Junel 1/20 Tablets 21s
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir (HCV combination products)
- Strong CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Phenobarbital, St. John's Wort)
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
Moderate Interactions
- Antibiotics (e.g., Tetracyclines, Penicillins - theoretical risk, clinical significance debated)
- Aprepitant
- Atorvastatin
- Ascorbic acid (Vitamin C)
- Paracetamol (Acetaminophen)
- Lamotrigine (reduced lamotrigine levels)
Minor Interactions
- Grapefruit juice (potential for increased estrogen levels, usually not clinically significant)
- Thyroid hormones (may require increased thyroid hormone dose)
Monitoring
Baseline Monitoring
Rationale: To identify risk factors for cardiovascular disease, VTE, and hormone-sensitive cancers.
Timing: Prior to initiation of therapy.
Rationale: To assess overall health status and rule out contraindications.
Timing: Prior to initiation of therapy.
Rationale: To assess cardiovascular risk.
Timing: Prior to initiation.
Routine Monitoring
Frequency: Annually
Target: <140/90 mmHg
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may require discontinuation or change in contraception.
Frequency: Annually
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Frequency: Annually or as clinically indicated
Target: Healthy BMI
Action Threshold: Significant weight gain may increase cardiovascular risk.
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
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:
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.
Pediatric Use
Not indicated for use before menarche. For adolescents, dosing is the same as adults once menstruation has begun.
Geriatric Use
Not indicated for post-menopausal women. Safety and efficacy have not been established in geriatric populations.
Clinical Information
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).
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