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Core Description and Indication
Isoben-20 belongs to a group of medicines called retinoids, which are closely related to Vitamin A. It is used to treat severe acne that has not responded to other conventional treatments, including systemic antibiotics.
Pharmacology (Mode of Action)
Isotretinoin is a synthetic retinoid that works by:
Reducing Sebaceous Gland Size and the production of sebum (a natural substance that causes acne).
Killing acne-causing bacteria through controlled sebum production.
Acting as an anti-inflammatory agent to decrease redness and swelling.
Dosage and Administration (Oral)
Isoben-20 must be taken with food and swallowed whole (do not chew, crush, or break). Treatment duration is typically 15-20 weeks.
| Population | Condition | Recommended Dose | Notes |
|---|---|---|---|
| Adults & Children > 12 years | Severe, Recalcitrant Nodular Acne | 0.5-1 mg/kg/day divided twice daily (BID) | Dose up to 2 mg/kg/day if acne is very severe or manifested on the trunk. |
| Severe Renal Impairment | Reduce initial dose | Start at 10 mg daily | Gradually increase up to 1 mg/kg as needed. |
| Hepatic Impairment | - | Contraindicated | - |
Critical Safety Information (Contraindications and Precautions)
CONTRAINDICATION (ABSOLUTE):Pregnancy and Lactation. This medicine may lead to severe birth defects. Patients must use two forms of contraception during treatment and for at least one month after stopping the drug.
Contraception: Decreased efficacy of microdosed progesterone (use 2 forms of contraception).
Blood Donation: Patient should not donate blood during therapy and for at least 1 month following drug discontinuation.
Skin Fragility: Avoid wax epilation and laser treatments for at least 6 months after treatment, as the skin becomes more fragile.
Sun Exposure: Limit exposure to sunlight and UV light; use protective measures (sun-cream, clothing).
Monitoring: Blood lipids (triglycerides), LFTs (Liver Function Tests), and blood glucose must be monitored regularly.
Interactions: Increased risk of pseudotumor cerebri with Tetracyclines. Additive toxicity with Vitamin A or its derivatives.
Common Side Effects
Side effects are often mild and include:
Cheilitis (90%): Severe dryness and cracking of the lips.
Xerosis/Xerostomia: Dry skin, dry nose, dry mouth.
Conjunctivitis: Dry or irritated eyes.
Increased LFTs (Liver Function Tests).
Hypertriglyceridemia (increased triglycerides).
Joint pain (Arthralgia) and muscle aches.
Rash, itching (Pruritus), and photosensitivity.
Management of Dryness: Drink plenty of water and use moisturizer. Avoid wearing contact lenses if eye dryness is severe.
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