Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

PLAN B (NDA-021045)

(LEVONORGESTREL)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

Download Data

Expand all

04/24/2018 (SUPPL-17)

Approved Drug Label (PDF)

5 Warnings and Precautions

Warnings

(Additions and/or revisions are underlined)

Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.

09/28/2017 (SUPPL-16)

Approved Drug Label (PDF)

7 Drug Interactions

(Additions and/or revisions are underlined)

…Some drugs or herbal products that may decrease the effectiveness of progestin-only pills include:

  • barbiturates (including primidone)

 

Concomitant administration of efavirenz has been found to reduce plasma levels of levonorgestrel (AUC) by around 50%, which may reduce the effectiveness of Plan B.

8 Use in Specific Populations

8.4 Pediatric Use

(Additions and/or revisions are underlined)

…Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older…

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Package Insert

(Additions and/or revisions are underlined)

What is Plan B?

It is a backup method of preventing pregnancy and should not be used as regular birth control.

When should I use Plan B?

The sooner you take emergency contraception, the better it works. You should use Plan B® within 72 hours (3 days) after you have had unprotected sex.

When not to use Plan B?

Plan B should not be used:

  • as a regular birth control method, because it’s not as effective as regular birth control.

When should I talk to a doctor or pharmacist?

Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of Plan B and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.

How does Plan B work?

Plan B is two tablets with levonorgestrel, a hormone that has been used in many birth control pills for several decades

How can I get the best results from Plan B?

You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex…

How effective is Plan B?

If Plan B is taken as directed, it can significantly decrease the chance that you will get pregnant…

How will I know Plan B worked?

You will know Plan B has been effective when you get your next period, which should come at the expected time, or within a week of the expected time…

Will I experience any side effects?

  • …If your period is more than a week late, you may be pregnant.

  • if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention.

  • if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.


Other information

If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about and, if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English