Junel 1.5/30 Tablets 21
Overview
What is this medicine?
How to Use This Medicine
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.
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.
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 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.
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
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 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.
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 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.
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
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).
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.
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.
Minor Interactions
- Acetaminophen: May increase ethinyl estradiol levels by competing for sulfation.
- Ascorbic acid (Vitamin C): May increase ethinyl estradiol levels.
Monitoring
Baseline Monitoring
Rationale: To identify contraindications and risk factors for adverse events.
Timing: Prior to initiation of therapy.
Rationale: To screen for hypertension, a contraindication or risk factor for cardiovascular events.
Timing: Prior to initiation and periodically during therapy.
Rationale: To assess overall health and screen for gynecological conditions.
Timing: Prior to initiation and annually thereafter, as per standard gynecological care.
Routine Monitoring
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.
Frequency: Annually
Target: Healthy BMI (18.5-24.9 kg/m²)
Action Threshold: Significant weight gain may increase cardiovascular risk.
Frequency: Periodically, based on clinical judgment.
Target: Within normal limits
Action Threshold: Significant dyslipidemia may warrant alternative contraception.
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
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:
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.
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.
Geriatric Use
Not indicated for contraception in post-menopausal women. No specific studies have been conducted in geriatric populations.
Clinical Information
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.
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)