Generic
Isotretinoin 0.05% Topical
4 brands available in the market
At a glance
Isotretinoin 0.05% Topical gel is used for the treatment of mild to moderate inflammatory and non-inflammatory acne vulgaris.
Description
Isotretinoin 0.05% Topical gel is a retinoid that reduces sebaceous gland size and sebum production, regulates cell proliferation and differentiation, and induces apoptosis. It reduces comedone formation and provides anti-inflammatory action. Percutaneous absorption after topical application is negligible.
Indications
- Mild to moderate inflammatory and non-inflammatory acne vulgaris
Therapeutic class
Topical retinoid and related preparations
Pharmacological class
Topical Retinoid
Pharmacology
Isotretinoin produces its effects through altering progress through the cell cycle, cell differentiation, survival, and apoptosis. These actions reduce sebum production, preventing the blockage of pores, and growth of acne causing bacteria. Isotretinoin induces apoptosis in sebocytes and reduces hyperkeratinization. It does not directly kill bacteria but reduces the size of sebum ducts and makes the microenvironment less hospitable to acne causing bacteria.
Mechanism of action
Reduces sebaceous gland size and sebum production; regulates cell proliferation and differentiation; provides anti-inflammatory action.
Dosage
Adult Dose (Topical):
- Apply sparingly over affected area once or twice daily
- Therapeutic effect observed within 6-8 weeks of treatment
Child Dose: Safety and efficacy not established in children
Administration
For external use only; use in the dose and duration as advised by your doctor; check the label for directions; clean and dry the affected area and apply the gel; wash hands after applying (unless hands are the affected area); avoid contact with mouth, eyes and mucous membranes.
Missed dose
If you miss a dose, apply it as soon as possible; if it is almost time for your next dose, skip the missed dose and go back to regular schedule; do not double the dose.
Side effects
Common Side Effects:
- Application site reactions (burning, irritation, itching and redness)
- Dry skin
- Cracked lips
- Peeling
Precautions & warnings
Precautions:
- Isotretinoin may affect your ability to drive (night vision decreased, drowsiness, dizziness)
- Avoid exposure to sunlight (use sun-cream or protective clothing)
- Avoid face waxing and laser treatment (skin becomes more fragile)
- Do not use if pregnant or breastfeeding
- Inform doctor if excessive skin dryness or skin sensitivity occurs
- Caution with peeling agents or abrasive cleansers
Contraindications
Contraindications:
- Pregnancy
- Lactation
- Hypersensitivity to Isotretinoin
Drug interactions
Drug Interactions:
- Additive toxicity with vitamin A or its derivatives
- Decreased efficacy of microdosed progesterone (use 2 forms of contraception)
- Increased risk of bone loss with phenytoin
- Increased risk of osteoporosis with systemic corticosteroids
- Increased risk of pseudotumor cerebri with tetracyclines (Potentially Fatal)
Food interactions
No food interaction found/established.
Use in pregnancy
Use in Pregnancy: Highly unsafe during pregnancy; significant harmful effects to developing baby; contraindicated in pregnancy; associated with teratogenicity when administered systemically.
Pregnancy Category: X — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Probably unsafe; limited data suggests drug may pass into breastmilk and harm baby; should not be used during lactation.
Pediatric use
Safety and efficacy not established in children.
Geriatric use
No specific recommendations for elderly; acne vulgaris does not present in the elderly.
Renal / hepatic impairment
No interaction found/established.
Overdose effects
Acute overdosage of Isotretinoin has not been reported; accidental ingestion could induce symptoms of hypervitaminosis A (severe headaches, nausea, vomiting, drowsiness, irritability, pruritus).
Storage conditions
Store in a cool and dry place, protected from light.
Chemical structure
Isotretinoin 0.05% Topical