Junel 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; Iron supplement
Pharmacologic Class
Estrogen/Progestin Combination; Mineral Supplement
Pregnancy Category
Category X
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Junel FE 1/20 is a birth control pill that contains two female hormones, ethinyl estradiol and norethindrone, to prevent pregnancy. It works by stopping ovulation (the release of an egg from the ovary) and changing the cervical mucus and uterine lining. It also contains iron (ferrous fumarate) to help prevent iron deficiency anemia, which can occur due to menstrual bleeding.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day, with or without food. If you experience stomach upset, take it with food to help alleviate the 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 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 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 the 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 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 certain period to prevent pregnancy.
Lifestyle & Tips
- Take one tablet every day at the same time, without missing any doses, to ensure effective contraception.
- Do not smoke, especially if you are over 35 years old, due to a significantly increased risk of serious cardiovascular side effects.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms for STI protection.
- If you miss a pill, follow the instructions in the package insert carefully, as missing pills can increase your risk of pregnancy.
- Be aware of potential drug interactions, especially with antibiotics, seizure medications, and St. John's Wort, which can reduce the effectiveness of birth control.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet daily, taken at the same time each day. Active tablets (21) are followed by inactive/iron tablets (7).
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
contraception:
One active tablet daily for 21 days, followed by one inactive (ferrous fumarate) tablet daily for 7 days. Begin new pack on day 29.
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 adjustment needed
Moderate:
No adjustment needed
Severe:
No specific dose adjustment, but caution advised due to potential fluid retention and impact on blood pressure. Ferrous fumarate may accumulate in severe renal impairment.
Dialysis:
Use with caution. Ferrous fumarate accumulation is a concern.
Hepatic Impairment:
Mild:
No specific adjustment, but monitor closely.
Moderate:
Use with caution; metabolism of hormones may be impaired.
Severe:
Contraindicated in severe liver disease or liver tumors due to impaired steroid metabolism.
Pharmacology
Mechanism of Action
Ethinyl Estradiol and Norethindrone primarily act by suppressing gonadotropins (LH and FSH), thereby inhibiting ovulation. They also cause changes in the cervical mucus (making it less permeable to sperm) and the endometrium (making it less receptive to implantation). Ferrous Fumarate provides iron supplementation to prevent iron deficiency anemia, which can be exacerbated by menstrual blood loss.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-60%; Norethindrone: ~60-90%
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 0.5-4 hours
FoodEffect:
Food may slightly decrease Cmax for norethindrone but generally does not significantly affect overall absorption or efficacy.
Distribution:
Vd:
Ethinyl Estradiol: ~2-4 L/kg; Norethindrone: ~2-4 L/kg
ProteinBinding:
Ethinyl Estradiol: ~98% (primarily to albumin, some to SHBG); Norethindrone: ~61% (primarily to albumin, some to SHBG)
CnssPenetration:
Limited (hormones are lipophilic but rapidly metabolized)
Elimination:
HalfLife:
Ethinyl Estradiol: Biphasic, terminal half-life ~10-20 hours; Norethindrone: ~5-14 hours
Clearance:
Ethinyl Estradiol: ~5-10 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 efficacy typically achieved after 7 consecutive days of active pill use. Iron supplementation effect is gradual.
PeakEffect:
Contraceptive effect maintained with continuous daily use. Iron levels gradually increase over weeks to months.
DurationOfAction:
24 hours (requires daily dosing for continuous 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 Junel FE 1/20, are contraindicated in women who are over 35 years of age and smoke.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical 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
Changes in eyesight or loss, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which can 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
Most people taking this medication will not experience severe side effects, and some may not have any side effects at all. However, if you experience 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
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical 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
Changes in eyesight or loss, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which can 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
Most people taking this medication will not experience severe side effects, and some may not have any side effects at all. However, if you experience 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
This list is not exhaustive, and you may experience other side effects not mentioned here. 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: Abdominal pain (severe)
- C: Chest pain (severe, shortness of breath, coughing blood)
- H: Headaches (severe, sudden, or worse than usual, with visual changes)
- E: Eye problems (blurred vision, loss of vision)
- S: Severe leg pain (calf or thigh, swelling, redness, warmth)
- Yellowing of skin or eyes (jaundice)
- Sudden numbness or weakness on one side of the body
- Severe mood changes or depression
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, and describe the symptoms you experienced.
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
+ 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 or vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling.
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation.
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy, as this medication is contraindicated 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or modify 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, and describe the symptoms you experienced.
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
+ 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 or vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling.
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation.
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy, as this medication is contraindicated 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or modify 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 lead to increased cholesterol and triglyceride levels. 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 maintain regular breast exams and gynecology check-ups, and to 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, 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.
Taking this medication may increase your risk of blood clots, stroke, or heart attack. Discuss this with your doctor.
The risk of blood clots is highest during the first year of using this medication and when restarting hormone-based birth control after a break of 4 weeks or more. Consult your doctor about this risk.
Some studies suggest that long-term use of hormone-based birth control may increase the risk of cervical cancer, although this may be due to other factors. If you have questions, discuss this with your doctor.
Additionally, some studies have shown a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not found this association. If you have concerns, consult your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not had their first menstrual period.
If you experience any signs of pregnancy or have a positive pregnancy test, contact your doctor immediately.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, 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 lead to increased cholesterol and triglyceride levels. 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 maintain regular breast exams and gynecology check-ups, and to 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, 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.
Taking this medication may increase your risk of blood clots, stroke, or heart attack. Discuss this with your doctor.
The risk of blood clots is highest during the first year of using this medication and when restarting hormone-based birth control after a break of 4 weeks or more. Consult your doctor about this risk.
Some studies suggest that long-term use of hormone-based birth control may increase the risk of cervical cancer, although this may be due to other factors. If you have questions, discuss this with your doctor.
Additionally, some studies have shown a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not found this association. If you have concerns, consult your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not had their first menstrual period.
If you experience any signs of pregnancy or have a positive pregnancy test, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Withdrawal bleeding (in females)
What to Do:
Overdose is generally not life-threatening. Treatment is symptomatic and supportive. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Contraindicated Interactions
- Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (increased ALT levels)
Major Interactions
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, topiramate, primidone, oxcarbazepine, St. John's Wort) - may reduce contraceptive efficacy and increase breakthrough bleeding.
- Protease inhibitors (e.g., ritonavir, nelfinavir) - variable effects, some may decrease, some may increase hormone levels.
- Aromatase inhibitors (e.g., anastrozole, letrozole) - concurrent use is not recommended.
- Tranexamic acid (increased risk of thrombosis)
- Lamotrigine (reduced lamotrigine levels, loss of seizure control)
Moderate Interactions
- CYP3A4 inhibitors (e.g., azole antifungals like ketoconazole, itraconazole; macrolide antibiotics like erythromycin, clarithromycin; grapefruit juice) - may increase hormone levels, potentially increasing side effects.
- Thyroid hormones (e.g., levothyroxine) - oral contraceptives can increase thyroid-binding globulin, requiring increased thyroid hormone dose.
- Corticosteroids (e.g., prednisone) - oral contraceptives can decrease corticosteroid clearance, increasing their effects.
- Cyclosporine (increased cyclosporine levels)
- Theophylline (increased theophylline levels)
- Tetracyclines, Fluoroquinolones (Ferrous Fumarate: reduced absorption of antibiotics)
- Antacids, Proton Pump Inhibitors (Ferrous Fumarate: reduced iron absorption)
Minor Interactions
- Acetaminophen (may increase ethinyl estradiol levels)
- Ascorbic acid (may increase ethinyl estradiol levels)
- Warfarin (may alter anticoagulant effect, monitor INR)
Monitoring
Baseline Monitoring
Complete medical history (including family history of thrombosis, breast cancer)
Rationale: To identify contraindications and risk factors for adverse events.
Timing: Prior to initiation
Physical examination (including blood pressure, breast exam, pelvic exam, Pap test)
Rationale: To establish baseline health status and rule out existing conditions.
Timing: Prior to initiation
Pregnancy test
Rationale: To ensure patient is not pregnant, as the drug is contraindicated in pregnancy.
Timing: Prior to initiation
Routine Monitoring
Blood pressure
Frequency: Annually, or more frequently if hypertension develops
Target: <140/90 mmHg
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may require discontinuation or change in contraception.
Annual physical examination (including breast exam, Pap test as per guidelines)
Frequency: Annually
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Symptoms of VTE, stroke, MI, liver dysfunction
Frequency: Ongoing patient education and self-monitoring
Target: Absence of symptoms
Action Threshold: Immediate medical attention for any concerning symptoms (e.g., ACHES).
Symptom Monitoring
- ACHES: Abdominal pain (severe)
- Chest pain (severe, shortness of breath, coughing blood)
- Headaches (severe, sudden, or worse than usual, with visual changes)
- Eye problems (blurred vision, loss of vision)
- Severe leg pain (calf or thigh, swelling, redness, warmth)
- Jaundice (yellowing of skin or eyes)
- Mood changes, depression
- Breakthrough bleeding or spotting (especially if persistent or heavy)
- Signs of iron overload (for ferrous fumarate, though rare with typical dosing)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for use of combined oral contraceptives in pregnancy, and there is evidence of fetal risk.
Trimester-Specific Risks:
First Trimester:
Studies have not shown an increased risk of birth defects in women who inadvertently used oral contraceptives early in pregnancy.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk. Small amounts of steroids may pass into breast milk and affect the infant.
Infant Risk:
Potential for decreased milk supply, and theoretical risk of adverse effects on the infant (e.g., jaundice, breast enlargement). Consider progestin-only methods if contraception is needed during breastfeeding.
Pediatric Use
Not indicated before menarche. Once menstruation has begun, dosing is the same as for adults. Safety and efficacy have been established in females of reproductive age.
Geriatric Use
Not indicated for use in postmenopausal women. Contraception is not required in this population.
Clinical Information
Clinical Pearls
- Junel FE 1/20 is a low-dose combined oral contraceptive, which may be associated with less estrogen-related side effects but potentially more breakthrough bleeding, especially during the initial cycles.
- The ferrous fumarate tablets are for iron supplementation during the placebo week and do not contribute to contraception.
- Consistent daily use at the same time is crucial for efficacy. Missing pills, especially early or late in the cycle, increases the risk of pregnancy.
- Non-contraceptive benefits include regulation of menstrual cycles, reduction of menstrual pain and blood loss, and potential reduction in risk of ovarian and endometrial cancers.
- Counsel patients on the ACHES warning signs for serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain).
Alternative Therapies
- Progestin-only pills (mini-pill)
- Contraceptive patch (Xulane)
- Vaginal ring (NuvaRing, Annovera)
- Contraceptive implant (Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Contraceptive injection (Depo-Provera)
- Barrier methods (condoms, diaphragm)
- Surgical sterilization
Cost & Coverage
Average Cost:
$15 - $50 per 28 tablets (1 cycle)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often covered by most insurance plans, sometimes with no co-pay under ACA)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it'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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.