CLINDAMYCIN

Posology Adults:

The usual dose is 150-450 mg every six hours, depending on the severity of the infection.

Elderly:

The half-life, volume of distribution and clearance, and extent of absorption after administration of clindamycin hydrochloride are not altered by increased age. Analysis of data from clinical studies has not revealed any age-related increase in toxicity.

Dosage requirements in elderly patients, therefore, should not be influenced by age alone.

Paediatric population:

The usual dose is 3 – 6 mg/kg every six hours depending on the severity of the infection (not to exceed the adult dose). Clindamycin capsules are not suitable for children who are unable to swallow them whole. The capsules do not provide exact mg/kg doses therefore it may be necessary to use an alternative formulation in some cases.

The dosage of clindamycin in children should be adjusted according to total body weight, regardless of obesity.

Renal impairment:

No dose adjustment is necessary in patients with mild to moderate impairment of renal function. In patients with severe renal impairment or anuria, plasma concentration should be monitored. Depending on the results, this measure can make a reduction in dosage or an increase in the dose interval of 8 or even 12 hours necessary.

Hepatic impairment:

In patients with moderate to severe hepatic impairment, elimination half-life of clindamycin is prolonged. A reduction in dosage is generally not necessary if clindamycin is administered every 8 hours. However, the plasma concentration of clindamycin should be monitored in patients with severe hepatic impairment.

Depending on the results, this measure can make a reduction in dosage or an increase in the dose intervals necessary. In cases of beta-haemolytic streptococcal infection, treatment with Clindamycin should continue for at least 10 days to diminish the likelihood of subsequent rheumatic fever or glomerulonephritis.

Method of administration For oral use. Clindamycin should be taken whole, by swallowing them with a full glass of water. The capsules should be taken in an upright position (standing up or sitting down), without lying down for at least 30 minutes after administration.

Absorption of clindamycin is not appreciably modified by the presence of food.

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics.

The frequency grouping is defined using the following convention:

Very common (≥1/10); 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); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ Class Common ≥1/100 to <1/10 Uncommon ≥1/1 000 to <1/100 Rare ≥1/10 000 to <1/1 000 Not Known (cannot be estimated from available data) Infections and infestations pseudomembranous colitis*# clostridium difficile colitis*, vaginal infection* Blood and Lymphatic System Disorders agranulocytosis*, neutropenia*, thrombocytopenia*, leukopenia*, eosinophilia Immune System Disorders anaphylactic shock*, anaphylactoid reaction*, anaphylactic reaction*, hypersensitivity* Nervous System Disorders dysgeusia Gastrointestinal Disorders diarrhoea, abdominal pain vomiting, nausea oesophageal ulcer*‡, oesophagitis*‡ Hepatobiliary Disorders jaundice* Skin and Subcutaneous Tissue Disorders rash maculo- papular, urticaria toxic epidermal necrolysis (TEN)*, Stevens-Johnson syndrome (SJS)*, drug reaction with eosinophilia and systemic symptoms (DRESS)*, acute generalised exanthematous pustulosis (AGEP)*, angioedema*, dermatitis exfoliative*, dermatitis bullous*, erythema multiforme, pruritus, rash morbilliform* Investigations liver function test abnormal *ADR identified post-marketing.

‡ADRs apply only to oral formulations. 4.

Reporting of suspected adverse reactions:

Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Hypersensitivity Severe hypersensitivity reactions, including severe skin 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) have been reported in patients receiving clindamycin therapy.

8). The choice of clindamycin should be based on factors such as severity of the infection, the prevalence of resistance to other suitable agents and the risk of selecting clindamycin-resistant bacteria. Care should be observed in the use of clindamycin in atopic individuals.

Antibiotic-associated colitis Clindamycin should only be used in the treatment of serious infections. In considering the use of the product, the practitioner should bear in mind the type of infection and the potential hazard of the diarrhoea which may develop, since cases of colitis have been reported during, or even two or three weeks following, the administration of clindamycin.

Treatment with antibacterial agents can significantly alter the normal flora of the colon leading to overgrowth of Clostridium difficile. This has been reported with use of nearly all antibacterial agents, including clindamycin. Clostridium difficile produces toxins A and B which contribute to the development of Clostridium difficile associated diarrhea (CDAD) and is a primary cause of “antibiotic-associated colitis”.

It is important to consider the diagnosis of CDAD in patients who present with diarrhea subsequent to the administration of antibacterial agents. 8). Colitis is a disease which has a clinical spectrum from mild, watery diarrhoea to severe, persistent diarrhoea, leucocytosis, fever, severe abdominal cramps, which may be associated with the passage of blood and mucus.

If allowed to progress, it may produce peritonitis, shock and toxic megacolon. This may be fatal. The appearance of marked diarrhoea should be regarded as an indication that the product should be discontinued immediately. The disease is likely to follow a more severe course in older patients or patients who are debilitated.

Diagnosis is usually made by the recognition of the clinical symptoms, but can be substantiated by endoscopic demonstration of pseudomembranous colitis. The presence of the disease may be further confirmed by culture of the stool for Clostridium difficile on selective media and assay of the stool specimen for the toxin(s) of C.

difficile. 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.

Drugs inhibiting peristalsis are contraindicated in this situation. Caution should be used when prescribing clindamycin to individuals with a history of gastrointestinal disease, especially colitis. Long-term treatment Clindamycin does not penetrate the blood/brain barrier in therapeutically effective quantities.

Since clindamycin does not diffuse adequately into cerebrospinal fluid, the drug should not be used in the treatment of meningitis. Periodic liver and kidney function tests should be carried out during prolonged therapy. Such monitoring is also recommended in neonates and infants.

Prolonged administration of clindamycin, as with any anti-infective, may result in super-infection due to organisms resistant to clindamycin. Acute kidney injury, including acute renal failure, has been reported infrequently. 8). 8). Excipients Clindamycin contains lactose.

Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

1. (List of excipients).