Isopto Carpine

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.

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

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

Manufactured by: ALCON LABORATORIES, INC. 6201 South Freeway, Fort Worth, Texas 76134 USA. Revised: June 2010

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.

In the U.S.

• Isopto Carpine
• Ocu-Carpine
• Ocusert Pilo
• Pilocar
• Pilopine-HS

In Canada

• Minims Pilocarpine 2%
• Minims Pilocarpine 4%

Available Dosage Forms:

• Device
• Suspension
• Solution
• Gel/Jelly

Therapeutic Class: Direct Acting Miotic

Pharmacologic Class: Cholinergic

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Increased sweating
• muscle tremors
• nausea, vomiting, or diarrhea
• troubled breathing or wheezing
• watering of mouth

• Eye pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blurred vision or change in near or far vision
• decrease in night vision

• Eye irritation
• headache or browache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat glaucoma.
• It is used to lower high eye pressure.
• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stinging.
• Burning.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Isopto Carpine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Isopto Carpine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Isopto Carpine.

Review Date: October 4, 2017