Isotretinoin

Is the active ingredient.

Severe recalcitrant nodular acne unresponsive to other therapies.

Severe cystic acne.

Sotret 0.5% Gel (Isotretinoin) reduces sebum production, inhibits inflammation, and alters keratinization, thereby decreasing the formation of acne lesions. Its exact mechanism is not fully understood but involves interactions with retinoid receptors.

Store at room temperature (20-25°C), protect from light and moisture. Keep out of reach of children.

Dosage is determined by the physician based on individual needs and severity of acne.

Typically taken once or twice daily with food.

Treatment duration varies but is usually for several months.

Strictly follow the prescribed dosage and schedule.

Dry skin, lips, and mucous membranes

Nosebleeds

Increased sun sensitivity

Muscle aches

Joint pain

Elevated cholesterol and triglyceride levels

Depression or mood changes

Inflammation of the pancreas (pancreatitis)

Vision changes

Alcohol Consumption

Should be minimized or avoided, as it can exacerbate side effects.



While Driving or operating Machinery

Caution is advised, especially during initial treatment, due to potential side effects like dizziness or vision changes.



Pregnant & Breastfeeding Women

Isotretinoin is highly teratogenic (causes birth defects). It is strictly contraindicated in pregnancy and breastfeeding women. Reliable contraception is mandatory.



Children

Use is typically restricted to adolescents and adults due to potential side effects and developmental concerns.



Kidney

Patients with kidney disease should be monitored closely.



Liver

Patients with liver disease should be monitored closely, as isotretinoin can affect liver function.

Your physician or dermatologist

The official prescribing information (package insert) for your specific isotretinoin formulation.