Amnesteem 40mg 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 medicine used to treat severe acne that hasn't responded to other treatments. It works by reducing the oil glands in your skin and helping your skin shed cells normally. It's very effective but has serious side effects, especially for pregnant women.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Some medications are best 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 tablets or capsules whole. Do not chew, break, or crush them, as this can affect the way the medication works. Take your medication with a full glass of water to help it go down smoothly.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. You will typically receive a month's supply of medication at a time. It's common for skin conditions to appear worse before they start to improve with treatment.
If you experience any changes in weight, inform your doctor, as your medication dose may need to be adjusted. Additionally, 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 in a dry place. Avoid storing your medication in a bathroom, as the humidity and temperature can affect the medication. Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose of your medication, skip the missed dose and resume your normal dosing schedule. Do not take two doses at the same time or take extra doses, as this can increase the risk of side effects.
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Some medications are best 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 tablets or capsules whole. Do not chew, break, or crush them, as this can affect the way the medication works. Take your medication with a full glass of water to help it go down smoothly.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. You will typically receive a month's supply of medication at a time. It's common for skin conditions to appear worse before they start to improve with treatment.
If you experience any changes in weight, inform your doctor, as your medication dose may need to be adjusted. Additionally, 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 in a dry place. Avoid storing your medication in a bathroom, as the humidity and temperature can affect the medication. Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose of your medication, skip the missed dose and resume your normal dosing schedule. Do not take two doses at the same time or take extra doses, as this can increase the risk of side effects.
Lifestyle & Tips
- **Contraception is critical:** If you are a female of childbearing potential, you MUST use two effective forms of birth control for one month before, during, and for one month after treatment. You will have monthly pregnancy tests.
- **Avoid pregnancy:** Do not become pregnant while taking this medication or for one month after stopping it.
- **Do not donate blood:** Do not donate blood during treatment and for one month after stopping, as it could be given to a pregnant woman.
- **Take with food:** Always take your dose with a full meal, preferably a high-fat meal, to help your body absorb the medicine better.
- **Moisturize:** Expect very dry skin, lips, and eyes. Use a good moisturizer, lip balm, and artificial tears regularly.
- **Sun protection:** Your skin will be more sensitive to the sun. Use sunscreen (SPF 30+) and wear protective clothing.
- **Avoid certain procedures:** Do not get waxing, dermabrasion, or laser skin treatments during treatment and for at least 6 months after stopping, as it can cause severe scarring.
- **Limit alcohol:** Alcohol can increase triglyceride levels and liver strain.
- **Avoid Vitamin A supplements:** Do not take extra Vitamin A, as it can increase side effects.
- **Report side effects:** Immediately report any severe headaches, vision changes, severe abdominal pain, yellowing of skin/eyes, or mood changes (depression, thoughts of self-harm) to your doctor.
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
Dose Range:
0.5 - 1 mg
Condition-Specific Dosing:
severe_recalcitrant_nodular_acne:
0.5 to 1 mg/kg/day orally in two divided doses. A dose of 2 mg/kg/day may be used for patients with very severe disease or those whose disease is primarily truncal. Total cumulative dose of 120-150 mg/kg is often targeted for sustained remission.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Same as adult dosing for severe recalcitrant nodular acne (typically >12 years old and skeletally mature).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but monitor for adverse effects.
Moderate:
No specific adjustment recommended, but monitor for adverse effects.
Severe:
Use with caution; consider lower starting dose (e.g., 10 mg/day) and titrate slowly. Monitor for adverse effects.
Dialysis:
Use with caution; consider lower starting dose (e.g., 10 mg/day) and titrate slowly. Monitor for adverse effects.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function tests closely.
Moderate:
Use with caution; monitor liver function tests closely. Consider lower starting dose.
Severe:
Contraindicated due to extensive hepatic metabolism and potential for hepatotoxicity.
Pharmacology
Mechanism of Action
Isotretinoin is a retinoid, a derivative of vitamin A. Its exact mechanism in acne is not fully understood but is thought to involve multiple actions: it reduces sebaceous gland size and inhibits sebaceous gland activity, thereby reducing sebum production. It also inhibits the growth of Propionibacterium acnes, normalizes follicular keratinization, and possesses anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (20-25% without food, significantly increased with high-fat meal)
Tmax:
2-4 hours (with food)
FoodEffect:
Absorption is significantly increased (up to 2-fold) when taken with a high-fat meal.
Distribution:
Vd:
Not available
ProteinBinding:
99.9% (primarily to albumin)
CnssPenetration:
Limited (detectable in CSF, but not extensively)
Elimination:
HalfLife:
Isotretinoin: 10-20 hours; 4-oxo-isotretinoin: 17-50 hours
Clearance:
Not available
ExcretionRoute:
Approximately equal amounts excreted in urine and feces
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Weeks to months (clinical improvement typically seen after 1-2 months)
PeakEffect:
Typically after 15-20 weeks of treatment
DurationOfAction:
Long-lasting remission often achieved after a single course of therapy, but can vary.
Safety & Warnings
BLACK BOX WARNING
Isotretinoin can cause severe birth defects. It is contraindicated in pregnant women. Females of reproductive potential must not be pregnant when isotretinoin treatment is initiated, and must use two forms of effective contraception for at least one month prior to initiation of therapy, during therapy, and for one month following discontinuation of therapy. Patients must be enrolled in and comply with the iPLEDGE REMS program.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of depression, suicidal thoughts, or mood changes, including:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of esophagus problems, including:
+ Chest pain
+ Trouble swallowing
+ New or worsening heartburn
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Behavior problems
Changes in eyesight, eye pain, or severe eye irritation
Back, bone, joint, or muscle pain
Muscle weakness
Unexplained bruising or bleeding
Feeling very tired or weak
Difficulty urinating or changes in urine output
Swelling
Swollen glands
Fast or abnormal heartbeat
Hearing problems, such as changes in hearing or ringing in the ears (which may be temporary or persistent)
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause severe health problems and may be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
Severe and potentially life-threatening pancreas problems (pancreatitis). Call your doctor right away if you experience:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in the eyes
If any of these side effects or other symptoms bother you or persist, contact your doctor or seek medical attention.
Reporting Side Effects
If you have questions or concerns about side effects, call 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 immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of depression, suicidal thoughts, or mood changes, including:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of esophagus problems, including:
+ Chest pain
+ Trouble swallowing
+ New or worsening heartburn
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Behavior problems
Changes in eyesight, eye pain, or severe eye irritation
Back, bone, joint, or muscle pain
Muscle weakness
Unexplained bruising or bleeding
Feeling very tired or weak
Difficulty urinating or changes in urine output
Swelling
Swollen glands
Fast or abnormal heartbeat
Hearing problems, such as changes in hearing or ringing in the ears (which may be temporary or persistent)
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause severe health problems and may be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
Severe and potentially life-threatening pancreas problems (pancreatitis). Call your doctor right away if you experience:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in the eyes
If any of these side effects or other symptoms bother you or persist, contact your doctor or seek medical attention.
Reporting Side Effects
If you have questions or concerns about side effects, call 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 with blurred vision or dizziness (signs of pseudotumor cerebri)
- Severe abdominal pain, nausea, vomiting (signs of pancreatitis)
- Yellowing of skin or eyes, dark urine (signs of liver problems)
- New or worsening depression, anxiety, irritability, thoughts of self-harm
- Severe muscle or joint pain
- Difficulty seeing at night (especially sudden onset)
- Allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
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 persistent decreased night vision, which can make it difficult to drive or perform tasks in low-light environments. Exercise caution when driving at night or engaging in activities that require good vision 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 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 to minimize your risk.
Blood Sugar Changes
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
Discuss alcohol consumption with your doctor before drinking.
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 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, as well as 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. Inform your doctor immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain, as these symptoms may persist even after stopping treatment.
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 methods with your doctor.
Pregnancy
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 persistent decreased night vision, which can make it difficult to drive or perform tasks in low-light environments. Exercise caution when driving at night or engaging in activities that require good vision 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 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 to minimize your risk.
Blood Sugar Changes
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
Discuss alcohol consumption with your doctor before drinking.
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 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, as well as 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. Inform your doctor immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain, as these symptoms may persist even after stopping treatment.
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 methods with your doctor.
Pregnancy
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
- Joint pain
- Hair loss
What to Do:
Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention. Treatment is supportive.
Drug Interactions
Contraindicated Interactions
- Tetracyclines (e.g., doxycycline, minocycline): Increased risk of pseudotumor cerebri (benign intracranial hypertension).
- Vitamin A supplements: Increased risk of hypervitaminosis A symptoms (e.g., pseudotumor cerebri, dry skin, cheilitis).
Major Interactions
- Progestin-only birth control pills: Isotretinoin may decrease the effectiveness of progestin-only contraceptives. Patients must use two forms of effective contraception.
- St. John's Wort: May decrease the effectiveness of hormonal contraceptives.
Moderate Interactions
- Systemic corticosteroids: May exacerbate osteoporosis risk, especially with long-term use.
- Phenytoin: May increase risk of osteomalacia/osteoporosis.
- Systemic retinoids (e.g., acitretin, tazarotene): Additive toxicity.
Minor Interactions
- Alcohol: May increase triglyceride levels and potential for hepatotoxicity.
- Waxing and dermabrasion: Increased risk of scarring during and for at least 6 months after treatment.
Monitoring
Baseline Monitoring
Pregnancy test (females of childbearing potential)
Rationale: Absolute contraindication in pregnancy due to severe teratogenicity. Required by iPLEDGE program.
Timing: Within 7 days prior to initiating therapy, and a second test within 7 days prior to initiating therapy (confirmatory).
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, alkaline phosphatase, bilirubin)
Rationale: Isotretinoin can cause transient or persistent elevations in liver enzymes.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: Rare reports of blood dyscrasias (e.g., anemia, thrombocytopenia, neutropenia).
Timing: Prior to initiation of therapy.
Mood assessment
Rationale: Reports of depression, mood disturbance, and suicidal ideation (causal link not definitively established but requires monitoring).
Timing: Prior to initiation of therapy.
Routine Monitoring
Pregnancy test (females of childbearing potential)
Frequency: Monthly, within 7 days prior to each refill
Target: Negative
Action Threshold: Positive test: immediately stop isotretinoin, refer to OB/GYN, report to iPLEDGE.
Lipid panel (triglycerides, cholesterol)
Frequency: Monthly or every 2-4 weeks during therapy, then as clinically indicated
Target: Triglycerides < 200 mg/dL (ideally), 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: Monthly or every 2-4 weeks during therapy, then as clinically indicated
Target: Within normal limits or < 2-3x upper limit of normal
Action Threshold: Persistent elevations > 2-3x ULN: consider dose reduction or discontinuation.
Mood assessment
Frequency: Monthly
Target: Stable mood
Action Threshold: New or worsening symptoms of depression, anxiety, or suicidal ideation: immediate psychiatric evaluation, consider discontinuation.
CBC with differential
Frequency: Periodically, or as clinically indicated
Target: Within normal limits
Action Threshold: Significant abnormalities: investigate and consider discontinuation.
Symptom Monitoring
- Dryness of skin, lips, eyes, nasal passages
- Muscle or joint pain
- Headache (especially severe, persistent, or with visual changes - rule out pseudotumor cerebri)
- Nausea, vomiting, severe abdominal pain (pancreatitis)
- Yellowing of skin/eyes, dark urine (liver dysfunction)
- Changes in vision (night vision impairment, blurred vision)
- Mood changes, irritability, depression, thoughts of self-harm
- 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 be enrolled in the iPLEDGE REMS program and comply with all requirements, including two negative pregnancy tests prior to initiation, monthly negative pregnancy tests, and use of two forms of effective contraception.
Trimester-Specific Risks:
First Trimester:
Highest risk of severe congenital malformations, including craniofacial, cardiovascular, central nervous system, and thymic abnormalities.
Second Trimester:
Significant risk of malformations, though potentially lower than first trimester.
Third Trimester:
Risk of malformations decreases, but still potential for adverse fetal effects.
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 due to high toxicity profile.
Pediatric Use
Approved for severe recalcitrant nodular acne in patients 12 years of age and older. Use in younger children is generally not recommended due to potential effects on bone growth (premature epiphyseal closure reported rarely). Close monitoring for adverse effects is crucial.
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 mineral density changes, lipid abnormalities).
Clinical Information
Clinical Pearls
- Isotretinoin is the most effective treatment for severe recalcitrant nodular acne, often leading to long-term remission.
- Compliance with the iPLEDGE program is mandatory for all prescribers, pharmacies, and patients.
- The most common side effects are mucocutaneous dryness (lips, skin, eyes, nasal passages).
- Patients should be advised to avoid blood donation during and for one month after treatment.
- A cumulative dose of 120-150 mg/kg is often targeted for optimal long-term remission, but individual response varies.
- Initial worsening of acne (flare) can occur at the beginning of treatment.
- Night vision impairment can occur and may be permanent in rare cases; advise caution when driving at night.
- Avoid concomitant use of St. John's Wort as it may reduce the efficacy of hormonal contraceptives.
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.
- Benzoyl peroxide (topical)
- Salicylic acid (topical)
- Chemical peels, laser therapy, photodynamic therapy (adjunctive or alternative for some cases).
Cost & Coverage
Average Cost:
$200 - $800+ per 30 capsules (40mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often requires prior authorization due to cost and REMS program requirements)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial 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.