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CLINDAMYCIN is a brand name for Clindamycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Clindamycin 150 mg/ml solution for injection/infusion is indicated for the treatment of the following severe infections caused by clindamycin sensitive bacteria in adults and children from the age of 1 month (see sections 4.2 and 5.1): Bone and joint infections Chronic sinusitis caused by anaerobic microorganisms…
Verbatim from this product's MHRA label. Tap a section to expand.
The dosage and method of administration should be determined depending on the severity of infection, patient condition and the susceptibility of the microorganism causing the disease. Local guidance should be taken into consideration.
Posology Adults Intramuscular or intravenous administration: 1200-2700 mg/day divided into 2-4 doses. The usual dose for infections of intra-abdominal area, female pelvic area or other severe infections is 2400-2700 mg daily IV or IM administered in 2, 3 or 4 equal doses (without exceeding the maximum recommended single dose of 1200 mg IV or 600 mg IM).
For the treatment of less complicated infections due to more susceptible microorganisms that may respond to lower doses: the dose is 1200-1800 mg daily IV or IM administered in 3 or 4 equal doses. In life-threatening infections the intravenous dose may be increased up to 4800 mg daily.
Prophylaxis in surgery The dosage should be determined depending on type and duration of the surgical procedure. The usual dose is 600-900 mg given every 4-8 hours, until the end of the procedure. 4). 2). In severe infections, it is recommended that children be given no less than 300 mg/day regardless of body weight.
The total daily dose should not exceed the maximum recommended daily dose for adults. Adolescents over 12 years of age Doses in adolescents over 12 years of age should be the same as in adults, taking into account possible dose adjustments based on liver function.
In underweight adolescent patients, between the ages of 12 and 18 it is not recommended to exceed the maximum dose of 40 mg/kg/day. The total daily dose should not exceed the maximum recommended daily dose for adults. Infants less than 1 month of age The safety and efficacy of Clindamycin in infants less than one month of age have not been established.
No data are available. 2). 2). However, when clindamycin is administered every 8 hours, accumulation occurs only rarely. In patients with severe hepatic impairment, it is recommended to monitor hepatic function and the patient's progress, and monitoring of plasma levels of clindamycin is recommended, where possible.
Depending on the results, the dose or dosing intervals should be adjusted, if necessary. 2). However, no dose adjustment is necessary in patients with mild to moderate renal impairment. In patients with severe renal impairment, it is recommended to monitor renal function and the patient's progress.
The Table 2 below lists the adverse reactions identified through clinical trial experience and post-marketing experience. Adverse reactions are ranked by MedDRA system organ class and frequency as follows: 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), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The most frequent side effects are gastrointestinal, predominantly diarrhoea. Gastrointestinal side effects occur in approx. 8 % of patients.
Table 2 Adverse reactions System Organ Class Common Uncommon Rare Very rare Not known Infections and infestations Pseudomembranous colitis*# Clostridioides difficile colitis*#, vaginal infection* Blood and lymphatic system disorders Eosinophilia Granulocytopenia Agranulocytosis*, neutropenia*, thrombocytopenia*, leucopenia*, thrombocytopenic purpura Immune system disorders Angioedema Anaphylactic shock*, anaphylactoid reaction*#, anaphylactic reaction*, hypersensitivity*+ Nervous system disorders Dysgeusia, neuromuscular blocking effect Changes in smell Cardiac disorders Cardio-respiratory arrest§ Vascular disorders Thrombophlebitis **** Hypotension§ Gastrointestinal disorders Inflammation of the oral mucosa, diarrhoea** Abdominal pain, oesophagitis, nausea, vomiting Dyspepsia Hepatobiliary disorders Jaundice* Skin and subcutaneous tissue disorders Maculo-papular rash Urticaria, erythema multiforme, pruritus Toxic epidermal necrolysis (TEN)*#, Stevens-Johnson syndrome (SJS)*#, drug reaction/drug exanthem with eosinophilia and systemic symptoms (DRESS)*#, acute generalised exanthematous pustulosis (AGEP)*#, exfoliative dermatitis*, dermatitis bullous*, morbilliform rash* Renal and urinary disorders Acute kidney injury# General disorders and administration site conditions Induration at the injection site*** Pain at the injection site, sterile abscess at the injection site*** Irritation at the injection site* Investigations Liver function tests abnormal, serum transaminases increased * Adverse reactions identified from post-marketing experience.
Hypersensitivity reactions Severe hypersensitivity reactions can occur even after the first administration. 8). Under certain circumstances, clindamycin therapy may be an alternative form of treatment in patients with a penicillin allergy (penicillin hypersensitivity).
There have been no reports of a cross-allergy between clindamycin and penicillin and, based on the structural differences between the substances, this is not to be expected. However, in individual cases, information does exist on anaphylaxis (hypersensitivity) towards clindamycin in persons with an already existing penicillin allergy.
This should be taken into consideration in a course of clindamycin treatment in patients with a penicillin allergy. Severe cutaneous adverse reactions Severe cutaneous adverse reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP), which could be life-threatening or fatal, have been reported in patients receiving clindamycin.
These can occur even after the first administration. If signs and symptoms of severe skin reactions appear, treatment with clindamycin must be discontinued immediately and the appropriate standard emergency measures initiated. 8). Gastrointestinal disorders Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridioides difficile.
This has been reported with use of nearly all antibacterial agents, including clindamycin. C. difficile produces toxins A and B which contribute to the development of C. difficile associated diarrhoea (CDAD) and is a primary cause of ‘antibiotic-associated colitis’.
It is important to consider the diagnosis of CDAD in patients who develop diarrhoea subsequent to the administration of antibacterial agents. 8), which may range from mild to fatal colitis. If antibiotic-associated diarrhoea or antibiotic-associated colitis is suspected or confirmed, ongoing treatment with antibacterial agents, including clindamycin, should be discontinued and adequate therapeutic measures should be initiated immediately.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Clindamycin cannot be removed by haemodialysis. Therefore, no additional dose is necessary before or after haemodialysis. Method of administration Intramuscular injection (IM) or intravenous infusion (IV). For intramuscular administration, Clindamycin should be used undiluted.
Intramuscular administration of more than 600 mg at once is not recommended. Intramuscular administration is indicated when intravenous infusion is not possible for any reasons. For intravenous administration, Clindamycin must be diluted prior IV administration and should be infused over at least 10-60 minutes.
The concentration should not exceed 18 mg clindamycin per ml solution and the infusion rate should not exceed 30 mg/min. 8). Intravenous infusions of more than 1200 mg in one hour are not recommended. 6.
** Often mild in nature and often resolve during or after discontinuation of treatment. These side effects depend on the method of administration and the dosage. *** May occur locally after IM injection. **** After IV administration. + After a rapid IV injection, hypersensitivity reactions in the form of flushing or feeling of nausea may occur.
4. § Cases of cardio-respiratory arrest and hypotension have been reported following too rapid IV administration. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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Medicinal products inhibiting peristalsis are contraindicated in this situation. Clindamycin therapy has been associated with a pseudomembranous colitis during and until 2 to 3 weeks after the treatment with clindamycin which may be fatal, and which is associated with severe and persistent diarrhoea.
Care should be taken when prescribing clindamycin to a patient who has a tendency towards gastrointestinal illnesses, in particular colitis. Antibiotic-associated colitis and diarrhoea are more frequent and severe in debilitated and/or elderly patients (> 60 years).
g. 8). In vitro, clindamycin has been shown to inhibit nicotinic acetylcholine receptors. Hepatic and renal impairment During long-term treatment, liver and kidney function should be regularly monitored. 2). Acute kidney injury, including acute renal failure, has been reported infrequently.
8). Overgrowth of non-susceptible organisms The use of clindamycin may also result in the overgrowth of non-susceptible organisms, particularly yeasts. Diffusion into cerebrospinal fluid Since clindamycin does not diffuse adequately into cerebrospinal fluid, it should not be used in the treatment of meningitis.
Other Caution should be exercised in patients with atopic diseases. 33 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.