Microgestin 1/20
Norethindrone Acetate/Ethinyl Estradiol · KIT · Mayne Pharma Inc.
Microgestin 1/20 is a kit containing norethindrone acetate/ethinyl estradiol. Manufactured by Mayne Pharma Inc..
Key Facts
- Brand Name
- Microgestin 1/20
- Generic Name
- Norethindrone Acetate/Ethinyl Estradiol
- NDC Code (Product)
51862-868- Manufacturer
- Mayne Pharma Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA202995
- Marketing Start
- 10/12/2020
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Microgestin 1/20 is 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. 2
Dosage & Administration
DOSAGE AND ADMINISTRATION The compact tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in three rows of seven tablets each, with the days of the week appearing on the compact tablet dispenser above the first row of tablets. Note: Each compact tablet dispenser has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label stickers have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label sticker that corresponds to her starting day over the preprinted days. Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen. The possibility of ovulation and conception prior to initiation of use should be considered. Dosage and Administration for 21-Day Dosage Regimen To achieve maximum contraceptive effectiveness, Microgestin 1/20 should be taken e…
Warnings
WARNINGS The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, …
Contraindications
CONTRAINDICATIONS Oral contraceptives should not be used in women who currently have the following conditions: ● Thrombophlebitis or thromboembolic disorders ● A past history of deep vein thrombophlebitis or thromboembolic disorders ● Cerebral vascular or coronary artery disease ● Known or suspected carcinoma of the breast ● Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia ● Undiagnosed abnormal genital bleeding ● Cholestatic jaundice of pregnancy or jaundice with prior pill use ● Hepatic adenomas or carcinomas ● 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 section): ● Thrombophlebitis ● Arterial thromboembolism ● Pulmonary embolism ● Myocardial infarction ● Cerebral hemorrhage ● Cerebral thrombosis ● Hypertension ● Gallbladder disease ● Hepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: ● Mesenteric thrombosis ● Retinal thrombosis 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 ● Temporary infertility after discontinuation of treatment ● Edema ● Melasma which may persist ● Breast changes: tenderness, enlargement, secretion ● Change in weight (increase or decrease) ● Change in cervical erosion and secretion ● Diminution in lactation when given immediately postpartum ● Cholestatic jaundice ● Rash (allergi…
Frequently Asked Questions
What is Microgestin 1/20 used for?
Microgestin 1/20 contains Norethindrone Acetate/Ethinyl Estradiol. It is a kit taken as directed. Consult your doctor for specific uses.
Is Microgestin 1/20 a controlled substance?
Microgestin 1/20 is not classified as a controlled substance by the DEA.
What is the generic name for Microgestin 1/20?
The generic name for Microgestin 1/20 is Norethindrone Acetate/Ethinyl Estradiol. There are 10 other brand versions of Norethindrone Acetate/Ethinyl Estradiol.
What is the NDC code for Microgestin 1/20 ?
The NDC (National Drug Code) for Microgestin 1/20 is 51862-868, listed by Mayne Pharma Inc..