Isopto Carpine(盐酸毛果芸香碱ophthalmic solution)

IsoptoCarpine (pilocarpinehydrochloride ophthalmic solution) is a cholinergic agonist prepared as a sterile topical ophthalmic solution.

Becauseclinical trialsare conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure in four controlled clinical trials of 90 days to 2 years duration in 317 patients diagnosed withopen-angle glaucomaorocularhypertension.

In the four clinical trials, patients were treated with Isopto Carpine 2%, two to four times daily or with pilocarpine 1%, 1.75% or 2% in fixed combination withbetaxolol0.25%, two or three times daily.

The most frequently reported adverse reactions occurring in ≥ 5% of patients in the pilocarpine 2% populations were:

• headache/browache,
• accommodative change,
• blurred vision,
• eye irritation,
• visual impairment (dim, dark, or “jumping” vision), and
• eye pain.

The adverse reaction profile reported for the use of Isopto Carpine in pediatric patients is comparable to that seen in adult patients.

Reduction Of Elevated Intraocular Pressure (IOP) In Patients With Open-Angle Glaucoma Or Ocular Hypertension

• One drop ofIsopto Carpine 1%, 2% or 4%should be applied topically in the eye(s) up to four times daily.
• Pilocarpine-naïve patients should be started on the1% concentrationas higher concentrations are often not tolerated initially.
• The frequency of instillation and concentration of Isopto Carpine are determined by the severity of the elevatedintraocular pressureand miotic response of the patient.
• To limit systemic exposure to pilocarpine, patients may be instructed to perform punctal occlusion for 2 minutes after instillation of Isopto Carpine ophthalmic solution.

Management Of Acute Angle-Closure Glaucoma

• Prior to Isopto Carpine use, treatment with secretory suppressants and hyperosmotic agents may be needed to lowerIOPbelow 50 mmHg and relieveirisischemia.
• For initial management of acute angleclosureglaucoma, one drop ofIsopto Carpine 1% or 2%may be applied topically in the eye(s) up to three times over a 30-minute period.
• If laser iridoplasty or iridomy is used to break the attack, one drop ofIsopto Carpine 4%should be administered prior to the procedure. Following laser iridoplasty, one drop ofIsopto Carpine 1%应每天四次,直到一个我吗ridotomy can be performed.

Prevention Of Postoperative Elevated IOP Associated With Laser Surgery

• One drop ofIsopto Carpine 1%, 2% or 4%(or two drops administered five minutes apart) should be applied topically in the eye(s) 15 to 60 minutes prior to surgery.

Induction Of Miosis

• One drop ofIsopto Carpine 1%, 2% or 4%(or two drops administered five minutes apart) should be applied topically in the eye(s).

Use With Other Topical Ophthalmic Medications

• Isopto Carpine may be used in combination withbeta-blockers, carbonic anhydrase inhibitors, sympathomimetics or hyperosmotic agents.
• If more than one topical ophthalmic drug is being used, thedrugsshould be administered at least five (5) minutes apart.

Use In Pediatric Patients

• In children under 2 years of age, one drop of Isopto Carpine 1% should be applied topically in the eye(s) three times daily.
• Children 2 years of age and over should be dosed as for adults.
• For the induction ofmiosisprior to goniotomy or trabeculotomy in children, one drop ofIsopto Carpine 1% or 2%should be applied topically in the eye 15 to 60 minutes prior to surgery.

• No Information Provided

• It is also not known whether pilocarpine hydrochloride can cause fetal harm when administered to apregnantwoman or can affect reproduction capacity. Isopto Carpine should be given to a pregnant woman only if clearly needed.
• It is not known whether this drug is excreted inhuman milk. Because many drugs are excreted in human milk, caution should be exercised when Isopto Carpine is administered to anursingwoman.