Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Pilocarpine Hydrochloride Ophthalmic Solution USP, 1.25% is supplied as a sterile, clear, colorless solution filled in low density polyethylene white opaque bottle and low density polyethylene white opaque nozzle with, dark green colored high density polyethylene cap. It is available as follows: 2.5 mL in 5 mL Bottle (Filled to 1/2 Capacity): NDC 60219-2366-2 5 mL in 5 mL Bottle: NDC 60219-2649-1 Storage Store at 15° to 25°C (59° to 77°F). After opening, pilocarpine hydrochloride ophthalmic solution, USP can be used until the expiration date on the bottle.; PRINCIPAL DISPLAY PANEL NDC 60219-2366-2 Pilocarpine Hydrochloride Ophthalmic Solution USP, 1.25% (2.5 mL) Rx onl y Amneal Pharmaceuticals LLC NDC 60219-2649-1 Pilocarpine Hydrochloride Ophthalmic Solution USP, 1.25% (5 mL) Rx onl y Amneal Pharmaceuticals LLC 1 1 1 1
- 16 HOW SUPPLIED/STORAGE AND HANDLING Pilocarpine Hydrochloride Ophthalmic Solution USP, 1.25% is supplied as a sterile, clear, colorless solution filled in low density polyethylene white opaque bottle and low density polyethylene white opaque nozzle with, dark green colored high density polyethylene cap. It is available as follows: 2.5 mL in 5 mL Bottle (Filled to 1/2 Capacity): NDC 60219-2366-2 5 mL in 5 mL Bottle: NDC 60219-2649-1 Storage Store at 15° to 25°C (59° to 77°F). After opening, pilocarpine hydrochloride ophthalmic solution, USP can be used until the expiration date on the bottle.
- PRINCIPAL DISPLAY PANEL NDC 60219-2366-2 Pilocarpine Hydrochloride Ophthalmic Solution USP, 1.25% (2.5 mL) Rx onl y Amneal Pharmaceuticals LLC NDC 60219-2649-1 Pilocarpine Hydrochloride Ophthalmic Solution USP, 1.25% (5 mL) Rx onl y Amneal Pharmaceuticals LLC 1 1 1 1
Overview
Pilocarpine hydrochloride ophthalmic solution USP, 1.25% is a cholinergic muscarinic receptor agonist prepared as an isotonic, clear, colorless, sterile ophthalmic solution containing 1.25% of pilocarpine hydrochloride, USP. The chemical name for pilocarpine hydrochloride, USP is (3S,4R)-3-ethyl-4-[(1-methyl-1H-imidazol-5-yl)methyl]-oxolan-2-one hydrochloride. Its molecular weight is 244.72 g/mol and its molecular formula is C 11 H 16 N 2 O 2 · HCl. Its structural formula is: Pilocarpine hydrochloride, USP is a white or almost white, crystalline powder or colorless crystals hygroscopic. It is very soluble in water and freely soluble in alcohol, slightly soluble in chloroform and insoluble in ether. Each mL of Pilocarpine Hydrochloride Ophthalmic Solution, USP contains: Active: Pilocarpine hydrochloride USP, 1.25% (12.5 mg) equivalent to 1.06% (10.6 mg) pilocarpine free-base. Preservative: Benzalkonium chloride, 0.0075%. Inactives: Boric acid, sodium citrate dihydrate, sodium chloride, water for injection and may also include hydrochloric acid and/or sodium hydroxide for pH adjustment to between 3.5 and 5.5, if necessary. 1
Indications & 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
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 )
Warnings & Precautions
Blurred Vision : Patients should be advised not to drive or operate machinery if vision is not clear (e.g., blurred vision). Exercise caution in night driving and other hazardous activities in poor illumination. ( 5.1 ) Risk of Retinal Detachment : Rare cases of retinal detachment and retinal tear have been reported with miotics, including pilocarpine hydrochloride ophthalmic solution. Individuals with pre-existing retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashing lights, floaters or vision loss. ( 5.2 ) Iritis : Caution is advised in patients with iritis. ( 5.3 ) 5.1 Blurred Vision Miotics, including pilocarpine hydrochloride ophthalmic solution, may cause accommodative spasm. Patients should be advised not to drive or operate machinery if vision is not clear (e.g., blurred vision). In addition, patients may experience temporary dim or dark vision with miotics, including pilocarpine hydrochloride ophthalmic solution. Patients should be advised to exercise caution in night driving and other hazardous activities in poor illumination. 5.2 Risk of Retinal Detachment Rare cases of retinal detachment and retinal tear have been reported with miotics, including pilocarpine hydrochloride ophthalmic solution. Individuals with pre-existing retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to the initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashing lights, floaters or vision loss. 5.3 Iritis Pilocarpine hydrochloride ophthalmic solution is not recommended to be used when iritis is present because adhesions (synechiae) may form between the iris and the lens. 5.4 Use with Contact Lenses Contact lens wearers should be advised to remove their lenses prior to the instillation of pilocarpine hydrochloride ophthalmic solution and to wait 10 minutes after dosing before reinserting their contact lenses. 5.5 Potential for Eye Injury or Contamination To prevent eye injury or contamination, care should be taken to avoid touching the dispensing bottle to the eye or to any other surface.
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
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 Experience The following adverse reactions have been identified during post-approval use of pilocarpine hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to pilocarpine hydrochloride ophthalmic solution exposure. Eye disorders: vitreous detachment, vitreomacular traction, retinal tear, retinal detachment.
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