Levonorgestrel (Oral)

Levonorgestrel is an emergency contraceptive that helps prevent pregnancy after unprotected sex or if another birth control method fails. It works by stopping a woman's egg from fully developing. It may also stop the egg from attaching to the wall of the uterus (womb).

No contraceptive method is 100 percent effective. Other birth control methods, like surgery to become sterile or abstaining from sex, are more effective. This medicine should not be used as a regular birth control method. Talk to your doctor about your birth control options.

Plan B One-Step® is available as an over-the-counter medicine for any woman who can become pregnant.

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

Even though 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 (for example, St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor will consider the risks of taking the medicine against the benefits it may provide. The following points should be taken into account for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Current studies have not shown any specific problems in teenage females that would limit the use of levonorgestrel. This medicine can be used for birth control in teenage females, but it is not recommended before menstruation begins.

Geriatric

There have not been any appropriate studies on how levonorgestrel affects elderly women. This medicine is not intended for use in elderly women.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. You should weigh the potential benefits against the possible risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if there is a risk of interaction. In such cases, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and may not include all possible interactions.

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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both of the medicines.

• Amoxicillin
• Ampicillin
• Amprenavir
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Bosentan
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Griseofulvin
• Guar Gum
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Meropenem
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rufinamide
• Secobarbital
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thioridazine
• Ticarcillin
• Tigecycline
• Tirzepatide
• Tizanidine
• Topiramate
• Ulipristal

Using this medicine with any of the following medicines may lead to a higher risk of certain side effects, but using both medicines might be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Acitretin
• Amitriptyline
• Atazanavir
• Clomipramine
• Diazepam
• Doxepin
• Imipramine
• Lamotrigine
• Licorice
• Lorazepam
• Perampanel
• Selegiline
• Tacrine
• Temazepam
• Triazolam
• Troleandomycin
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are based on their potential significance and may not cover all possibilities.

Using this medicine with any of the following may increase the risk of certain side effects, but this may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Caffeine

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

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

More common

• Heavy or light menstrual bleeding

Incidence not known

• 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. Your health care professional may also 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:

More common

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

Less common

• 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.

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

Use this medicine exactly as directed by your doctor or follow the instructions on the package. This medicine is for occasional use as emergency birth control. It should not replace your regular birth control method. You may use this medicine at any time during your monthly period.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Plan B One-Step® is available as an over-the-counter medicine for any woman of childbearing potential.

If you vomit within 2 hours after taking this medicine, call your doctor right away. Your doctor may prescribe another tablet for you.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For emergency contraception:For oral dosage form (Plan B One-Step® tablets):Adults and teenagers—One tablet taken as soon as possible and not more than 72 hours (3 days) after unprotected sex or after failure of another birth control method.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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