TRIAX POWDER FOR INJECTION (I.M./I.V.) 1G + 10mL DILUENT

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THIS IS A PRESCRIPTION DRUG. The contents of this page are provided for information purposes only and should not be a substitute for a professional medical advice or for self-medication. Consult your physician or pharmacist before administration and read all labels prior to use.

TRIAX POWDER FOR INJECTION VIAL (I.M./I.V.)
Ceftriaxone Sodium .......... 1 g / mL

ANTIBACTERIAL |  1 VIAL PER BOX + 10 mL DILUENT

INDICATIONS:

Indicated for the following infections when known or thought likely to be due one or more susceptible microorganisms and when parenteral therapy is required:

• Meningitis
• Infections in neutropenic patients
• Gonorrhea
• Septicaemia
• Peri-operative prophylaxis of infections associated with surgery
• Bone, skin and soft tissue infections

Treatment may be started before the results of susceptible tests are known.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.

DOSAGE AND ADMIRATION:
Ceftriaxone is for parenteral use only and may be administered by deep intramuscular injection, slow intravenous injection, or as a slow intravenous infusion, after reconstitution of the solution. Follow reconstitution, a colourless solution is produced.

Dosage and method of admiration should be determined by the severity of the infection, susceptibility of the causative organism and the patient's condition. Usually a once daily dose will give satisfactory therapeutic results. In some indications (see below), a single dose is sufficient.

Adults and children over 12 years of age
Standard therapeutic dosage: 1g once a day
Severe infections: 2-4g daily, normally as a single dose every 24 hours.

The duration of therapy should be varied according to the course of the disease. As with antibiotic therapy in general, administration of ceftriaxone should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or as there is evidence of bacterial eradication.

Acute, uncomplicated gonorrhoea: A single dose of 250mg intramuscularly should be administered. Simultaneous administration of probenecid is not indicated.

Peri-operative prophylaxis: Usually 1 g as a single intramuscular or slow intravenous dose. In colorectal surgery, 2g should be given intramuscularly or by slow intravenous infusion, in conjunction with a suitable agent against anaerobic bacteria.

Elderly
As for adult dose, subject to normal hepatic and renal function.

Neonates, infants and children up to 12 years
The following dosage schedules are recommended for once daily administration:
Neonates
A daily dose of 20-50mg/kg body weight, not to exceed 50mg/kg. In the neonate, the intravenous dose should be given over 60 minutes to reduce the displacement of bilirubin form albumin, thereby reducing the potential risk of biliburin encephalopathy.
Infants and children of up to 12 years
Standard therapeutic dosage: 20-50mg/kg body weight once daily. In severe infections up to 80mg/kg body weight daily may be given. For children with bodyweights of 50kg or more, the useual adult dosage should be given.
Doses of 50mg/kg or over should be given by slow intravenous infusion over at least 30 minutes.
Doses greater than 80mg/kg body weight should be avoided except in meningitis.

Special dosage recommendations:
Meningitis:
Treatment is initiated with 100mg/kg bodyweight once daily - not exceeding 4g daily. After determining the sensitivity of the pathogen, the dose may be reduced accordingly. In new born infants 0-14 days of age the dose should not exceed 50mg/kg/24h.

Renal and hepatic impairment
In patients with impaired renal function, there is no need to reduced the dosage of ceftriaxone provided liver function is normal. Only in cases of pre-terminal renal failure (creatinine clearance < 10mL per minute) should the daily dosage be limited to 2g or less.

In patients with liver damage there is no need for the dosage to be reduced provided renal function is normal.

In severe renal impairment accompanied by hepatic insufficiency, the plasma concentration of ceftriaxone should be determined at regular intervals and dosage adjusted accordingly.

In patients undergoing dialysis, no additional supplementary dosing is required following the dialysis.

Serum concentrations should be monitored, however, to determine whether dosage adjustments are necessary, since the elimination rate these patients may be reduced.

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