API

Tacrolimus (0.03% w/w)

Drug classification

Immunosuppressant; calcineurin inhibitor subclass.

Dosage form

Sterile ophthalmic ointment containing tacrolimus 0.03% w/w for topical eye use.

API strength per dosage

Dose

Entrak Soothe Eye Ointment (Tacrolimus 0.03% w/w) is typically applied as a thin layer to the affected eye(s) once or twice daily. Dosing adjustments for adults, paediatric patients, or those with renal or hepatic impairment are not well established; use with caution. Always follow specific prescribing information and consult an ophthalmologist.

Mechanism of action

Tacrolimus inhibits calcineurin, blocking T-lymphocyte activation by preventing dephosphorylation of nuclear factor of activated T-cells (NFAT). This reduces transcription of pro-inflammatory cytokines such as interleukin-2, thereby decreasing ocular surface inflammation and immune-mediated damage in conditions like allergic conjunctivitis or vernal keratoconjunctivitis.

Indications

Treatment of Allergic eye disease

Side effects

Eye irritation Burning sensation

Pregnancy category

Safety of topical tacrolimus in pregnancy is not established; use only if potential benefit justifies potential risk to the fetus. Avoid unless clearly needed.

Precautions

Avoid contact with infected eyes, monitor for local irritation or hypersensitivity, do not use with active ocular infections, avoid touching tube tip to eye or surfaces, monitor for changes in vision, use with caution in immunocompromised patients, inform physician of persistent symptoms, avoid use in pregnancy or breastfeeding unless necessary.

Contraindications

Hypersensitivity to tacrolimus or any ointment component, active ocular or periocular infections, particularly viral (e.g., herpes simplex), bacterial, or fungal infections.