LOTEMAX Eye-drops, suspension Ref.[9454] Active ingredients: Loteprednol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Bausch & Lomb GmbH, Brunsbรผtteler Damm 165-173, 13581, Berlin, Germany

Therapeutic indications

Treatment of post-operative inflammation following ocular surgery.

Posology and method of administration

Posology

Adults and elderly

One to two drops four times daily beginning 24 hours after surgery and continuing throughout the post-operative period.

The duration of treatment should not exceed 2 weeks.

Paediatric Population

Lotemax should not be used in the paediatric age group until further data become available.

Method of administration

Ocular use.

Shake the bottle vigorously before using the eye drops.

This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. The bottle should be closed immediately after use.

Overdose

No case of overdose has been reported. Acute overdosage is unlikely to occur via the ophthalmic route.

Shelf life

Shelf life:

  • 2,5 mL: 15 months (unopened).
  • 5 mL, 10 mL: 2 years (unopened).

Discard any unused contents 28 days after first opening the bottle.

Special precautions for storage

Do not store above 25ยฐC. Do not freeze.

Store the container in an upright position.

Nature and contents of container

Lotemax is available in the following packaging configurations:

2.5 mL and 5 mL supplied in a white low density polyethylene bottle (7.5 mL) with a white control drop tip and a pink polypropylene cap.

10 mL supplied in a white low density polyethylene bottle (10 mL) with a white control drop tip and a pink polypropylene cap.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Store the container in an upright position.

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