Description

Acnotin 10 mg is an oral isotretinoin soft‑gel capsule used to treat severe, treatment‑resistant nodular acne (e.g., cystic or recalcitrant acne) when other therapies have failed.

 Prescription

Prescription-only; isotretinoin is tightly regulated due to its high teratogenic risk and requires careful medical supervision .

Therapeutic Category

A retinoid (vitamin A analogue) with potent sebaceous gland suppression and anti-inflammatory effects. Used primarily for severe acne but also off-label for conditions like ichthyosis and certain cancers.

Active Ingredients / Composition

• Isotretinoin 10 mg per capsule
• Inactive ingredients include: hydrogenated soybean oil, beeswax, butylated hydroxyanisole (BHA), disodium edetate, sorbitol, gelatin, glycerin, titanium dioxide, iron oxide.

Vitamins /  Minerals

• None. Though isotretinoin is a retinoid (related to vitamin A), no vitamins or minerals are included in the capsule formulation.
  

 Variant

• Soft-gel capsule available in 10 mg strength (Acnotin); other strengths (e.g. 20 mg, 40 mg) may exist under other isotretinoin brands .
  

 Consume Type

• Oral soft-gel capsule, swallowed whole with water; best taken with food to enhance absorption .

 Directions / Usage

• Typical dosing: 0.5 mg/kg/day, often rounded to 10–20 mg once or twice daily; some cases may require up to 1 mg/kg/day .
• Course duration usually spans 16–20 weeks, with treatment effect continuing several weeks post-therapy.
• Capsules must not be crushed or chewed; discontinue use if pregnant or planning pregnancy .

Common Side Effects

Mucocutaneous

• Dry lips (cheilitis), dry/fragile skin, nosebleeds, chapped skin, eczema-like rash, eczema

 Ocular

• Dry eyes, irritation, decreased night vision
  

 Systemic

• Elevated liver enzymes, increased lipids (cholesterol/triglycerides), musculoskeletal symptoms (joint pain), photosensitivity, headache
  

 Psychiatric

• Mood changes, depression, anxiety, rarely suicidal ideation.
  

Teratogenicity

• Highly teratogenic—severe birth defects if taken during pregnancy; strict pregnancy prevention protocols required (e.g., iPLEDGE in the US)

 Package Type

• Typically supplied in blister packs of 10 capsules per strip, with boxes containing 30 capsules or similar configuration, depending on region.

Storage Advice

• Store at controlled room temperature (approximately 15–25 °C) in a dry, dark place, away from moisture and children; keep blister sealed until use .

Safety Advice

• Strict contraindications: pregnancy, breastfeeding, women planning pregnancy; require two effective contraceptive methods before, during, and 1 month after treatment .
• Monitoring during treatment: regular checks of liver function tests, lipid profile, mood/mental health, and pregnancy tests for females of childbearing potential.
• Avoid excessive vitamin A supplements, tetracyclines (risk of intracranial hypertension), and other interacting agents (e.g. orlistat, progestin-only contraceptives) .
• No blood donation during treatment and for at least 1 month after cessation.
• Avoid cosmetic procedures (laser, waxing, dermabrasion) during and for at least 6 months post-therapy due to scarring risk.
  

Product Substitutes

• Other isotretinoin brands: Accutane® (Roche), Roaccutane®, Claravis®, Amnesteem®, Myorisan®, Sotret®, Zenatane®, Absorica®, and generics from companies like Sun Pharma (e.g. marketed as 10 mg capsules in UK/EU) .

• Alternatives: topical retinoids, oral antibiotics or hormonal therapies depending on acne severity and patient profile.
  

Manufacturer / Marketer

• Acnotin® is manufactured by Mega Lifesciences, headquartered in Thailand, and marketed in various countries including Vietnam, Peru, Bangladesh, Ecuador, Chile, Singapore, Myanmar; multiple local distributors handle regional supply.

Country of Origin

• Originates from Mega Lifesciences Thailand; distributed in multiple international markets. Local origin depends on country-specific registration.