Enpresse Tablets 28

Manufacturer TEVA Active Ingredient Ethinyl Estradiol and Levonorgestrel Tablets(ETH in il es tra DYE ole & LEE voe nor jes trel) Pronunciation EN-press (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
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Pharmacologic Class
Estrogen and Progestin Combination
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Pregnancy Category
Category X
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FDA Approved
Jul 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Enpresse is a birth control pill that contains two female hormones, ethinyl estradiol (an estrogen) and levonorgestrel (a progestin). 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 pills.
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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 the information provided. It's essential to take this 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 period to prevent pregnancy. Be sure to follow your doctor's guidance on using this additional form of birth control.

You can take this medication with or without food. If it causes stomach upset, taking it with food may help. To establish a routine, take this medication at the same time every day. If you're also taking colesevelam, take it at least 4 hours before or after taking this medication.

If you vomit or have diarrhea, this 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 as soon as possible. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and consult your doctor. If you're unsure what to do, call your doctor for guidance.

Important Considerations for Pregnancy Prevention

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, also take a pregnancy test before starting a new cycle.

Storing and Disposing of Your Medication

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

What to Do If You Miss a Dose

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

  • Do not smoke, especially if you are over 35 years old, as this significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
  • Take the pill at the same time every day to maximize effectiveness and minimize breakthrough bleeding.
  • Use a backup method of birth control (like condoms) if you miss pills, have vomiting or severe diarrhea, or are taking medications that can reduce the effectiveness of birth control pills.
  • Regularly monitor your blood pressure.
  • Maintain a healthy lifestyle, including a balanced diet and regular exercise.
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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. Active tablets are taken for 21 days, followed by 7 inactive tablets.

Condition-Specific Dosing:

Contraception: One tablet orally once daily, starting on the first day of menstruation or the first Sunday after menstruation begins. Active tablets are taken for 21 days, followed by 7 inactive tablets. A new pack is started immediately after the last tablet of the previous pack.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Same as adult dosing for contraception, once menarche has occurred.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific recommendations; use with caution due to potential fluid retention.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Contraindicated in acute or severe hepatic disease.
Severe: Contraindicated in acute or severe hepatic disease.

Pharmacology

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Mechanism of Action

Combination oral contraceptives (COCs) act primarily by suppression of gonadotropins. Although the primary mechanism of action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and changes in the endometrium (which reduce the likelihood of implantation).
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-60%; Levonorgestrel: ~100%
Tmax: Ethinyl Estradiol: 1-2 hours; Levonorgestrel: 1 hour
FoodEffect: Food may slightly decrease Cmax for ethinyl estradiol but does not significantly affect bioavailability. No significant effect on levonorgestrel.

Distribution:

Vd: Ethinyl Estradiol: ~4.3 L/kg; Levonorgestrel: ~1.8 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (primarily to albumin); Levonorgestrel: ~97.5% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: ~18-24 hours; Levonorgestrel: ~24-45 hours
Clearance: Ethinyl Estradiol: ~5-13 mL/min/kg; Levonorgestrel: ~0.8-1.2 mL/min/kg
ExcretionRoute: Ethinyl Estradiol: Renal (40%) and Fecal (60%); 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 pill use. Full protection typically after the first full cycle.
PeakEffect: Not applicable in terms of a single peak effect for contraception, rather sustained hormonal levels.
DurationOfAction: Daily dosing maintains contraceptive effect throughout the cycle.

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including Enpresse, are contraindicated in women who are over 35 years of age and 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 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Changes in appetite
Dizziness or headache
Weight gain or loss
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Period 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:

  • ACHES: Abdominal pain (severe)
  • Chest pain (severe), cough, shortness of breath
  • Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
  • Eye problems (sudden vision loss or blurring)
  • Severe leg pain (calf or thigh), swelling, redness, warmth
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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. 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:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
If you experienced jaundice (yellowing of the skin and eyes) 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
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 conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments. 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 instruct you on when to resume taking it after the surgery or procedure.

This medication may increase the risk of blood clots, stroke, or heart attack. Be sure to discuss this with your doctor. If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, inform your doctor, as this can also increase the 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 lab tests and blood work are crucial while taking this medication, so be sure to follow your doctor's instructions. It is also essential to have regular breast exams and gynecology check-ups, and to perform breast self-exams as directed 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 whether you need to use a non-hormone form of birth control, 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 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 your doctor if you have any questions.

There may be a higher risk of cervical cancer associated with long-term use of hormone-based birth control, although this may be due to other factors. Discuss any concerns with your doctor. Some studies have also suggested a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not found this association. If you have questions or concerns, consult 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
  • Breast tenderness
  • Drowsiness
  • Vaginal bleeding (in females)

What to Do:

There is no specific antidote. Treatment is symptomatic. Contact a poison control center immediately or seek emergency medical attention. Call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/paritaprevir/ritonavir with or without dasabuvir (increased ALT levels)
  • Glecaprevir/pibrentasvir (increased ALT levels)
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Major Interactions

  • Strong CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, Topiramate, Griseofulvin, Oxcarbazepine, Felbamate, Rufinamide, Bosentan) - may decrease contraceptive efficacy and increase breakthrough bleeding.
  • Ritonavir-boosted protease inhibitors (e.g., Atazanavir/Ritonavir, Darunavir/Ritonavir) - may alter estrogen/progestin levels.
  • St. John's Wort (Hypericum perforatum) - may decrease contraceptive efficacy.
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Moderate Interactions

  • Antibiotics (e.g., Ampicillin, Tetracycline) - theoretical risk of reduced efficacy due to altered enterohepatic circulation, though clinical evidence is limited.
  • Lamotrigine - COCs may decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
  • Thyroid hormone replacement therapy - COCs may increase thyroid-binding globulin, requiring increased thyroid hormone dose.
  • Cyclosporine - COCs may increase cyclosporine plasma concentrations.
  • Theophylline - COCs may increase theophylline plasma concentrations.
  • Corticosteroids - COCs may decrease the clearance of corticosteroids, leading to increased plasma concentrations.
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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 (including family history)

Rationale: To identify contraindications, risk factors for cardiovascular disease, and other conditions that may be affected by COC use.

Timing: Prior to initiation of therapy

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

Rationale: To establish baseline health status and screen for conditions that may be contraindications or require monitoring.

Timing: Prior to initiation of therapy

Lipid profile (if indicated by risk factors)

Rationale: To assess cardiovascular risk, as COCs can affect lipid metabolism.

Timing: Prior to initiation of therapy

Liver function tests (if history of liver disease or unexplained jaundice)

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

Timing: Prior to initiation of therapy

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Routine Monitoring

Blood pressure

Frequency: Annually, or more frequently if hypertension develops or worsens.

Target: <140/90 mmHg

Action Threshold: Sustained elevation >140/90 mmHg may warrant 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.

Weight

Frequency: Annually

Target: Stable or healthy BMI

Action Threshold: Significant weight gain may be a concern for some patients.

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Symptom Monitoring

  • Severe abdominal pain (possible liver tumor, blood clot)
  • Chest pain, shortness of breath, coughing up blood (possible pulmonary embolism, myocardial infarction)
  • Severe headache, sudden partial or complete loss of vision, double vision, slurred speech, weakness or numbness in an arm or leg (possible stroke, blood clot)
  • Leg pain, swelling, warmth, redness (possible deep vein thrombosis)
  • Jaundice (yellowing of skin or eyes), dark urine, light-colored stools (possible liver problems)
  • Lump in the breast
  • Severe mood changes, depression

Special Patient Groups

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Pregnancy

Contraindicated in pregnancy. There is no indication for Enpresse in pregnancy, and there is evidence of fetal harm.

Trimester-Specific Risks:

First Trimester: Contraindicated. Potential for virilization of female fetus with progestins, though risk with low-dose COCs is considered low.
Second Trimester: Contraindicated.
Third Trimester: Contraindicated.
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Lactation

Not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk. Small amounts of steroids are excreted in breast milk and may affect the infant.

Infant Risk: Potential for decreased milk supply, potential for adverse effects on the infant (e.g., jaundice, breast enlargement), though generally considered low risk for serious harm.
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Pediatric Use

Enpresse is indicated for contraception in females of reproductive age. Safety and efficacy are established for post-menarchal adolescents. Use in pre-menarchal girls is not indicated.

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Geriatric Use

Enpresse is not indicated for use in postmenopausal women. Estrogen-containing products are generally not recommended for contraception in this age group.

Clinical Information

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Clinical Pearls

  • Advise patients to take the pill at the same time each day to maintain consistent hormone levels and maximize contraceptive efficacy.
  • Emphasize the importance of using a backup method of contraception (e.g., condoms) for the first 7 days of the first pack, or if pills are missed.
  • Counsel patients on the 'ACHES' warning signs of serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain) and to seek immediate medical attention if they experience any.
  • Stress the absolute contraindication for smoking, especially in women over 35, due to significantly increased risk of cardiovascular events.
  • Inform patients that breakthrough bleeding or spotting is common, especially during the first few cycles, and usually resolves with continued use. If persistent or heavy, medical evaluation is warranted.
  • Remind patients that COCs do not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).
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Alternative Therapies

  • Progestin-only pills (mini-pill)
  • Contraceptive patch (Xulane)
  • Contraceptive vaginal ring (NuvaRing, Annovera)
  • Contraceptive injection (Depo-Provera)
  • Contraceptive implant (Nexplanon)
  • Intrauterine devices (IUDs - hormonal or copper)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Sterilization (tubal ligation, vasectomy)
  • Emergency contraception
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Cost & Coverage

Average Cost: $15 - $50 per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered with low or no 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 information. 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 details about the medication taken, the amount, and the time it happened.