Aurovela FE 1/20 Tablets
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.It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Contraceptive, Oral; Iron Supplement
Pharmacologic Class
Estrogen/Progestin Combination; Mineral Supplement
Pregnancy Category
Category X
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aurovela FE 1/20 is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone), and iron (ferrous fumarate). 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. The iron helps prevent anemia that can occur with menstrual bleeding.
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. Take your medication at the same time every day, with or without food. If you experience stomach upset, take it with food.
If you are also taking colesevelam, take it at least 4 hours before or after taking this medication. After starting this medication, you may need to use a non-hormone form of birth control, such as condoms, to prevent pregnancy for a period of time. Be sure to follow your doctor's guidance on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't have sex frequently. 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 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.
If you miss two periods in a row, 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 call your doctor for instructions. 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 period of time to prevent pregnancy.
To use this medication effectively, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day, with or without food. If you experience stomach upset, take it with food.
If you are also taking colesevelam, take it at least 4 hours before or after taking this medication. After starting this medication, you may need to use a non-hormone form of birth control, such as condoms, to prevent pregnancy for a period of time. Be sure to follow your doctor's guidance on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't have sex frequently. 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 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.
If you miss two periods in a row, 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 call your doctor for instructions. 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 period of time to prevent pregnancy.
Lifestyle & Tips
- Take one tablet at the same time every day, without missing any doses, to ensure maximum 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 (like condoms) if you miss a pill, have vomiting or severe diarrhea, or are taking medications that can reduce the effectiveness of birth control pills.
- Report any unusual or severe symptoms immediately to your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally daily, taken at the same time each day, starting on the first day of menstruation or the first Sunday after menstruation begins. Follow the 21-day active/7-day inactive (ferrous fumarate) regimen.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
contraception:
One active tablet daily for 21 days, followed by one inactive (ferrous fumarate) tablet daily for 7 days. Begin new pack immediately after the 7 inactive days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Same as adult dosing for post-menarcheal adolescents requiring contraception.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Use with caution; monitor for fluid retention and electrolyte imbalance. No specific dose adjustment for hormonal components, but iron accumulation could be a concern in severe renal failure.
Dialysis:
Use with caution; monitor for fluid retention and electrolyte imbalance. Not typically recommended due to potential for fluid overload and cardiovascular risks.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Contraindicated due to impaired steroid metabolism.
Severe:
Contraindicated due to impaired steroid metabolism and increased risk of liver tumors.
Pharmacology
Mechanism of Action
Ethinyl Estradiol and Norethindrone primarily act by suppressing gonadotropins (luteinizing hormone and follicle-stimulating hormone), thereby inhibiting ovulation. They also induce changes in the cervical mucus (making it less permeable to sperm) and the endometrium (making it less receptive to implantation). Ferrous fumarate provides iron supplementation to prevent iron deficiency anemia, which can be associated with menstrual blood loss.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-48%; Norethindrone: ~64-90%
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 1-2 hours
FoodEffect:
Food may slightly decrease Cmax for both components but does not significantly affect bioavailability. Ferrous fumarate absorption is enhanced by vitamin C and inhibited by certain foods (e.g., dairy, tea, coffee).
Distribution:
Vd:
Ethinyl Estradiol: ~4.3 L/kg; Norethindrone: ~4 L/kg
ProteinBinding:
Ethinyl Estradiol: ~98% (primarily to albumin, some to SHBG); Norethindrone: ~61% (primarily to albumin, some to SHBG)
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: ~18-24 hours; Norethindrone: ~8-12 hours
Clearance:
Ethinyl Estradiol: ~5-10 mL/min/kg; Norethindrone: ~0.4 mL/min/kg
ExcretionRoute:
Ethinyl Estradiol: Renal (40%) and Fecal (60%); Norethindrone: Renal (50%) and Fecal (50%)
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <1%
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy typically achieved after 7 consecutive days of active pill use.
PeakEffect:
Not applicable for contraceptive effect; hormonal levels peak within hours of dosing.
DurationOfAction:
Daily dosing maintains contraceptive effect.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events from 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, oral contraceptives, including Aurovela FE 1/20, are contraindicated in women who are over 35 years of age and smoke.
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 high blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
A lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal itching or discharge.
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel.
Severe or persistent vaginal bleeding or spotting.
Swelling or fluid retention in the body, which can cause weight gain or trouble breathing.
If you experience any of these symptoms, contact your doctor immediately.
Additionally, be aware of the following serious condition:
Blood clots: 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. If you experience any of these symptoms, seek medical attention right away.
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 help if they bother you or do not go away:
Changes in appetite.
Weight gain or loss.
Dizziness or headache.
Upset stomach or vomiting.
Stomach cramps.
Bloating.
Enlarged or tender breasts.
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).
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles.
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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 high blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
A lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal itching or discharge.
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel.
Severe or persistent vaginal bleeding or spotting.
Swelling or fluid retention in the body, which can cause weight gain or trouble breathing.
If you experience any of these symptoms, contact your doctor immediately.
Additionally, be aware of the following serious condition:
Blood clots: 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. If you experience any of these symptoms, seek medical attention right away.
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 help if they bother you or do not go away:
Changes in appetite.
Weight gain or loss.
Dizziness or headache.
Upset stomach or vomiting.
Stomach cramps.
Bloating.
Enlarged or tender breasts.
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).
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles.
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 (A)
- Severe chest pain, cough, or shortness of breath (C)
- Severe headaches, dizziness, weakness, or numbness (H)
- Eye problems (vision loss or blurring) (E)
- Severe leg pain (calf or thigh), swelling, or redness (S)
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, such as foods or medications. 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
+ Chest pain caused by angina
+ Heart attack or stroke
+ 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
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation
Recent use of certain medications, including ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
Current use of glecaprevir and pibrentasvir
Pregnancy or suspected pregnancy, as this medication is contraindicated during pregnancy
Breastfeeding or plans to breastfeed
A history of jaundice or yellowing of the skin during pregnancy or while using estrogen-containing products, such as hormonal birth control
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. 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, such as foods or medications. 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
+ Chest pain caused by angina
+ Heart attack or stroke
+ 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
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation
Recent use of certain medications, including ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
Current use of glecaprevir and pibrentasvir
Pregnancy or suspected pregnancy, as this medication is contraindicated during pregnancy
Breastfeeding or plans to breastfeed
A history of jaundice or yellowing of the skin during pregnancy or while using estrogen-containing products, such as hormonal birth control
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and 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. If you need to stop taking this medication, your doctor will provide guidance on when to resume taking it after your surgery or procedure.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor. Prolonged immobility may increase your risk of developing 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.
This medication may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
High cholesterol and triglyceride levels have been associated with this medication. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests as directed by your doctor.
It is crucial to have regular breast exams and gynecology check-ups. Additionally, perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication.
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. You may need to use a non-hormone form of birth control, such as condoms, in addition to this medication.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity. If you have questions, consult your doctor.
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this with your doctor. The risk of blood clots is highest during the first year of using this medication and when restarting hormone-based birth control after a break of 4 weeks or more.
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 questions, consult your doctor.
Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while other studies have not found this association. If you have questions, discuss this with your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not had their first menstrual period.
If you experience any signs of pregnancy or have a positive pregnancy test, contact your doctor immediately.
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. If you need to stop taking this medication, your doctor will provide guidance on when to resume taking it after your surgery or procedure.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor. Prolonged immobility may increase your risk of developing 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.
This medication may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
High cholesterol and triglyceride levels have been associated with this medication. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests as directed by your doctor.
It is crucial to have regular breast exams and gynecology check-ups. Additionally, perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication.
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. You may need to use a non-hormone form of birth control, such as condoms, in addition to this medication.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity. If you have questions, consult your doctor.
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this with your doctor. The risk of blood clots is highest during the first year of using this medication and when restarting hormone-based birth control after a break of 4 weeks or more.
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 questions, consult your doctor.
Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while other studies have not found this association. If you have questions, discuss this with your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not had their first menstrual period.
If you experience any signs of pregnancy or have a positive pregnancy test, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Withdrawal bleeding (in females)
What to Do:
There are no specific antidotes. Treatment is symptomatic and supportive. In case of suspected overdose, contact a poison control center (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 (increased ALT levels)
- Drugs that induce CYP3A4 (e.g., rifampin, barbiturates, carbamazepine, oxcarbazepine, phenytoin, topiramate, felbamate, griseofulvin, St. John's Wort) due to potential for reduced contraceptive efficacy and increased breakthrough bleeding.
Major Interactions
- Aromatase inhibitors (e.g., anastrozole, exemestane, letrozole) - concurrent use may reduce efficacy of both.
- Tyrosine kinase inhibitors (e.g., bosutinib, dabrafenib) - may alter hormonal levels.
- HIV protease inhibitors (e.g., nelfinavir, ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine, efavirenz) - may alter hormonal levels, requiring alternative contraception.
- Lamotrigine - oral contraceptives can decrease lamotrigine levels, potentially leading to loss of seizure control.
Moderate Interactions
- Antibiotics (e.g., ampicillin, tetracycline) - theoretical risk of reduced efficacy due to altered gut flora, though clinical significance is debated. Backup contraception often recommended.
- Grapefruit juice - may increase ethinyl estradiol levels, potentially increasing side effects.
- Thyroid hormone replacement therapy - oral contraceptives can increase thyroid-binding globulin, requiring increased thyroid hormone dose.
- Cyclosporine, prednisolone, theophylline - oral contraceptives may increase levels of these drugs due to inhibition of their metabolism.
Minor Interactions
- Acetaminophen - may increase ethinyl estradiol levels.
- Vitamin C - may increase ethinyl estradiol levels.
Monitoring
Baseline Monitoring
Complete medical history (including family history of cardiovascular disease, breast cancer)
Rationale: To identify contraindications and risk factors for adverse events.
Timing: Prior to initiation of therapy.
Physical examination (including blood pressure, breast exam, pelvic exam, Pap test)
Rationale: To assess overall health status and rule out underlying conditions.
Timing: Prior to initiation of therapy.
Lipid profile
Rationale: To assess cardiovascular risk, as OCs can affect lipid levels.
Timing: Prior to initiation, especially in patients with risk factors.
Routine Monitoring
Blood pressure
Frequency: Annually, or more frequently if elevated.
Target: <120/80 mmHg
Action Threshold: Sustained elevation >140/90 mmHg may warrant discontinuation or change in contraception.
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, healthy BMI
Action Threshold: Significant weight gain may increase cardiovascular risk.
Symptom Monitoring
- ACHES: Abdominal pain (severe)
- Chest pain (severe, sudden, or shortness of breath)
- Headaches (severe, sudden, or worse than usual, especially with visual changes)
- Eye problems (sudden partial or complete vision loss, double vision)
- Severe leg pain (calf or thigh, with or without swelling, warmth, or redness)
Special Patient Groups
Pregnancy
Contraindicated. Oral contraceptives should not be used during pregnancy. If pregnancy occurs during use, discontinue immediately.
Trimester-Specific Risks:
First Trimester:
No evidence of increased risk of birth defects from inadvertent exposure during early pregnancy.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Not recommended. Estrogen-containing oral contraceptives can decrease the quantity and quality of breast milk and may be excreted in breast milk. Non-hormonal or progestin-only methods are generally preferred during lactation.
Infant Risk:
Small amounts of steroids and/or metabolites may be transferred to the infant, but no serious adverse effects have been reported. However, potential long-term effects on the infant are unknown.
Pediatric Use
Safety and efficacy have been established for post-menarcheal adolescents. Use in pre-menarcheal children is not indicated.
Geriatric Use
Not indicated for postmenopausal women for contraception. Risk of cardiovascular events increases with age, especially in smokers.
Clinical Information
Clinical Pearls
- Strict adherence to the daily dosing schedule is crucial for contraceptive efficacy. Missing pills, especially early in the cycle, significantly increases the risk of pregnancy.
- Counsel patients on the 'missed pill' rules as per the package insert, which vary depending on the number of pills missed and the week of the cycle.
- Emphasize the importance of using a backup method of contraception (e.g., condoms) during the first 7 days of the first pack, or if pills are missed or drug interactions are suspected.
- Be aware of medications that can reduce the effectiveness of oral contraceptives, such as certain antibiotics, anticonvulsants, and herbal supplements (e.g., St. John's Wort).
- Educate patients about the signs and symptoms of serious adverse events (ACHES) and when to seek immediate medical attention.
Alternative Therapies
- Progestin-only pills (mini-pill)
- Contraceptive patch (e.g., Xulane)
- Vaginal ring (e.g., NuvaRing, Annovera)
- Contraceptive injection (e.g., Depo-Provera)
- Contraceptive implant (e.g., Nexplanon)
- Intrauterine devices (IUDs) (hormonal and non-hormonal)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Sterilization (tubal ligation, vasectomy)
- Emergency contraception (e.g., Plan B, Ella)
Cost & Coverage
Average Cost:
$15 - $50 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often covered under ACA as preventive care)
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 this 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.