CLINDAMYCIN PHOSPHATE INJECTION 600MG/4ML

Indications:

Antibacterial. Serious infections caused by susceptible Gram-positive organisms, staphylococci (both penicillinase- and non-penicillinase-producing), streptococci (except Streptococcus faecalis) and pneumococci. It is also indicated for the treatment of severe infections caused by susceptible anaerobic pathogens such as Bacteroides spp, Fusobacterium spp, Propionibacterium spp, Peptostreptococcus spp. and microaerophilic streptococci.

Clindamycin does not penetrate the blood/brain barrier in therapeutically effective quantities.

Dosage and Administration:

Posology

Adults:

Serious infections: 600mg-1.2g/day in two, three or four equal doses.

More severe infections: 1.2-2.7g/day in two, three or four equal doses.

Single I.M. injections of greater than 600mg are not recommended nor is administration of more than 1.2g in a single one-hour infusion.

Elderly: The half-life, volume of distribution and clearance, and extent of absorption after administration of clindamycin phosphate are not altered by increased age. Analysis of data from clinical studies has not revealed any age-related increase in toxicity. Dosage requirements in elderly patients should not be influenced, therefore, by age alone. See Precautions for other factors which should be taken into consideration.

Paediatric population (over 1 month of age):

Serious infections: 15-25mg/kg/day in three or four equal doses.

More severe infections: 25-40mg/kg/day in three or four equal doses. In severe infections it is recommended that children be given no less than 300mg/day regardless of body weight.

Method of administration

Parenteral (IM or IV administration).

Clindamycin Solution for Injection and Infusion should be used undiluted for IM administration.

Clindamycin Solution for Injection and Infusion must be diluted prior to I.V. administration and should be infused over at least 10-60 minutes.

Precautions & Warning:

The use of Clindamycin Solution for Injection and Infusion may result in the overgrowth of non-susceptible organisms particularly yeasts.

Prolonged administration of Clindamycin Solution for Injection and Infusion, as with any anti-infective, may result in super-infection due to organisms resistant to clindamycin.

Care should be observed in the use of Clindamycin Solution for Injection and Infusion in atopic individuals.

Clindamycin phosphate should not be injected intravenously undiluted as a bolus, but should be infused over at least 10-60 minutes.

Contra-indications:

Hypersensitivity to the active substance or to any of the excipients.

Clindamycin Solution for Injection and Infusion is contra-indicated in patients previously found to be sensitive to lincomycin

Drug interactions:

Clindamycin administered by injection has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. It should be used with caution, therefore, in patients receiving such agents.

Vitamin K antagonists

Increased coagulation tests (PT/INR) and/or bleeding have been reported in patients treated with clindamycin in combination with a vitamin K antagonist (e.g. warfarin, acenocoumarol and fluindione).

Co-administration of clindamycin with inhibitors of CYP3A4 and CYP3A5

Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N desmethylclindamycin. Therefore inhibitors of CYP3A4 and CYP3A5 may reduce clindamycin clearance and inducers of these isoenzymes may increase clindamycin clearance.

Storage instructions:

Do not store above 25°C. Keep ampoules in the outer carton. Do not refrigerate or freeze. From a microbiological point of view, the product should be used immediately.