MAXIDEX Eye drops, suspension Ref.[2732] Active ingredients: Dexamethasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom

Therapeutic indications

Indicated for treatment of steroid responsive inflammatory conditions of the conjunctiva, cornea and anterior segment of the eye, such as, anterior uveitis, iritis, cyclitis, allergic and vernal conjunctivitis, herpes zoster keratitis, superficial punctate keratitis and non-specific superficial keratitis.

Also indicated for the treatment of corneal injury from chemical, radiation or thermal burns or following penetration by foreign bodies. Indicated for post-operative use to reduce inflammatory reactions and suppress graft reaction.

Posology and method of administration

Adults, adolescents, and children (2 years of age and above)

The frequency of instillation of drops and the duration of treatment will vary depending upon the severity of the underlying condition and the response to treatment.

Severe inflammations require one to two drops instilled into the eye every thirty to sixty minutes until a satisfactory response occurs.

Subconjunctival or systemic steroid therapy should be considered if there is no response. When a favourable response has been observed reduce the dosage towards one drop every four hours.

Method of Administration

For ocular use only.

Shake the bottle well before use.

After cap is removed, if tamper evident snap collar is loose, remove before using product.

Do not let the tip of the dropper touch the eye.

Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.

Paediatric patients

The safety and efficacy of this product has not been established in children below 2 years of age.

Hepatic and renal impairment

The safety and efficacy of MAXIDEX in patients with hepatic or renal impairment have not been established.

Overdose

Long-term intensive topical use may lead to systemic effects. Oral ingestion of the contents of the bottle (up to 10 mls) is unlikely to lead to any serious adverse effects.

An ocular overdose of Maxidex can be flushed from the eye(s) with lukewarm water.

Shelf life

20 months (unopened), 1 month (after first opening).

Special precautions for storage

Do not store above 25°C.

Do not refrigerate or freeze.

Keep container tightly closed.

Discard 1 month after first opening.

Store in the original package.

Nature and contents of container

Drop-Tainer – 5ml and 10ml Natural Low Density Polyethylene Bottles and Plugs.

Polystyrene or Polypropylene cap.

Special precautions for disposal and other handling

Do not touch dropper tip to any surface as this may contaminate the contents.

If the drop of medication is not retained in the eye upon dosing for any reason then instill another drop.

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