







Resight
DESCRIPTION
ResightTM is a cholinergic agonist
prepared as a sterile Ophthalmic Solution, containing 2% of Pilocarpine
Hydrochloride. Pilocarpine Hydrochloride 2% is a miotic agent for topical
administration to the eyes.
COMPOSITION
Each mL of ResightTM contains Pilocarpine
Hydrochloride USP 20 mg as the active ingredient.
Preservative: Benzalkonium Chloride 0.01%.
CLINICAL PHARMACOLOGY
Pilocarpine Hydrochloride directly stimulates cholinergic
receptors, it produces contraction of the iris sphincter muscle, resulting in
pupillary constriction (miosis). Constriction of the ciliary muscle, resulting
in increased accommodation; and reduction in intraocular pressure associated
with an increase in the outflow and a decrease in the inflow of aqueous humor.
INDICATIONS
ResightTM Ophthalmic Solution is indicated
for the reduction of elevated intraocular pressure (IOP) in patients with
open-angle glaucoma or ocular hypertension, management of acute angle-closure
glaucoma.
DOSAGE & ADMINISTRATION
Instill 1 drop 2-4 times daily. To minimize systemic
absorption of the active ingredient of the eye drops, pressure should be
applied for one minute on the tear duct after application.
CONTRAINDICATIONS
None.
ADVERSE REACTION
Most common adverse reactions are headache/browache, eye
irritation, eye pain, blurred vision, and/or visual impairment.
PRECAUTION
• Poor illumination: Exercise caution in night driving and
other hazardous occupations in poor illumination.
• Pre-existing retinal disease: Rare cases of retinal
detachment have been reported; a thorough examination of the retina including
funduscopy is advised in all patients prior to the initiation of therapy.
• Iritis: Caution is advised in patients with iritis.
• Congenital glaucoma: Caution is advised in pediatric
patients with primary congenital glaucoma for control of IOP as cases of a
paradoxical increase in IOP have been reported.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C: Animal reproduction studies have not
been conducted with pilocarpine hydrochloride. ResightTM 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.
Caution should be exercised when ResightTM is administered to
a nursing woman.
Pediatric Use
Safety and effectiveness of pilocarpine hydrochloride
ophthalmic solution in pediatric patients have been established.
Geriatric Use
No overall differences in safety or effectiveness have been
observed between elderly and younger patients.
OVERDOSAGE
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 patients demonstrating severe
poisoning, atropine, the pharmacologic antagonist to pilocarpine, should be
used.
PHARMACEUTICAL PRECAUTION
Store below 25 °C temperature. Keep away from light and wet
place. Keep out of reach of children. To prevent contamination of the dropper
tip and solution, care should be taken. Don't touch the eyelids, surrounding
areas, finger or other surfaces with the dropper tip of the bottle. The bottle
should be tightly closed when not in use. Do not use after 4 weeks of first
opening.
PACKAGING
ResightTM Ophthalmic Solution: LDPE
dropper bottle containing 10 mL sterile ophthalmic solution. Each mL contains
Pilocarpine Hydrochloride USP 20 mg.