Claravis 20mg Capsules
WARNING: Do not take if you are pregnant or may get pregnant. The risk of severe and sometimes deadly birth defects is very high if you take this drug at any time while you are pregnant. Any unborn baby can be harmed. There is no good way to tell if an unborn baby has been harmed. The risk of losing an unborn baby is also raised, and premature births have happened. Talk with your doctor before you start this drug. If you know all the facts and can follow how to take this drug, you must sign a patient fact/consent form. Do not sign the form and do not take this drug if you do not know everything on the form.You must have 2 pregnancy tests that show you are NOT pregnant before starting this drug. You must have pregnancy tests done while taking this drug. Talk with your doctor.You must either use 2 kinds of birth control or commit to not having any sex that could cause pregnancy while taking this drug. You must do this for 1 month before starting this drug, during treatment, and for at least 1 month after the last dose. Talk about this with your doctor.If you get pregnant while taking this drug or within 1 month after your last dose, call your doctor right away. @ COMMON USES: It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid; Vitamin A derivative
Pregnancy Category
Category X
FDA Approved
May 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
Claravis (isotretinoin) is a strong medicine used to treat very severe acne that hasn't responded to other treatments. It works by reducing the oil your skin makes and helping to prevent clogged pores. It has serious side effects, especially birth defects, so it's only used under strict conditions.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on the best way to take your medication.
Swallow your medication whole, without chewing, breaking, or crushing it. Take it with a full glass of water.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
You will typically receive a one-month supply of medication at a time.
It's common for 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.
Keep it in a dry place, away from the bathroom.
* Store all medications in a secure location, 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 ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on the best way to take your medication.
Swallow your medication whole, without chewing, breaking, or crushing it. Take it with a full glass of water.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
You will typically receive a one-month supply of medication at a time.
It's common for 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.
Keep it in a dry place, away from the bathroom.
* Store all medications in a secure location, 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
- Do NOT become pregnant while taking this medicine or for one month after stopping it. Use two reliable forms of birth control.
- Do NOT donate blood during treatment and for one month after stopping, as pregnant women could receive your blood.
- Avoid sun exposure and use sunscreen (SPF 30+) and protective clothing, as skin will be more sensitive to sunburn.
- Avoid waxing for hair removal during treatment and for at least 6 months after stopping, as it can cause severe skin tearing.
- Avoid cosmetic procedures like dermabrasion or laser skin treatments during and for at least 6 months after treatment due to risk of scarring.
- Do NOT take vitamin A supplements, as this can increase side effects.
- Avoid alcohol, as it can increase triglyceride levels.
- Use lip balm, moisturizer, and eye drops regularly to manage dryness.
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:
severe recalcitrant nodular acne:
Initial dose 0.5 mg/kg/day. May increase to 1 mg/kg/day if severe disease or if initial dose is well-tolerated and response is inadequate. 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
Adolescent:
Same as adult dosing (0.5 to 1 mg/kg/day divided into two doses for 15 to 20 weeks) for severe recalcitrant nodular acne, typically for patients 12 years and older.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but monitor closely.
Moderate:
Start at a lower dose (e.g., 0.5 mg/kg/day or less) and titrate carefully.
Severe:
Use with extreme caution, consider lower initial doses (e.g., 10 mg/day) and close monitoring.
Dialysis:
Use with extreme caution, consider lower initial doses and close monitoring. Not dialyzable.
Hepatic Impairment:
Mild:
No specific adjustment recommended, but monitor liver function tests closely.
Moderate:
Contraindicated due to risk of hepatotoxicity.
Severe:
Contraindicated due to risk of 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. These combined actions reduce comedogenesis and inflammation associated with acne.
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 readily available, but widely distributed.
ProteinBinding:
>99.9% (primarily to albumin)
CnssPenetration:
Limited, but can cross the blood-brain barrier; detectable in CSF.
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 urine and feces.
Unchanged:
<1% (very little unchanged drug excreted)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 months, but can take longer.
PeakEffect:
Peak therapeutic effect often observed after completing the full course of treatment (15-20 weeks), with continued improvement for several weeks post-treatment.
DurationOfAction:
Long-lasting remission in many patients, often for years, even after discontinuation of therapy.
Safety & Warnings
BLACK BOX WARNING
Isotretinoin is associated with severe birth defects. It is contraindicated in pregnant women. Females of reproductive potential must not be pregnant when isotretinoin therapy 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 registered in the iPLEDGE REMS program.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of depression or mood changes, including:
+ Suicidal thoughts or feelings
+ Emotional ups and downs or abnormal thinking
+ Anxiety or loss of interest in life
Signs of liver problems, such as:
+ Dark urine or tiredness
+ Decreased appetite or upset stomach
+ Stomach pain or yellow skin and eyes
+ Light-colored stools or vomiting
Signs of esophagus problems, including:
+ Chest pain or difficulty swallowing
+ New or worsening heartburn
Signs of high blood sugar, such as:
+ Confusion or feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination or flushing
+ Fast breathing or fruity-smelling breath
Behavior problems or changes in behavior
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
Difficulty urinating or changes in urine output
Swelling or swollen glands
Abnormal or fast heartbeat
Hearing problems, such as changes in hearing or ringing in the ears (which may or may not go away after stopping the medication)
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
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in the eyes
If you experience any of these side effects or any other symptoms that concern you or do not go away, contact your doctor for guidance.
Reporting Side Effects
If you have questions or concerns about side effects, you can:
Call your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
Submit a report 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 immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of depression or mood changes, including:
+ Suicidal thoughts or feelings
+ Emotional ups and downs or abnormal thinking
+ Anxiety or loss of interest in life
Signs of liver problems, such as:
+ Dark urine or tiredness
+ Decreased appetite or upset stomach
+ Stomach pain or yellow skin and eyes
+ Light-colored stools or vomiting
Signs of esophagus problems, including:
+ Chest pain or difficulty swallowing
+ New or worsening heartburn
Signs of high blood sugar, such as:
+ Confusion or feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination or flushing
+ Fast breathing or fruity-smelling breath
Behavior problems or changes in behavior
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
Difficulty urinating or changes in urine output
Swelling or swollen glands
Abnormal or fast heartbeat
Hearing problems, such as changes in hearing or ringing in the ears (which may or may not go away after stopping the medication)
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
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Dry mouth, skin, or eyes
Dry lips
Nose or throat irritation
Changes in how contact lenses feel in the eyes
If you experience any of these side effects or any other symptoms that concern you or do not go away, contact your doctor for guidance.
Reporting Side Effects
If you have questions or concerns about side effects, you can:
Call your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
Submit a report online at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- Severe headache, blurred vision, dizziness (could be signs of increased pressure in the brain)
- Severe stomach pain, nausea, vomiting (could be signs of pancreatitis)
- New or worsening depression, thoughts of harming yourself, or unusual behavior changes
- Rectal bleeding, severe diarrhea, or new stomach pain (could be signs of inflammatory bowel disease)
- Severe muscle weakness, especially with dark urine (could be rhabdomyolysis)
- Yellowing of skin or eyes, dark urine (could be liver problems)
- 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 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 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
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all the medications you are taking, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
You must verify that it is safe to take this medication with all your other medications and health conditions. Do not initiate, stop, or modify the dosage of any medication without 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 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
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all the medications you are taking, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
You must verify that it is safe to take this medication with all your other medications and health conditions. Do not initiate, stop, or modify the dosage of any medication without 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 or 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 unknown. Discuss this with your doctor and monitor your blood work as instructed.
Blood Work and Monitoring
Regularly check your blood work as directed by your doctor and discuss the results with them.
Sun Sensitivity
You may be more susceptible to sunburn. Avoid exposure to the sun, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear.
Blood Sugar Changes
This medication may cause high blood sugar, including new or worsening diabetes. Monitor your blood sugar levels as instructed by your doctor.
Alcohol Consumption
Consult your doctor before consuming alcohol while taking this medication.
Cosmetic Skin Treatments
Avoid cosmetic skin treatments like waxing, dermabrasion, or laser treatments during treatment and for at least 6 months after the last dose, as they may increase the risk of scarring.
Bone Health
This medication may cause weak bones and tendon problems in some individuals. The risk of bone problems, such as fractures, may be higher in people who participate in certain sports. Discuss this with your doctor and undergo bone density tests as recommended.
Infection Risk
Low white blood cell counts have been reported with this medication, increasing the risk of infection. Seek medical attention immediately if you experience symptoms such as fever, chills, or sore throat.
Raised Brain Pressure
This medication may cause increased pressure in the brain, leading to permanent vision loss or death. Seek medical attention immediately if you experience severe headache, dizziness, nausea, vomiting, or seizures.
Severe Bowel Problems
Inflammatory bowel disease may occur with this medication. Inform your doctor immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain.
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 ineffective. Consult your doctor for alternative birth control options.
Pregnancy and Contraception
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 or 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 unknown. Discuss this with your doctor and monitor your blood work as instructed.
Blood Work and Monitoring
Regularly check your blood work as directed by your doctor and discuss the results with them.
Sun Sensitivity
You may be more susceptible to sunburn. Avoid exposure to the sun, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear.
Blood Sugar Changes
This medication may cause high blood sugar, including new or worsening diabetes. Monitor your blood sugar levels as instructed by your doctor.
Alcohol Consumption
Consult your doctor before consuming alcohol while taking this medication.
Cosmetic Skin Treatments
Avoid cosmetic skin treatments like waxing, dermabrasion, or laser treatments during treatment and for at least 6 months after the last dose, as they may increase the risk of scarring.
Bone Health
This medication may cause weak bones and tendon problems in some individuals. The risk of bone problems, such as fractures, may be higher in people who participate in certain sports. Discuss this with your doctor and undergo bone density tests as recommended.
Infection Risk
Low white blood cell counts have been reported with this medication, increasing the risk of infection. Seek medical attention immediately if you experience symptoms such as fever, chills, or sore throat.
Raised Brain Pressure
This medication may cause increased pressure in the brain, leading to permanent vision loss or death. Seek medical attention immediately if you experience severe headache, dizziness, nausea, vomiting, or seizures.
Severe Bowel Problems
Inflammatory bowel disease may occur with this medication. Inform your doctor immediately if you experience severe diarrhea, stomach pain, rectal bleeding, or rectal pain.
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 ineffective. Consult your doctor for alternative birth control options.
Pregnancy and Contraception
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
- Joint pain
- Hair loss
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive; there is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Vitamin A supplements (risk of hypervitaminosis A)
- Tetracyclines (e.g., doxycycline, minocycline) (risk of pseudotumor cerebri/benign intracranial hypertension)
Major Interactions
- Systemic corticosteroids (may exacerbate osteoporosis risk, especially with long-term use)
- Phenytoin (may reduce isotretinoin levels, increased risk of osteomalacia)
- St. John's Wort (may reduce efficacy of hormonal contraceptives, critical for iPLEDGE)
Moderate Interactions
- Progestin-only birth control pills (may be less effective, use two forms of birth control)
- Alcohol (may increase triglyceride levels)
- Herbal supplements (e.g., those affecting liver function or vitamin A levels)
Minor Interactions
- Topical acne treatments (e.g., benzoyl peroxide, salicylic acid) (may increase skin irritation/dryness)
Monitoring
Baseline Monitoring
Pregnancy test (females of childbearing potential)
Rationale: Absolute contraindication in pregnancy due to severe teratogenicity. Two negative tests required before initiation.
Timing: Within 7 days prior to initiation of therapy, and a second test on the day of initiation.
Lipid panel (triglycerides, cholesterol)
Rationale: Isotretinoin can cause significant elevations in triglycerides and cholesterol.
Timing: Before starting therapy.
Liver function tests (ALT, AST)
Rationale: Isotretinoin can cause transient or persistent elevations in liver enzymes.
Timing: Before starting therapy.
Complete Blood Count (CBC)
Rationale: Rare reports of blood dyscrasias.
Timing: Before starting therapy.
Routine Monitoring
Pregnancy test (females of childbearing potential)
Frequency: Monthly, prior to receiving each new prescription.
Target: Negative
Action Threshold: Positive test requires immediate discontinuation and referral to an obstetrician/gynecologist.
Lipid panel (triglycerides, cholesterol)
Frequency: Monthly or every 2-4 weeks during therapy.
Target: Triglycerides <200 mg/dL (ideally <150 mg/dL)
Action Threshold: Triglycerides >400 mg/dL (consider dose reduction or discontinuation); >800 mg/dL (immediate discontinuation due to pancreatitis risk).
Liver function tests (ALT, AST)
Frequency: Monthly or every 2-4 weeks during therapy.
Target: Within normal limits or stable.
Action Threshold: Persistent elevations >2-3 times upper limit of normal (ULN) may require dose reduction or 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
- Changes in night vision or vision disturbances
- Rectal bleeding, severe diarrhea (signs 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 abnormalities, intellectual disability). Females of reproductive potential must participate in the iPLEDGE REMS program and use two forms of contraception.
Trimester-Specific Risks:
First Trimester:
Highest risk of severe birth defects (e.g., CNS, cardiovascular, craniofacial, thymic, parathyroid abnormalities).
Second Trimester:
Continued risk of birth defects, though potentially lower than first trimester.
Third Trimester:
Continued risk of birth defects, though potentially lower than first trimester.
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 one month after discontinuation.
Infant Risk:
High risk of serious adverse effects, including potential for teratogenicity if absorbed by the infant, and other retinoid-related toxicities.
Pediatric Use
Approved for severe recalcitrant nodular acne in patients 12 years of age and older. Use in younger children is not established and generally not recommended due to potential effects on bone growth (premature epiphyseal closure) and other long-term effects.
Geriatric Use
Not commonly used in the geriatric population for acne. If used, caution is advised due to potential for increased susceptibility to adverse effects (e.g., bone mineral density changes, lipid abnormalities, dry skin/eyes) and presence of comorbidities.
Clinical Information
Clinical Pearls
- Isotretinoin is the most effective treatment for severe acne, often leading to long-term remission or cure.
- The iPLEDGE REMS program is mandatory for all prescribers, pharmacies, and patients to ensure safe use and prevent fetal exposure.
- Patients must commit to using two forms of contraception and having monthly pregnancy tests.
- Dryness of skin, lips, and eyes is a universal side effect; advise patients on moisturizers, lip balms, and artificial tears.
- Monitor for mood changes, including depression and suicidal ideation, and educate patients/families to report any concerns immediately.
- Educate patients about the importance of avoiding sun exposure and certain cosmetic procedures (waxing, dermabrasion, laser) during and after treatment.
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 - $400 per 30 capsules (20mg)
Generic Available:
Yes
Insurance Coverage:
Tier 3 or higher (Specialty drug), often requires prior authorization due to iPLEDGE program 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, a patient fact sheet that provides crucial information. 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 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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. 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 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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.