Desogen 0.15mg-30mcg Tabs28s
Overview
What is this medicine?
How to Use This Medicine
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.
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).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
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: 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.
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
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. 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.
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. 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.
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
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
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.
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.
Minor Interactions
- Acetaminophen - may increase ethinyl estradiol levels.
- Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
Monitoring
Baseline Monitoring
Rationale: To identify contraindications and risk factors for adverse events.
Timing: Prior to initiation of therapy.
Rationale: To identify pre-existing hypertension, which is a contraindication or risk factor.
Timing: Prior to initiation of therapy.
Rationale: To assess overall health and rule out gynecological conditions.
Timing: Prior to initiation of therapy, as clinically indicated.
Routine Monitoring
Frequency: Annually
Target: <140/90 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 and potential discontinuation.
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
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:
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.
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.
Geriatric Use
Not indicated for use in post-menopausal women. Safety and efficacy have not been established in this population.
Clinical Information
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.
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)