Claravis 40mg Capsules
WARNING: Do not take if you are pregnant or may get pregnant. The risk of severe and sometimes deadly birth defects is very high if you take this drug at any time while you are pregnant. Any unborn baby can be harmed. There is no good way to tell if an unborn baby has been harmed. The risk of losing an unborn baby is also raised, and premature births have happened. Talk with your doctor before you start this drug. If you know all the facts and can follow how to take this drug, you must sign a patient fact/consent form. Do not sign the form and do not take this drug if you do not know everything on the form.You must have 2 pregnancy tests that show you are NOT pregnant before starting this drug. You must have pregnancy tests done while taking this drug. Talk with your doctor.You must either use 2 kinds of birth control or commit to not having any sex that could cause pregnancy while taking this drug. You must do this for 1 month before starting this drug, during treatment, and for at least 1 month after the last dose. Talk about this with your doctor.If you get pregnant while taking this drug or within 1 month after your last dose, call your doctor right away. @ COMMON USES: It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid; Vitamin A derivative
Pregnancy Category
Category X
FDA Approved
May 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
Isotretinoin is a strong medicine used to treat very severe acne that hasn't responded to other treatments. It works by reducing the amount of oil your skin makes and helps prevent clogged pores. Because it's so strong, it has serious side effects, especially if you get pregnant while taking it.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow these guidelines:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Some medications must be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on the best way to take your medication.
Swallow your medication whole, without chewing, breaking, or crushing it. Take it with a full glass of water.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
You will typically receive a one-month supply of medication at a time.
It's common for skin conditions to appear worse before they start to improve with treatment.
If you experience any changes in weight, inform your doctor, as your medication dosage may need to be adjusted.
If you have an allergy to tartrazine (FD&C Yellow No. 5), discuss this with your doctor, as some products contain this ingredient.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep all medications in a secure location, out of 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 ensure you get the most out of your medication, follow these guidelines:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Some medications must be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on the best way to take your medication.
Swallow your medication whole, without chewing, breaking, or crushing it. Take it with a full glass of water.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
You will typically receive a one-month supply of medication at a time.
It's common for skin conditions to appear worse before they start to improve with treatment.
If you experience any changes in weight, inform your doctor, as your medication dosage may need to be adjusted.
If you have an allergy to tartrazine (FD&C Yellow No. 5), discuss this with your doctor, as some products contain this ingredient.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep all medications in a secure location, out of 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
- Do NOT get pregnant while taking this medicine or for at least one month after stopping it. Use two forms of effective birth control.
- Do NOT breastfeed while taking this medicine or for at least one month after stopping it.
- Do NOT donate blood during treatment and for at least one month after stopping, as pregnant women could receive your blood.
- Avoid excessive sun exposure and use sunscreen (SPF 30+) and protective clothing, as skin will be more sensitive.
- Avoid waxing, dermabrasion, and laser skin treatments during and for at least 6 months after treatment due to increased risk of scarring.
- Use moisturizers and lip balm frequently to combat dryness.
- Avoid alcohol due to potential for liver problems.
- 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 - 1 mg
Condition-Specific Dosing:
severeNodularAcne:
Initial: 0.5 mg/kg/day. If severe disease or primarily truncal acne, dose may be increased to 1 mg/kg/day. Cumulative dose of 120-150 mg/kg is often associated with remission.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established in pediatric patients under 12 years of age)
Adolescent:
0.5 to 1 mg/kg/day divided into two doses for 15 to 20 weeks (similar to adult dosing for severe nodular acne)
Dose Adjustments
Renal Impairment:
Mild:
Consider lower initial dose (e.g., 10 mg/day)
Moderate:
Consider lower initial dose (e.g., 10 mg/day)
Severe:
Consider lower initial dose (e.g., 10 mg/day)
Dialysis:
Use with extreme caution; lower initial dose and close monitoring required. Data are limited.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function closely.
Moderate:
Use with caution; monitor liver function closely. Consider lower initial dose.
Severe:
Contraindicated due to risk of 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 inhibits the growth of Propionibacterium acnes (now Cutibacterium acnes) and has anti-inflammatory properties. It normalizes follicular keratinization, preventing comedone formation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 25% (variable, increased with food)
Tmax:
2-4 hours
FoodEffect:
Bioavailability is significantly increased (up to 2-fold) when taken with a high-fat meal.
Distribution:
Vd:
Not readily available, but distributes widely into tissues.
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 readily available, but primarily hepatic.
ExcretionRoute:
Approximately equal amounts excreted in feces and urine.
Unchanged:
<1% (parent drug)
Pharmacodynamics
OnsetOfAction:
Weeks to months (typically 1-2 months for noticeable improvement)
PeakEffect:
Typically within 3-5 months of 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 women who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for short periods of time. Any female patient of childbearing potential must be enrolled in and comply with the iPLEDGE REMS 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 (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 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 upset stomach or vomiting
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in the eyes
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek 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 (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 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 upset stomach or vomiting
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in the eyes
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any signs of pregnancy
- Severe headache, blurred vision, dizziness, nausea, vomiting (signs of increased pressure in the brain)
- Severe stomach pain, rectal bleeding, severe diarrhea (signs of inflammatory bowel disease)
- Yellowing of skin or eyes, dark urine (signs of liver problems)
- New or worsening feelings of sadness, anxiety, irritability, aggression, thoughts of harming yourself or others
- Severe muscle or joint pain
- Difficulty seeing at night (night blindness)
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 capable of becoming pregnant and are not using two reliable 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 treatment.
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 capable of becoming pregnant and are not using two reliable 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 treatment.
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
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, which can make it difficult to drive or perform tasks in low-light environments. Exercise caution when driving at night or engaging in activities that require good vision in low-light conditions.
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 directed.
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 Protection
You may be more susceptible to sunburn while taking this medication. Avoid exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear to minimize your risk.
Blood Sugar Changes
This medication may cause high blood sugar levels, including new-onset or worsening diabetes. Monitor your blood sugar levels as directed by your doctor.
Alcohol Consumption
Discuss your 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 participate in certain sports. Discuss this with your doctor and undergo bone density tests as directed.
Infection Risk
Low white blood cell counts have been reported with this medication, which may increase 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, as well as weakness on one side of the body, speech or thinking difficulties, balance changes, or vision changes.
Bowel Problems
Severe bowel problems, including inflammatory bowel disease, may occur with this medication. Inform your doctor immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain, as these symptoms may persist even after stopping treatment.
Growth Effects in Children and Teens
This medication may affect growth in children and 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 methods 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 irreversible decreased night vision, which can make it difficult to drive or perform tasks in low-light environments. Exercise caution when driving at night or engaging in activities that require good vision in low-light conditions.
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 directed.
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 Protection
You may be more susceptible to sunburn while taking this medication. Avoid exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear to minimize your risk.
Blood Sugar Changes
This medication may cause high blood sugar levels, including new-onset or worsening diabetes. Monitor your blood sugar levels as directed by your doctor.
Alcohol Consumption
Discuss your 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 participate in certain sports. Discuss this with your doctor and undergo bone density tests as directed.
Infection Risk
Low white blood cell counts have been reported with this medication, which may increase 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, as well as weakness on one side of the body, speech or thinking difficulties, balance changes, or vision changes.
Bowel Problems
Severe bowel problems, including inflammatory bowel disease, may occur with this medication. Inform your doctor immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain, as these symptoms may persist even after stopping treatment.
Growth Effects in Children and Teens
This medication may affect growth in children and 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 methods 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
- Hair loss
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222.
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 (additive toxicity)
Major Interactions
- Progestin-only birth control pills - may be less effective (use two forms of effective contraception)
- Phenytoin - increased risk of osteomalacia/osteoporosis
- Systemic corticosteroids - increased risk of osteomalacia/osteoporosis
- St. John's Wort - may decrease efficacy of hormonal contraceptives
Moderate Interactions
- Alcohol - potential for additive hepatotoxicity
- Topical peeling agents (e.g., salicylic acid, benzoyl peroxide, sulfur) - increased skin irritation and dryness
- Methotrexate - potential for additive hepatotoxicity
Minor Interactions
- Waxing and dermabrasion - increased risk of scarring and skin fragility (avoid during and for at least 6 months after treatment)
Monitoring
Baseline Monitoring
Pregnancy tests (2 negative tests required before initiation)
Rationale: Absolute contraindication in pregnancy due to severe teratogenicity.
Timing: Within 7 days prior to initiation, and a second confirmatory test within 24 hours prior to initiation.
Lipid panel (fasting 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 reversible elevations in liver enzymes.
Timing: Prior to initiation.
Complete Blood Count (CBC) with differential
Rationale: Rare reports of blood dyscrasias (e.g., anemia, thrombocytopenia, neutropenia).
Timing: Prior to initiation.
Routine Monitoring
Pregnancy test
Frequency: Monthly (prior to each prescription refill)
Target: Negative
Action Threshold: Positive test requires immediate discontinuation and referral to OB/GYN.
Lipid panel (fasting triglycerides, cholesterol)
Frequency: Weekly or bi-weekly until response to treatment is established, then monthly or as clinically indicated.
Target: Triglycerides <200 mg/dL (ideally), Cholesterol within normal limits.
Action Threshold: Triglycerides >400 mg/dL (consider dose reduction or discontinuation), >800 mg/dL (discontinue immediately due to pancreatitis risk).
Liver function tests (ALT, AST)
Frequency: Weekly or bi-weekly until response to treatment is established, then monthly or as clinically indicated.
Target: Within normal limits or <2x upper limit of normal.
Action Threshold: Elevations >2x upper limit of normal (consider dose reduction or discontinuation).
Mood and psychological symptoms
Frequency: At each visit
Target: Stable mood, no suicidal ideation.
Action Threshold: New or worsening depression, anxiety, aggression, or suicidal ideation (discontinue and refer for psychiatric evaluation).
Symptom Monitoring
- Dry skin, lips, eyes, and nasal passages
- Muscle or joint pain
- Headache (especially severe, persistent, or with visual changes, suggestive of pseudotumor cerebri)
- Vision changes (e.g., night blindness, blurred vision)
- Gastrointestinal symptoms (e.g., abdominal pain, rectal bleeding, severe diarrhea, suggestive of inflammatory bowel disease)
- Mood changes, irritability, depression, anxiety, suicidal thoughts
- Hair thinning
- Sun sensitivity
Special Patient Groups
Pregnancy
Absolutely contraindicated. Isotretinoin is a potent human teratogen. Even a single dose can cause severe birth defects.
Trimester-Specific Risks:
First Trimester:
Extremely high risk of severe and life-threatening birth defects (e.g., craniofacial, cardiovascular, CNS, thymic abnormalities).
Second Trimester:
High risk of severe birth defects.
Third Trimester:
High risk of severe birth defects.
Lactation
Contraindicated. It is not known if isotretinoin is excreted in human milk, but due to its potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment and for at least one month after stopping.
Infant Risk:
High risk of serious adverse effects, including potential for teratogenicity if absorbed by infant.
Pediatric Use
Safety and efficacy not established in pediatric patients under 12 years of age. Use in adolescents (12-17 years) is common for severe nodular acne, with dosing similar to adults. Growth plate closure should be monitored in younger adolescents.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Not commonly used in this population for acne. Use with caution due to potential for increased susceptibility to adverse effects (e.g., bone effects, lipid abnormalities).
Clinical Information
Clinical Pearls
- iPLEDGE program compliance is mandatory for all patients, prescribers, and pharmacies. No exceptions.
- Two forms of effective contraception must be used by female patients of childbearing potential, starting one month before, during, and for one month after treatment.
- Patients should be counseled extensively on potential psychiatric side effects, including depression and suicidal ideation. Any new or worsening symptoms warrant immediate discontinuation and psychiatric evaluation.
- Dryness of skin, lips, and eyes is almost universal. Advise patients on frequent use of moisturizers, lip balm, and artificial tears.
- Avoid blood donation during and for one month after treatment due to teratogenic risk.
- Patients should avoid vigorous physical activity that could lead to muscle or joint injury, as isotretinoin can cause musculoskeletal pain and elevated CPK.
Alternative Therapies
- Oral antibiotics (e.g., doxycycline, minocycline, azithromycin)
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Hormonal therapies (e.g., oral contraceptives, spironolactone for females)
- Photodynamic therapy
- Chemical peels
- Laser therapy
Cost & Coverage
Average Cost:
$150 - $400 per 30 capsules (40mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (requires prior authorization due to iPLEDGE and cost)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. 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 about its use. It is essential to 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 for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. It is essential to 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 for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.