The treatment of gynecological disorders and prostate cancer.
This contains two active ingredients- Ethinylestradiol and Drospirenone. Ethinylestradiol is a synthetic version of estrogen and Drospirenone is a synthetic form of progesterone. The hormonal components of this preparation inhibit ovulation by suppressing gonadotropin release. Secondary mechanisms, which may contribute to the effectiveness of this tablet as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).
Drospirenone has antimineralocorticoid activity, counteracting estrogen-related sodium retention. In combination with Ethinyloestradiol, Drospirenone displays a favorable lipid profile with an increase in high-density lipoprotein HDL. Drospirenone exerts antiandrogenic activity and does not counteract the ethinyloestradiol-related sex hormone-binding globulin increase which is useful for binding and inactivating the endogenous androgens.
ORAL Menopausal hormone replacement therapy: Adult: In menopausal women: 10-20 mcg daily in conjunction w/ a progestogen in women w/ uterus. Female hypogonadism: Adult: 10-50 mcg daily in a cyclical regimen. As part of combined oral contraceptive: Adult: As the oestrogenic component of combined oral contraceptive: 20-40 mcg/ day.
Interactions between ethinylestradiol and other drugs may lead to decreased or increased ethinylestradiol concentrations, respectively. Decreased ethinylestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the oral contraceptive. Example of substances that may decrease serum ethinylestradiol concentrations include rifampicin, phenytoin, primidone, rifabutin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil, ritonavir and barbiturates. Certain antibiotics including ampicillin, other penicillins and tetracyclines may reduce the efficacy of oral contraceptives. During concomitant use of this tablet & other drugs that may lead to decreased ethinylestradiol serum concentrations, it is recommended that a non hormonal back-up method of contraception to be used in addition to the regular intake of this tablet.
Uterine, liver & mammary carcinoma, thromboembolic disorders. Pregnancy, lactation, untreated endometriosis, jaundice, undiagnosed vag bleeding. Asthma; epilepsy; migraine; DM; cardiac or renal dysfunction; hepatic disease; familial defects of lipoprotein metabolism. Increased risk of endometrial cancer in unopposed oestrogen therapy. Increased risk of gallbladder disease in women on postmenopausal oestrogens. Large doses may increase CV risk, BP, risk of thrombophlebitis & pulmonary embolism.
Oedema, hypertension; dizziness; headache; thromboembolism; cholestatic jaundice; nausea, vomiting; disturbance of menstrual cycle; fluid retention, discomfort in breast, wt gain/loss; increased appetite, increased tendency for vag candidiasis; mental depression; alteration In libido; rashes; alopoecia, hirsutism; gynaecomastia & Impotence. Endometrial cancer (prolonged use).
Use is contraindicated during pregnancy. Breastfeeding is not recommended during use of this drug.
Symptoms of oral contraceptive overdose may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.
Do not store above 30°C. Keep away from light and out of the reach of children.
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