Claravis 30mg 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 1982
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 amount of oil your skin produces. Because it can cause serious birth defects, there are very strict rules for its use, especially for women who can become pregnant.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Some medications need to be 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.
Important Reminders
You will typically receive a month's supply of medication at a time.
It's common for skin conditions to appear worse before they start to improve with treatment.
If you experience any changes in weight, inform your doctor, as your medication dose may need to be adjusted.
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, away from the bathroom.
Store all medications in a secure location, out of 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, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Some medications need to be 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.
Important Reminders
You will typically receive a month's supply of medication at a time.
It's common for skin conditions to appear worse before they start to improve with treatment.
If you experience any changes in weight, inform your doctor, as your medication dose may need to be adjusted.
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, away from the bathroom.
Store all medications in a secure location, out of 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
- Always take with food, preferably a high-fat meal, to help your body absorb the medication.
- Do not donate blood during treatment and for at least one month after stopping, as pregnant women could receive your blood.
- Avoid waxing for hair removal during treatment and for at least 6 months after stopping, as it can cause severe skin tearing.
- Avoid cosmetic procedures like dermabrasion or laser skin treatments during and for at least 6 months after treatment due to risk of scarring.
- Limit sun exposure and use sunscreen (SPF 30+) and protective clothing, as your skin will be more sensitive to the sun.
- Avoid alcohol, as it can increase the risk of liver problems.
- Do not take Vitamin A supplements, as this can increase side effects.
- Use lip balm, moisturizer, and eye drops regularly to manage dryness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 to 1 mg/kg/day orally in two divided doses for 15 to 20 weeks. A second course may be initiated after a 2-month off-treatment period if necessary.
Dose Range:
0.5 - 2 mg
Condition-Specific Dosing:
severe_cystic_acne:
1 mg/kg/day
very_severe_or_truncal_acne:
Up to 2 mg/kg/day for a limited period
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established in children under 12 years of age)
Adolescent:
0.5 to 1 mg/kg/day orally in two divided doses for 15 to 20 weeks. A second course may be initiated after a 2-month off-treatment period if necessary.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution, consider lower starting dose (e.g., 10 mg/day)
Moderate:
Use with caution, consider lower starting dose (e.g., 10 mg/day)
Severe:
Use with caution, consider lower starting dose (e.g., 10 mg/day)
Dialysis:
Not well studied, use with extreme caution, consider lower starting dose and close monitoring.
Hepatic Impairment:
Mild:
Use with caution, monitor liver function closely.
Moderate:
Contraindicated due to risk of hepatotoxicity.
Severe:
Contraindicated due to risk of hepatotoxicity.
Pharmacology
Mechanism of Action
Isotretinoin is a retinoid that acts by reducing sebaceous gland size and inhibiting sebaceous gland activity, thereby decreasing sebum production. It also inhibits the growth of Propionibacterium acnes (now Cutibacterium acnes), and has anti-inflammatory effects. The exact mechanism by which it exerts its therapeutic effect in severe cystic acne is unknown, but it is thought to involve the normalization of follicular keratinization.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (approximately 25% with food, significantly reduced on an empty stomach)
Tmax:
2-4 hours (for isotretinoin), 6-20 hours (for 4-oxo-isotretinoin)
FoodEffect:
Absorption is significantly increased when taken with a high-fat meal.
Distribution:
Vd:
Not available (highly lipophilic)
ProteinBinding:
99.9% (primarily to albumin)
CnssPenetration:
Limited (detectable in CSF, but not primary site of action)
Elimination:
HalfLife:
10-20 hours (isotretinoin), 17-50 hours (4-oxo-isotretinoin)
Clearance:
Not available
ExcretionRoute:
Approximately equal amounts excreted in urine and feces (as metabolites)
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Weeks to months (therapeutic effect)
PeakEffect:
Typically after 8-16 weeks of treatment
DurationOfAction:
Long-lasting remission often achieved after a single course of treatment, effects can persist 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 for at least one month prior to initiation of therapy, during therapy, and for one month following discontinuation of therapy. Patients must be registered in the iPLEDGE REMS program.
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
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 right away:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of depression, suicidal thoughts, or mood changes, including:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of esophagus problems, including:
+ Chest pain
+ Trouble swallowing
+ New or worsening heartburn
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Behavior problems
Changes in eyesight, eye pain, or severe eye irritation
Back, bone, joint, or muscle pain
Muscle weakness
Unexplained bruising or bleeding
Feeling very tired or weak
Difficulty urinating or changes in urine output
Swelling
Swollen glands
Fast or abnormal heartbeat
Hearing problems, such as changes in hearing or ringing in the ears (which may be temporary or persistent)
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause severe health problems and may be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
Severe and potentially life-threatening pancreas problems (pancreatitis). Call your doctor right away if you experience:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in the eyes
If you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention. Not all side effects are listed here, so if you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects
You can 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 or seek medical attention right away:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of depression, suicidal thoughts, or mood changes, including:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of esophagus problems, including:
+ Chest pain
+ Trouble swallowing
+ New or worsening heartburn
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Behavior problems
Changes in eyesight, eye pain, or severe eye irritation
Back, bone, joint, or muscle pain
Muscle weakness
Unexplained bruising or bleeding
Feeling very tired or weak
Difficulty urinating or changes in urine output
Swelling
Swollen glands
Fast or abnormal heartbeat
Hearing problems, such as changes in hearing or ringing in the ears (which may be temporary or persistent)
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause severe health problems and may be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
Severe and potentially life-threatening pancreas problems (pancreatitis). Call your doctor right away if you experience:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in the eyes
If you experience any of these side effects or any other symptoms that concern you, contact your doctor or seek medical attention. Not all side effects are listed here, so if you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects
You can 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:
- Any signs of pregnancy (for females)
- Severe headache, blurred vision, dizziness, nausea, vomiting (signs of pseudotumor cerebri)
- Yellowing of skin or eyes, dark urine, severe fatigue (signs of liver problems)
- Severe stomach pain, nausea, vomiting (signs of pancreatitis)
- New or worsening depression, anxiety, suicidal thoughts, aggressive behavior
- Severe muscle or joint pain
- Rectal bleeding, severe diarrhea, abdominal pain (signs of inflammatory bowel disease)
- Difficulty seeing at night (decreased night vision)
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.
If you are able to become pregnant and are not using two forms of birth control.
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.
Additionally, tell your doctor if you are taking any of the following medications:
Demeclocycline
Doxycycline
Minocycline
Tetracycline
Products containing vitamin A
Products similar to vitamin A
St. John's wort
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
You must verify that it is safe to take this medication with all your other medications and health conditions. Do not initiate, stop, or modify the dosage 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.
If you are able to become pregnant and are not using two forms of birth control.
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.
Additionally, tell your doctor if you are taking any of the following medications:
Demeclocycline
Doxycycline
Minocycline
Tetracycline
Products containing vitamin A
Products similar to vitamin A
St. John's wort
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
You must verify that it is safe to take this medication with all your other medications and health conditions. Do not initiate, stop, or modify the dosage 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. This will help ensure your safety and the effectiveness of your treatment.
When starting this medication, be cautious when driving or performing tasks that require alertness and clear vision, as it may affect your ability to do so. You may experience sudden and potentially persistent decreased night vision, which can make it difficult to drive or navigate in low-light environments. To minimize risks, exercise caution when driving at night or engaging in activities that require good eyesight in low-light conditions.
Do not donate blood while taking this medication or for 1 month after stopping treatment, as this can help prevent potential complications.
Treatment with this medication may lead to increased cholesterol and triglyceride levels. Although the impact of these changes on heart health is not fully understood, it is crucial to discuss this with your doctor. Regular blood tests, as directed by your doctor, will help monitor your condition and address any concerns.
You may be more susceptible to sunburn while taking this medication. To protect yourself, avoid excessive sun exposure, sunlamps, and tanning beds. Use sunscreen with a suitable SPF, wear protective clothing, and eyewear to minimize your risk of sunburn.
There is a risk of developing high blood sugar levels, including new-onset or worsening diabetes, while taking this medication. Monitor your blood sugar levels as instructed by your doctor and report any concerns.
Before consuming alcohol, consult with your doctor to discuss potential interactions and risks.
Avoid cosmetic skin treatments, such as waxing, dermabrasion, or laser treatments, during treatment and for at least 6 months after the last dose, as this may increase the risk of scarring.
This medication may cause bone weakness and tendon problems in some individuals. If you participate in sports that increase the risk of bone problems, such as fractures, discuss this with your doctor. Regular bone density tests, as recommended by your doctor, will help monitor your bone health.
Low white blood cell counts have been reported in patients taking this medication, which can increase the risk of infection. If you experience symptoms such as fever, chills, or sore throat, contact your doctor immediately.
In rare cases, 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, seizures, weakness on one side of the body, speech or thinking difficulties, balance problems, or changes in vision.
Severe bowel problems, including inflammatory bowel disease, may occur while taking this medication. If you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain, inform your doctor promptly, as these symptoms may persist even after stopping treatment.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks will help monitor and address any concerns. Discuss this with your doctor to determine the best course of action.
If you use progestin-only birth control pills (minipills), be aware that they may not be effective. Consult with your doctor to discuss alternative birth control options.
If you have unprotected sex, suspect you may be pregnant, or miss your period, contact your doctor immediately to discuss the best course of action and potential risks.
When starting this medication, be cautious when driving or performing tasks that require alertness and clear vision, as it may affect your ability to do so. You may experience sudden and potentially persistent decreased night vision, which can make it difficult to drive or navigate in low-light environments. To minimize risks, exercise caution when driving at night or engaging in activities that require good eyesight in low-light conditions.
Do not donate blood while taking this medication or for 1 month after stopping treatment, as this can help prevent potential complications.
Treatment with this medication may lead to increased cholesterol and triglyceride levels. Although the impact of these changes on heart health is not fully understood, it is crucial to discuss this with your doctor. Regular blood tests, as directed by your doctor, will help monitor your condition and address any concerns.
You may be more susceptible to sunburn while taking this medication. To protect yourself, avoid excessive sun exposure, sunlamps, and tanning beds. Use sunscreen with a suitable SPF, wear protective clothing, and eyewear to minimize your risk of sunburn.
There is a risk of developing high blood sugar levels, including new-onset or worsening diabetes, while taking this medication. Monitor your blood sugar levels as instructed by your doctor and report any concerns.
Before consuming alcohol, consult with your doctor to discuss potential interactions and risks.
Avoid cosmetic skin treatments, such as waxing, dermabrasion, or laser treatments, during treatment and for at least 6 months after the last dose, as this may increase the risk of scarring.
This medication may cause bone weakness and tendon problems in some individuals. If you participate in sports that increase the risk of bone problems, such as fractures, discuss this with your doctor. Regular bone density tests, as recommended by your doctor, will help monitor your bone health.
Low white blood cell counts have been reported in patients taking this medication, which can increase the risk of infection. If you experience symptoms such as fever, chills, or sore throat, contact your doctor immediately.
In rare cases, 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, seizures, weakness on one side of the body, speech or thinking difficulties, balance problems, or changes in vision.
Severe bowel problems, including inflammatory bowel disease, may occur while taking this medication. If you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain, inform your doctor promptly, as these symptoms may persist even after stopping treatment.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks will help monitor and address any concerns. Discuss this with your doctor to determine the best course of action.
If you use progestin-only birth control pills (minipills), be aware that they may not be effective. Consult with your doctor to discuss alternative birth control options.
If you have unprotected sex, suspect you may be pregnant, or miss your period, contact your doctor immediately to discuss the best course of action and potential risks.
Overdose Information
Overdose Symptoms:
- Headache
- Nausea
- Vomiting
- Drowsiness
- Irritability
- Itching
- Dry skin and mucous membranes
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive.
Drug Interactions
Contraindicated Interactions
- Tetracyclines (e.g., doxycycline, minocycline) - risk of pseudotumor cerebri (benign intracranial hypertension)
- Vitamin A supplements - risk of additive toxicity (hypervitaminosis A)
Major Interactions
- Systemic corticosteroids - increased risk of osteoporosis and bone mineral density changes
- Phenytoin - isotretinoin may reduce phenytoin protein binding, potentially altering levels
- St. John's Wort - may reduce efficacy of hormonal contraceptives, increasing pregnancy risk
Moderate Interactions
- Progestin-only oral contraceptives - may be less effective, requiring two forms of contraception
- Alcohol - potential for additive hepatotoxicity
- Topical acne treatments (e.g., benzoyl peroxide, salicylic acid) - increased skin irritation and dryness
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pregnancy test (females of childbearing potential)
Rationale: Absolute contraindication in pregnancy due to severe teratogenicity.
Timing: Within 7 days prior to initiating therapy, and again immediately prior to initiation (second test).
Liver function tests (LFTs)
Rationale: Risk of hepatotoxicity.
Timing: Prior to initiation of therapy.
Lipid panel (triglycerides, cholesterol)
Rationale: Risk of hypertriglyceridemia and hypercholesterolemia.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC)
Rationale: Rare reports of blood dyscrasias.
Timing: Prior to initiation of therapy.
Routine Monitoring
Pregnancy test (females of childbearing potential)
Frequency: Monthly, prior to receiving each new prescription.
Target: Negative
Action Threshold: Positive test: immediately discontinue isotretinoin, refer to OB/GYN, report to iPLEDGE.
Liver function tests (LFTs)
Frequency: Monthly or as clinically indicated.
Target: Within normal limits
Action Threshold: Significant elevation (e.g., >2-3x ULN): dose reduction or discontinuation.
Lipid panel (triglycerides, cholesterol)
Frequency: Monthly or as clinically indicated.
Target: Triglycerides <200 mg/dL (ideally), Cholesterol <200 mg/dL
Action Threshold: Triglycerides >800 mg/dL: immediate discontinuation due to risk of pancreatitis. Triglycerides >400 mg/dL: consider dose reduction or discontinuation.
Mood and behavioral changes assessment
Frequency: At each visit.
Target: Stable mood, no new or worsening psychiatric symptoms.
Action Threshold: New or worsening depression, anxiety, suicidal ideation: discontinue isotretinoin, refer for psychiatric evaluation.
Symptom Monitoring
- Dry skin, lips, eyes, nasal passages
- Muscle or joint pain
- Headache (especially severe, persistent, or with visual changes - pseudotumor cerebri)
- Nausea, vomiting, severe abdominal pain (pancreatitis)
- Yellowing of skin or eyes, dark urine (liver problems)
- Vision changes (night vision, blurred vision)
- Mood changes, depression, anxiety, suicidal thoughts
- Rectal bleeding, severe diarrhea (inflammatory bowel disease)
Special Patient Groups
Pregnancy
Absolute contraindication. Isotretinoin is a potent human teratogen, causing severe and life-threatening birth defects (e.g., craniofacial, cardiac, CNS abnormalities). Females of reproductive potential must participate in the iPLEDGE REMS program and use two forms of effective contraception.
Trimester-Specific Risks:
First Trimester:
Highest risk of severe birth defects (e.g., hydrocephalus, microcephaly, ear abnormalities, cardiovascular defects, facial dysmorphia, cleft palate, thymic gland abnormalities, parathyroid hormone deficiency).
Second Trimester:
Significant risk of birth defects, though potentially less severe than first trimester exposure.
Third Trimester:
Risk of birth defects, but also potential for premature epiphyseal closure in the fetus.
Lactation
Contraindicated. It is not known whether isotretinoin is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment and for at least one month after stopping.
Infant Risk:
High risk (potential for serious adverse effects, including teratogenicity if absorbed by infant).
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 12 years of age. Use in adolescents (12 years and older) is similar to adults, with careful consideration of bone effects (premature epiphyseal closure) and psychiatric side effects.
Geriatric Use
Clinical studies of isotretinoin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Use with caution due to potential for increased susceptibility to adverse effects (e.g., bone mineral density changes, lipid abnormalities).
Clinical Information
Clinical Pearls
- Isotretinoin is a highly effective treatment for severe nodular acne but requires strict adherence to the iPLEDGE program due to its teratogenic risk.
- Always emphasize the importance of taking the medication with a high-fat meal to maximize absorption and efficacy.
- Counsel patients extensively on common side effects, especially dryness of skin, lips, and eyes, and provide strategies for management.
- Be vigilant for psychiatric side effects, including depression and suicidal ideation, and educate patients and their families to report any changes immediately.
- Regular monitoring of liver function and lipid levels is crucial, and patients should be advised on dietary modifications to help manage lipid elevations.
- Patients should avoid blood donation during and for at least one month after treatment.
- Advise against concomitant use of tetracyclines, vitamin A supplements, and St. John's Wort.
Alternative Therapies
- Oral antibiotics (e.g., doxycycline, minocycline, azithromycin) in combination with topical retinoids or benzoyl peroxide for moderate to severe acne.
- Hormonal therapies (e.g., oral contraceptives, spironolactone) for hormonal acne in females.
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene) for less severe acne.
- Dermatological procedures (e.g., chemical peels, laser therapy, extractions) as adjunctive treatments.
Cost & Coverage
Average Cost:
Varies widely, e.g., $300-$800+ per 30 capsules (30mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization and adherence to iPLEDGE program for coverage)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial resource for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.