Next Choice

Levonorgestrel emergency contraceptive is not intended for use as a routine form of birth control and should not be used in this manner. Talk with your doctor about the many forms of birth control available.

Do not use this medication if you are already pregnant. Levonorgestrel emergency contraceptive will not terminate a pregnancy that has already begun (the fertilized egg has attached to the uterus).

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have diabetes. You may not be able to use levonorgestrel emergency contraceptive, or you may need special tests during treatment.

Levonorgestrel can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to anyone younger than 17 years old. Contact a doctor for medical advice.

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

The first dose of levonorgestrel emergency contraceptive must be taken as soon as possible after unprotected sex (no later than 72 hours afterward). The second dose must be taken 12 hours after the first dose. The timing of these doses is very important for this medication to be effective.

Call your doctor right away if you vomit within 1 hour after taking either dose of levonorgestrel emergency contraceptive. Do not take another dose until you talk with your doctor.

You should be examined by your doctor within 3 weeks after taking levonorgestrel emergency contraceptive. The doctor will need to confirm that you are not pregnant and that this medication has not caused any harmful effects.

If your period is late by 1 week or longer after the expected date, you may be pregnant. Get a pregnancy test and contact your doctor if you are pregnant. Levonorgestrel emergency contraceptive will not terminate a pregnancy that has already begun (the fertilized egg has attached to the uterus).

Store levonorgestrel emergency contraceptive at room temperature away from moisture and heat.

Levonorgestrel emergency contraceptive will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases. Avoid having unprotected sex.

In the U.S.

• My Way
• Next Choice
• Plan B
• Plan B One-Step

In Canada

• Option 2

Available Dosage Forms:

• Tablet

Therapeutic Class: Contraceptive, Progestin

Pharmacologic Class: Progestin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of levonorgestrel in teenage females. This medicine may be used for birth control in teenage females but is not recommended before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of levonorgestrel have not been performed in the geriatric population. This medicine is not indicated for use in elderly women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aprepitant
• Bosentan
• Carbamazepine
• Ceritinib
• Dabrafenib
• Darunavir
• Dexamethasone
• Efavirenz
• Eliglustat
• Enzalutamide
• Fosphenytoin
• Griseofulvin
• Idelalisib
• Isotretinoin
• Lesinurad
• Lixisenatide
• Lumacaftor
• Mitotane
• Modafinil
• Oxcarbazepine
• Phenytoin
• Pitolisant
• Prednisone
• Rifabutin
• Rifampin
• St John's Wort
• Sugammadex
• Theophylline
• Tizanidine
• Topiramate
• Ulipristal

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acitretin
• Alprazolam
• Amprenavir
• Atazanavir
• Bacampicillin
• Betamethasone
• Bexarotene
• Colesevelam
• Cyclosporine
• Delavirdine
• Eslicarbazepine Acetate
• Fosamprenavir
• Fosaprepitant
• Lamotrigine
• Licorice
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nelfinavir
• Perampanel
• Prednisolone
• Rifapentine
• Ritonavir
• Rosuvastatin
• Rufinamide
• Selegiline
• Tacrine
• Telaprevir
• Troglitazone
• Troleandomycin
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

It is very important that your doctor check you closely to make sure this medicine is working properly and does not cause unwanted effects.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. Your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Call your doctor right away if you have severe lower abdominal or stomach pain 3 to 5 weeks after taking this medicine. You may have a pregnancy outside of the uterus (womb), which is called an ectopic pregnancy. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

You may have some blood spotting a few days after taking this medicine. If the bleeding continues for more than 1 week, check with your doctor right away.

This medicine may make your next monthly period later than expected by a few days. If your next period after taking this medicine is more than 1 week late, check with your doctor right away for a pregnancy test.

This medicine will not protect you from getting HIV/AIDS or other sexually transmitted infections. If this is a concern for you, talk with your doctor.

Your regular birth control method such as birth control pills or patch may not work as well while you are using this medicine. After using this medicine, you must use two forms of birth control. Use birth control pills or patch together with another form of birth control, such as a condom, diaphragm, or contraceptive foam or jelly, during any other times that you have sex in the same monthly period you used this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Heavy or light menstrual bleeding

• Absent missed or irregular menstrual periods
• cramps
• irregular menstruation
• pain
• pain in the pelvis
• stopping of menstrual bleeding

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• dizziness
• headache
• nausea
• tenderness of the breasts
• unusual tiredness or weakness
• vomiting

• Diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of progestin-only pills. Some drugs or herbal products that may decrease the effectiveness of progestin-only pills include:

• barbiturates
  
• bosentan
  
• carbamazepine
  
• felbamate
  
• griseofulvin
  
• oxcarbazepine
  
• phenytoin
  
• rifampin
  
• St. John’s wort
  
• topiramate

Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of coadministration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.

Consult the labeling of all concurrently used drugs to obtain further information about interactions with progestin-only pills or the potential for enzyme alterations.

Next Choice One DoseTM (Levonorgestrel) tablet 1.5 mg is available in a PVC/aluminum foil blister package. The tablet is supplied as a peach, round tablet and is embossed with 287 on one side and WATSON on the other side.

NDC 52544-287-54 (1 tablet unit of use package)

Store Next Choice One DoseTM at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].