Overdosage can produce sweating, salivation, nausea, tremors, and slowing of the pulse and a decrease in blood pressure. Bronchial constriction may develop in asthmatic patients. 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 an ophthalmic product containing pilocarpine hydrochloride may be flushed from the eye(s) with warm tap water.
Miotics are contraindicated where constriction is undesirable, such as in acute iritis, and in those persons showing hypersensitivity to any of their components.
The following adverse experiences associated with pilocarpine therapy have been reported: lacrimation, burning or discomfort, temporal or periorbital headache, ciliary spasm, conjunctival vascular congestion, superficial keratitis and induced myopia. Systemic reactions following topical administration are extremely rare, but occasional patients are peculiarly sensitive to develop sweating and gastrointestinal overactivity following suggested dosage and administration. Ocular reactions usually occur during initiation of therapy and often will not persist with continued therapy. Reduced visual acuity in poor illumination is frequently experienced in older individuals and in those with lens opacity. A subtle corneal granularity was observed in about 10% of patients treated with PILOPINE HS® (pilocarpine hydrochloride ophthalmic gel). Cases of retinal detachment have been reported during treatment with miotic agents; especially in young myopic patients. Lens opacity may occur with prolonged use of pilocarpine.
PILOPINE HS® (pilocarpine hydrochloride ophthalmic gel) 4% 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.
PILOPINE HS® (pilocarpine hydrochloride ophthalmic gel) 4% is supplied as a 4% sterile aqueous gel in 4 gram tubes with ophthalmic tip.
4 gram: NDC 0065-0215-35
StorageStore at room temperature 2°-27°C (36° - 80° F). Avoid excessive heat. Do not freeze.
Rev: October 2007. ALCON LABORATORIES, INC. Fort Worth, Texas 76134, USA. FDA rev date: 04/17/08
FOR TOPICAL OPHTHALMIC USE ONLY.
PRECAUTIONS GeneralThe miosis usually causes difficulty in dark adaptation. Patient should be advised to exercise caution in night driving and other hazardous occupations in poor illumination.
Information For PatientsDo not touch tube tip to any surface, as this may contaminate the gel.
Carcinogenesis, Mutagenesis, Impairment of FertilityThere have been no long-term studies done using pilocarpine hydrochloride in animals to evaluate carcinogenic potential.
Pregnancy: Category C.Animal reproduction studies have not been conducted with pilocarpine hydrochloride. It is also not known whether pilocarpine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PILOPINE HS® (pilocarpine hydrochloride ophthalmic gel) should be given to a pregnant woman only if clearly needed.
Nursing MothersIt is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pilocarpine hydrochloride is administered to a nursing woman.
Pediatric UseSafety and effectiveness in pediatric patients have not been established.
Geriatric UseNo overall differences in safety or effectiveness have been observed between elderly and younger patients.
Apply a one-half inch ribbon in the lower conjunctival sac of the affected eye(s) once a day at bedtime.
The following adverse experiences associated with pilocarpine therapy have been reported: lacrimation, burning or discomfort, temporal or periorbital headache, ciliary spasm, conjunctival vascular congestion, superficial keratitis and induced myopia. Systemic reactions following topical administration are extremely rare, but occasional patients are peculiarly sensitive to develop sweating and gastrointestinal overactivity following suggested dosage and administration. Ocular reactions usually occur during initiation of therapy and often will not persist with continued therapy. Reduced visual acuity in poor illumination is frequently experienced in older individuals and in those with lens opacity. A subtle corneal granularity was observed in about 10% of patients treated with PILOPINE HS® (pilocarpine hydrochloride ophthalmic gel). Cases of retinal detachment have been reported during treatment with miotic agents; especially in young myopic patients. Lens opacity may occur with prolonged use of pilocarpine.
DRUG INTERACTIONSNo information provided.
