Contradiction:

Bysipin ophthalmic solution is contraindicated in patients with glaucoma or narrow angle glaucoma. Also patients with the history of hypersensitivity to atropine or any of the inactive ingredients in this formulation.

Special Warnings & Precaution of Use:

For External Use Only Not for Injection.

Overdose and allergy to any of the ingredients may cause systemic toxicity in children. Blurred vision may occur after use. Due to low Ph which is necessary to stabilize the atropine, the drop may cause mild burning.

Drug Interactions:

The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended, because of the potential to precipitate hypertensive crisis.

Use in Special Population:

Atropine Sulphate Ophthalmic solution USP 0.01% w/v is indicated for children. It is contraindicated in patients in glaucoma or narrow angle glaucoma.

Effect on Ability to Drive and Use Machines:

Blurred vision many occur after the use of atropine sulphate ophthalmic solution USP 0.01% w/v. Patients should avoid driving a vehicle.

Undesirable Effects:

During use photophobia and lack of adequate vision may occur. There have been reports of eyelid allergic reaction, local irritation, hyperaemia, swelling, follicular conjunctivitis or dermatitis.

Overdose:

Use to single administration and low expected systemic passage of atropine, overdose is not expected. However, a risk of overdose cannot be excluded. Systemic of systemic atropine toxicity include flushing of face, dry skin (red rash may occur in children), blurred vision, accelerated or 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 or gastric lavage. Systemic support measures and intravenous injection of physostigmine should be used, if necessary.

Pharmacological Properties:

Atropine sulphate is a competitive antagonist of the parasympathetic (and sympathetic) acetylcholine muscarinic receptors.

Pharmacodynamic Properties:

In a single-centre, double masked, randomised study (ATOM 2 Study) in Singapore.

The lowest concentration of 0.01% atropine thus seemed to retain efficacy and is a viable concentration for reducing myopia progression in children, while attaining a clinically significant improved safety profile in terms of accommodation, pupil size and near visual acuity and subsequently reduced adverse impact on visual function. Moreover, the 0.01% formulation exhibited fewer adverse events.

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.

Pharmacology Descriptions:

The chemical name of atropine sulphate is (RS)-(1R,3r,5S)-3-tropoyloxytropanium sulphate monohydrate. Each ml contains atropine sulphate IP 0.1 mg. Bysipin ophthalmic solution is sterile, isotonic, buffered aqueous solution of atropine sulphate for topical administration.

Mechanism of Action:

A broad band muscarinic antagonist, atropine, is believed to have a therapeutic effect in reducing the progression of axial myopia in humans by a non-accommodative mechanism, however, its exact mechanism of actions is not being determined.

Precautions:

• Advice the patients to take the medicine only as prescribed.
• Advice the patients to report any side effects.
• Advice the patients to avoid driving a vehicle, since blurred vision may occur after use.
• Do not swallow the eye drop solution.
• Close the bottle immediately after the use.
• Do not use after the expiry date marked on the product.
• Do not use the bottle if the tamper proof seal on the bottle neck is broken before your first use.
• Avoid contamination, do not touch the bottle tip to any surface and avoid direct contact with the eye.
• Do not use the if allergic to any of its ingredients.
• Retain the carton with the bottle for future reference.
• Allow 5 minutes between the admiration of other ophthalmic products.

Storage: Store in a cool & dry place. Protect from light.

Presentation: Bysipin ophthalmic solution is available in a pack of 5ml/sterile bottle.