DEXAMETHASONE KALCEKS SOLUTION FOR INJECTION/INFUSION 4 MG/ML

INFUSION, SOLUTION

**4.2 Posology and method of administration** **Dosage** Dosage of dexamethasone sodium phosphate is usually expressed in terms of dexamethasone phosphate. Dosage requirements are variable and must be individualised on the basis of the disease being treated and patient response. **Intravenous (IV) and intramuscular administration** Intravenous or intramuscular dosage usually ranges from 0.5 to 24 mg of dexamethasone phosphate daily. The duration of therapy is dependent on the clinical response of the patient and as soon as improvement is indicated, the dosage should be adjusted to the minimum required to maintain the desired clinical response. Withdrawal of the drug on completion of therapy should be gradual. Parenteral dexamethasone is generally reserved for patients who are unable to take the drug orally, or for use in an emergency situation. _Shock (of haemorrhagic, traumatic or surgical origin)_ The usual dose for the treatment of shock is 2 to 6 mg/kg bodyweight as a single intravenous injection. This may be repeated in 2 to 6 hours if shock persists. An alternative regimen of 20 mg by intravenous injection initially, followed by continuous intravenous infusion of 3 mg/kg bodyweight per 24 hours, has been suggested. If required for intravenous infusion, dexamethasone phosphate may be diluted with glucose or sodium chloride injection. High dose therapy should be continued only until the patient’s condition has stabilised and usually for no longer than 48 to 72 hours. To avoid microbial contamination hazards, infusion should be commenced as soon as practicable after preparation of the mixture and if storage is necessary, store solution at 2 to 8°C. Infusion should be completed within 24 hours of preparation of the solution and any residue discarded. **WARNING**: Further diluted solutions which are not clear, or which show evidence of particulate matter contamination, should be discarded. _Cerebral oedema_ The treatment schedule and route of administration should reflect the severity and aetiology of the cerebral oedema. Treatment needs to be tailored to the individual response. An initial dose of 10 mg intravenously followed by 4 mg intramuscularly every 6 hours until the symptoms of oedema subside (usually after 12 to 24 hours). After 2 to 4 days the dosage should be reduced and gradually stopped over a period of 5 to 7 days. Patients with cerebral malignancy may require maintenance therapy with doses of 2 mg intramuscularly or intravenously 2 to 3 times daily. High doses of dexamethasone may be used to initiate short-term intensive therapy for acute cerebral oedema. Following an initial high loading dose, the dose is scaled down over the 7- to 10-day period of intensive therapy, and subsequently reduced to zero over the next 7 to 10 days. High dose schedule  NOTE: The intravenous and intramuscular routes of administration of dexamethasone should only be used where acute illness or life-threatening situations exist. Oral therapy should be substituted as soon as possible. **Intra-synovial & soft tissue injections** Dosage varies with the degree of inflammation and the size and location of the affected area. Injections may be repeated from once every 3 to 5 days (e.g. for bursae) to once every 2 to 3 weeks (for joints). Frequent intra-articular injection may result in damage to joint tissues. Site of InjectionDosageLarge Joints2 mg to 4 mgSmall Joints800 micrograms to 1 mgBursae2 mg to 3 mgTendon Sheaths400 micrograms to 1 mgSoft Tissue Infiltration2 mg to 6 mgGanglia1 mg to 2 mg **Method of administration** Dexamethasone may be administered intravenously or intramuscularly for systemic effect, or as an intra-synovial or soft tissue injection for local effect. Contains no antimicrobial agent. For single patient use. Use once only and discard any residue.