| name | Isotretinoin (Accutane) |
| classification | Retinoid, Vitamin A derivative |
| pharmacokinetics | Isotretinoin is rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations are reached within 2-4 hours after oral administration. It is extensively metabolized in the liver, primarily by oxidation. The major metabolites are inactive and are excreted in the urine and bile. The drug has a half-life of approximately 15-20 hours, though it can accumulate in the body over time due to continuous intake. Plasma protein binding is approximately 99%. |
| suggested dosage | | adult male 25 years 70kg | | start dose | 0.5 mg/kg/day | | typical dose | 0.5-2.0 mg/kg/day | | important note | Dosage must be individualized based on the severity of acne and patient response. This is a crucial point for clinicians and should not be extrapolated from general information. Specific consultation with a dermatologist or physician is needed. | | frequency | Once daily |
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| indications | Treatment of severe nodulocystic acne that is unresponsive to other treatments. |
| safety in pregnancy | | category | X | | description | Isotretinoin is absolutely contraindicated during pregnancy. It is a potent teratogen, significantly increasing the risk of severe birth defects. Thorough contraception is required for women of childbearing potential. A pregnancy test should be performed prior to initiating treatment. Post-treatment contraception is necessary for at least one month after discontinuation. | | important note | Women of childbearing age must use two effective forms of birth control, and must acknowledge the substantial risk to a potential pregnancy during and after treatment. |
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| safety in breast feeding | | status | Not recommended | | description | Isotretinoin is not recommended for use during breastfeeding due to potential effects on the infant. It is not known whether the drug passes into breast milk and what the consequences are, so it is important to exclude breastfeeding. Consult a physician. |
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| side effects | | 1 | Dry lips, dry skin, hair loss | | 2 | Dry eyes, nosebleeds | | 3 | Fatigue | | 4 | Headache | | 5 | Elevated liver enzymes | | 6 | Depression or mood changes | | 7 | Joint or muscle pain | | 8 | Elevated triglycerides or cholesterol | | 9 | Psychosis (rare) | | 10 | Severe congenital defects in the fetus when used by pregnant women |
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| alternatives | |
| contraindications | | 1 | Pregnancy | | 2 | Known hypersensitivity to isotretinoin | | 3 | Severe liver disease | | 4 | Severe depression or other significant psychiatric conditions | | 5 | Active or untreated thyroid disorders |
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| interactions | | 1 | Other retinoids | | 2 | Alcohol | | 3 | Certain medications affecting liver function (e.g., some anti-seizure medications) | | 4 | Drugs that decrease vitamin A metabolism. |
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| warnings and precautions | | 1 | Regular monitoring of liver function tests (LFTs) and lipids. | | 2 | Caution in patients with pre-existing cardiovascular risk factors or conditions. | | 3 | Close monitoring of mental health is crucial during treatment. | | 4 | Avoid excessive sun exposure |
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| additional information | | long term use | Isotretinoin is typically used for a limited period of time to clear acne, and typically not for ongoing maintenance. | | important physician consultation | Consultation with a dermatologist or other qualified healthcare professional is crucial due to potential serious side effects and complications. | | mandatory counseling | Patients need thorough counseling about potential risks, including pregnancy prevention, liver monitoring, side effects, and long-term management. | | follow up schedule | Regular follow-up appointments and monitoring are necessary to assess treatment efficacy and manage potential side effects. | | black box warning | The US FDA has issued a black box warning regarding the potential for severe psychiatric events, including depression and thoughts of suicide, in patients taking this medication. |
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| patient information important points | | 1 | Isotretinoin is a powerful drug with significant potential risks. Do not take it without specific medical supervision. | | 2 | Follow the prescribed instructions meticulously. | | 3 | Take prescribed medications as directed and report any unusual symptoms to your physician immediately. | | 4 | Be aware that treatment may take weeks or months for significant improvement. | | 5 | If you have a history of depression or other mental health concerns, inform your doctor. |
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