Accutane 20mg 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 side effects, especially birth defects, it requires strict monitoring and participation in a special program called iPLEDGE.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow these guidelines:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on the best way to take your medication.
Swallow your medication whole, without chewing, breaking, or crushing it. Take it with a full glass of water.
Continue taking your medication as prescribed 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.
It's common for your skin to appear worse before it starts to improve.
If you experience any changes in weight, inform your doctor, as your medication dosage 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 and moisture.
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 ensure you get the most out of your medication, follow these guidelines:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on the best way to take your medication.
Swallow your medication whole, without chewing, breaking, or crushing it. Take it with a full glass of water.
Continue taking your medication as prescribed 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.
It's common for your skin to appear worse before it starts to improve.
If you experience any changes in weight, inform your doctor, as your medication dosage 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 and moisture.
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
- Avoid pregnancy: Females must use two effective forms of birth control and have monthly pregnancy tests.
- Do not donate blood during treatment and for one month after stopping, as pregnant women could receive your blood.
- Avoid sun exposure: Skin will be more sensitive to the sun; use sunscreen and protective clothing.
- Avoid waxing, dermabrasion, and laser skin treatments during and for at least 6 months after treatment due to increased risk of scarring.
- Avoid alcohol: May increase risk of side effects like high triglycerides.
- Do not take vitamin A supplements: Can lead to vitamin A toxicity.
- Use lip balm, moisturizers, and eye drops regularly to combat dryness.
- Report any mood changes, severe headaches, vision changes, or stomach pain immediately.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 to 1 mg/kg/day divided into two doses for 15 to 20 weeks
Dose Range:
0.5 - 1 mg
Condition-Specific Dosing:
severe_cystic_acne:
0.5 to 1 mg/kg/day divided into two doses. A dose of 2 mg/kg/day may be used for very severe disease or if the disease is primarily truncal.
relapse:
A second course may be initiated if necessary, usually after a period of at least 2 months off therapy.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
0.5 to 1 mg/kg/day divided into two doses for 15 to 20 weeks (same as adult dosing for severe cystic acne)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but monitor for adverse effects.
Moderate:
No specific adjustment recommended, but monitor for adverse effects.
Severe:
Use with caution; consider lower starting dose (e.g., 10 mg/day) and titrate slowly.
Dialysis:
Use with caution; consider lower starting dose and close monitoring.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function tests closely.
Moderate:
Use with caution; monitor liver function tests closely. Consider lower starting dose.
Severe:
Contraindicated due to potential for hepatotoxicity and altered metabolism.
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 has anti-inflammatory properties and normalizes follicular keratinization, preventing comedone formation. Its exact mechanism in severe acne is not fully understood but involves binding to retinoic acid receptors (RARs) and retinoid X receptors (RXRs) in the nucleus, influencing gene expression.
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:
Not readily available, but widely distributed to tissues.
ProteinBinding:
>99.9% (primarily to albumin)
CnssPenetration:
Limited, but can cross the blood-brain barrier.
Elimination:
HalfLife:
Isotretinoin: 10-20 hours; 4-oxo-isotretinoin: 17-50 hours
Clearance:
Not readily available
ExcretionRoute:
Renal (43-65%) and fecal (32-57%)
Unchanged:
<1% (renal)
Pharmacodynamics
OnsetOfAction:
Weeks to months (clinical effect)
PeakEffect:
Typically 8-16 weeks into treatment
DurationOfAction:
Long-lasting remission often achieved after a single course, but can vary.
Safety & Warnings
BLACK BOX WARNING
Isotretinoin can cause 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 enrolled in and comply with the iPLEDGE REMS program. Psychiatric adverse events, including depression, psychosis, and, rarely, suicidal ideation, have been reported. Inflammatory bowel disease and severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) have also been reported.
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 or seek medical attention immediately:
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're concerned about any side effects or if they persist or bother you, contact your doctor or seek medical attention.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions about side effects, consult your doctor for medical advice.
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, 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're concerned about any side effects or if they persist or bother you, contact your doctor or seek medical attention.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions about side effects, consult your doctor for medical advice.
Seek Immediate Medical Attention If You Experience:
- Severe headache, blurred vision, dizziness (signs of increased pressure in the brain)
- Yellowing of skin or eyes, dark urine, severe nausea/vomiting (signs of liver problems)
- Severe stomach pain, rectal bleeding, severe diarrhea (signs of inflammatory bowel disease)
- New or worsening feelings of sadness, anxiety, irritability, thoughts of harming yourself
- Severe skin rash, peeling, blistering
- Severe muscle or joint pain
- Difficulty seeing at night (night blindness)
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 allergic reaction 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 taking this drug.
Additionally, tell your doctor if you are taking any of the following medications:
Demeclocycline
Doxycycline
Minocycline
Tetracycline
Products containing vitamin A or similar substances
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 dose of any medication without first 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 allergic reaction 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 taking this drug.
Additionally, tell your doctor if you are taking any of the following medications:
Demeclocycline
Doxycycline
Minocycline
Tetracycline
Products containing vitamin A or similar substances
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 dose of any medication without first 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. Exercise caution when driving at night or engaging in activities in low-light environments.
Blood Donation
Do not donate blood while taking this medication or for 1 month after stopping treatment.
Cholesterol and Triglycerides
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is unknown. Discuss this with your doctor and have your blood work checked as directed.
Sun Sensitivity
You may be more susceptible to sunburn. Avoid exposure to sunlight, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to minimize sun exposure.
Blood Sugar Control
This medication may cause high blood sugar levels, including new or worsening diabetes. Monitor your blood sugar as instructed by your doctor.
Alcohol Consumption
Consult your doctor before consuming alcohol while taking this medication.
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. The risk of bone problems, such as fractures, may be higher in people who participate in certain sports. Discuss this with your doctor and have a bone density test as directed.
Infection Risk
This medication may cause low white blood cell counts, increasing the risk of infection. Seek medical attention immediately if you experience symptoms of infection, 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 death. Seek medical attention immediately if you experience severe headache, dizziness, nausea, vomiting, or seizures.
Severe Bowel Problems
This medication may cause severe bowel problems, including inflammatory bowel disease. Seek medical attention immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain.
Growth Effects in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Discuss this with your doctor.
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, seek medical attention 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. Exercise caution when driving at night or engaging in activities in low-light environments.
Blood Donation
Do not donate blood while taking this medication or for 1 month after stopping treatment.
Cholesterol and Triglycerides
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is unknown. Discuss this with your doctor and have your blood work checked as directed.
Sun Sensitivity
You may be more susceptible to sunburn. Avoid exposure to sunlight, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to minimize sun exposure.
Blood Sugar Control
This medication may cause high blood sugar levels, including new or worsening diabetes. Monitor your blood sugar as instructed by your doctor.
Alcohol Consumption
Consult your doctor before consuming alcohol while taking this medication.
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. The risk of bone problems, such as fractures, may be higher in people who participate in certain sports. Discuss this with your doctor and have a bone density test as directed.
Infection Risk
This medication may cause low white blood cell counts, increasing the risk of infection. Seek medical attention immediately if you experience symptoms of infection, 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 death. Seek medical attention immediately if you experience severe headache, dizziness, nausea, vomiting, or seizures.
Severe Bowel Problems
This medication may cause severe bowel problems, including inflammatory bowel disease. Seek medical attention immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain.
Growth Effects in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Discuss this with your doctor.
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, seek medical attention immediately.
Overdose Information
Overdose Symptoms:
- Headache
- Nausea
- Vomiting
- Drowsiness
- 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): Risk of pseudotumor cerebri (benign intracranial hypertension).
- Vitamin A supplements: Risk of additive toxicity (hypervitaminosis A symptoms).
Major Interactions
- Progestin-only birth control pills: Isotretinoin may decrease the effectiveness of progestin-only contraceptives. Two forms of effective contraception are required for females of childbearing potential.
- St. John's Wort: May decrease the effectiveness of hormonal contraceptives.
- Phenytoin: May increase the risk of osteomalacia/osteoporosis.
- Systemic corticosteroids: May increase the risk of osteoporosis.
Moderate Interactions
- Alcohol: May increase the risk of elevated triglycerides and liver enzyme abnormalities.
- Topical acne treatments (e.g., benzoyl peroxide, salicylic acid): May increase skin irritation and dryness.
Minor Interactions
- Waxing: Increased risk of skin tearing and scarring due to skin fragility.
- Dermabrasion/Laser skin treatments: Increased risk of scarring due to impaired wound healing.
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.
Lipid panel (triglycerides, cholesterol)
Rationale: Isotretinoin can cause significant elevations in triglycerides and cholesterol.
Timing: Prior to initiating therapy.
Liver function tests (ALT, AST)
Rationale: Isotretinoin can cause transient or persistent elevations in liver enzymes.
Timing: Prior to initiating therapy.
Complete Blood Count (CBC)
Rationale: Rare reports of blood dyscrasias (e.g., anemia, neutropenia).
Timing: Prior to initiating therapy.
Blood glucose (optional, for patients with risk factors for diabetes)
Rationale: Rare reports of new onset diabetes or worsening of existing diabetes.
Timing: Prior to initiating therapy.
Routine Monitoring
Pregnancy test (females of childbearing potential)
Frequency: Monthly, within 7 days prior to each refill.
Target: Negative
Action Threshold: Positive test requires immediate discontinuation and referral to OB/GYN.
Lipid panel (triglycerides, cholesterol)
Frequency: Monthly or every 2-4 weeks during treatment, then as clinically indicated.
Target: Triglycerides < 200 mg/dL (ideally < 150 mg/dL); Cholesterol within normal limits.
Action Threshold: Triglycerides > 400 mg/dL (consider dose reduction or discontinuation); > 800 mg/dL (discontinue immediately due to pancreatitis risk).
Liver function tests (ALT, AST)
Frequency: Monthly or every 2-4 weeks during treatment, then as clinically indicated.
Target: Within normal limits or stable.
Action Threshold: Persistent elevations > 2-3 times upper limit of normal (ULN) may require dose reduction or discontinuation.
Mood/Psychiatric symptoms assessment
Frequency: At each visit.
Target: Stable mood, no new or worsening psychiatric symptoms.
Action Threshold: Report of depression, anxiety, suicidal ideation, or other mood changes requires immediate evaluation and potential discontinuation.
Symptom Monitoring
- Severe headache, blurred vision, dizziness (signs of pseudotumor cerebri)
- Severe abdominal pain, nausea, vomiting (signs of pancreatitis or inflammatory bowel disease)
- Yellowing of skin or eyes, dark urine (signs of liver problems)
- Severe muscle or joint pain
- New or worsening depression, anxiety, irritability, suicidal thoughts
- Severe skin rash, peeling, blistering (signs of severe cutaneous reactions)
- Rectal bleeding, severe diarrhea (signs of inflammatory bowel disease)
Special Patient Groups
Pregnancy
Absolutely contraindicated. Causes severe, life-threatening birth defects (teratogenicity). Females of childbearing potential must be enrolled in the iPLEDGE program and use two forms of effective contraception.
Trimester-Specific Risks:
First Trimester:
Highest risk of severe congenital malformations (e.g., craniofacial, cardiovascular, CNS, thymic abnormalities).
Second Trimester:
Significant risk of malformations, though potentially less severe than first trimester.
Third Trimester:
Risk of malformations, but also potential for premature epiphyseal closure and other retinoid-related effects.
Lactation
Contraindicated. Isotretinoin and its metabolites are likely excreted in human milk. Due to the potential for serious adverse reactions in the nursing infant, breastfeeding is not recommended.
Infant Risk:
High (L5 - Contraindicated)
Pediatric Use
Approved for severe recalcitrant nodular acne in patients 12 years of age and older. Use with caution in younger patients due to potential effects on bone growth (premature epiphyseal closure), though this is rare and typically associated with high doses or prolonged treatment.
Geriatric Use
Safety and efficacy have not been established in geriatric patients. Acne is less common in this population. Use with caution due to potential for increased susceptibility to adverse effects (e.g., lipid abnormalities, bone effects) and comorbidities.
Clinical Information
Clinical Pearls
- Isotretinoin is a highly effective treatment for severe acne but requires strict adherence to the iPLEDGE program due to its teratogenic risk.
- Always take isotretinoin with a high-fat meal to maximize absorption and efficacy.
- Dryness of skin, lips, and eyes is almost universal; advise patients on emollients, lip balm, and artificial tears.
- Monitor for psychiatric symptoms, especially depression and suicidal ideation, and educate patients and families on these risks.
- Regular monitoring of lipids and LFTs is crucial; dose adjustments or discontinuation may be necessary for significant elevations.
- Patients should avoid blood donation during treatment and for one month after stopping.
- Advise against cosmetic procedures like waxing, dermabrasion, and laser treatments during and for several months after treatment due to increased risk of scarring.
Alternative Therapies
- Oral antibiotics (e.g., doxycycline, minocycline) in combination with topical retinoids and/or benzoyl peroxide for moderate to severe acne.
- Spironolactone (for hormonal acne in females).
- Oral contraceptives (for hormonal acne in females).
- Photodynamic therapy (less common for severe nodular acne).
- Dapsone (topical or oral).
Cost & Coverage
Average Cost:
$100 - $500+ per 30 capsules (20mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization due to cost and REMS program requirements)
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 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 reporting the incident, be prepared to provide detailed information, including the substance taken, the quantity, and the time it occurred.