CLINDAMYCIN

Posology Adults The usual dose is 150-450 mg every six hours, depending on the severity of the infection. Elderly patients Dosage requirements in elderly patients should not be influenced by age alone Paediatric population The usual dose is 3-6 mg/kg every six hours depending on the severity of the infection (not to exceed the adult dose).

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. Clindamycin should be dosed based on total body weight regardless of obesity.

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. Method of administration Clindamycin capsules are given orally. 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 Clindamycin capsules 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.

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 Not Known (cannot be estimated from available data) Infections and Infestations pseudomembranous 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*, hypersensitivity* Nervous System Disorders dysgeusia Gastrointestinal Disorders diarrhoea, abdominal pain vomiting, nausea oesophageal ulcer*, oesophagitis* Hepatobiliary Disorders jaundice* Renal and urinary disorders acute kidney injury# Skin and Subcutaneous Tissue Disorders rash maculopapular, urticaria toxic epidermal necrolysis (TEN)*, Stevens Johnson syndrome (SJS)*, drug reaction with eosinophilia and systemic symptoms (DRESS)*, acute generalized exanthematous pustulosis (AGEP*, angioedema*, dermatitis exfoliative*, dermatitis bullous*, erythema multiforme*, pruritus, rash morbilliform* Investigations Liver function test abnormal * ADR identified post-marketing.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 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 Clostridioidesdifficile) 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 mucous. 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 Clostridioidesdifficile on selective media and assay of the stool specimen for the toxin(s) of C.

difficile. Clostridioidesdifficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

8) Precautions: Caution should be used when prescribing Clindamycin capsules to individuals with a history of gastro-intestinal disease, especially colitis. Since clindamycin does not diffuse adequately into cerebrospinal fluid, the drug should not be used in the treatment of meningitis.

Laboratory tests for renal and hepatic function should be carried out during prolonged therapy. Close monitoring is also recommended in patients with renal or hepatic insufficiency and in neonates and infants, all of whom may require dose reduction and/or an extended interval between doses.

Acute kidney injury, including acute renal failure, has been reported infrequently. 8). Prolonged administration of Clindamycin capsules, as with any anti-infective, may result in super – infection due to organisms resistant to clindamycin.

Care should be observed in the use of Clindamycin capsules in atopic individuals. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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.

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