Junel FE 24 Tablets 28s

Manufacturer TEVA Active Ingredient Ethinyl Estradiol, Norethindrone, and Ferrous Fumarate(ETH in il es tra DYE ole, nor eth IN drone, & FER uhs FYOO mar rate) Pronunciation ETH-in-il ES-tra-dye-ol, nor-ETH-in-drone, & FER-uhs FYOO-mar-rate
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.
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Drug Class
Contraceptive, Oral; Iron Supplement
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Pharmacologic Class
Estrogen/Progestin Combination; Iron Preparation
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Pregnancy Category
Category X
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FDA Approved
Jul 2003
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Junel FE 24 is a birth control pill that contains two female hormones, ethinyl estradiol (an estrogen) and norethindrone (a progestin), to prevent pregnancy. It works by stopping your body from releasing an egg (ovulation) and by changing your cervical mucus and the lining of your uterus. The last four pills in the pack contain iron (ferrous fumarate) to help prevent iron deficiency.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day, with or without food. If you experience stomach upset, take it with food to help alleviate discomfort.

If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication. After starting this medication, you may need to use a non-hormone form of birth control, such as condoms, for a period of time to prevent pregnancy. Follow your doctor's guidance on using non-hormone birth control.

It's essential to take your medication as directed, even if you don't have sex frequently. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well. If this occurs within 3 to 4 hours after taking an active tablet, take another tablet as soon as possible. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and consult your doctor. If you're unsure what to do, call your doctor for guidance.

If you miss two periods in a row, take a pregnancy test before starting a new cycle of medication.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.

Missing a Dose

If you miss a dose, refer to the package insert or call your doctor for instructions on what to do. If you're using this medication for birth control, you may need to use a non-hormone form of birth control, such as condoms, for a period of time to prevent pregnancy.
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Lifestyle & Tips

  • Do not smoke while taking this medication, especially if you are over 35, as it significantly increases your risk of serious side effects like blood clots and heart attack.
  • Take one pill at the same time every day to ensure maximum effectiveness.
  • Use a backup method of birth control (like condoms) if you miss pills, have vomiting or severe diarrhea, or are taking certain medications that can reduce the effectiveness of birth control pills.
  • This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs).

Dosing & Administration

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Adult Dosing

Standard Dose: One active tablet (light yellow) daily for 24 consecutive days, followed by one inert tablet (ferrous fumarate) daily for 4 consecutive days. Tablets must be taken in the order directed on the blister pack.

Condition-Specific Dosing:

missedDose: Refer to package insert for specific instructions based on number of missed pills and week of cycle.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Same as adult dosing for post-menarcheal adolescents requiring contraception.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment required.
Moderate: No specific adjustment required, but use with caution.
Severe: Use with caution; monitor for fluid retention and electrolyte imbalance.
Dialysis: Not specifically studied; use with caution and monitor closely.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution; consider alternative contraception.
Severe: Contraindicated due to impaired steroid metabolism.
Confidence: High

Pharmacology

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Mechanism of Action

Junel FE 24 primarily acts by suppressing gonadotropins (FSH and LH), which in turn inhibits ovulation. Other mechanisms include changes in the cervical mucus (making it more viscous and less permeable to sperm) and alterations in the endometrium (making it less receptive to implantation). The ferrous fumarate tablets are included to provide iron supplementation during the placebo days, helping to prevent iron deficiency anemia.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-90%
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: ~4-15 L/kg; Norethindrone: ~2-4 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (primarily to albumin); Norethindrone: ~61% (primarily to albumin and SHBG)
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: ~18-24 hours; Norethindrone: ~8-12 hours
Clearance: Ethinyl Estradiol: ~5-13 mL/min/kg; Norethindrone: ~0.4 mL/min/kg
ExcretionRoute: Ethinyl Estradiol: Renal (40%) and Fecal (60%); Norethindrone: Renal (50-80%) and Fecal (20-50%)
Unchanged: Ethinyl Estradiol: <5%; Norethindrone: <10%
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically begins after 7 consecutive days of active pill use in the first cycle, provided the first pill is taken on the first day of menstruation or the first Sunday after menstruation begins. Full protection after the first cycle.
PeakEffect: Daily dosing maintains steady-state concentrations for contraceptive effect.
DurationOfAction: 24 hours (requires daily dosing for continuous effect)
Confidence: High

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular events from combination 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, combination oral contraceptives, including Junel FE 24, are contraindicated in women who are over 35 years of age and smoke.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellow skin and eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Breast lump, breast pain or tenderness, or nipple discharge.
Vaginal itching or discharge.
Vision changes or loss, bulging eyes, or changes in how contact lenses feel.
Severe or persistent vaginal bleeding or spotting.
Swelling or fluid retention, which may cause weight gain or breathing difficulties.

Additionally, be aware of the following potential signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing. If you experience any of these symptoms, seek medical help immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Changes in appetite.
Weight gain or loss.
Dizziness or headache.
Stomach upset or vomiting.
Stomach cramps.
Bloating.
Enlarged or tender breasts.
Period (menstrual) changes, including heavy bleeding, spotting, or bleeding between cycles.
Dark skin patches on the face (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear).

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe abdominal pain
  • Severe chest pain, shortness of breath, or coughing up blood
  • Severe headaches, especially if sudden or worse than usual
  • Eye problems such as blurred vision, double vision, or loss of vision
  • Severe leg pain (calf or thigh), swelling, or redness
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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, or abnormal heart rhythms like atrial fibrillation
+ Chest pain caused by angina, heart attack, or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical or vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling.
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation.
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed.
Previous experiences of jaundice during pregnancy or 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 conditions with your doctor and pharmacist. They will help you determine the safety of taking this medication with your other treatments and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & 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 stationary 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 drug 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 recommended.

Regular breast exams, gynecology check-ups, and breast self-exams, as directed by your doctor, are crucial while taking this medication.

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 personnel that you are taking this drug.

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 additional non-hormonal 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.

Some studies suggest that long-term use of hormone-based birth control may increase the risk of cervical cancer, although this may be attributed to other factors. If you have concerns, discuss them 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 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.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Withdrawal bleeding (vaginal bleeding)

What to Do:

There is no specific antidote. Treatment is symptomatic and supportive. Contact your poison control center or emergency services. Call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (risk of ALT elevations)
  • Certain aromatase inhibitors (e.g., anastrozole, letrozole) - theoretical interaction, not typically co-administered
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Major Interactions

  • Strong CYP3A4 inducers (e.g., rifampin, barbiturates, carbamazepine, oxcarbazepine, phenytoin, topiramate, felbamate, griseofulvin, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
  • Protease inhibitors (e.g., ritonavir, nelfinavir) - variable effects, some may decrease COC levels, others may increase.
  • Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, nevirapine) - may decrease COC levels.
  • Lamotrigine - COCs can significantly decrease lamotrigine plasma concentrations, leading to loss of seizure control.
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Moderate Interactions

  • CYP3A4 inhibitors (e.g., azole antifungals like ketoconazole, itraconazole, voriconazole; macrolide antibiotics like erythromycin, clarithromycin; grapefruit juice) - may increase COC levels, potentially increasing side effects.
  • Thyroid hormone replacement therapy - COCs can increase thyroid binding globulin, leading to increased thyroid hormone requirements.
  • Cyclosporine - COCs may increase cyclosporine levels, increasing toxicity risk.
  • Theophylline - COCs may increase theophylline levels.
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Minor Interactions

  • Acetaminophen - may increase ethinyl estradiol levels.
  • Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.

Monitoring

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Baseline Monitoring

Complete medical history (including family history)

Rationale: To identify contraindications, risk factors for cardiovascular disease, and other conditions that may be affected by or affect COC use.

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 (e.g., pregnancy, cervical abnormalities).

Timing: Prior to initiation

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Routine Monitoring

Blood pressure

Frequency: Annually

Target: <140/90 mmHg

Action Threshold: Sustained elevation; consider discontinuation if hypertension develops or worsens.

Annual physical examination (including breast and pelvic exam, Pap test as per guidelines)

Frequency: Annually

Target: Normal findings

Action Threshold: Abnormal findings requiring further investigation.

Weight

Frequency: Annually or as clinically indicated

Target: Stable or healthy BMI

Action Threshold: Significant weight gain/loss, especially if associated with other risk factors.

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Symptom Monitoring

  • ACHES: Abdominal pain (severe)
  • Chest pain (severe), shortness of breath, coughing blood
  • Headaches (severe, sudden, or worse than usual, especially with visual changes)
  • Eye problems (blurred vision, loss of vision, flashing lights)
  • Severe leg pain (calf or thigh), swelling, warmth, redness

Special Patient Groups

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Pregnancy

Contraindicated. Junel FE 24 should not be used during pregnancy. If pregnancy occurs while taking this medication, discontinue use immediately.

Trimester-Specific Risks:

First Trimester: No evidence of teratogenicity, but contraindicated.
Second Trimester: Contraindicated.
Third Trimester: Contraindicated.
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Lactation

Not recommended. Estrogens and progestins can decrease the quantity and quality of breast milk and may be excreted in breast milk. Non-hormonal methods or progestin-only methods are generally preferred for breastfeeding mothers.

Infant Risk: Small amounts of steroids may pass into breast milk; potential for adverse effects on the infant (e.g., jaundice, breast enlargement) is low but possible. Long-term effects on breastfed infants have not been established.
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Pediatric Use

Not indicated before menarche. For post-menarcheal adolescents, dosing is the same as adults.

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Geriatric Use

Not indicated for postmenopausal women. Safety and efficacy have not been established in this population.

Clinical Information

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Clinical Pearls

  • Emphasize the importance of consistent daily dosing at the same time to maintain contraceptive efficacy.
  • Counsel patients on the Black Box Warning regarding smoking and cardiovascular risk, especially for women over 35.
  • Advise patients about potential drug interactions, particularly with enzyme-inducing medications, and the need for backup contraception.
  • Educate patients on the 'ACHES' warning signs of serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain) and when to seek immediate medical attention.
  • The ferrous fumarate tablets are for iron supplementation during the placebo week and do not contribute to contraceptive efficacy.
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Alternative Therapies

  • Progestin-only pills (mini-pill)
  • Contraceptive patch
  • Vaginal ring
  • Contraceptive injection (Depo-Provera)
  • Contraceptive implant (Nexplanon)
  • Intrauterine devices (IUDs - hormonal and non-hormonal)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $25 - $75 per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.