A-BYOPIN EYE DROPS /5mL

(Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25%w/v)

THIS LEAFLET CONTAINS IMPORTANT PRODUCT USE AND SAFETY INFORMATION, PLEASE READ CAREFULLYAND RETAIN FOR FURTHER REFERENCE.

DESCRIPTION:

A-BYOPIN Eye Drops(Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v) is a cholinergic muscarinic receptor agonist prepared as an isotonic, colorless, sterile ophthalmic solution containing 1.25% of Pilocarpine Hydrochloride. The chemical name for pilocarpine hydrochloride is ( 3 S, 4 R)- 3 - ethyl-4 - [ ( 1 - methyl-1 H- imidazol- 5 - yl) methyl] oxolan- 2 - one hydrochloride. Its molecular weight is 244.72 and its molecular formula is C11H16N2O2 · HCl.

COMPOSITION:

Each ML Contains:

• Pilocarpine Hydrochloride USP                  12.5mg
• Benzalkonium Chloride Solution USP    0.0075% w/v
  (As Preservative)
• Sterile Aqueous Vehicle                                q.s.

INDICATION AND USAGE

A-BYOPIN Eye Drops (Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v) is indicated for the treatment of presbyopia in adults.

CLINICAL PHARMACOLOGY

Mechanism of Action
Pilocarpine Hydrochloride is a cholinergic muscarinic agonist which activates muscarinic receptors located at smooth muscles such as their is sphincter muscle and ciliary muscle. A-BYOPIN Eye Drops (Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v) contracts the iris sphincter muscle, constricting the pupil to improve near and intermediate visual acuity while maintaining some pupillary response to light. A-BYOPIN Eye Drops (Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v) also contracts the ciliary muscle and may shift the eye to a more myopic state.

Pharmacokinetics                                                                                  
Systemic exposure to pilocarpine was evaluated in 22 participants with presbyopia who were administered 1 drop of A-BYOPIN Eye Drops (Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25%w/v) in each eye once daily for 30 days. The mean Cmax and AUC0-t,ss values on Day 30 were 1.95 ng/mL and 4.14 ng·hr/mL, respectively. The median Tmax value on Day 30 was 0.3 hours post dose with a range from 0.2 to 0.5 hours post dose.

CONTRAINDICATIONS

A-BYOPIN Eye Drops(Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v) is contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients.

WARNINGS AND PRECAUTIONS

Poor Illumination Patients should be advised to exercise caution in night driving and other
hazardous occupations in poor illumination. In addition, miotics may cause accommodative spasm. Patients should be advised not to drive or use machinery if vision is not clear. Risk of Retinal Detachment: Rare cases of retinal detachment have been reported with other miotics when used insusceptible individuals and those with pre-existing retinal disease. Patients should be advised to seek immediate medical care with sudden onset of vision loss. Iritis: A-BYOPIN Eye Drops (Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25%w/v) is not recommended to be used when iritis is present because adhesions (synechiae) may form between the iris and the lens. Use with Contact Lenses: Contact lens wearers should be advised to remove their lenses prior to the instillation of A-BYOPIN Eye Drops (Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v) and to wait 10 minutes after dosing before reinserting their contact lenses. Potential for Eye Injury or Contamination: To prevent eye injury or contamination, care should be taken to avoid touching the dispensing bottle to the eye or to any other surface

ADVERSE REACTIONS

The following clinically significant adverse reactions are described else where in labeling:
‍Hypersensitivity
‍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.
The most common adverse reactions reported in >5% of patients were headache and conjunctival hyperemia. Ocular adverse reactions reported in 1-5% of patients were blurred vision, eye pain, visual impairment, eye irritation, and increased lacrimation.
Pediatric Use : Presbyopia does not occur in the pediatric population.
‍Geriatric Use : Clinical studies of A-BYOPIN Eye Drops (Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v) 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.

DOSAGE AND ADMINISTRATION

The recommended dosage of A-BYOPIN Eye Drops (Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v) is one drop in each eye once daily. If more than one topical ophthalmic product is being used, the products should be administered at least5 minutes apart.

STORAGE

Preserve in tight containers, Store below 30°C.
Do not allow to Freeze.

SHELF LIFE:

24 Months

HOW SUPPLIED:

A-BYOPIN Eye Drops / 5mL (Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v) is supplied in 5 mL sterile poly bottle.
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