Pilocor

 
     
 

DESCRIPTION

Pilocar (Pilocarpine Hydrochloride) is a cholinergic prepared as a sterile topical ophthalmic solution. Its chemical name is 2(3H)-Furanone,3-ethyldihydro-4-((1-methyl-1H- imidazol-5-yl)-methyl)-, monohydrochloride,(3S- cis)-. Pilocar contains pilocarpine hydrochloride 2% and 4%, benzalkonium chloride 0.01%, and hydroxypropyl methycellulose as vehicle.
 

ACTIONS/CLINICAL PHARMACOLOGY

Pilocarpine is a direct acting cholinergic parasympathomimetic agent which acts through direct stimulation of muscarinic neuro receptors and smooth muscle such as the iris and secretory glands. Pilocarpine produces miosis through contraction of the iris sphincter, causing increased tension on the scleral spur and opening of the trabecular mesh work spaces to facilitate outflow of aqueous humor. Outflow resistance is thereby reduced, lowering intraocular pressure.
 

INDICATIONS AND USAGE

Pilocar is a miotic (parasympathomimetic) used to control intraocular pressure. It may be used in combination with other miotics, beta blockers, carbonic anhydrase inhibitors, sympathomimetics, or hyperosmotic agents.
 

CONTRAINDICATIONS

Miotics are contraindicated where constriction is undesirable such as in acute iritis, in those persons showing hypersensitivity to any of their components, and in pupillary block glaucoma.
 

WARNINGS

For topical use only

NOT FOR INJECTION
 

PRECAUTIONS

General

The miosis usually causes difficulty in dark adaptation. Patient should be advised to exercise caution in night driving and other hazardous occupations in poor illumination.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

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

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with pilocarpine. It is also not known whether pilocarpine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pilocar should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pilocar is administered to a nursing woman.

Information For Patients

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

 

ADVERSE REACTIONS

Transient symptoms of stinging and burning may occur. Ciliary spasm, conjunctival vascular congestion, temporal or supraorbital headache, and induced myopia may occur. This is especially true in younger individuals who have recently started administration. Reduced visual acuity in poor illumination is frequently experienced by older individuals and individuals with lens opacity.
As with all miotics, rare cases of retinal detachment have been reported when used in certain susceptible individuals. Lens opacity may occur with prolonged use of Pilocar.

Overdosage

Systemic toxicity following topical ocular administration of Pilocar is rare, but occasional patients are peculiarly sensitive and develop sweating and gastrointestinal overactivity following suggested dosage and administration. Overdosage can produce sweating, salivation, nausea, tremors and slowing of the pulse and a decrease in blood pressure. In moderate overdosage, spontaneous recovery is to be expected and is aided by intravenous fluids to compensate for dehydration. For cases demonstrating severe poisoning, atropine is the pharmacologic antagonist to pilocarpine.

A topical ocular overdose of Pilocar may be flushed from the eye(s) with warm tap water.

 

DOSAGE AND ADMINISTRATION

Two drops topically in the eye(s) up to three or four times daily as directed by a physician. Under selected conditions, more frequent instillations may be indicated. Individuals with heavily pigmented irides may require higher strengths.
 

HOW SUPPLIED

2% In 5mL plastic dropper bottle
4% In 5mL plastic dropper bottle
STORAGE: Store at 8° to 27°C