Zenatane 20mg Capsules
WARNING: Do not take if you are pregnant or may get pregnant. The risk of severe and sometimes deadly birth defects is very high if you take this drug at any time while you are pregnant. Any unborn baby can be harmed. There is no good way to tell if an unborn baby has been harmed. The risk of losing an unborn baby is also raised, and premature births have happened. Talk with your doctor before you start this drug. If you know all the facts and can follow how to take this drug, you must sign a patient fact/consent form. Do not sign the form and do not take this drug if you do not know everything on the form.You must have 2 pregnancy tests that show you are NOT pregnant before starting this drug. You must have pregnancy tests done while taking this drug. Talk with your doctor.You must either use 2 kinds of birth control or commit to not having any sex that could cause pregnancy while taking this drug. You must do this for 1 month before starting this drug, during treatment, and for at least 1 month after the last dose. Talk about this with your doctor.If you get pregnant while taking this drug or within 1 month after your last dose, call your doctor right away. @ COMMON USES: It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid; 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 amount of oil your skin produces. Because it can cause serious side effects, especially birth defects, it requires strict monitoring and participation in a special program called iPLEDGE.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, 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.
When taking your medication:
Swallow the tablets whole; do not chew, break, or crush them.
Take the 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 to appear worse before it starts to improve.
Important Considerations
If you experience a change in weight, inform your doctor, as your medication dosage may need to be adjusted.
If you are allergic to tartrazine (FD&C Yellow No. 5), a dye found in some products, discuss this with your doctor.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, protected from light.
Keep it in a dry place, avoiding storage in a bathroom.
* Keep all medications in a secure location, out of the 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 get the most benefit from your medication, 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.
When taking your medication:
Swallow the tablets whole; do not chew, break, or crush them.
Take the 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 to appear worse before it starts to improve.
Important Considerations
If you experience a change in weight, inform your doctor, as your medication dosage may need to be adjusted.
If you are allergic to tartrazine (FD&C Yellow No. 5), a dye found in some products, discuss this with your doctor.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, protected from light.
Keep it in a dry place, avoiding storage in a bathroom.
* Keep all medications in a secure location, out of the 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
- Take with food: Always take your isotretinoin capsule with a full meal, preferably the largest meal of the day, to ensure proper absorption.
- Avoid pregnancy: If you are a female of childbearing potential, you MUST use two effective forms of birth control (one primary, one secondary) for one month before, during, and for one month after treatment. Do not get pregnant.
- Do not donate blood: Do not donate blood during treatment and for at least one month after stopping, as pregnant women could receive your blood.
- Avoid sun exposure: Your skin will be more sensitive to the sun. Use sunscreen (SPF 30+) and wear protective clothing.
- Avoid waxing/laser procedures: Do not wax or have laser skin treatments during treatment and for at least 6 months after, as it can cause severe scarring.
- Avoid alcohol: Limit or avoid alcohol due to potential for increased liver enzyme and triglyceride elevations.
- Moisturize: Use lip balm, moisturizers, and eye drops regularly to combat dryness.
- Avoid contact lenses if eyes become too dry.
- Do not share medication: This medication is only for you and your specific condition.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 to 1 mg/kg/day orally, divided into two doses, for 15 to 20 weeks. A second course may be considered after a 2-month off-treatment period if severe nodular acne persists.
Dose Range:
0.5 - 1 mg
Condition-Specific Dosing:
severe_nodular_acne:
Initial dose 0.5 mg/kg/day. Dose may be adjusted to 1 mg/kg/day based on response and tolerability. Cumulative dose of 120-150 mg/kg is often targeted for remission.
severe_recalcitrant_acne:
Up to 2 mg/kg/day may be used for very severe disease, particularly truncal acne, or if the initial response is inadequate.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established in children under 12 years of age)
Adolescent:
Same as adult dosing (0.5 to 1 mg/kg/day) for severe nodular acne, typically for patients 12 years and older.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but use with caution.
Moderate:
No specific adjustment recommended, but use with caution.
Severe:
Use with caution; consider lower initial dose (e.g., 10 mg/day) and titrate slowly. Monitor for adverse effects.
Dialysis:
Not well studied; use with extreme caution, if at all, and at reduced doses.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function closely.
Moderate:
Use with caution; consider lower initial dose and titrate slowly. Monitor liver function closely.
Severe:
Contraindicated due to potential for hepatotoxicity and altered metabolism.
Pharmacology
Mechanism of Action
Isotretinoin is a retinoid that acts by reducing sebaceous gland size and inhibiting sebaceous gland function, thereby decreasing sebum production. It also has anti-inflammatory properties and inhibits the growth of Propionibacterium acnes. It normalizes follicular keratinization, preventing comedone formation.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable, approximately 25% (fasted state). Significantly increased with food.
Tmax:
2-4 hours (fasted); 8 hours (with food)
FoodEffect:
Absorption is significantly increased (up to 2-fold) when taken with a high-fat meal. Must be taken with food.
Distribution:
Vd:
Not precisely determined, but extensive tissue distribution.
ProteinBinding:
>99.9% (primarily to albumin)
CnssPenetration:
Limited, but can cross the blood-brain barrier and cause CNS effects.
Elimination:
HalfLife:
Isotretinoin: 10-20 hours; 4-oxo-isotretinoin: 17-50 hours
Clearance:
Not precisely quantified, but primarily hepatic metabolism.
ExcretionRoute:
Approximately equal amounts excreted in urine and feces.
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 months.
PeakEffect:
Maximum therapeutic effect often observed after 4-5 months of treatment.
DurationOfAction:
Remission can be prolonged, often lasting for several months to years after a single course of treatment.
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 (one primary and one secondary) for at least one month prior to starting therapy, during therapy, and for one month after discontinuing 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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of depression or mood changes, including:
+ Suicidal thoughts or feelings
+ Emotional ups and downs or abnormal thinking
+ Anxiety or loss of interest in life
Signs of liver problems, such as:
+ Dark urine or tiredness
+ Decreased appetite or upset stomach/stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes (jaundice)
Signs of esophagus problems, including:
+ Chest pain or difficulty swallowing
+ New or worsening heartburn
Signs of high blood sugar, such as:
+ Confusion or drowsiness
+ Increased thirst or hunger
+ Frequent urination or flushing
+ Rapid breathing or fruity-smelling breath
Behavioral problems
Changes in vision, eye pain, or severe eye irritation
Back, bone, joint, or muscle pain
Muscle weakness
Unexplained bruising or bleeding
Feeling extremely tired or weak
Urination problems (difficulty starting or stopping urination, or changes in urine output)
Swelling or swollen lymph nodes
Abnormal heartbeat or heart rhythm
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), 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), marked by:
+ Severe stomach pain
+ Severe back pain
+ Severe nausea or vomiting
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following symptoms or any other unusual effects, contact your doctor for advice:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
* Changes in how contact lenses feel in your eyes
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have 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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of depression or mood changes, including:
+ Suicidal thoughts or feelings
+ Emotional ups and downs or abnormal thinking
+ Anxiety or loss of interest in life
Signs of liver problems, such as:
+ Dark urine or tiredness
+ Decreased appetite or upset stomach/stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes (jaundice)
Signs of esophagus problems, including:
+ Chest pain or difficulty swallowing
+ New or worsening heartburn
Signs of high blood sugar, such as:
+ Confusion or drowsiness
+ Increased thirst or hunger
+ Frequent urination or flushing
+ Rapid breathing or fruity-smelling breath
Behavioral problems
Changes in vision, eye pain, or severe eye irritation
Back, bone, joint, or muscle pain
Muscle weakness
Unexplained bruising or bleeding
Feeling extremely tired or weak
Urination problems (difficulty starting or stopping urination, or changes in urine output)
Swelling or swollen lymph nodes
Abnormal heartbeat or heart rhythm
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), 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), marked by:
+ Severe stomach pain
+ Severe back pain
+ Severe nausea or vomiting
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following symptoms or any other unusual effects, contact your doctor for advice:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
* Changes in how contact lenses feel in your eyes
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe headache, blurred vision, dizziness, nausea, vomiting (signs of pseudotumor cerebri)
- Yellowing of skin or eyes, dark urine, severe fatigue (signs of liver problems)
- Severe stomach pain, nausea, vomiting (signs of pancreatitis)
- New or worsening feelings of sadness, irritability, anxiety, thoughts of harming yourself (signs of mental health changes)
- Severe muscle or joint pain, especially with exercise
- Rectal bleeding, severe abdominal pain (signs of inflammatory bowel disease)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are able to become pregnant and are not using two forms of birth control.
If you plan to become pregnant within one month before starting treatment, during treatment, or within one month after your last dose.
If you are breastfeeding. You should not breastfeed for a certain period after receiving this medication. Consult your doctor to determine how long you should avoid breastfeeding after taking this drug.
Additionally, tell your doctor if you are taking any of the following medications:
Demeclocycline
Doxycycline
Minocycline
Tetracycline
Products containing vitamin A
Products similar to vitamin A
* St. John's wort
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may affect your treatment. 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 issues you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are able to become pregnant and are not using two forms of birth control.
If you plan to become pregnant within one month before starting treatment, during treatment, or within one month after your last dose.
If you are breastfeeding. You should not breastfeed for a certain period after receiving this medication. Consult your doctor to determine how long you should avoid breastfeeding after taking this drug.
Additionally, tell your doctor if you are taking any of the following medications:
Demeclocycline
Doxycycline
Minocycline
Tetracycline
Products containing vitamin A
Products similar to vitamin A
* St. John's wort
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may affect your treatment. 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 issues 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 permanent decreased night vision, which can make it difficult to drive or perform tasks in low-light conditions. Exercise caution when driving at night or engaging in activities that require good vision 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
Regular blood tests are necessary to monitor your condition. Follow your doctor's instructions for blood work and discuss any concerns or questions you may have.
Sun Sensitivity
You may be more susceptible to sunburn while taking this medication. Avoid excessive sun exposure, sunlamps, and tanning beds. Use protective measures such as sunscreen, clothing, and eyewear to minimize your risk of sunburn.
Blood Sugar Changes
This medication may cause high blood sugar levels, including new or worsening diabetes. Monitor your blood sugar levels as directed by your doctor.
Alcohol Consumption
Discuss alcohol consumption with your doctor before drinking while taking this medication.
Cosmetic Skin Treatments
Avoid cosmetic skin treatments, such as 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 engage 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 attention immediately if you experience severe headache, dizziness, nausea, vomiting, or seizures. Additionally, seek help 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 in some cases, they may persist.
Growth Effects in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Discuss this with your doctor.
Birth Control
Do not use progestin-only birth control pills (minipills), as they may not be effective. Discuss alternative birth control options with your doctor. 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 permanent decreased night vision, which can make it difficult to drive or perform tasks in low-light conditions. Exercise caution when driving at night or engaging in activities that require good vision 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
Regular blood tests are necessary to monitor your condition. Follow your doctor's instructions for blood work and discuss any concerns or questions you may have.
Sun Sensitivity
You may be more susceptible to sunburn while taking this medication. Avoid excessive sun exposure, sunlamps, and tanning beds. Use protective measures such as sunscreen, clothing, and eyewear to minimize your risk of sunburn.
Blood Sugar Changes
This medication may cause high blood sugar levels, including new or worsening diabetes. Monitor your blood sugar levels as directed by your doctor.
Alcohol Consumption
Discuss alcohol consumption with your doctor before drinking while taking this medication.
Cosmetic Skin Treatments
Avoid cosmetic skin treatments, such as 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 engage 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 attention immediately if you experience severe headache, dizziness, nausea, vomiting, or seizures. Additionally, seek help 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 in some cases, they may persist.
Growth Effects in Children and Teens
This medication may affect growth in children and teens. Regular growth checks may be necessary. Discuss this with your doctor.
Birth Control
Do not use progestin-only birth control pills (minipills), as they may not be effective. Discuss alternative birth control options with your doctor. 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
- Pseudotumor cerebri (severe headache, visual disturbances)
What to Do:
Seek immediate medical attention or call 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: Additive toxicity (hypervitaminosis A symptoms).
Major Interactions
- Oral contraceptives (progestin-only): May be less effective; two forms of birth control are required for females of childbearing potential, one of which must be a primary method.
- Phenytoin: May alter phenytoin metabolism, leading to increased phenytoin levels or toxicity.
- Systemic corticosteroids: May increase risk of osteoporosis, especially with long-term use.
Moderate Interactions
- St. John's Wort: May decrease efficacy of hormonal contraceptives.
- Alcohol: May increase risk of hypertriglyceridemia and hepatotoxicity.
- Herbal supplements (e.g., those affecting liver function): Potential for additive hepatotoxicity.
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 starting therapy, and a second test on the day of initiation.
Lipid panel (triglycerides, cholesterol)
Rationale: Isotretinoin can cause significant elevations in triglycerides and cholesterol.
Timing: Before starting therapy.
Liver function tests (ALT, AST, alkaline phosphatase, bilirubin)
Rationale: Isotretinoin can cause transient or persistent elevations in liver enzymes.
Timing: Before starting therapy.
Complete Blood Count (CBC)
Rationale: Rare reports of blood dyscrasias (e.g., anemia, neutropenia).
Timing: Before starting therapy.
Mood assessment/mental health screening
Rationale: Reports of depression, mood disturbance, psychosis, and suicidal ideation.
Timing: Before starting therapy.
Routine Monitoring
Pregnancy test (females of childbearing potential)
Frequency: Monthly, within 7 days prior to each refill.
Target: Negative
Action Threshold: Positive test requires immediate discontinuation and referral to an OB/GYN.
Lipid panel (triglycerides, cholesterol)
Frequency: Weekly or bi-weekly until response to dose is established, then monthly or every 2-4 weeks.
Target: Triglycerides <200 mg/dL (ideally <150 mg/dL); Cholesterol within normal limits.
Action Threshold: Triglycerides >400 mg/dL (consider dose reduction/discontinuation); >800 mg/dL (immediate discontinuation due to pancreatitis risk).
Liver function tests (ALT, AST)
Frequency: Weekly or bi-weekly until response to dose is established, then monthly or every 2-4 weeks.
Target: Within normal limits or <2x upper limit of normal.
Action Threshold: Persistent elevations >2x upper limit of normal (consider dose reduction/discontinuation).
Mood assessment/mental health screening
Frequency: At each visit.
Target: Stable mood, no new or worsening psychiatric symptoms.
Action Threshold: New or worsening symptoms of depression, anxiety, psychosis, or suicidal ideation (discontinue and refer to mental health professional).
Symptom Monitoring
- Dryness of skin, lips, eyes, nasal passages
- Headache (especially severe, persistent, or with visual changes - pseudotumor cerebri)
- Visual disturbances (night blindness, blurred vision)
- Muscle or joint pain
- Nausea, vomiting, abdominal pain (pancreatitis)
- Yellowing of skin/eyes, dark urine (hepatotoxicity)
- Mood changes, irritability, depression, suicidal thoughts
- Rectal bleeding, severe abdominal pain (inflammatory bowel disease)
Special Patient Groups
Pregnancy
ABSOLUTELY CONTRAINDICATED. Isotretinoin is a potent human teratogen, causing severe and life-threatening birth defects (e.g., craniofacial malformations, CNS abnormalities, cardiovascular defects, thymic and parathyroid gland abnormalities).
Trimester-Specific Risks:
First Trimester:
Highest risk of severe birth defects if exposure occurs during the first trimester.
Second Trimester:
Significant risk of birth defects, though potentially less severe than first trimester.
Third Trimester:
Risk of birth defects, but also potential for premature birth and other complications.
Lactation
CONTRAINDICATED. It is not known if isotretinoin is excreted in human milk, but due to its lipophilicity and potential for serious adverse effects in the nursing infant, breastfeeding is not recommended.
Infant Risk:
L5 (Contraindicated - high risk of adverse effects to infant or milk production)
Pediatric Use
Safety and efficacy not established in pediatric patients under 12 years of age. Use in adolescents (12 years and older) is similar to adults, with 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 elevations).
Clinical Information
Clinical Pearls
- iPLEDGE Program: Mandatory for all patients (male and female) and prescribers. Females of childbearing potential must meet strict requirements, including two negative pregnancy tests and two forms of contraception.
- Take with food: Crucial for optimal absorption and efficacy.
- Dryness is expected: Counsel patients on managing dry skin, lips, eyes, and nasal passages with moisturizers, lip balms, and saline sprays.
- Mental health monitoring: Be vigilant for mood changes, depression, or suicidal ideation. Discontinue if severe symptoms occur.
- Avoid Vitamin A and Tetracyclines: Strict contraindications due to additive toxicity.
- Cumulative dose: Aim for a cumulative dose of 120-150 mg/kg for optimal long-term remission, even if acne clears earlier.
- Post-treatment: Advise patients that some dryness and sensitivity may persist for a few weeks after stopping. Avoid cosmetic procedures (waxing, laser) for at least 6 months.
Alternative Therapies
- Oral antibiotics (e.g., doxycycline, minocycline, azithromycin) in combination with topical retinoids (e.g., tretinoin, adapalene, tazarotene) and/or benzoyl peroxide for moderate to severe acne.
- Oral contraceptives (for hormonal acne in females).
- Spironolactone (for hormonal acne in females).
- Photodynamic therapy (PDT).
- Chemical peels, extractions, intralesional corticosteroid injections (adjunctive therapies).
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 30 capsules (20mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (generics often Tier 2, brands Tier 3 or higher)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 your prescription is refilled. 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.