Junel 1.5/30 Tablets 21

Manufacturer BARR LABS Active Ingredient Ethinyl Estradiol and Norethindrone Tablets(ETH in il es tra DYE ole & nor eth IN drone) Pronunciation ETH-in-il es-TRA-dye-ole & nor-ETH-in-drone
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 may be given to you for other reasons. Talk with the doctor.
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Drug Class
Contraceptive
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Pharmacologic Class
Estrogen and Progestin Combination
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Pregnancy Category
Category X
FDA Approved
Jan 1982
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Junel 1.5/30 is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone). It works by preventing ovulation (the release of an egg from the ovary) and by changing the cervical mucus and uterine lining to make it harder for sperm to reach the egg and for a fertilized egg to implant. It is used to prevent pregnancy.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from this medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.

Take this medication at the same time every day.
You can take it with or without food. If it causes stomach upset, take it with food.
If you are also taking colesevelam, take it at least 4 hours before or after you take this medication.

Important Information for Women Taking This Medication for Birth Control

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 a non-hormone form of birth control.

Do not skip doses, even if you do not have sex frequently.
If you vomit or have diarrhea, this medication may not work as well to prevent pregnancy. If this happens within 3 to 4 hours after taking an active tablet, take another tablet. If the vomiting or diarrhea lasts for more than a day, use an extra form of birth control and call your doctor. If you are unsure what to do, call your doctor.

What to Do If You Miss a Period

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, away from light.
* Keep it in a dry place, not in the bathroom.

Missing a Dose

If you miss a dose, refer to the package insert or call your doctor for advice. If you are using this medication for birth control, you may need to use a non-hormone form of birth control, such as condoms, for a while to prevent pregnancy.
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Lifestyle & Tips

  • Do not smoke, especially if you are over 35 years old, as smoking significantly increases the risk of serious cardiovascular side effects (blood clots, heart attack, stroke).
  • Maintain a healthy diet and exercise regularly to support cardiovascular health.
  • Inform your doctor about all medications, supplements, and herbal products you are taking, as they can interact with birth control pills.
  • Use a backup method of birth control (like condoms) if you miss pills, are taking certain interacting medications, or have severe vomiting or diarrhea.

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally daily for 21 consecutive days, followed by 7 hormone-free days (or 7 placebo tablets), then a new cycle begins.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

contraception: Take at the same time each day, starting on the first day of menstruation or the first Sunday after menstruation begins.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: One tablet orally daily for 21 consecutive days, followed by 7 hormone-free days (or 7 placebo tablets), for post-menarcheal adolescents requiring contraception.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but monitor for fluid retention.
Moderate: Use with caution; monitor for fluid retention and adverse effects.
Severe: Contraindicated due to potential for fluid retention and exacerbation of renal conditions.
Dialysis: Contraindicated.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Contraindicated due to impaired steroid metabolism.
Severe: Contraindicated due to impaired steroid metabolism and risk of cholestasis.
Confidence: Medium

Pharmacology

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Mechanism of Action

Combined oral contraceptives (COCs) primarily act by suppressing gonadotropins (FSH and LH), which in turn inhibits ovulation. They also cause changes in the cervical mucus (making it thicker and less permeable to sperm) and the endometrium (making it less receptive to implantation). The progestin component (norethindrone) is primarily responsible for ovulation inhibition and cervical mucus changes, while the estrogen component (ethinyl estradiol) suppresses FSH and stabilizes the endometrium to prevent breakthrough bleeding.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-45%; Norethindrone: ~64-100%
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: ~2.8-8.6 L/kg; Norethindrone: ~2-4 L/kg
ProteinBinding: Ethinyl Estradiol: >95% (primarily to albumin); Norethindrone: ~80% (primarily to albumin and sex hormone-binding globulin [SHBG])
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: ~18-24 hours; Norethindrone: ~5-14 hours
Clearance: Ethinyl Estradiol: ~5-13 mL/min/kg; Norethindrone: ~0.4 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%
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy begins after 7 consecutive days of active pill use in the first cycle, if started correctly. Full efficacy typically achieved after the first full cycle.
PeakEffect: Consistent hormonal suppression achieved with daily dosing.
DurationOfAction: Daily dosing required to maintain contraceptive effect.
Confidence: Medium

Safety & Warnings

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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 1.5/30, 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, 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 vision
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 of vision, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm; or trouble speaking or swallowing

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual 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 (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns 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.
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Seek Immediate Medical Attention If You Experience:

  • ACHES: Abdominal pain (severe)
  • ACHES: Chest pain (severe), shortness of breath, coughing up blood
  • ACHES: Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
  • ACHES: Eye problems (vision changes, blurring, loss of vision)
  • ACHES: Severe leg pain (calf or thigh), swelling, redness, warmth
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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 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 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 or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain caused by angina
+ Heart attack or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer, cervical cancer, vaginal cancer, or unexplained vaginal bleeding
+ Hereditary angioedema (a genetic condition that causes swelling)
+ Chloasma (dark skin patches) or increased sensitivity to sunlight or radiation
Recent use of certain medications, including:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy: Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed
* A history of jaundice (yellowing of the skin) during pregnancy or while using estrogen-containing products, such as hormonal birth control

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. Verify that it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will instruct you on when to resume taking it after the surgery or procedure.

If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as 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.

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, consult your doctor.

Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while others have not found this association. If you have questions, discuss this with your doctor.

If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not had their first menstrual period.

If you 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
  • Breast tenderness
  • Dizziness
  • Abdominal pain
  • Drowsiness/fatigue
  • Vaginal bleeding (especially in young girls)

What to Do:

There are no specific antidotes. Treatment is symptomatic and supportive. Contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention if a large overdose is suspected.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/paritaprevir/ritonavir, dasabuvir (used for Hepatitis C): Risk of significant ALT elevations.
  • Tranexamic acid (concurrent use with COCs increases risk of thrombosis).
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Major Interactions

  • CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, Topiramate, Oxcarbazepine, Felbamate, Griseofulvin, St. John's Wort): Can significantly decrease COC efficacy, leading to contraceptive failure and breakthrough bleeding.
  • Certain HIV protease inhibitors (e.g., Nelfinavir, Ritonavir) and NNRTIs (e.g., Efavirenz, Nevirapine): Can alter COC levels, requiring alternative contraception or dose adjustment.
  • Lamotrigine: COCs can decrease lamotrigine levels, potentially leading to loss of seizure control.
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Moderate Interactions

  • Antibiotics (e.g., Ampicillin, Tetracycline): While historically thought to reduce efficacy, most studies do not support this for broad-spectrum antibiotics, except for rifampin. However, some clinicians still advise backup methods.
  • Grapefruit juice: May increase ethinyl estradiol levels due to CYP3A4 inhibition, potentially increasing adverse effects.
  • Thyroid hormones (e.g., Levothyroxine): COCs can increase thyroid-binding globulin, leading to increased thyroid hormone requirements.
  • Cyclosporine: COCs can increase cyclosporine levels, increasing toxicity risk.
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Minor Interactions

  • Acetaminophen: May increase ethinyl estradiol levels by competing for sulfation.
  • Ascorbic acid (Vitamin C): May increase ethinyl estradiol levels.

Monitoring

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Baseline Monitoring

Complete Medical History (including family history of VTE, breast cancer)

Rationale: To identify contraindications and risk factors for adverse events.

Timing: Prior to initiation of therapy.

Blood Pressure

Rationale: To screen for hypertension, a contraindication or risk factor for cardiovascular events.

Timing: Prior to initiation and periodically during therapy.

Physical Examination (including breast and pelvic exam, Pap test)

Rationale: To assess overall health and screen for gynecological conditions.

Timing: Prior to initiation and annually thereafter, as per standard gynecological care.

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Routine Monitoring

Blood Pressure

Frequency: Annually or more frequently if clinically indicated.

Target: <140/90 mmHg

Action Threshold: Sustained elevation >140/90 mmHg may warrant discontinuation or change in contraception.

Weight/BMI

Frequency: Annually

Target: Healthy BMI (18.5-24.9 kg/m²)

Action Threshold: Significant weight gain may increase cardiovascular risk.

Lipid Profile (if risk factors present)

Frequency: Periodically, based on clinical judgment.

Target: Within normal limits

Action Threshold: Significant dyslipidemia may warrant alternative contraception.

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Symptom Monitoring

  • Severe abdominal pain (liver problems, blood clot)
  • Chest pain, shortness of breath, coughing up blood (blood clot in lungs, heart attack)
  • Severe headache, dizziness, weakness, numbness, vision changes (stroke)
  • Eye problems (vision loss, bulging eyes) (blood clot in eye)
  • Severe leg pain, swelling, warmth, redness (blood clot in leg)
  • Jaundice (yellowing of skin/eyes), dark urine, light-colored stools (liver problems)
  • Lump in breast
  • Mood changes, depression

Special Patient Groups

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Pregnancy

Contraindicated. Junel 1.5/30 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 unnecessary exposure should be avoided.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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Lactation

Not recommended. Estrogen-containing oral contraceptives can decrease the quantity and quality of breast milk and may be excreted in breast milk. Small amounts of hormonal steroids have been identified in the milk of nursing mothers. Consider progestin-only methods or non-hormonal contraception if breastfeeding.

Infant Risk: Potential for adverse effects on the infant (e.g., jaundice, breast enlargement), though generally considered low risk. Long-term effects on breastfed infants are unknown.
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Pediatric Use

Junel 1.5/30 is indicated for contraception in post-menarcheal adolescents. Safety and efficacy are expected to be similar to adult women. Use before menarche is not indicated.

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Geriatric Use

Not indicated for contraception in post-menopausal women. No specific studies have been conducted in geriatric populations.

Clinical Information

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Clinical Pearls

  • Missed Pills: If one active pill is missed, take it as soon as remembered and the next pill at the regular time (may mean taking two pills in one day). If two or more active pills are missed, refer to the package insert for specific instructions, as backup contraception may be needed.
  • Smoking Cessation: Strongly advise patients to quit smoking, especially if over 35, due to significantly increased risk of serious cardiovascular events.
  • VTE Risk: Counsel patients on the signs and symptoms of venous thromboembolism (VTE) and emphasize seeking immediate medical attention if they occur.
  • Drug Interactions: Always inquire about all concomitant medications, including herbal supplements (e.g., St. John's Wort), due to potential for reduced contraceptive efficacy.
  • Breakthrough Bleeding: Common, especially during the first few cycles. Usually resolves spontaneously. If persistent or heavy, evaluate for other causes.
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Alternative Therapies

  • Progestin-only pills (mini-pills)
  • Contraceptive patch (e.g., Xulane)
  • Vaginal ring (e.g., NuvaRing, Annovera)
  • Contraceptive implant (e.g., Nexplanon)
  • Intrauterine devices (IUDs) (hormonal or non-hormonal)
  • Contraceptive injection (e.g., Depo-Provera)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Natural family planning methods
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $15 - $50 per 28 tablets (1 cycle)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred generic) for most insurance plans, often covered without co-pay under ACA.
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.