Isopto Carpine Information
Isopto carpine (Pilocarpine) Indications And Usage
Isopto® Carpine is indicated for the:
Isopto carpine (Pilocarpine) Dosage And Administration
One drop of Isopto® 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 the 1% concentration as higher concentrations are often not tolerated initially. The frequency of instillation and concentration of Isopto® Carpine are determined by the severity of the elevated intraocular pressure and 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.
Prior to Isopto® Carpine use, treatment with secretory suppressants and hyperosmotic agents may be needed to lower IOP below 50 mmHg and relieve iris ischemia.
For initial management of acute angle-closure glaucoma, one drop of Isopto® 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 of Isopto® Carpine 4% should be administered prior to the procedure. Following laser iridoplasty, one drop of Isopto® Carpine 1% should be administered four times daily until an iridotomy can be performed.
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 of miosis prior to goniotomy or trabeculotomy in children, one drop of Isopto® Carpine 1% or 2% should be applied topically in the eye 15 to 60 minutes prior to surgery.
Isopto carpine (Pilocarpine) Dosage Forms And Strengths
Bottle filled with 15 mL of 1% (10 mg/mL), 2% (20 mg/mL) or 4% (40 mg/mL) pilocarpine hydrochloride sterile ophthalmic solution.
Isopto carpine (Pilocarpine) Contraindications
Isopto carpine (Pilocarpine) Adverse Reactions
Because clinical trials are 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 with open-angle glaucoma or ocular hypertension. 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 with betaxolol 0.25%, 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.
Isopto carpine (Pilocarpine) Overdosage
Systemic toxicity following topical ocular administration of pilocarpine is rare, but occasionally patients who are sensitive may develop sweating and gastrointestinal overactivity following the suggested dosage and administration. Overdosage can produce sweating, salivation, nausea, tremors and slowing of the pulse and a decrease in blood pressure. In moderate overdosage, spontaneous recovery is to be expected and is aided by intravenous fluids to compensate for dehydration. For patients demonstrating severe poisoning, atropine, the pharmacologic antagonist to pilocarpine, should be used.
Isopto carpine (Pilocarpine) Description
Isopto® Carpine (pilocarpine hydrochloride ophthalmic solution) is a cholinergic agonist prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure:
Established name: pilocarpine hydrochloride Chemical name: 2(3)-furanone, 3-ethyldihydro-4-[(1-methyl-1-imidazol-5-yl)-methyl]-monohydrochloride, (3S-)-.
Molecular Formula: CHNO • HCl
Molecular Weight: 244.72
Each mL of Isopto® Carpine (pilocarpine hydrochloride ophthalmic solution) contains:pilocarpine hydrochloride 1% (10 mg/mL), 2% (20 mg/mL), or 4% (40 mg/mL). benzalkonium chloride 0.01%. hypromellose 2910, boric acid, sodium citrate, sodium chloride (present in 1% only); hydrochloric acid and/or sodium hydroxide (to adjust pH); purified water. Isopto® Carpine has a pH of 3.5 to 5.5 and an osmolality of 290 to 350 mOsm/kg (1% and 2% products) and 550 to 600 mOsm/kg (4% product).
Isopto carpine (Pilocarpine) Clinical Studies
In clinical trials reported in the medical literature, pilocarpine ophthalmic solution reduced intraocular pressure (IOP) by 3-7 mmHg in patients with open-angle glaucoma. Pilocarpine ophthalmic solution has also been shown to be effective in the induction of miosis, in the prevention of postoperative elevated IOP, and in the management of acute angle-closure glaucoma.
Isopto carpine (Pilocarpine) How Supplied/storage And Handling
Isopto® Carpine (pilocarpine hydrochloride ophthalmic solution) 1%, 2% and 4% is supplied sterile in natural low density polyethylene plastic ophthalmic DROP-TAINER® dispensers and green low density polyethylene tips with green polypropylene caps.
15 mL in 15 mL bottles
1%: 0998-0203-15
2%: 0998-0204-15
4%: 0998-0206-15
Isopto carpine (Pilocarpine) Patient Counseling Information
To limit exposure to pilocarpine to the eye alone, close eyes gently and apply pressure with finger to the corner of eye by the nose for 2 minutes after instillation of Isopto® Carpine ophthalmic solution.
Rx Only
ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, Texas 76134 USA
1-800-757-9195
Printed in USA
©2009, 2010 Alcon, Inc.
Isopto carpine (Pilocarpine) Principal Display Panel
NDC 0998-0203-15
Alcon®
Isopto® Carpine 1%
(pilocarpine hydrochloride ophthalmic solution)
15 mL Sterile
