Lyleq .35 mg/1

NORETHINDRONE · TABLET · Afaxys Pharma, LLC

No Recall History

Plain English

Lyleq is a tablet containing norethindrone at .35 mg/1, taken oral. Manufactured by Afaxys Pharma, LLC.

Key Facts

Brand Name: Lyleq
Generic Name: NORETHINDRONE
NDC Code (Product): 50102-300
Manufacturer: Afaxys Pharma, LLC
Strength: .35 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA207304
Drug Class: Progestin [EPC]
Marketing Start: 09/23/2016

Recall History

No Recall History

Side Effects Reported to FDA

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

nausea228 reports

headache220 reports

off label use195 reports

drug ineffective180 reports

fatigue173 reports

pain159 reports

hot flush155 reports

vaginal haemorrhage141 reports

abdominal pain137 reports

diarrhoea124 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 1. Indications Progestin - only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin - only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2: 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. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 Method (1) Typical Use 1 (2) Perfect Use 2 (3) (4) Chance 4 85 85 Spermicides 5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal 6 2 Post-Ovulation 1 Cap 7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 7 20 6 56 Withdrawal 19 4 Condom 8 Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only 0.5 Combined 0.1 IUDs Progester…

Dosage & Administration

DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Lyleq tablets must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See PATIENT LABELING for detailed instructions.

Warnings

WARNINGS Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke. Lyleq does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin - only pill (POP) use to an increased risk of heart attack or stroke. The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate. 1 . Ectopic Pregnancy The incidence of ectopic pregnancies for progestin - only oral contraceptive us…

Contraindications

CONTRAINDICATIONS Progestin - only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Known or suspected pregnancy Known or suspected carcinoma of the breast Undiagnosed abnormal genital bleeding Hypersensitivity to any component of this product Benign or malignant liver tumors Acute liver disease

Adverse Reactions

ADVERSE REACTIONS Menstrual irregularity is the most frequently reported side effect. Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely. Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies. Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.

Frequently Asked Questions

What is Lyleq used for?

Lyleq contains NORETHINDRONE. It is a tablet taken oral. Consult your doctor for specific uses.

Is Lyleq a controlled substance?

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

What is the generic name for Lyleq?

The generic name for Lyleq is NORETHINDRONE. There are 12 other brand versions of NORETHINDRONE.

What is the NDC code for Lyleq .35 mg/1?

The NDC (National Drug Code) for Lyleq .35 mg/1 is 50102-300, listed by Afaxys Pharma, LLC.

Product NDC

50102-300

Package NDC

50102-300-13

Other Norethindrone Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)