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Pilocarpine
PILOPINE HS® (pilocarpine hydrochloride ophthalmic gel) 4% is a sterile topical ophthalmic aqueous gel which contains more than 90% water and employs CARBOPOL 940, a synthetic high molecular weight cross-linked polymer of acrylic acid, to impart a high viscosity. The active ingredient, Pilocarpine Hydrochloride, is a cholinergic. Established name: Pilocarpine Hydrochloride Chemical name: 2(3H)-Furanone,3-ethyldihydro-4-[(1-methyl-iH-imidazol-5-yl)-methyl]-, monohydrochloride, (3S-cis)-. Each Gram Contains: Active: Pilocarpine Hydrochloride 4% (40 mg). Preservative: Benzalkonium Chloride 0.008%. Inactive: Carbopol 940, Edetate Disodium, Hydrochloric
Acid and/or Sodium Hydroxide (to adjust pH) and Purified Water.
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
meshwork spaces to facilitate outflow of aqueous
humor. Outflow resistance
is thereby reduced, lowering intraocular pressure.
Pilocarpine Hydrochloride 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.
Apply a one-half inch ribbon in the lower conjunctival sac of the affected eye(s) once a day at bedtime. HOW SUPPLIED PILOPINE HS Gel is supplied as a 4% sterile aqueous gel in 4 gram tubes with ophthalmic tip. 4 gram: NDC 0065-0215-35 STORAGE: Store at room temperature 2°-27° C (36°-80° F). Avoid excessive heat. Do not freeze. CAUTION: Federal (USA) law
prohibits dispensing without prescription.
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 p.o.
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 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.
For topical use only.
General The miosis usually causes difficulty in dark adaptation. Patient should be advised to exercise caution in night driving and other hazardous occupations in p.o. illumination. Carcinogenesis, Mutagenesis, Impairment of Fertility There have been no long-term studies done using Pilocarpine Hydrochloride in animals to evaluate carcinogenic potential. Pregnancy 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® Gel 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 Pilocarpine Hydrochloride is administered to a nursing woman. Pediatric Use Safety and effectiveness
in pediatric patients
have not been established.
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