ACNEPRO

Description

Dosage Information

Adult Dosing:

• Severe, Recalcitrant Nodular Acne:
  • Initially, 0.5-1 mg/kg/day orally, divided into two daily doses, for 15-20 weeks.
  • For very severe disease with scarring or primarily affecting the trunk, the dose may be increased up to 2 mg/kg/day, if tolerated.
• Hepatic Impairment: Contraindicated (should not be used).

Child Dosing:

• Severe, Recalcitrant Nodular Acne:
  • Under 12 years: Safety and efficacy have not been established.
  • Over 12 years: 0.5-1 mg/kg/day orally, divided into two daily doses, for 15-20 weeks.
  • For very severe disease with scarring or primarily affecting the trunk, the dose may be increased up to 2 mg/kg/day, if tolerated.

Renal Dosing:

• Severe Renal Impairment: The initial dose should be reduced (e.g., 10 mg daily), and then gradually increased up to 1 mg/kg if necessary, based on patient response and tolerability.

Administration

• ACNEPRO Tablet should be taken with food to ensure proper absorption.

Important Considerations

• Contraindications:
  • Pregnancy: Isotretinoin is highly teratogenic and is strictly contraindicated during pregnancy due to the high risk of severe birth defects.
  • Lactation (Breastfeeding): Contraindicated.
• Precautions:
  • Hypertriglyceridemia: Use with caution in patients with pre-existing or a predisposition to high triglyceride levels (e.g., diabetes mellitus, obesity, increased alcohol intake). Triglyceride levels, blood lipids, and liver function tests (LFTs) should be monitored weekly or bi-weekly.
  • Diabetes Mellitus: Monitor blood glucose levels in patients with known or suspected diabetes.
  • Bone Health: Caution in patients with a genetic predisposition to age-related osteoporosis, a history of childhood osteoporosis, osteomalacia, or other bone metabolism disorders.
  • Mental Health: History of psychiatric disorder.
  • Vision: May impair night vision.
  • Skin Procedures: Avoid wax epilation and skin resurfacing procedures (like dermabrasion or laser) for at least 6 months after discontinuing the drug.
  • UV Exposure: Avoid prolonged exposure to UV light or sunlight.
  • Discontinuation: Discontinue the drug if hearing impairment, abdominal pain, rectal bleeding, severe diarrhea, or adverse ocular effects occur.
  • Blood Donation: Patients should not donate blood during therapy and for at least 1 month after discontinuing the drug due to the risk to pregnant recipients.
  • Lactation: It is unknown whether isotretinoin is distributed into breast milk; however, due to the potential for serious adverse reactions in nursing infants, it should not be administered to breastfeeding women.
• Drug Interactions:
  • Vitamin A or its derivatives: Additive toxicity.
  • Microdosed progesterone (contraceptives): Decreased efficacy; use two forms of contraception.
  • Phenytoin: May increase the risk of bone loss.
  • Systemic corticosteroids: May increase the risk of osteoporosis.
  • Carbamazepine: Reduces plasma levels of carbamazepine.
  • Potentially Fatal: Increased risk of pseudotumor cerebri (a condition of increased pressure around the brain) with tetracyclines. Avoid concomitant use.