My Choice 1.5mg Tablet

Manufacturer SUN Active Ingredient Levonorgestrel (Systemic)(LEE voe nor jes trel) Pronunciation LEE voe nor jes trel
It is used to lower the chance of pregnancy after unprotected sex.
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Drug Class
Emergency Contraceptive
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Pharmacologic Class
Progestin
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Pregnancy Category
Not applicable for emergency contraception; not indicated in established pregnancy.
FDA Approved
Jul 2009
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

My Choice 1.5mg Tablet is an emergency contraceptive, sometimes called the 'morning-after pill.' It's used to prevent pregnancy after unprotected sex or if your regular birth control failed. It works mainly by stopping or delaying the release of an egg (ovulation). It is not a regular birth control method and does not protect against sexually transmitted infections (STIs).
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Take the medication as soon as possible within 72 hours after unprotected sex. If you vomit within 2 hours of taking the medication, you may need to take an additional dose; contact your doctor immediately.

Storing and Disposing of Your Medication

Store the medication at room temperature in a dry location, avoiding bathrooms. Keep all medications in a secure place, out of reach of children and pets, to prevent accidental ingestion.

Missing a Dose

If you miss a dose, consult your doctor for guidance on the next steps. Do not take two doses at the same time or take extra doses, as this may increase the risk of adverse effects.
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Lifestyle & Tips

  • This medication is for emergency use only and should not replace regular birth control methods.
  • It does not protect against HIV/AIDS or other STIs.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 1.5 mg orally as a single dose, as soon as possible within 72 hours (3 days) of unprotected intercourse.
Dose Range: 1.5 - 1.5 mg

Condition-Specific Dosing:

efficacy_window: Most effective when taken within 24 hours, efficacy decreases with time up to 72 hours.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Post-menarcheal adolescents: 1.5 mg orally as a single dose, as soon as possible within 72 hours (3 days) of unprotected intercourse.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended.
Dialysis: No specific data; unlikely to be significantly affected by dialysis due to high protein binding and metabolism.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: Use with caution; no specific dose adjustment guidelines.
Severe: Use with caution; levonorgestrel is extensively metabolized by the liver. Not recommended unless benefits outweigh risks, and close monitoring is possible.

Pharmacology

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Mechanism of Action

Levonorgestrel primarily works by preventing or delaying ovulation. It may also inhibit fertilization by altering sperm or egg transport, or by preventing implantation through changes in the endometrium. It is not effective if implantation has already occurred and does not interrupt an established pregnancy.
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Pharmacokinetics

Absorption:

Bioavailability: Nearly 100%
Tmax: 1 to 2 hours
FoodEffect: Minimal effect on absorption.

Distribution:

Vd: Approximately 1.8 L/kg
ProteinBinding: Approximately 97-99% (primarily to albumin and sex hormone-binding globulin [SHBG])
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 24 to 28 hours
Clearance: Not readily available as a single value, but extensively metabolized.
ExcretionRoute: Approximately 40-50% excreted in urine and 30-40% in feces, primarily as metabolites.
Unchanged: <0.1% in urine
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Pharmacodynamics

OnsetOfAction: Rapid absorption, effects on ovulation begin shortly after.
PeakEffect: Not applicable for single-dose EC in terms of a measurable peak effect on pregnancy prevention.
DurationOfAction: Sufficient to prevent ovulation if taken before the LH surge.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Severe stomach pain

Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- Headache
- Upset stomach or vomiting
- Breast soreness
- Feeling dizzy, tired, or weak
- Changes in menstrual periods
- Stomach pain

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • If your period is more than a week late, or if it's unusually light or heavy, take a pregnancy test.
  • Seek immediate medical attention if you experience severe lower abdominal pain, especially if your period is delayed, as this could be a sign of an ectopic pregnancy.
  • Seek immediate medical attention for signs of a severe allergic reaction (e.g., rash, itching/swelling, severe dizziness, trouble breathing).
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant, as it may cause harm.
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
Any existing health problems you have. Your doctor needs to be aware of your complete medical history to assess the safety of this medication for you.

To guarantee your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that this medication is compatible with all your other medications and health conditions before taking it.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

This medication does not protect against the transmission of diseases such as HIV or hepatitis that can be spread through sexual contact. To reduce the risk of transmission, it is crucial to use a latex or polyurethane condom during any sexual activity. If you have questions or concerns, consult your doctor.

This medication is not intended to terminate a pregnancy and should not be used as a regular method of contraception. If you require frequent use of emergency birth control, discuss alternative options with your doctor. Instead, use a reliable form of birth control to prevent pregnancy.

Certain medications or herbal products may interact with this drug and reduce its effectiveness. Ensure that your doctor and pharmacist are aware of all the medications you are taking. If your menstrual period is delayed by more than 7 days, consult your doctor.

If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Uterine bleeding

What to Do:

There is no specific antidote. Treatment is symptomatic and supportive. Call 1-800-222-1222 (Poison Control) for advice.

Drug Interactions

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Major Interactions

  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, barbiturates, St. John's Wort, efavirenz, ritonavir-boosted protease inhibitors): Can significantly decrease levonorgestrel plasma concentrations, potentially reducing efficacy. Consider alternative EC or higher dose/repeat dose if appropriate.
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Moderate Interactions

  • Other less potent CYP3A4 inducers (e.g., bosentan, griseofulvin, modafinil, topiramate): May reduce levonorgestrel efficacy.

Monitoring

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Baseline Monitoring

Pregnancy test (if indicated)

Rationale: To rule out existing pregnancy, as levonorgestrel EC is not effective if pregnancy is already established.

Timing: Before administration if there is any doubt about existing pregnancy.

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Symptom Monitoring

  • Monitor for return of menstruation: If menstruation is delayed by more than 1 week beyond the expected date, or if it is unusually light or heavy, a pregnancy test should be performed.
  • Monitor for severe lower abdominal pain: May indicate an ectopic pregnancy, especially if accompanied by delayed period.
  • Monitor for signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing).

Special Patient Groups

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Pregnancy

Levonorgestrel EC is not indicated for use in established pregnancy. It will not terminate an existing pregnancy and studies have shown no adverse effects on the fetus if taken inadvertently during early pregnancy.

Trimester-Specific Risks:

First Trimester: Not indicated; no evidence of harm to fetus if inadvertently taken.
Second Trimester: Not indicated.
Third Trimester: Not indicated.
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Lactation

Levonorgestrel is excreted in breast milk. However, the amount is small and generally considered compatible with breastfeeding. To minimize infant exposure, some experts suggest taking the dose immediately after a feeding and waiting 3-4 hours before the next feeding.

Infant Risk: Low risk to breastfed infant.
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Pediatric Use

Safe and effective for use in post-menarcheal adolescents. Not indicated for pre-menarcheal children.

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Geriatric Use

Not indicated for use in geriatric women, as emergency contraception is not relevant for this population.

Clinical Information

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Clinical Pearls

  • Levonorgestrel EC is most effective when taken as soon as possible after unprotected intercourse, ideally within 24 hours, but can be used up to 72 hours (3 days).
  • It is not a substitute for routine contraception and does not protect against sexually transmitted infections (STIs).
  • If vomiting occurs within 2 hours of taking the dose, contact a healthcare provider as a repeat dose may be necessary.
  • If the next menstrual period is delayed by more than 7 days, or is unusually light or heavy, a pregnancy test should be performed.
  • Efficacy may be reduced in women with a BMI > 25-30 kg/m²; however, it is still recommended as the best available option for these individuals if other EC methods (like copper IUD or ulipristal acetate) are not accessible.
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Alternative Therapies

  • Ulipristal acetate (Ella): Another oral emergency contraceptive, effective up to 120 hours (5 days) after unprotected intercourse, and may be more effective than levonorgestrel in women with higher BMI.
  • Copper Intrauterine Device (IUD): The most effective method of emergency contraception, can be inserted up to 5 days after unprotected intercourse, and provides ongoing contraception for up to 10 years.
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Cost & Coverage

Average Cost: $10 - $50 per 1.5mg tablet
Generic Available: Yes
Insurance Coverage: Often available over-the-counter without prescription. Some insurance plans may cover it with a prescription.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.