MYOPED PLUS _{Eye Drops}

(Atropine Sulphate Ophthalmic Solution USP 0.05% w/v)

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

DESCRIPTION:

Myoped-PlusEye Drops (Atropine Sulfate Ophthalmic Solution USP 0.05% w/v) is a sterile topical Ophthalmic solution. The active ingredient is represented by the Chemical Name is Benzeneacetic acid,ɑ-(hydroxymethyl), 8-methyl-8-azabicyclo- (3.2.1) Oct-3-ylester, endo-(+)-, Sulfate(2:1) (salt), monohydrate and chemical structural formula:

COMPOSITION:

Each ML Contains:

• Atropine Sulfate USP                                0.05%w/v
• Polyhexamethylene Biguanide                0.05mg
  (As Preservative)
• aqueous buffered vehicle                            q.s.

INDICATION AND USAGE

Myoped Plus Eye Drops (Atropine Sulphate Ophthalmic Solution USP 0.01% w/v) is indicated to control the progression of myopia in children of 5 years and above.

CLINICAL PHARMACOLOGY

Myoped-Plus Eye Drops (Atropine Sulphate Ophthalmic Solution USP 0.01% w/v) is a competitive antagonist of the parasympathetic (and sympathetic) acetylcholine muscarinic receptors.

Mechanism of Action
The broad-band muscarinic antagonist, atropine, is believed to have a therapeutic effect in reducing the progression of axial myopia in humans via a non-accommodative mechanism. However, its exact mechanism of action has not been determined.

Pharmacodynamic properties
Randomized, double-masked trial extended from the Low-Concentration Atropine for Myopia Progression (LAMP) Study, American Optometric Association - Researchers evaluated three hundred eighty-three of 438 children (87%) aged 4 to 12 years with myopia of at least -1.0 diopter (D)originally randomized to receive atropine 0.05%, 0.025%, 0.01%, or placebo once daily in both eyes in the LAMP phase 1 study were continued in this extended trial (phase 2).
Children in the placebo group (phase 1) were switched to receive 0.05%atropine from the beginning of the second-year follow-up, whereas those in the 0.05%, 0.025%,and 0.01% atropine groups continued with the same regimen. Cycloplegic refraction, axial length (AL), accommodation amplitude, photopic and mesopic pupil diameter, and best- corrected visual acuity were measured at 4-month intervals. Changes in spherical equivalent (SE) and AL and their differences between groups. Over the 2-yearperiod, the mean SE progression was 0.55±0.86 D, 0.85±0.73 D, and 1.12±0.85 D in the 0.05%, 0.025%,and 0.01% atropine groups, respectively (P = 0.015, P< 0.001, and P = 0.02, respectively, for pair wise comparisons), with mean AL changes over 2 years of 0.39±0.35 mm, 0.50±0.33 mm, and 0.59±0.38mm (P = 0.04, P < 0.001, and P = 0.10, respectively). Compared with the first year, the second-year efficacy of 0.05% and 0.025% atropine remained similar (P >0.1), but improved mildly in the 0.01% atropine group (P = 0.04). For the phase 1 placebo group, the myopia progression was reduced significantly after switching to0.05% atropine (SE change, 0.18 D in second year vs. 0.82 D in first year [P < 0.001]; AL elongated 0.15 mm in second year vs. 0.43 mm in first year [P < 0.001]). Accommodation loss and change in pupil size in all concentrations remained similar to the first-year results and were well tolerated. Visual acuity and vision-related quality of life remained unaffected. Over 2 years, the efficacy of 0.05% atropine observed was double that observed with 0.01% atropine, and it remained the optimal concentration among the studied atropine concentrations in slowing myopia progression.

Pharmacokinetic properties
The broad-band muscarinic antagonist, atropine, is believed to have a therapeutic effect in reducing the progression of axial myopia in humans via a non-accommodative mechanism. In a study of healthy subjects, after topical ocular administration of 30 μl of atropine sulfate ophthalmic solution, 1%, the mean (± SD)systemic bioavailability of l- hyoscyamine was reported to be approximately 64 ± 29% (range 19% to 95%) as compared to intravenous administration of atropine Sulfate. The mean (± SD) time to maximum plasma concentration (Tmax) was approximately 28 ± 27 minutes (range 3 to 60 minutes), and the mean (±SD) peak plasma concentration (Cmax) of l-hyoscyaminewas 288 ± 73 pg/ml. The mean (±SD) plasma half-life was reported to be approximately2.5 ± 0.8 hours.In a separate study of patients undergoing ocular surgery, after topical ocular administration of 40 μl of atropine sulphfate ophthalmic solution, 1%, the mean (± SD) plasma Cmax of l-hyoscyamine was 860 ± 402 pg/ml.

CONTRAINDICATIONS

Myoped Eye Drops (Atropine Sulphate Ophthalmic Solution USP 0.01% w/v) is contraindicated in:
• patients with glaucoma or narrow angle glaucoma
.• patients with history of hypersensitivity to atropine or any of the inactive ingredients in this formulation.

WARNING

Overdose and allergy to any of ingredients may cause systemic toxicity in children. Blurred vision may occur after use. Due to low pH which is necessary to stabilize atropine, the drop may cause mild burning.
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Keep out of reach of children.
Not for use in children with down’s syndrome.

ADVERSE REACTIONS

Due to single administration and low expected systemic passage of atropine, overdose is not expected. However, a risk of overdose cannot be excluded. Symptoms of systemic atropine toxicity include flushing of the face, dry skin (red rash may occur in children), blurred vision, accelerated or irregular heartbeat, fever, abdominal distention, constipation, delirium, uncoordinated nerves and muscles, trance and long-term mydriasis in the elderly. In case of overdose, rinse with water or 0.9%normal saline water. In case of accidental ingestion (if swallowed), it may cause vomiting orgastric lavage. Systemic support measures and intravenous injection of physostigmine should be used, if necessary.

DOSAGE AND ADMINISTRATION

Instill one drop daily to each affected eye(s)at night or as directed by the Physician.

STORAGE

Preserve in tight containers, and store at controlled room temperature. Do not allow to Freeze. 

SHELF LIFE:

24 Months

HOW SUPPLIED:

Myoped Eye Drops (Atropine Sulphate Ophthalmic Solution USP 0.01% w/v) is supplied in 5 mL clear poly bottles.
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