Isopto Carpine label

Isopto Carpine

Isopto Carpine Recall

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Uses

Isopto® Carpine is indicated for the:

1.1 Reduction of Elevated Intraocular Pressuare (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension

1.2 Management of Acute Angle-Closure Glaucoma

1.3 Prevention of Postoperative Elevated IOP Associated with Laser Surgery

1.4 Induction of Miosis

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History

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Other Information

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:

Chemical Diagram

Established name: pilocarpine hydrochloride

Chemical name: 2(3H)-furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)-methyl]- monohydrochloride, (3S-cis)-. Molecular Formula: C11H16N2O2 • HCl Molecular Weight: 244.72.

Each mL of Isopto® Carpine (pilocarpine hydrochloride ophthalmic solution) contains: Active: pilocarpine hydrochloride 1% (10 mg/mL), 2% (20 mg/mL), or 4% (40 mg/mL). 

Preservative: benzalkonium chloride 0.01%. 

Inactives: 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).

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Isopto Carpine Manufacturers

  • Alcon Laboratories, Inc.
    Isopto Carpine | Alcon Laboratories, Inc.
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    Isopto Carpine | Alcon Laboratories, Inc.

    Isopto Carpine | Alcon Laboratories, Inc.
    2.1 Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension

    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.

    2.2 Management of Acute Angle-Closure Glaucoma

    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.

    2.3 Prevention of Postoperative Elevated IOP Associated with Laser Surgery

    One drop of Isopto® 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.

    2.4 Induction of Miosis

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

    2.5 Use with Other Topical Ophthalmic Medications

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

    2.6 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 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.

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