Azurette Tablets 28s

Manufacturer MAYNE 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
Contraceptive, Oral
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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?

Azurette is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and 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 must be taken daily to be effective.
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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.

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.
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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).
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally once daily at the same time each day, starting on the first day of menstruation or the first Sunday after menstruation begins. Follow the 21-day active tablet/7-day inactive tablet regimen.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

missedDose: If one active tablet is missed, take it as soon as remembered and take the next tablet at the usual time. If two or more active tablets are missed, refer to package insert for specific instructions based on week of cycle.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: One tablet orally once daily at the same time each day, starting on the first day of menstruation or the first Sunday after menstruation begins. Use in post-menarcheal females.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed

Hepatic Impairment:

Mild: Use with caution
Moderate: Contraindicated
Severe: Contraindicated

Pharmacology

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Mechanism of Action

Combination oral contraceptives (COCs) act primarily by suppressing gonadotropins, which in turn inhibits ovulation. Other mechanisms include changes in the cervical mucus (increasing its viscosity to impede sperm penetration) and alterations in the endometrium (rendering it unfavorable for implantation). Ethinyl estradiol provides the estrogenic component, while desogestrel (a progestin) provides the progestational effects.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-60%; Desogestrel (as 3-keto-desogestrel): ~76%
Tmax: Ethinyl Estradiol: 1-2 hours; Desogestrel (as 3-keto-desogestrel): 1.5 hours
FoodEffect: Food may slightly decrease Cmax for ethinyl estradiol but does not significantly affect bioavailability. No significant effect on desogestrel.

Distribution:

Vd: Ethinyl Estradiol: ~4.3 L/kg; Desogestrel (as 3-keto-desogestrel): ~1.5 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (primarily to albumin); Desogestrel (as 3-keto-desogestrel): ~95-98% (primarily to sex hormone-binding globulin [SHBG] and albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: ~18-24 hours; Desogestrel (as 3-keto-desogestrel): ~30 hours
Clearance: Ethinyl Estradiol: ~5-13 mL/min/kg; Desogestrel (as 3-keto-desogestrel): Not readily available, but primarily hepatic
ExcretionRoute: Ethinyl Estradiol: Renal (40%) and Fecal (60%); Desogestrel (as 3-keto-desogestrel): Renal (60%) and Fecal (40%)
Unchanged: Ethinyl Estradiol: <2%; Desogestrel: Negligible
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy begins after 7 consecutive days of active tablet use, if started on the first day of menstruation, immediate protection. If started on Sunday after menstruation, backup method for 7 days.
PeakEffect: Steady-state concentrations typically reached within 3-4 days of daily dosing.
DurationOfAction: Daily dosing required for continuous contraceptive 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 Azurette, 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, 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.
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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)
  • 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
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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 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.
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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 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.
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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

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Contraindicated Interactions

  • Ombitasvir/paritaprevir/ritonavir with or without dasabuvir (increased ALT levels)
  • Glecaprevir/pibrentasvir (increased ALT levels)
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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).
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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).
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Minor Interactions

  • Acetaminophen (may increase ethinyl estradiol levels slightly).
  • Ascorbic acid (Vitamin C) (may increase ethinyl estradiol levels slightly).

Monitoring

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Baseline Monitoring

Complete medical history (including family history)

Rationale: To identify contraindications, risk factors for cardiovascular disease, thromboembolism, and other conditions.

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

Target: <120/80 mmHg

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

Annual physical examination (including breast exam, Pap test as per guidelines)

Frequency: Annually

Target: Normal findings

Action Threshold: Abnormal findings require further investigation.

Weight/BMI

Frequency: Annually

Target: Healthy range

Action Threshold: Significant weight gain may increase cardiovascular risk.

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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

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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:

First Trimester: Potential for adverse effects on fetal development, though data on specific risks are limited and conflicting for inadvertent exposure.
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 their metabolites are excreted in breast milk. Consider progestin-only methods or non-hormonal methods if breastfeeding.

Infant Risk: Potential for adverse effects on the infant, including jaundice and breast enlargement. Long-term effects on the breastfed infant have not been fully determined.
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Pediatric Use

Indicated for contraception in post-menarcheal females. Safety and efficacy are expected to be similar to adult women. Not indicated before menarche.

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Geriatric Use

Not indicated for use in postmenopausal women. Risk of cardiovascular events increases with age, particularly over 35 years.

Clinical Information

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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.
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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)
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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 may be Tier 2 or 3)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.