Product Name & Packaging

Product Name: Isotretinoin 20 mg Softgel Capsules
Generic Name: Isotretinoin
Dosage Form: Softgel capsule
Pack Size: 1 blister pack x 10 softgel capsules
Route of Administration: Oral
Prescription Status: Prescription-only medicine.

Description

Isotretinoin is an oral retinoid indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older whose condition has not responded adequately to conventional therapy, including systemic antibiotics. Because of its significant safety risks, it is reserved for carefully selected patients under close medical supervision.

Indications

Indicated for:

Severe recalcitrant nodular acne
Patients with multiple inflammatory nodules, typically 5 mm or greater in diameter
Cases unresponsive to standard acne treatments, including systemic antibiotics

Dosage & Administration

Recommended dosage: 0.5 to 1 mg/kg/day in two divided doses for 15 to 20 weeks, with dose adjustments based on clinical response and tolerability. Some adults with very severe disease may require doses up to 2 mg/kg/day in divided doses. Capsules should be swallowed whole with a full glass of liquid. If a dose is missed, it should be skipped rather than doubled.

Mechanism of Action

The exact mechanism of action of isotretinoin in severe nodular acne is not fully known. It is classified as a retinoid, and patient information from MedlinePlus notes that it works by slowing the production of certain natural substances that can contribute to acne formation.

Precautions

Important precautions:

Contraindicated in pregnancy due to a very high risk of severe birth defects; treatment is restricted through the iPLEDGE REMS program.
Use with caution in patients with a history of depression, mental health disorders, liver disease, hyperlipidemia, diabetes, or bone disorders.
Avoid vitamin A supplements and tetracycline antibiotics during therapy due to increased risk of adverse effects.
Patients should avoid blood donation during treatment and for 1 month after stopping, and should avoid waxing, dermabrasion, and laser skin procedures during treatment and for at least 6 months afterward.
May impair night vision and increase sun sensitivity.

Side Effects

Common side effects may include:

Dry, cracked lips
Dry skin
Dry eyes, mouth, or nose
Nosebleeds
Skin peeling or irritation

Serious adverse effects may include:

Embryo-fetal toxicity
Mood or behavioral changes
Intracranial hypertension
Pancreatitis
Elevated cholesterol or triglycerides
Liver abnormalities
Severe skin reactions
Vision or hearing disturbances

Storage

Storage: Store at 20°C to 25°C (68°F to 77°F). Protect from light. Keep out of reach of children.