Levonorgestrel Oral

Levonorgestrel Oral is a prescription as well as over-the-counter emergency contraception medication used for preventing pregnancy following unprotected sexual intercourse.

• Levonorgestrel Oral is available under the following different brand names: Plan B One-Step, Next Choice One Dose, My Way, Aftera, Econtra EZ, Fallback Solo, Opcicon One-Step, React, Take Action, Preventeza

Adult and pediatric dosage

Tablet

• 1.5mg

Emergency Post-coital Contraception

Adult and pediatric dosage

• 1 tablet (1.5 mg) Orally as soon as possible within 72 hr of unprotected coitus
• Most effective if taken as soon as possible after unprotected intercourse

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Levonorgestrel Oral include:

• mild stomach pain,
• breast pain or tenderness,
• nausea,
• vomiting,
• diarrhea,
• headache,
• dizziness,
• feeling tired, and
• changes in the menstrual periods

Serious side effects of the Levonorgestrel Oral include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat, and
• vomiting within two hours of taking the medication
• severe lower stomach pain, especially 3-5 weeks after taking the pill

Rare side effects of the Levonorgestrel Oral include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Levonorgestrel Oral has severe interactions with no other drugs.
• Levonorgestrel Oral has serious interactions with at least 34 other drugs.
• Levonorgestrel Oral has moderate interactions with at least 57 other drugs.
• Levonorgestrel Oral has no noted minor interactions with the following drugs:
  • enasidenib
  • levoketoconazole

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity
• Breastfeeding

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Levonorgestrel Oral?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Levonorgestrel Oral?”

Cautions

• Cigarette smoking & risk of cardiovascular disease
• Cigarette smoking increases the risk of serious cardiovascular adverse effects from combination hormonal contraceptive use
• This risk increases with age (above 35 years) and with heavy smoking (15 or more cigarettes/day)
• Advise women who use hormonal Oral contraceptives not to smoke
• Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (e.g., migraine, asthma, epilepsy)
• Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significang blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery
• Discontinue 4 weeks before major surgery or prolonged immobilization. Patients on warfarin, Oral anticoagulants (increase in anticoagulant dose may be warranted)
• Some studies link OCP use with an increased risk of breast cancer, whereas other studies have not shown a change in risk. A woman's risk depends on conditions where naturally high hormone levels persist for long periods of time including early-onset menstruation before age 12, late-onset menopause, after age 55, first child after age 30, nulliparity
• Increased risk of cervical cancer with OCP use, however, HPV remains the main risk factor for this cancer. Evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk
• Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use
• Delay product insertion a minimum of six weeks or until involution complete following a delivery or a second-trimester abortion
• Lactation at the time of insertion of an IUD/IUS associated with an increased risk of perforation

Pregnancy and Lactation

• Use of the drug is contraindicated in pregnancy or with a suspected pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant and therapy may cause adverse pregnancy outcomes; if a woman becomes pregnant likelihood of ectopic pregnancy is increased and there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery; remove a product if possible, if pregnancy occurs in a woman; if the product cannot be removed, follow pregnancy closely
• Studies report no adverse effects on fetal and infant development associated with long-term use of contraceptive doses of Oral progestins in a pregnant woman; however, there have been reported cases of masculinization of the external genitalia of female fetus following exposure to progestins at doses greater than those currently used for Oral contraception; animal reproduction studies not conducted.
• Lactation
  • Published studies report the presence of LNG in human milk; small amounts of progestins (approximately 0.1% of total maternal doses) were detected in the breast milk of nursing mothers who used other LNG-releasing IUSs, resulting in exposure of LNG to the breastfed infants; there are no reports of adverse effects in breastfed infants with maternal use of progestin-only contraceptives; isolated cases of decreased milk production reported with an LNG-releasing IUS; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child therapy or from the underlying maternal condition