CLINDAMYCIN

Where the required dosage cannot be achieved with capsules of this strength, there are other medicinal products containing clindamycin in capsules of other strengths on the market, which can be used. Posology Adults Moderately severe infection: 150 - 300 mg every six hours Severe infection: 1200 - 1800 mg daily in divided doses given every six to eight hours Elderly The half-life, volume of distribution and clearance, and extent of absorption after administration of clindamycin hydrochloride 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, therefore, should not be influenced by age alone. Children: 3 - 6 mg/kg every six hours depending on the severity of the infection.

Clindamycin capsules are not suitable for children who are unable to swallow them whole. The capsules do not provide exact mg/kg doses therefore it may be necessary to use an alternative formulation in some cases. Renal impairment No dose adjustment is necessary in patients with mild to moderate impairment of renal function.

In patients with severe renal impairment or anuria, plasma concentration should be monitored. Depending on the results, this measure can make a reduction in dosage or an increase in the dose interval of 8 or even 12 hours necessary.

Hepatic impairment In patients with moderate to severe hepatic impairment, elimination half-life of clindamycin is prolonged. A reduction in dosage is generally not necessary if clindamycin is administered every 8 hours. However, the plasma concentration of clindamycin should be monitored in patients with severe hepatic impairment.

Depending on the results, this measure can make a reduction in dosage or an increase in the dose intervals necessary. Clindamycin capsules should always be swallowed whole with a full glass of water. Absorption of Clindamycin is not appreciably modified by the presence of food.

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics.

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); 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 Uncommo n ≥1/1 000 to <1/100 Rare ≥1/10 000 to <1/1 000 Not Known (cannot be estimated from available data) Infections and infestations pseudomembra nous colitis*# clostridium difficile colitis*, vaginal infection* Blood and Lymphatic System Disorders agranulocytosis*, neutropenia*, thrombocytopeni a*, leukopenia*, eosinophilia Immune System Disorders anaphylactic shock*, anaphylactoid reaction*, anaphylactic reaction*, hypersensitivity* Nervous System Disorders dysgeusia Gastrointestinal Disorders diarrhoea, abdominal pain vomiting, nausea oesophageal ulcer*‡, oesophagitis*‡ Hepatobiliary Disorders jaundice* Skin and Subcutaneous Tissue Disorders rash maculo- papular, urticaria toxic epidermal necrolysis (TEN)*, Stevens- Johnson syndrome (SJS)*, drug reaction with eosinophilia and systemic symptoms (DRESS)*, acute generalised exanthematous pustulosis (AGEP)*, angioedema*, dermatitis exfoliative*, dermatitis bullous*, erythema multiforme, pruritus, rash morbilliform* Renal and urinary disorders acute kidney injury# Investigations liver function test abnormal * ADR identified post-marketing.

‡ ADRs apply only to oral formulations. 4. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

The choice of clindamycin should be based on factors such as severity of the infection, the prevalence of resistance to other suitable agents and the risk of selecting clindamycin-resistant bacteria. 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 generalised exanthematous pustulosis (AGEP) have been reported in patients receiving clindamycin therapy.

8). Studies indicate a toxin(s) produced by clostridia (especially Clostridium difficile) is the principal direct cause of antibiotic associated colitis. These studies also indicate that this toxigenic clostridium is usually sensitive in vitro to vancomycin.

When 125 mg to 500 mg of vancomycin are administered orally four times a day for 7 - 10 days, there is a rapid observed disappearance of the toxin from faecal samples and a coincident clinical recovery from the diarrhoea. (Where the patient is receiving cholestyramine in addition to vancomycin, consideration should be given to separating the times of administration).

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 appearance of marked diarrhoea should be regarded as an indication that the product should be discontinued immediately. 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. The presence of the disease may be further confirmed by culture of the stool for Clostridium difficile on selective media and assay of the stool specimen for the toxin(s) of C.

1. Clindamycin should not be used in patients with existing diarrhoea.