Volnea Tablets 28s
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 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.
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.
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 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.
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
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (increased ALT levels)
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).
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).
Minor Interactions
- Tricyclic antidepressants, Cyclosporine, Theophylline, Corticosteroids (COCs may increase plasma concentrations of these drugs).
Monitoring
Baseline Monitoring
Rationale: To identify contraindications and risk factors for adverse events.
Timing: Prior to initiation
Rationale: To assess overall health, identify contraindications, and establish baseline for future monitoring.
Timing: Prior to initiation
Routine Monitoring
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.
Frequency: Annually
Target: Stable or within healthy BMI range
Action Threshold: Significant unexplained weight gain or loss.
Frequency: Annually
Target: Normal
Action Threshold: New lumps or changes.
Frequency: As per national guidelines (e.g., every 3-5 years)
Target: Normal
Action Threshold: Abnormal results requiring follow-up.
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
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:
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.
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.
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
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).
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)