Hailey 24 FE 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, Hormonal; Iron Supplement
Pharmacologic Class
Estrogen/Progestin Combination; Mineral Supplement
Pregnancy Category
Category X
FDA Approved
Feb 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hailey 24 FE is a birth control pill that contains two female hormones, ethinyl estradiol and norethindrone, which work together to prevent pregnancy. It also includes iron tablets for the last few days of your cycle to help prevent iron deficiency. You take one pill every day at the same time.
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, to prevent pregnancy for a certain period. 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. 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 certain period 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, to prevent pregnancy for a certain period. 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. 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 certain period to prevent pregnancy.
Lifestyle & Tips
- Do not smoke, especially if you are over 35, as this significantly increases your risk of serious side effects like blood clots and heart attack.
- Maintain a healthy diet and exercise routine.
- Report any unusual or severe symptoms to your doctor immediately.
- Use a backup method of contraception (e.g., condoms) for the first 7 days of your first pack, or if you miss pills.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally daily, starting with the first active tablet on the first day of menstruation or the first Sunday after menstruation begins. Active tablets are taken for 24 consecutive days, followed by 4 days of ferrous fumarate tablets.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
missedDose:
Refer to package insert for specific instructions based on number of missed doses and week of cycle.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Same as adult dosing for post-menarcheal females requiring contraception.
Prepubertal:
Not indicated
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for hormonal components. Ferrous fumarate generally safe.
Moderate:
No specific adjustment needed for hormonal components. Ferrous fumarate generally safe.
Severe:
Use with caution; monitor for fluid retention. Ferrous fumarate may accumulate in severe renal failure; consult nephrologist.
Dialysis:
Use with caution; monitor for fluid retention. Ferrous fumarate may accumulate; consult nephrologist.
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, thereby inhibiting ovulation. Other effects include changes in the cervical mucus (increasing its viscosity to impede sperm penetration) and the endometrium (rendering it unfavorable for implantation). Ferrous Fumarate provides iron supplementation to prevent or treat iron deficiency anemia, particularly during the placebo phase.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-80%
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 1-2 hours
FoodEffect:
Minimal effect on hormonal components; iron absorption is enhanced by vitamin C and inhibited by certain foods (e.g., dairy, tea, coffee).
Distribution:
Vd:
Ethinyl Estradiol: ~4 L/kg; Norethindrone: ~4 L/kg
ProteinBinding:
Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin); Norethindrone: ~96-98% (to albumin and sex hormone-binding globulin)
CnssPenetration:
Yes (hormones)
Elimination:
HalfLife:
Ethinyl Estradiol: ~18-24 hours; Norethindrone: ~8-12 hours
Clearance:
Ethinyl Estradiol: ~5 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 effect typically within 7 days of consistent use. Full protection after 7 consecutive active pills.
PeakEffect:
Daily dosing maintains steady-state hormone levels.
DurationOfAction:
Daily dosing required for continuous 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 Hailey 24 FE, are contraindicated in women who are over 35 years of age and smoke.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting or yellow skin and eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder, 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
Breast changes, such as:
+ A lump in the breast
+ Breast pain or soreness
+ 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
Fluid retention, which may cause swelling, weight gain, or difficulty breathing
If you experience any of these symptoms, contact your doctor immediately.
Blood Clots: Seek Medical Help Right Away
This medication may increase the risk of blood clots. If you notice any of the following symptoms, seek medical attention immediately:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Difficulty speaking or swallowing
Other Possible Side Effects
Most people do not experience serious side effects, and many have only minor side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention 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 (avoid sun exposure and use sunscreen)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Reporting Side Effects
If you have questions about side effects or experience any symptoms that concern you, contact your doctor for medical advice. 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 right away:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting or yellow skin and eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder, 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
Breast changes, such as:
+ A lump in the breast
+ Breast pain or soreness
+ 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
Fluid retention, which may cause swelling, weight gain, or difficulty breathing
If you experience any of these symptoms, contact your doctor immediately.
Blood Clots: Seek Medical Help Right Away
This medication may increase the risk of blood clots. If you notice any of the following symptoms, seek medical attention immediately:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Difficulty speaking or swallowing
Other Possible Side Effects
Most people do not experience serious side effects, and many have only minor side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention 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 (avoid sun exposure and use sunscreen)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Reporting Side Effects
If you have questions about side effects or experience any symptoms that concern you, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- ACHES: Abdominal pain (severe)
- Chest pain (severe), shortness of breath, coughing blood
- Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
- Eye problems (sudden vision loss or blurring)
- Severe leg pain (calf or thigh), swelling, redness, warmth
Before Using This Medicine
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. Describe the allergic reaction and its symptoms.
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
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain caused by angina
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical cancer, 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 experience with jaundice (yellowing of the skin and eyes) 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 (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine whether 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. Describe the allergic reaction and its symptoms.
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
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain caused by angina
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical cancer, 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 experience with jaundice (yellowing of the skin and eyes) 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 (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine whether 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. Consult your doctor to discuss this risk.
Some studies suggest that 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, discuss this with your doctor.
Long-term use of hormone-based birth control may be associated with an increased risk of breast cancer, although not all studies confirm this finding. If you have questions, 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 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. Consult your doctor to discuss this risk.
Some studies suggest that 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, discuss this with your doctor.
Long-term use of hormone-based birth control may be associated with an increased risk of breast cancer, although not all studies confirm this finding. If you have questions, 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
- Breast tenderness
- Dizziness
- Abdominal pain
- Drowsiness/fatigue
- Withdrawal bleeding (in females)
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive. There is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (risk of ALT elevations)
- Certain enzyme inducers (e.g., rifampin) where alternative contraception is recommended.
Major Interactions
- CYP3A4 inducers (e.g., carbamazepine, phenytoin, phenobarbital, primidone, topiramate, rifampin, St. John's Wort): May decrease contraceptive efficacy and increase breakthrough bleeding.
- Lamotrigine: Decreased lamotrigine plasma concentrations, potentially leading to loss of seizure control.
- Thyroid hormones (e.g., levothyroxine): Oral contraceptives can increase thyroid-binding globulin, requiring increased thyroid hormone dose.
- Tetracyclines, Fluoroquinolones (with iron): Decreased absorption of both iron and the antibiotic.
- Bisphosphonates (with iron): Decreased absorption of bisphosphonates.
Moderate Interactions
- CYP3A4 inhibitors (e.g., azole antifungals like ketoconazole, itraconazole; macrolide antibiotics like erythromycin, clarithromycin; grapefruit juice): May increase plasma concentrations of hormonal components, potentially increasing side effects.
- Colesevelam: May decrease absorption of ethinyl estradiol; administer oral contraceptive at least 4 hours prior to colesevelam.
- Ursodiol: May decrease absorption of ursodiol.
- Antacids, proton pump inhibitors (with iron): May decrease iron absorption.
- Calcium supplements (with iron): May decrease iron absorption.
Minor Interactions
- Acetaminophen: May increase ethinyl estradiol levels.
- Ascorbic acid (Vitamin C): May increase ethinyl estradiol levels and enhance iron absorption.
- Corticosteroids: May increase corticosteroid plasma concentrations.
Monitoring
Baseline Monitoring
Complete Medical History and Physical Exam
Rationale: To identify contraindications, risk factors for cardiovascular disease, and other conditions that may be affected by or affect oral contraceptive use.
Timing: Prior to initiation
Blood Pressure
Rationale: To establish baseline and identify hypertension, a risk factor for cardiovascular events.
Timing: Prior to initiation
Breast and Pelvic Exam, Pap Smear
Rationale: Routine gynecological screening.
Timing: Prior to initiation (as per standard care, not specifically for COC initiation)
Lipid Profile (if indicated)
Rationale: To assess cardiovascular risk factors.
Timing: Prior to initiation (if clinically indicated)
Routine Monitoring
Blood Pressure
Frequency: Annually or more frequently if clinically indicated
Target: <140/90 mmHg
Action Threshold: Sustained elevation >140/90 mmHg; consider discontinuation or alternative contraception.
Weight/BMI
Frequency: Annually
Target: Healthy range
Action Threshold: Significant weight gain or obesity, which can increase cardiovascular risk.
Adherence to Dosing Regimen
Frequency: At each visit
Target: Consistent daily use
Action Threshold: Frequent missed doses, indicating need for counseling or alternative method.
Side Effects and Adverse Reactions
Frequency: At each visit
Target: Absence or manageable
Action Threshold: Persistent or severe side effects (e.g., severe headaches, vision changes, leg pain, chest pain, jaundice).
Symptom Monitoring
- Severe abdominal pain (liver problems, blood clot)
- Chest pain, shortness of breath, coughing blood (pulmonary embolism, heart attack)
- Severe headaches, sudden vision changes, speech disturbances, weakness/numbness (stroke)
- Leg pain, swelling, warmth, redness (deep vein thrombosis)
- Yellowing of skin or eyes (jaundice, liver problems)
- Unexplained vaginal bleeding or spotting
- Mood changes, depression
Special Patient Groups
Pregnancy
Contraindicated during pregnancy. There is no indication for oral contraceptives in pregnancy, and there is no evidence of teratogenicity from inadvertent exposure.
Trimester-Specific Risks:
First Trimester:
No increased risk of birth defects.
Second Trimester:
No increased risk of birth defects.
Third Trimester:
No increased risk of birth defects.
Lactation
Not recommended during lactation. Estrogen-containing oral contraceptives can decrease the quantity and quality of breast milk and may be excreted in breast milk, potentially affecting the infant.
Infant Risk:
Low risk of adverse effects, but potential for decreased milk supply and transfer of hormones to infant. Consider progestin-only methods or non-hormonal methods if breastfeeding.
Pediatric Use
Not indicated before menarche. For post-menarcheal adolescents, dosing is the same as for adults. Safety and efficacy are expected to be similar.
Geriatric Use
Not indicated for postmenopausal women. Risk of cardiovascular events increases with age.
Clinical Information
Clinical Pearls
- Counsel patients on the importance of taking the pill at the same time every day to maximize efficacy and minimize breakthrough bleeding.
- Emphasize the critical importance of not smoking while on oral contraceptives, especially for women over 35.
- Discuss potential drug interactions, particularly with enzyme-inducing medications, and advise on backup contraception if needed.
- Educate patients on the 'ACHES' warning signs of serious adverse events and when to seek immediate medical attention.
- Remind patients that this medication does not protect against STIs.
- For missed pills, always refer to the specific instructions in the package insert, as guidance varies based on the number of pills missed and the week of the cycle.
Alternative Therapies
- Progestin-only pills (mini-pill)
- Progestin injection (Depo-Provera)
- Progestin implant (Nexplanon)
- Hormonal IUD (Mirena, Skyla, Kyleena, Liletta)
- Copper IUD (Paragard)
- Contraceptive patch (Xulane)
- Vaginal ring (NuvaRing, Annovera)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Natural family planning methods
- Sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
$25 - $75 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 promptly. 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.