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 skin reactions and should be closely monitored. If signs and symptoms of a severe skin reaction 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 during clindamycin use, treatment with clindamycin must not be restarted 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 and the like), as well as a history of gastrointestinal disease (e.g. previous inflammation of the colon); - with atopic disease. Hypersensitivity Serious 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 in those concomitantly taking 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. Diarrhoea ranges in severity from mild diarrhoea to fatal colitis. Treatment with antibacterials alters the normal microbial flora of the colon, which may permit overgrowth of Clostridioides difficile. Cases of colitis have been reported during clindamycin therapy or even two to three weeks after its administration. The condition 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 are 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 who develop diarrhoea following the administration of antibacterial agents. The condition may progress to colitis, including pseudomembranous colitis (see section 4.8), which can range from mild to fatal. A careful clinical history should be taken in such cases, as CDAD may occur up to 2 months after antibiotic therapy. If antibiotic-associated diarrhoea or colitis is suspected or confirmed, ongoing antibiotic therapy, including clindamycin, must be discontinued and appropriate therapeutic measures initiated without delay. 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 concentrations of the antibiotic achieved in the cerebrospinal fluid are too low. Monitoring In patients on prolonged treatment (therapy lasting more than 10 days), full 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 of the skin and mucous membranes with resistant pathogens or yeasts. Cross-allergy Under certain circumstances, clindamycin may be used as an alternative form of treatment 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 is expected. In isolated cases, however, anaphylaxis (hypersensitivity) to clindamycin has been reported in individuals with a pre-existing penicillin allergy. This should be borne in mind during clindamycin treatment of patients with penicillin allergy. Rapid intravenous injection may produce serious cardiac adverse effects (see section 4.8) and must not be administered in this manner. 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. Toxicity is more likely to develop in preterm infants and those with low birth weight. This medicinal product should therefore not be administered to neonates (up to 4 weeks of age) unless it is considered absolutely essential. Benzyl alcohol may cause an allergic reaction. Because of the risk of accumulation and toxicity (metabolic acidosis) due to 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, the substance may accumulate in the body, which can lead to adverse reactions (so-called "metabolic acidosis"). This should be taken into account in pregnant and breast-feeding women. Large volumes of benzyl alcohol should be administered with caution and only when necessary, particularly in patients with impaired hepatic or renal function, due to the risk of accumulation and toxic reactions (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) sodium per 2 ml ampoule, that is to say essentially "sodium-free". 4 ml: This medicinal product contains up to 34.4 mg 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.