Accutane 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; Vitamin A derivative
Pregnancy Category
Category X
FDA Approved
May 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
Isotretinoin is a powerful medication used to treat severe acne that hasn't responded to other treatments. It works by reducing the oil your skin produces and helping your skin renew itself. Because it can cause serious birth defects, there are very strict rules for its use, especially for women who can become pregnant.
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 medication and follow the instructions closely. Some medications should be 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. Take your medication with a full glass of water.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. You will typically receive a one-month supply of medication at a time. It's common for your skin condition to appear worse before it starts to improve.
If you experience any changes in weight, inform your doctor, as your medication dosage may need to be adjusted. 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. Keep all medications in a secure location, out of the 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 dose.
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 medication and follow the instructions closely. Some medications should be 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. Take your medication with a full glass of water.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. You will typically receive a one-month supply of medication at a time. It's common for your skin condition to appear worse before it starts to improve.
If you experience any changes in weight, inform your doctor, as your medication dosage may need to be adjusted. 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. Keep all medications in a secure location, out of the 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 dose.
Lifestyle & Tips
- Always take with food, preferably a high-fat meal, to ensure proper absorption.
- Do not donate blood during treatment and for at least one month after stopping, as pregnant women could receive your blood.
- Avoid sun exposure and use sunscreen (SPF 30+) and protective clothing, as skin becomes very sensitive 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 alcohol, as it may increase the risk of side effects like high triglycerides and liver problems.
- Use lip balm, moisturizers, and eye drops regularly to manage common side effects like dry skin, lips, and eyes.
- Do not share this medication with anyone else.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 to 1 mg/kg/day orally, divided into two doses, for 15 to 20 weeks.
Dose Range:
0.5 - 1 mg
Condition-Specific Dosing:
severe_cystic_acne:
Initial dose 0.5 mg/kg/day. Dose may be increased to 1 mg/kg/day if severe cystic acne is unresponsive to initial therapy, particularly on the trunk. A second course may be initiated after a minimum of 2 months off therapy if needed.
very_severe_acne_or_acne_on_trunk:
Up to 2 mg/kg/day may be used for a limited time.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established in pediatric patients under 12 years of age)
Adolescent:
0.5 to 1 mg/kg/day orally, divided into two doses, for 15 to 20 weeks (same as adult dosing for severe cystic acne).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
Use with extreme caution; consider lower initial dose (e.g., 10 mg/day) and titrate slowly. Monitor for adverse effects.
Dialysis:
Not available (limited data, use with extreme caution if at all).
Hepatic Impairment:
Mild:
Use with caution; monitor liver function tests.
Moderate:
Use with caution; monitor liver function tests. Consider lower initial dose.
Severe:
Contraindicated due to potential for hepatotoxicity and altered drug metabolism.
Pharmacology
Mechanism of Action
Isotretinoin is a retinoid that acts by reducing sebaceous gland size and inhibiting sebaceous gland activity, leading to a substantial reduction in sebum secretion. It also inhibits the growth of Propionibacterium acnes (now Cutibacterium acnes), normalizes follicular keratinization, and possesses anti-inflammatory properties. These combined actions reduce comedogenesis and inflammation, leading to improvement in severe acne.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (approximately 25% for a single dose, significantly increased with food).
Tmax:
2-4 hours (parent drug), 6-20 hours (4-oxo-isotretinoin).
FoodEffect:
Absorption is significantly increased (up to 2-fold) when taken with a high-fat meal.
Distribution:
Vd:
Not precisely quantified, but extensively distributed.
ProteinBinding:
Greater than 99.9% (primarily to albumin).
CnssPenetration:
Limited (detectable in CSF, but lower concentrations than plasma).
Elimination:
HalfLife:
Parent drug: 10-20 hours; 4-oxo-isotretinoin: 17-50 hours.
Clearance:
Not precisely quantified due to extensive metabolism and enterohepatic recirculation.
ExcretionRoute:
Approximately equal amounts excreted in urine and feces.
Unchanged:
Very little unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 months, but can take up to 4 months.
PeakEffect:
Peak therapeutic effect often observed after completion of the 15-20 week course, with continued improvement for several weeks after discontinuation.
DurationOfAction:
Long-lasting remission in many patients after a single course; effects can persist for months to years.
Safety & Warnings
BLACK BOX WARNING
Isotretinoin is associated with severe birth defects. It is contraindicated in pregnant women. Females of reproductive potential must not be pregnant when isotretinoin treatment is initiated, and must use two forms of effective contraception (one primary and one secondary) at least one month prior to initiation of therapy, during therapy, and for one month following discontinuation of therapy. Patients must enroll 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 medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of depression, suicidal thoughts, or mood changes, including:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of esophagus problems, including:
+ Chest pain
+ Trouble swallowing
+ New or worsening heartburn
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Behavior problems
Changes in eyesight, eye pain, or severe eye irritation
Back, bone, joint, or muscle pain
Muscle weakness
Unexplained bruising or bleeding
Feeling very tired or weak
Difficulty urinating or changes in urine output
Swelling
Swollen glands
Fast or abnormal heartbeat
Hearing problems, such as changes in hearing or ringing in the ears (which may 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 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
Most people do not experience significant side effects, but some may occur. If you notice 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 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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of depression, suicidal thoughts, or mood changes, including:
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of esophagus problems, including:
+ Chest pain
+ Trouble swallowing
+ New or worsening heartburn
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Behavior problems
Changes in eyesight, eye pain, or severe eye irritation
Back, bone, joint, or muscle pain
Muscle weakness
Unexplained bruising or bleeding
Feeling very tired or weak
Difficulty urinating or changes in urine output
Swelling
Swollen glands
Fast or abnormal heartbeat
Hearing problems, such as changes in hearing or ringing in the ears (which may 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 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
Most people do not experience significant side effects, but some may occur. If you notice 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 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:
- Severe headache, blurred vision, dizziness (could be signs of increased pressure in the brain)
- Severe stomach pain, nausea, vomiting, diarrhea, or rectal bleeding (could be signs of pancreatitis or inflammatory bowel disease)
- Yellowing of skin or eyes, dark urine (signs of liver problems)
- New or worsening feelings of sadness, anxiety, irritability, aggression, or thoughts of harming yourself (signs of mental health changes)
- Severe muscle weakness, joint pain, or back pain
- Difficulty swallowing or painful swallowing
- Any signs of 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 allergic reaction you experienced.
If you are able to become pregnant and are not using two forms of birth control.
If you plan to become pregnant within one month before starting treatment, during treatment, or within one month after your last dose.
If you are breastfeeding. You should not breastfeed for a certain period after receiving this medication. Consult your doctor to determine how long you should avoid breastfeeding after taking this drug.
Additionally, tell your doctor if you are taking any of the following medications:
Demeclocycline
Doxycycline
Minocycline
Tetracycline
Products containing vitamin A or similar substances
St. John's wort
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 allergic reaction you experienced.
If you are able to become pregnant and are not using two forms of birth control.
If you plan to become pregnant within one month before starting treatment, during treatment, or within one month after your last dose.
If you are breastfeeding. You should not breastfeed for a certain period after receiving this medication. Consult your doctor to determine how long you should avoid breastfeeding after taking this drug.
Additionally, tell your doctor if you are taking any of the following medications:
Demeclocycline
Doxycycline
Minocycline
Tetracycline
Products containing vitamin A or similar substances
St. John's wort
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 or for 1 month after stopping treatment.
Cholesterol and Triglycerides
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not well 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 Sensitivity
You may be more susceptible to sunburn. Avoid exposure to sunlight, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to minimize sun exposure.
Blood Sugar Control
This medication may cause high blood sugar levels, including new or worsening diabetes. Monitor your blood sugar as instructed by your doctor.
Alcohol Consumption
Consult your doctor before consuming alcohol while taking this medication.
Cosmetic Skin Treatments
Avoid cosmetic skin treatments like waxing, dermabrasion, or laser treatments during treatment and for at least 6 months after the last dose, as the risk of scarring may be increased.
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. Immediately contact your doctor if you experience symptoms like fever, chills, or sore throat.
Raised Brain Pressure
This medication may cause increased pressure in the brain, leading to permanent vision loss or death. Seek immediate medical attention if you experience severe headache, dizziness, nausea, vomiting, or seizures. Also, contact your doctor right away if you experience weakness on one side of the body, speech or thinking difficulties, balance changes, or vision changes.
Bowel Problems
Severe bowel problems, including inflammatory bowel disease, may occur with this medication. Inform your doctor immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain. These symptoms may resolve after stopping the medication, but sometimes they may persist.
Growth Effects in Children and Teens
This medication may affect growth in children and teens. They may require regular growth checks. Discuss this with your doctor.
Birth Control
Do not use progestin-only birth control pills (minipills), as they may not be effective. Consult your doctor for alternative birth control options.
Pregnancy
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 or for 1 month after stopping treatment.
Cholesterol and Triglycerides
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not well 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 Sensitivity
You may be more susceptible to sunburn. Avoid exposure to sunlight, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to minimize sun exposure.
Blood Sugar Control
This medication may cause high blood sugar levels, including new or worsening diabetes. Monitor your blood sugar as instructed by your doctor.
Alcohol Consumption
Consult your doctor before consuming alcohol while taking this medication.
Cosmetic Skin Treatments
Avoid cosmetic skin treatments like waxing, dermabrasion, or laser treatments during treatment and for at least 6 months after the last dose, as the risk of scarring may be increased.
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. Immediately contact your doctor if you experience symptoms like fever, chills, or sore throat.
Raised Brain Pressure
This medication may cause increased pressure in the brain, leading to permanent vision loss or death. Seek immediate medical attention if you experience severe headache, dizziness, nausea, vomiting, or seizures. Also, contact your doctor right away if you experience weakness on one side of the body, speech or thinking difficulties, balance changes, or vision changes.
Bowel Problems
Severe bowel problems, including inflammatory bowel disease, may occur with this medication. Inform your doctor immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain. These symptoms may resolve after stopping the medication, but sometimes they may persist.
Growth Effects in Children and Teens
This medication may affect growth in children and teens. They may require regular growth checks. Discuss this with your doctor.
Birth Control
Do not use progestin-only birth control pills (minipills), as they may not be effective. Consult your doctor for alternative birth control options.
Pregnancy
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
What to Do:
Seek immediate medical attention or call 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)
Major Interactions
- Systemic corticosteroids (may exacerbate osteoporosis risk, especially with long-term use)
- Phenytoin (may reduce isotretinoin levels, increased risk of osteopenia/osteoporosis)
- 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 risk of hypertriglyceridemia and hepatotoxicity)
- Topical peeling agents (e.g., salicylic acid, benzoyl peroxide, sulfur) (may increase skin irritation and dryness)
- Waxing and dermabrasion (increased risk of scarring and skin damage during and for 5-6 months after treatment)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pregnancy test (females of childbearing potential)
Rationale: Absolute contraindication in pregnancy due to severe teratogenicity. Two negative tests required before initiation.
Timing: Within 7 days prior to initiation of therapy, and a second test on the day of initiation.
Lipid panel (triglycerides, cholesterol)
Rationale: Isotretinoin can cause significant elevations in triglycerides and cholesterol, increasing risk of pancreatitis.
Timing: Before treatment initiation.
Liver function tests (ALT, AST, bilirubin)
Rationale: Isotretinoin can cause reversible elevations in liver enzymes.
Timing: Before treatment initiation.
Complete Blood Count (CBC) with differential
Rationale: Rare reports of blood dyscrasias (e.g., anemia, neutropenia).
Timing: Before treatment initiation.
Mood assessment (depression, suicidal ideation)
Rationale: Reports of depression, psychosis, and suicidal ideation, though causal link is debated.
Timing: Before treatment initiation.
Routine Monitoring
Pregnancy test (females of childbearing potential)
Frequency: Monthly, within 7 days prior to each 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 drug is established, then monthly or 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: Weekly or bi-weekly until response to drug 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 discontinuation.
Mood assessment
Frequency: At each visit/refill.
Target: Stable mood, no new psychiatric symptoms.
Action Threshold: New or worsening symptoms of depression, anxiety, aggression, or suicidal ideation: immediately discontinue, refer to mental health professional.
Musculoskeletal symptoms (joint/muscle pain)
Frequency: At each visit/refill.
Target: No new or worsening pain.
Action Threshold: Severe or persistent pain: investigate, consider dose adjustment or discontinuation.
Vision assessment (night vision, dry eyes)
Frequency: At each visit/refill.
Target: No significant changes.
Action Threshold: Significant vision changes, especially night vision: refer to ophthalmologist.
Symptom Monitoring
- Severe headache
- Blurred vision or other vision changes
- Nausea, vomiting, severe abdominal pain
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe diarrhea or rectal bleeding
- New or worsening depression, anxiety, irritability, aggression, or thoughts of self-harm
- Muscle weakness or severe muscle/joint pain
- Hearing impairment or ringing in ears
- Severe skin peeling or rash
- Difficulty swallowing or painful swallowing
Special Patient Groups
Pregnancy
Absolutely contraindicated. Isotretinoin is a potent human teratogen, causing severe and life-threatening birth defects (e.g., craniofacial, cardiovascular, CNS abnormalities, intellectual disability). Females of reproductive potential must use two forms of contraception and comply with the iPLEDGE program.
Trimester-Specific Risks:
First Trimester:
Highest risk of severe birth defects (e.g., hydrocephalus, microcephaly, ear abnormalities, cardiovascular defects, facial dysmorphia, cleft palate, thymic aplasia, parathyroid hormone deficiency).
Second Trimester:
Continued risk of severe birth defects, though potentially lower than first trimester.
Third Trimester:
Continued risk of severe birth defects, though potentially lower than first trimester.
Lactation
Contraindicated. It is not known whether isotretinoin is excreted in human milk, but due to its lipophilicity and potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment and for at least one month after discontinuation.
Infant Risk:
L5 (Contraindicated - significant documented risk to infant).
Pediatric Use
Safety and efficacy not established in pediatric patients under 12 years of age. Use in adolescents (12-17 years) for severe recalcitrant nodular acne is similar to adult dosing, with strict adherence to iPLEDGE. Potential for premature epiphyseal closure has been reported, requiring careful monitoring.
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 a highly effective but high-risk medication. Patient education and adherence to the iPLEDGE program are paramount.
- Always take isotretinoin with a substantial meal (especially one containing fat) to maximize absorption and efficacy.
- Dryness of skin, lips, and eyes is almost universal. Advise patients on frequent use of moisturizers, lip balms, and artificial tears.
- Patients should be advised to avoid blood donation during treatment and for at least one month after stopping due to the risk of exposing pregnant recipients.
- Monitor for mood changes and psychiatric symptoms, and educate patients and their families to report any concerns immediately.
- Emphasize the importance of consistent and effective contraception for females of childbearing potential.
- Patients should avoid cosmetic procedures like waxing, dermabrasion, and laser treatments during and for at least 6 months after treatment due to increased risk of scarring.
Alternative Therapies
- Oral antibiotics (e.g., doxycycline, minocycline, azithromycin)
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Salicylic acid
- Oral contraceptives (for hormonal acne in females)
- Spironolactone (for hormonal acne in females)
- Photodynamic therapy
- Chemical peels
- Corticosteroid injections (for individual cysts)
Cost & Coverage
Average Cost:
$200 - $800 per 30 capsules (40mg)
Generic Available:
Yes
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization and adherence to iPLEDGE program)
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 your doctor, pharmacist, or other healthcare provider for guidance. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.