking increases the risk of serious cardiovascular (heart and blood vessel problems) from hormonal contraceptives, including death from heart attack, blood clots, or stroke. This risk increases with age and with heavy smoking (15  or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
  • Known or suspected pregnancy
  • A history of heart attack or stroke
  • Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
  • A history of blood clots in the deep veins of your legs
  • An inherited problem that makes your blood clot more than normal
  • Chest pain (angina pectoris)
  • Known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina
  • Unexplained vaginal bleeding (until your doctor reaches a diagnosis)
  • Hepatitis or yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives
  • Benign or cancerous liver tumor (Hepatic adenomas or carcinomas)
  • Severe high blood pressure
  • Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
  • Headaches with neurological symptoms
  • Disease of heart valves with complications
  • Major surgery with prolonged immobilization

[edit] WARNINGS AND PRECAUTIONS

  • Vascular risks: Stop Estradiol valerate/Dienogest pill if a thrombotic event occurs. Stop Estradiol valerate/Dienogest pill at least 4 weeks before and through 2 weeks after major surgery. Start Estradiol valerate/Dienogest pill no earlier than 4 weeks after delivery, in women who are not breastfeeding.
  • Liver disease: Discontinue Estradiol valerate/Dienogest pill if jaundice occurs.
  • High blood pressure: Do not prescribe Estradiol valerate/Dienogest pill for women with uncontrolled hypertension or hypertension with vascular disease.
  • Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Estradiol valerate/Dienogest pill. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
  • Headache: Evaluate significant change in headaches and discontinue Estradiol valerate/Dienogest pill 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 Estradiol valerate/Dienogest pill as their oral contraceptive due to the possibility of decreased contraceptive efficacy

[edit] 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

[edit] PREGNANCY AND LACTATION

  • Nursing mothers: Not recommended; can decrease milk production.

[edit] SIDE EFFECTS

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

[edit] RELATED LINKS

[edit] BIBLIOGRAPHY

[edit] REFERENCES

Acne
Oral antibiotics Clindamycin (Oral route)   Doxycycline   Erythromycin (Oral route)   Josamycin   Lymecycline   Minocycline   Tetracycline
Topical antibiotics Clindamycin (Topical)   Erythromycin (Topical)
Topical retinoids Adapalene   Tazarotene   Tretinoin
Oral retinoids Isotretinoin (Oral)
Oral contraceptives Estradiol valerate/Dienogest   Ethinyl Estradiol/Cyproterone acetate
Topical Antibacterial/Keratolytic Benzoyl peroxide   Hydrogen Peroxide Cream
Topical combination products Clindamycin/Benzoyl peroxide   Adapalene/Benzoyl peroxide   Clindamycin/Tretinoin   Miconazole/Benzoyl peroxide   Erythromycin/Benzoyl peroxide   Erythromycin/Isotretinoin