PILOCARPINE HYDROCHLORIDE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Pilocarpine Hydrochloride (UNII: 0WW6D218XJ) (Pilocarpine - UNII:01MI4Q9DI3)

Available from:

Sandoz Inc

INN (International Name):

Pilocarpine Hydrochloride

Composition:

Pilocarpine Hydrochloride 10 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pilocarpine hydrochloride ophthalmic solution is indicated for the: . . . . None. 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. Pilocarpine hydrochloride ophthalmic solution should be given to a pregnant woman only if clearly needed. 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 ophthalmic solution is administered to a nursing woman. Safety and effectiveness of pilocarpine hydrochloride ophthalmic solution in pediatric patients have been established. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Product summary:

Pilocarpine hydrochloride ophthalmic solution 1%, 2%, and 4% is supplied sterile in natural low density polyethylene plastic ophthalmic dispensers and green low density polyethylene tips with green polypropylene caps.   15 mL in 15 mL bottles 1%: NDC 61314-203-15 2%: NDC 61314-204-15 4%: NDC 61314-206-15  STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PILOCARPINE HYDROCHLORIDE
OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR PILOCARPINE
HYDROCHLORIDE OPHTHALMIC SOLUTION.
PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION
INITIAL U.S. APPROVAL: 1974
INDICATIONS AND USAGE
Pilocarpine hydrochloride ophthalmic solution is a muscarinic
cholinergic agonist indicated for:
•
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•
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DOSAGE AND ADMINISTRATION
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions are headache/browache, accommodative
change, eye irritation, eye pain, blurred vision,
and/or visual impairment. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Reduction of Elevated Intraocular Pressure (IOP) in Patients With
Open-Angle Glaucoma or
Ocular Hypertension
1.2 Management of Acute Angle-Closure Glaucoma
1.3 Prevention of Postoperative Elevated IOP Associated With Laser
Surgery
1.4 Induction of Miosis
The reduction of elevated intraocular pressure (IOP) in patients with
open-angle glaucoma or ocular hypertension.
(1.1)
The management of acute angle-closure glaucoma. (1.2)
The prevention of postoperative elevated IOP associated with laser
surgery. (1.3)
The induction of miosis. (1.4)
Instill one drop in the eye(s) up to four times daily. (2)
Solution containing 1% (10 mg/mL), 2% (20 mg/mL) or 4% (40 mg/mL)
pilocarpine hydrochloride. (3)
Poor Illumination: Exercise caution in night driving and other
hazardous occupations in poor illumination. (5.1)
Preexisting Retinal Disease: Rare cases of retinal detachment have
been reported; a thorough examination of the
retina, includi