Product Dossier

ISOPTO CARPINE

Product Dossier for ISOPTO CARPINE (pilocarpine hydrochloride, Novartis Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

Isopto Carpine is pilocarpine hydrochloride supplied in 1%, 2%, and 4% formulations as clear eye drops solutions. It is administered topically as 1–2 drops in the eye(s) 3–4 times daily.

Approved indications

— Treatment of glaucoma.

Dosing overview

The recommended dose is 1–2 drops in the eye(s) 3–4 times daily.

Key safety warnings

Retinal detachment has been reported when miotics are used in susceptible individuals, such as young patients with myopia or patients with a history of retinal detachment. A paradoxical rise in intraocular pressure may be observed in patients with severely compromised trabecular outflow. Caution is advised in the presence of corneal or conjunctival damage to avoid excessive penetration which can produce systemic toxicity. Isopto Carpine should be used with caution in patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, gastro-intestinal spasms, Parkinson's disease, urinary tract obstruction, recent myocardial infarction, hypertension and hypotension due to the risk of exacerbating these conditions. Isopto Carpine contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses; patients must be instructed to remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Isopto Carpine has a major influence on the ability to drive and use machines; miosis may cause blurred vision and difficulty in dark adaptation, and patients should be advised to exercise caution while driving at night or while performing hazardous tasks in poor light.

Contraindications

Miotics are contraindicated in conditions where pupillary constriction is undesirable such as in acute iritis or anterior uveitis. Isopto Carpine is contraindicated in hypersensitivity to the active substance or to any of the excipients.

PBS listing

Isopto Carpine is listed on the PBS in three strengths: eye drops containing pilocarpine hydrochloride 10 mg per mL (ex-manufacturer price A$4.94), 20 mg per mL (ex-manufacturer price A$5.95), and 40 mg per mL (ex-manufacturer price A$8.26), each supplied as 15 mL bottles with 3 PBS items per strength.

Regulatory history

Isopto Carpine was first approved on the ARTG on 15 October 1991 in three formulations: pilocarpine hydrochloride 1%, 2%, and 4% eye drops bottles.