Hailey 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
Jul 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hailey FE 1.5/30 is a birth control pill that contains two female hormones, estrogen and progestin, to prevent pregnancy. It works by stopping your body from releasing an egg (ovulation) and by changing the lining of your womb and the mucus in your cervix. The last 7 pills in the pack contain iron to help prevent anemia.
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
- Take one pill at the same time every day to ensure maximum effectiveness.
- Do not smoke, especially if you are over 35, as this significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms for STI protection.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking, especially St. John's Wort, as they can reduce the effectiveness of birth control.
- If you experience severe vomiting or diarrhea, the effectiveness of the pill may be reduced; use a backup method of contraception.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally daily for 28 consecutive days, starting on the first day of menstruation or the first Sunday after menstruation begins. The first 21 tablets contain active hormones, and the last 7 tablets contain ferrous fumarate (iron) as a placebo.
Condition-Specific Dosing:
missedDose:
If one active tablet is missed, take it as soon as remembered. If two active tablets are missed in week 1 or 2, take two tablets the day remembered and two tablets the next day, and use back-up contraception for 7 days. If two active tablets are missed in week 3 or three or more active tablets are missed in any week, discard the pack and start a new pack immediately (Day 1 start) or start a new pack on Sunday (Sunday start) and use back-up contraception for 7 days. Refer to package insert for detailed instructions.
postpartum:
Initiate no earlier than 4 weeks postpartum in non-breastfeeding women due to increased risk of thromboembolism.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Dosing is the same as for adults once menstruation has begun and contraception is desired.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Use with caution; monitor for fluid retention and electrolyte imbalances, though not primarily renally cleared.
Dialysis:
Considerations: Not specifically studied, but generally not recommended due to potential fluid retention and cardiovascular risks.
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Use with caution; monitor liver function.
Severe:
Contraindicated due to impaired steroid metabolism and potential for exacerbation of liver disease.
Pharmacology
Mechanism of Action
Hailey FE 1.5/30 contains a combination of ethinyl estradiol (an estrogen) and norethindrone (a progestin). These hormones primarily act by suppressing gonadotropins (FSH and LH), thereby inhibiting ovulation. They also cause changes in the cervical mucus, making it less permeable to sperm, and alter the endometrium, making it less receptive to implantation. The ferrous fumarate tablets are inert placebos for the last 7 days of the cycle, providing iron supplementation to prevent or treat iron deficiency anemia often associated with menstrual blood loss.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-90%
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 0.5-4 hours
FoodEffect:
Food may slightly decrease Cmax for norethindrone but does not significantly affect overall bioavailability or efficacy.
Distribution:
Vd:
Ethinyl Estradiol: ~4-13 L/kg; Norethindrone: ~2-4 L/kg
ProteinBinding:
Ethinyl Estradiol: >95% (to albumin and sex hormone-binding globulin [SHBG]); Norethindrone: ~80% (to albumin and SHBG)
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: ~6-20 hours (terminal); Norethindrone: ~5-14 hours (terminal)
Clearance:
Ethinyl Estradiol: ~5-13 mL/min/kg; Norethindrone: ~0.4-0.8 L/hr/kg
ExcretionRoute:
Ethinyl Estradiol: Renal (40%) and Fecal (60%); Norethindrone: Renal (50-80%) and Fecal (20-50%)
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <1%
Pharmacodynamics
OnsetOfAction:
Contraceptive effect typically begins after 7 consecutive days of active pill use. Full protection is usually achieved after the first full cycle.
PeakEffect:
Not directly applicable for contraceptive effect; hormonal levels peak within hours of dosing.
DurationOfAction:
Daily dosing maintains continuous hormonal suppression.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to 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 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 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
Eyesight changes 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
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. 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 or any other unusual symptoms, contact your doctor or seek medical help:
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
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 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 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
Eyesight changes 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
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. 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 or any other unusual symptoms, contact your doctor or seek medical help:
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
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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:
- A: Abdominal pain (severe)
- C: Chest pain (severe), cough, shortness of breath
- H: Headaches (severe, sudden, or worse than usual)
- E: Eye problems (blurred vision, flashing lights, partial or complete loss of vision)
- S: Severe leg pain (calf or thigh), swelling, redness, or warmth
- Yellowing of skin or eyes (jaundice)
- Dark urine or light-colored stools
- Unexplained swelling of hands, ankles, or feet
- Depressed mood or changes in mood
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, and describe the symptoms you experienced.
A history of certain health problems, 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, or abnormal heart rhythms like 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 other specific health problems, including:
+ Endometrial cancer, cervical cancer, vaginal cancer, or unexplained vaginal bleeding
+ Hereditary angioedema
+ Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation
Recent use of certain medications, such as:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy, as this medication should not be taken during pregnancy
Breastfeeding or plans to breastfeed
* A history of jaundice during pregnancy or with estrogen use, such as hormonal birth control
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. Do not start, stop, or change the dose of any medication without consulting your doctor to ensure safe use of this medication.
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, and describe the symptoms you experienced.
A history of certain health problems, 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, or abnormal heart rhythms like 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 other specific health problems, including:
+ Endometrial cancer, cervical cancer, vaginal cancer, or unexplained vaginal bleeding
+ Hereditary angioedema
+ Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation
Recent use of certain medications, such as:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy, as this medication should not be taken during pregnancy
Breastfeeding or plans to breastfeed
* A history of jaundice during pregnancy or with estrogen use, such as hormonal birth control
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. Do not start, stop, or change the dose of any medication without consulting your doctor to ensure safe use of this medication.
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, and will instruct you on when to resume taking it after the 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, as it 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 frequently consume grapefruit juice or eat grapefruit, 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, and discuss the potential need for non-hormone birth control methods, such as condoms.
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.
Using 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 to discuss 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.
Research on the link between hormone-based birth control and breast cancer has yielded conflicting results. Some studies have shown an increased risk, while others have not. If you have concerns, 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 suspect you are pregnant 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, and will instruct you on when to resume taking it after the 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, as it 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 frequently consume grapefruit juice or eat grapefruit, 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, and discuss the potential need for non-hormone birth control methods, such as condoms.
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.
Using 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 to discuss 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.
Research on the link between hormone-based birth control and breast cancer has yielded conflicting results. Some studies have shown an increased risk, while others have not. If you have concerns, 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 suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Withdrawal bleeding (in females)
What to Do:
Overdose is generally not life-threatening. Treatment is symptomatic and supportive. Call a poison control center (1-800-222-1222) for advice.
Drug Interactions
Contraindicated Interactions
- Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (increased ALT levels)
Major Interactions
- CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Phenobarbital, Topiramate, Griseofulvin, St. John's Wort) - may decrease contraceptive efficacy.
- Lamotrigine - oral contraceptives can significantly decrease lamotrigine plasma concentrations, leading to loss of seizure control.
- Warfarin - may alter anticoagulant response (monitor INR).
Moderate Interactions
- CYP3A4 inhibitors (e.g., Azole antifungals like Ketoconazole, Itraconazole; Macrolide antibiotics like Erythromycin, Clarithromycin; Grapefruit juice) - may increase estrogen/progestin levels, potentially increasing side effects.
- Certain antibiotics (e.g., Ampicillin, Tetracycline) - historically thought to reduce efficacy, but clinical evidence is largely lacking for most antibiotics except rifampin. Still, some clinicians advise backup contraception.
- Thyroid hormones (e.g., Levothyroxine) - OCs can increase thyroid-binding globulin, requiring increased thyroid hormone dose.
- Cyclosporine - OCs can increase cyclosporine levels, increasing toxicity risk.
Minor Interactions
- Acetaminophen - may increase ethinyl estradiol levels.
- Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
Monitoring
Baseline Monitoring
Complete Medical History and Physical Exam
Rationale: To identify contraindications, risk factors (e.g., cardiovascular disease, breast cancer, liver disease), and establish baseline health status.
Timing: Prior to initiation of therapy.
Blood Pressure
Rationale: Oral contraceptives can cause an increase in blood pressure. Baseline measurement is crucial.
Timing: Prior to initiation of therapy.
Breast and Pelvic Exam, Pap Smear
Rationale: Standard gynecological care; to screen for cervical cancer and breast abnormalities.
Timing: Prior to initiation or as per routine screening guidelines.
Routine Monitoring
Blood Pressure
Frequency: Annually, or more frequently if elevated.
Target: <140/90 mmHg (or individualized)
Action Threshold: Persistent elevation (e.g., >140/90 mmHg) may require discontinuation or change in contraception.
Annual Physical Exam
Frequency: Annually.
Target: N/A
Action Threshold: N/A
Screening for STIs/Cervical Cancer
Frequency: As per national guidelines (e.g., Pap smear every 3-5 years, STI screening as indicated).
Target: N/A
Action Threshold: N/A
Symptom Monitoring
- Severe abdominal pain (A)
- Severe chest pain, shortness of breath, or coughing up blood (C)
- Severe headaches (H)
- Eye problems (blurred vision, loss of vision, flashing lights) (E)
- Severe leg pain (calf or thigh), swelling, redness, or warmth (S)
- Jaundice (yellowing of skin or eyes)
- Mood changes, depression
- Unusual vaginal bleeding (heavy, prolonged, or breakthrough bleeding after initial adjustment period)
- New or worsening migraines
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for oral contraceptives in pregnancy, and there is evidence of fetal harm (Category X).
Trimester-Specific Risks:
First Trimester:
Exposure during early pregnancy has not been shown to increase the risk of birth defects, but continued use is not recommended.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Not recommended for use during lactation. Estrogens can decrease the quantity and quality of breast milk and may be excreted in breast milk, potentially affecting the infant. Progestins also pass into breast milk.
Infant Risk:
L3 (Moderate risk). Potential for decreased milk supply, and infant exposure to hormones. Non-hormonal or progestin-only methods are generally preferred during breastfeeding, especially in the first 6 weeks postpartum.
Pediatric Use
Not indicated for use before menarche. Once menstruation has begun, dosing for adolescents is the same as for adults.
Geriatric Use
Not indicated for postmenopausal women. Oral contraceptives are generally not used for contraception in women over 50 years of age.
Clinical Information
Clinical Pearls
- Adherence is key: Emphasize taking the pill at the same time every day to maintain consistent hormone levels and maximize contraceptive efficacy.
- Missed pills: Provide clear, concise instructions for missed pills, stressing the importance of backup contraception if multiple pills are missed.
- Breakthrough bleeding: Common, especially in the first few cycles. Reassure patients that it usually resolves and does not indicate reduced efficacy if pills are taken correctly.
- Drug interactions: Always inquire about all concomitant medications, including OTCs and herbal supplements, especially St. John's Wort and certain anticonvulsants/antibiotics.
- Smoking cessation: Strongly advise patients who smoke to quit, particularly those over 35, due to the significantly increased risk of cardiovascular events.
- Iron supplementation: The ferrous fumarate pills are for iron supplementation during the placebo week; they do not contribute to contraception.
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 or copper)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Sterilization (tubal ligation, vasectomy)
- Natural family planning methods
Cost & Coverage
Average Cost:
$15 - $50 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often preferred generic)
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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 information about the medication taken, the amount, and the time it happened.