ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
ethynodiol diacetate and ethinyl estradiol · KIT · Mylan Pharmaceuticals Inc.
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL is a kit containing ethynodiol diacetate and ethinyl estradiol. Manufactured by Mylan Pharmaceuticals Inc..
Key Facts
- Brand Name
- ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
- Generic Name
- ethynodiol diacetate and ethinyl estradiol
- NDC Code (Product)
0378-7307- Manufacturer
- Mylan Pharmaceuticals Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA204703
- Marketing Start
- 09/19/2017
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 1. Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States. Emergency Contraceptive Pills : Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of…
Dosage & Administration
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, oral contraceptives must be taken exactly as directed and at intervals of 24 hours. IMPORTANT: If the Sunday start schedule is selected, the patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle. The possibility of ovulation and conception prior to initiation of use should be considered. Dosage Schedules Each ethynodiol diacetate and ethinyl estradiol tablet dispenser contains 21 light orange colored active tablets arranged in three numbered rows of 7 tablets each, followed by a fourth row of 7 green placebo tablets. Days of the week are printed above the tablets, starting with Sunday on the left. 28-Day Schedule: For a DAY 1 START, count the first day of menstrual flow as Day 1 and the first tablet (light orange) is then taken on Day 1. For a SUNDAY START when menstrual flow begins on or before Sunday, the first tablet (light orange) is taken on that day. With either a DAY 1 START or SUNDAY START, 1 tablet (light orange) is taken each day at the same time for 21 days. Then the green tablets are taken for 7 days, whether bleedi…
Warnings
WARNINGS Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. 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. The use of oral contraceptives is associated with increased risk of several serious conditions including venous and arterial thromboembolism, thrombotic and hemorrhagic stroke, myocardial infarction, liver tumors or other liver lesions, and gallbladder disease. The risk of morbidity and mortality increases significantly in the presence of other risk factors such as hypertension, hyperlipidemia, obesity, and diabetes mellitus. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these and other risks. The information contained herein is principally based on studies carried out in patients who used oral contraceptives with formulations containing higher amounts of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lesser amounts of both estrogen…
Contraindications
CONTRAINDICATIONS Ethynodiol diacetate and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: • Thrombophlebitis or thromboembolic disorders • A past history of deep vein thrombophlebitis or thromboembolic disorders • Cerebral vascular disease, myocardial infarction, or coronary artery disease, or a past history of these conditions • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive • Known or suspected carcinoma of the female reproductive organs or suspected estrogen-dependent neoplasia, or a history of these conditions • Undiagnosed abnormal genital bleeding • History of cholestatic jaundice of pregnancy or jaundice with prior oral contraceptive use • Past or present, benign or malignant liver tumors • Known or suspected pregnancy • Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings , RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).
Adverse Reactions
ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS ): • Thrombophlebitis and thrombosis • Arterial thromboembolism • Pulmonary embolism • Myocardial infarction and coronary thrombosis • Cerebral hemorrhage • Cerebral thrombosis • Hypertension • Gallbladder disease • Benign and malignant liver tumors, and other hepatic lesions There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: • Mesenteric thrombosis • Neuro-ocular lesions (e.g., retinal thrombosis and optic neuritis) The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: • Nausea • Vomiting • Gastrointestinal symptoms (such as abdominal cramps and bloating) • Breakthrough bleeding • Spotting • Change in menstrual flow • Amenorrhea during or after use • Temporary infertility after discontinuation of use • Edema • Chloasma or melasma, which may persist • Breast changes: tenderness, enlargement, secretion • Change in weight (increase or decrease) • Change in c…
Frequently Asked Questions
What is ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL used for?
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL contains ethynodiol diacetate and ethinyl estradiol. It is a kit taken as directed. Consult your doctor for specific uses.
Is ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL a controlled substance?
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL is not classified as a controlled substance by the DEA.
What is the generic name for ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL?
The generic name for ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL is ethynodiol diacetate and ethinyl estradiol. There are 6 other brand versions of ethynodiol diacetate and ethinyl estradiol.
What is the NDC code for ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ?
The NDC (National Drug Code) for ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL is 0378-7307, listed by Mylan Pharmaceuticals Inc..