Aurovela 24 FE 1/20 Tablets

Manufacturer AUROBINDO Active Ingredient Ethinyl Estradiol, Norethindrone, and Ferrous Fumarate(ETH in il es tra DYE ole, nor eth IN drone, & FER uhs FYOO mar rate) Pronunciation ETH in il es tra DYE ole, nor eth IN drone, & FER uhs FYOO mar rate
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 is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Contraceptive, Oral; Iron Supplement
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Pharmacologic Class
Estrogen/Progestin Combination; Iron Preparation
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Pregnancy Category
Category X
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FDA Approved
Feb 2006
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Aurovela 24 FE is a daily birth control pill that contains two female hormones, ethinyl estradiol (an estrogen) and norethindrone (a progestin), to prevent pregnancy. It works by stopping ovulation (the release of an egg from the ovary) and by changing the cervical mucus and uterine lining. The last four pills in the pack contain iron (ferrous fumarate) to help prevent iron deficiency.
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How to Use This Medicine

Taking Your Medication Correctly

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.
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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.
  • 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).
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: One active tablet (light pink) daily for 24 consecutive days, followed by one ferrous fumarate tablet (brown) daily for 4 consecutive days. Take tablets in the order directed on the blister pack, at the same time each day.

Condition-Specific Dosing:

missedDose: Refer to package insert for specific instructions based on number of missed pills and week in cycle. Generally, take missed pill as soon as remembered, and if more than one, use backup contraception.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Same as adult dosing for post-menarcheal adolescents requiring contraception.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but caution advised due to potential fluid retention.
Dialysis: No specific adjustment needed.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution.
Severe: Contraindicated in severe hepatic impairment or liver tumors.

Pharmacology

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Mechanism of Action

Aurovela 24 FE prevents pregnancy primarily by suppressing gonadotropins (luteinizing hormone and follicle-stimulating hormone), which in turn inhibits ovulation. It also causes changes in the cervical mucus (increasing its viscosity, making it less permeable to sperm) and the endometrium (making it less suitable for implantation). The ferrous fumarate tablets provide supplemental iron during the inactive pill phase to prevent iron deficiency anemia.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: Approximately 40-45%; Norethindrone: Approximately 60-100%. Ferrous Fumarate: Variable, depends on iron stores and dietary factors.
Tmax: Ethinyl Estradiol: 1-2 hours; Norethindrone: 0.5-4 hours.
FoodEffect: Food may slightly decrease the rate but not the extent of absorption for hormones. Iron absorption can be affected by food.

Distribution:

Vd: Ethinyl Estradiol: 2.8-8.6 L/kg; Norethindrone: 2-4 L/kg.
ProteinBinding: Ethinyl Estradiol: ~98% (primarily to albumin); Norethindrone: ~96-97% (to albumin and sex hormone-binding globulin (SHBG)). Ferrous Fumarate: Iron binds to transferrin.
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: 6-20 hours; Norethindrone: 5-14 hours.
Clearance: Ethinyl Estradiol: 5-13 mL/min/kg; Norethindrone: 0.4-1.2 L/hr/kg.
ExcretionRoute: Ethinyl Estradiol: Urine and feces (as metabolites); Norethindrone: Urine and feces (as metabolites). Ferrous Fumarate: Primarily conserved and recycled; small amounts lost via shedding of cells.
Unchanged: Ethinyl Estradiol: <5%; Norethindrone: <10%
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically achieved after 7 consecutive days of active pill use when started correctly.
PeakEffect: Not directly applicable for contraceptive effect, which is sustained.
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 Aurovela 24 FE, 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 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.
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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 (in calf or thigh), swelling, or 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 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.
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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 instruct you on when to resume taking it after the surgery or procedure.

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.
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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

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Contraindicated Interactions

  • Ombitasvir/paritaprevir/ritonavir with or without dasabuvir (risk of ALT elevation)
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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.
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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.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Complete medical history (including family history)

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.

Physical examination (including blood pressure, breast, abdominal, and pelvic examination, and Pap test)

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.

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Routine Monitoring

Blood pressure

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.

Annual physical examination

Frequency: Annually

Target: Not applicable

Action Threshold: Not applicable

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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

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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:

First Trimester: No increased risk of birth defects reported.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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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.

Infant Risk: Small amounts of hormones are transferred to the infant via breast milk. Potential for adverse effects on the infant (e.g., jaundice, breast enlargement) is low but possible. Long-term effects on breastfed infants have not been fully established.
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Pediatric Use

Safety and efficacy are established for post-menarcheal adolescents. Use before menarche is not indicated.

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Geriatric Use

Not indicated for use in postmenopausal women. Safety and efficacy have not been established in this population.

Clinical Information

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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.
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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)
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Cost & Coverage

Average Cost: Varies widely, typically $15-$50 per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered with no or low 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 promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.