Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING VUITY is supplied as an isotonic, clear, colorless sterile ophthalmic solution in colorless low density polyethylene (LDPE) ophthalmic dispenser bottles and tips, with dark green high impact polystyrene caps as follows: 2.5 mL fill in 5 mL bottle (Box containing 1 bottle) NDC 0074-7098-01 2.5 mL fill in 5 mL bottle (Box containing 3 bottles) NDC 0074-7098-03 2.5 mL fill in 5 mL bottle (Carton containing 1 bottle) NDC 0074-7098-04 5 mL fill in 5 mL bottle (Carton) NDC 0074-7098-06 Storage Store at 15°C to 25°C (59°F to 77°F). After opening, VUITY can be used until the expiration date on the bottle.; PRINCIPAL DISPLAY PANEL NDC 0074-7098-01 Vuity ™ (pilocarpine HCI ophthalmic solution) 1.25% Contains one 2.5 mL bottle Rx Only Sterile For topical application in the eye 1 x 2.5 mL Allergan ™ An AbbVie company PRINCIPAL DISPLAY PANEL NDC 0074-7098-01 Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Contains one 2.5 mL bottle Rx Only Sterile For topical application in the eye 1 x 2.5 mL Allergan™ An AbbVie company PRINCIPAL DISPLAY PANEL NDC 0074-7098-01 Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Contains one 2.5 mL bottle Rx Only Sterile For topical application in the eye 1 x 2.5 mL Allergan™ An AbbVie company; PRINCIPAL DISPLAY PANEL NDC 0074-7098-03 Vuity ™ (pilocarpine HCI ophthalmic solution) 1.25% Contains three 2.5 mL bottles Rx Only Sterile For topical application in the eye 3 x 2.5 mL Allergan ™ An AbbVie company NDC 0074-7098-03 Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Contains three 2.5 mL bottles Rx Only Sterile For topical application in the eye 3 x 2.5 mL Allergan™ An AbbVie company; PRINCIPAL DISPLAY PANEL NDC 0074-7098-04 Vuity ™ (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 2.5 mL For Topical Application in the Eye Allergan ™ An AbbVie company PRINCIPAL DISPLAY PANEL NDC 0074-7098-04 Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 2.5 mL For Topical Application in the Eye Allergan™ An AbbVie company; PRINCIPAL DISPLAY PANEL NDC 0074-7098-05 Professional Sample Not for Resale Vuity ™ (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 1.5 mL For Topical Application in the Eye Allergan ™ An AbbVie company PRINCIPAL DISPLAY PANEL NDC 0074-7098-05 Professional Sample Not for Resale Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 1.5 mL For Topical Application in the Eye Allergan™ An AbbVie company; PRINCIPAL DISPLAY PANEL NDC: 0074-7098-06 Vuity ® (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 5 mL For Topical Application in the Eye Allergan ™ An AbbVie company PRINCIPAL DISPLAY PANEL NDC: 0074-7098-06 Vuity® (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 5 mL For Topical Application in the Eye Allergan™ An AbbVie company
- 16 HOW SUPPLIED/STORAGE AND HANDLING VUITY is supplied as an isotonic, clear, colorless sterile ophthalmic solution in colorless low density polyethylene (LDPE) ophthalmic dispenser bottles and tips, with dark green high impact polystyrene caps as follows: 2.5 mL fill in 5 mL bottle (Box containing 1 bottle) NDC 0074-7098-01 2.5 mL fill in 5 mL bottle (Box containing 3 bottles) NDC 0074-7098-03 2.5 mL fill in 5 mL bottle (Carton containing 1 bottle) NDC 0074-7098-04 5 mL fill in 5 mL bottle (Carton) NDC 0074-7098-06 Storage Store at 15°C to 25°C (59°F to 77°F). After opening, VUITY can be used until the expiration date on the bottle.
- PRINCIPAL DISPLAY PANEL NDC 0074-7098-01 Vuity ™ (pilocarpine HCI ophthalmic solution) 1.25% Contains one 2.5 mL bottle Rx Only Sterile For topical application in the eye 1 x 2.5 mL Allergan ™ An AbbVie company PRINCIPAL DISPLAY PANEL NDC 0074-7098-01 Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Contains one 2.5 mL bottle Rx Only Sterile For topical application in the eye 1 x 2.5 mL Allergan™ An AbbVie company PRINCIPAL DISPLAY PANEL NDC 0074-7098-01 Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Contains one 2.5 mL bottle Rx Only Sterile For topical application in the eye 1 x 2.5 mL Allergan™ An AbbVie company
- PRINCIPAL DISPLAY PANEL NDC 0074-7098-03 Vuity ™ (pilocarpine HCI ophthalmic solution) 1.25% Contains three 2.5 mL bottles Rx Only Sterile For topical application in the eye 3 x 2.5 mL Allergan ™ An AbbVie company NDC 0074-7098-03 Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Contains three 2.5 mL bottles Rx Only Sterile For topical application in the eye 3 x 2.5 mL Allergan™ An AbbVie company
- PRINCIPAL DISPLAY PANEL NDC 0074-7098-04 Vuity ™ (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 2.5 mL For Topical Application in the Eye Allergan ™ An AbbVie company PRINCIPAL DISPLAY PANEL NDC 0074-7098-04 Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 2.5 mL For Topical Application in the Eye Allergan™ An AbbVie company
- PRINCIPAL DISPLAY PANEL NDC 0074-7098-05 Professional Sample Not for Resale Vuity ™ (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 1.5 mL For Topical Application in the Eye Allergan ™ An AbbVie company PRINCIPAL DISPLAY PANEL NDC 0074-7098-05 Professional Sample Not for Resale Vuity™ (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 1.5 mL For Topical Application in the Eye Allergan™ An AbbVie company
- PRINCIPAL DISPLAY PANEL NDC: 0074-7098-06 Vuity ® (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 5 mL For Topical Application in the Eye Allergan ™ An AbbVie company PRINCIPAL DISPLAY PANEL NDC: 0074-7098-06 Vuity® (pilocarpine HCI ophthalmic solution) 1.25% Rx Only Sterile 5 mL For Topical Application in the Eye Allergan™ An AbbVie company
Overview
VUITY (pilocarpine hydrochloride ophthalmic solution) 1.25% is a cholinergic muscarinic receptor agonist prepared as an isotonic, clear, colorless, sterile ophthalmic solution containing 1.25% of pilocarpine hydrochloride. The chemical name for pilocarpine hydrochloride is (3S,4R)-3-ethyl-4-[(1-methyl-1H-imidazol-5-yl)methyl]oxolan-2-one hydrochloride. Its molecular weight is 244.72 and its molecular formula is C 11 H 16 N 2 O 2 · HCl. Its structural formula is: Each mL of VUITY contains pilocarpine hydrochloride 1.25% (12.5 mg) as the active ingredient, equivalent to 1.06% (10.6 mg) pilocarpine free-base. Preservative is: benzalkonium chloride 0.0075%. Inactive ingredients in the ophthalmic solution are: boric acid, sodium citrate dihydrate, sodium chloride, purified water, and may also include hydrochloric acid and/or sodium hydroxide for pH adjustment to between 3.5 and 5.5, if necessary. structural formula
Indications & Usage
VUITY ® is indicated for the treatment of presbyopia in adults. VUITY is a cholinergic muscarinic receptor agonist indicated for the treatment of presbyopia in adults. ( 1 )
Dosage & Administration
The recommended dosage of VUITY is one drop in each eye once daily. A second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart. Instill one drop of VUITY in each eye once daily. A second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose. ( 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 D etachment : Rare cases of retinal detachment and retinal tear have been reported with miotics, including VUITY. 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 VUITY, 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 VUITY. Patients should be advised to exercise caution in night driving and other hazardous activities in poor illumination. 5. 2 Risk of Retinal D etachment Rare cases of retinal detachment and retinal tear have been reported with miotics, including VUITY. 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 VUITY 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 VUITY 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
VUITY 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 Allergan at 1-800-678-1605 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. VUITY 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 1-5% of participants were blurred vision, eye pain, visual impairment, eye irritation, and increased lacrimation. VUITY was also evaluated in 114 participants with presbyopia in a randomized, double-masked, vehicle-controlled 14-day study (VIRGO) in which participants received two doses of VUITY in each eye, 6 hours apart daily. The most common adverse reactions reported in >5 % of participants were headache and eye irritation. Ocular adverse reactions reported in 1-5% of participants were visual impairment, eye pain, blurred vision, and vitreous floaters. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of VUITY. 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 VUITY exposure. Eye disorders : vitreous detachment, vitreomacular traction, retinal tear, retinal detachment.
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