Simpesse Tablets 91s
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.
Drug Class
Contraceptive
Pharmacologic Class
Estrogen/Progestin Combination
Pregnancy Category
Category X
FDA Approved
May 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Simpesse is an extended-cycle 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 an ovary) and by changing the cervical mucus and uterine lining to prevent pregnancy. Unlike traditional birth control pills, Simpesse is taken for 91 days, resulting in only 4 periods per year.
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-hormone form of birth control, such as condoms, to prevent pregnancy for a certain period. 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, taking it with food may help. To establish a routine, take your 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, the effectiveness of this medication in preventing pregnancy may be reduced. If you experience vomiting or diarrhea 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 what to do, don't hesitate to call your doctor.
Important Considerations for Women
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 women with a menstrual cycle longer than 91 days, if you miss one period, take a pregnancy test before starting 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.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert or consult your doctor for guidance. If you're using this medication for birth control, you may need to use a non-hormone form of birth control, such as condoms, for a certain period to prevent pregnancy.
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-hormone form of birth control, such as condoms, to prevent pregnancy for a certain period. 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, taking it with food may help. To establish a routine, take your 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, the effectiveness of this medication in preventing pregnancy may be reduced. If you experience vomiting or diarrhea 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 what to do, don't hesitate to call your doctor.
Important Considerations for Women
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 women with a menstrual cycle longer than 91 days, if you miss one period, take a pregnancy test before starting 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.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert or consult your doctor for guidance. If you're using this medication for birth control, you may need to use a non-hormone form of birth control, such as condoms, for a certain period to prevent pregnancy.
Lifestyle & Tips
- Do not smoke, especially if you are over 35 years old, as this significantly increases the risk of serious cardiovascular side effects.
- Maintain a healthy diet and exercise routine to support cardiovascular health.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as they can interact with Simpesse.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet daily for 91 consecutive days. The first 84 tablets contain 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol. The last 7 tablets contain 0.01 mg ethinyl estradiol.
Condition-Specific Dosing:
missedDose:
Refer to package insert for specific instructions based on number of missed pills and week of cycle. Generally, take as soon as remembered, and continue daily. May require backup contraception.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Post-menarche, same as adult dosing.
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
Moderate:
Use with caution
Severe:
Contraindicated
Pharmacology
Mechanism of Action
Combination oral contraceptives (COCs) primarily act by suppressing gonadotropins, which in turn inhibits ovulation. Other mechanisms include changes in the cervical mucus (increasing viscosity to impede sperm penetration) and alterations in the endometrium (rendering it unfavorable for implantation).
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45%; Levonorgestrel: ~90-100%
Tmax:
Ethinyl Estradiol: ~1-2 hours; Levonorgestrel: ~1-2 hours
FoodEffect:
Minimal effect on absorption
Distribution:
Vd:
Ethinyl Estradiol: ~5-15 L/kg; Levonorgestrel: ~1.8 L/kg
ProteinBinding:
Ethinyl Estradiol: High (to albumin and SHBG); Levonorgestrel: High (to albumin and SHBG)
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: ~10-20 hours (terminal); Levonorgestrel: ~24-45 hours
Clearance:
Ethinyl Estradiol: ~5-13 mL/min/kg; Levonorgestrel: ~0.8-1.2 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%
Pharmacodynamics
OnsetOfAction:
Effective from the first cycle if started on the first day of menstruation or Sunday after menstruation begins (with backup for 7 days).
PeakEffect:
Consistent suppression of ovulation achieved with daily dosing.
DurationOfAction:
Daily dosing required for continuous contraceptive effect.
Safety & Warnings
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 Simpesse, are contraindicated in women who are over 35 years of age and smoke.
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 immediate 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 or dizziness, fainting, or changes in vision.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Weakness on one side of the body, difficulty speaking or thinking, balance changes, 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 changes in contact lens comfort.
Fluid retention, swelling, weight gain, or difficulty breathing.
If you experience any of these symptoms, contact your doctor immediately.
Additional Side Effects:
Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention 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).
Reporting 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.
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 immediate 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 or dizziness, fainting, or changes in vision.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Weakness on one side of the body, difficulty speaking or thinking, balance changes, 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 changes in contact lens comfort.
Fluid retention, swelling, weight gain, or difficulty breathing.
If you experience any of these symptoms, contact your doctor immediately.
Additional Side Effects:
Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention 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).
Reporting 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:
- Severe abdominal pain
- Severe chest pain, shortness of breath, or coughing up blood
- Severe headaches, especially if sudden, unusual, or accompanied by visual changes
- Eye problems such as blurred vision, double vision, or partial/complete loss of vision
- Severe leg pain, swelling, redness, or warmth in the calf or thigh
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 use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to 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 or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain) or a history of heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical or vaginal cancer, or 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 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.
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to 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 or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain) or a history of heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical or vaginal cancer, or 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 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.
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. It is crucial to 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 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 levels as directed by your doctor. Additionally, this medication may cause high blood pressure, so it is essential to have your blood pressure checked regularly, as advised by your doctor.
Regular blood work and other laboratory tests are also necessary, as directed by your doctor. Furthermore, it is vital to have regular breast exams and gynecology check-ups, and to perform breast self-exams as instructed by your doctor.
This medication may interfere with certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this drug. Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues, and discuss the potential need for additional non-hormonal 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 high cholesterol and triglyceride levels, so discuss this with your doctor.
It is essential 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.
The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. If you have concerns, discuss them 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 your doctor.
This medication is not intended for use in children who have not yet had their first menstrual period.
This medication may increase the risk of blood clots, stroke, or heart attack. It is crucial to 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 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 levels as directed by your doctor. Additionally, this medication may cause high blood pressure, so it is essential to have your blood pressure checked regularly, as advised by your doctor.
Regular blood work and other laboratory tests are also necessary, as directed by your doctor. Furthermore, it is vital to have regular breast exams and gynecology check-ups, and to perform breast self-exams as instructed by your doctor.
This medication may interfere with certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this drug. Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues, and discuss the potential need for additional non-hormonal 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 high cholesterol and triglyceride levels, so discuss this with your doctor.
It is essential 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.
The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. If you have concerns, discuss them 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 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
- Withdrawal bleeding (vaginal bleeding)
What to Do:
There is no specific antidote. Treatment is symptomatic. In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (risk of ALT elevations)
- Drugs that are strong inducers of CYP3A4 (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort) due to reduced contraceptive efficacy
Major Interactions
- Aromatase inhibitors (e.g., anastrozole, exemestane, letrozole) - reduced efficacy of both agents
- Ospemifene - increased risk of adverse events
- Tranexamic acid - increased risk of thrombosis
- Certain antibiotics (e.g., rifampin) - reduced contraceptive efficacy (see contraindicated)
- Griseofulvin - reduced contraceptive efficacy
Moderate Interactions
- Lamotrigine - decreased lamotrigine plasma concentrations, loss of seizure control
- Thyroid hormone replacement (e.g., levothyroxine) - increased thyroid binding globulin, requiring higher thyroid hormone dose
- Cyclosporine - increased cyclosporine plasma concentrations
- Theophylline - increased theophylline plasma concentrations
- Voriconazole, Fluconazole, Itraconazole (CYP3A4 inhibitors) - may increase plasma concentrations of ethinyl estradiol and levonorgestrel
- Grapefruit juice - may increase plasma concentrations of ethinyl estradiol
Minor Interactions
- Acetaminophen - increased plasma concentrations of ethinyl estradiol
- Ascorbic acid (Vitamin C) - increased plasma concentrations of ethinyl estradiol
Monitoring
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 contraindicate COC use.
Timing: Prior to initiation of therapy
Routine Monitoring
Blood Pressure
Frequency: Annually, or more frequently if clinically indicated
Target: <140/90 mmHg
Action Threshold: Sustained elevation >140/90 mmHg may warrant discontinuation or change in contraception.
Annual physical examination (including breast exam, pelvic exam, Pap test as per guidelines)
Frequency: Annually
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Symptom Monitoring
- ACHES: Abdominal pain (severe)
- Chest pain (severe, shortness of breath, coughing blood)
- Headaches (severe, sudden, or worse than usual, with visual changes)
- Eye problems (blurred vision, loss of vision)
- Severe leg pain (calf or thigh), swelling, redness, warmth
Special Patient Groups
Pregnancy
Simpesse is contraindicated during pregnancy. If pregnancy occurs during use, the medication should be discontinued immediately. There is no evidence of teratogenicity from inadvertent exposure to COCs during early pregnancy.
Trimester-Specific Risks:
First Trimester:
No increased risk of birth defects has been found with inadvertent exposure during early pregnancy.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Use is generally not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk. Small amounts of contraceptive steroids are excreted in breast milk and may affect the infant. Non-hormonal methods are preferred while breastfeeding.
Infant Risk:
Potential for decreased milk supply, and possible transfer of hormones to the infant, though adverse effects on the infant are generally not well-established but cannot be ruled out.
Pediatric Use
Simpesse is indicated for use in females of reproductive age. Safety and efficacy have been established in post-menarcheal adolescents. Use is not indicated before menarche.
Geriatric Use
Simpesse is not indicated for use in postmenopausal women. No data are available for geriatric use.
Clinical Information
Clinical Pearls
- Simpesse is an extended-cycle oral contraceptive, providing 4 periods per year, which can be beneficial for women who experience dysmenorrhea or desire fewer menstrual cycles.
- Consistent daily use is crucial for contraceptive efficacy. Missing pills, especially active pills, can increase the risk of pregnancy.
- Breakthrough bleeding or spotting is common, especially during the first few cycles of extended-cycle regimens, but usually decreases over time.
- Patients should be advised about the increased risk of venous thromboembolism (VTE), myocardial infarction, and stroke, particularly if they smoke or have other cardiovascular risk factors.
- Backup contraception (e.g., condoms) should be used for the first 7 days of the first cycle, or if pills are missed, or if interacting medications are used.
- This formulation contains a lower dose of ethinyl estradiol (0.01 mg) during the 7-day placebo period, which may help reduce the incidence of estrogen withdrawal symptoms like headaches.
Alternative Therapies
- Progestin-only pills (POPs)
- Contraceptive patch (e.g., Xulane)
- Vaginal ring (e.g., NuvaRing, Annovera)
- Contraceptive implant (e.g., Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Contraceptive injection (e.g., Depo-Provera)
- Barrier methods (e.g., condoms, diaphragm)
- Surgical sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
Highly variable, typically $30-$100+ per 91-day supply
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. It's also important to note that some medications may come with a separate 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.