Oin 20 Softgel | 1 Strip

✔️ Dosage & Administration

Adults:

• Recommended dose: 0.5–1 mg/kg/day orally, in 2 divided doses, for 15–20 weeks.
• Dose may be increased up to 2 mg/kg/day in very severe or trunk-dominant acne.
• Hepatic impairment: Contraindicated.

Children:

• <12 years: Safety and efficacy not established.
• ≥12 years: Same as adult dosing guidelines.

Renal impairment:

• Severe: Start with 10 mg daily; titrate gradually up to 1 mg/kg/day if tolerated.

Administration:

• Take with food to improve absorption.
• Swallow whole—do not chew, crush, or break.

✔️ OIN 20 contains isotretinoin, a synthetic derivative of vitamin A. It acts by:

• Reducing sebaceous gland size and activity, thereby lowering sebum production.
• Decreasing Propionibacterium acnes colonization due to reduced sebum.
• Regulating keratinocyte proliferation and differentiation.
• Exhibiting anti-inflammatory activity, minimizing redness and swelling.

Together, these actions target the root causes of severe acne, promoting long-term remission.

✔️ Side Effects

Very Common (>10%)

• Cheilitis (lip inflammation)
• Dry skin, dry mouth, dry nose, epistaxis
• Conjunctivitis, eye irritation
• Hypertriglyceridemia
• Bone/joint pain, muscle aches
• Increased liver enzymes

Common (1–10%)

• Skin rash, fragility, infections
• Photosensitivity
• Decreased HDL, increased CPK
• Hair thinning, palmoplantar desquamation

Uncommon / Rare

• Premature epiphyseal closure (in adolescents)
• Decreased bone mineral density
• Psychiatric symptoms (lethargy, fatigue, depression)
• Gastrointestinal upset (nausea, vomiting, anorexia)
• Severe allergic reactions (rare but potentially fatal anaphylaxis)
• Hemorrhagic pancreatitis (rare but life-threatening)

✔️ Contraindications

• Pregnancy (high teratogenic risk)
• Lactation
• Known hypersensitivity to isotretinoin or its excipients
• Severe hepatic impairment

✔️ Drug Interactions

• Vitamin A / Retinoids: Additive toxicity
• Tetracyclines: Risk of pseudotumor cerebri (potentially fatal)
• Microdosed progesterone contraceptives: Reduced efficacy—avoid, use dual contraception
• Phenytoin / Corticosteroids: May increase risk of bone loss/osteoporosis
• Carbamazepine: Reduced plasma concentrations

✔️

Precautions & Warnings

Pregnancy prevention: Women of childbearing potential must use two effective contraceptive methods during therapy and for at least 1 month after discontinuation.

Monitoring: Regular monitoring of liver function, lipid profile, and glucose levels (especially in diabetic patients).

Psychiatric effects: Use with caution in patients with a history of depression or other psychiatric disorders.

Musculoskeletal effects: Monitor patients at risk of osteoporosis or bone metabolism disorders.

Dermatologic precautions: Avoid waxing, laser treatments, or skin resurfacing during and 6 months post-therapy due to risk of scarring.

Sun sensitivity: Limit UV exposure; use sunscreen and protective clothing.

Other warnings: Discontinue if severe abdominal pain, rectal bleeding, visual disturbances, or hearing impairment occur. Patients should not donate blood during therapy and for at least 1 month after stopping treatment.

✔️ Pregnancy & Lactation

Pregnancy: Contraindicated due to severe teratogenicity. Strict pregnancy prevention measures are mandatory.

Lactation: Unknown if excreted in breast milk; contraindicated due to potential harm to nursing infants.

✔️ Storage: