Isotrin 20 mg (Capsule)

Indications

• Severe acne treatment
• Nodular or conglobate acne treatment
• Acne at risk of scarring treatment

Pharmacology

• Alters cell cycle progress
• Reduces sebum production
• Prevents pore blockage
• Reduces acne bacteria growth
• Induces apoptosis in sebocytes
• Reduces comedone formation
• Reduces hyperkeratinization

Dosage & Administration

• Take with food once or twice daily
• Prescribed by physicians with retinoid expertise
• Starting dose of 0.5 mg/kg daily
• Therapeutic response and adverse effects are dose-related
• Dose ranges from 0.5-1.0 mg/kg per day
• Treatment duration depends on the individual dose
• Treatment course of 16-24 weeks
• Lower starting dose for severe renal insufficiency
• Not indicated for prepubertal acne
• Treatment may be continued at lower dose for intolerant patients

Interaction

• Additive adverse effects with vitamin A or its derivatives
• Decreased efficacy with microdosed progesterone
• Increased risk of local irritation with topical keratolytic agents
• Reduced efficacy with oxidizing agents like benzoyl peroxide

Contraindications

• Pregnancy or breastfeeding
• Hypersensitivity to Isotretinoin or excipients
• Hepatic insufficiency
• Excessively elevated blood lipid values
• Hypervitaminosis A
• Concomitant treatment with tetracyclines

Side Effects

• Dryness of skin
• Dryness of mucosae (e.g. lips, nasal, eyes)
• Infections like gram positive bacterial infection
• Blood and lymphatic system disorders like anaemia and thrombocytopenia
• Psychiatric disorders like depression and anxiety
• Eye disorders like conjunctivitis and blurred vision
• Hepatobiliary disorders like increased transaminase
• Skin and subcutaneous tissues disorders like pruritus and rash
• Musculo-skeletal and connective tissue disorders like arthralgia and myalgia
• Renal and urinary disorders like glomerulonephritis
• General disorders and administration site conditions like malaise

Pregnancy & Lactation

• Absolute contraindication in pregnancy
• Great risk of severe foetal malformations
• Increased risk of spontaneous abortion
• Contraindicated in nursing mothers due to potential adverse effects in child exposed via milk

Precautions & Warnings

• Comprehensive information on pregnancy prevention for female patients
• Medically supervised pregnancy tests prior to starting and during treatment
• Follow-up visits at 28 day intervals
• Appropriate contraceptive advice for male patients
• Precautions for donating blood, sun exposure, and chemical dermabrasion
• Monitoring and referral for psychiatric and skin reactions
• Caution in patients with diabetes, obesity, alcoholism, or lipid metabolism disorder

Therapeutic Class

• Oral retinoids for Acne

Storage Conditions

• Keep below 30°C temperature
• Away from light and moisture
• Keep out of the reach of children

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