Aurovela FE 1.5/30 Tablets 28s
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
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aurovela FE is a birth control pill that contains two female hormones, ethinyl estradiol and norethindrone, which work together to prevent pregnancy. It also contains iron (ferrous fumarate) to help prevent iron deficiency, which can be common with menstrual bleeding. You take one pill every day to prevent pregnancy.
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 to help alleviate discomfort.
If you are also taking colesevelam, be sure to 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, for a period of time to prevent pregnancy. 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. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well. 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.
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.
Missing a Dose
If you miss a dose, refer to the package insert or call your doctor for instructions on what to do. 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 to help alleviate discomfort.
If you are also taking colesevelam, be sure to 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, for a period of time to prevent pregnancy. 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. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well. 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.
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.
Missing a Dose
If you miss a dose, refer to the package insert or call your doctor for instructions on what to do. 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
- 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 reduce the risk of breakthrough bleeding.
- Use a backup method of birth control (like condoms) if you miss pills, start a new pack late, or are taking medications that can reduce the effectiveness of your birth control.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally daily, taken at the same time each day. Follow the 28-day regimen: 21 active tablets (Norethindrone Acetate/Ethinyl Estradiol) followed by 7 inactive tablets (Ferrous Fumarate).
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
missed_dose:
If one active tablet is missed, take it as soon as remembered and the next tablet at the usual time. If two or more active tablets are missed, refer to package insert for specific instructions, as backup contraception may be needed.
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 dose adjustment required for hormonal components. Ferrous fumarate may be used with caution.
Moderate:
No specific dose adjustment required for hormonal components. Ferrous fumarate may be used with caution.
Severe:
No specific dose adjustment required for hormonal components. Ferrous fumarate may be used with caution, but iron overload is a risk in patients with chronic kidney disease.
Dialysis:
No specific dose adjustment required for hormonal components. Ferrous fumarate use should be carefully monitored due to risk of iron accumulation.
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Contraindicated due to impaired steroid metabolism.
Severe:
Contraindicated due to impaired steroid metabolism.
Pharmacology
Mechanism of Action
Ethinyl Estradiol and Norethindrone Acetate act primarily by suppressing gonadotropins, which in turn inhibits ovulation. They also induce changes in the cervical mucus (increasing its viscosity, making sperm penetration difficult) and the endometrium (making it unsuitable for implantation). Ferrous Fumarate provides iron supplementation to prevent or treat iron deficiency anemia, which can be exacerbated by menstrual blood loss.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45%; Norethindrone Acetate: ~60-100% (after first-pass metabolism); Ferrous Fumarate: Variable (typically 10-30% of elemental iron absorbed)
Tmax:
Ethinyl Estradiol: ~1-2 hours; Norethindrone Acetate: ~1-2 hours
FoodEffect:
Food may slightly decrease the rate but not the extent of absorption for hormonal components. Iron absorption can be affected by food components (e.g., phytates, tannins).
Distribution:
Vd:
Ethinyl Estradiol: ~2-4 L/kg; Norethindrone Acetate: ~4 L/kg
ProteinBinding:
Ethinyl Estradiol: ~98% (to albumin and SHBG); Norethindrone Acetate: ~96-98% (to albumin and SHBG)
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: ~18-24 hours; Norethindrone Acetate: ~5-14 hours
Clearance:
Ethinyl Estradiol: ~5-10 mL/min/kg; Norethindrone Acetate: ~0.4 L/hr/kg
ExcretionRoute:
Ethinyl Estradiol: Renal (40%) and Fecal (60%); Norethindrone Acetate: Renal (50-80%) and Fecal (20-50%)
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone Acetate: <1%
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy typically achieved after 7 consecutive days of active tablet use when starting on the first day of menstruation or the first Sunday after menstruation begins.
PeakEffect:
Contraceptive effect maintained with continuous daily use.
DurationOfAction:
Daily dosing required to maintain 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, 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, 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 eyesight.
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, bulging eyes, or changes in how contact lenses feel.
Severe or persistent spotting or vaginal bleeding.
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing.
If you experience any of these symptoms, contact your doctor immediately.
Additional Serious Side Effects:
This medication may also increase your risk of developing a blood clot. Seek medical help right away if you experience:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing
Common Side Effects:
Most people who take this medication will not experience serious side effects, but some may encounter mild or moderate side effects. If you experience any of the following, contact your doctor 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
Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Other Important Information:
This medication may cause dark patches of skin on your face. To minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside.
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, 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 eyesight.
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, bulging eyes, or changes in how contact lenses feel.
Severe or persistent spotting or vaginal bleeding.
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing.
If you experience any of these symptoms, contact your doctor immediately.
Additional Serious Side Effects:
This medication may also increase your risk of developing a blood clot. Seek medical help right away if you experience:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing
Common Side Effects:
Most people who take this medication will not experience serious side effects, but some may encounter mild or moderate side effects. If you experience any of the following, contact your doctor 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
Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Other Important Information:
This medication may cause dark patches of skin on your face. To minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside.
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 or accompanied by vision changes
- Eye problems such as blurred vision, double vision, or loss of vision
- Severe leg pain, swelling, 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 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 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 (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed.
Previous experiences of jaundice during pregnancy or with estrogen use, such as hormonal birth control.
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 the safety of taking this medication with your other treatments and health issues. Never start, stop, or change the dosage of any medication without consulting 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 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 (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed.
Previous experiences of jaundice during pregnancy or with estrogen use, such as hormonal birth control.
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 the safety of taking this medication with your other treatments and health issues. Never start, stop, or change the dosage 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 instruct you on when to resume taking it after your surgery or procedure.
If you will be stationary 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 instructed by your doctor.
It is crucial to have regular breast exams and gynecology check-ups. Additionally, perform breast self-exams as directed 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.
Taking this medication may increase your 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. Consult your doctor about this risk.
Some studies suggest that long-term use of hormone-based birth control may increase the risk of cervical cancer, although this may be due to other factors. If you have questions, discuss this with your doctor.
Additionally, some studies have shown 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 concerns, consult 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 instruct you on when to resume taking it after your surgery or procedure.
If you will be stationary 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 instructed by your doctor.
It is crucial to have regular breast exams and gynecology check-ups. Additionally, perform breast self-exams as directed 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.
Taking this medication may increase your 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. Consult your doctor about this risk.
Some studies suggest that long-term use of hormone-based birth control may increase the risk of cervical cancer, although this may be due to other factors. If you have questions, discuss this with your doctor.
Additionally, some studies have shown 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 concerns, consult 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 (vaginal bleeding)
- In young girls, vaginal bleeding may occur.
What to Do:
There are no specific antidotes. Treatment is symptomatic and supportive. In case of suspected overdose, contact a poison control center immediately (1-800-222-1222 in the US) 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)
- Tranexamic acid (increased risk of thrombosis)
Major Interactions
- Strong CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Barbiturates, Topiramate, Griseofulvin, St. John's Wort) - can decrease contraceptive efficacy and increase breakthrough bleeding.
- Aromatase inhibitors (e.g., Anastrozole, Letrozole) - may reduce efficacy of both.
- Bosentan (decreased contraceptive efficacy).
- Colesevelam (decreased absorption of ethinyl estradiol).
- Lamotrigine (decreased lamotrigine levels, loss of seizure control).
- Thyroid hormones (may increase thyroid hormone binding globulin, requiring increased thyroid hormone dose).
Moderate Interactions
- CYP3A4 inhibitors (e.g., Azole antifungals like Ketoconazole, Itraconazole; Macrolide antibiotics like Erythromycin, Clarithromycin; Protease inhibitors like Ritonavir, Indinavir) - may increase estrogen/progestin levels, potentially increasing side effects.
- Tetracyclines and Penicillins (historical concern for reduced efficacy, but current evidence suggests minimal impact; backup method often recommended for caution).
- Grapefruit juice (may increase estrogen levels).
- Warfarin (may alter anticoagulant effect, monitor INR).
- Corticosteroids (may increase corticosteroid levels).
Minor Interactions
- Acetaminophen (may increase ethinyl estradiol levels).
- Ascorbic acid (may increase ethinyl estradiol levels).
- Iron absorption can be reduced by antacids, calcium supplements, and certain foods (e.g., dairy, tea, coffee).
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To identify pre-existing hypertension and monitor for potential increases due to oral contraceptive use.
Timing: Prior to initiation
Physical Examination (including breast and pelvic exam)
Rationale: To assess overall health, rule out contraindications, and establish baseline for future monitoring.
Timing: Prior to initiation
Medical History (including family history of VTE, breast cancer)
Rationale: To identify risk factors for adverse events.
Timing: Prior to initiation
Hemoglobin/Hematocrit (for iron status)
Rationale: To assess baseline iron status and need for iron supplementation.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP)
Frequency: Annually, or more frequently if concerns arise
Target: <140/90 mmHg
Action Threshold: Sustained elevation >140/90 mmHg may require discontinuation or alternative contraception.
Annual Physical Exam
Frequency: Annually
Target: N/A
Action Threshold: Identification of new risk factors or contraindications.
Hemoglobin/Hematocrit (if indicated)
Frequency: Periodically, if iron deficiency is a concern or symptoms arise
Target: Normal range for age/sex
Action Threshold: Persistent low levels may indicate inadequate iron absorption or other issues.
Symptom Monitoring
- ACHES: Abdominal pain (severe)
- Chest pain (severe), shortness of breath, coughing blood
- Headaches (severe, sudden, or worse than usual, especially with visual changes)
- Eye problems (blurred vision, loss of vision, flashing lights)
- Severe leg pain (calf or thigh), swelling, redness, warmth
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for oral contraceptive use in pregnancy, and there is no evidence of increased risk of birth defects with inadvertent use during early pregnancy.
Trimester-Specific Risks:
First Trimester:
No evidence of increased risk of birth defects.
Second Trimester:
Not indicated.
Third Trimester:
Not indicated.
Lactation
Not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk. Small amounts of hormonal steroids are excreted in breast milk and may affect the infant.
Infant Risk:
Potential for decreased milk supply, and possible adverse effects on the infant (e.g., jaundice, breast enlargement). Consider progestin-only methods if contraception is needed during breastfeeding.
Pediatric Use
Not indicated for use before menarche. For post-menarcheal adolescents, dosing is the same as for adults.
Geriatric Use
Not indicated for post-menopausal women. Oral contraceptives are not used for contraception in this population.
Clinical Information
Clinical Pearls
- Emphasize the importance of taking the pill at the same time every day for maximum efficacy.
- Counsel patients on the 'ACHES' warning signs for serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain).
- Reinforce that combined oral contraceptives do not protect against STIs.
- Advise patients about potential drug interactions, especially with enzyme-inducing medications, and the need for backup contraception.
- The ferrous fumarate tablets are for iron supplementation during the placebo week and do not contribute to contraceptive efficacy.
Alternative Therapies
- Progestin-only pills (POPs)
- Intrauterine devices (IUDs - hormonal or copper)
- Contraceptive implant (e.g., Nexplanon)
- Contraceptive injection (e.g., Depo-Provera)
- Contraceptive patch
- Vaginal ring (e.g., NuvaRing)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
$15 - $50 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic) under most insurance plans, often covered without cost-sharing under ACA.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.