DALACIN C

Posology Adults Moderately severe infection, 150 - 300 mg every six hours; severe infection, 300 - 450 mg every six hours. Elderly patients 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. Paediatric population Clindamycin capsules should only be used for children who are able to swallow capsules.

Clindamycin should be dosed based on total body weight regardless of obesity. Doses of 12-25 mg/kg/day six hourly depending on the severity of the infection. The use of whole capsules may not be suitable to provide the exact mg/kg doses required for the treatment of children.

Dosage in renal/hepatic impairment Clindamycin dosage modification is not necessary in patients with renal or hepatic insufficiency.

Note:

In cases of beta-haemolytic streptococcal infection, treatment with this medicine should continue for at least 10 days to diminish the likelihood of subsequent rheumatic fever or glomerulonephritis. Method of administration Oral. Capsules should always be taken whole with a full glass of water and no less than 30 minutes before lying down to avoid the possibility of oesophageal irritation.

Absorption of this medicine 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); 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 <1/1 000 Not Known (cannot be estimated from available data) Infections and infestations pseudomembran ous colitis*# Clostridioides difficile colitis*, vaginal infection* Blood and Lymphatic System Disorders agranulocytosis*, neutropenia*, thrombocytopenia* , leukopenia*, eosinophilia Immune System Disorders anaphylactic shock*, anaphylactoid reaction*, anaphylactic reaction*, Kounis syndrome*, 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*, cutaneous vasculitis*, erythema multiforme, pruritus, rash morbilliform*, symmetrical drug- related intertriginous and flexural exanthema* Renal and urinary disorders acute kidney injury# Investigations liver function test abnormal * ADR identified post-marketing.

‡ ADRs apply only to oral formulations. 4. ≠ Possible occurrence of oesophagitis and oesophageal ulcer, particularly if taken in a lying position and/or with a small amount of water. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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), acute generalised exanthematous pustulosis (AGEP), and Kounis syndrome have been reported in patients receiving clindamycin therapy.

8). This medicine 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.

Studies indicate a toxin(s) produced by clostridia (especially Clostridioides difficile) is the principal direct cause of antibiotic-associated colitis. These studies also indicate that this toxigenic clostridioidesis 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.

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