QLOSI
Generic Name/API: pilocarpine hydrochloride ophthalmic solution
Manufacturer: Orasis Pharmaceuticals, Ltd.
Dosage Forms & Strength & Pack Size:
Ophthalmic solution: pilocarpine hydrochloride 0.4% (4 mg/mL) in a single-patient-use vial.
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.
QlosiTM is indicated for the treatment of presbyopia in adults.
CONTRAINDICATIONS
Hypersensitivity
WARNINGS AND PRECAUTIONS
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.
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.
QLOSI is not recommended to be used when iritis is present.
QLOSI should not be administered while wearing contact lenses. Remove lenses prior to the installation of QLOSI and wait 10 minutes before reinsertion.
Avoid touching the tip of the vial to the eye or any other surface.
ADVERSE REACTIONS
The most common adverse reactions (5% to 8%) are instillation site pain and headaches.
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