Ikervis

Ikervis

ciclosporin

Manufacturer:

Santen

Distributor:

The Glory Medicina
/
DKSH
Concise Prescribing Info
Contents
Ciclosporin
Indications/Uses
Severe keratitis in adults w/ dry eye disease, which has not improved despite treatment w/ tear substitutes. Severe vernal keratoconjunctivitis (VKC) in childn ≥4 yr & adolescents.
Dosage/Direction for Use
Severe keratitis w/ dry eye disease Adult Instill 1 drop once daily to the affected eye(s) at bedtime. Reassess response to treatment at least every 6 mth. Severe VKC Childn ≥4 yr & adolescent Instill 1 drop qds (morning, noon, afternoon & evening) to each affected eye during VKC season. If signs & symptoms of VKC persist after end of season, treatment can be maintained at recommended dose or decreased to 1 drop bd once adequate control of signs & symptoms is achieved.
Contraindications
Hypersensitivity. Ocular or peri-ocular malignancies or premalignant conditions. Active or suspected ocular or peri-ocular infection.
Special Precautions
Use nasolacrimal occlusion & close eyelids for 2 min after instillation to reduce systemic absorption. Administer at least 15 min apart if >1 topical ophth medicinal product is being used; Ikervis should be administered last. May affect host defences against local infections & malignancies. Contains cetalkonium Cl. Moderate influence on the ability to drive & use machines. Not recommended in women of childbearing potential not using effective contraception. Pregnancy & lactation. Treatment of severe keratitis w/ dry eye disease: Caution in patients w/ history of ocular herpes. Remove contact lenses before instillation at bedtime; may reinsert at wake-up time. Exercise regular clinical monitoring in patients w/ glaucoma concomitantly treated w/ β-blockers. Regular eye exam is recommended (eg, at least every 6 mth) when used for >1 yr. No relevant use in childn & adolescents <18 yr. Treatment of severe VKC: Caution in patients w/ active orofacial herpes simplex infection, history of ocular herpes, varicella-zoster, or vaccinia virus infection. Not recommended w/ contact lenses. Regular eye exam is recommended (eg, every 3-6 mth) when used for >12 mth. Caution w/ corticosteroids. No relevant use in childn <4 yr. Effect has not been studied in patients >18 yr.
Adverse Reactions
Treatment of severe keratitis w/ dry eye disease: Eye pain &/or irritation. Eyelid erythema &/or oedema, increased lacrimation, ocular &/or conjunctival hyperaemia, blurred vision, eye pruritus. Treatment of severe VKC: Eye pain. URTI; headache; eye pruritus &/or irritation, ocular hyperaemia &/or discomfort, foreign body sensation in eyes, increased lacrimation, blurred vision, eyelid erythema &/or oedema; cough.
Drug Interactions
Co-administration w/ corticosteroid-containing eye drops could potentiate the effects of ciclosporin on the immune system.
MIMS Class
Ophthalmic Decongestants, Anesthetics, Anti-Inflammatories
ATC Classification
S01XA18 - ciclosporin ; Belongs to the class of other ophthalmologicals .
Presentation/Packing
Form
Ikervis ophth emulsion (single dose) 1 mg/mL
Packing/Price
30 × 1's
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