Enpresse Tablets 28
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Ombitasvir/paritaprevir/ritonavir with or without dasabuvir (increased ALT levels)
- Glecaprevir/pibrentasvir (increased ALT levels)
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.
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.
Minor Interactions
- Acetaminophen - may increase ethinyl estradiol levels.
- Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
Monitoring
Baseline Monitoring
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
Rationale: To establish baseline health status and screen for conditions that may be contraindications or require monitoring.
Timing: Prior to initiation of therapy
Rationale: To assess cardiovascular risk, as COCs can affect lipid metabolism.
Timing: Prior to initiation of therapy
Rationale: To assess hepatic function, as COCs are contraindicated in severe liver disease.
Timing: Prior to initiation of therapy
Routine Monitoring
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.
Frequency: Annually
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Frequency: Annually
Target: Stable or healthy BMI
Action Threshold: Significant weight gain may be a concern for some patients.
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
Pregnancy
Contraindicated in pregnancy. There is no indication for Enpresse in pregnancy, and there is evidence of fetal harm.
Trimester-Specific Risks:
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.
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.
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
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).
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