| name | Isotretinoin |
| classification | Oral Retinoid, Vitamin A Derivative |
| pharmacokinetics | Isotretinoin is readily absorbed from the gastrointestinal tract. Peak plasma concentrations are typically reached within 2-4 hours. It is highly bound to plasma proteins. Metabolism occurs primarily in the liver, and the primary metabolites are inactive. Elimination half-life varies, but it is generally in the range of 20-40 hours. Significant individual variability exists. |
| suggested dosage | | note | Dosage must be individualized based on patient response and clinical factors, and should be managed by a dermatologist or prescribing physician. | | typical range | 0.5-2.0 mg/kg/day, adjusted based on individual response. |
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| indications | Isotretinoin is primarily used in the treatment of severe, recalcitrant nodular and inflammatory acne that is unresponsive to other treatments. |
| safety in pregnancy | | warning | ABSOLUTELY CONTRAINDICATED during pregnancy. Isotretinoin causes severe birth defects in the fetus. Women of childbearing potential must have a negative pregnancy test and adhere to rigorous contraception methods (e.g., two reliable methods) throughout and for at least one month after completing treatment. | | details | Women of childbearing potential must engage in intensive counseling and rigorous contraception measures to prevent pregnancy. |
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| safety in breastfeeding | Isotretinoin is contraindicated during breastfeeding as it is excreted in breast milk and may cause adverse effects in the infant. |
| side effects | | 1 | Dry mouth, lips, and skin; dry eyes; nasal dryness; conjunctivitis; headache; fatigue; elevated liver enzymes; muscle pain; depression; increased risk of suicide ideation or attempts, especially in susceptible individuals; photosensitivity; increased triglycerides and cholesterol levels. | | 2 | Significant potential for elevation of serum lipid profiles (cholesterol, triglycerides). |
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| alternatives | |
| contraindications | | 1 | Pregnancy | | 2 | Known hypersensitivity to isotretinoin or other retinoids | | 3 | Severe liver disease | | 4 | History of depression or suicide attempts | | 5 | Current or recent history of psychosis. |
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| interactions | | 1 | Certain medications can increase the risk of side effects, especially liver toxicity. | | 2 | Concomitant use with certain medications that affect liver enzymes (e.g., some antibiotics, certain anticonvulsants) could increase the risk of drug-induced liver injury. Careful monitoring of liver function tests is crucial in such cases. |
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| warnings and precautions | | 1 | Detailed discussion with the patient about risks, benefits, and management of possible side effects is crucial. | | 2 | Regular monitoring of liver function tests (LFTs), lipid profile, and mental health status is mandatory during treatment. Careful monitoring of weight is crucial to evaluate for nutritional deficiencies and anorexia. | | 3 | Patients should be advised to use sunscreen and avoid prolonged sun exposure due to increased photosensitivity. |
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| additional informations | | monitoring | Regular follow-up visits are necessary to assess efficacy, manage side effects, and monitor liver function, lipid profile, and mental health. Regular blood tests are required. | | patient education | Comprehensive patient education regarding the importance of contraception and potential side effects is essential. Women of childbearing potential should be counseled extensively about the risks of pregnancy and the required contraception measures. |
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