Levora 0.15/30 Tablets 28

Manufacturer MAYNE PHARMA Active Ingredient Ethinyl Estradiol and Levonorgestrel Tablets(ETH in il es tra DYE ole & LEE voe nor jes trel) Pronunciation ETH in il es tra DYE ole & LEE voe nor jes trel
WARNING: Smoking cigarettes while using this drug raises the chance of severe heart and blood-related side effects. This chance is raised with age (mainly older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this drug if you smoke and are older than 35 years of age. @ COMMON USES: It is used to prevent pregnancy. If you have been given this drug for some other reason, talk with your doctor for more information.
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Drug Class
Contraceptive, Hormonal
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Pharmacologic Class
Estrogen and Progestin Combination
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Pregnancy Category
Category X
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Levora is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (levonorgestrel). It works by preventing ovulation (the release of an egg from the ovary) and by changing the cervical mucus and uterine lining to prevent pregnancy. It is taken daily for 28 days, with 21 active pills and 7 inactive (placebo) pills.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions carefully. Read all the information provided and adhere to the guidelines.

Do not miss any doses, even if you do not have sexual intercourse frequently.
After starting this medication, you may need to use a non-hormonal form of birth control, such as condoms, for a certain period to prevent pregnancy. Follow your doctor's advice on using non-hormonal birth control.
You can take this medication with or without food. If it causes stomach upset, take it with food.
Take the medication at the same time every day.
If you are also taking colesevelam, take it at least 4 hours before or after taking this medication.
If you vomit or have diarrhea, the medication may not work as well to prevent pregnancy. If this occurs within 3 to 4 hours after taking an active tablet, take another tablet. If the symptoms persist for more than 1 day, use an additional form of birth control and consult your doctor. If you are unsure what to do, call your doctor.

Pregnancy Testing

If your menstrual cycle is 28 days and you miss two consecutive periods, take a pregnancy test before starting a new dosing cycle. If your cycle is longer than 91 days and you miss one period, take a pregnancy test before starting a new dosing cycle.

Storing and Disposing of Your Medication

Store the medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom.

Missing a Dose

If you miss a dose, refer to the package insert or consult your doctor for guidance. If you are using this medication to prevent pregnancy, you may need to use a non-hormonal form of birth control, such as condoms, for a certain period to prevent pregnancy.
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Lifestyle & Tips

  • Take one tablet at the same time every day to maximize effectiveness.
  • Do not smoke, especially if you are over 35 years old, as smoking significantly increases the risk of serious cardiovascular side effects.
  • Use a backup method of contraception (e.g., condoms) for the first 7 days of your first pack, or if you miss pills.
  • This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms to prevent STIs.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally once daily, starting on the first day of menstruation or the first Sunday after menstruation begins. Follow a 21-day active tablet regimen followed by 7 days of inert (placebo) tablets.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

missedDose: If one active tablet is missed, take it as soon as remembered. If two active tablets are missed in week 1 or 2, take two tablets the day remembered and two tablets the next day, use backup contraception for 7 days. If two active tablets are missed in week 3 or three or more active tablets are missed in any week, discard the rest of the pack and start a new pack immediately (Day 1 start) or start a new pack on Sunday (Sunday start) and use backup contraception for 7 days.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Same as adult dosing for post-menarcheal females requiring contraception.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific adjustment, but caution advised due to potential fluid retention.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Use with caution; monitor for adverse effects.
Severe: Contraindicated due to impaired steroid metabolism.

Pharmacology

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Mechanism of Action

Combination oral contraceptives primarily act by suppressing gonadotropins (FSH and LH), thereby inhibiting ovulation. They also cause changes in the cervical mucus (making it thicker and less permeable to sperm) and the endometrium (making it less receptive to implantation), contributing to their contraceptive effect.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: Approximately 40-60% (due to first-pass metabolism); Levonorgestrel: Approximately 90-100%
Tmax: Ethinyl Estradiol: 1-2 hours; Levonorgestrel: 1-2 hours
FoodEffect: Food may slightly decrease the rate but not the extent of absorption for both components.

Distribution:

Vd: Ethinyl Estradiol: Approximately 2-4 L/kg; Levonorgestrel: Approximately 1.8 L/kg
ProteinBinding: Ethinyl Estradiol: Approximately 98% (primarily to albumin); Levonorgestrel: Approximately 97-99% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration: Limited (not primary site of action)

Elimination:

HalfLife: Ethinyl Estradiol: 10-20 hours (terminal); Levonorgestrel: 24-48 hours (terminal)
Clearance: Ethinyl Estradiol: Approximately 5-10 mL/min/kg; Levonorgestrel: Approximately 1 mL/min/kg
ExcretionRoute: Ethinyl Estradiol: Renal (60%) and fecal (40%); Levonorgestrel: Renal (40-50%) and fecal (30-40%)
Unchanged: Ethinyl Estradiol: <5%; Levonorgestrel: <1%
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy begins after 7 consecutive days of active tablet use. Full protection typically after the first full cycle.
PeakEffect: Peak hormonal levels reached within 1-2 hours of dosing.
DurationOfAction: Daily dosing maintains therapeutic levels for contraceptive effect.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; changes in stools; dark urine or yellow skin or eyes; or fever with chills
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, fast breathing, or breath that smells like fruit
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight
New or worsening migraines
Depression or other mood changes
Breast changes: lump, pain, or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent spotting or vaginal bleeding
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Fluid retention: swelling, weight gain, or trouble breathing
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm; or trouble speaking or swallowing

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. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Appetite changes
Dizziness or headache
Weight gain or loss
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Period (menstrual) changes, including spotting or bleeding between cycles
Back pain
Dark patches of skin on the face (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear)

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns 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:

  • Severe abdominal pain
  • Severe chest pain, shortness of breath, or coughing up blood
  • Severe headaches, especially if sudden or accompanied by vision changes
  • Eye problems such as blurred vision, double vision, or loss of vision
  • Severe leg pain, swelling, warmth, or redness in the calf or thigh
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or light-colored stools
  • Unexplained vaginal bleeding or spotting that is heavy or prolonged
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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. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
If you experienced jaundice (turned yellow) during pregnancy or while using estrogen-containing products, such as hormonal birth control
Recent use of certain medications, including:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
If you are breast-feeding or plan to breast-feed

This is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about:

All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
* Any health problems you have

Ensure that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
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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. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.

This medication may increase the risk of blood clots, stroke, or heart attack. Discuss these potential risks with your doctor. If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, inform your doctor, as this may further increase your risk of blood clots.

If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor. Additionally, this medication may cause high blood pressure, so have your blood pressure checked regularly as advised by your doctor.

Regular laboratory tests, including blood work, are crucial while taking this medication. Ensure that you have these tests done as scheduled, and inform all your healthcare providers and laboratory personnel that you are taking this medication.

It is also important to maintain regular breast exams and gynecology check-ups, and to perform breast self-exams as instructed by your doctor. Certain medications, herbal products, or health conditions may interfere with the effectiveness of hormone-based birth control. Inform your doctor about all your medications and health issues, and discuss the potential need for non-hormone birth control methods, such as condoms.

If you are allergic to tartrazine (FD&C Yellow No. 5), consult your doctor, as some products contain this ingredient. This medication may also cause elevated cholesterol and triglyceride levels; discuss this with your doctor.

Remember that this medication does not protect against sexually transmitted diseases, such as HIV or hepatitis. Always use latex or polyurethane condoms during sexual activity, and consult your doctor if you have any questions.

There may be a potential increased risk of cervical cancer associated with long-term use of hormone-based birth control, although this may be attributed to other factors. Additionally, some studies suggest a possible link between long-term use of hormone-based birth control and an increased risk of breast cancer, while other studies have not found this association. If you have concerns, discuss them with your doctor.

This medication is not intended for use in children who have not yet had their first menstrual period.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Vaginal bleeding (especially in females)

What to Do:

Overdose is generally not life-threatening. Treatment is supportive. Contact a poison control center (1-800-222-1222) or seek emergency medical attention if symptoms are severe or concerning.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (risk of ALT elevations)
  • Glecaprevir/pibrentasvir (risk of ALT elevations)
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Major Interactions

  • Strong CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, Topiramate, Oxcarbazepine, Griseofulvin, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
  • Aromatase inhibitors (e.g., Anastrozole, Letrozole) - may reduce efficacy of aromatase inhibitors.
  • Thyroid hormone replacement therapy (e.g., Levothyroxine) - may increase thyroid hormone binding globulin, requiring increased thyroid hormone dose.
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Moderate Interactions

  • Certain antibiotics (e.g., Ampicillin, Tetracycline) - theoretical risk of reduced efficacy due to altered enterohepatic circulation, though clinical significance is debated; backup contraception often recommended.
  • CYP3A4 inhibitors (e.g., Itraconazole, Ketoconazole, Voriconazole, Grapefruit juice) - may increase estrogen/progestin levels, potentially increasing adverse effects.
  • Lamotrigine - may decrease lamotrigine levels, leading to loss of seizure control.
  • Cyclosporine - may increase cyclosporine levels, increasing toxicity.
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Minor Interactions

  • Acetaminophen - may increase ethinyl estradiol levels.
  • Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.

Monitoring

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Baseline Monitoring

Complete medical history and physical examination (including blood pressure, breast exam, pelvic exam, Pap test)

Rationale: To identify contraindications, risk factors for adverse events (e.g., VTE, cardiovascular disease), and establish baseline health status.

Timing: Prior to initiation of therapy

Lipid profile (cholesterol, triglycerides)

Rationale: To assess cardiovascular risk, especially in patients with pre-existing dyslipidemia or family history.

Timing: Prior to initiation, if indicated by risk factors

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess hepatic function, as oral contraceptives are contraindicated in severe liver disease.

Timing: Prior to initiation, if indicated by history of liver disease

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Routine Monitoring

Blood pressure

Frequency: Every 6-12 months

Target: <140/90 mmHg

Action Threshold: Sustained elevation >140/90 mmHg may require discontinuation or change in contraception.

Annual physical examination (including breast exam, pelvic exam, Pap test)

Frequency: Annually

Target: Normal findings

Action Threshold: Abnormal findings require further investigation and potential discontinuation.

Weight

Frequency: Annually or as clinically indicated

Target: Stable, healthy BMI

Action Threshold: Significant weight gain may increase cardiovascular risk.

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Symptom Monitoring

  • ACHES: Abdominal pain (severe)
  • Chest pain (severe), shortness of breath, coughing blood
  • Headaches (severe, sudden, or worse than usual, especially with visual changes)
  • Eye problems (blurred vision, loss of vision, flashing lights)
  • Severe leg pain (calf or thigh), swelling, warmth, redness

Special Patient Groups

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Pregnancy

Contraindicated. There is no indication for use in pregnancy, and there is evidence of fetal harm. Discontinue immediately if pregnancy is confirmed.

Trimester-Specific Risks:

First Trimester: Potential for adverse effects on fetal development, though data on specific malformations are inconsistent.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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Lactation

Not recommended. Estrogens can decrease the quantity and quality of breast milk. Small amounts of steroids may pass into breast milk and affect the infant. Non-hormonal methods or progestin-only methods are generally preferred during lactation.

Infant Risk: Low risk of adverse effects on the infant, but potential for reduced milk supply and altered milk composition.
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Pediatric Use

Indicated only for post-menarcheal females. Safety and efficacy are similar to adults once menstruation has begun.

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Geriatric Use

Not indicated for use in postmenopausal women for contraception. Risks of cardiovascular events increase with age.

Clinical Information

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Clinical Pearls

  • Emphasize the importance of consistent daily dosing at the same time to maintain efficacy.
  • Counsel patients on missed pill instructions thoroughly, as this is a common cause of contraceptive failure.
  • Remind patients that oral contraceptives do not protect against STIs.
  • Advise patients to report any signs of serious adverse events (e.g., DVT, PE, stroke, MI) immediately using the 'ACHES' mnemonic.
  • Be aware of potential drug interactions, especially with enzyme-inducing medications, which can significantly reduce contraceptive efficacy.
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Alternative Therapies

  • Progestin-only pills (mini-pill)
  • Progestin injection (Depo-Provera)
  • Progestin implant (Nexplanon)
  • Intrauterine devices (IUDs - hormonal or copper)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Surgical sterilization (vasectomy, tubal ligation)
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Cost & Coverage

Average Cost: $10 - $50 per 28 tablets (1 cycle)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered with no or low co-pay under ACA)
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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 details. If you have any questions or concerns about your 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.