Junel 1/20 Tablets 21s

Manufacturer TEVA 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
Hormonal Contraceptive
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Pharmacologic Class
Estrogen and Progestin Combination
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Pregnancy Category
Category X
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FDA Approved
Mar 2004
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Junel 1/20 is an oral contraceptive, commonly known as a birth control pill. It contains two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone), which work together to prevent pregnancy by stopping the release of an egg from the ovary (ovulation) and making it harder for sperm to reach the egg or for a fertilized egg to implant in the womb.
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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, with or without food. If you experience stomach upset, taking it with food may help.

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 while. 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 happens 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 extra form of birth control and consult your doctor. If you're unsure what to do, call your doctor for guidance.

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

Storing and Disposing of Your Medication

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

What to Do If You Miss a Dose

If you miss a dose, refer to the package insert or call your doctor for instructions. If you're using this medication to prevent pregnancy, 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 this significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
  • Maintain a healthy diet and exercise regularly to support cardiovascular health.
  • This medication does not protect against sexually transmitted infections (STIs). Always use barrier methods (like condoms) to prevent STIs.

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally daily for 21 consecutive days, followed by 7 tablet-free days. A new cycle begins on the 8th day.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

contraception: One tablet daily at the same time each day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Same as adult dosing, typically initiated after menarche for contraception.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed.
Dialysis: No specific recommendations; use with caution due to potential fluid retention.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution; monitor for adverse effects.
Severe: Contraindicated due to impaired steroid metabolism.

Pharmacology

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Mechanism of Action

Combination oral contraceptives (COCs) primarily act by suppressing gonadotropins. Although the primary mechanism is inhibition of ovulation, other alterations include changes in the cervical mucus (which increases the difficulty of sperm entry into the uterus) and changes in the endometrium (which reduce the likelihood of implantation).
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-45%; Norethindrone: ~64-90%
Tmax: Ethinyl Estradiol: 1-2 hours; Norethindrone: 0.5-4 hours
FoodEffect: Minimal clinically significant effect on absorption.

Distribution:

Vd: Ethinyl Estradiol: ~5 L/kg; Norethindrone: ~4 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (primarily to albumin); Norethindrone: ~96-98% (primarily to albumin and sex hormone-binding globulin [SHBG])
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: 10-20 hours; Norethindrone: 5-14 hours
Clearance: Ethinyl Estradiol: ~5-13 mL/min/kg; Norethindrone: ~0.4 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide and sulfate conjugates) and Fecal (biliary excretion)
Unchanged: Less than 5% for both
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically begins after 7 consecutive days of active pill use, assuming proper initiation on the first day of menstruation or first Sunday after menstruation.
PeakEffect: Achieved with consistent daily dosing.
DurationOfAction: 24 hours (requires daily dosing for continuous effect)

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 1/20, are contraindicated in women who are over 35 years of age and smoke.
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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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

Signs of an allergic reaction: 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 abdominal area, 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.
Fluid retention, swelling, or weight gain, which can cause breathing difficulties.

If you experience any of these symptoms, contact your doctor immediately. Additionally, be aware of the signs of a blood clot, such as:

Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, or pain in a leg or arm
Difficulty speaking or swallowing

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Changes in appetite
Weight gain or loss
Dizziness or headache
Stomach upset or vomiting
Stomach cramps
Bloating
Breast enlargement or tenderness
Period (menstrual) changes, including heavy bleeding, spotting, or bleeding between cycles

This medication may also cause 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 when outdoors.

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.
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Seek Immediate Medical Attention If You Experience:

  • A: Abdominal pain (severe)
  • C: Chest pain (severe), cough, shortness of breath
  • H: Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
  • E: Eye problems (sudden vision loss or blurring)
  • S: 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 problems, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems 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 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.
A history of jaundice (yellowing of the skin) 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 problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose 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. Follow your doctor's instructions for regular blood pressure checks.

Additionally, this drug may increase 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 advised by your doctor.

It is crucial to maintain regular breast exams and gynecology check-ups, and 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, discuss your consumption of grapefruit juice or grapefruit with 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 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 to understand 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 attributed to other factors. If you have concerns, discuss them with your doctor.

Research on the link between hormone-based birth control and breast cancer risk has yielded conflicting results. 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 yet had their first menstrual period.

If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Withdrawal bleeding (in females)

What to Do:

Seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222. Treatment is generally supportive.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir (HCV combination products)
  • Strong CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Phenobarbital, St. John's Wort)
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Major Interactions

  • Certain anticonvulsants (e.g., Topiramate, Oxcarbazepine, Felbamate, Rufinamide)
  • Bosentan
  • Griseofulvin
  • Ritonavir-boosted protease inhibitors (e.g., Lopinavir/Ritonavir)
  • Non-nucleoside reverse transcriptase inhibitors (e.g., Efavirenz, Nevirapine)
  • Modafinil
  • Barbiturates
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Moderate Interactions

  • Antibiotics (e.g., Tetracyclines, Penicillins - theoretical risk, clinical significance debated)
  • Aprepitant
  • Atorvastatin
  • Ascorbic acid (Vitamin C)
  • Paracetamol (Acetaminophen)
  • Lamotrigine (reduced lamotrigine levels)
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Minor Interactions

  • Grapefruit juice (potential for increased estrogen levels, usually not clinically significant)
  • Thyroid hormones (may require increased thyroid hormone dose)

Monitoring

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Baseline Monitoring

Complete Medical History (including family history)

Rationale: To identify risk factors for cardiovascular disease, VTE, and hormone-sensitive cancers.

Timing: Prior to initiation of therapy.

Physical Examination (including blood pressure, breast, abdominal, and pelvic exam with Pap test)

Rationale: To assess overall health status and rule out contraindications.

Timing: Prior to initiation of therapy.

Lipid Profile (optional, consider for high-risk patients)

Rationale: To assess cardiovascular risk.

Timing: Prior to initiation.

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Routine Monitoring

Blood Pressure

Frequency: Annually

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 and pelvic exam)

Frequency: Annually

Target: Normal findings

Action Threshold: Abnormal findings require further investigation.

Weight

Frequency: Annually or as clinically indicated

Target: Healthy BMI

Action Threshold: Significant weight gain may increase cardiovascular risk.

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Symptom Monitoring

  • Severe abdominal pain (especially right upper quadrant, may indicate liver issues)
  • Chest pain, shortness of breath, coughing up blood (may indicate pulmonary embolism)
  • Severe headaches, sudden vision changes, speech difficulties, weakness or numbness (may indicate stroke)
  • Sudden severe leg pain, swelling, warmth, redness (may indicate deep vein thrombosis)
  • Jaundice (yellowing of skin or eyes, may indicate liver dysfunction)
  • Breast lumps
  • Mood changes, depression

Special Patient Groups

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Pregnancy

Contraindicated. There is no indication for Junel 1/20 in pregnancy, and there is evidence of fetal risk. Discontinue if pregnancy is confirmed.

Trimester-Specific Risks:

First Trimester: Potential for adverse effects on fetal development, though data on specific malformations are inconsistent.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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Lactation

Not recommended. Estrogens can decrease the quantity and quality of breast milk. Small amounts of contraceptive steroids and/or metabolites are excreted in breast milk, which may affect the nursing infant.

Infant Risk: Potential for adverse effects on infant development (e.g., jaundice, breast enlargement), though generally considered low risk. However, milk supply reduction is a primary concern.
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Pediatric Use

Not indicated for use before menarche. For adolescents, dosing is the same as adults once menstruation has begun.

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Geriatric Use

Not indicated for post-menopausal women. Safety and efficacy have not been established 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 continue with the rest of the pack. If two or more active pills are missed, refer to the package insert for specific instructions, as backup contraception may be needed.
  • Smoking cessation is crucial for women using COCs, especially those over 35, due to significantly increased risk of cardiovascular events.
  • COCs do not protect against HIV/AIDS or other sexually transmitted infections (STIs).
  • Breakthrough bleeding or spotting is common, especially during the first few cycles, and usually resolves. Persistent or heavy bleeding should be evaluated.
  • Effectiveness can be reduced by certain medications (e.g., enzyme inducers) or conditions (e.g., severe vomiting or diarrhea).
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Alternative Therapies

  • Progestin-only pills (POPs)
  • Progestin injection (e.g., Depo-Provera)
  • Progestin implant (e.g., Nexplanon)
  • Intrauterine devices (IUDs - hormonal or copper)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Sterilization (tubal ligation, vasectomy)
  • Natural family planning methods
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Cost & Coverage

Average Cost: $15 - $50 per 21 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered with low or no co-pay under ACA)
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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 and the effectiveness of your 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 check with your pharmacist for more information. If you have any questions or concerns about your 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 details about the medication taken, the amount, and the time it happened, as this information is crucial for proper treatment.