DESCRIPTION
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| 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. |
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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. |
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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.
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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. |
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WARNINGS |
For topical use only
NOT FOR INJECTION |
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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. |
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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. |
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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.
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HOW SUPPLIED |
2% In 5mL plastic dropper bottle
4% In 5mL plastic dropper bottle
STORAGE: Store at 8° to 27°C |
