Qlosi
Pilocarpine Hydrochloride · Solution · Ophthalmic
Uses
1 INDICATIONS AND 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 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. 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 )
Dosage forms and strengths
3 DOSAGE 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. Ophthalmic solution: pilocarpine hydrochloride 0.4% (4 mg/mL) in a single-patient-use vial. ( 3 )
Contraindications
4 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 ) 5.1 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.
Side effects
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.
Use in specific populations
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of QLOSI administration in pregnant women to inform a drug associated risk. Oral administration of pilocarpine to pregnant rats throughout organogenesis and lactation did not produce adverse effects at clinically relevant doses. Data Animal Data In embryofetal development studies, oral administration of pilocarpine to pregnant rats throughout organogenesis produced maternal toxicity, skeletal anomalies and reduction in fetal body weight at 90 mg/kg/day (approximately 1200-fold higher than the maximum recommended human ophthalmic dose [MRHOD] of 0.012mg/kg/day, on a mg/m 2 basis). In peri-/postnatal study in rats, oral administration of pilocarpine during late gestation through lactation increased stillbirths at a dose of 36 mg/kg/day (approximately 475-fold higher than the MRHOD of 0.012mg/kg/day, on a mg/m 2 basis). Decreased neonatal survival and reduced mean body weight of pups were observed at ≥18mg/kg/day (approximately 240-fold higher than the MRHOD of 0.012mg/kg/day, on a mg/m 2 basis). 8.2 Lactation Risk Summary There are no data on the presence of pilocarpine in human milk, the effects on breastfed infants, or the effects on milk production to inform the risk of QLOSI to an infant during lactation. Pilocarpine and/or its metabolites are excreted in the milk of lactating rats following single oral administration. Systemic levels of pilocarpine following topical ocular administration are low [see Clinical Pharmacology (12.3) ], and it is not known whether measurable levels of pilocarpine would be present in maternal milk following ocular administration of QLOSI. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for QLOSI and any potential adverse effects on the breastfed child from QLOSI. Data Animal Data Following a single oral administration of 14 C-pilocarpine to lactating rats, the radioactivity concentrations in milk were similar to those in plasma. Peak concentrations were observed at 0.5 h, with both milk and plasma levels declining at similar rates, but still detectable at 24 h. 8.4 Pediatric Use Presbyopia is an age-related condition which does not appear in the pediatric population. 8.5 Geriatric Use Clinical studies of QLOSI did not include subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience with ophthalmic pilocarpine solutions have not identified overall differences in safety between elderly and younger patients. Safety and effectiveness have not been established in patients over the age of 65.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of QLOSI administration in pregnant women to inform a drug associated risk. Oral administration of pilocarpine to pregnant rats throughout organogenesis and lactation did not produce adverse effects at clinically relevant doses. Data Animal Data In embryofetal development studies, oral administration of pilocarpine to pregnant rats throughout organogenesis produced maternal toxicity, skeletal anomalies and reduction in fetal body weight at 90 mg/kg/day (approximately 1200-fold higher than the maximum recommended human ophthalmic dose [MRHOD] of 0.012mg/kg/day, on a mg/m 2 basis). In peri-/postnatal study in rats, oral administration of pilocarpine during late gestation through lactation increased stillbirths at a dose of 36 mg/kg/day (approximately 475-fold higher than the MRHOD of 0.012mg/kg/day, on a mg/m 2 basis). Decreased neonatal survival and reduced mean body weight of pups were observed at ≥18mg/kg/day (approximately 240-fold higher than the MRHOD of 0.012mg/kg/day, on a mg/m 2 basis).
Pediatric use
8.4 Pediatric Use Presbyopia is an age-related condition which does not appear in the pediatric population.
Geriatric use
8.5 Geriatric Use Clinical studies of QLOSI did not include subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience with ophthalmic pilocarpine solutions have not identified overall differences in safety between elderly and younger patients. Safety and effectiveness have not been established in patients over the age of 65.
Overdosage
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.
Description
(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
Mechanism of action
12.1 Mechanism of Action Pilocarpine hydrochloride is a cholinergic muscarinic agonist which activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle. QLOSI contracts the iris sphincter muscle, constricting the pupil to enhance the depth of focus and improve near visual acuity while maintaining some pupillary response to light.
How supplied
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.
Storage
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.
Patient information
Night Driving QLOSI may cause temporary dim or dark vision. Advise patients to exercise caution with night driving and when hazardous activities are undertaken in poor illumination. Blurred Vision Temporary problems when changing focus between near objects and distant objects may occur. Advise patients to not drive or use machinery if vision is not clear. When to Seek Physician Advice Advise patients to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss [see Warnings and Precautions (5.2) ]. Contact Lens Wear Advise patients to remove contact lenses prior to the instillation of QLOSI. Wait 10 minutes after dosing before reinserting contact lenses. Potential for Eye Injury or Contamination Advise patients to avoid touching the tip of the single-patient-use vial to the eye or to any other surface, in order to prevent eye injury or contamination. Concomitant Topical Ocular Therapy Advise patients if more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. Storage Information 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.
Label text from the FDA structured product label by Orasis Pharmaceuticals, Inc. (revised May 30, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Pilocarpine Hydrochloride in 1 product
Qlosi NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 83661-018 | Pilocarpine Hydrochloride 4 mg/mL Solution | Orasis Pharmaceuticals, Inc. | NDA |
Frequently asked questions
What is Qlosi used for?
1 INDICATIONS AND 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 )
What are the side effects of Qlosi?
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… See the full label for the complete list.
Who makes Qlosi?
Qlosi is listed by 1 labeler in the FDA NDC directory, including Orasis Pharmaceuticals, Inc..