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Generic Name
Hydrchloride
Brand Names
Qlosi, Salagen, VUITY
FDA approval date: October 14, 2005
Classification: Cholinergic Receptor Agonist
Form: Tablet, Solution
What is Qlosi (Hydrchloride)?
QLOSI is indicated for the treatment of presbyopia in adults. QLOSI is a cholinergic agonist indicated for the treatment of presbyopia in adults.
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Brand Information
Qlosi (Pilocarpine Hydrochloride)
1INDICATIONS AND USAGE
QLOSI is indicated for the treatment of presbyopia in adults.
2DOSAGE AND 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.
3DOSAGE FORMS AND STRENGTHS
QLOSI is a clear, colorless to slightly yellowish ophthalmic solution containing pilocarpine hydrochloride 0.4% (4 mg /mL) in a single-patient-use vial.
4CONTRAINDICATIONS
QLOSI is contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients.
5OVERDOSAGE
Systemic toxicity following topical ocular administration of pilocarpine is rare, but occasionally patients who are sensitive may develop sweating and gastrointestinal overactivity.
Accidental ingestion can produce sweating, salivation, nausea, tremors and slowing of the pulse and a decrease in blood pressure.
In moderate overdosage, spontaneous recovery is to be expected and is aided by intravenous fluids to compensate for dehydration. For patients demonstrating severe poisoning, atropine, the pharmacologic antagonist to pilocarpine, should be used.
6DESCRIPTION
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
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.
7CLINICAL STUDIES
The efficacy of QLOSI for the treatment of presbyopia was demonstrated in two Phase 3, randomized, double-masked, vehicle-controlled studies, namely NEAR-1 (NCT04599933) and NEAR-2 (NCT04599972). A total of 613 participants aged 45 to 64 years old with presbyopia were randomized (309 to QLOSI group) in these two studies. Participants were instructed to instill one drop of QLOSI or vehicle, in each eye, once in the morning and to repeat the instillation 2 to 3 hours later. Participants were treated for two weeks. Ophthalmic assessments were conducted on Day 1, 8 and 15 of the study at various timepoints.
Responders demonstrated improvement by achieving a gain from baseline of 3 lines or more in near BDCVA at 40 centimeters without a loss of 1 line or more (≥ 5 letters) in BDCVA at 4 meters. Overall, the percentages of responders were consistently higher in the QLOSI group than in the Vehicle group at each assessment day.
Figure 1 presents the percentage of responders for each time point at Day 15. (Standard analysis of pooled data NEAR-1 and NEAR-2)
Abbreviations: HRS: hours; min: minutes
This figure demonstrates the onset of the QLOSI effect on presbyopia, from 20 minutes post dose 1, and lasting up to 8 hours (i.e., 5 hours from the second dose).
8PRINCIPAL DISPLAY PANEL - 0.4 mL Vial Box
Qlosi
Sterile / Rx only
For topical application in the eye
6 pouches containing 5 single-
NDC 83661-018-30
