Zenatane 10mg Capsules
WARNING: Do not take if you are pregnant or may get pregnant. The risk of severe and sometimes deadly birth defects is very high if you take this drug at any time while you are pregnant. Any unborn baby can be harmed. There is no good way to tell if an unborn baby has been harmed. The risk of losing an unborn baby is also raised, and premature births have happened. Talk with your doctor before you start this drug. If you know all the facts and can follow how to take this drug, you must sign a patient fact/consent form. Do not sign the form and do not take this drug if you do not know everything on the form.You must have 2 pregnancy tests that show you are NOT pregnant before starting this drug. You must have pregnancy tests done while taking this drug. Talk with your doctor.You must either use 2 kinds of birth control or commit to not having any sex that could cause pregnancy while taking this drug. You must do this for 1 month before starting this drug, during treatment, and for at least 1 month after the last dose. Talk about this with your doctor.If you get pregnant while taking this drug or within 1 month after your last dose, call your doctor right away. @ COMMON USES: It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid
Pregnancy Category
Category X
FDA Approved
May 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Isotretinoin is a powerful medication used to treat severe acne that hasn't responded to other treatments. It works by reducing the oil glands in your skin, which helps clear up acne. It's very effective but has serious side effects, especially if you get pregnant while taking it.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Some medications work best when taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist.
When taking your medication:
Swallow the tablet whole - do not chew, break, or crush it.
Take it with a full glass of water.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. You will typically receive a one-month supply of medication at a time. Keep in mind that your skin may appear to worsen before it improves.
It's essential to monitor your weight while taking this medication, as changes may require a dose adjustment. Inform your doctor if you experience any weight fluctuations.
If you have an allergy to tartrazine (FD&C Yellow No. 5), discuss this with your doctor, as some products contain this ingredient.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, protected from light.
Keep it in a dry place, avoiding storage in a bathroom.
* Ensure all medications are kept in a secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Some medications work best when taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist.
When taking your medication:
Swallow the tablet whole - do not chew, break, or crush it.
Take it with a full glass of water.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. You will typically receive a one-month supply of medication at a time. Keep in mind that your skin may appear to worsen before it improves.
It's essential to monitor your weight while taking this medication, as changes may require a dose adjustment. Inform your doctor if you experience any weight fluctuations.
If you have an allergy to tartrazine (FD&C Yellow No. 5), discuss this with your doctor, as some products contain this ingredient.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, protected from light.
Keep it in a dry place, avoiding storage in a bathroom.
* Ensure all medications are kept in a secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Do NOT become pregnant while taking this medication or for one month after stopping it. Use two reliable forms of birth control.
- Do NOT donate blood during treatment and for at least one month after stopping treatment, as your blood could be given to a pregnant woman.
- Avoid sun exposure and use sunscreen (SPF 30+) and protective clothing, as your skin will be more sensitive to the sun.
- Avoid waxing, dermabrasion, and laser skin treatments during and for at least 6 months after treatment, as your skin will be fragile and prone to scarring.
- Use moisturizers and lip balm regularly to combat severe dryness of skin and lips.
- Avoid alcohol, especially if you have high triglycerides.
- Do NOT take Vitamin A supplements.
- Do NOT share this medication with anyone else.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 to 1 mg/kg/day orally, divided into two doses, for 15 to 20 weeks. A second course may be initiated if necessary after a 2-month off-treatment period.
Dose Range:
0.5 - 2 mg
Condition-Specific Dosing:
severe recalcitrant nodular acne:
Initial dose 0.5 mg/kg/day. Dose may be increased to 1.0 mg/kg/day if severe cystic acne or primarily truncal acne. Max 2 mg/kg/day for very severe disease or if initial dose is well tolerated and response is inadequate. Cumulative dose target is 120-150 mg/kg.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (generally not recommended for children under 12 years of age or before puberty)
Adolescent:
0.5 to 1 mg/kg/day orally, divided into two doses, for 15 to 20 weeks, similar to adult dosing for severe recalcitrant nodular acne.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment, but use with caution.
Moderate:
Use with caution, consider lower initial dose (e.g., 0.5 mg/kg/day or less).
Severe:
Contraindicated or use with extreme caution and close monitoring due to potential for increased systemic exposure and toxicity.
Dialysis:
Considerations: Not well studied, generally avoided. If used, extreme caution and close monitoring.
Hepatic Impairment:
Mild:
Use with caution, monitor liver function tests closely.
Moderate:
Use with caution, consider lower initial dose and close monitoring. May be contraindicated.
Severe:
Contraindicated due to extensive hepatic metabolism and risk of hepatotoxicity.
Pharmacology
Mechanism of Action
Isotretinoin is a retinoid that acts by reducing sebaceous gland size and inhibiting sebaceous gland function, thereby decreasing sebum production. It also inhibits the growth of Propionibacterium acnes (now Cutibacterium acnes) and normalizes follicular keratinization, preventing comedone formation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 25% (variable, increased with food)
Tmax:
2-4 hours
FoodEffect:
Absorption is significantly increased (up to 2-fold) when taken with a high-fat meal.
Distribution:
Vd:
20-40 L
ProteinBinding:
>99.9% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Isotretinoin: 10-20 hours; 4-oxo-isotretinoin: 17-50 hours
Clearance:
Not readily available, but primarily hepatic metabolism and excretion.
ExcretionRoute:
Biphasic elimination, approximately equal amounts excreted in feces (65-83%) and urine (17-35%).
Unchanged:
<1% (renal)
Pharmacodynamics
OnsetOfAction:
Typically 1-2 months for noticeable improvement, full effect seen after completion of treatment course.
PeakEffect:
At the end of the 15-20 week treatment course.
DurationOfAction:
Long-lasting remission often achieved after a single course, with effects persisting for months to years after discontinuation.
Safety & Warnings
BLACK BOX WARNING
Isotretinoin is associated with severe birth defects. It is contraindicated in pregnant women. Females of reproductive potential must not be pregnant when isotretinoin treatment is initiated, and must use two forms of effective contraception (one primary and one secondary) at least one month prior to initiation of therapy, during therapy, and for one month following discontinuation of therapy. Patients must enroll in and comply with the requirements of the iPLEDGE REMS program.
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, 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of depression or mood changes, including:
+ Suicidal thoughts or feelings
+ Emotional ups and downs or abnormal thinking
+ Anxiety or loss of interest in life
Signs of liver problems, such as:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes (jaundice)
Signs of esophagus problems, including:
+ Chest pain or difficulty swallowing
+ New or worsening heartburn
Signs of high blood sugar, such as:
+ Confusion or drowsiness
+ Increased thirst or hunger
+ Frequent urination or flushing
+ Rapid breathing or fruity-smelling breath
Behavior problems or changes in behavior
Vision changes, eye pain, or severe eye irritation
Back, bone, joint, or muscle pain
Muscle weakness
Unexplained bruising or bleeding
Feeling extremely tired or weak
Urination problems, such as difficulty starting to urinate or changes in urine output
Swelling or swollen lymph nodes
Abnormal heartbeat or heart rhythm
Hearing problems, such as changes in hearing or ringing in the ears (which may be temporary or permanent)
A severe skin reaction (Stevens-Johnson syndrome or toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Severe and potentially life-threatening pancreas problems (pancreatitis), which may cause:
+ Severe stomach pain
+ Severe back pain
+ Severe nausea or vomiting
Other Possible Side Effects
Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
* Changes in how contact lenses feel in your eyes
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.
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, 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of depression or mood changes, including:
+ Suicidal thoughts or feelings
+ Emotional ups and downs or abnormal thinking
+ Anxiety or loss of interest in life
Signs of liver problems, such as:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes (jaundice)
Signs of esophagus problems, including:
+ Chest pain or difficulty swallowing
+ New or worsening heartburn
Signs of high blood sugar, such as:
+ Confusion or drowsiness
+ Increased thirst or hunger
+ Frequent urination or flushing
+ Rapid breathing or fruity-smelling breath
Behavior problems or changes in behavior
Vision changes, eye pain, or severe eye irritation
Back, bone, joint, or muscle pain
Muscle weakness
Unexplained bruising or bleeding
Feeling extremely tired or weak
Urination problems, such as difficulty starting to urinate or changes in urine output
Swelling or swollen lymph nodes
Abnormal heartbeat or heart rhythm
Hearing problems, such as changes in hearing or ringing in the ears (which may be temporary or permanent)
A severe skin reaction (Stevens-Johnson syndrome or toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Severe and potentially life-threatening pancreas problems (pancreatitis), which may cause:
+ Severe stomach pain
+ Severe back pain
+ Severe nausea or vomiting
Other Possible Side Effects
Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
* Changes in how contact lenses feel in your eyes
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:
- Signs of pregnancy (missed period, nausea, breast tenderness)
- Severe headache, blurred vision, dizziness, nausea, vomiting (signs of increased pressure in the brain)
- Severe stomach pain, rectal bleeding, severe diarrhea (signs of inflammatory bowel disease)
- Yellowing of skin or eyes, dark urine, severe fatigue (signs of liver problems)
- Severe muscle or joint pain, especially with weakness
- New or worsening depression, anxiety, irritability, thoughts of self-harm
- Difficulty seeing at night (night blindness)
- Ringing in the ears or hearing loss
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, such as foods or drugs. Be sure to describe the symptoms you experienced.
Your pregnancy plans: If you are able to become pregnant and are not using two forms of birth control, or if you plan to become pregnant within one month before starting treatment, during treatment, or within one month after your last dose.
If you are breastfeeding: You should not breastfeed for a certain period after receiving this medication. Consult your doctor to determine how long you should avoid breastfeeding after treatment.
Any medications you are currently taking, including:
+ Demeclocycline
+ Doxycycline
+ Minocycline
+ Tetracycline
+ Products containing vitamin A or similar substances
+ St. John's wort
* Please note that this is not an exhaustive list of interacting medications or health issues. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe treatment.
Remember, you must verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting 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, such as foods or drugs. Be sure to describe the symptoms you experienced.
Your pregnancy plans: If you are able to become pregnant and are not using two forms of birth control, or if you plan to become pregnant within one month before starting treatment, during treatment, or within one month after your last dose.
If you are breastfeeding: You should not breastfeed for a certain period after receiving this medication. Consult your doctor to determine how long you should avoid breastfeeding after treatment.
Any medications you are currently taking, including:
+ Demeclocycline
+ Doxycycline
+ Minocycline
+ Tetracycline
+ Products containing vitamin A or similar substances
+ St. John's wort
* Please note that this is not an exhaustive list of interacting medications or health issues. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe treatment.
Remember, you must verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you. Be aware that this medication may cause sudden and potentially irreversible decreased night vision, which can make it difficult to drive or perform tasks in low-light conditions.
Blood Donation
Do not donate blood while taking this medication and for at least 1 month after stopping treatment.
Cholesterol and Triglyceride Changes
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood, so it is crucial to discuss this with your doctor. Regular blood tests will be necessary to monitor these levels, as directed by your doctor.
Sun Protection
You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear that provide adequate sun protection.
Blood Sugar Monitoring
High blood sugar levels, including new or worsening diabetes, have been reported with this medication. Monitor your blood sugar levels as instructed by your doctor.
Alcohol Consumption
Before consuming alcohol, consult with your doctor to discuss any potential risks or interactions.
Cosmetic Skin Treatments
Avoid cosmetic skin treatments, such as waxing, dermabrasion, or laser treatments, during treatment and for at least 6 months after the last dose, as they may increase the risk of scarring.
Bone Health
This medication may cause weak bones and tendon problems in some individuals. People who participate in certain sports may be at a higher risk of bone problems, such as fractures. Discuss this with your doctor and undergo bone density tests as recommended.
Infection Risk
Low white blood cell counts have been reported with this medication, which may increase the risk of infection. Seek medical attention immediately if you experience symptoms such as fever, chills, or sore throat.
Raised Brain Pressure
This medication may cause increased pressure in the brain, leading to permanent vision loss or even death. Seek medical attention immediately if you experience severe headache, dizziness, nausea, vomiting, or seizures, as well as weakness on one side of the body, speech or thinking difficulties, balance changes, or vision changes.
Bowel Problems
Severe bowel problems, including inflammatory bowel disease, may occur with this medication. Inform your doctor immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain, as these symptoms may persist even after stopping treatment.
Growth Effects in Children and Teens
This medication may affect growth in children and teens. Regular growth checks will be necessary to monitor any potential effects.
Birth Control
Do not use progestin-only birth control pills (minipills), as they may not be effective. Discuss alternative birth control options with your doctor. If you have unprotected sex, think you may be pregnant, or miss your period, contact your doctor immediately.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you. Be aware that this medication may cause sudden and potentially irreversible decreased night vision, which can make it difficult to drive or perform tasks in low-light conditions.
Blood Donation
Do not donate blood while taking this medication and for at least 1 month after stopping treatment.
Cholesterol and Triglyceride Changes
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood, so it is crucial to discuss this with your doctor. Regular blood tests will be necessary to monitor these levels, as directed by your doctor.
Sun Protection
You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear that provide adequate sun protection.
Blood Sugar Monitoring
High blood sugar levels, including new or worsening diabetes, have been reported with this medication. Monitor your blood sugar levels as instructed by your doctor.
Alcohol Consumption
Before consuming alcohol, consult with your doctor to discuss any potential risks or interactions.
Cosmetic Skin Treatments
Avoid cosmetic skin treatments, such as waxing, dermabrasion, or laser treatments, during treatment and for at least 6 months after the last dose, as they may increase the risk of scarring.
Bone Health
This medication may cause weak bones and tendon problems in some individuals. People who participate in certain sports may be at a higher risk of bone problems, such as fractures. Discuss this with your doctor and undergo bone density tests as recommended.
Infection Risk
Low white blood cell counts have been reported with this medication, which may increase the risk of infection. Seek medical attention immediately if you experience symptoms such as fever, chills, or sore throat.
Raised Brain Pressure
This medication may cause increased pressure in the brain, leading to permanent vision loss or even death. Seek medical attention immediately if you experience severe headache, dizziness, nausea, vomiting, or seizures, as well as weakness on one side of the body, speech or thinking difficulties, balance changes, or vision changes.
Bowel Problems
Severe bowel problems, including inflammatory bowel disease, may occur with this medication. Inform your doctor immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain, as these symptoms may persist even after stopping treatment.
Growth Effects in Children and Teens
This medication may affect growth in children and teens. Regular growth checks will be necessary to monitor any potential effects.
Birth Control
Do not use progestin-only birth control pills (minipills), as they may not be effective. Discuss alternative birth control options with your doctor. If you have unprotected sex, think you may be pregnant, or miss your period, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Headache
- Dizziness
- Nausea
- Vomiting
- Irritability
- Itching
- Dry skin and mucous membranes
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive.
Drug Interactions
Contraindicated Interactions
- Tetracyclines (e.g., doxycycline, minocycline): Increased risk of pseudotumor cerebri (benign intracranial hypertension).
- Vitamin A supplements: Additive hypervitaminosis A, increasing risk of adverse effects (e.g., dry skin, cheilitis, headache, bone pain).
Major Interactions
- St. John's Wort: May decrease the effectiveness of hormonal contraceptives, leading to unintended pregnancy.
- Systemic corticosteroids: May increase the risk of osteoporosis and bone mineral density loss when co-administered with isotretinoin, especially with long-term use.
Moderate Interactions
- Phenytoin: May increase the risk of osteomalacia/osteoporosis.
- Progestin-only oral contraceptives: May be less effective, leading to unintended pregnancy. Combined oral contraceptives are generally preferred for contraception during isotretinoin therapy.
- Alcohol: May increase triglyceride levels, which are already a concern with isotretinoin.
Minor Interactions
- Topical acne medications (e.g., benzoyl peroxide, topical retinoids): May cause excessive skin irritation, dryness, or peeling. Avoid concomitant use.
- Waxing and dermabrasion: Increased risk of scarring or skin damage during and for at least 6 months after treatment due to fragile skin.
Monitoring
Baseline Monitoring
Pregnancy test (females of childbearing potential)
Rationale: Absolute contraindication in pregnancy due to severe teratogenicity. Two negative tests required before initiation.
Timing: Within 7 days prior to starting therapy, and a second test on the day of initiation.
Liver Function Tests (LFTs)
Rationale: Isotretinoin can cause reversible elevations in liver enzymes.
Timing: Before treatment initiation.
Lipid Panel (Triglycerides, Cholesterol)
Rationale: Isotretinoin can cause significant and reversible elevations in serum triglycerides and cholesterol.
Timing: Before treatment initiation.
Complete Blood Count (CBC)
Rationale: Rare reports of blood dyscrasias (e.g., anemia, thrombocytopenia, neutropenia).
Timing: Before treatment initiation.
Routine Monitoring
Pregnancy test (females of childbearing potential)
Frequency: Monthly, prior to each refill.
Target: Negative
Action Threshold: Positive test: Immediately discontinue isotretinoin, refer to OB/GYN, and report to iPLEDGE.
Liver Function Tests (LFTs)
Frequency: Monthly or as clinically indicated.
Target: Within normal limits or stable elevations.
Action Threshold: Significant or progressive elevations (e.g., >3x ULN): Dose reduction or discontinuation may be necessary.
Lipid Panel (Triglycerides, Cholesterol)
Frequency: Monthly or as clinically indicated.
Target: Triglycerides <200 mg/dL (ideally), Cholesterol <200 mg/dL.
Action Threshold: Triglycerides >400 mg/dL: Consider dose reduction or discontinuation. Triglycerides >800 mg/dL: Discontinue immediately due to risk of pancreatitis.
CBC
Frequency: Periodically or as clinically indicated.
Target: Within normal limits.
Action Threshold: Significant abnormalities: Investigate and manage appropriately.
Symptom Monitoring
- Mood changes (depression, anxiety, irritability, suicidal ideation)
- Vision changes (decreased night vision, blurred vision, dry eyes, papilledema)
- Headache (severe, persistent, with nausea/vomiting, visual disturbances - suggestive of pseudotumor cerebri)
- Gastrointestinal symptoms (severe abdominal pain, rectal bleeding, diarrhea - suggestive of inflammatory bowel disease)
- Musculoskeletal pain (joint pain, muscle pain, back pain)
- Skin and mucous membrane dryness (severe cheilitis, dry skin, epistaxis)
- Hair loss
- Hearing impairment
Special Patient Groups
Pregnancy
Absolutely contraindicated. Isotretinoin is a potent human teratogen, causing severe and life-threatening birth defects (e.g., craniofacial, cardiovascular, CNS abnormalities, intellectual disability).
Trimester-Specific Risks:
First Trimester:
Highest risk of severe birth defects (e.g., CNS, cardiac, craniofacial, thymic, parathyroid abnormalities).
Second Trimester:
Continued risk of birth defects, though potentially lower than first trimester.
Third Trimester:
Risk of premature birth, low birth weight, and other complications.
Lactation
Contraindicated. It is unknown if isotretinoin is excreted in human milk, but due to its potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment and for one month after discontinuation.
Infant Risk:
High risk of serious adverse effects due to potential systemic exposure and retinoid effects.
Pediatric Use
Generally not recommended for children under 12 years of age or before puberty due to potential effects on bone growth (premature epiphyseal closure). Used in adolescents (12 years and older) for severe recalcitrant nodular acne, with careful monitoring.
Geriatric Use
Limited data available as severe nodular acne is uncommon in this population. Use with caution, considering potential for increased susceptibility to adverse effects (e.g., bone mineral density loss, lipid abnormalities).
Clinical Information
Clinical Pearls
- Isotretinoin is a highly effective treatment for severe acne but requires strict adherence to the iPLEDGE REMS program due to its severe teratogenic risk.
- Patients must use two forms of contraception and have monthly negative pregnancy tests.
- Dryness of skin, lips, and mucous membranes (eyes, nose) is almost universal and can be managed with moisturizers, lip balm, and artificial tears.
- Monitor for mood changes, including depression and suicidal ideation, and advise patients to report any such symptoms immediately.
- Regular monitoring of liver function tests and lipid profiles is crucial due to potential for elevations.
- Patients should avoid blood donation during and for one month after treatment.
- Avoid concomitant use of tetracyclines and Vitamin A supplements.
- Cumulative dose is important for long-term remission; aim for 120-150 mg/kg over the course of treatment.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene) for less severe acne.
- Oral antibiotics (e.g., doxycycline, minocycline, azithromycin) for inflammatory acne.
- Topical antibiotics (e.g., clindamycin, erythromycin).
- Benzoyl peroxide.
- Hormonal therapies (e.g., oral contraceptives, spironolactone) for hormonal acne in females.
- Photodynamic therapy.
- Chemical peels, laser therapy, extractions.
Cost & Coverage
Average Cost:
$100 - $500+ per 30 capsules (10mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization due to REMS program and cost)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.