Clindamycin Injection 600 mg (Clindawel)

Clindamycin 150mg/ml, solution for injection

Each ml of solution contains clindamycin phosphate equivalent to 150 mg clindamycin.

For the full list of excipients, see section 6.1.

Solution for Injection.

Clear, colourless, sterile solution.

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 in serious 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.

Consideration should be given to official guidance on the appropriate use of antibacterial agents including national and local guidelines

Parenteral (IM or IV administration) – ‘see Method of administration’ below

Posology

Adults:

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

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

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

For more serious infections, these doses may have to be increased. In life-threatening situations, doses as high as 4.8 g daily have been given intravenously to adults.

Alternatively, the drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion.

Method of administration

Parenteral (intramuscular or intravenous administration).

Clindamycin injection should be used undiluted for intramuscular administration. Clindamycin injection must be diluted prior to intravenous administration and should be infused over at least 10 – 60 minutes.

Clindamycin Injection should only be used in the treatment of serious infections. In considering the use of the product, the practitioner should bear in mind the type of infection and the potential hazard of the diarrhoea which may develop, since cases of colitis have been reported during, or even two or three weeks following, the administration of clindamycin.

The disease is likely to follow a more severe course in older patients or patients who are debilitated. Diagnosis is usually made by the recognition of the clinical symptoms, but can be substantiated by endoscopic demonstration of pseudomembranous colitis.

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