Product Monograph - Isopto Carpine (Novartis Pharmaceuticals Canada, 4 %, 2 %)

RECENT MAJOR LABEL CHANGES

Not Applicable

TABLE OF CONTENTS

Sections or subsections that are not applicable at the time of authorization are not listed.

RECENT MAJOR LABEL CHANGES .......................................................................................... 2

TABLE OF CONTENTS ............................................................................................................ 2

PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4

1 INDICATIONS ............................................................................................................. 4

1.1 Pediatrics ...................................................................................................................... 4

1.2 Geriatrics ...................................................................................................................... 4

2 CONTRAINDICATIONS ................................................................................................ 4

4 DOSAGE AND ADMINISTRATION ................................................................................ 4

4.1 Dosing Considerations ................................................................................................. 4

4.2 Recommended Dose and Dosage Adjustment ............................................................ 4

4.4 Administration ............................................................................................................. 4

4.5 Missed Dose ................................................................................................................. 5

5 OVERDOSAGE ............................................................................................................ 5

6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 5

7 WARNINGS AND PRECAUTIONS ................................................................................. 5

7.1 Special Populations ...................................................................................................... 6

7.1.1 Pregnant Women ............................................................................................... 6

7.1.2 Breast-feeding .................................................................................................... 6

7.1.3 Pediatrics ............................................................................................................ 7

7.1.4 Geriatrics ............................................................................................................ 7

8 ADVERSE REACTIONS................................................................................................. 7

8.1 Adverse Reaction Overview ......................................................................................... 7

8.2 Clinical Trial Adverse Reactions ................................................................................... 7

8.5 Post-Market Adverse Reactions ................................................................................... 7

9 DRUG INTERACTIONS ................................................................................................ 8

9.4 Drug-Drug Interactions ................................................................................................ 8

9.5 Drug-Food Interactions ................................................................................................ 8

9.6 Drug-Herb Interactions ................................................................................................ 8

9.7 Drug-Laboratory Test Interactions ............................................................................... 8

10 CLINICAL PHARMACOLOGY ........................................................................................ 8

11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 8

12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 8

PART II: SCIENTIFIC INFORMATION ....................................................................................... 9

13 PHARMACEUTICAL INFORMATION ............................................................................ 9

14 CLINICAL TRIALS ........................................................................................................ 9

15 MICROBIOLOGY ........................................................................................................ 9

16 NON-CLINICAL TOXICOLOGY ...................................................................................... 9

PATIENT MEDICATION INFORMATION ................................................................................ 10

PART I: HEALTH PROFESSIONAL INFORMATION

1 INDICATIONS

ISOPTO® CARPINE (Pilocarpine hydrochloride ophthalmic solution, USP) is indicated for the reduction of intraocular pressure.

1.1 Pediatrics

Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

1.2 Geriatrics

Geriatrics (> 65 years of age): Elderly patients may be at a higher risk for pilocarpine-induced mental status changes, including psychosis and dementia of the Alzheimer type.

2 CONTRAINDICATIONS

Pilocarpine hydrochloride ophthalmic solution is contraindicated in:

Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see section 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Conditions where pupillary constriction is undesirable, such as acute iritis or anterior uveitis.

4 DOSAGE AND ADMINISTRATION

4.1 Dosing Considerations

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointment should be administered last.

4.2 Recommended Dose and Dosage Adjustment

Instill 2 drops topically in the affected eye(s) 3 or 4 times daily.

Health Canada has not authorized an indication for pediatric use.

4.4 Administration

Nasolacrimal occlusion or gently closing the eyelid after administration is recommended (see section 7 WARNINGS AND PRECAUTIONS, General).

To prevent contamination of the solution, care must be taken to avoid touching the dropper tip to any surface.

4.5 Missed Dose

If a dose is missed, eye drops should be administered as soon as possible before reverting to regular routine. Do not use a double dose to make up for the one missed.

5 OVERDOSAGE

In case of overdose, symptoms of toxicity may include headache, salivation, sweating, syncope, bradycardia, hypotension, abdominal cramps, vomiting, asthma and diarrhea. Treatment of overdose should be supportive. In cases of severe systemic toxicity, therapy with anticholinergics may be necessary.

For management of a suspected drug overdose, contact your regional poison control centre.

6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING

Table 1– Dosage Forms, Strengths, Composition and Packaging

Description

ISOPTO CARPINE is a sterile ophthalmic solution and is available in two strengths (2% and 4%). ISOPTO CARPINE is supplied in 15 mL plastic bottle. Tamper evidence is provided by a closure with an extended skirt that locks to the bottle finish on application and breaks away from the closure on opening. After cap is removed: if the tamper evident snap collar is loose, remove collar before using product.

7 WARNINGS AND PRECAUTIONS

General

ISOPTO CARPINE should be used with caution in patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, gastro-intestinal spasm, Parkinson’s disease, urinary tract obstruction, recent myocardial infarction, hypertension and hypotension due to the risk

Route of Administration	Dosage Form / Strength/Composition	Non-medicinal Ingredients
Topical (ophthalmic)	2% w/v Pilocarpine hydrochloride	Benzalkonium chloride (as preservative), boric acid, hydroxypropyl methylcellulose, sodium citrate, sodium hydroxide and/or hydrochloric acid (to adjust pH) and purified water.
Topical (ophthalmic)	4% w/v Pilocarpine hydrochloride	Benzalkonium chloride (as preservative), boric acid, hydroxypropyl methylcellulose, sodium citrate, sodium hydroxide and/or hydrochloric acid (to adjust pH) and purified water.

of exacerbating these conditions.

Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal ingredients administered via the ocular route and result in a decrease in systemic adverse reactions.

Driving and Operating Machinery

ISOPTO CARPINE has a major influence on the ability to drive and use machines. Miosis may cause blurred vision and difficulty in dark adaptation. Patients should be advised to exercise caution while driving at night or while performing hazardous tasks in poor light.

Ophthalmologic

Retinal detachment has been reported when miotics are used in susceptible individuals, such as young patients with myopia or patients with a history of retinal detachment. Fundus examination is advised prior to initiation of treatment with ISOPTO CARPINE.

Miotics should be avoided in acute inflammatory diseases of the anterior chamber.

A paradoxical rise in intraocular pressure may be observed in patients with severely compromised trabecular outflow.

Caution is advised in the presence of corneal or conjunctival damage to avoid excessive penetration, which can produce systemic toxicity.

ISOPTO CARPINE contains the preservative benzalkonium chloride, which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to the application of ISOPTO CARPINE and wait at least 15 minutes before reinsertion.

Reproductive Health: Female and Male Potential

Fertility

Studies have not been performed to evaluate the effect of topical ocular administration of ISOPTO CARPINE on fertility.

7.1 Special Populations

7.1.1 Pregnant Women

There are no or limited amount of data from the use of ISOPTO CARPINE in pregnant women. Animal studies have, however, showed harmful effects of systemic pilocarpine exposure with respect to reproductive toxicity in rats. ISOPTO CARPINE should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

7.1.2 Breast-feeding

It is unknown whether pilocarpine is excreted in human milk. Because many drugs are excreted in breast milk, caution should be exercised when administering ISOPTO CARPINE to a nursing woman.

7.1.3 Pediatrics

Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

7.1.4 Geriatrics

Geriatrics (>65 years of age): See 1.2 Geriatrics.

8 ADVERSE REACTIONS

8.1 Adverse Reaction Overview

Not available at the time of initial authorization.

8.2 Clinical Trial Adverse Reactions

Clinical trials are conducted under very specific conditions. Therefore, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

The following adverse reactions were reported during clinical trials with ISOPTO CARPINE:

Eye disorders:

Very common: vision blurred;

Common: eye irritation, eye pain, ocular hyperemia, photopsia, visual acuity reduced, vitreous floaters;

Uncommon: eyelid edema, foreign body sensation in eyes, glare, miosis, retinal tear, vitreous detachment, vitreous hemorrhage;

Gastrointestinal disorders:

Common: nausea;

Nervous system disorders:

Very common: headache;

common: dizziness.

8.5 Post-Market Adverse Reactions

Additional adverse reactions identified from post-marketing surveillance include the following:

Eye disorders: corneal edema, increased intraocular pressure;

Gastrointestinal disorders: vomiting.

9 DRUG INTERACTIONS

9.4 Drug-Drug Interactions

Interactions with other drugs have not been established.

9.5 Drug-Food Interactions

Interactions with food have not been established.

9.6 Drug-Herb Interactions

Interactions with herbal products have not been established.

9.7 Drug-Laboratory Test Interactions

Interactions with laboratory tests have not been established.

10 CLINICAL PHARMACOLOGY

This information is not available for this drug product.

11 STORAGE, STABILITY AND DISPOSAL

Store at room temperature. Avoid excessive heat. Keep bottle tightly closed when not in use. Keep out of the reach and sight of children.

12 SPECIAL HANDLING INSTRUCTIONS