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Ikervis

Ikervis

ciclosporin

Manufacturer:

Santen

Distributor:

Santen
Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing
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 & adolescent 4-18 yr.
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Dosage/Direction for Use
Severe keratitis in dry eye disease Adult 1 drop once daily to the affected eye(s) at bedtime. Do not instill >1 drop in the affected eye. Severe VKC Adolescent & childn >4 yr 1 drop qid (morning, noon, afternoon & evening) to each affected eye. If signs & symptoms persist after the end of the season, treatment can be maintained at the recommended dose or decreased to 1 drop bid once adequate control of signs & symptoms is achieved. Use nasolacrimal occlusion & close eyelids for 2 min after instillation. If >1 topical ophth medicinal product is being used, administer at least 15 min after all other ophth drops.
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Overdosage
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Contraindications
Hypersensitivity. Active or suspected ocular or peri-ocular infection. Ocular or peri-ocular malignancies or premalignant conditions.
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Special Precautions
In treatment of severe keratitis in dry eye disease: Patients w/ history of ocular herpes; glaucoma. Monitor patients w/ severe keratitis. Concomitant w/ β-blockers. May affect host defenses against infections & malignancies. Remove contact lenses before instillation. In treatment of severe VKC: Active orofacial herpes simplex infection, history of ocular herpes, varicella-zoster or vaccinia virus infection. Not recommended to wear contact lenses. Co-administration w/ corticosteroids. May affect host defenses against infections & malignancies. Contains cetalkonium Cl which may cause eye irritation. Moderate influence on the ability to drive & use machines. Not recommended during pregnancy & in women of childbearing potential. Lactation. Childn & adolescents <18 yr.
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Use In Pregnancy & Lactation
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Adverse Reactions
In treatment of severe keratitis in dry eye disease: Instillation site pain; erythema of eyelid, increased lacrimation, ocular hyperaemia, blurred vision, eye pruritus, eyelid oedema, conjunctival hyperaemia, eye irritation, eye pain; instillation site irritation, erythema & lacrimation, headache. In treatment of severe VKC: Eye pain; URTI, eye pruritus, ocular hyperaemia, eye irritation, ocular discomfort, foreign body sensation in eyes, increased lacrimation, blurred vision, erythema of eyelid, eyelid oedema.
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Drug Interactions
Potentiated effects on the immune system when co-administered w/ eye drops containing corticosteroid. Decreased tear secretion w/ β-blockers.
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Storage
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Description
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Action
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MIMS Class
Ophthalmic Decongestants, Anesthetics, Anti-Inflammatories
ATC Classification
S01XA18 - ciclosporin ; Belongs to the class of other ophthalmologicals.
Regulatory Classification
Rx
Presentation/Packing
Form
Ikervis ophth emulsion 1 mg/mL
Packing/Price
0.3 mL x 30 × 1's