Elisa®
Ethinylestradiol USP 0.020 mg & Drospirenone USP 3 mg
Dosage Form: TabletPack Size: 24's
Composition:
Elisa ® tablet: Each Elisa ® package contains 28 tablets. Among these 24 tablets are light pink in color and each contains Ethinylestradiol USP 0.020 mg & Drospirenone USP 3 mg. Each of 4 white colored tablets is placebo tablet.
Elisa ® 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 Elisa ® inhibit ovulation by suppressing gonadotropin release. Secondary mechanisms, which may contribute to the effectiveness of Elisa ® 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 favourable lipid profile with an increase in high-density lipoprote in 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.
Indications:
Elisa ® is indicated for:
* As an oral contraceptive
* Treatment of moderate acne vulgaris
* Treatment of premenstrual dysphoric disorder (PMDD)
Dosage & Administration:
To achieve maximum contraceptive effectiveness tablets must be taken in the order directed on the package every day at about the same time. Tablet-taking should be started with the first pink tablet of the upper row & have to continue daily for 24 consecutive days. After completion of pink tablet, white tablet should be taken from 25th day to 28th day. Withdrawal bleeding usually starts on day 2 - 3 after starting the white tablets & don’t stop taking white tablets though your menstruation is already started. Each subsequent new pack is started on the day after the last white tablet of the previous pack.
Contraindications:
Elisa ® should not be used if - known or suspected pregnancy, heart disease, clotting of blood in the vein, liver disease or jaundice, high blood pressure, migraine, unexplained breast lumps, diabetes with vascular involvement, excessive unexplained bleeding, venous or arterial thromboembolic events, history of migraine with focal neurological symptoms, pancreatitis with severe hypertriglyceridemia, severe renal insufficiency, liver tumours, undiagnosed vaginal bleeding, or hypersensitivity to any components.
Warning & Precautions:
If any circulatory disorder (like myocardial infarction, deep venous thrombosis, pulmonary embolism, cerebrovascular injury etc) or other risk factors (like smoking, obesity, hypertension, dyslipidemia, migraine, atrial fibrillation etc.) are present, the benefits of COC use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors after taking pill, the woman should contact with her physician. The physician should then decide on whether its use should be discontinued.
Overdose:
Symptoms of oral contraceptive overdose may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur. No specific antidote exists; treatment is symptomatic.
Storage Conditions:
Store below 30°C in a dry place. Keep away from light and out of the reach of children.
Commercial Pack:
Each blister contains 24 light pink tablets (each containing Ethinylestradiol USP 0.020 mg and Drospirenone USP 3 mg) and 4 white placebo tablets.