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 If signs and symptoms of severe cutaneous reactions appear, clindamycin should be withdrawn immediately and alternative treatment considered. If a patient has developed a serious reaction such as DRESS, SJS, TEN or AGEP while taking clindamycin, treatment with clindamycin must not be restarted in that 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 impaired neuromuscular transmission (myasthenia gravis, Parkinson's disease, etc.), as well as those with a history of gastrointestinal disease (e.g. previous inflammation of the colon); with atopic disease. Hypersensitivity Severe allergic reactions may occur even after the first dose. 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 concurrently 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 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 following, clindamycin administration. The course of the disease is likely to be more severe 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. It is important to consider the diagnosis of CDAD in patients who develop diarrhoea following the administration of antibacterial agents. This may progress to colitis, including pseudomembranous colitis (see section 4.8), which can range from mild to fatal. In such cases, a careful medical 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 antibiotic therapy, including clindamycin, should be discontinued and appropriate therapeutic measures initiated immediately. Caution is required when prescribing Clindamycin hameln to patients with a history of gastrointestinal disease, particularly colitis. Medicinal products that inhibit peristalsis are contraindicated in this setting. Meningitis Clindamycin hameln is not suitable for the treatment of meningitis, as concentrations of the antibiotic achieved in cerebrospinal fluid are too low. Monitoring In patients receiving long-term therapy (treatment exceeding 10 days), the 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 by resistant pathogens or yeasts. Cross-allergy Under certain circumstances, clindamycin may serve as an alternative therapy in patients with penicillin allergy (hypersensitivity to penicillin). 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. In individual cases, however, there have been reports of anaphylaxis (hypersensitivity) to clindamycin in individuals with pre-existing penicillin allergy. This should be taken into account during clindamycin treatment of patients with penicillin allergy. Rapidly administered intravenous injection may have serious adverse effects 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 respiration, 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 infants 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 allergic reactions. Owing to 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, accumulation in the body may occur and may give rise to adverse reactions (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 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 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, i.e. it is 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 of 2 g for an adult.