Aurovela 24 FE 1/20 Tablets
Overview
What is this medicine?
How to Use This Medicine
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, to prevent pregnancy for a period of time. 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.
Important: Pregnancy Testing
If you miss two consecutive periods, 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 period of time 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.
- Take one pill at the same time every day, even if you do not have sex often or are bleeding.
- 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 pill's effectiveness.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs).
Available Forms & Alternatives
Available Strengths:
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 eyesight
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, 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 may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
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:
- 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 (in calf or thigh), swelling, or 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 cancer, 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 potential pregnancy. Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed.
A history of jaundice (yellowing of the skin and eyes) 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 the safety of taking 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
If you will be immobile 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 instructed 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 frequently consume grapefruit juice or eat grapefruit, 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 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 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 pause 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. 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 suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Withdrawal bleeding (in females)
- For iron overdose: abdominal pain, vomiting, diarrhea, lethargy, pallor, cyanosis, shock, metabolic acidosis (seek immediate medical attention for suspected iron overdose).
What to Do:
For hormone overdose, treatment is generally supportive. For suspected iron overdose, immediately contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention. Management may include gastric lavage, chelation therapy (e.g., deferoxamine), and supportive care.
Drug Interactions
Contraindicated Interactions
- Ombitasvir/paritaprevir/ritonavir with or without dasabuvir (risk of ALT elevation)
Major Interactions
- CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, barbiturates, topiramate, St. John's Wort) - may decrease contraceptive efficacy.
- CYP3A4 inhibitors (e.g., azole antifungals, macrolide antibiotics, grapefruit juice) - may increase estrogen/progestin levels.
- Lamotrigine - COCs can significantly decrease lamotrigine plasma concentrations, leading to loss of seizure control.
Moderate Interactions
- Antibiotics (e.g., ampicillin, tetracycline) - theoretical risk of reduced efficacy due to altered gut flora, though clinical significance is debated. Backup contraception often recommended.
- Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
- Acetaminophen - may increase ethinyl estradiol levels.
- Thyroid hormones (e.g., levothyroxine) - COCs can increase thyroid-binding globulin, requiring increased thyroid hormone dose.
- Iron chelators (e.g., deferoxamine) - may reduce iron absorption.
- Antacids, proton pump inhibitors, H2 blockers - may decrease iron absorption.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
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 of therapy.
Rationale: To establish baseline health status and screen for conditions that may contraindicate or require caution with COC use.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Annually, or more frequently if clinically indicated.
Target: Normal range (e.g., <120/80 mmHg)
Action Threshold: Sustained hypertension (e.g., >140/90 mmHg) may require discontinuation or change in contraception.
Frequency: Annually
Target: Not applicable
Action Threshold: Not applicable
Symptom Monitoring
- Severe abdominal pain (especially if sudden or persistent)
- Chest pain, shortness of breath, or coughing up blood
- Sudden severe headache, dizziness, or fainting
- Sudden partial or complete loss of vision, or double vision
- Sudden numbness or weakness in an arm or leg, especially on one side of the body
- Severe pain, swelling, or warmth in the calf or thigh
- Jaundice (yellowing of skin or eyes), dark urine, or light-colored stools (signs of liver problems)
- Symptoms of depression (persistent sadness, loss of interest, changes in sleep/appetite)
Special Patient Groups
Pregnancy
Contraindicated. There is no indication for oral contraceptives in pregnancy, and there is no evidence of risk to the fetus from inadvertent exposure during early pregnancy.
Trimester-Specific Risks:
Lactation
Not recommended. Estrogens and progestins are excreted in breast milk and may decrease the quantity and quality of breast milk. Non-hormonal methods or progestin-only methods are generally preferred during lactation.
Pediatric Use
Safety and efficacy are established for post-menarcheal adolescents. Use before menarche is not indicated.
Geriatric Use
Not indicated for use in postmenopausal women. Safety and efficacy have not been established in this population.
Clinical Information
Clinical Pearls
- Adherence is paramount for contraceptive efficacy. Missing pills, especially early or late in the cycle, significantly increases the risk of pregnancy.
- Counsel patients on the 'ACHES' warning signs of serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain).
- Emphasize the black box warning regarding smoking and cardiovascular risk, especially for women over 35.
- Aurovela 24 FE does not protect against sexually transmitted infections (STIs); advise concurrent use of barrier methods for STI prevention.
- Patients may experience breakthrough bleeding or spotting, especially during the first few cycles, which usually resolves with continued use.
- The iron pills are for iron supplementation and do not have contraceptive properties; they are taken during the inactive pill phase.
Alternative Therapies
- Other combination oral contraceptives (different estrogen/progestin doses or types)
- Progestin-only pills (POPs)
- Contraceptive patch (e.g., Xulane)
- Vaginal ring (e.g., NuvaRing, Annovera)
- Contraceptive injection (e.g., Depo-Provera)
- Contraceptive implant (e.g., Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Permanent contraception (tubal ligation, vasectomy)