Clindamycin

Severe cutaneous adverse reactions Severe cutaneous adverse reactions (SCAR), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN: also known as Lyell's syndrome) and acute generalised exanthematous pustulosis (AGEP), which are life-threatening or fatal, have been reported in patients receiving clindamycin. At the time of prescribing, patients should be informed of the signs and symptoms of severe cutaneous reactions and should be monitored closely. If signs and symptoms of severe cutaneous reactions occur, clindamycin should be discontinued immediately and alternative treatment considered. If a patient develops a serious reaction such as DRESS, SJS, TEN or AGEP while receiving clindamycin, treatment with clindamycin must not be reinstituted in that patient (see sections 4.3 and 4.8). Caution should be exercised in patients: - with impaired hepatic or renal function (see section 4.2); - with disorders of neuromuscular transmission (myasthenia gravis, Parkinson's disease, etc.), as well as a history of gastrointestinal disease (e.g. prior inflammation of the large bowel); - with atopic disease. Hypersensitivity Severe allergic reactions may occur even after the first administration. In such cases, treatment with Clindamycin hameln must be discontinued immediately and standard emergency measures initiated. Acute kidney injury Cases of acute kidney injury, including acute renal failure, have been reported rarely. Monitoring of renal function should be considered in patients with pre-existing renal dysfunction or those receiving concomitant nephrotoxic medicinal products (see section 4.8). Gastrointestinal disorders Clostridioides difficile-associated diarrhoea (CDAD) has been reported with the use of nearly all antibacterial agents, including clindamycin. The severity may range from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal microbial flora of the colon, which may lead to overgrowth of Clostridioides difficile. Cases of colitis have been reported during or even two to three weeks after clindamycin administration. The disease is likely to take a more severe course in elderly or debilitated patients. Clostridioides difficile produces toxins A and B, which contribute to the development of diarrhoea (CDAD) and is the primary cause of "post-antibiotic colitis." Hypervirulent strains of Clostridioides difficile are associated with increased morbidity and mortality, as these infections may be refractory to antibacterial therapy and may require colectomy. A diagnosis of CDAD should be considered in patients presenting with diarrhoea following the administration of antibacterial agents. This may progress to colitis, including pseudomembranous colitis (see section 4.8), with a course ranging from mild to fatal. In this setting, a careful history should be taken, as CDAD may occur up to 2 months after antibacterial therapy. If antibiotic-associated diarrhoea or colitis is suspected or confirmed, ongoing antibacterial therapy, including clindamycin, should be discontinued and appropriate therapeutic measures instituted immediately. Caution is required when prescribing Clindamycin hameln to individuals with a history of gastrointestinal disease, particularly colitis. Medicinal products that inhibit peristalsis are contraindicated in this situation. Meningitis Clindamycin hameln is not suitable for the treatment of meningitis, as the concentration of the antibiotic achieved in the cerebrospinal fluid is too low. Monitoring In patients receiving prolonged treatment (longer than 10 days), the haemogram and hepatic and renal function should be monitored at regular intervals. Superinfection and overgrowth Prolonged and repeated administration of Clindamycin hameln may give rise to superinfection and/or colonisation with resistant pathogens or yeasts on the skin and mucous membranes. Cross-allergy Under certain circumstances, treatment with clindamycin may be an alternative form of therapy in patients with penicillin allergy (penicillin hypersensitivity). No cases of cross-allergy between clindamycin and penicillin have been reported, and on the basis of the structural differences between these substances none would be expected. However, isolated reports exist of anaphylaxis (hypersensitivity) to clindamycin in individuals with pre-existing penicillin allergy. This should be taken into account during clindamycin treatment in patients with penicillin allergy. Rapid intravenous injection may produce a serious adverse effect on the heart (see section 4.8) and must not be administered. Benzyl alcohol This medicinal product contains benzyl alcohol as a preservative at a concentration of 9 mg/ml. Intravenous administration of benzyl alcohol has been associated with serious adverse reactions and death in neonates, characterised by central nervous system depression, metabolic acidosis, gasping respiration, cardiovascular collapse and haematological abnormalities ("gasping syndrome"). The minimum amount of benzyl alcohol at which toxicity may occur is not known. The development of toxicity may be more likely in preterm and low birth-weight infants. This medicinal product should therefore not be administered to neonates (up to 4 weeks of age) unless considered absolutely necessary. Benzyl alcohol may cause an allergic reaction. Owing to the risk of accumulation and toxicity (metabolic acidosis) resulting from benzoic acid (a metabolite of benzyl alcohol), this product must not be used in young children (under 3 years of age) for longer than one week unless necessary. Administration of larger amounts of benzyl alcohol may lead to its accumulation in the body, which can give rise to adverse effects (so-called "metabolic acidosis"). This should be taken into account in pregnant and breastfeeding women. Large volumes of benzyl alcohol should be administered with caution and only where necessary, particularly in patients with impaired renal or hepatic function, owing to the risk of accumulation and toxic reaction (metabolic acidosis). Sodium This medicinal product contains a maximum of 8.6 mg sodium per 1 ml of solution. 2 ml: This medicinal product contains less than 1 mmol (23 mg) of sodium per 2 ml ampoule, that is to say essentially "sodium-free." 4 ml: This medicinal product contains up to 34.4 mg of sodium per 4 ml ampoule, equivalent to 1.7% of the WHO recommended maximum daily dietary sodium intake for an adult, which is 2 g of sodium.