Azurette 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 alleviate 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 effectiveness of this medication in preventing pregnancy may be reduced. In such cases, 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 consult 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
- Take the pill at the same time every day to maximize effectiveness and minimize breakthrough bleeding.
- Do not smoke, especially if you are over 35 years old, as this significantly increases the risk of serious side effects like blood clots.
- Use a backup method of birth control (like condoms) if you miss pills, are taking certain medications (e.g., antibiotics, anticonvulsants), or have severe vomiting/diarrhea.
- 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, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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 or changes in eyesight
Neurological symptoms, such as:
+ 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 extremely tired or weak
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine output
Breast-related symptoms, including:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal symptoms, such as:
+ Itching or discharge
+ Severe or persistent spotting or vaginal bleeding
Fluid retention, which may cause:
+ Swelling
+ Weight gain
+ Trouble breathing
Signs of a blood clot, including:
+ 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 notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Appetite changes
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:
- A - Abdominal pain (severe)
- C - Chest pain (severe), cough, shortness of breath
- H - Headaches (severe, sudden, or worse than usual)
- E - Eye problems (blurred vision, flashing lights, partial or complete loss of vision)
- S - Severe leg pain (calf or thigh), swelling, warmth, or redness
- Yellowing of the skin or eyes (jaundice)
- Dark urine or pale stools
- Lump in the breast
Before Using This Medicine
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, 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
+ 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 health conditions, including:
+ Endometrial cancer
+ Cervical or vaginal cancer
+ Unexplained vaginal bleeding
Recent use of certain medications, such as ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir), within the past 2 weeks
A history of jaundice (turning yellow) during pregnancy or while using estrogen-containing products, such as hormonal birth control
Pregnancy or potential pregnancy: Do not take this medication if you are pregnant
* Breastfeeding or plans to breastfeed
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss these potential risks with your doctor. If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, consult with your doctor, as prolonged inactivity may increase the risk of blood clots.
If you have diabetes (high blood sugar), inform your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar levels 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 associated with medications like this one. Have your blood pressure checked regularly, as advised by your doctor. Additionally, undergo blood tests as recommended by your doctor, and discuss the results with them.
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 it may interact with this 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 elevated cholesterol and triglyceride levels; discuss this with your doctor.
Prolonged use of this medication may lead to dark skin patches on your face. Avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside.
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 sexual activity to reduce the risk of transmission. If you have questions or concerns, consult with 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 attributed 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 with 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
- Withdrawal bleeding (in females)
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. In case of suspected overdose, contact a poison control center or emergency medical services immediately. Call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Ombitasvir/paritaprevir/ritonavir with or without dasabuvir (increased ALT levels)
- Glecaprevir/pibrentasvir (increased ALT levels)
Major Interactions
- CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, Topiramate, Griseofulvin, Bosentan, Modafinil, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
- HIV Protease Inhibitors (e.g., Ritonavir, Nelfinavir) - may alter COC concentrations.
- Non-nucleoside Reverse Transcriptase Inhibitors (e.g., Nevirapine, Efavirenz) - may alter COC concentrations.
- Lamotrigine (decreased lamotrigine levels, loss of seizure control).
Moderate Interactions
- CYP3A4 inhibitors (e.g., Azole antifungals like Ketoconazole, Itraconazole; Macrolide antibiotics like Erythromycin, Clarithromycin) - may increase COC concentrations, potentially increasing adverse effects.
- Grapefruit juice (may increase ethinyl estradiol levels slightly).
- Thyroid hormone replacement therapy (may increase thyroid-binding globulin, requiring increased thyroid hormone dose).
Minor Interactions
- Acetaminophen (may increase ethinyl estradiol levels slightly).
- Ascorbic acid (Vitamin C) (may increase ethinyl estradiol levels slightly).
Monitoring
Baseline Monitoring
Rationale: To identify contraindications, risk factors for cardiovascular disease, thromboembolism, and other conditions.
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
Target: <120/80 mmHg
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may require discontinuation or change in contraceptive method.
Frequency: Annually
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Frequency: Annually
Target: Healthy range
Action Threshold: Significant weight gain may increase cardiovascular risk.
Symptom Monitoring
- Severe abdominal pain (A)
- Severe chest pain, shortness of breath, or coughing up blood (C)
- Severe headaches (H)
- Eye problems (blurred vision, loss of vision) (E)
- Severe leg pain (calf or thigh), swelling, warmth, or redness (S)
- Jaundice (yellowing of skin or eyes)
- Mood changes, depression
- New or worsening migraines
Special Patient Groups
Pregnancy
Contraindicated. There is no indication for use in pregnancy, and there is evidence of fetal risk. Discontinue 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 their metabolites are excreted in breast milk. Consider progestin-only methods or non-hormonal methods if breastfeeding.
Pediatric Use
Indicated for contraception in post-menarcheal females. Safety and efficacy are expected to be similar to adult women. Not indicated before menarche.
Geriatric Use
Not indicated for use in postmenopausal women. Risk of cardiovascular events increases with age, particularly over 35 years.
Clinical Information
Clinical Pearls
- Adherence is key: Taking the pill at the same time every day significantly improves efficacy. Missing pills, especially early or late in the cycle, increases the risk of pregnancy.
- Smoking cessation is critical: Counsel all patients, especially those over 35, about the significantly increased risk of serious cardiovascular events with COC use and smoking.
- Drug interactions: Always inquire about all concomitant medications, including over-the-counter drugs, herbal supplements (e.g., St. John's Wort), and new prescriptions, as many can reduce COC efficacy.
- Breakthrough bleeding: Common, especially in the first few cycles. Usually resolves spontaneously. If persistent or heavy, evaluate for other causes or consider a different formulation.
- Emergency contraception: Advise patients on options for emergency contraception if pills are missed or other contraceptive methods fail.
- Not for STI prevention: Emphasize that COCs do not protect against sexually transmitted infections; condoms are necessary for STI prevention.
Alternative Therapies
- 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 and non-hormonal)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Natural family planning methods
- Sterilization (tubal ligation, vasectomy)