Isopto Carpine Ophthalmic Solution

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.

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.

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.

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).

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.

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.

Bottle filled with 15 mL of 1% (10 mg/mL), 2% (20 mg/mL) or 4% (40 mg/mL) pilocarpine hydrochloride sterile ophthalmic solution.

Clinical Studies Experience

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no long-term studies done using pilocarpine hydrochloride in animals to evaluate carcinogenic potential.

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%: NDC 0998-0203-15
2%: NDC 0998-0204-15
4%: NDC 0998-0206-15

STORAGE: Store at 15°- 25°C (59° - 77°F) and protect from freezing.

Avoiding Contamination of the Product

Do not touch dropper tip to any surface, as this may contaminate the contents.

Night Driving

Caution is advised with night driving and when hazardous activities are undertaken in poor illumination.

Accommodative Spasm

Isopto® Carpine ophthalmic solution may cause problems when changing focus between near objects and distant objects. Do not drive or use machinery if vision is not clear.

Contact Lens Wear

Contact lens should be removed prior to the instillation of Isopto® Carpine ophthalmic solution. Wait 10 minutes after dosing before reinserting contact lenses.

Concomitant Topical Ocular Therapy

If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.

Systemic Exposure

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.

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