Levonorgestrel and Ethinyl Estradiol

LEVONORGESTREL AND ETHINYL ESTRADIOL-
Exeltis USA, Inc.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including Levonorgestrel and Ethinyl Estradiol Tablets, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

Levonorgestrel and Ethinyl Estradiol Tablets (LNG/EE Tablets) is indicated for use by females of reproductive potential to prevent pregnancy.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Take Levonorgestrel and Ethinyl Estradiol Tablets (LNG/EE Tablets) in one of two ways: (1) swallow whole on an empty stomach or (2) chew and then immediately swallow with a full glass of 240 mL of water on an empty stomach [see Dosage and Administration (2.2)].

2.2 Additional Administration Information

To achieve maximum contraceptive effectiveness, take LNG/EE Tablets exactly as directed (one tablet orally at the same time every day) and at intervals not exceeding 24 hours. The failure rate may increase when tablets are missed or taken incorrectly. The recommended dosage of LNG/EE Tablets is one tablet daily for 28 consecutive days: one white active tablet daily during the first 21 consecutive days, followed by one peach inactive tablet daily during the 7 following days (see Table 1).

Table 1 Instructions for Administration of LNG/EE Tablets
Starting LNG/EE Tablets in females with no current use of hormonal contraception (start on Day 1 or Sunday)
Day 1 start
  • Take first tablet without food (i.e. empty stomach) on the first day of menses
  • Take subsequent tablets once daily at the same time each day
  • Begin each subsequent 28-day 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 food (i.e. empty stomach) 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 LNG/EE Tablets use
  • Begin each subsequent 28-day pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet)
Switching to LNG/EE Tablets from another contraceptive method
Start LNG/EE Tablets:
  • A combined oral contraceptive (COC)
  • On the day when the new pack of the previous COC would have been started
  • Transdermal system
  • On the day when next application would have been scheduled
  • Vaginal ring
  • On the day when next insertion would have been scheduled
  • Injection
  • On the day when next injection would have been scheduled
  • Intrauterine system
  • On the day of removal
  • Implant
  • On the day of removal
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling (Instructions for Use).

2.3 Missed Doses

Instruct patients about the handling of missed doses (e.g., to take a missed tablet as soon as possible) and to follow the dosing instructions provided in the FDA-approved patient labeling (Instructions for Use).

Table 2 Instructions for Missed LNG/EE Tablets
  • If one white active tablet is missed in Weeks 1, 2, or 3
Take the missed active tablet as soon as possible, even if two active tablets are taken in one day. Continue taking one tablet a day until the pack is finished.
  • If two white active tablets are missed in Week 1 or Week 2
Take two active tablets as soon as possible. Then, take two active tablets the next day. This means taking 4 tablets in 2 days. Continue taking one tablet a day until the pack is finished. Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
  • If two white active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3
Day 1 start: Throw out the rest of the 28-day pack and start a new pack that same day.Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
  • If one or more peach (inactive) tablets are missed in the fourth week
Throw away the missed inactive tablets. Keep taking one tablet each day until the pack is empty. Back-up nonhormonal birth-control method is not needed but take the next pack on time.

2.4 Administration Recommendations after Vomiting or Acute Diarrhea

If vomiting or acute diarrhea occurs within 3 to 4 hours after taking an active tablet, take the new active tablet (scheduled for the next day) as soon as possible. If more than two active tablets are missed, see the recommendations in Table 2 [see Dosage and Administration (2.3)].

3 DOSAGE FORMS AND STRENGTHS

One pack of Levonorgestrel and Ethinyl Estradiol Tablets consists of 28 tablets:

  • 21 active tablets are white, round, and debossed with 30 on one side and L2 on the other side. Each active tablet contains levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg.
  • 7 inactive tablets (placebo) are peach-colored, round, and debossed with 1 on one side and L2 on the other side.

4 CONTRAINDICATIONS

Levonorgestrel and Ethinyl Estradiol Tablets (LNG/EE Tablets) is contraindicated in females who are known to have the following conditions:

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.