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Eyediten Eye Drop

Al-Tinez Visions Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Email: altinezvisions@gmail.com
Tel: 01-7418609, 08296588658, 0708900917

Brand Name

Eyediten Eye Drop

Manufacturer

Hanbul Pharm. Co., Ltd. #40-8, Banjwe-Ri, Wongok-Myeon, Anseong-Si, Gyeonggi-Do, Korea.

Therapeutic Class

Anti-allergics and decongestants, Eye

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Eye drops (NRN A4-5412): Ketotifen fumarate 0.69 mg, Chlorobutanol 3 mg per mL.

How to identify the product: Colourless to pale yellow solution in a semitransparent container.

Pack size: 5 mL/ 1 bottle/ carton box

eyediten

Pharmacology

Ketotifen is a histamine H1-receptor antagonist. It inhibits the release of mediators (such as histamines, prostaglandins, leukotrienes) from cells involved in type 1 or immediate allergic reactions.

Alongside the classical pharmacology of antihistamines, studies suggest the additional activities of mast cell stabilisation and inhibition of infiltration, activation and degranulation of eosinophils.

The antihistaminic effect of ketotifen has a rapid onset following instillation into the eye and persists for 8-12 hours.

Indications

Allergic conjunctivitis.

Contra-indications

In patients with a history of hypersensitivity to ketotifen or to any of the excipients.

Precautions/Warnings

May cause blurred vision; do not drive or operate machinery until you can see clearly. Sedation and drowsiness may occur rarely. Care should therefore be exercised when driving a vehicle, operating machinery.

If you wear soft contact lenses, wait at least 15 minutes after instilling the drops before inserting your contact lenses.

Pregnancy and Nursing mothers:

Animal studies have revealed no evidence of harm to the fetus due to ketotifen ophthalmic solution. There are, however, no adequate and well-controlled studies in human. It should therefore be used with caution during pregnancy, and only if the benefits to the mother outweigh any risks to the foetus.

Interactions

1) The use of oral dosage forms of ketotifen fumarate may potentially enhance the effects of CNS depressant antihistamines, and alcohol.

2) A reversible fall in the thrombocyte count in patients receiving ketotifen concomitantly with oral diet drug has been observed. However no significant drug interactions have been reported using any other eye drop.

[PREGANACNY and NURSING MOTHERS]

Animal studies have revealed no evidence of harm to the fetus due to ketotifen ophthalmic solution. There are, however, no adequate and well-controlled studies in human. It should therefore be used with caution during pregnancy and only if the benefits to the mother outweigh any risks to the fetus.

[OVERDOSAGE]

Overdosage highly unlikely since swallowing even a whole bottle of this medicine would give you only a fraction of the amount considered toxic. Equivalent to ketotifen fumarae of a 5 mL bottle is remarkable Iower than recommended oral daily dose.

Adverse Effects

While using this medicine, temporary eye burning may occur occasionally.

There have been rare reports of local irritations such as eye redness, edema, itching.

If inflammation of the lining of the eye and dermatitis of the eyelids occur, the administration should be discontinued.

Dosage & Administration

Adult: Put one (1) drop into each eye 2 to 4 times a day. Instil appropriately depending on severity.

Infants and children: Follow your doctor's prescription.

Note: This medicine should be discarded four (4) weeks after opening.

Storage/Handling Recommendations

Store in a tight container at ordinary temperature (15-25oC).

This medicine should be discarded four weeks after opening.

[SHELF LIFE] 2 years from manufacturing date.

Review Date

2016-05-11 04:04:21