Drugplain

Kurvelo

levonorgestrel and ethinyl estradiol · KIT · Lupin Pharmaceuticals, Inc.

No Recall History
Plain English

Kurvelo is a kit containing levonorgestrel and ethinyl estradiol. Manufactured by Lupin Pharmaceuticals, Inc..

Key Facts

Brand Name
Kurvelo
Generic Name
levonorgestrel and ethinyl estradiol
NDC Code (Product)
68180-844
Manufacturer
Lupin Pharmaceuticals, Inc.
Dosage Form
KIT
Marketing Status
Application #
ANDA091408
Marketing Start
02/07/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea56 reports
headache39 reports
drug ineffective36 reports
dizziness33 reports
fatigue33 reports
vomiting32 reports
diarrhoea26 reports
pulmonary embolism26 reports
anxiety24 reports
dyspnoea24 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Kurvelo is indicated for use by females of reproductive potential to prevent pregnancy.

Dosage & Administration

DOSAGE AND ADMINISTRATION 1.How to Start and Take Kurvelo Kurvelo is dispensed in a compact dispenser containing 28 tablets (see HOW SUPPLIED ). Kurvelo may be started using either a Day 1 start or a Sunday start (see Table 3). For the first cycle of a Sunday start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. Table 3: Instructions for Administration of Kurvelo Starting Kurvelo in females with no current use of hormonal contraception Day 1 start • Take first tablet without regard to meals on the first day of menses • Take subsequent tablets once daily at the same time each day • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) Sunday start • Take first tablet without regard to meals on the first Sunday after the onset of menstrual period • Take subsequent tablets once daily at the same time each day • Use additional nonhormonal contraception for the first seven days of product use • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) Switching from another …

Warnings

WARNINGS 1.Thromboembolic Disorders and Other Vascular Conditions Stop Kurvelo if an arterial or venous thrombotic/thromboembolic event occurs. Stop Kurvelo if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately. Discontinue Kurvelo during prolonged immobilization. If feasible, stop Kurvelo at least four weeks before and through two weeks after major surgery, or other surgeries known to have an elevated risk of thromboembolism. Start Kurvelo no earlier than four weeks after delivery in females who are not breast-feeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the likelihood of ovulation increases after the third postpartum week. Before starting Kurvelo evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy. Kurvelo is contraindicated in females with a high risk of arterial or venous thrombotic/thromboembolic diseases (see CONTRAINDICATIONS ). Arterial Events COCs increase the risk of cardiovascular events and ce…

Contraindications

CONTRAINDICATIONS Kurvelo is contraindicated in females who are known to have the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see BOXED WARNING and WARNINGS (1) ]. Have current or history of deep vein thrombosis or pulmonary embolism [see WARNINGS (1) ] . Have cerebrovascular disease [see WARNINGS (1) ] . Have coronary artery disease [see WARNINGS (1) ] . Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS (1) ] . Have inherited or acquired hypercoagulopathies [see WARNINGS (1) ] . Have uncontrolled hypertension or hypertension with vascular disease [see WARNINGS (3) ] . Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration [see WARNINGS (7) ] . Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see WARNINGS (8) ] . Current diagnosis of, or history of, breast cancer, which may …

Frequently Asked Questions

What is Kurvelo used for?

Kurvelo contains levonorgestrel and ethinyl estradiol. It is a kit taken as directed. Consult your doctor for specific uses.

Is Kurvelo a controlled substance?

Kurvelo is not classified as a controlled substance by the DEA.

What is the generic name for Kurvelo?

The generic name for Kurvelo is levonorgestrel and ethinyl estradiol. There are 10 other brand versions of levonorgestrel and ethinyl estradiol.

What is the NDC code for Kurvelo ?

The NDC (National Drug Code) for Kurvelo is 68180-844, listed by Lupin Pharmaceuticals, Inc..

Product NDC

68180-844

Package NDC

68180-844-73

Other Kurvelo Dosages

Other Levonorgestrel Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)