Zenatane 30mg Capsules
WARNING: Do not take if you are pregnant or may get pregnant. The risk of severe and sometimes deadly birth defects is very high if you take this drug at any time while you are pregnant. Any unborn baby can be harmed. There is no good way to tell if an unborn baby has been harmed. The risk of losing an unborn baby is also raised, and premature births have happened. Talk with your doctor before you start this drug. If you know all the facts and can follow how to take this drug, you must sign a patient fact/consent form. Do not sign the form and do not take this drug if you do not know everything on the form.You must have 2 pregnancy tests that show you are NOT pregnant before starting this drug. You must have pregnancy tests done while taking this drug. Talk with your doctor.You must either use 2 kinds of birth control or commit to not having any sex that could cause pregnancy while taking this drug. You must do this for 1 month before starting this drug, during treatment, and for at least 1 month after the last dose. Talk about this with your doctor.If you get pregnant while taking this drug or within 1 month after your last dose, call your doctor right away. @ COMMON USES: It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
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 significantly reducing the oil (sebum) produced by your skin, which helps clear up acne and prevent new breakouts. Because it's so strong, it has serious side effects, especially if you become pregnant while taking it.
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 your skin 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.
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.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To 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 your skin 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.
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.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- **Pregnancy Prevention (for females):** Absolutely critical. You MUST use two forms of birth control (one primary, one secondary) for one month before, during, and for one month after stopping this medication. You will have monthly pregnancy tests.
- **Do NOT get pregnant:** If you become pregnant, stop the medication immediately and contact your doctor.
- **Do NOT breastfeed:** This medication can pass into breast milk and harm a baby.
- **Avoid sun exposure:** Your skin will be very sensitive to the sun. Use sunscreen (SPF 30+) and wear protective clothing.
- **Avoid waxing:** Your skin will be fragile; waxing can cause severe skin tearing and scarring. Avoid dermabrasion and laser skin treatments during and for at least 6 months after treatment.
- **Do NOT donate blood:** You must not donate blood during treatment and for at least one month after stopping, as your blood could be given to a pregnant woman.
- **Moisturize:** Use lip balm, moisturizers, and eye drops frequently to combat dryness.
- **Avoid alcohol:** Limit or avoid alcohol as it can increase triglyceride levels and liver strain.
- **Take with food:** Always take your capsule with a meal, preferably a high-fat meal, to help your body absorb the medication better.
- **Report mood changes:** Tell your doctor immediately if you experience any changes in mood, sadness, irritability, or thoughts of harming yourself.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 to 1 mg/kg/day divided into two doses
Dose Range:
0.5 - 1 mg
Condition-Specific Dosing:
severe_cystic_acne:
Initial: 0.5 mg/kg/day. May increase to 1 mg/kg/day if severe disease or primarily truncal acne. Max: 2 mg/kg/day. Duration: 15-20 weeks or until total cumulative dose of 120-150 mg/kg is reached.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (generally not recommended for prepubertal children)
Adolescent:
0.5 to 1 mg/kg/day divided into two doses for severe recalcitrant nodular acne, similar to adult dosing. Max: 2 mg/kg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, monitor for adverse effects.
Moderate:
Consider lower initial dose (e.g., 10 mg/day or 0.1 mg/kg/day), titrate carefully.
Severe:
Consider lower initial dose (e.g., 10 mg/day or 0.1 mg/kg/day), titrate carefully. Use with extreme caution.
Dialysis:
Use with extreme caution; consider lower initial dose and close monitoring. Not dialyzable.
Hepatic Impairment:
Mild:
No specific adjustment recommended, monitor LFTs closely.
Moderate:
Use with caution; consider lower initial dose and close monitoring of LFTs.
Severe:
Contraindicated due to extensive hepatic metabolism and potential for hepatotoxicity.
Pharmacology
Mechanism of Action
Isotretinoin is a synthetic retinoid, structurally related to vitamin A. Its exact mechanism of action in severe acne is not fully understood, but it is known to: 1. Reduce sebaceous gland size and inhibit sebaceous gland function, leading to a substantial reduction in sebum production (by 70-90%). 2. Inhibit the proliferation of Propionibacterium acnes (P. acnes) by reducing sebum, which is a primary nutrient source for the bacteria. 3. Normalize follicular keratinization, preventing comedone formation. 4. Possess anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 25% (highly variable, increased with food)
Tmax:
2-4 hours (for isotretinoin); 6-20 hours (for 4-oxo-isotretinoin)
FoodEffect:
Absorption is significantly increased (up to 2-fold) when taken with a high-fat meal.
Distribution:
Vd:
Not precisely determined, but widely distributed to tissues.
ProteinBinding:
>99.9% (primarily to albumin)
CnssPenetration:
Limited, but can cross the blood-brain barrier and cause CNS effects.
Elimination:
HalfLife:
10-20 hours (isotretinoin); 17-50 hours (4-oxo-isotretinoin)
Clearance:
Not precisely quantified, but primarily hepatic.
ExcretionRoute:
Biliary/fecal (65-83%), renal/urinary (17-25%)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Weeks to months (initial worsening of acne may occur)
PeakEffect:
Typically 8-16 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 pregnancy. 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) for 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 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
+ Frequent urination
+ 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 extremely tired or weak
Urination problems, such as difficulty starting to urinate or changes in urine output
Swelling
Swollen glands
Fast or abnormal heartbeat
Hearing problems, including changes in hearing or ringing in the ears (which may be temporary or permanent)
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Severe and potentially life-threatening pancreas problems (pancreatitis), which may cause:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Other Possible Side Effects
Most people do not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
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, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek 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
+ Frequent urination
+ 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 extremely tired or weak
Urination problems, such as difficulty starting to urinate or changes in urine output
Swelling
Swollen glands
Fast or abnormal heartbeat
Hearing problems, including changes in hearing or ringing in the ears (which may be temporary or permanent)
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Severe and potentially life-threatening pancreas problems (pancreatitis), which may cause:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Other Possible Side Effects
Most people do not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
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, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe headache, blurred vision, dizziness (signs of increased pressure in the brain)
- Severe abdominal pain, rectal bleeding, severe diarrhea (signs of inflammatory bowel disease)
- Yellowing of skin or eyes, dark urine, severe nausea/vomiting (signs of liver problems)
- Severe muscle or joint pain, especially with weakness
- New or worsening depression, anxiety, irritability, or thoughts of self-harm
- Difficulty seeing at night (night blindness)
- Allergic reaction (rash, itching, swelling, severe dizziness, trouble 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.
Your pregnancy status or plans to become pregnant. This includes:
+ If you are able to get pregnant and are not using two forms of birth control.
+ If you plan to get 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.
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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure it is safe to take 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.
Your pregnancy status or plans to become pregnant. This includes:
+ If you are able to get pregnant and are not using two forms of birth control.
+ If you plan to get 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.
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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure it is safe to take 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 at least 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 advised 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, and use protective measures such as sunscreen, clothing, and eyewear to minimize sun exposure.
Blood Sugar Changes
This medication may cause high blood sugar levels, including new-onset 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
Low white blood cell counts have been reported with this medication, 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 help 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
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, as these symptoms may persist even after stopping treatment.
Growth Effects in Children and Teens
This medication may affect growth in children and adolescents. 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 be ineffective. Consult your doctor for alternative birth control options.
Pregnancy and Contraception
If you have unprotected sex, suspect pregnancy, or miss a 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 at least 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 advised 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, and use protective measures such as sunscreen, clothing, and eyewear to minimize sun exposure.
Blood Sugar Changes
This medication may cause high blood sugar levels, including new-onset 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
Low white blood cell counts have been reported with this medication, 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 help 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
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, as these symptoms may persist even after stopping treatment.
Growth Effects in Children and Teens
This medication may affect growth in children and adolescents. 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 be ineffective. Consult your doctor for alternative birth control options.
Pregnancy and Contraception
If you have unprotected sex, suspect pregnancy, or miss a period, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Severe headache
- Nausea/vomiting
- Drowsiness
- Irritability
- Dry skin and mucous membranes
- Cheilitis (inflamed lips)
- Hair loss
- Bone pain
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. 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., dry skin, cheilitis, headache, bone pain).
Major Interactions
- Systemic corticosteroids: May increase risk of osteoporosis and bone mineral density changes when used long-term with isotretinoin.
- Phenytoin: Isotretinoin may alter phenytoin metabolism, potentially leading to altered phenytoin levels.
- St. John's Wort: May reduce the effectiveness of hormonal contraceptives, increasing the risk of pregnancy.
Moderate Interactions
- Progestin-only contraceptives (e.g., 'mini-pill'): May be less effective when used with isotretinoin; two forms of effective contraception are required.
- Methotrexate: Potential for increased hepatotoxicity when used concurrently, though data are limited.
- Topical acne treatments (e.g., benzoyl peroxide, topical retinoids): May cause excessive skin irritation and dryness; generally avoided during isotretinoin therapy.
Minor Interactions
- Alcohol: May increase risk of elevated triglycerides and liver enzyme abnormalities.
Monitoring
Baseline Monitoring
Pregnancy test (serum or urine)
Rationale: Absolute contraindication in pregnancy due to severe teratogenicity. Two negative tests required before initiation.
Timing: First test within 10 days prior to starting therapy, second test within 24 hours prior to starting therapy.
Lipid panel (triglycerides, cholesterol)
Rationale: Isotretinoin can cause significant elevations in triglycerides and cholesterol.
Timing: Before treatment initiation.
Liver function tests (ALT, AST, alkaline phosphatase, bilirubin)
Rationale: Isotretinoin can cause transient or sustained elevations in liver enzymes.
Timing: Before treatment initiation.
Complete Blood Count (CBC) with differential
Rationale: Rare reports of blood dyscrasias (e.g., anemia, neutropenia, thrombocytopenia).
Timing: Before treatment initiation.
Mood assessment/mental health screening
Rationale: Reports of depression, mood disturbance, psychosis, and suicidal ideation.
Timing: Before treatment initiation.
Routine Monitoring
Pregnancy test (serum or urine)
Frequency: Monthly, prior to each refill
Target: Negative
Action Threshold: Positive test: Immediately discontinue isotretinoin, refer to OB/GYN, and report to iPLEDGE.
Lipid panel (triglycerides, cholesterol)
Frequency: Weekly or bi-weekly until response to dose 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 discontinuation. Triglycerides > 800 mg/dL: Discontinue immediately due to risk of pancreatitis.
Liver function tests (ALT, AST)
Frequency: Weekly or bi-weekly until response to dose is established, then monthly or as clinically indicated.
Target: Within normal limits or < 2-3 times upper limit of normal.
Action Threshold: Persistent elevations > 2-3 times ULN: Consider dose reduction or discontinuation.
Mood assessment/mental health screening
Frequency: At each visit, or as clinically indicated.
Target: Stable mood, no new psychiatric symptoms.
Action Threshold: New or worsening symptoms of depression, anxiety, psychosis, or suicidal ideation: Discontinue isotretinoin and refer to mental health specialist.
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)
- Vision changes (e.g., night blindness, blurred vision)
- Gastrointestinal symptoms (e.g., abdominal pain, rectal bleeding, severe diarrhea, suggestive of inflammatory bowel disease)
- Mood changes, irritability, depression, anxiety, suicidal thoughts
- Hair thinning or loss
- Sun sensitivity
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 comply with the iPLEDGE REMS program, including using two forms of contraception and monthly pregnancy testing.
Trimester-Specific Risks:
First Trimester:
Highest risk of severe birth defects (craniofacial, cardiac, CNS, thymic, parathyroid abnormalities).
Second Trimester:
Continued risk of birth defects, though potentially lower than first trimester. Risk of spontaneous abortion.
Third Trimester:
Risk of premature birth, low birth weight, and potential for retinoid-related adverse effects on fetal development.
Lactation
Contraindicated. It is unknown if isotretinoin is excreted in human milk, but due to its lipophilicity and potential for serious adverse reactions in the nursing infant, breastfeeding is not recommended during treatment and for at least one month after discontinuation.
Infant Risk:
L5 (Contraindicated - significant documented risk)
Pediatric Use
Generally not recommended for prepubertal children due to potential effects on bone growth and epiphyseal closure, though data are limited. Use in adolescents (post-puberty) is common for severe recalcitrant nodular acne, with dosing similar to adults. Close monitoring for adverse effects, including psychiatric and musculoskeletal, is crucial.
Geriatric Use
Limited data available. Isotretinoin is rarely used in the geriatric population for acne. Use with caution due to potential for increased susceptibility to adverse effects (e.g., bone mineral density changes, lipid abnormalities, liver enzyme elevations) and presence of comorbidities. Close monitoring is advised.
Clinical Information
Clinical Pearls
- Isotretinoin is a highly effective treatment for severe, recalcitrant nodular acne, often leading to long-term remission.
- The iPLEDGE REMS program is mandatory for all patients, prescribers, and pharmacies due to the severe teratogenicity. No exceptions.
- Patients must be educated extensively on the risks, especially pregnancy prevention, and the importance of adherence to monitoring requirements.
- Dryness of skin, lips, and eyes is an expected and almost universal side effect; advise patients on proactive moisturizing.
- Initial worsening of acne ('flare') can occur during the first few weeks of treatment.
- Monitor for mood changes and psychiatric symptoms closely; discontinue if severe symptoms develop.
- Cumulative dose (typically 120-150 mg/kg) is often a better predictor of long-term remission than duration of therapy.
- Avoid concomitant use of tetracyclines, vitamin A supplements, and St. John's Wort.
- Advise patients to avoid blood donation during and for one month after treatment.
Alternative Therapies
- Oral antibiotics (e.g., doxycycline, minocycline, azithromycin) in combination with topical agents (e.g., benzoyl peroxide, topical retinoids)
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Hormonal therapies (e.g., oral contraceptives, spironolactone) for female patients
- Chemical peels, laser therapy, photodynamic therapy (adjunctive or alternative for some cases)
Cost & Coverage
Average Cost:
$100 - $500+ per 30 capsules (30mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization due to iPLEDGE program and monitoring requirements)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.