Marlissa 0.15/30mcg Tablets

Manufacturer GLENMARK Active Ingredient Ethinyl Estradiol and Levonorgestrel Tablets(ETH in il es tra DYE ole & LEE voe nor jes trel) Pronunciation MAR-liss-uh (Ethinyl Estradiol: ETH-in-il es-tra-DYE-ole; Levonorgestrel: 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/Progestin Combination
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Pregnancy Category
Category X
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FDA Approved
Aug 1982
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Marlissa is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (levonorgestrel). It works by preventing your body from releasing an egg (ovulation) and by making it harder for sperm to reach the egg or for a fertilized egg to implant in the womb. When taken correctly, it is a very effective method of preventing pregnancy.
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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. It's essential to take your medication as directed, even if you don't have sex 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. Be sure to follow your doctor's advice on using this additional form of birth control.

You can take this medication with or without food. If it causes stomach upset, take it with food to help alleviate this issue. Establish a routine by taking your medication at the same time every day.

If you're also taking colesevelam, take it at least 4 hours before or after you take this medication. If you vomit or experience diarrhea, the effectiveness of this medication in preventing pregnancy may be reduced. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, take another tablet as soon as possible. If these symptoms persist for more than a day, use an additional form of birth control and consult your doctor. If you're unsure about what to do in case of vomiting or diarrhea, contact your doctor for guidance.

Monitoring Your Menstrual Cycle

If your menstrual cycle is 28 days and you miss two consecutive periods, take a pregnancy test before starting a new cycle of medication. For cycles longer than 91 days, if you miss one period, take a pregnancy test before beginning a new cycle of medication.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.

Missing a Dose

If you miss a dose, refer to the package insert or contact your doctor for instructions on what to do next. If you're using this medication for pregnancy prevention and miss a dose, 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 pill at the same time every day to maximize effectiveness.
  • Do not smoke, especially if you are over 35 years old, due to increased risk of serious cardiovascular side effects.
  • Marlissa does not protect against sexually transmitted infections (STIs), including HIV/AIDS. Use condoms to prevent STIs.
  • Discuss all medications, including over-the-counter drugs, herbal supplements (especially St. John's Wort), and recreational drugs, with your healthcare provider, as they can affect the effectiveness of birth control pills.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally once daily for 28 consecutive days, starting on the first day of menstruation or the first Sunday after menstruation begins. The first 21 tablets contain active ingredients, followed by 7 inert tablets.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

missedDose: If one active tablet is missed, take it as soon as remembered and continue with the next tablet at the regular time. If two active tablets are missed in a row, take two tablets on the day remembered and two tablets the next day, then continue with one tablet daily. Use back-up contraception for 7 days. Refer to package insert for specific instructions on multiple missed pills or missed placebo pills.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Dosing is the same as for adults once menstruation has begun and contraception is desired.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: Use with caution; monitor for adverse effects. No specific dose adjustment guidelines available.
Dialysis: No specific recommendations; use with caution.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Use with caution; monitor for adverse effects. Consider lower dose or alternative if clinically indicated.
Severe: Contraindicated due to impaired steroid metabolism and potential for cholestasis.

Pharmacology

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Mechanism of Action

Combined oral contraceptives (COCs) primarily act by suppressing gonadotropins (Luteinizing Hormone and Follicle-Stimulating Hormone), which in turn inhibits ovulation. Additional mechanisms include changes to the cervical mucus, making it more viscous and less permeable to sperm, and alterations to the endometrium, making it less receptive to implantation.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol (EE): Approximately 40-45%; Levonorgestrel (LNG): Approximately 100%
Tmax: EE: 1-2 hours; LNG: 1 hour
FoodEffect: Food does not significantly affect the bioavailability of levonorgestrel or ethinyl estradiol.

Distribution:

Vd: EE: Approximately 2.8-8.6 L/kg; LNG: Approximately 1.8 L/kg
ProteinBinding: EE: Approximately 98% (primarily to albumin, also to sex hormone-binding globulin [SHBG]); LNG: Approximately 97-99% (primarily to albumin and SHBG)
CnssPenetration: Limited

Elimination:

HalfLife: EE: Approximately 6-20 hours (terminal); LNG: Approximately 24-45 hours (terminal)
Clearance: EE: Approximately 5-13 mL/min/kg; LNG: Approximately 0.6 mL/min/kg
ExcretionRoute: Renal (approximately 40-60%) and Fecal (approximately 30-50%)
Unchanged: Less than 10% for both components
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy begins after 7 consecutive days of active pill use, assuming proper initiation on the first day of menstruation or first Sunday after menstruation. Full efficacy typically achieved within the first cycle.
PeakEffect: Peak hormonal levels reached within 1-2 hours of administration.
DurationOfAction: Daily administration maintains therapeutic levels for contraceptive effect.

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
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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 immediately or seek emergency medical attention:

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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, changes in stool, dark urine, yellow skin or eyes, or fever with chills.
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision.
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
New or worsening migraines.
Depression or other mood changes.
Breast lump, breast pain or tenderness, or nipple discharge.
Vaginal itching or discharge.
Severe or persistent vaginal bleeding or spotting.
Changes in vision, bulging eyes, or discomfort with contact lenses.
Fluid retention, swelling, weight gain, or difficulty breathing.

This medication may cause fluid retention, leading to swelling or weight gain. If you experience any of these symptoms, inform your doctor.

Blood Clots: Seek Emergency Medical Help

If you notice any signs of a blood clot, such as chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing, seek emergency medical attention immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or persist:

Changes in appetite.
Dizziness or headache.
Weight gain or loss.
Stomach upset or vomiting.
Stomach cramps.
Bloating.
Breast enlargement or tenderness.
Menstrual changes, including spotting or bleeding between periods.
Back pain.
* Dark skin patches on the face (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear).

This list is not exhaustive. If you have questions or concerns about side effects, consult 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
  • Sudden, severe chest pain, shortness of breath, or coughing up blood
  • Sudden, severe headache, especially with visual changes or weakness/numbness
  • Sudden partial or complete loss of vision, or double vision
  • Severe pain, swelling, or redness in one leg
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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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of certain health issues, including:
+ Blood clots or blood clotting problems
+ 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 issues, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
If you have ever experienced jaundice (yellowing of the skin and eyes) during pregnancy or while taking estrogen-containing medications, 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
Pregnancy or potential pregnancy: Do not take this medication if you are pregnant.
* Breastfeeding or plans to breastfeed.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Never 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, consult with your doctor, as this may also increase your risk of blood clots.

If you have diabetes (high blood sugar), inform 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 undergo these tests as recommended by your doctor. It is also essential to have regular breast exams, gynecology check-ups, and 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 with your doctor, as some products contain this ingredient. This medication may also cause high cholesterol and triglyceride levels, so discuss this with your doctor.

It is crucial to note that this medication does not protect against sexually transmitted diseases, such as HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity, and consult with your doctor if you have any questions.

The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be attributed to other factors. Discuss any concerns with your doctor. Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while others have not found this association. If you have questions or concerns, consult 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
  • Withdrawal bleeding (in females)

What to Do:

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

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir (risk of ALT elevation)
  • Glecaprevir/Pibrentasvir (risk of ALT elevation)
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Major Interactions

  • Strong CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Phenobarbital, Topiramate, Oxcarbazepine, Felbamate, Griseofulvin, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
  • Lamotrigine - COCs can decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
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Moderate Interactions

  • Certain antibiotics (e.g., Ampicillin, Tetracycline) - theoretical risk of reduced efficacy due to altered enterohepatic recirculation (clinical significance debated, but backup method often advised).
  • Protease Inhibitors (e.g., Ritonavir, Nelfinavir) and Non-nucleoside Reverse Transcriptase Inhibitors (e.g., Nevirapine, Efavirenz) - may alter COC levels, requiring dose adjustment or alternative contraception.
  • Colesevelam - may decrease absorption of EE; administer COCs at least 4 hours before colesevelam.
  • Thyroid hormones (e.g., Levothyroxine) - COCs can increase thyroid-binding globulin, requiring increased thyroid hormone dose.
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Minor Interactions

  • Grapefruit juice - may slightly increase EE levels (clinical significance generally minor).
  • Acetaminophen - may increase EE levels by inhibiting glucuronidation.

Monitoring

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Baseline Monitoring

Complete medical history (including family history of cardiovascular disease, breast cancer)

Rationale: To identify contraindications, risk factors for adverse events (e.g., VTE, stroke, MI, certain cancers).

Timing: Prior to initiation of therapy.

Physical examination (including blood pressure, breast exam, pelvic exam, Pap test)

Rationale: To establish baseline health status, rule out pregnancy, and screen for cervical abnormalities.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure

Frequency: Annually, or more frequently if clinically indicated.

Target: <140/90 mmHg

Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may necessitate discontinuation or change in contraceptive method.

Annual physical examination (including breast exam, Pap test as per guidelines)

Frequency: Annually

Target: Normal findings

Action Threshold: Abnormal findings require further investigation.

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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, redness, warmth)

Special Patient Groups

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Pregnancy

Contraindicated in pregnancy. There is no indication for use of COCs in pregnancy, and there is no evidence of teratogenicity from inadvertent exposure during early pregnancy.

Trimester-Specific Risks:

First Trimester: No increased risk of birth defects reported with inadvertent exposure.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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Lactation

Use is generally not recommended during lactation, especially in the immediate postpartum period, as estrogens can decrease the quantity and quality of breast milk. Small amounts of contraceptive steroids may be excreted in breast milk.

Infant Risk: Small amounts of steroids may be transferred to the infant, but no adverse effects have been consistently reported. However, potential for effects on infant growth or development cannot be excluded. Non-hormonal or progestin-only methods are generally preferred for breastfeeding mothers.
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Pediatric Use

Not indicated before menarche. Once menstruation has begun, dosing is the same as for adults. Safety and efficacy are expected to be similar to adults.

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Geriatric Use

Not indicated for use in postmenopausal women. Use is generally discontinued at menopause.

Clinical Information

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Clinical Pearls

  • Emphasize strict adherence to the daily dosing schedule for optimal contraceptive efficacy.
  • Advise patients that breakthrough bleeding or spotting is common, especially during the first few cycles, and usually resolves.
  • Counsel patients on the importance of using a backup method of contraception (e.g., condoms) for the first 7 days of the first cycle, or if pills are missed.
  • Remind patients that oral contraceptives do not protect against STIs.
  • Educate patients about the 'ACHES' warning signs of serious adverse events and when to seek immediate medical attention.
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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
  • Sterilization (tubal ligation, vasectomy)
  • Natural family planning methods
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Cost & Coverage

Average Cost: $15 - $50 per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 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 is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.