CLINDAMYCIN

Parenteral (IM or IV administration) – ‘see Method of administration’ below. 2 g/day in two, three or four equal doses. 7 g/day in two, three or four equal doses. 2 g in a single one-hour infusion. For more serious infections, these doses may have to be increased.

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. Treatment for infections caused by beta-haemolytic streptococci should be continued for at least 10 days to guard against subsequent rheumatic fever or glomerulonephritis.

Paediatric population (over 1 month in age):

Serious infections: 15-25 mg/kg/day in three or four equal doses. Clindamycin should be dosed based on total body weight regardless of obesity. More severe infections: 25-40 mg/kg/day in three or four equal doses. In severe infections it is recommended that children be given no less than 300 mg/day regardless of body weight.

Elderly patients:

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.

Method of administration:

Parental (IM or IV administration). Clindamycin Injection should be used undiluted for IM administration. Clindamycin Injection must be diluted prior to IV administration and should be infused over at least 10-60 minutes. Dilution for IV use and IV infusion rates The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml and INFUSION RATES SHOULD NOT EXCEED 30 MG PER MINUTE.

The usual infusion rates are as follows:

Dose Diluent Time 300 mg 50 ml 10 min 600 mg 50 ml 20 min 900 mg 50-100 ml 30 min 1200 mg 100 ml 40 min

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency.

The frequency grouping is defined using the following convention:

Very common(≥1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very Rare (<1/10,000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ Class Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1 000 to <1/100 Rare ≥ 1/10 000 to <1/1000 Very Rare < 1/10 000 Not Known (cannot be estimated from available data) Infections and Infestations pseudomembranous colitis*# vaginal infection* Blood and Lymphatic System Disorders agranulocytosis*, neutropenia*, thrombocytopenia*, leukopenia*, eosinophilia Immune System Disorders anaphylactic shock*, anaphylactoid reaction*, anaphylactic reaction*, hypersensitivity* Nervous System Disorders dysgeusia Cardiac Disorders cardio-respiratory arrest†§ Vascular Disorders thrombophlebitis† hypotension†§ Gastrointestinal Disorders diarrhoea, nausea, abdominal pain, vomiting, oesophageal ulcers, oesophagitis Hepatobiliary Disorders Jaundice* Skin and Subcutaneous Tissue Disorders rash maculopapular urticaria erythema multiforme, pruritus toxic epidermal necrolysis (TEN)*, Stevens-Johnson syndrome (SJS)*, drug reaction with eosinophilia and systemic symptom (DRESS)*, acute generalized exanthematous pustulosis (AGEP)*, dermatitis exfoliative*, dermatitis bullous*, rash morbilliform*, Renal and urinary disorders acute kidney injury# General Disorders and Administrative Conditions pain†, injection site abscess† injection site irritation†* Investigations liver function test abnormal * ADR identified post-marketing.

† ADRs apply only to injectable formulations. 4. 2). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Warnings Severe hypersensitivity reactions, including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported in patients receiving clindamycin therapy.

8). 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.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile. This has been reported with use of nearly all antibacterial agents, including clindamycin. Clostridium difficile produces toxins A and B which contribute to the development of Clostridium difficile associated diarrhoea (CDAD) and is a primary cause of ‘antibiotic-associated colitis’.

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.

Colitis is a disease, which has a clinical spectrum from mild, watery diarrhoea to severe, persistent diarrhoea, leucocytosis, fever, severe abdominal cramps, which may be associated with the passage of blood and mucus. If allowed to progress, it may produce peritonitis, shock and toxic megacolon.

This may be fatal. The presence of the disease may be further confirmed by culture of the stool for C. difficile on selective media and assay of the stool specimen for the toxin(s) of C. difficile. It is important to consider the diagnosis of CDAD in patients who present with diarrhoea subsequent to the administration of antibacterial agents.

1.