CLINDAMYCIN

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.

Pediatric population:

Clindamycin should be dosed based on total body weight regardless of obesity. The total daily dose should not exceed the maximum recommended daily dose for adults. Doses of 12-25 mg/kg/day six hourly depending on the severity of the infection.

Clindamycin Capsules are not suitable for children who are unable to swallow them whole. 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 Clindamycin Capsules should continue for at least 10 days to diminish the likelihood of subsequent rheumatic fever or glomerulonephritis. Method of administration To be taken orally with water.

Clindamycin Capsules may be taken without regard to food. Clindamycin Capsules should always be swallowed whole and washed down with a full glass of water while in an upright position. and no less than 30 minutes before lying down to avoid possible irritation of the oesophagus.

SUMMARY OF THE PRODUCT CHARACTERISTICS

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 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 available data) Infections and infestations pseudomem branous colitis*# Clostridioides difficile colitis*, Vaginal infection* Blood and Lymphatic System Agranulocytosis* Leukopenia*, Neutropenia* Thrombocytopenia* Disorders Eosinophilia Immune System Disorders Anaphylactic shock*, Anaphylactoid Reactions*, anaphylactic reaction*, hypersensitivity* Nervous System Disorders Dysgeusia Gastrointestinal Disorders Abdominal pain, Diarrhoea Nausea, Vomiting Oesophageal ulcer*‡ ≠ Oesophagitis*‡≠ Hepatobiliary Disorders Jaundice* Skin and Subcutaneous Tissue Disorders Rash maculopapular , Urticaria Toxic epidermal Necrolysis (TEN)*, Steven Johnson syndrome (SJS)*, drug reaction with eosinophilia and systemic symptoms (DRESS)*, Acute generalized exanthematous pustulosis (AGEP*), angioedema*, Erythema multiforme*, Dermatitis, exfoliative*, Dermatitis bullous*, Rash Morbilliform*, Pruritus 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.

Hypersensitivity 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). Clostridioides Difficile associated diarrhoea Clindamycin Capsules should only be used in the treatment of serious infections. In considering the use of this product the practitioner should bear in mind the type of infection and the potential hazard of the diarrhoea that 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 cause of antibiotic-associated colitis. These studies also indicate that this toxigenic clostridium is usually sensitive in vitro to vancomycin.

When 125 - 500 mg of vancomycin is 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 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. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridioides difficile. This has been reported with use of nearly all antibacterial agents, including clindamycin.

1. Diarrhoea or intestinal inflammatory disease. SUMMARY OF THE PRODUCT CHARACTERISTICS