Enpresse 28 Day Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I 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 the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
What should I know before taking it?
Oral contraceptives should not be used in women with any of 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.
What important warnings are listed?
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.
How is this medication usually taken?
To achieve maximum contraceptive effectiveness, Enpresse-28 Tablets (levonorgestrel and ethinyl estradiol tablets, USP—triphasic regimen) must be taken exactly as directed and at intervals not exceeding 24 hours. Enpresse-28 Tablets are a three-phase preparation plus 7 inert tablets. The dosage of Enpresse-28 Tablets is one tablet daily for 28 consecutive days per menstrual cycle in the following order: 6 pink tablets (phase 1), followed by 5 white tablets (phase 2), followed by 10 orange tablets (phase 3), plus 7 light-green inert tablets, according to the prescribed schedule. It is recommended that Enpresse-28 Tablets be taken at the same time each day, preferably after the evening meal.
What side effects are listed?
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see "WARNINGS" section): ThrombophlebitisArterial thromboembolismPulmonary embolismMyocardial infarctionCerebral hemorrhageCerebral thrombosisHypertensionGallbladder diseaseHepatic 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: NauseaVomitingGastrointestinal.
What interactions are listed?
Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin, and tetracyclines.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.