Ikervis

Ikervis

ciclosporin

Manufacturer:

Santen

Distributor:

DKLL
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 adolescent & childn ≥4 yr.
Dosage/Direction for Use
Administer at least 15 min apart if >1 topical ophth medicinal product is being used. Severe keratitis in dry eye disease Adult Max: 1 drop once daily to affected eye(s) at bedtime. Reassess treatment response at least every 6 mth. Severe VKC Adolescent & childn ≥4 yr 1 drop qid (morning, noon, afternoon & evening) to each affected eye. Maintain dose if signs & symptoms persist after end of season or decrease to 1 drop bid once control is achieved. Max: 1 drop for each instillation in affected eye(s).
Contraindications
Hypersensitivity. Active or suspected ocular or periocular infection. Ocular malignancies or pre-malignant conditions.
Special Precautions
Not recommended to use w/ contact lenses. Patients w/ glaucoma; active orofacial herpes simplex infection, history of ocular herpes, varicella-zoster, or vaccinia virus infection. May affect host defences against local infections & malignancies. May cause eye irritation due to cetalkonium Cl. Monitor patients w/ severe keratitis. Remove contact lenses before instillation of eye drops at bedtime & may be reinserted at wake-up time. Perform regular eye exam every 3-6 mth when used for >12 mth. Concomitant use w/ β-blockers & corticosteroids. May affect ability to drive & use machines. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Childn & adolescents <18 yr w/ severe keratitis; childn <4 yr & adults >18 yr w/ severe VKC.
Adverse Reactions
Eye pain. Eye irritation, ocular hyperaemia, increased lacrimation, blurred vision/reduced visual acuity, eyelid erythema & oedema. Severe keratitis in dry eye disease: Instillation site pain. Conjunctival hyperaemia; instillation site irritation, erythema & lacrimation. Severe VKC: URTI; headache; eye pruritus, ocular discomfort, foreign body sensation in eyes; cough.
Drug Interactions
Potentiated immune system effects w/ eye drops containing corticosteroids.
MIMS Class
Ophthalmic Decongestants, Anesthetics, Anti-Inflammatories
ATC Classification
S01XA18 - ciclosporin ; Belongs to the class of other ophthalmologicals .
Presentation/Packing
Form
Ikervis eye drops 1 mg/mL
Packing/Price
6 × 5 × 1's
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