DICLOXACILLIN ORION Capsule Ref.[8254] Active ingredients: Dicloxacillin

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Therapeutic indications

Infections caused by penicillinase-producing, methicillin-sensitive staphyloccoci, e.g. wound infections, abscesses, osteomyelitis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology and method of administration

Posology

Adults

500 mg to 1 g 3-4 times daily. In severe and serious infections the daily dose may be increased to a maximum of 6 grams.

Paediatric population

Children 20-40 kg

250 mg 3-4 times daily. In severe and serious infections the daily dose may be doubled.

Children (>40 kg)

500 mg 3-4 times daily. In severe and serious infections the daily dose may be increased to a maximum of 6 grams.

Experience with use in premature babies and neonates is limited and therefore no recommendation on a posology can be made in this age group. It is not recommended to use capsules in children under 20 kg.

Patients with renal impairment

Dose reduction may be necessary.

Method of administration

The capsules must be swallowed whole with at least half a glass of water and not in a supine position or immediately before bedtime. The dose must be taken at least 1 hour before or 2 hours following a meal to obtain maximum absorption.

Overdose

High doses of penicillin are generally well tolerated.

Possible toxic reactions include gastrointestinal symptoms, electrolyte disturbances, convulsions, impaired consciousness. Haemolytic reactions, renal failure, acidosis.

Gastric lavage can be considered. Otherwise symptomatic treatment. Dicloxacillin cannot be removed by dialysis.

Shelf life

2 years.

Special precautions for storage

Store below 30°C.

Store in the original package in order to protect from moisture.

Nature and contents of container

30, 50 or 100 capsules in HDPE plastic jar with PP closure.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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