Drugplain

Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mL

Pilocarpine Hydrochloride · SOLUTION/ DROPS · Amneal Pharmaceuticals NY LLC

4 Recalls on RecordCurrently in Shortage
Plain English

Pilocarpine Hydrochloride Ophthalmic is a solution/ drops containing pilocarpine hydrochloride at 12.5 mg/mL, taken ophthalmic. Manufactured by Amneal Pharmaceuticals NY LLC.

Key Facts

Brand Name
Pilocarpine Hydrochloride Ophthalmic
Generic Name
Pilocarpine Hydrochloride
NDC Code (Product)
60219-2366
Manufacturer
Amneal Pharmaceuticals NY LLC
Strength
12.5 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
ANDA217733
Marketing Start
05/01/2025

Recall History

4 Recalls on Record
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated
Class III03/22/2017

Novartis Pharmaceuticals Corp.

Failed Impurities/Degradation Specifications.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective124 reports
fatigue90 reports
pain90 reports
headache86 reports
eye pain84 reports
dyspnoea82 reports
diarrhoea71 reports
dizziness71 reports
nausea68 reports
fall67 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Pilocarpine hydrochloride ophthalmic solution is indicated for the treatment of presbyopia in adults. Pilocarpine hydrochloride is a cholinergic muscarinic receptor agonist indicated for the treatment of presbyopia in adults. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended dosage of pilocarpine hydrochloride ophthalmic solution is one drop in each eye once daily. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart. Instill one drop of pilocarpine hydrochloride ophthalmic solution 1.25% in each eye once daily. ( 2 )

Contraindications

4 CONTRAINDICATIONS Pilocarpine hydrochloride ophthalmic solution is contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients. Hypersensitivity. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity [see Contraindications ( 4) ] Most common adverse reactions (> 5%) are headache, conjunctival hyperemia and eye irritation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 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. Pilocarpine hydrochloride ophthalmic solution dosed once daily was evaluated in 375 participants with presbyopia in two randomized, double-masked, vehicle-controlled studies (GEMINI 1 and GEMINI 2) of 30 days duration. The most common adverse reactions reported in > 5% of participants were headache and conjunctival hyperemia. Ocular adverse reactions reported in 1% to 5% of participants were blurred vision, eye pain, visual impairment, eye irritation and increased lacrimation. 6.2 Post-marketing E…

Frequently Asked Questions

What is Pilocarpine Hydrochloride Ophthalmic used for?

Pilocarpine Hydrochloride Ophthalmic contains Pilocarpine Hydrochloride. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Pilocarpine Hydrochloride Ophthalmic a controlled substance?

Pilocarpine Hydrochloride Ophthalmic is not classified as a controlled substance by the DEA.

What is the generic name for Pilocarpine Hydrochloride Ophthalmic?

The generic name for Pilocarpine Hydrochloride Ophthalmic is Pilocarpine Hydrochloride. There are 10 other brand versions of Pilocarpine Hydrochloride.

What is the NDC code for Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mL?

The NDC (National Drug Code) for Pilocarpine Hydrochloride Ophthalmic 12.5 mg/mL is 60219-2366, listed by Amneal Pharmaceuticals NY LLC.

Product NDC

60219-2366

Package NDC

60219-2366-2

Other Pilocarpine Hydrochloride Ophthalmic Dosages

Other Pilocarpine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)