Glanatec

Glanatec Special Precautions

Manufacturer:

Teika Pharma

Distributor:

DKSH
Full Prescribing Info
Special Precautions
Acute primary angle-closure glaucoma: Consider treatments other than drug therapy, such as surgical therapy, when using GLANATEC for acute primary angle-closure glaucoma.
Conjunctival hyperaemia: In clinical studies conducted prior to the time of approval in Japan, conjunctival hyperaemia in association with the use of ripasudil has been reported. The event usually occurs transiently at the time of instillation, but be cautious if it continues. Take any appropriate measures such as discontinuation of treatment if this event occurs.
Conjunctivitis (including conjunctivitis allergic) and blepharitis (including allergic blepharitis): In clinical studies conducted prior to the time of approval in Japan, conjunctivitis (including conjunctivitis allergic) and blepharitis (including allergic blepharitis) have been reported in association with the use of ripasudil. The incidence of conjunctivitis allergic and blepharitis allergic tends to be high in patients with long-term instillation. Take any appropriate measures such as discontinuation of treatment if these events occur.
Other adverse reactions: The adverse reactions listed under Adverse Reactions were observed in clinical studies conducted prior to the time of approval in Japan and may occur. Take any appropriate measures such as discontinuation of treatment if these events occur.
Contact lenses: GLANATEC has not been studied in patients wearing contact lenses. The preservative in GLANATEC, benzalkonium chloride may be adsorbed by the soft contact lens. Patients must be instructed to remove contact lenses prior to the application of GLANATEC and wait at least 15 minutes after instillation of the dose before reinsertion.
Use in children: Safety in low birth weight infants, newborns, infants, and children has not been established (there is no use experience).
Effects on ability to drive and use machines: No findings suggesting that GLANATAC affects the ability to drive or operate machinery or impairment of mental ability were obtained during the development phase of GLANATEC in Japan.
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