Generic
Isotretinoin
33 brands available in the market
At a glance
Isotretinoin is a retinoid medication used for the treatment of severe acne that has not responded to other treatments.
Description
Isotretinoin is a synthetic retinoid which reduces sebaceous gland size and sebum production. It regulates cell proliferation and differentiation. It is a derivative of vitamin A that increases skin cell turnover and prevents clogged pores. It kills acne-causing bacteria by controlling sebum production and acts as an anti-inflammatory to decrease inflammation (redness and swelling).
Indications
- Severe, recalcitrant nodular acne (unresponsive to conventional therapy and systemic antibiotics)
Therapeutic class
Retinoids
Pharmacological class
Synthetic Retinoid
Pharmacology
Isotretinoin is a synthetic retinoid which reduces sebaceous gland size and sebum production. It regulates cell proliferation and differentiation. It is a derivative of vitamin A that increases skin cell turnover and prevents clogged pores. By controlling sebum production, it kills acne-causing bacteria and acts as an anti-inflammatory to decrease inflammation.
Mechanism of action
Reduces sebaceous gland size and sebum production; regulates cell proliferation and differentiation; provides anti-inflammatory action.
Dosage
Adult Dose (Oral):
- 0.5-1 mg/kg/day divided BID for 15-20 weeks
- Up to 2 mg/kg/day (as tolerated) if very severe with scarring
- Hepatic impairment: Contraindicated
Child Dose (≥12 years):
- 0.5-1 mg/kg/day divided BID for 15-20 weeks
- Up to 2 mg/kg/day (as tolerated) if very severe with scarring
Renal Dose: Severe renal impairment: Reduce initial dose (e.g., 10 mg daily), then gradually increase to 1 mg/kg as necessary
Administration
Take with food; swallow whole capsule; do not chew, crush or break; take at the same time every day (to avoid missed dose).
Missed dose
If you miss a dose, take it as soon as possible; if it is almost time for your next dose, skip the missed dose and go back to regular schedule; do not double the dose.
Side effects
Common Side Effects:
- Dry skin
- Rash
- Increased liver enzymes
- Dry mouth, lips and eyes
Others: Night vision decreased, drowsiness, dizziness, headache, muscle and joint pain, increased cholesterol and triglycerides
Precautions & warnings
Precautions:
- Isotretinoin may affect your ability to drive (night vision decreased, drowsiness, dizziness)
- Take with food
- Avoid sunlight exposure (use sun-cream or protective clothing)
- Avoid face waxing and laser treatment (skin becomes more fragile)
- Avoid tetracycline (may reduce effectiveness)
- Do not use if pregnant, planning pregnancy or breastfeeding
- For dry mouth, lips and eyes: drink plenty of water, use moisturizer, avoid contact lenses
- Regular monitoring of liver function and lipid profile required
Contraindications
Contraindications:
- Pregnancy
- Lactation
- Hepatic impairment
- Liver disease
Drug interactions
Drug Interactions:
- Additive toxicity with vitamin A or its derivatives
- Decreased efficacy of microdosed progesterone (use 2 forms of contraception)
- Increased risk of bone loss with phenytoin
- Increased risk of osteoporosis with systemic corticosteroids
- Increased risk of pseudotumor cerebri with tetracyclines (Potentially Fatal)
Food interactions
Food Interactions: Caution is advised when consuming alcohol with Isotretinoin; consult your doctor.
Use in pregnancy
Use in Pregnancy: Highly unsafe during pregnancy; significant harmful effects to developing baby; contraindicated in pregnancy; effective contraception required during and after treatment.
Pregnancy Category: X — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Probably unsafe; limited data suggests drug may pass into breastmilk and harm baby.
Pediatric use
Pediatric dose provided for patients ≥12 years above.
Geriatric use
No specific data for elderly; however caution advised.
Renal / hepatic impairment
Renal Impairment: Probably safe in kidney disease; dose adjustment may not be needed; severe renal impairment: reduce initial dose (e.g., 10 mg daily).
Hepatic Impairment: Unsafe in liver disease; avoid use; regular monitoring of liver function required.
Overdose effects
Overdose: Symptoms of vitamin A toxicity (headache, nausea, vomiting, drowsiness, dizziness, blurred vision, dry skin); symptomatic treatment; no specific antidote.
Storage conditions
Store in a cool and dry place, protected from light; keep out of reach of children.
Chemical structure
Isotretinoin