Clindamycin

Severe cutaneous adverse reactions Severe cutaneous adverse reactions (SCARs), 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 advised of the signs and symptoms of severe cutaneous reactions and should be closely monitored. If signs and symptoms of severe cutaneous reactions occur, clindamycin should be discontinued immediately and alternative treatment considered. If a patient has developed a severe reaction such as DRESS, SJS, TEN, or AGEP while taking clindamycin, treatment with clindamycin must not be restarted in this patient at any time (see sections 4.3 and 4.8). Caution is required 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., previous colitis); with atopic disease. Hypersensitivity Serious allergic reactions may occur even after the first dose. In such cases, treatment with Clindamycin hameln must be discontinued immediately and standard emergency treatment must be initiated. Acute kidney injury Cases of acute kidney injury, including acute renal failure, have been reported rarely. In patients with pre-existing renal dysfunction or those concomitantly receiving nephrotoxic medicinal products, monitoring of renal function should be considered (see section 4.8). Gastrointestinal disorders Clostridioides difficile-associated diarrhoea (CDAD) has been reported with the use of nearly all antibacterial agents, including clindamycin. Diarrhoea ranges in severity from mild diarrhoea to fatal colitis. Treatment with antibacterials 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 administration of clindamycin. The disease is likely to follow 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. The diagnosis of CDAD should be considered in patients who develop diarrhoea after the administration of antibacterial agents. This may progress to colitis, including pseudomembranous colitis (see section 4.8), which may range from mild to fatal. In such cases, a careful history should be taken, as CDAD may occur up to 2 months after antibiotic therapy. If antibiotic-associated diarrhoea or colitis is suspected or confirmed, ongoing antibacterial therapy, including clindamycin, should be discontinued and appropriate therapeutic measures initiated immediately. Caution is advised when prescribing Clindamycin hameln to patients with a history of gastrointestinal disease, particularly colitis. Medicinal products inhibiting peristalsis are contraindicated in this situation. Meningitis Clindamycin hameln is not suitable for the treatment of meningitis, as the concentration of antibiotic achieved in the cerebrospinal fluid is too low. Monitoring In patients receiving long-term treatment (longer than 10 days), the complete blood count 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 by resistant pathogens or yeasts on the skin and mucous membranes. Cross-allergy Under certain circumstances, clindamycin may be an alternative therapeutic option in patients allergic to penicillin (penicillin hypersensitivity). No cases of cross-allergy between clindamycin and penicillin have been reported, and this is not anticipated on the basis of the structural differences between these substances. Nevertheless, isolated reports of anaphylaxis (hypersensitivity) to clindamycin in individuals with pre-existing penicillin allergy exist. This should be taken into account when treating penicillin-allergic patients with clindamycin. A rapidly administered intravenous injection may have a serious adverse effect on the heart (see section 4.8) and must not be given. 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 respirations, cardiovascular collapse, and haematological abnormalities ("gasping syndrome"). The minimum amount of benzyl alcohol at which toxicity may occur is not known. Toxicity may be more likely to develop in preterm and low-birth-weight infants. Therefore, this medicinal product should 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) caused by benzoic acid (a metabolite of benzyl alcohol), this product must not be used in young children (under 3 years of age) for more than one week unless necessary. Following administration of larger amounts of benzyl alcohol, accumulation in the body may occur, which can lead to adverse reactions (so-called "metabolic acidosis"). This should be taken into account in pregnant and breastfeeding women. Large volumes of benzyl alcohol must be administered with caution and only when necessary, particularly in patients with impaired renal or hepatic function, owing to the risk of accumulation and toxic reactions (metabolic acidosis). Sodium This medicinal product contains up to 8.6 mg of sodium per 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 of 2 g.