Volnea Tablets 28s

Manufacturer XIROMED Active Ingredient Ethinyl Estradiol and Desogestrel(ETH in il es tra DYE ole & des oh JES trel) Pronunciation ETH-in-il es-TRA-dye-ole & des-oh-JES-trel
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. If you have been given this drug for some other reason, talk with your doctor for more information.
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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
Aug 1992
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Volnea is a birth control pill that contains two female hormones, an estrogen (ethinyl estradiol) and a progestin (desogestrel). It works by preventing ovulation (the release of an egg from the ovary) and by changing the cervical mucus and uterine lining to prevent pregnancy. It is taken once daily.
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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 minimize discomfort.

After starting this medication, you may need to use a non-hormonal form of birth control, such as condoms, for a period of time to prevent pregnancy. Be sure to follow your doctor's guidance on using non-hormonal birth control.

If you are also taking colesevelam, take it at least 4 hours before or after taking this medication. Do not skip doses, even if you do not have sexual intercourse frequently.

If you vomit or have diarrhea, the medication may not be as effective in preventing pregnancy. In this case, use an additional form of birth control, such as condoms, until you consult with your doctor.

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 in a dry place, avoiding storage in a bathroom.

What to Do If You Miss a Dose

If you miss a dose, refer to the package insert or contact your doctor for guidance. If you are using this medication for birth control, you may need to use a non-hormonal 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 smoking significantly increases the risk of serious side effects like blood clots, heart attack, and stroke.
  • Maintain a healthy diet and exercise routine.
  • Report any unusual or severe symptoms immediately to your healthcare provider.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally daily at the same time each day, starting on the first day of menstruation or the first Sunday after menstruation begins. Follow the specific regimen (e.g., 21 active tablets followed by 7 placebo tablets, or 24 active tablets followed by 4 placebo tablets).
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

missedDose: Refer to package insert for specific instructions based on number of missed doses and week in cycle. Generally, take missed dose as soon as remembered, and if multiple doses missed, use backup contraception.
postpartum: Initiate no earlier than 4 weeks postpartum in non-lactating women due to increased risk of thromboembolism. In lactating women, not recommended until weaning or at least 6 weeks postpartum.
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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 recommended.
Moderate: No specific adjustment recommended.
Severe: Not specifically studied; use with caution. Consider contraindication in severe renal impairment if associated with conditions that increase VTE risk.
Dialysis: Not specifically studied; use with caution.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: Contraindicated in women with acute or chronic liver disease with abnormal liver function.
Severe: Contraindicated in women with acute or chronic liver disease with abnormal liver function.
Confidence: High

Pharmacology

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Mechanism of Action

Combined oral contraceptives (COCs) primarily act by suppressing gonadotropins (FSH and LH), thereby inhibiting ovulation. Additional mechanisms include changes in the cervical mucus, which increases its viscosity and impedes sperm penetration, and alterations in the endometrium, which reduce the likelihood of implantation.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: Approximately 40-45% (due to significant first-pass metabolism). Desogestrel (as etonogestrel): Approximately 60-80%.
Tmax: Ethinyl Estradiol: 1-2 hours. Desogestrel (as etonogestrel): 1.5 hours.
FoodEffect: Food does not significantly affect the extent of absorption of desogestrel or ethinyl estradiol.

Distribution:

Vd: Ethinyl Estradiol: Approximately 5 L/kg. Etonogestrel: Approximately 200 L.
ProteinBinding: Ethinyl Estradiol: Approximately 98% (primarily to albumin). Etonogestrel: Approximately 95-98% (primarily to sex hormone-binding globulin [SHBG] and albumin).
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: Approximately 10-20 hours. Etonogestrel: Approximately 25-30 hours.
Clearance: Ethinyl Estradiol: Approximately 5 mL/min/kg. Etonogestrel: Approximately 10 L/hour.
ExcretionRoute: Both ethinyl estradiol and etonogestrel metabolites are excreted in urine and feces (bile).
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy begins after 7 consecutive days of active pill use if started on the first Sunday after menstruation. Immediate if started on Day 1 of menstruation.
PeakEffect: Steady-state concentrations typically reached within 3-5 days of daily dosing.
DurationOfAction: Daily dosing is required to maintain contraceptive efficacy.

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular events from combined 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, combined oral contraceptives, including Volnea, 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, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of gallbladder problems, such as:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ Severe upset stomach or vomiting
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Depression or other mood changes
Trouble sleeping
Feeling very tired or weak
Eyesight changes or loss
Bulging eyes
Changes in how contact lenses feel
Difficulty urinating or changes in urine output
Breast lump, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent vaginal bleeding or spotting
Swelling or fluid retention in the body (tell your doctor if you experience swelling, weight gain, or trouble breathing)

Blood Clots: Seek Medical Help Immediately

If you experience any of the following symptoms, contact your doctor right away, as they may indicate 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
Trouble speaking or swallowing

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Changes in appetite
Dizziness or headache
Weight gain or loss
Upset stomach or vomiting
Stomach pain or cramps
Bloating
Menstrual changes, including spotting or bleeding between cycles
Enlarged breasts
Tender breasts
Decreased interest in sex
Hair loss
* Feeling nervous and excitable

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:

  • ACHES: Abdominal pain (severe)
  • ACHES: Chest pain (severe), cough, shortness of breath
  • ACHES: Headaches (severe, sudden, or worse than usual, especially with vision changes)
  • ACHES: Eye problems (blurred vision, flashing lights, partial or complete loss of vision)
  • ACHES: Severe leg pain (calf or thigh), swelling, redness, or warmth
  • Jaundice (yellowing of skin or eyes)
  • Depressed mood or mood changes
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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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. 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
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ 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
+ Cancer of the cervix or vagina
+ Vaginal bleeding with an unknown cause
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir)
If you experienced jaundice (turned yellow) during pregnancy or while using estrogen-containing products, such as hormonal birth control
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
If you are breast-feeding or plan to breast-feed.

This is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your complete medical history

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety.
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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.

This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk with your doctor. If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, inform your doctor, as this can also increase the risk of 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, and report any signs of high blood sugar, such as confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.

High blood pressure has been reported in patients taking medications like this one. Have your blood pressure checked regularly, as advised by your doctor. Additionally, follow your doctor's instructions for regular blood tests and discuss any concerns with your doctor.

Regular breast exams and gynecology check-ups are crucial while taking this medication. Perform breast self-exams as instructed by your doctor. If you consume grapefruit juice or eat grapefruit frequently, inform your doctor, as this may interact with the medication.

This medication may affect certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication. It may also cause increased cholesterol and triglyceride levels; discuss this with your doctor.

Prolonged sun exposure may cause dark skin patches on your face while taking this medication. Avoid sun, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when outdoors.

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 need for additional non-hormonal birth control methods, such as condoms.

This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Use latex or polyurethane condoms during sex to reduce the risk of transmission. If you have questions, consult your doctor.

If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.

The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. Discuss any concerns with your doctor. Some studies suggest a potential increased risk of breast cancer associated with long-term use of hormone-based birth control, while others have not found this link. If you have questions, consult your doctor.

This medication is not intended for use 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
  • Vaginal bleeding (withdrawal bleeding may occur in females)

What to Do:

There is no specific antidote. Treatment is symptomatic and supportive. Contact a poison control center or emergency medical services immediately. Call 1-800-222-1222 for poison control.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (increased ALT levels)
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Major Interactions

  • CYP3A4 inducers (e.g., Carbamazepine, Phenytoin, Rifampin, Barbiturates, Topiramate, Griseofulvin, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
  • Lamotrigine (decreased lamotrigine plasma concentrations, potentially leading to loss of seizure control).
  • Hepatitis C antiviral combinations containing glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (potential for increased ALT).
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Moderate Interactions

  • CYP3A4 inhibitors (e.g., Azole antifungals like Ketoconazole, Itraconazole; Macrolide antibiotics like Erythromycin, Clarithromycin; Grapefruit juice) - may increase plasma concentrations of ethinyl estradiol and etonogestrel.
  • Atorvastatin, Rosuvastatin (may increase AUC of ethinyl estradiol).
  • Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
  • Acetaminophen - may increase ethinyl estradiol levels.
  • Thyroid hormone replacement therapy (may decrease thyroid hormone levels, requiring increased dose).
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Minor Interactions

  • Tricyclic antidepressants, Cyclosporine, Theophylline, Corticosteroids (COCs may increase plasma concentrations of these drugs).

Monitoring

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Baseline Monitoring

Complete medical history (including family history of cardiovascular disease, breast cancer)

Rationale: To identify contraindications and risk factors for adverse events.

Timing: Prior to initiation

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

Rationale: To assess overall health, identify contraindications, and establish baseline for future monitoring.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure

Frequency: Annually or more frequently if clinically indicated

Target: <140/90 mmHg

Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may necessitate discontinuation or change in contraception.

Weight

Frequency: Annually

Target: Stable or within healthy BMI range

Action Threshold: Significant unexplained weight gain or loss.

Breast Examination

Frequency: Annually

Target: Normal

Action Threshold: New lumps or changes.

Cervical Cancer Screening (Pap test)

Frequency: As per national guidelines (e.g., every 3-5 years)

Target: Normal

Action Threshold: Abnormal results requiring follow-up.

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Symptom Monitoring

  • Severe chest pain or shortness of breath (possible pulmonary embolism or myocardial infarction)
  • Sudden severe headache, weakness or numbness on one side of the body, speech disturbance (possible stroke)
  • Sudden partial or complete loss of vision (possible retinal thrombosis)
  • Severe pain, swelling, warmth, or redness in the leg (possible deep vein thrombosis)
  • Jaundice or severe abdominal pain (possible liver problems)
  • Migraine with aura (contraindication for continued use)
  • Unexplained vaginal bleeding

Special Patient Groups

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Pregnancy

Contraindicated. There is no indication for use of COCs in pregnancy, and there is evidence of fetal harm. Discontinue immediately if pregnancy is confirmed.

Trimester-Specific Risks:

First Trimester: Increased risk of congenital anomalies (e.g., limb reduction defects, cardiovascular defects) if exposure occurs during early pregnancy, though data are conflicting and overall risk is low.
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 infant. Non-hormonal methods or progestin-only methods are generally preferred during lactation.

Infant Risk: Low risk of adverse effects on the infant, but potential for decreased milk supply and altered milk composition.
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Pediatric Use

Not indicated before menarche. For post-menarcheal adolescents, dosing is the same as for adults. Safety and efficacy are expected to be similar to adults.

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Geriatric Use

Not indicated for post-menopausal women. Contraception is not needed in this population. Estrogen-progestin therapy for hormone replacement in post-menopausal women uses different formulations and indications.

Clinical Information

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Clinical Pearls

  • Emphasize the importance of taking the pill at the same time every day to maintain efficacy.
  • Counsel patients on the 'ACHES' warning signs of serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain).
  • Reinforce the absolute contraindication for women over 35 who smoke due to significantly increased cardiovascular risk.
  • Advise patients about potential drug interactions, especially with enzyme-inducing medications (e.g., certain antiepileptics, rifampin, St. John's Wort), which can reduce contraceptive efficacy.
  • Discuss the need for backup contraception (e.g., condoms) during the first 7 days of use if starting on the first Sunday after menstruation, or if pills are missed.
  • Inform patients that COCs do not protect against HIV/AIDS or other sexually transmitted infections (STIs).
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Alternative Therapies

  • Progestin-only pills (mini-pill)
  • Progestin implant (e.g., Nexplanon)
  • Progestin IUD (e.g., Mirena, Skyla, Kyleena, Liletta)
  • Copper IUD (e.g., Paragard)
  • Depot medroxyprogesterone acetate injection (e.g., Depo-Provera)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Natural family planning/fertility awareness methods
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $20 - $100+ per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generics often Tier 1, brands Tier 2 or 3)
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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 safe and effective 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.