Loestrin FE 1/20 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
Pharmacologic Class
Estrogen/Progestin Combination
Pregnancy Category
Category X
FDA Approved
Jul 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Loestrin FE 1/20 is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone), and iron pills for the last week. It works by preventing your body from releasing an egg (ovulation) and by changing your cervical mucus and uterine lining to make it harder for sperm to reach an egg or for a fertilized egg to implant. The iron pills help prevent iron deficiency during your period.
How to Use This Medicine
Taking Your Medication Correctly
To get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day. You can take it with or without food, but if it upsets your stomach, take it with food.
If you're 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 while. Follow your doctor's advice on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't have sex frequently. Don't 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 happens within 3 to 4 hours after taking an active tablet, take another tablet. If the vomiting or diarrhea persists for more than a day, use an extra form of birth control and contact 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
Keep your medication at room temperature, away from light and moisture. Store it in a dry place, avoiding the bathroom.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert or call your doctor for advice. If you're using this medication to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a while to prevent pregnancy.
To get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day. You can take it with or without food, but if it upsets your stomach, take it with food.
If you're 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 while. Follow your doctor's advice on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't have sex frequently. Don't 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 happens within 3 to 4 hours after taking an active tablet, take another tablet. If the vomiting or diarrhea persists for more than a day, use an extra form of birth control and contact 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
Keep your medication at room temperature, away from light and moisture. Store it in a dry place, avoiding the bathroom.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert or call your doctor for advice. If you're using this medication to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a while 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, heart attack, and stroke.
- Take the pill at the same time every day to maximize effectiveness and reduce breakthrough bleeding.
- Use a backup method of birth control (like condoms) for the first 7 days when starting the pill or if you miss pills.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms to protect against STIs.
- Maintain regular physical activity and a healthy diet to support overall cardiovascular health.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally once daily, starting on the first day of menstruation or the first Sunday after menstruation begins. Active tablets (ethinyl estradiol/norethindrone) are taken for 21 consecutive days, followed by inactive tablets (ferrous fumarate) for 7 consecutive days.
Condition-Specific Dosing:
missedDose:
If one active tablet is missed, take it as soon as remembered. If two consecutive active tablets are missed in Week 1 or 2, take two tablets on the day remembered and two tablets the next day, then continue with one tablet daily. Use back-up contraception for 7 days. If two consecutive active tablets are missed in Week 3 or three or more consecutive active tablets are missed anytime, discard the rest of the pack and start a new pack the same day (Sunday start: continue taking one tablet daily until Sunday, then discard the rest of the pack and start a new pack on Sunday). Use back-up contraception for 7 days. If inactive tablets are missed, discard them and continue with the next pack as scheduled.
postpartum:
Initiate no earlier than 4 weeks postpartum in non-lactating women. For lactating women, consider non-hormonal methods or delay initiation until weaning.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
One tablet orally once daily, as per adult dosing, after menarche and when contraception is desired.
Note:
Safety and efficacy are expected to be similar for post-menarchal adolescents and adult women.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; however, use with caution in patients with severe renal impairment due to potential fluid retention.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Contraindicated due to impaired steroid metabolism.
Severe:
Contraindicated due to impaired steroid metabolism.
Pharmacology
Mechanism of Action
Combined oral contraceptives (COCs) primarily act by suppressing gonadotropins (follicle-stimulating hormone [FSH] and luteinizing hormone [LH]). Although the primary mechanism is inhibition of ovulation, other alterations include changes in the cervical mucus (which increases the difficulty of sperm penetration into the uterus) and the endometrium (which reduces the likelihood of implantation). The ferrous fumarate component is an iron supplement and does not contribute to the contraceptive action.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: Approximately 40-45%; Norethindrone: Approximately 60-100%
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 1-2 hours
FoodEffect:
Food may slightly decrease Cmax for both components but does not significantly affect bioavailability.
Distribution:
Vd:
Ethinyl Estradiol: 2-4 L/kg; Norethindrone: 4 L/kg
ProteinBinding:
Ethinyl Estradiol: Approximately 98% (primarily to albumin, some to sex hormone-binding globulin [SHBG]); Norethindrone: Approximately 96-97% (primarily to albumin, some to SHBG)
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: Approximately 10-20 hours; Norethindrone: Approximately 5-14 hours
Clearance:
Ethinyl Estradiol: 5-13 L/hr; Norethindrone: 0.6-1.0 L/hr/kg
ExcretionRoute:
Ethinyl Estradiol: Renal (40%) and Fecal (60%); Norethindrone: Renal (50-80%) and Fecal (20-50%)
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <10%
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy typically achieved after 7 consecutive days of active pill use, if started correctly.
PeakEffect:
Not directly applicable for contraceptive effect; hormonal levels peak within hours of dosing.
DurationOfAction:
Daily dosing maintains contraceptive effect.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events from combined 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, combined oral contraceptives, including Loestrin FE 1/20, are contraindicated in women who are over 35 years of age and smoke.
Side Effects
Serious 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.
Blood Clots: Seek Medical Help Right Away
If you experience any of the following symptoms, contact your doctor immediately, as they may indicate 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
Trouble speaking or swallowing
Other Possible Side Effects
Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects, 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 (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, 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.
Blood Clots: Seek Medical Help Right Away
If you experience any of the following symptoms, contact your doctor immediately, as they may indicate 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
Trouble speaking or swallowing
Other Possible Side Effects
Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects, 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 (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- **A**bdominal pain (severe)
- **C**hest pain (severe), cough, shortness of breath
- **H**eadaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
- **E**ye problems (sudden partial or complete loss of vision, blurred vision, double vision)
- **S**evere leg pain (calf or thigh), swelling, redness, warmth
- Yellowing of skin or eyes (jaundice)
- Dark urine or light-colored stools
- Severe mood changes or depression
- Lump in the breast
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
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation
Recent use of certain medications, such as ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir), within the past 2 weeks
Current use of glecaprevir and pibrentasvir
Pregnancy or suspected pregnancy, as this medication is contraindicated during pregnancy
Breastfeeding or plans to breastfeed
A history of jaundice (yellowing of the skin and eyes) 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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. Do not 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 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
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation
Recent use of certain medications, such as ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir), within the past 2 weeks
Current use of glecaprevir and pibrentasvir
Pregnancy or suspected pregnancy, as this medication is contraindicated during pregnancy
Breastfeeding or plans to breastfeed
A history of jaundice (yellowing of the skin and eyes) 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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. Do not 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, and will provide guidance 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. Additionally, this medication may increase cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor and have your blood work and other lab tests checked as directed.
Regular breast exams, gynecology check-ups, and breast self-exams are crucial. 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, consult your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab workers 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 need for additional non-hormonal birth control methods, such as condoms.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Use latex or polyurethane condoms during sexual activity, and consult your doctor if you have questions.
Taking this medication may increase your risk of blood clots, stroke, or heart attack. Discuss this with your doctor, as the risk is highest during the first year of use and when restarting hormone-based birth control after a 4-week or longer break.
Some studies suggest a potential increased risk of cervical cancer and breast cancer associated with long-term use of hormone-based birth control. However, the evidence is not conclusive, and you should discuss any concerns with your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication is not intended for use 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 provide guidance 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. Additionally, this medication may increase cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor and have your blood work and other lab tests checked as directed.
Regular breast exams, gynecology check-ups, and breast self-exams are crucial. 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, consult your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab workers 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 need for additional non-hormonal birth control methods, such as condoms.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Use latex or polyurethane condoms during sexual activity, and consult your doctor if you have questions.
Taking this medication may increase your risk of blood clots, stroke, or heart attack. Discuss this with your doctor, as the risk is highest during the first year of use and when restarting hormone-based birth control after a 4-week or longer break.
Some studies suggest a potential increased risk of cervical cancer and breast cancer associated with long-term use of hormone-based birth control. However, the evidence is not conclusive, and you should discuss any concerns with your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication is not intended for use 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
- Vaginal bleeding (especially 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
- Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (increased ALT elevations)
- Dasabuvir (increased ALT elevations)
- Glecaprevir/Pibrentasvir (increased ALT elevations)
Major Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole) - reduced efficacy of aromatase inhibitor
- CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's Wort, topiramate, barbiturates) - decreased contraceptive efficacy, increased breakthrough bleeding
- CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, voriconazole, grapefruit juice) - increased estrogen/progestin levels, increased risk of adverse effects
- Lamotrigine (decreased lamotrigine levels, loss of seizure control)
- Tranexamic acid (increased risk of thrombosis)
- Hepatitis C antiviral combinations (e.g., ledipasvir/sofosbuvir, sofosbuvir/velpatasvir) - potential for increased estrogen levels
Moderate Interactions
- Broad-spectrum antibiotics (e.g., ampicillin, tetracycline) - theoretical reduction in efficacy due to altered enterohepatic recirculation, though clinical significance is debated.
- Thyroid hormones (e.g., levothyroxine) - increased thyroid binding globulin, requiring increased thyroid hormone dose.
- Corticosteroids (e.g., prednisone) - increased corticosteroid levels due to reduced clearance.
- Cyclosporine (increased cyclosporine levels, increased risk of toxicity).
- Theophylline (increased theophylline levels).
- Warfarin (variable effect on INR, monitor closely).
Minor Interactions
- Acetaminophen (increased ethinyl estradiol levels)
- Ascorbic acid (increased ethinyl estradiol levels)
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: To identify pre-existing hypertension and monitor for drug-induced hypertension.
Timing: Prior to initiation
Medical History (including family history of VTE, breast cancer)
Rationale: To identify contraindications and risk factors for adverse events.
Timing: Prior to initiation
Physical Exam (including breast and pelvic exam, Pap test)
Rationale: To ensure no contraindications and establish baseline health.
Timing: Prior to initiation (as clinically indicated)
Lipid Profile
Rationale: To assess cardiovascular risk, as COCs can affect lipid levels.
Timing: Prior to initiation (consider for high-risk patients)
Glucose (HbA1c or fasting glucose)
Rationale: To assess for pre-existing diabetes or impaired glucose tolerance, as COCs can affect glucose metabolism.
Timing: Prior to initiation (consider for high-risk patients)
Routine Monitoring
Blood Pressure
Frequency: Annually or more frequently if clinically indicated
Target: <140/90 mmHg
Action Threshold: Sustained elevation >140/90 mmHg may require discontinuation or change in contraception.
Weight
Frequency: Annually
Target: Stable or within healthy BMI range
Action Threshold: Significant unexplained weight gain may warrant investigation.
Breast Exam
Frequency: Annually
Target: Normal
Action Threshold: New lumps or changes require further evaluation.
Pelvic Exam and Pap Test
Frequency: As per national screening guidelines (e.g., every 3-5 years for Pap test)
Target: Normal
Action Threshold: Abnormal findings require further evaluation.
Symptom Monitoring
- Severe abdominal pain (A)
- Chest pain (C)
- Headaches (severe, sudden) (H)
- Eye problems (blurred vision, loss of vision) (E)
- Severe leg pain (S)
- Jaundice or dark urine
- Mood changes or depression
- Unusual vaginal bleeding or spotting
- Signs of allergic reaction (rash, itching, swelling)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for COC use in pregnancy, and there is no evidence of teratogenicity from inadvertent exposure during early pregnancy.
Trimester-Specific Risks:
First Trimester:
No increased risk of birth defects has been found with inadvertent exposure.
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. Non-hormonal methods are preferred.
Infant Risk:
Low risk of adverse effects to the infant, but potential for decreased milk supply and transfer of hormones to the infant. Monitor for jaundice or breast enlargement in the infant.
Pediatric Use
Safety and efficacy are expected to be similar for post-menarchal adolescents and adult women. Not indicated before menarche.
Geriatric Use
Not indicated for use in postmenopausal women. Risk of cardiovascular events increases with age, especially in women over 35. Generally, COCs are not used in this population.
Clinical Information
Clinical Pearls
- The ferrous fumarate tablets are placebo pills and are included to help maintain iron levels and to serve as a reminder to take a pill daily.
- Breakthrough bleeding or spotting is common, especially during the first few cycles, and usually resolves. If persistent or heavy, evaluate for other causes.
- Missed pills are the most common cause of contraceptive failure. Emphasize consistent daily dosing.
- Counsel patients on the importance of using backup contraception when starting the pill or after missing pills.
- Be aware of drug interactions, especially with CYP3A4 inducers (e.g., certain anticonvulsants, rifampin, St. John's Wort) which can significantly reduce contraceptive efficacy.
- COCs can improve acne and reduce symptoms of dysmenorrhea and premenstrual dysphoric disorder (PMDD).
Alternative Therapies
- Progestin-only pills (POPs)
- Progestin implants (e.g., Nexplanon)
- Progestin-releasing intrauterine devices (IUDs) (e.g., Mirena, Kyleena)
- Copper IUD (e.g., Paragard)
- Depot medroxyprogesterone acetate (DMPA) injection (e.g., Depo-Provera)
- Barrier methods (e.g., condoms, diaphragm)
- Spermicides
- Natural family planning
- Sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
$25 - $100+ per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generics often Tier 1, brand Tier 2 or 3)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.