Zenatane 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; Retinoid
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 shed dead cells more normally. Because it's very strong, it has serious side effects, especially if you are pregnant, so strict rules must be followed.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Some medications must 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, as this can affect their effectiveness. Take your medication with a full glass of water to help it move smoothly through your digestive system.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. You will typically receive a month's supply of medication at a time. Keep in mind that your skin may 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 moisture. Avoid storing your medication in a bathroom, and keep it in a dry, secure location. Ensure that all medications are kept 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 one.
To get the most benefit from your medication, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Some medications must 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, as this can affect their effectiveness. Take your medication with a full glass of water to help it move smoothly through your digestive system.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. You will typically receive a month's supply of medication at a time. Keep in mind that your skin may 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 moisture. Avoid storing your medication in a bathroom, and keep it in a dry, secure location. Ensure that all medications are kept 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 one.
Lifestyle & Tips
- Avoid pregnancy: Absolutely critical. Use two forms of birth control for one month before, during, and one month after treatment. Do not get pregnant.
- Do not donate blood: During treatment and for at least one month after, to prevent exposure to pregnant recipients.
- Avoid sun exposure: Skin will be more sensitive to the sun; use sunscreen and protective clothing.
- Avoid waxing, dermabrasion, and laser skin treatments: During treatment and for at least 6 months after, due to increased risk of scarring.
- Avoid alcohol: May increase risk of liver problems and high triglycerides.
- Moisturize: Use lip balm, eye drops, and moisturizers regularly to combat dryness.
- Do not share medication: This medication is only for the person it was prescribed to.
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
Dose Range:
0.5 - 1 mg
Condition-Specific Dosing:
severeRecalcitrantNodularAcne:
Initial dose 0.5 mg/kg/day. May increase to 1 mg/kg/day if severe disease or if disease is primarily truncal. Cumulative dose of 120-150 mg/kg is often associated with long-term remission.
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 orally, divided into two doses, for 15 to 20 weeks (similar to adult dosing for severe recalcitrant nodular acne)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, use with caution
Moderate:
No specific adjustment, 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 well studied; use with extreme caution and close monitoring. Consider lower initial dose.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function tests closely.
Moderate:
Contraindicated or use with extreme caution; significant dose reduction may be necessary. Monitor liver function tests frequently.
Severe:
Contraindicated due to extensive hepatic metabolism and potential for hepatotoxicity.
Pharmacology
Mechanism of Action
Isotretinoin is a retinoid that acts by reducing sebaceous gland size and inhibiting sebaceous gland activity, thereby decreasing sebum production. It also inhibits the growth of Propionibacterium acnes (now Cutibacterium acnes), normalizes follicular keratinization, and possesses anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 25% (variable, increased with food)
Tmax:
2-4 hours
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:
Parent drug: 10-20 hours; 4-oxo-isotretinoin: 17-50 hours
Clearance:
Not precisely quantified, but primarily hepatic.
ExcretionRoute:
Approximately equal amounts excreted in urine and feces.
Unchanged:
<1% (parent drug)
Pharmacodynamics
OnsetOfAction:
Weeks to months (initial worsening of acne may occur)
PeakEffect:
Typically 8-16 weeks into treatment
DurationOfAction:
Effects can be long-lasting, with many patients experiencing prolonged remission after a single course of treatment.
Safety & Warnings
BLACK BOX WARNING
Isotretinoin is associated with severe birth defects. It is contraindicated in pregnant women and women of childbearing potential unless all conditions of the iPLEDGE REMS program are met. Patients must not become pregnant for at least one month before, during, or for one month after treatment. Two forms of effective contraception must be used concurrently.
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
+ Fruity-smelling breath
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 (difficulty starting or stopping urination, or changes in urine output)
Swelling
Swollen glands
Fast or abnormal heartbeat
Hearing problems, such as changes in hearing or ringing in the ears (which may be temporary or permanent)
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause:
+ 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 can cause:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in the eyes
Reporting 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 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
+ Fruity-smelling breath
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 (difficulty starting or stopping urination, or changes in urine output)
Swelling
Swollen glands
Fast or abnormal heartbeat
Hearing problems, such as changes in hearing or ringing in the ears (which may be temporary or permanent)
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause:
+ 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 can cause:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in the eyes
Reporting 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 (signs of increased pressure in the brain)
- Severe stomach pain, nausea, vomiting (signs of pancreatitis)
- Yellowing of skin or eyes, dark urine (signs of liver problems)
- New or worsening depression, anxiety, thoughts of self-harm
- Muscle weakness, severe muscle or joint pain
- Rectal bleeding, severe diarrhea (signs of inflammatory bowel disease)
- Difficulty seeing at night
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 interactions. It is crucial to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you 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 interactions. It is crucial to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you. Be aware that this medication may cause sudden and potentially irreversible decreased night vision. Exercise caution when driving at night or engaging in activities in low-light environments.
Blood Donation
Do not donate blood while taking this medication and for 1 month after stopping treatment.
Cholesterol and Triglyceride Changes
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not well understood. Discuss this with your doctor and monitor your blood work as directed.
Blood Work and Monitoring
Regularly check your blood work as instructed 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.
Blood Sugar Changes
This medication may cause high blood sugar levels, including new or worsening diabetes. Monitor your blood sugar as directed by your doctor.
Alcohol Consumption
Consult your doctor before consuming alcohol while taking this medication.
Cosmetic Skin Treatments
Avoid cosmetic skin treatments like waxing, dermabrasion, or laser treatments during treatment and for at least 6 months after the last dose, as 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
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 and potentially death. Seek medical attention immediately if you experience severe headache, dizziness, nausea, vomiting, or seizures, as well as weakness on one side of the body, speech or thinking difficulties, balance changes, or vision changes.
Severe Bowel Problems
This medication may cause severe bowel problems, including inflammatory bowel disease. Inform your doctor immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain, as these symptoms may persist even after stopping the medication.
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 be less effective. Consult your doctor about reliable birth control methods. If you have unprotected sex, think you may be pregnant, or miss your period, contact your doctor immediately.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness or clear vision until you understand how this medication affects you. Be aware that this medication may cause sudden and potentially irreversible decreased night vision. Exercise caution when driving at night or engaging in activities in low-light environments.
Blood Donation
Do not donate blood while taking this medication and for 1 month after stopping treatment.
Cholesterol and Triglyceride Changes
Treatment with this medication may lead to increased cholesterol and triglyceride levels. The impact of these changes on heart health is not well understood. Discuss this with your doctor and monitor your blood work as directed.
Blood Work and Monitoring
Regularly check your blood work as instructed 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.
Blood Sugar Changes
This medication may cause high blood sugar levels, including new or worsening diabetes. Monitor your blood sugar as directed by your doctor.
Alcohol Consumption
Consult your doctor before consuming alcohol while taking this medication.
Cosmetic Skin Treatments
Avoid cosmetic skin treatments like waxing, dermabrasion, or laser treatments during treatment and for at least 6 months after the last dose, as 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
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 and potentially death. Seek medical attention immediately if you experience severe headache, dizziness, nausea, vomiting, or seizures, as well as weakness on one side of the body, speech or thinking difficulties, balance changes, or vision changes.
Severe Bowel Problems
This medication may cause severe bowel problems, including inflammatory bowel disease. Inform your doctor immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain, as these symptoms may persist even after stopping the medication.
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 be less effective. Consult your doctor about reliable birth control methods. 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
- Loss of appetite
- Dry skin and mucous membranes
- Visual disturbances
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Tetracyclines (e.g., doxycycline, minocycline): Risk of pseudotumor cerebri (benign intracranial hypertension).
- Vitamin A supplements: Risk of hypervitaminosis A (additive toxicity).
Major Interactions
- Systemic corticosteroids: May exacerbate osteoporosis risk, especially with long-term use.
- Phenytoin: May reduce isotretinoin levels (theoretical, not well-established clinically).
- St. John's Wort: May reduce efficacy of hormonal contraceptives, which are critical for iPLEDGE compliance.
Moderate Interactions
- Progestin-only birth control pills: May be less effective; two forms of contraception are required.
- Alcohol: May increase risk of hypertriglyceridemia and hepatotoxicity.
- Topical acne treatments (e.g., benzoyl peroxide, salicylic acid): May cause excessive skin irritation and dryness.
Minor Interactions
- Waxing and dermabrasion: Increased risk of scarring during and for at least 6 months after treatment.
Monitoring
Baseline Monitoring
Pregnancy test (females of reproductive potential)
Rationale: Absolute contraindication in pregnancy due to severe teratogenicity.
Timing: Within 7 days prior to initiating therapy, and monthly thereafter.
Liver Function Tests (LFTs) - AST, ALT
Rationale: Risk of hepatotoxicity.
Timing: Prior to initiation.
Lipid Panel (Triglycerides, Cholesterol)
Rationale: Risk of hypertriglyceridemia and hypercholesterolemia.
Timing: Prior to initiation.
Complete Blood Count (CBC)
Rationale: Rare reports of blood dyscrasias.
Timing: Prior to initiation.
Routine Monitoring
Pregnancy test (females of reproductive potential)
Frequency: Monthly, within 7 days prior to each refill.
Target: Negative
Action Threshold: Positive test requires immediate discontinuation and referral to an obstetrician/gynecologist.
Liver Function Tests (LFTs)
Frequency: Monthly or every 2-4 weeks during treatment.
Target: Within normal limits or stable.
Action Threshold: Significant elevation (e.g., >2-3x ULN) requires dose reduction or discontinuation.
Lipid Panel (Triglycerides, Cholesterol)
Frequency: Monthly or every 2-4 weeks during treatment.
Target: Triglycerides <200 mg/dL, Cholesterol <200 mg/dL.
Action Threshold: Triglycerides >400 mg/dL requires dose reduction or discontinuation; >800 mg/dL requires immediate discontinuation due to pancreatitis risk.
CBC
Frequency: Periodically, or if symptoms suggest.
Target: Within normal limits.
Action Threshold: Significant abnormalities require investigation and potential discontinuation.
Symptom Monitoring
- Mood changes (depression, anxiety, suicidal ideation)
- Severe headache, blurred vision, dizziness (signs of pseudotumor cerebri)
- Severe abdominal pain, nausea, vomiting (signs of pancreatitis)
- Muscle or joint pain, back pain
- Dryness of skin, lips, eyes, nasal passages
- Hair thinning
- Vision changes (especially night vision)
- Hearing impairment
- Rectal bleeding (inflammatory bowel disease symptoms)
Special Patient Groups
Pregnancy
Isotretinoin is an absolute contraindication in pregnancy due to severe teratogenicity. It causes severe and life-threatening birth defects (e.g., craniofacial, cardiovascular, CNS abnormalities, intellectual disability).
Trimester-Specific Risks:
First Trimester:
Highest risk of severe birth defects (craniofacial, cardiac, CNS, thymic, parathyroid abnormalities).
Second Trimester:
Significant risk of birth defects, though potentially less severe than first trimester.
Third Trimester:
Risk of premature birth, low birth weight, and potential for developmental issues.
Lactation
Contraindicated. It is unknown if isotretinoin is excreted in human milk, but due to its high lipophilicity and potential for serious adverse effects in the infant, breastfeeding is not recommended during treatment and for at least one month after.
Infant Risk:
High risk of serious adverse effects due to potential exposure.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients less than 12 years of age or for the treatment of acne other than severe recalcitrant nodular acne. Use in adolescents (12-17 years) is generally for severe recalcitrant nodular acne, with careful consideration of potential effects on bone growth (premature epiphyseal closure, though rare).
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 is rare in this population, and caution is advised due to potential for increased susceptibility to adverse effects (e.g., lipid abnormalities, bone effects).
Clinical Information
Clinical Pearls
- Isotretinoin is a highly effective treatment for severe recalcitrant nodular acne but requires strict adherence to the iPLEDGE Risk Management Program due to its severe teratogenicity.
- Patients must use two forms of effective contraception and have monthly negative pregnancy tests.
- Initial worsening of acne is common before improvement begins.
- Dryness of skin, lips, and eyes is a universal side effect; advise patients on moisturizers and lip balms.
- Monitor liver function tests and lipid profiles regularly due to potential for hepatotoxicity and hypertriglyceridemia.
- Counsel patients on potential psychiatric side effects, including depression and suicidal ideation, and advise immediate reporting of any mood changes.
- Avoid blood donation during and for at least one month after treatment.
- Avoid waxing, dermabrasion, and laser procedures 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
- Hormonal therapies (e.g., oral contraceptives, spironolactone for females)
- Photodynamic therapy
- Chemical peels
- Laser therapy
Cost & Coverage
Average Cost:
$150 - $600+ per 30 capsules (40mg)
Generic Available:
Yes
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization, often due to iPLEDGE program and monitoring requirements)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource 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, we encourage you 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 seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.