Description
Levonorgestrel is an emergency contraceptive that is used to prevent pregnancy after unprotected sex or after failure of another birth control method. It works by preventing a woman's egg from fully developing. It may also prevent the attachment of the woman's egg to the wall of the uterus (womb).
No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective. This medicine should not be used as a regular method of birth control. Discuss your options for birth control with your doctor.
Plan B One-Step® is available as an over-the-counter medicine for any woman of childbearing potential.
This product is available in the following dosage forms:
- Tablet
Before Using
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.
Breastfeeding
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.
Drug Interactions
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.
- Dasabuvir
- Fezolinetant
- Ombitasvir
- Paritaprevir
- Ritonavir
- 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.
- Amobarbital
- Amoxicillin
- Ampicillin
- Amprenavir
- Apalutamide
- Aprepitant
- Armodafinil
- Artemether
- Bacampicillin
- Belzutifan
- Betamethasone
- Bexarotene
- Bosentan
- Butabarbital
- Butalbital
- Carbamazepine
- Carbenicillin
- Cefaclor
- Cefadroxil
- Cefdinir
- Cefditoren
- Cefixime
- Cefpodoxime
- Cefprozil
- Ceftazidime
- Ceftibuten
- Cefuroxime
- Cenobamate
- Ceritinib
- Chlortetracycline
- Clobazam
- Cloxacillin
- Colesevelam
- Cyclacillin
- Cyclosporine
- Dabrafenib
- Darunavir
- Demeclocycline
- Dexamethasone
- Dicloxacillin
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
- Amitriptyline
- Atazanavir
- Clomipramine
- Diazepam
- Doxepin
- Imipramine
- Lamotrigine
- Leflunomide
- Licorice
- Lorazepam
- Perampanel
- Selegiline
- Tacrine
- Temazepam
- Teriflunomide
- Triazolam
- Voriconazole
Other Interactions
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 is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
- Tobacco
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
Proper Use
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.
- For oral dosage form (Plan B One-Step® tablets):
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.
Precautions
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.
Side Effects
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:
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. 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:
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.
DRG-20074413
