Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/ STORAGE AND HANDLING 16.1 How Supplied QLOSI is supplied as a sterile, clear, colorless to slightly yellowish and slightly viscous ophthalmic solution in configurations of 5 single-patient-use vials of 0.4 mL fill. Each single-patient-use vial is comprised of transparent low-density polyethylene (LDPE). 5 single-patient-use vials are packaged in a foil pouch. QLOSI is supplied in: NDC 83661-018-10: carton box of 10 single-patient-use vials (2 pouches containing 5 vials) NDC 83661-018-20: carton box of 20 single-patient-use vials (4 pouches containing 5 vials) NDC 83661-018-30: carton box of 30 single-patient-use vials (6 pouches containing 5 vials) NDC 83661-018-60: carton box of 60 single-patient-use vials (12 pouches containing 5 vials) 16.2 Storage Store refrigerated at 36°F to 46°F (2°C to 8°C). Once a pouch is open, the single-patient-use vials may be stored at room temperature [up to 77°F (25°C)] and used within 30 days. Store unused product away from light. Discard opened vials after use.; PRINCIPAL DISPLAY PANEL - 0.4 mL Vial Box Qlosi ™ (pilocarpine HCl ophthalmic solution) 0.4% Sterile / Rx only For topical application in the eye 6 pouches containing 5 single- patient-use vials (0.4 mL each) NDC 83661-018-30 Principal Display Panel qlosi-04
- 16 HOW SUPPLIED/ STORAGE AND HANDLING 16.1 How Supplied QLOSI is supplied as a sterile, clear, colorless to slightly yellowish and slightly viscous ophthalmic solution in configurations of 5 single-patient-use vials of 0.4 mL fill. Each single-patient-use vial is comprised of transparent low-density polyethylene (LDPE). 5 single-patient-use vials are packaged in a foil pouch. QLOSI is supplied in: NDC 83661-018-10: carton box of 10 single-patient-use vials (2 pouches containing 5 vials) NDC 83661-018-20: carton box of 20 single-patient-use vials (4 pouches containing 5 vials) NDC 83661-018-30: carton box of 30 single-patient-use vials (6 pouches containing 5 vials) NDC 83661-018-60: carton box of 60 single-patient-use vials (12 pouches containing 5 vials) 16.2 Storage Store refrigerated at 36°F to 46°F (2°C to 8°C). Once a pouch is open, the single-patient-use vials may be stored at room temperature [up to 77°F (25°C)] and used within 30 days. Store unused product away from light. Discard opened vials after use.
- PRINCIPAL DISPLAY PANEL - 0.4 mL Vial Box Qlosi ™ (pilocarpine HCl ophthalmic solution) 0.4% Sterile / Rx only For topical application in the eye 6 pouches containing 5 single- patient-use vials (0.4 mL each) NDC 83661-018-30 Principal Display Panel qlosi-04
Overview
QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% is a sterile, clear, colorless to slightly yellowish and slightly viscous ophthalmic solution for topical ophthalmic use which has a pH between 5.1-6.1. The structural formula of pilocarpine hydrochloride is: The chemical name for pilocarpine hydrochloride is: 2(3 H )-Furanone, 3-ethyldihydro-4-[(1-methyl-1 H -imidazol-5-yl)- methyl]-monohydrochloride, (3 S -cis). Its molecular weight is 244.72 g/mol and its molecular formula is C 11 H 16 N 2 O 2 ∙ HCl. Each mL contains 0.4% (4 mg) of pilocarpine hydrochloride as the active ingredient, equivalent to 0.3% (3.4 mg) of pilocarpine free-base. The inactive ingredients in QLOSI are: hypromellose, sodium chloride, sodium hyaluronate, edetate disodium dihydrate, water for injection, and may also include sodium hydroxide and/or hydrochloric acid for pH adjustment. QLOSI does not contain an anti-microbial preservative. Chemical Structure
Indications & Usage
QLOSI is indicated for the treatment of presbyopia in adults. QLOSI is a cholinergic agonist indicated for the treatment of presbyopia in adults. ( 1 )
Dosage & Administration
Instill one drop of QLOSI in each eye. This can be repeated a second time after 2 to 3 hours for an effect up to 8 hours. QLOSI can be administered on a daily basis, or as needed, up to twice each day. If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. Discard single-patient-use vial after use. Instill one drop of QLOSI in each eye. This can be repeated a second time after 2 to 3 hours for an effect up to 8 hours. QLOSI can be administered on a daily basis, or as needed, up to twice each day. ( 2 )
Warnings & Precautions
Blurred Vision : Advise patients to not drive or operate machinery if vision is not clear (e.g., blurred vision). Exercise caution in night driving and other hazardous occupations in poor illumination. ( 5.1 ) Risk of Retinal Detachment : Rare cases of retinal detachment have been reported with miotics. Examination of the retina is advised in all patients prior to initiation of therapy. Advise patients to seek immediate medical care with sudden onset of flashes of lights, floaters, or vision loss. ( 5.2 ) Iritis : Caution is advised in patients with iritis. ( 5.3 ) 5.1 Blurred Vision Miotics, including QLOSI, may cause accommodative spasm. Advise patients to not 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 QLOSI. Advise patients to exercise caution in night driving and other hazardous activities in poor illumination. 5.2 Risk of Retinal Detachment Rare cases of retinal detachment have been reported with miotics when used in susceptible individuals and those with pre-existing retinal disease. Examination of the retina is advised in all patients prior to the initiation of therapy. Advise patients to seek immediate medical care with sudden onset of flashes of lights, floaters, or vision loss. 5.3 Iritis QLOSI is not recommended to be used when iritis is present because adhesions (synechiae) may form between the iris and the lens. 5.4 Contact Lens Wear Contact lens wearers should be advised to remove their lenses prior to the instillation of QLOSI 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, avoid touching the tip of the single-patient-use vial to the eye or to any other surface.
Contraindications
QLOSI is contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients. Hypersensitivity ( 4 )
Adverse Reactions
Most common adverse reactions (5% to 8%) are instillation site pain and headaches. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Orasis Pharmaceuticals Inc. at 1-866-ORASIS1 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. QLOSI was evaluated in 309 patients with presbyopia in two randomized, double-masked, vehicle-controlled studies (NEAR-1 and NEAR-2) of 15 days duration. The most commonly reported treatment-related adverse events in 5-8% of patients were instillation site pain, and headache. Ocular adverse reaction reported in 2-5% of patients was blurred vision. The majority of the adverse events were mild, transient and self-resolving.
Storage & Handling
16.2 Storage Store refrigerated at 36°F to 46°F (2°C to 8°C). Once a pouch is open, the single-patient-use vials may be stored at room temperature [up to 77°F (25°C)] and used within 30 days. Store unused product away from light. Discard opened vials after use.
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