Isopto Carpine 4%: Indications, Dosage, Precautions, Adverse Effects
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Isopto Carpine 4% - Product Information

Manufacture: Alcon
Country: Canada
Condition: Glaucoma
Class: Cholinesterase inhibitors
Form: Drops
Ingredients: Pilocarpine hydrochloride 4% w/v, benzalkonium chloride, boric acid, hydroxypropyl methylcellulose, sodium chloride, sodium citrate, sodium hydroxide and/or hydrochloric acid (to adjust pH), and purified water.

Summary Product Information

Route of
Administration
Dosage Form /
Strength
Clinically Relevant Nonmedicinal
Ingredients
Topical (ophthalmic) Solution/
Pilocarpine
hydrochloride 1, 2 and
4% w/v
Benzalkonium chloride as preservative.
For a complete listing see Dosage Forms,
Composition and Packaging section.

Indications and Clinical Use

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

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.

Contraindications

ISOPTO* CARPINE 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 the Dosage Forms, Composition and Packaging section of the Prescribing Information.
  • Conditions where pupillary constriction is undesirable, such as acute iritis or anterior uveitis.

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, Parkinsons disease, urinary tract obstruction, recent myocardial infarction, hypertension and hypotension due to the risk 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.

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

Sexual Function/Reproduction

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

Special Populations

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.

Nursing Women

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.

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.

Adverse Reactions

The following adverse reactions that have been 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.

Additional adverse reactions identified from post-marketing surveillance include the following: Eye disorders: corneal edema, intraocular pressure increased;

Gastrointestinal disorders: vomiting.

Drug Interactions

No clinically relevant interactions have been described.

Dosage and Administration

Recommended Dose

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

Administration

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

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

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.

Storage and Stability

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

Dosage Forms, Composition and Packaging

ISOPTO* CARPINE is a sterile ophthalmic solution and is available in three strengths (1%, 2% and 4%).

ISOPTO* CARPINE 1%:

Each mL of ISOPTO* CARPINE 1% contains:

Active: pilocarpine hydrochloride 1% w/v

Preservative: benzalkonium chloride 0.01% w/v

Inactives: boric acid, hydroxypropyl methylcellulose, sodium chloride, sodium citrate, sodium hydroxide and/or hydrochloric acid (to adjust pH) and purified water.

ISOPTO* CARPINE 2%:

Each mL of ISOPTO* CARPINE 2% contains:

Active: pilocarpine hydrochloride 2% w/v

Preservative: benzalkonium chloride 0.01% w/v

Inactives: boric acid, hydroxypropyl methylcellulose, sodium citrate, sodium hydroxide and/or hydrochloric acid (to adjust pH) and purified water.

ISOPTO* CARPINE 4%:

Each mL of ISOPTO* CARPINE 4% contains:

Active: pilocarpine hydrochloride 4% w/v

Preservative: benzalkonium chloride 0.01% w/v

Inactives: boric acid, hydroxypropyl methylcellulose, sodium citrate, sodium hydroxide and/or hydrochloric acid (to adjust pH) and purified water.

ISOPTO* CARPINE is supplied in 15 mL DROPTAINER* dispensers. 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.