Amnesteem 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 oil glands in your skin, which helps prevent pimples. Because it's so strong, it has serious side effects, especially if taken during pregnancy, so strict rules must be followed.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.
Some medications are taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist to determine the best way to take your medication.
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 prescribed by your doctor or healthcare provider, even if you start feeling better. You will typically receive a month's supply of medication at a time.
Important Considerations
Your skin condition may appear to worsen before it improves.
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, avoiding storage in a bathroom.
Ensure all medications are kept out of the reach of children and pets, and stored in a secure location.
Missing 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 take it as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.
Some medications are taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist to determine the best way to take your medication.
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 prescribed by your doctor or healthcare provider, even if you start feeling better. You will typically receive a month's supply of medication at a time.
Important Considerations
Your skin condition may appear to worsen before it improves.
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, avoiding storage in a bathroom.
Ensure all medications are kept out of the reach of children and pets, and stored in a secure location.
Missing 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 a full meal, preferably a high-fat meal, to ensure proper absorption.
- Do NOT get pregnant during treatment or for one month after stopping. Use two reliable forms of birth control.
- Do NOT donate blood during treatment or for one month after stopping.
- Avoid waxing for hair removal during treatment and for at least 6 months after, due to increased risk of skin tearing and scarring.
- Avoid cosmetic procedures like dermabrasion or laser skin treatments during treatment and for at least 6 months after, due to increased risk of scarring.
- Use a good moisturizer and lip balm frequently to combat dryness.
- Use sunscreen and protective clothing, as skin will be more sensitive to the sun.
- Avoid alcohol, as it can increase triglyceride levels and liver strain.
- Do NOT take Vitamin A supplements.
- Do NOT share this medication with anyone.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 to 1 mg/kg/day orally, divided into two doses, for 15 to 20 weeks. A second course may be considered after a 2-month off-treatment period if severe nodular acne persists.
Dose Range:
0.5 - 1 mg
Condition-Specific Dosing:
severe_recalcitrant_nodular_acne:
Initial dose 0.5 mg/kg/day. Dose may be adjusted to 1 mg/kg/day if response is inadequate after 1 month or if severe disease warrants. Cumulative dose target 120-150 mg/kg.
very_severe_disease_or_truncal_acne:
Up to 2 mg/kg/day may be used, but this is less common and requires careful monitoring.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Same as adult dosing for severe recalcitrant nodular acne (typically >12 years of age and skeletally mature).
Prepubertal:
Use in prepubertal children is generally not recommended due to potential for premature epiphyseal closure.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required, but monitor closely.
Moderate:
No specific dose adjustment required, but monitor closely.
Severe:
Use with caution; consider lower initial dose (e.g., 10 mg/day) and titrate slowly. Monitor for adverse effects.
Dialysis:
Not well studied; use with extreme caution, if at all, and consider lower initial doses.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function tests closely.
Moderate:
Use with caution; consider lower initial dose and titrate slowly. Monitor liver function tests closely.
Severe:
Contraindicated due to potential for hepatotoxicity and impaired drug metabolism.
Cirrhosis:
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 inhibits the growth of Propionibacterium acnes (now Cutibacterium acnes), normalizes follicular keratinization, and has anti-inflammatory effects. These actions collectively reduce the formation of comedones and inflammatory lesions.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable, approximately 25% (fasted state).
Tmax:
2-4 hours (fasted state); 8 hours (with food).
FoodEffect:
Absorption is significantly increased (up to 2-fold) when taken with a high-fat meal. This is crucial for optimal absorption and efficacy.
Distribution:
Vd:
Not precisely determined, but distributes widely into tissues.
ProteinBinding:
>99.9% (primarily to albumin).
CnssPenetration:
Limited, but can cross the blood-brain barrier to some extent, leading to CNS side effects.
Elimination:
HalfLife:
Isotretinoin: 10-20 hours; 4-oxo-isotretinoin: 17-50 hours.
Clearance:
Not precisely quantified, but involves hepatic metabolism and renal/biliary excretion.
ExcretionRoute:
Approximately equal amounts excreted in urine and feces.
Unchanged:
<1% (very little unchanged drug excreted).
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically begins within 1-2 months.
PeakEffect:
Maximum therapeutic effect usually seen after 3-4 months of treatment.
DurationOfAction:
Long-lasting remission often achieved after a single course, with effects persisting for months to years after discontinuation.
Cumulative effect:
Therapeutic effect is related to cumulative dose.
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 registered in the iPLEDGE 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: 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 fruity-smelling breath
Behavior problems
Changes in eyesight, eye pain, or severe eye irritation
Back, bone, joint, or muscle pain
Muscle weakness
Unexplained bruising or bleeding
Feeling extremely tired or weak
Urination problems (difficulty starting or stopping urine flow, 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, 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 unusual symptoms, contact your doctor or seek medical attention:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in your eyes
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor 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 fruity-smelling breath
Behavior problems
Changes in eyesight, eye pain, or severe eye irritation
Back, bone, joint, or muscle pain
Muscle weakness
Unexplained bruising or bleeding
Feeling extremely tired or weak
Urination problems (difficulty starting or stopping urine flow, 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, 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 unusual symptoms, contact your doctor or seek medical attention:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in your eyes
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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 (signs of pseudotumor cerebri)
- Severe abdominal pain, with or without nausea/vomiting (signs of pancreatitis)
- Yellowing of skin or eyes, dark urine, severe fatigue (signs of liver problems)
- New or worsening feelings of sadness, anxiety, irritability, thoughts of harming yourself (signs of depression/mood changes)
- Severe muscle or joint pain
- Rectal bleeding, severe diarrhea (signs of inflammatory bowel disease, rare but reported)
- 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 reliable 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
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 may have. This will help ensure your safety while 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 reliable 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
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 may have. This will help ensure your safety while 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, which can make it difficult to drive or perform tasks in low-light conditions.
Blood Donation
Do not donate blood while taking this medication or for 1 month after stopping treatment.
Cholesterol and Triglyceride Changes
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood. Discuss this with your doctor and have your blood work checked as directed.
Sun Protection
You may be more susceptible to sunburn while taking this medication. Avoid exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear to minimize your risk.
Blood Sugar Monitoring
This medication may cause high blood sugar levels, including new 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. If you participate in sports that increase the risk of bone problems, such as broken bones, discuss this with your doctor. Have a bone density test as directed by your doctor.
Infection Risk
Low white blood cell counts have been reported with this medication, which may increase the risk of infection. Seek medical attention immediately if you experience symptoms 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 even death. Seek medical attention immediately if you experience severe headache, dizziness, nausea, vomiting, or seizures.
Severe Bowel Problems
Inflammatory bowel disease may occur with this medication, causing severe diarrhea, stomach pain, rectal bleeding, or rectal pain. Inform your doctor immediately if you experience any of these symptoms.
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. Consult your doctor about reliable birth control options. If you have unprotected sex, think you may be pregnant, or miss your period, contact your doctor immediately.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you. Be aware that this medication may cause sudden and potentially irreversible decreased night vision, which can make it difficult to drive or perform tasks in low-light conditions.
Blood Donation
Do not donate blood while taking this medication or for 1 month after stopping treatment.
Cholesterol and Triglyceride Changes
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not fully understood. Discuss this with your doctor and have your blood work checked as directed.
Sun Protection
You may be more susceptible to sunburn while taking this medication. Avoid exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear to minimize your risk.
Blood Sugar Monitoring
This medication may cause high blood sugar levels, including new 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. If you participate in sports that increase the risk of bone problems, such as broken bones, discuss this with your doctor. Have a bone density test as directed by your doctor.
Infection Risk
Low white blood cell counts have been reported with this medication, which may increase the risk of infection. Seek medical attention immediately if you experience symptoms 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 even death. Seek medical attention immediately if you experience severe headache, dizziness, nausea, vomiting, or seizures.
Severe Bowel Problems
Inflammatory bowel disease may occur with this medication, causing severe diarrhea, stomach pain, rectal bleeding, or rectal pain. Inform your doctor immediately if you experience any of these symptoms.
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. Consult your doctor about reliable birth control options. If you have unprotected sex, think you may be pregnant, or miss your period, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Headache
- Nausea
- Vomiting
- Drowsiness
- Irritability
- Itching
- Dry skin and mucous membranes
- Visual disturbances
What to Do:
Seek immediate medical attention or call a poison control center (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, increasing pregnancy risk)
- Progestin-only birth control pills (may be less effective, increasing pregnancy risk)
Moderate Interactions
- Alcohol (may increase triglyceride levels, potential for hepatotoxicity)
- Herbal supplements with Vitamin A (e.g., cod liver oil)
- Topical acne treatments (e.g., benzoyl peroxide, salicylic acid, topical retinoids) (may cause excessive skin irritation/dryness)
- Waxing (increased risk of skin tearing/scarring)
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).
Lipid panel (triglycerides, cholesterol)
Rationale: Isotretinoin can cause significant elevations in triglycerides and cholesterol.
Timing: Prior to initiation.
Liver function tests (ALT, AST, bilirubin)
Rationale: Isotretinoin can cause reversible elevations in liver enzymes.
Timing: Prior to initiation.
Complete Blood Count (CBC)
Rationale: Rare reports of blood dyscrasias (e.g., anemia, neutropenia).
Timing: Prior to initiation.
Mood assessment/mental health screening
Rationale: Reports of depression, mood disturbance, and suicidal ideation.
Timing: Prior to initiation.
Routine Monitoring
Pregnancy test (females of childbearing potential)
Frequency: Monthly, within 7 days prior to each refill, and 1 month after the last dose.
Target: Negative
Action Threshold: Positive test: immediately stop isotretinoin, refer to OB/GYN, report to FDA/manufacturer.
Lipid panel (triglycerides, cholesterol)
Frequency: Weekly or bi-weekly until response to isotretinoin is established, then monthly or 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 temporary discontinuation. Triglycerides >800 mg/dL: immediate discontinuation due to pancreatitis risk.
Liver function tests (ALT, AST)
Frequency: Weekly or bi-weekly until response to isotretinoin is established, then monthly or as clinically indicated.
Target: Within normal limits or <2x upper limit of normal.
Action Threshold: Elevations >2-3x upper limit of normal: consider dose reduction or temporary discontinuation. Persistent or significant elevations: discontinue.
Mood assessment/mental health screening
Frequency: At each visit.
Target: Stable mood, no new or worsening psychiatric symptoms.
Action Threshold: New or worsening symptoms of depression, anxiety, or suicidal ideation: immediate evaluation, consider discontinuation, refer to mental health specialist.
Skin and mucous membrane assessment
Frequency: At each visit.
Target: Manageable dryness, no severe irritation.
Action Threshold: Severe dryness, cheilitis, epistaxis, or skin fragility: provide symptomatic relief, consider dose adjustment.
Symptom Monitoring
- Dry skin, lips, eyes, nasal passages (epistaxis)
- Muscle or joint pain
- Headache (especially severe, persistent, or with visual changes - pseudotumor cerebri)
- Nausea, vomiting, abdominal pain (pancreatitis, liver issues)
- Vision changes (night vision decrease, blurred vision)
- Mood changes, depression, anxiety, irritability, suicidal thoughts
- Hair thinning
- Sun sensitivity
Special Patient Groups
Pregnancy
ABSOLUTELY CONTRAINDICATED. Isotretinoin is a potent human teratogen, causing severe and life-threatening birth defects. Females of reproductive potential must participate in the iPLEDGE program and use two forms of contraception.
Trimester-Specific Risks:
First Trimester:
Highest risk of severe congenital malformations, including craniofacial, cardiovascular, CNS, and thymic abnormalities.
Second Trimester:
Significant risk of malformations, though potentially less severe than first trimester.
Third Trimester:
Risk of malformations persists, though specific patterns may differ. Premature epiphyseal closure has been reported in infants exposed in utero.
Lactation
CONTRAINDICATED. It is not known if isotretinoin is excreted in human milk. However, due to the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment and for one month after discontinuation.
Infant Risk:
L5 (Contraindicated) - Potential for serious adverse effects in the infant, including developmental abnormalities or toxicity from retinoid exposure.
Pediatric Use
Generally used in adolescents (typically >12 years) with severe recalcitrant nodular acne. Use in younger children is limited due to concerns about premature epiphyseal closure and potential for long-term effects on bone growth. Dosing is weight-based.
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 polypharmacy.
Clinical Information
Clinical Pearls
- Isotretinoin is the most effective treatment for severe recalcitrant nodular acne, often leading to long-term remission.
- Strict adherence to the iPLEDGE program is mandatory for all patients (male and female) and prescribers.
- Absorption is significantly enhanced by food, especially high-fat meals. Instruct patients to take it with their largest meal of the day.
- The most common side effects are mucocutaneous (dryness of skin, lips, eyes, nasal passages). Proactive management with moisturizers, lip balms, and artificial tears is essential.
- Monitor for psychiatric side effects, including depression and suicidal ideation, and educate patients/families on these risks.
- Cumulative dose (typically 120-150 mg/kg) is a key factor for long-term remission, not just duration of therapy.
- Patients should avoid blood donation during and for one month after treatment due to the risk of exposing pregnant recipients to isotretinoin.
- Avoid concomitant use of tetracyclines due to the risk of pseudotumor cerebri.
Alternative Therapies
- Oral antibiotics (e.g., doxycycline, minocycline, azithromycin) 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 (PDT).
- Chemical peels, laser therapy (adjunctive treatments).
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 iPLEDGE program and cost)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure 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 valuable patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.