Indications
QLOSI is indicated for the treatment of presbyopia in adults. QLOSI is a cholinergic agonist indicated for the treatment of presbyopia in adults. ( 1 )
Contraindications
QLOSI is contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients. Hypersensitivity ( 4 )
Warnings and 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 )
5.1Blurred 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.
5.2Risk 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.
5.3Iritis
QLOSI is not recommended to be used when iritis is present because adhesions (synechiae) may form between the iris and the lens.
5.4Contact 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.
At a glance
- Brand name
- Qlosi
- Active substance
- pilocarpine hydrochloride
- Route
- Eye
- Dosage form
- Solution/drops
- Applicant
- Orasis Pharms
- Status
- Prescription
- FDA approval
- 17 Oct 2023
- Application
- NDA217836-001



