Dinoges-EV Tablet
Dienogest + Estradiol valerate
2mg + 2mg
Nuvista Pharma Ltd
| Pack size | 28's Pack |
|---|---|
| Unite Price | 1,680.00 BDT |
Indications
Dinoges-EV Tablet is used for:
Contraception
Adult Dose
Oral
Contraception.
Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception.
1 tab PO once daily
Initiate by beginning pack on day 1 of menstrual cycle and use nonhormonal contraceptive back-up method during first 9 days
Child Dose
Renal Dose
Administration
Tablets must be taken in the order directed on every day at about the same time with some liquid as needed. Tablet taking is continuous. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous wallet.
Withdrawal bleeding usually starts during the intake of the last tablets of a wallet and may not have finished before the next wallet is started. In some women, the bleeding starts after the first tablets of the new wallet are taken.
Contra Indications
the first time during CHC use, the product should be stopped immediately.
• Presence or risk of venous thromboembolism (VTE)
o Venous thromboembolism – current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE])
o Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency
o Major surgery with prolonged immobilisation (see section 4.4)
o A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4)
• Presence or risk of arterial thromboembolism (ATE)
o Arterial thromboembolism – current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris)
o Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA)
o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
o History of migraine with focal neurological symptoms.
o A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as:
• diabetes mellitus with vascular symptoms
• severe hypertension
• severe dyslipoproteinaemia
• Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
• Presence or history of liver tumours (benign or malignant).
• Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts).
• Undiagnosed vaginal bleeding.
• Hypersensitivity to the active substances or to any of the excipients
Precautions
Poorly metabolized with hepatic impairment
Use caution in patients with history of migraine, seizure disorder,
Not recommended for women smokers >35 years
Oral contraceptives can reduce production of milk in breastfeeding mothers
Evaluate significant change in headaches and discontinue therapy if indicated
Women taking strong CYP3A4 inducers (for example, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should choose an alternate oral contraceptive due to the possibility of decreased contraceptive efficacy
Discontinue therapy if jaundice occurs
Not for administration for women with uncontrolled hypertension or hypertension with vascular disease
Monitor prediabetic and diabetic women receiving therapy
Consider an alternate contraceptive method for women with uncontrolled dyslipidemia
Evaluate uterine bleeding or amenorrhea
Thromboembolic disease may occur; stop therapy for at least 4 weeks before and through 2 weeks after major surgery; initiate therapy no sooner than 4 weeks after delivery, in women who are not breastfeeding
Safety and efficacy not established for BMI >30 kg/m²
Some studies report a small increase in risk of breast cancer among current or recent users(<6 months since last use) and current users with longer duration of COC use
CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section to decrease risk for venous thromboembolism before initiating combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives
Pregnancy-Lactation
Pregnancy
Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy; studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb reduction defects are concerned, when taken inadvertently during early pregnancy
Administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy; oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion
It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use; if the patient has not adhered to prescribed schedule, possibility of pregnancy should be considered at time of first missed period; oral contraceptive use should be discontinued if pregnancy is confirmed
Lactation
Small amounts of oral contraceptive steroids identified in the milk of nursing mothers, and a few adverse effects on child reported, including jaundice and breast enlargement; in addition, oral contraceptives given in postpartum period may interfere with lactation by decreasing quantity and quality of breast milk
If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child
Interactions
Side Effects
Side effects of Dienogest + Estradiol valerate :
>10%
Headache, including migraines (13.2%)
1-10%
Metrorrhagia and irregular menstruation (8%)
Breast pain, discomfort, or tenderness (6.6%)
Nausea or vomiting (6.5%)
Acne (3.9%)
Weight gain (2.85)
<1%
Venous thromboembolism
Jaundice or cholestasis
Gallbladder disease
Depression
Mode of Action
Estrogen/progestin combined oral contraceptive; decreases risk of becoming pregnant primarily by suppressing ovulation May also cause cervical mucus changes that inhibit sperm penetration and endometrial changes that decrease ability for implantation.
Note
Dinoges-EV 2mg + 2mg Tablet generic name is Dienogest + Estradiol valerate. Dinoges-EV 2mg + 2mg Tablet is manufactured by Nuvista Pharma LtdDinoges-EV is availble in all over Bangladesh.
Mes BD drug index information on Dinoges-EV Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.