Isibloom 0.15mg-0.03mg 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-ol & 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
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Pharmacologic Class
Estrogen and Progestin Combination
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Pregnancy Category
Category X
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FDA Approved
Jul 1992
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Isibloom is a birth control pill that contains two types of hormones, estrogen (ethinyl estradiol) and progestin (desogestrel). It works by preventing your body from releasing an egg (ovulation) and by making it harder for sperm to reach the egg or for a fertilized egg to implant in the womb. When taken correctly, it is a very effective method of preventing pregnancy.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from this medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.

Take your medication at the same time every day.
You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
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 instructions regarding the use of 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, this medication may not be as effective in preventing pregnancy. 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 the 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 taking this medication to prevent pregnancy, 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 one 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 smoking significantly increases the risk of serious side effects like blood clots, heart attack, and stroke.
  • This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms for STI protection.
  • Discuss all medications, including over-the-counter drugs, herbal supplements (especially St. John's Wort), and recreational drugs, with your doctor, as they can interact with birth control pills.
  • If you experience severe vomiting or diarrhea, the effectiveness of the pill may be reduced; use a backup birth control method.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally once daily for 28 consecutive days, starting on the first day of menstrual bleeding or the first Sunday after onset of menstruation. The first 21 tablets contain active ingredients, followed by 7 inert tablets.
Dose Range: 0.15 - 0.03 mg

Condition-Specific Dosing:

missedDose: If one active tablet is missed, take it as soon as remembered and the next tablet at the usual time. If two or more active tablets are missed, refer to package insert for specific instructions, which usually involve taking the last missed tablet, discarding others, and using backup contraception.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Indicated for post-menarcheal females for contraception. Dosing is the same as adults.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: Use with caution; no specific dose adjustment guidelines, but monitor for fluid retention.
Dialysis: Considerations: Not specifically studied, but generally not recommended due to potential for fluid retention and cardiovascular risk.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Contraindicated due to impaired steroid metabolism.
Severe: Contraindicated due to impaired steroid metabolism.

Pharmacology

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Mechanism of Action

Combined oral contraceptives (COCs) primarily act by suppressing gonadotropins (FSH and LH), which in turn inhibits ovulation. Additional mechanisms include changes in the cervical mucus, increasing its viscosity to impede sperm penetration, and alterations in the endometrium, making it less receptive to implantation.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-60%; Desogestrel (as etonogestrel): ~80%
Tmax: Ethinyl Estradiol: 1.5-2 hours; Etonogestrel (active metabolite of desogestrel): 1.5-12 hours
FoodEffect: Food does not significantly affect the rate or extent of absorption.

Distribution:

Vd: Ethinyl Estradiol: ~5 L/kg; Etonogestrel: ~1.5 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (to albumin); Etonogestrel: ~95-98% (to albumin and sex hormone-binding globulin [SHBG])
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: ~18-24 hours; Etonogestrel: ~25-30 hours
Clearance: Ethinyl Estradiol: ~5-13 mL/min/kg; Etonogestrel: ~10 mL/min
ExcretionRoute: Renal (urine) and Fecal (bile)
Unchanged: Ethinyl Estradiol: <5%; Etonogestrel: <1%
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically begins after 7 consecutive days of active pill use. Full protection is usually achieved after the first full cycle.
PeakEffect: Peak suppression of ovulation occurs within the first cycle of consistent use.
DurationOfAction: Daily dosing maintains therapeutic levels for continuous contraceptive effect.

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 Isibloom, 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 immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellowing of the skin or eyes (jaundice).
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellowing of the skin or eyes (jaundice), fever with chills, bloating, or severe stomach upset or vomiting.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Weakness or numbness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Depression or mood changes.
Difficulty sleeping.
Feeling extremely tired or weak.
Changes in vision or loss of vision, bulging eyes, or changes in how contact lenses feel.
Urination problems, such as inability to pass urine or changes in urine output.
Breast changes: lump, pain, soreness, or nipple discharge.
Vaginal itching or discharge.
Severe or persistent vaginal bleeding or spotting.
Fluid retention, swelling, weight gain, or difficulty breathing.

Other Potential Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to report any concerns to your doctor. If you experience any of the following side effects, contact your doctor if they bother you or do not resolve:

Changes in appetite.
Dizziness or headache.
Weight gain or loss.
Stomach upset or vomiting.
Stomach pain or cramps.
Bloating.
Menstrual changes, such as spotting or bleeding between cycles.
Breast changes: enlargement, tenderness, or reduced interest in sex.
Hair loss.
Feeling nervous or excitable.

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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, loss of vision)
  • S: Severe leg pain (calf or thigh), swelling, redness, 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:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of certain health conditions, such as:
+ 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, or abnormal heart rhythms like atrial fibrillation
+ Angina (chest pain), heart attack, or 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, cervical cancer, vaginal cancer, or unexplained vaginal bleeding
Recent use of certain medications, such as ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir), within the past 2 weeks
If you have ever experienced jaundice (yellowing of the skin and eyes) 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 your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first 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 this risk with your doctor. If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, talk to 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 associated with medications like this one. Have your blood pressure checked regularly, as advised by your doctor. Additionally, have blood work done as directed 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 this may interact with the medication.

This medication may affect certain laboratory tests. Inform all your healthcare providers and lab personnel that you are taking this drug. It may also cause high 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 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-hormone 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, talk to 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 (vaginal bleeding)

What to Do:

Overdose is generally not life-threatening. Treatment is symptomatic. Call 1-800-222-1222 (Poison Control) for advice if a large overdose is suspected.

Drug Interactions

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Contraindicated Interactions

  • Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (risk of ALT elevations)
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, primidone, topiramate, St. John's Wort) due to reduced contraceptive efficacy and increased breakthrough bleeding.
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Major Interactions

  • Lamotrigine (reduced lamotrigine plasma concentrations, potentially leading to loss of seizure control)
  • Griseofulvin (reduced contraceptive efficacy)
  • Certain HIV protease inhibitors (e.g., nelfinavir, ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine, efavirenz) (variable effects on COC levels, potential for reduced efficacy or increased adverse effects)
  • Bosentan (reduced contraceptive efficacy)
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Moderate Interactions

  • Antibiotics (e.g., ampicillin, tetracycline): While widely cited, clinical evidence for reduced COC efficacy is weak for most antibiotics, except for rifampin. Backup method often recommended during and for 7 days after short-term antibiotic use.
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, grapefruit juice): May increase plasma concentrations of ethinyl estradiol and desogestrel/etonogestrel, potentially increasing adverse effects.
  • Thyroid hormone replacement therapy (e.g., levothyroxine): COCs can increase thyroid-binding globulin, requiring increased thyroid hormone dose.
  • Cyclosporine, prednisolone, theophylline, tizanidine: COCs may increase plasma concentrations of these drugs, requiring dose adjustment.
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Minor Interactions

  • Acetaminophen: May increase ethinyl estradiol levels.
  • Ascorbic acid (Vitamin C): May increase ethinyl estradiol levels.

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 COC use.

Timing: Prior to initiation of therapy

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

Rationale: To establish baseline health status and screen for conditions that may contraindicate COC use.

Timing: Prior to initiation of therapy

Lipid profile (cholesterol, triglycerides)

Rationale: To assess baseline cardiovascular risk, especially in patients with family history of dyslipidemia or cardiovascular disease.

Timing: Prior to initiation of therapy (optional, based on risk factors)

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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 contraceptive method.

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

Frequency: Annually

Target: Normal findings

Action Threshold: Abnormal findings require further investigation and potential discontinuation of COC.

Review of adverse effects and adherence

Frequency: At each follow-up visit (e.g., annually)

Target: Not applicable

Action Threshold: Significant or persistent adverse effects may warrant discontinuation or change in COC.

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Symptom Monitoring

  • Severe abdominal pain (especially sudden, severe, or radiating)
  • Chest pain (sudden, severe, or radiating), shortness of breath, coughing up blood
  • Severe headaches (sudden, unusually severe, or associated with neurological symptoms)
  • Eye problems (sudden partial or complete loss of vision, double vision, bulging eyes)
  • Severe leg pain (sudden, swelling, warmth, redness, especially in one leg)
  • Jaundice (yellowing of skin or eyes), dark urine, light-colored stools (signs of liver problems)
  • Mood changes, depression

Special Patient Groups

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Pregnancy

Contraindicated in pregnancy. There is no indication for COC use in pregnancy, and there is no evidence of teratogenicity from inadvertent exposure during early pregnancy.

Trimester-Specific Risks:

First Trimester: No increased risk of birth defects has been found with 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 during lactation. Estrogens can decrease the quantity and quality of breast milk. Small amounts of contraceptive steroids and/or metabolites are excreted in breast milk.

Infant Risk: Potential for adverse effects on the infant, including jaundice and breast enlargement. Consider progestin-only methods or non-hormonal methods if breastfeeding.
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Pediatric Use

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

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Geriatric Use

Not indicated for postmenopausal women. Contraception is not needed, and hormone replacement therapy (HRT) formulations are more appropriate for menopausal symptoms.

Clinical Information

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Clinical Pearls

  • Adherence is crucial for efficacy; missing pills, especially early in a cycle or at the end of the active pills, significantly increases the risk of pregnancy.
  • Always advise patients on backup contraception (e.g., condoms) for the first 7 days of the first cycle, or if pills are missed, or if interacting medications are used.
  • Counsel patients on the ACHES warning signs of serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain).
  • Breakthrough bleeding is common, especially during the first few cycles, and usually resolves. It does not necessarily indicate reduced efficacy if pills are taken correctly.
  • COCs can improve acne and reduce menstrual pain and heavy bleeding in some women.
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Alternative Therapies

  • Progestin-only pills (mini-pill)
  • Progestin injections (e.g., Depo-Provera)
  • Progestin implants (e.g., Nexplanon)
  • Intrauterine devices (IUDs - hormonal or copper)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Natural family planning methods
  • Permanent contraception (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $20 - $60 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'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 medication taken, the amount, and the time it happened.