LODINE SR Tablet Ref.[9345] Active ingredients:

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Almirall, S.A., Ronda General Mitre 151, 08022, Barcelona, Spain

Therapeutic indications

Lodine (etodolac) is indicated for acute or long-term use in rheumatoid arthritis and osteoarthritis.

Posology and method of administration

Posology

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4)

Adults

One tablet daily. If a lower dose is sufficient, conventional Lodine capsules or tablets may be used.

The safety of doses in excess of 600mg per day has not been established.

No occurrence of tolerance or tachyphylaxis has been reported.

Elderly

No change in initial dosage is generally required in the elderly (see precautions).

The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Paediatric population

Not recommended.

Method of administration

For oral administration.

To be taken preferably with or after food. Swallow the tablet whole with a tumblerful of water.

Overdose

(a) Symptoms

Symptoms include headache, nausea, vomiting, epigastric pain, gastrointaestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.

(b) Therapeutic measure

Patients should be treated symptomatically as required.

Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of indigestion of a potentially life-threatening overdose.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Patients should be observed for at least four hours after ingestion of potentially toxic amounts.

Frequent or prolonged convulsions should be treated with intravenous diazepam.

Other measures may be indicated by the patient’s clinical condition.

The standard practices of gastric lavage, activated charcoal administration and general supportive therapy should be undertaken.

Shelf life

Shelf life: Lodine SR Tablets may be stored for up to 3 years.

Special precautions for storage

Store at room temperature, below 25°C.

Nature and contents of container

Vinyl Aclar or PVdC/PVC/Aluminium foil blister packs of 2, 28 or 30 tablets.

HDPE bottle with child resistant closures of 28 or 30 tablets.

Polypropylene securitainers with polyethylene caps of 28 or 30 tablets.

Special precautions for disposal and other handling

None.

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