Accutane 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
Antiacne agent
Pharmacologic Class
Retinoid; Vitamin A derivative
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, women who can become pregnant must follow strict rules, including using two forms of birth control and registering with a special program called iPLEDGE.
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.
Important Reminders
You will typically receive a one-month supply of medication at a time.
It's common for skin conditions to appear worse before they start 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
Store your medication at room temperature, protected from light and moisture.
Keep it in a dry place, away from the bathroom.
Ensure all medications are kept in a safe 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, 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.
Important Reminders
You will typically receive a one-month supply of medication at a time.
It's common for skin conditions to appear worse before they start 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
Store your medication at room temperature, protected from light and moisture.
Keep it in a dry place, away from the bathroom.
Ensure all medications are kept in a safe 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
- Take with food (preferably a high-fat meal) to improve absorption.
- Avoid pregnancy at all costs; use two reliable forms of birth control.
- Do not donate blood during treatment and for at least one month after stopping, as pregnant women could receive your blood.
- Avoid sun exposure and use sunscreen (SPF 30+) and protective clothing, as skin becomes very sensitive.
- Avoid waxing, dermabrasion, or laser skin treatments during treatment and for at least 6 months after stopping, due to increased risk of scarring.
- Use lip balm, moisturizers, and eye drops regularly to manage dryness.
- Avoid alcohol, especially if you have high triglycerides.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
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 considered after a 2-month off-treatment period if severe nodular acne persists.
Dose Range:
0.5 - 1 mg
Condition-Specific Dosing:
severe_nodular_acne:
0.5 to 1 mg/kg/day
very_severe_or_truncal_acne:
Up to 2 mg/kg/day
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, divided into two doses, for 15 to 20 weeks (similar to adult dosing for severe nodular acne).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but monitor closely.
Moderate:
Start with a lower dose (e.g., 10 mg/day or 0.1 mg/kg/day) and titrate as tolerated.
Severe:
Start with a lower dose (e.g., 10 mg/day or 0.1 mg/kg/day) and titrate as tolerated.
Dialysis:
Use with extreme caution; start with very low dose and monitor closely. Limited data.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function tests closely.
Moderate:
Contraindicated or use with extreme caution; significant risk of toxicity.
Severe:
Contraindicated.
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 normalizes follicular keratinization, preventing comedone formation, and has anti-inflammatory properties. These actions collectively reduce the growth of Propionibacterium acnes (now Cutibacterium acnes) and the inflammatory response.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (approximately 25% with food, significantly less in fasting state)
Tmax:
2-4 hours (parent drug), 6-20 hours (4-oxo-isotretinoin)
FoodEffect:
Absorption is significantly increased (up to 2-fold) when taken with a high-fat meal.
Distribution:
Vd:
Approximately 29 L (for 70 kg individual)
ProteinBinding:
Greater than 99.9% (primarily to albumin)
CnssPenetration:
Limited, but can cross the blood-brain barrier and has been associated with pseudotumor cerebri.
Elimination:
HalfLife:
10-20 hours (isotretinoin), 17-50 hours (4-oxo-isotretinoin)
Clearance:
Not readily available, but primarily hepatic metabolism.
ExcretionRoute:
Approximately equal amounts excreted in feces and urine.
Unchanged:
<1% (parent drug)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 months.
PeakEffect:
Maximum therapeutic effect often observed after 3-4 months of treatment.
DurationOfAction:
Effects can be long-lasting, with many patients experiencing prolonged remission after a single course of treatment.
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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of depression, suicidal thoughts, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of esophagus problems: chest pain, trouble swallowing, or new or worse heartburn
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, fast breathing, or 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
Urination problems (difficulty starting or stopping urination, 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 permanent)
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, or 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, or severe upset stomach or vomiting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in your eyes
Reporting Side Effects
This list is not exhaustive, and you may experience other 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of depression, suicidal thoughts, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of esophagus problems: chest pain, trouble swallowing, or new or worse heartburn
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, fast breathing, or 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
Urination problems (difficulty starting or stopping urination, 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 permanent)
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, or 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, or severe upset stomach or vomiting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in your eyes
Reporting Side Effects
This list is not exhaustive, and you may experience other 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:
- Severe headache, blurred vision, dizziness, nausea, vomiting (could be signs of increased pressure in the brain)
- New or worsening feelings of sadness, anxiety, irritability, or thoughts of harming yourself (report immediately)
- Severe stomach pain, rectal bleeding, severe diarrhea (could be signs of serious bowel problems)
- Yellowing of skin or eyes, dark urine (could be signs of liver problems)
- Severe muscle or joint pain, especially after exercise
- 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 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 taking this drug.
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
Please note that this is not an exhaustive list of all potential interactions. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety when taking this medication. Never start, stop, or change 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 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 taking this drug.
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
Please note that this is not an exhaustive list of all potential interactions. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety when taking this medication. Never start, stop, or change 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 monitor your blood work as instructed.
Blood Work and Monitoring
Regularly check your blood work as directed by your doctor and discuss the results with them.
Sun Protection
You may be more susceptible to sunburn. Avoid exposure to the sun, 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-onset or worsening diabetes. Monitor your blood sugar levels as instructed by your doctor.
Alcohol Consumption
Consult your doctor before consuming alcohol while taking this medication.
Cosmetic Skin Treatments
Avoid cosmetic skin treatments like 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 undergo bone density tests as recommended.
Infection Risk
This medication may cause low white blood cell counts, increasing the risk of infection. Seek medical attention immediately if you experience symptoms like 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. Also, seek help if you experience weakness on one side of the body, speech or thinking difficulties, balance changes, or vision changes.
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. These symptoms may resolve after stopping the medication, but sometimes they may persist.
Growth Effects in Children and Teens
This medication may affect growth in children and teens. They may require regular growth checks. Discuss this with your doctor.
Birth Control
Do not use progestin-only birth control pills (minipills), as they may not be effective. Consult your doctor for alternative birth control options.
Pregnancy and Contraception
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 monitor your blood work as instructed.
Blood Work and Monitoring
Regularly check your blood work as directed by your doctor and discuss the results with them.
Sun Protection
You may be more susceptible to sunburn. Avoid exposure to the sun, 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-onset or worsening diabetes. Monitor your blood sugar levels as instructed by your doctor.
Alcohol Consumption
Consult your doctor before consuming alcohol while taking this medication.
Cosmetic Skin Treatments
Avoid cosmetic skin treatments like 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 undergo bone density tests as recommended.
Infection Risk
This medication may cause low white blood cell counts, increasing the risk of infection. Seek medical attention immediately if you experience symptoms like 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. Also, seek help if you experience weakness on one side of the body, speech or thinking difficulties, balance changes, or vision changes.
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. These symptoms may resolve after stopping the medication, but sometimes they may persist.
Growth Effects in Children and Teens
This medication may affect growth in children and teens. They may require regular growth checks. Discuss this with your doctor.
Birth Control
Do not use progestin-only birth control pills (minipills), as they may not be effective. Consult your doctor for alternative birth control options.
Pregnancy and Contraception
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
- Pseudotumor cerebri (severe headache, visual disturbances)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive; there is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Vitamin A supplements (risk of hypervitaminosis A)
- Tetracyclines (e.g., doxycycline, minocycline) (risk of pseudotumor cerebri/benign intracranial hypertension)
Major Interactions
- Systemic corticosteroids (may exacerbate osteoporosis risk)
- Phenytoin (may alter isotretinoin metabolism, increased risk of osteopenia)
- St. John's Wort (may reduce efficacy of hormonal contraceptives, critical for iPLEDGE)
Moderate Interactions
- Progestin-only birth control pills (efficacy may be reduced, use two forms of birth control)
- Alcohol (may increase triglyceride levels)
- Topical acne treatments (e.g., benzoyl peroxide, salicylic acid, topical retinoids) (may cause excessive skin irritation/dryness)
Minor Interactions
- Waxing (increased risk of skin tearing/scarring)
- Dermabrasion/laser skin treatments (increased risk of scarring)
Monitoring
Baseline Monitoring
Pregnancy test (females of reproductive potential)
Rationale: Absolute contraindication in pregnancy due to severe teratogenicity. Two negative tests required before initiation.
Timing: Within 7 days prior to initiation of therapy and again within 24 hours prior to initiation.
Lipid panel (triglycerides, cholesterol)
Rationale: Isotretinoin can cause significant elevations in triglycerides and cholesterol.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST)
Rationale: Isotretinoin can cause transient or persistent elevations in liver enzymes.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC)
Rationale: Rare reports of blood dyscrasias (e.g., anemia, neutropenia).
Timing: Prior to initiation of therapy.
Routine Monitoring
Pregnancy test (females of reproductive potential)
Frequency: Monthly (prior to each refill)
Target: Negative
Action Threshold: Positive test requires immediate discontinuation and referral to an obstetrician/gynecologist.
Lipid panel (triglycerides, cholesterol)
Frequency: Monthly or every 2-4 weeks for the first 1-2 months, then less frequently if stable.
Target: Triglycerides < 200 mg/dL (ideally), 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 for the first 1-2 months, then less frequently if stable.
Target: Within normal limits or < 2-3 times upper limit of normal.
Action Threshold: Persistent elevations > 2-3 times upper limit of normal (consider dose reduction or discontinuation).
Mood and behavioral changes assessment
Frequency: Monthly
Target: Stable mood, no new or worsening psychiatric symptoms.
Action Threshold: Report of depression, anxiety, suicidal ideation, or psychosis (discontinue and refer for psychiatric evaluation).
Symptom Monitoring
- Severe headache (especially with blurred vision, nausea, vomiting - signs of pseudotumor cerebri)
- Blurred vision or other visual disturbances (especially night vision changes)
- Severe abdominal pain, nausea, vomiting (signs of pancreatitis or inflammatory bowel disease)
- New or worsening depression, anxiety, irritability, or suicidal thoughts
- Severe muscle or joint pain
- Rectal bleeding, severe diarrhea (signs of inflammatory bowel disease)
- Yellowing of skin or eyes, dark urine (signs of liver problems)
- Excessive dryness of skin, lips, eyes, nasal passages
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). 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 (craniofacial, cardiac, CNS, 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 not known if isotretinoin is excreted in human milk, but due to its lipophilicity and potential for serious adverse effects in the nursing infant, breastfeeding is not recommended.
Infant Risk:
High risk of serious adverse effects, including potential for developmental abnormalities or toxicity.
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 common for severe nodular acne, with dosing similar to adults. Caution is advised regarding potential for premature epiphyseal closure, though this is rare and not definitively linked to typical therapeutic doses.
Geriatric Use
Limited data available. Use with caution in elderly patients due to potential for increased susceptibility to adverse effects (e.g., bone density changes, lipid abnormalities) and presence of comorbidities. Dosing should be individualized and monitoring intensified.
Clinical Information
Clinical Pearls
- Always take isotretinoin with a meal, preferably a high-fat meal, to maximize absorption and efficacy.
- Strict adherence to the iPLEDGE program is mandatory for all patients (male and female) and prescribers.
- Emphasize the importance of two forms of birth control for females of reproductive potential, even if they believe they are infertile or not sexually active.
- Manage dryness: Advise patients to use liberal amounts of lip balm, moisturizers, and artificial tears from the start of treatment.
- Warn patients about potential initial flare-up of acne during the first few weeks of treatment, which is usually transient.
- Educate patients about the importance of avoiding blood donation during and for at least one month after treatment.
- Monitor for mood changes and encourage patients to report any new or worsening psychiatric symptoms immediately.
Alternative Therapies
- Oral antibiotics (e.g., doxycycline, minocycline, azithromycin)
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Salicylic acid
- Hormonal therapies (e.g., oral contraceptives, spironolactone) for female patients
- Corticosteroid injections for cystic lesions
- Photodynamic therapy
- Chemical peels
Cost & Coverage
Average Cost:
$200 - $800 per 30 capsules (30mg)
Generic Available:
Yes
Insurance Coverage:
Tier 3 or Specialty Tier (often requires prior authorization and adherence to iPLEDGE program for coverage)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and avoid taking medication prescribed to someone else. 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, don't hesitate to consult 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 details about the medication taken, the amount, and the time it occurred.