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:

Amneal Pharmaceuticals NY LLC

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 USP, 1% , 2% and 4% is supplied sterile in natural low density polyethylene plastic bottles and natural low density polyethylene tips with dark green high density polyethylene caps. It is available as follows: 1%: 15 mL in 15 mL Container:                            NDC 69238-1745-8 2%: 15 mL in 15 mL Container:                            NDC 69238-1746-8 4%: 15 mL in 15 mL Container:                            NDC 69238-1747-8 STORAGE: Store at 15º to 25°C (59º to 77°F) and protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PILOCARPINE HYDROCHLORIDE- PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS
AMNEAL PHARMACEUTICALS NY LLC
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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:
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)
DOSAGE AND ADMINISTRATION
Instill one drop in the eye(s) up to four times daily. (2)
DOSAGE FORMS AND STRENGTHS
Solution containing 1% (10 mg/mL), 2% (20 mg/mL) or 4% (40 mg/mL)
pilocarpine hydrochloride. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Poor illumination: Exercise caution in night driving and other
hazardous occupations in poor illumination.
(5.1)
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.
(5.2)
Iritis: Caution is advised in patients with iritis. (5.3)
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. (5.4)
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 AMNEAL PHARMACEUTICALS
AT 1-877-835-
5472 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH_._
_ _
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2022
FULL