Qlosi滴眼液的详细说明书：作用与功效,用法用量,副作用,注意事项等

Qlosi eye drops are a cholinergic agonist that was approved for marketing by the US FDA in October 2023.

Indications of Qlosi eye drops

It is suitable for the treatment of presbyopia in adults.

Qlosi eye drops usage and dosage

1. Specific usage

Put one drop of Qlosi eye drops into each eye. To achieve effects lasting up to 8 hours, repeat eye drops for a second time 2-3 hours later.

2. Frequency of medication

It can be used daily or as needed, up to twice a day.

3. Interval administration

If multiple topical ophthalmic drugs are used at the same time, there must be an interval of at least 5 minutes between administration of different drugs.

Single-dose vials should be discarded after use.

4. Dosage forms and specifications

Qlosi eye drops are a clear, colorless to slightly yellow ophthalmic solution containing 0.4% (4 mg/ml) pilocarpine hydrochloride, packaged in single-dose vials.

5. Drug overdose

Systemic toxic reactions after topical use of pilocarpine in the eyes are rare, but sensitive patients may occasionally experience sweating and gastrointestinal hyperfunction.

Accidental ingestion can cause sweating, salivation, nausea, tremors, slowed pulse and decreased blood pressure.

For moderate overdose, spontaneous recovery is expected and may be assisted by intravenous fluids to correct dehydration. Atropine, the pharmacological antagonist of pilocarpine, should be used in patients exhibiting severe intoxication.

The pictures come from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Contraindications of Qlosi Eye Drops

Qlosi Eye Drops are contraindicated in patients with known allergies to the active ingredient or any excipients.

Precautions for Qlosi Eye Drops

1. Blurred vision

Qlosi Eye Drops may cause accommodation spasm. Advise patients not to drive or operate machinery if their vision is unclear (eg, blurred vision).

In addition, patients may experience temporary dimming or darkening of vision when using Qlosi eye drops. Patients are advised to be cautious when driving at night and engaging in other hazardous activities in poorly lit environments.

2. Risk of retinal detachment

Rare cases of retinal detachment have been reported when using miotic agents in susceptible individuals and patients with existing retinal diseases. A retinal examination is recommended for all patients before starting treatment. Inform patients to seek immediate medical attention if they suddenly experience flashes of light, floaters, or vision loss.

3. Iritis

When iritis is present, it is not recommended to use Qlosi eye drops because synechiae between the iris and the lens (posterior iris synechiae) may form.

4. Contact lens wear

Contact lens wearers should be informed to remove the lenses before instilling Qlosi eye drops and wait 10 minutes after administration before wearing them again.

5. Risk of eye damage or contamination

To prevent eye damage or contamination, avoid allowing the tip of the single-dose vial to come into contact with the eyes or any other surface.

Adverse reactions of Qlosi eye drops

The most commonly reported treatment-related adverse events (incidence 5%-8%) are infusion site pain and headache. An ocular adverse reaction occurring in 2%-5% of patients is blurred vision. Most adverse events were mild, transient, and resolved spontaneously.

Qlosi Eye Drops Medication for Special Populations

1. Pregnancy

There are currently no adequate and well-controlled studies on the use of Qlosi Eye Drops in pregnant women to inform drug-related risks. Oral pilocarpine was administered to pregnant rats during the organogenesis and lactation periods, and no adverse effects occurred at clinically relevant doses.

2. Lactation period

There are no data on the presence of pilocarpine in human milk, the effects on breastfed infants, or the effects on lactation to inform the risk of Qlosi eye drops to nursing infants. Following a single oral administration, pilocarpine and/or its metabolites are excreted in the milk of lactating rats.

Systemic exposure to pilocarpine after topical ocular administration is low, and it is unknown whether measurable levels of pilocarpine will be present in breast milk following ocular use of Qlosi eye drops.

The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for Qlosi Eye Drops and any potential adverse effects of Qlosi Eye Drops on the breastfed child.

3. Pediatric use

Presbyopia is an age-related disease that does not occur in the pediatric population.

4. Geriatric use

Clinical studies of Qlosi eye drops did not include subjects aged 65 and above to determine whether their responses were different from younger subjects. Other reports of clinical experience with pilocarpine ophthalmic solution found no differences in overall safety in older patients compared with younger patients. Safety and effectiveness in patients over 65 years of age have not been established.

Mechanism of action of Qlosi eye drops

Pilocarpine hydrochloride is a cholinergic muscarinic receptor agonist that activates muscarinic receptors located on smooth muscles (such as iris sphincter and ciliary muscle). Qlosi eye drops contract the iris sphincter, narrowing the pupil to enhance depth of field and improve near vision, while maintaining a certain pupillary response to light.

Qlosi Eye Drops Pharmacokinetics

The systemic absorption of pilocarpine after administration of QLOSI (twice per eye daily, 2 hours apart, for 8 days) was evaluated in 12 healthy subjects. The overall median Tmax in plasma after dosing on day 8 was 2.20 hours, and the average overall plasma Cmax and AUC0-t after dosing on day 8 were 897.2pg/mL and 2699hr*pg/mL, respectively. The average T1/2 after dosing on day 8 was 3.96 hours.

Qlosi Eye Drops Packaging

Qlosi Eye Drops is a sterile, transparent, colorless to slightly yellow, slightly viscous ophthalmic solution. The packaging specification is 5 single-dose vials per pack, each with a capacity of 0.4 ml. Each single-dose vial is made of clear low-density polyethylene.

Five single-dose vials are packaged in an aluminum foil pouch.

The supply specifications of Qlosi eye drops are as follows:

NDC83661-018-10: carton packaging, containing 10 single-dose vials (2 bags, 5 bottles each).

NDC83661-018-20: Carton packaging, containing 20 single-dose vials (4 bags of 5 each).

NDC83661-018-30: Carton packaging, containing 30 single-dose vials (6 bags of 5 each).

NDC83661-018-60: Carton packaging, containing 60 single-dose vials (12 bags of 5 each).

Qlosi Eye Drops Storage

Qlosi Eye Drops should be stored refrigerated at 36°F to 46°F (2°C to 8°C). Once the foil pouch is opened, the single-dose vial may be stored at room temperature [up to 77°F (25°C)] and used within 30 days. Store unused product away from light and discard opened vials after use.

Warm reminder

1. Patients are advised to be cautious when driving at night and performing dangerous activities in poorly lit environments.

2. Blurred vision may temporarily cause difficulty in switching focus between near objects and distant objects. Patients are advised not to drive or use machinery if their vision is unclear.

3. When to consult a doctor Advise patients to seek medical attention immediately if they suddenly experience flashes of light, floaters, or vision loss.

4. Wearing contact lenses It is recommended that patients take off their contact lenses before instilling Qlosi eye drops. Wait 10 minutes before putting your lenses back on.

5. Risk of Eye Damage or Contamination Patients are advised to avoid contacting the tip of the single-dose vial with the eye or any other surface to prevent eye damage or contamination.

6. Combined topical eye treatment recommends that if patients use multiple topical eye medications at the same time, there must be at least a 5-minute interval between administration of different medications.