Amnesteem 10mg Capsules
WARNING: Do not take if you are pregnant or may get pregnant. The risk of severe and sometimes deadly birth defects is very high if you take this drug at any time while you are pregnant. Any unborn baby can be harmed. There is no good way to tell if an unborn baby has been harmed. The risk of losing an unborn baby is also raised, and premature births have happened. Talk with your doctor before you start this drug. If you know all the facts and can follow how to take this drug, you must sign a patient fact/consent form. Do not sign the form and do not take this drug if you do not know everything on the form.You must have 2 pregnancy tests that show you are NOT pregnant before starting this drug. You must have pregnancy tests done while taking this drug. Talk with your doctor.You must either use 2 kinds of birth control or commit to not having any sex that could cause pregnancy while taking this drug. You must do this for 1 month before starting this drug, during treatment, and for at least 1 month after the last dose. Talk about this with your doctor.If you get pregnant while taking this drug or within 1 month after your last dose, call your doctor right away. @ COMMON USES: It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid
Pregnancy Category
Category X
FDA Approved
May 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 makes. Because it can cause serious birth defects, there are very strict rules for its use, especially for women who can get pregnant.
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 skin conditions to appear worse before they start to improve with treatment.
If you experience any changes in weight, inform your doctor, as your medication 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 bathrooms.
* 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 skin conditions to appear worse before they start to improve with treatment.
If you experience any changes in weight, inform your doctor, as your medication 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 bathrooms.
* Store all medications in a secure location, out of reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Always take with food (preferably a high-fat meal) to ensure proper absorption.
- Do not donate blood during treatment and for one month after stopping, as pregnant women could receive your blood.
- Avoid sun exposure and use sunscreen, as skin becomes more sensitive to the sun.
- Avoid waxing, dermabrasion, and laser skin treatments during and for at least 6 months after treatment due to increased risk of scarring.
- Avoid contact lens use if experiencing severe dry eyes; use lubricating eye drops.
- Do not share this medication with anyone else.
- Limit alcohol intake due to potential for increased triglyceride levels and liver effects.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 to 1 mg/kg/day orally in two divided doses for 15 to 20 weeks. A second course may be initiated after a 2-month off-treatment period if necessary.
Dose Range:
0.5 - 1 mg
Condition-Specific Dosing:
severe_cystic_acne:
Initial dose 0.5 mg/kg/day. Dose may be adjusted to 1 mg/kg/day based on clinical response and tolerability. Cumulative dose target: 120-150 mg/kg.
very_severe_acne_or_truncal_acne:
Up to 2 mg/kg/day may be used for a limited time.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (generally not recommended for children under 12 years of age due to potential for premature epiphyseal closure)
Adolescent:
0.5 to 1 mg/kg/day orally in two divided 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 closely.
Moderate:
Start with a lower dose (e.g., 10 mg/day or 0.1 mg/kg/day) and titrate carefully.
Severe:
Start with a lower dose (e.g., 10 mg/day or 0.1 mg/kg/day) and titrate carefully.
Dialysis:
Use with caution; start with a lower dose and monitor closely. Data are limited.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function tests closely.
Moderate:
Contraindicated due to extensive hepatic metabolism and potential for hepatotoxicity.
Severe:
Contraindicated due to extensive hepatic metabolism and potential for hepatotoxicity.
Pharmacology
Mechanism of Action
Isotretinoin is a retinoid, a derivative of vitamin A. Its exact mechanism of action in severe acne is not fully understood but is thought to involve multiple effects. It significantly reduces sebaceous gland size and inhibits sebaceous gland activity, thereby decreasing sebum production. It also inhibits the growth of Propionibacterium acnes, normalizes follicular keratinization, and has anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (25-60%)
Tmax:
2-4 hours (with food)
FoodEffect:
Absorption is significantly increased (up to 2-fold) when taken with a high-fat meal. Must be taken with food.
Distribution:
Vd:
Not available (extensively distributed)
ProteinBinding:
>99.9% (primarily to albumin)
CnssPenetration:
Limited, but can cross the blood-brain barrier and cause pseudotumor cerebri in rare cases.
Elimination:
HalfLife:
Isotretinoin: 10-20 hours; 4-oxo-isotretinoin: 17-50 hours
Clearance:
Not available
ExcretionRoute:
Approximately equal amounts excreted in urine and feces (as metabolites)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 months, but initial flare-up can occur.
PeakEffect:
Maximal effect usually observed after 15-20 weeks of treatment.
DurationOfAction:
Long-lasting remission often achieved after a single course; effects can persist for months to years after discontinuation.
Safety & Warnings
BLACK BOX WARNING
Isotretinoin is associated with severe birth defects. It is contraindicated in pregnant women and women of childbearing potential unless all conditions of the iPLEDGE REMS program are met. Females of childbearing potential must not be pregnant when isotretinoin treatment is initiated, must not become pregnant during treatment, and must not become pregnant for one month after discontinuing isotretinoin therapy. Two forms of effective contraception must be used concurrently, unless abstinence is chosen, 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 Attention 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 help 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, passing urine more often, flushing, fast breathing, or breath that smells like fruit
Behavior problems
Change 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 or may not go away after stopping the medication)
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause severe health problems and even death. 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 deadly pancreas problems (pancreatitis). Call your doctor right away if you have 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. Many people experience no side effects or only minor ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in the eyes
This is not an exhaustive list of possible 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 help 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, passing urine more often, flushing, fast breathing, or breath that smells like fruit
Behavior problems
Change 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 or may not go away after stopping the medication)
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause severe health problems and even death. 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 deadly pancreas problems (pancreatitis). Call your doctor right away if you have 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. Many people experience no side effects or only minor ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in the eyes
This is not an exhaustive list of possible 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:
- Any signs of pregnancy (missed period, nausea, breast tenderness)
- Severe headache, blurred vision, dizziness, nausea, vomiting (signs of pseudotumor cerebri)
- Severe abdominal pain, nausea, vomiting (signs of pancreatitis)
- Yellowing of skin or eyes, dark urine, unusual tiredness (signs of liver problems)
- New or worsening feelings of sadness, crying spells, loss of interest in activities, irritability, thoughts of harming yourself (signs of depression/mood changes)
- Severe muscle or joint pain
- Rectal bleeding, severe diarrhea (signs of inflammatory bowel disease)
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 or similar substances
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 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
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. Exercise caution when driving at night or engaging in activities in low-light environments.
Blood Donation
Do not donate blood while taking this medication and 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 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 while taking this medication. Avoid exposure to the sun, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear.
Blood Sugar Changes
This medication may cause increased blood sugar levels, including new or worsening diabetes. Monitor your blood sugar as directed 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 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
This medication may cause severe bowel problems, including inflammatory bowel disease. Seek medical attention immediately if you experience symptoms such as 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.
Pregnancy and Contraception
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. Exercise caution when driving at night or engaging in activities in low-light environments.
Blood Donation
Do not donate blood while taking this medication and 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 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 while taking this medication. Avoid exposure to the sun, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear.
Blood Sugar Changes
This medication may cause increased blood sugar levels, including new or worsening diabetes. Monitor your blood sugar as directed 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 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
This medication may cause severe bowel problems, including inflammatory bowel disease. Seek medical attention immediately if you experience symptoms such as 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.
Pregnancy and Contraception
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
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive.
Drug Interactions
Contraindicated Interactions
- Vitamin A supplements (risk of hypervitaminosis A)
- Tetracyclines (e.g., doxycycline, minocycline) (risk of pseudotumor cerebri/benign intracranial hypertension)
- Methotrexate (potential for increased hepatotoxicity)
Major Interactions
- Systemic corticosteroids (may exacerbate osteoporosis risk)
- Phenytoin (may reduce isotretinoin levels, increased risk of osteoporosis)
- St. John's Wort (may reduce efficacy of hormonal contraceptives)
Moderate Interactions
- Oral contraceptives (efficacy may be reduced by some antibiotics, though not directly by isotretinoin; important for iPLEDGE)
- Alcohol (potential for increased triglyceride levels and hepatotoxicity)
- Topical acne treatments (e.g., benzoyl peroxide, salicylic acid, topical retinoids) (increased 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 childbearing potential)
Rationale: Absolute contraindication in pregnancy due to severe teratogenicity. Required by iPLEDGE.
Timing: Within 7 days prior to initiating therapy and monthly thereafter.
Lipid panel (triglycerides, cholesterol)
Rationale: Isotretinoin can cause significant elevations in triglycerides and cholesterol.
Timing: Prior to initiation.
Liver function tests (ALT, AST)
Rationale: Isotretinoin can cause transient or persistent 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
Rationale: Reports of depression, mood disturbance, psychosis, and suicidal ideation.
Timing: Prior to initiation and throughout treatment.
Routine Monitoring
Pregnancy test (females of childbearing potential)
Frequency: Monthly, prior to each prescription refill.
Target: Negative
Action Threshold: Positive test: immediately discontinue isotretinoin, refer to OB/GYN, report to iPLEDGE.
Lipid panel (triglycerides, cholesterol)
Frequency: Weekly or bi-weekly until response to treatment 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 risk of pancreatitis.
Liver function tests (ALT, AST)
Frequency: Weekly or bi-weekly until response to treatment is established, then monthly or as clinically indicated.
Target: Within normal limits or stable.
Action Threshold: Elevations > 2-3 times upper limit of normal: consider dose reduction or temporary discontinuation.
Mood assessment
Frequency: At each visit.
Target: Stable mood, no new psychiatric symptoms.
Action Threshold: New or worsening symptoms of depression, anxiety, or suicidal ideation: discontinue isotretinoin, refer to mental health professional.
Symptom Monitoring
- Dryness of skin, lips, eyes, nasal passages
- Muscle or joint pain
- Headache (especially severe, persistent, or with visual changes, suggestive of pseudotumor cerebri)
- Nausea, vomiting, severe abdominal pain (suggestive of pancreatitis)
- Vision changes (especially night vision)
- Mood changes, depression, anxiety, suicidal thoughts
- Rectal bleeding, severe diarrhea (suggestive of inflammatory bowel disease)
- Yellowing of skin or eyes, dark urine (suggestive of liver problems)
Special Patient Groups
Pregnancy
ABSOLUTELY CONTRAINDICATED. Causes severe and life-threatening birth defects (e.g., craniofacial, cardiac, CNS, thymic abnormalities). All females of childbearing potential must participate in the iPLEDGE REMS program.
Trimester-Specific Risks:
First Trimester:
Highest risk of severe congenital malformations.
Second Trimester:
Significant risk of congenital malformations.
Third Trimester:
Significant risk of congenital malformations.
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 infant, breastfeeding is not recommended.
Infant Risk:
L5 (Contraindicated - significant documented hazard to infant)
Pediatric Use
Generally not recommended for children under 12 years of age due to potential for premature epiphyseal closure. Use in adolescents (12 years and older) for severe cystic acne is common and follows adult dosing guidelines, with strict adherence to iPLEDGE for females.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Use with caution due to potential for increased susceptibility to adverse effects (e.g., bone effects, lipid abnormalities).
Clinical Information
Clinical Pearls
- Isotretinoin is a highly effective treatment for severe, recalcitrant nodular acne, but its use is strictly regulated due to its teratogenicity.
- Emphasize the importance of taking isotretinoin with a high-fat meal to maximize absorption and efficacy.
- Counsel patients extensively on the iPLEDGE program requirements, including two forms of contraception for females of childbearing potential.
- Monitor for psychiatric side effects, including depression and suicidal ideation, and educate patients and families on these risks.
- Regular monitoring of lipids and liver function tests is crucial throughout treatment.
- Patients will experience significant dryness of skin, lips, and eyes; recommend emollients, lip balm, and artificial tears.
- Initial flare-up of acne can occur at the beginning of treatment; reassure patients this is temporary.
Alternative Therapies
- Oral antibiotics (e.g., doxycycline, minocycline, azithromycin) in combination with topical retinoids and/or benzoyl peroxide for moderate to severe acne.
- Hormonal therapies (e.g., oral contraceptives, spironolactone) for hormonal acne in females.
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene) for less severe acne or maintenance.
- Photodynamic therapy (PDT) for severe acne.
- Chemical peels or laser therapy as adjunctive treatments.
Cost & Coverage
Average Cost:
$100 - $400 per 30 capsules (10mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (requires prior authorization and adherence to iPLEDGE for females of childbearing potential)
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 provides crucial information 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, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.