A-Tropin _{Eye Drops}

(Atropine Sulphate Ophthalmic Solution1% w/v)
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THIS LEAFLET CONTAINS IMPORTANT PRODUCT USE AND SAFETY INFORMATION, PLEASE READ CAREFULLY AND RETAIN FOR FURTHER FUTURE REFERENCE.

CHEMICAL NAME:

Benzeneacetic acid,ɑ-(hydroxymethyl),8-methyl-8-azabicyclo-(3.2.1) Oct-3-yl ester, endo-(+)-, Sulphate(2:1) (salt),monohydrate.

COMPOSITION:

Each ML Contains :

Atropine Sulphate IP 1.0 % w/v
Phenyl Mercuric
Nitrate IP            0.001%w/v
( As preservative)
Aqueous Buffered Vehicle q.s.

INDICATIONS AND USAGE

A-Tropin Eye Drops(Atropine Sulphate Ophthalmic Solution 1% w/v) is a cycloplegic and mydriatic agent indicated for uveitis and refraction.
Geriatrics (>65 years of age):
Elderly patients may be at a higher risk for undiagnosed glaucoma as well as atropine-induced psychotic reactions and behavioural disturbances
Pediatrics (<12 years of age):
A-Tropin Eye Drops(Atropine Sulphate Ophthalmic Solution 1% w/v) is contraindicated in pediatric patients<12 years of age because of the risk of serious systemic side effects.

CONTRAINDICATIONS

A-Tropin Eye Drops(Atropine Sulphate Ophthalmic Solution 1%w/v) is contraindicated in:
-  Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging sectionof the Prescribing Information.
-  Patients with known or suspected angle-closure glaucoma.
-  Children less than 12 years of age. 
-Children with Down’s syndrome, spastic paralysis or brain damage

WARNINGS AND PRECAUTIONS

General
FOR TOPICAL OPHTHALMIC USE ONLY.
A-Tropin Eye Drops (Atropine Sulphate Ophthalmic Solution 1% w/v) may provoke hyperthermia and should be used with caution in patients, especially children, who may be exposed to elevated environmental temperatures or who are febrile. Atropine may cause drowsiness, blurred vision and sensitivity to light. Patients receiving A-Tropin Eye Drops (Atropine Sulphate Ophthalmic Solution1% w/v) should be advised not to drive or use machinery until their vision clears. Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal ingredients administered via the ocular route and result in a decrease in systemic adverse reactions.

Ophthalmologic
A-Tropin Eye Drops (Atropine Sulphate Ophthalmic Solution 1% w/v) may cause increased intraocular pressure (IOP) and provoke glaucoma attacks inpatients predisposed to acute angle closure. The possibility of undiagnosed glaucoma should be considered in some patients, in particular geriatric patients. To avoid glaucoma attacks, IOP and an estimation of the depth of the angle of the anterior chamber should be determined prior to initiation of therapy.

Special Populations
‍Pregnant Women: There are no or limited amount of data from the use of A-Tropin Eye Drops (Atropine Sulphate Ophthalmic Solution 1%w/v) in pregnant women. There are documented systemic effects stemming from ophthalmic atropine use. A-Tropin Eye Drops (Atropine Sulphate Ophthalmic Solution1% w/v) should only be used to treat pregnant women when the benefit to the mother outweighs the potential risk to the fetus.
‍Pediatrics (<12 years of age): A-Tropin Eye Drops (Atropine Sulphate Ophthalmic Solution1% w/v) is contraindicated in pediatric patients< 12 years of age.
‍Pediatrics (≥ 12 years of age): Children, especially premature and low birth weight, or patients with Down syndrome, spastic paralysis or brain damage are particularly susceptible to central nervous system disturbances, cardiopulmonary and gastrointestinal toxicity from systemic absorption of atropine. A-Tropin Eye Drops (Atropine Sulphate Ophthalmic Solution1% w/v) should be used with extreme caution, if at all, in children ≥ 12 years of age with Down syndrome, spastic paralysis or brain damage.
Geriatrics (> 65 years of age): Elderly patients may be at a higher risk of undiagnosed glaucoma as well as atropine-induced psychotic reactions and behavioural disturbances.

ADVERSE REACTIONS

Adverse Drug Reaction Overview
A-Tropin Eye Drops (Atropine Sulphate Ophthalmic Solution1% w/v) produces reactions similarto those of other anticholinergic drugs. Central nervous system manifestations, such as ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people are possible. Other toxic manifestations of anticholinergic drugs are skin rash, abdominal distension in infants, unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility, and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe reactions are manifested by hypotension with rapid progressive respiratory depression. Symptoms of toxicity are usually transient (lasting a few hours), but may last up to 24 hours. Prolonged use of mydriatics may produce local irritation characterized by conjunctivitis (follicular), ocular hyperemia, eye edema, eye discharge and eczema.

DOSAGE AND ADMINISTRATION

Recommended Dose
For uveitis: Apply one drop in the eye(s) three times daily.
For cycloplegic refraction: Apply one drop in the eye(s) three times daily for three days. Repeat 1 hour prior to examination.
Missed Dose
In the case of a missed dose, the patient should be advised to take the dose as soon as they remember. However, if it is close to the next scheduled dose, the missed dose should be skipped. A double dose should not be taken to make up for the missed dose.
Administration
A-Tropin Eye Drops (Atropine Sulphate Ophthalmic Solution 1% w/v)
Prescribing Information
 Nasolacrimal occlusion or gently closing the eyelid after administration is recommended to reduce systemic absorption of A-Tropin Eye Drops (Atropine Sulphate Ophthalmic Solution1% w/v)

STORAGE:

Store in dry place, at a temperature not exceeding 25°C. Do not allow to Freeze.

SHELF LIFE:

24 Months.

HOW SUPPLIED:

A-Tropin Eye Drops (Atropine Sulphate Ophthalmic Solution 1% w/v) is supplied in 5 mL poly bottles.
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