Pilocarpine Hydrochloride
Generic: PILOCARPINE HYDROCHLORIDE
Basic Information
Manufacturer
Sandoz Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
53fa0b7a-f982-48a7-92c4-6f098683c1ed
Indications & Usage
1 INDICATIONS AND USAGE Pilocarpine hydrochloride ophthalmic solution is indicated for the: 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 ) 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 .
( 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 ) 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 .
Adverse Reactions
6 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 .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described below reflect exposure in four controlled clinical trials of 90 days to 2 years duration in 317 patients diagnosed with open-angle glaucoma or ocular hypertension.
In the four clinical trials, patients were treated with pilocarpine hydrochloride ophthalmic solution 2%, two to four times daily or with pilocarpine 1%, 1.75%, or 2% in fixed combination with betaxolol 0.25%, two or three times daily.
The most frequently reported adverse reactions occurring in ≥ 5% of patients in the pilocarpine 2% populations were: headache/brow ache, accommodative change, blurred vision, eye irritation, visual impairment (dim, dark, or “jumping” vision), and eye pain.
The adverse reaction profile reported for the use of pilocarpine hydrochloride ophthalmic solution in pediatric patients is comparable to that seen in adult patients.
( 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 .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described below reflect exposure in four controlled clinical trials of 90 days to 2 years duration in 317 patients diagnosed with open-angle glaucoma or ocular hypertension.
In the four clinical trials, patients were treated with pilocarpine hydrochloride ophthalmic solution 2%, two to four times daily or with pilocarpine 1%, 1.75%, or 2% in fixed combination with betaxolol 0.25%, two or three times daily.
The most frequently reported adverse reactions occurring in ≥ 5% of patients in the pilocarpine 2% populations were: headache/brow ache, accommodative change, blurred vision, eye irritation, visual impairment (dim, dark, or “jumping” vision), and eye pain.
The adverse reaction profile reported for the use of pilocarpine hydrochloride ophthalmic solution in pediatric patients is comparable to that seen in adult patients.