Desogen 0.15mg-30mcg Tabs28s

Manufacturer ORGANON 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
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Pharmacologic Class
Estrogen/Progestin Combination
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Pregnancy Category
Category X
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FDA Approved
Sep 1992
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Desogen is a birth control pill that contains two female hormones, an estrogen (ethinyl estradiol) and a progestin (desogestrel). It works primarily by preventing your ovaries from releasing an egg (ovulation). It also thickens the mucus in your cervix, making it harder for sperm to reach an egg, and changes the lining of your uterus to prevent a fertilized egg from implanting.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from this medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.

Take this medication at the same time every day to establish a routine.
You can take this medication with or without food. However, if it causes stomach upset, taking it with food may help alleviate this issue.
After starting this medication, you may need to use a non-hormonal form of birth control, such as condoms, for a period 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 you take this medication to ensure proper absorption.
Do not skip doses, even if you don't have sex frequently. Consistency is crucial to maintain the medication's effectiveness.
If you experience vomiting or diarrhea, the medication may not work as well to prevent pregnancy. In such cases, use an additional form of birth control, like 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

To maintain the medication's potency and safety:
Store it at room temperature in a dry place.
* Avoid storing it in a bathroom, where moisture and temperature fluctuations can affect the medication.

What to Do If You Miss a Dose

If you miss a dose, refer to the package insert or contact your doctor for guidance on what to do next. If you're using this medication for birth control, you may need to use a non-hormonal form of birth control, such as condoms, for a period to prevent pregnancy.
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Lifestyle & Tips

  • Take one pill at the same time every day to maximize effectiveness and maintain cycle control.
  • Do not smoke, especially if you are over 35 years old, as this significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
  • Use a backup method of birth control (like condoms) for the first 7 days of your first pack of pills.
  • This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs).
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally daily at the same time each day for 28 consecutive days, starting on the first day of menstrual bleeding or the first Sunday after the onset of menstruation.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

missed_dose_1_pill: Take as soon as remembered, then continue daily as usual. No backup method needed.
missed_dose_2_pills_in_week_1_or_2: Take 2 pills on the day remembered and 2 pills the next day. Use backup contraception for 7 days. Continue daily as usual.
missed_dose_2_pills_in_week_3: Discard the rest of the pack and start a new pack the same day (Day 1 start) or Sunday (Sunday start). Use backup contraception for 7 days.
missed_dose_3_or_more_pills: Discard the rest of the pack and start a new pack the same day (Day 1 start) or Sunday (Sunday start). Use backup contraception for 7 days.
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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 dose adjustment recommended, but monitor for fluid retention.
Moderate: No specific dose adjustment recommended, but monitor for fluid retention.
Severe: Use with caution; monitor for fluid retention and potential electrolyte imbalances.
Dialysis: Use with caution; monitor for fluid retention and potential electrolyte imbalances. Consult specialist.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Contraindicated in acute or severe liver disease.
Severe: Contraindicated.

Pharmacology

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Mechanism of Action

Combination oral contraceptives (COCs) primarily act by suppressing gonadotropins (luteinizing hormone and follicle-stimulating hormone), which in turn inhibits ovulation. They also induce changes in the cervical mucus, making it less permeable to sperm, and alter the endometrium, reducing the likelihood of implantation.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-60%; Etonogestrel (active metabolite of Desogestrel): ~62-81%
Tmax: Ethinyl Estradiol: ~1.5-2 hours; Etonogestrel: ~1.5 hours
FoodEffect: Minimal effect on absorption.

Distribution:

Vd: Etonogestrel: ~200 L
ProteinBinding: Ethinyl Estradiol: Highly bound to albumin; Etonogestrel: Highly bound to sex hormone-binding globulin (SHBG) and albumin.
CnssPenetration: Limited data, but steroid hormones can cross the blood-brain barrier.

Elimination:

HalfLife: Ethinyl Estradiol: ~18-24 hours; Etonogestrel: ~25-30 hours
Clearance: Not readily available for combination products, varies by individual.
ExcretionRoute: Both Ethinyl Estradiol and Etonogestrel metabolites are primarily excreted in urine and feces.
Unchanged: <1% (Ethinyl Estradiol); <1% (Etonogestrel)
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy is achieved after 7 consecutive days of active pill use.
PeakEffect: Sustained hormonal levels are maintained with daily dosing.
DurationOfAction: Daily dosing is required to maintain 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 Desogen, 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 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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin or eyes, fever with chills, bloating, or severe upset stomach or vomiting
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or 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
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

This medication may cause fluid retention, leading to swelling, weight gain, or breathing difficulties. If you experience any of these symptoms, inform your doctor.

Blood Clots: Seek Medical Help Right Away

If you notice any of the following symptoms, contact your doctor immediately, as they may indicate a blood clot:

Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Trouble speaking or swallowing

Other 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 persist:

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:

  • A: Abdominal pain (severe)
  • C: Chest pain (severe), cough, shortness of breath
  • H: Headaches (severe, sudden, or worse than usual)
  • E: Eye problems (sudden vision loss or blurring)
  • S: Severe leg pain (calf or thigh), swelling, redness, or 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, 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)
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
* Breast-feeding or plans to breast-feed

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. Ensure that it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and 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. If you need to stop taking this medication, your doctor will provide guidance on when to resume taking it after your surgery or procedure.

Blood Clots, Stroke, and Heart Attack

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.

Diabetes

If you have high blood sugar (diabetes), inform your doctor, as this medication may raise 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, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.

Blood Pressure and Lab Tests

High blood pressure has been reported 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.

Breast and Gynecologic Health

Regular breast exams and gynecology check-ups are crucial while taking this medication. Perform breast self-exams as instructed by your doctor.

Grapefruit Juice and Sun Exposure

If you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor. Avoid excessive sun exposure, sunlamps, and tanning beds, as this medication may cause dark skin patches on your face. Use sunscreen and protective clothing and eyewear when going outside.

Lab Tests and Interactions

This medication may affect certain lab tests. Inform all your healthcare providers and lab workers that you are taking this medication. Certain medications, herbal products, or health conditions may interfere with 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.

Sexually Transmitted Diseases

This medication does not protect against diseases like HIV or hepatitis that can be transmitted through sexual contact. Always use a latex or polyurethane condom during sex. If you have questions, consult your doctor.

Allergies and Sensitivities

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

Cancer Risks

Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, although other studies have not confirmed this association. Additionally, 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.

Pediatric Use and Pregnancy

This medication should not be used in children who have not 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 (e.g., 1-800-222-1222) or seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

  • Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (risk of ALT elevations)
  • Certain anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital, primidone, topiramate, oxcarbazepine, felbamate) due to enzyme induction
  • Rifampin
  • St. John's Wort
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Major Interactions

  • CYP3A4 inducers (e.g., bosentan, griseofulvin, rufinamide, modafinil, some protease inhibitors, some non-nucleoside reverse transcriptase inhibitors) - may decrease contraceptive efficacy.
  • Lamotrigine - COCs can significantly decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
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Moderate Interactions

  • CYP3A4 inhibitors (e.g., azole antifungals like ketoconazole, itraconazole; macrolide antibiotics like erythromycin, clarithromycin; grapefruit juice) - may increase estrogen/progestin levels, potentially increasing side effects.
  • Thyroid hormone replacement therapy - COCs can increase thyroid-binding globulin, requiring increased thyroid hormone dose.
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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 of VTE, breast cancer)

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

Timing: Prior to initiation of therapy.

Blood pressure measurement

Rationale: To identify pre-existing hypertension, which is a contraindication or risk factor.

Timing: Prior to initiation of therapy.

Physical examination (including breast and pelvic exam, Pap test)

Rationale: To assess overall health and rule out gynecological conditions.

Timing: Prior to initiation of therapy, as clinically indicated.

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Routine Monitoring

Blood pressure measurement

Frequency: Annually

Target: <140/90 mmHg

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

Annual physical examination (including breast and pelvic exam, Pap test)

Frequency: Annually

Target: Normal findings

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

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Symptom Monitoring

  • Severe abdominal pain (possible liver tumor, blood clot)
  • Chest pain, shortness of breath, coughing up blood (possible pulmonary embolism)
  • Severe headaches, sudden partial or complete loss of vision, speech disturbances, weakness or numbness in an arm or leg (possible stroke)
  • Severe leg pain, swelling, warmth, redness (possible deep vein thrombosis)
  • Yellowing of skin or eyes (jaundice, possible liver problems)
  • Breast lumps
  • Unusual vaginal bleeding or spotting (especially if persistent or heavy)

Special Patient Groups

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Pregnancy

Desogen is contraindicated during pregnancy (Pregnancy Category X). There is no indication for use in pregnancy, and there is evidence of fetal risk. If pregnancy occurs during use, discontinue immediately.

Trimester-Specific Risks:

First Trimester: Potential for adverse effects on fetal development, though data on specific risks from inadvertent exposure are limited and often reassuring for major malformations.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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Lactation

Not recommended for use during lactation, especially during the first 6 weeks postpartum or until breastfeeding is well established. Estrogens can decrease the quantity and quality of breast milk. Small amounts of hormonal steroids are excreted in breast milk.

Infant Risk: L3 (Moderately Safe). Potential for decreased milk supply and transfer of hormones to the infant. Monitor breastfed infants for adverse effects such as jaundice or breast enlargement.
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Pediatric Use

Not indicated for use in pre-menarcheal females. For post-menarcheal adolescents, the safety and efficacy are expected to be similar to adults.

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Geriatric Use

Not indicated for use in post-menopausal women. Safety and efficacy have not been established in this population.

Clinical Information

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Clinical Pearls

  • Consistent daily use at the same time is crucial for contraceptive efficacy. Missing pills, especially active pills, increases the risk of pregnancy.
  • Vomiting or severe diarrhea within 3-4 hours of taking an active pill may reduce absorption; consider it a missed pill and follow instructions for missed doses.
  • The risk of venous thromboembolism (VTE) is highest during the first year of COC use and after restarting COCs following a break of 4 weeks or more.
  • Inform patients about the ACHES warning signs of serious adverse events and advise them to seek immediate medical attention if they experience any.
  • COCs can improve symptoms of dysmenorrhea and acne in some women, though these are not primary indications for Desogen.
  • Always rule out pregnancy before initiating or restarting COCs.
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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 or copper)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Fertility awareness-based methods
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $50 - $100+ per 28 tablets (1 cycle)
Generic Available: Yes
Insurance Coverage: Generics are typically covered as Tier 1 or Tier 2. Brand-name Desogen may be Tier 3 or require prior authorization.
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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 your 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.