Claravis 10mg Capsules
WARNING: Do not take if you are pregnant or may get pregnant. The risk of severe and sometimes deadly birth defects is very high if you take this drug at any time while you are pregnant. Any unborn baby can be harmed. There is no good way to tell if an unborn baby has been harmed. The risk of losing an unborn baby is also raised, and premature births have happened. Talk with your doctor before you start this drug. If you know all the facts and can follow how to take this drug, you must sign a patient fact/consent form. Do not sign the form and do not take this drug if you do not know everything on the form.You must have 2 pregnancy tests that show you are NOT pregnant before starting this drug. You must have pregnancy tests done while taking this drug. Talk with your doctor.You must either use 2 kinds of birth control or commit to not having any sex that could cause pregnancy while taking this drug. You must do this for 1 month before starting this drug, during treatment, and for at least 1 month after the last dose. Talk about this with your doctor.If you get pregnant while taking this drug or within 1 month after your last dose, call your doctor right away. @ COMMON USES: It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid
Pregnancy Category
Category X
FDA Approved
May 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
Isotretinoin is a strong medicine used to treat severe acne that hasn't responded to other treatments. It works by reducing the oil glands in your skin, which helps clear up acne. Because it can cause serious birth defects, it's very important for women who can get pregnant to follow strict rules, including using two forms of birth control and getting monthly pregnancy tests.
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 taken with food, while others are taken on an empty stomach. If you're unsure, consult your pharmacist for guidance on the best way to take your medication.
When taking your medication:
Swallow the tablet whole; do not chew, break, or crush it.
Take it 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.
Important Considerations
Your skin condition may appear to worsen before it improves.
If you experience any changes 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), 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.
Keep it in a dry place, avoiding storage in a bathroom.
Keep all medications in a safe 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 taken with food, while others are taken on an empty stomach. If you're unsure, consult your pharmacist for guidance on the best way to take your medication.
When taking your medication:
Swallow the tablet whole; do not chew, break, or crush it.
Take it 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.
Important Considerations
Your skin condition may appear to worsen before it improves.
If you experience any changes 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), 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.
Keep it in a dry place, avoiding storage in a bathroom.
Keep all medications in a safe 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 (preferably a high-fat meal) to improve absorption.
- Do not donate blood during treatment and for one month after stopping, due to the risk of pregnant recipients.
- Avoid waxing for hair removal during treatment and for at least 6 months after, as it can cause skin tearing.
- Avoid cosmetic procedures like dermabrasion or laser skin treatments during and for at least 6 months after treatment, due to increased risk of scarring.
- Use sunscreen and protective clothing, as skin may become more sensitive to the sun.
- Use lip balm and moisturizers regularly to combat dryness.
- Avoid contact lenses if experiencing severe dry eyes; use lubricating eye drops.
- Do not share this medication with anyone else.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 to 1 mg/kg/day divided into two doses for 15 to 20 weeks
Dose Range:
0.5 - 2 mg
Condition-Specific Dosing:
severe recalcitrant nodular acne:
0.5 to 1 mg/kg/day divided into two doses. A cumulative dose of 120-150 mg/kg is often associated with prolonged remission. Doses up to 2 mg/kg/day may be used for very severe disease or predominantly truncal acne.
relapse:
A second course may be initiated if necessary, generally after a period of at least 2 months off therapy.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Same as adult dosing for severe recalcitrant nodular acne (typically >12 years old and skeletally mature).
Prepubertal:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor closely.
Moderate:
Consider lower initial dose (e.g., 10 mg/day or 0.1 mg/kg/day) and titrate slowly.
Severe:
Consider lower initial dose (e.g., 10 mg/day or 0.1 mg/kg/day) and titrate slowly.
Dialysis:
Use with caution; consider lower initial dose and close monitoring.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but monitor liver function tests closely.
Moderate:
Use with caution; consider lower initial dose and close monitoring of liver function.
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 activity, leading to a substantial reduction in sebum production. It also inhibits the growth of Propionibacterium acnes (now Cutibacterium acnes), has anti-inflammatory effects, and normalizes follicular keratinization, preventing comedone formation.
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 quantified, but extensively distributed to tissues.
ProteinBinding:
>99.9% (primarily to albumin)
CnssPenetration:
Limited, but can cross the blood-brain barrier to some extent.
Elimination:
HalfLife:
Isotretinoin: 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% (renal)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 months, but can take longer.
PeakEffect:
Peak therapeutic effect often observed after 8-16 weeks of treatment.
DurationOfAction:
Remission can be prolonged, lasting months to years after a single course of therapy.
Safety & Warnings
BLACK BOX WARNING
Isotretinoin can cause severe birth defects. It is contraindicated in pregnant women. Females of reproductive potential must not be pregnant when isotretinoin treatment is initiated, and must use two forms of effective contraception for at least one month prior to initiation of therapy, during therapy, and for one month following discontinuation of therapy. Patients must be enrolled in the iPLEDGE risk management program.
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
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, 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
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 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
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
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, 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
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 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
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, nausea, vomiting (signs of pseudotumor cerebri)
- Yellowing of skin or eyes, dark urine, severe fatigue (signs of liver problems)
- Severe abdominal pain, nausea, vomiting (signs of pancreatitis)
- New or worsening feelings of sadness, crying spells, loss of interest in activities, irritability, thoughts of harming yourself (signs of depression/mood changes)
- Severe muscle or joint pain
- Rectal bleeding, severe diarrhea, 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 interactions. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are able to become pregnant and are not using two 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 your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, avoid driving and other activities that require alertness and clear vision until you understand how it affects you. Be aware that this medication may cause sudden and potentially irreversible decreased night vision. Exercise caution when driving at night or performing tasks in low-light conditions.
Do not donate blood while taking this medication and for at least 1 month after stopping treatment.
Treatment with this drug may lead to increased cholesterol and triglyceride levels. Although the impact of these changes on heart health is not fully understood, it is crucial to discuss this with your doctor. Regular blood tests, as directed by your doctor, are necessary to monitor your condition.
You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear.
There is a risk of developing high blood sugar, including new-onset or worsening diabetes, associated with this medication. Monitor your blood sugar levels as instructed by your doctor.
Before consuming alcohol, consult with your doctor to discuss any potential risks.
During treatment and for at least 6 months after the last dose, avoid cosmetic skin treatments like waxing, dermabrasion, or laser treatments, as they may increase the risk of scarring.
This medication may cause bone weakness and tendon problems in some individuals. People participating in certain sports may have a higher risk of bone problems, such as fractures. Discuss this with your doctor and undergo bone density tests as recommended.
Low white blood cell counts, which can increase the risk of infection, have been reported with this medication. If you experience symptoms of infection, such as fever, chills, or sore throat, contact your doctor immediately.
Raised intracranial pressure, a potentially life-threatening condition, has been associated with this medication. It can cause permanent vision loss and, in severe cases, death. Seek immediate medical attention if you experience severe headache, dizziness, nausea, vomiting, seizures, weakness on one side of the body, speech or cognitive difficulties, balance problems, or changes in vision.
Severe bowel problems, including inflammatory bowel disease, may occur with this medication. If you experience severe diarrhea, abdominal pain, rectal bleeding, or rectal pain, notify your doctor promptly, as these symptoms may persist even after stopping the medication.
In children and adolescents, this medication may affect growth. Regular growth checks may be necessary; discuss this with your doctor.
If you are using progestin-only birth control pills (minipills), be aware that they may not be effective. Consult your doctor to discuss alternative birth control options.
If you have unprotected sex, suspect you may be pregnant, or miss a menstrual period, contact your doctor immediately.
When starting this medication, avoid driving and other activities that require alertness and clear vision until you understand how it affects you. Be aware that this medication may cause sudden and potentially irreversible decreased night vision. Exercise caution when driving at night or performing tasks in low-light conditions.
Do not donate blood while taking this medication and for at least 1 month after stopping treatment.
Treatment with this drug may lead to increased cholesterol and triglyceride levels. Although the impact of these changes on heart health is not fully understood, it is crucial to discuss this with your doctor. Regular blood tests, as directed by your doctor, are necessary to monitor your condition.
You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear.
There is a risk of developing high blood sugar, including new-onset or worsening diabetes, associated with this medication. Monitor your blood sugar levels as instructed by your doctor.
Before consuming alcohol, consult with your doctor to discuss any potential risks.
During treatment and for at least 6 months after the last dose, avoid cosmetic skin treatments like waxing, dermabrasion, or laser treatments, as they may increase the risk of scarring.
This medication may cause bone weakness and tendon problems in some individuals. People participating in certain sports may have a higher risk of bone problems, such as fractures. Discuss this with your doctor and undergo bone density tests as recommended.
Low white blood cell counts, which can increase the risk of infection, have been reported with this medication. If you experience symptoms of infection, such as fever, chills, or sore throat, contact your doctor immediately.
Raised intracranial pressure, a potentially life-threatening condition, has been associated with this medication. It can cause permanent vision loss and, in severe cases, death. Seek immediate medical attention if you experience severe headache, dizziness, nausea, vomiting, seizures, weakness on one side of the body, speech or cognitive difficulties, balance problems, or changes in vision.
Severe bowel problems, including inflammatory bowel disease, may occur with this medication. If you experience severe diarrhea, abdominal pain, rectal bleeding, or rectal pain, notify your doctor promptly, as these symptoms may persist even after stopping the medication.
In children and adolescents, this medication may affect growth. Regular growth checks may be necessary; discuss this with your doctor.
If you are using progestin-only birth control pills (minipills), be aware that they may not be effective. Consult your doctor to discuss alternative birth control options.
If you have unprotected sex, suspect you may be pregnant, or miss a menstrual period, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Headache
- Nausea
- Vomiting
- Drowsiness
- Irritability
- Itching
- Dry skin and mucous membranes
What to Do:
Seek immediate medical attention. There is no specific antidote. Treatment is supportive. Call 1-800-222-1222 (Poison Control).
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, pseudotumor cerebri).
Major Interactions
- Progestin-only birth control pills: Isotretinoin may decrease the effectiveness of progestin-only contraceptives. Patients must use two forms of effective contraception.
- St. John's Wort: May decrease the effectiveness of hormonal contraceptives.
Moderate Interactions
- Systemic corticosteroids: May increase the risk of osteoporosis, especially with long-term use.
- Phenytoin: May increase the risk of osteomalacia/osteoporosis.
- Alcohol: May increase the risk of elevated triglycerides and liver enzyme abnormalities.
Minor Interactions
- Topical acne medications (e.g., benzoyl peroxide, topical retinoids): May cause additive irritation and dryness; generally avoided during isotretinoin therapy.
Monitoring
Baseline Monitoring
Pregnancy test (females of childbearing potential)
Rationale: Isotretinoin is a severe human teratogen. Two negative pregnancy tests are required prior to initiation.
Timing: Within 7 days prior to initiation, and a second test on the day of or day prior to initiation.
Lipid panel (triglycerides, cholesterol)
Rationale: Isotretinoin can cause significant elevations in triglycerides and cholesterol.
Timing: Prior to initiation.
Liver function tests (ALT, AST)
Rationale: Isotretinoin can cause transient or sustained elevations in liver enzymes.
Timing: Prior to initiation.
Complete Blood Count (CBC) with differential
Rationale: Rare reports of blood dyscrasias (e.g., anemia, neutropenia, thrombocytopenia).
Timing: Prior to initiation.
Mood assessment (depression, suicidal ideation)
Rationale: Isotretinoin has been associated with mood changes, depression, and suicidal ideation.
Timing: Prior to initiation.
Routine Monitoring
Pregnancy test (females of childbearing potential)
Frequency: Monthly, prior to each prescription refill.
Target: Negative
Action Threshold: Positive test requires immediate discontinuation and referral to an OB/GYN.
Lipid panel (triglycerides, cholesterol)
Frequency: Monthly or every 2-4 weeks during treatment.
Target: Triglycerides <200 mg/dL (ideally <150 mg/dL); Cholesterol within normal limits.
Action Threshold: Triglycerides >400 mg/dL (consider dose reduction or temporary discontinuation); >800 mg/dL (immediate discontinuation due to pancreatitis risk).
Liver function tests (ALT, AST)
Frequency: Monthly or every 2-4 weeks during treatment.
Target: Within normal limits or stable.
Action Threshold: Significant or persistent elevations (e.g., >2-3x ULN) may require dose reduction or discontinuation.
Mood assessment
Frequency: Monthly at each visit.
Target: Stable mood, no new or worsening depressive symptoms.
Action Threshold: Report of new or worsening depression, anxiety, or suicidal ideation requires immediate evaluation and potential discontinuation.
CBC with differential
Frequency: Periodically, or if symptoms suggest hematologic abnormality.
Target: Within normal limits.
Action Threshold: Significant abnormalities may require further investigation or discontinuation.
Symptom Monitoring
- Dry skin, lips, eyes, nasal passages
- Muscle or joint pain
- Headache (especially severe, persistent, or with visual changes, suggestive of pseudotumor cerebri)
- Nausea, vomiting, severe abdominal pain (suggestive of pancreatitis)
- Yellowing of skin or eyes, dark urine (suggestive of liver problems)
- Vision changes, night blindness
- Mood changes, depression, anxiety, irritability, suicidal thoughts
- Rectal bleeding, severe diarrhea (suggestive of 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, cardiovascular, CNS, thymic abnormalities). Females of reproductive potential must be enrolled in the iPLEDGE program and adhere to strict contraception requirements.
Trimester-Specific Risks:
First Trimester:
Highest risk of severe birth defects (craniofacial, cardiovascular, CNS, thymic, ear abnormalities).
Second Trimester:
Continued risk of birth defects, though potentially lower than first trimester.
Third Trimester:
Risk of premature birth, low birth weight, and potential for retinoid-related adverse effects on fetal development.
Lactation
Contraindicated. It is not known if isotretinoin is excreted in human milk, but due to its high lipophilicity and potential for serious adverse reactions in the nursing infant, breastfeeding is not recommended.
Infant Risk:
L5 (Contraindicated - significant documented risk to infant)
Pediatric Use
Approved for severe recalcitrant nodular acne in patients typically >12 years old and skeletally mature. Safety and effectiveness in children <12 years of age or prepubertal patients have not been established. Use in younger patients should be carefully considered due to potential effects on bone growth (premature epiphyseal closure).
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 density changes, lipid abnormalities).
Clinical Information
Clinical Pearls
- Isotretinoin is a highly effective treatment for severe acne, but its use is strictly regulated due to severe teratogenicity.
- Adherence to the iPLEDGE program is mandatory for all prescribers, pharmacies, and patients.
- Patients should be counseled extensively on potential side effects, especially dryness, mood changes, and the importance of contraception.
- Monthly monitoring of lipids and LFTs is crucial. Dose adjustments or temporary discontinuation may be necessary.
- Patients should be advised to avoid blood donation during and for one month after treatment.
- A second course of treatment can be considered if relapse occurs, typically after a break of at least 2 months.
- The cumulative dose (120-150 mg/kg) is often a better predictor of long-term remission than daily dose or duration.
Alternative Therapies
- Oral antibiotics (e.g., doxycycline, minocycline, azithromycin) in combination with topical retinoids and/or benzoyl peroxide for moderate to severe acne.
- Hormonal therapies (e.g., oral contraceptives, spironolactone) for hormonal acne in females.
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene) for less severe acne.
- Photodynamic therapy (PDT) for severe acne.
- Dermatological procedures (e.g., chemical peels, extractions, laser therapy).
Cost & Coverage
Average Cost:
$100 - $500+ per 30 capsules (10mg)
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 is essential to contact your doctor promptly. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a detailed patient fact sheet. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not 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 information about the medication taken, the quantity consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a detailed patient fact sheet. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not 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 information about the medication taken, the quantity consumed, and the time it occurred.