Summary of Product Characteristics Updated 04-Aug-2016 | Accord-UK Ltd
Excipient with known effect:Each capsule contains 33.91 mg anhydrous lactose (see section 4.4). For the full list of excipients, see section 6.1.
AdultsModerately severe infection: 150 - 300 mg every six hoursSevere infection: 1200 - 1800 mg daily in divided doses given every six to eight hours
ElderlyThe 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. Children: 3 - 6 mg/kg every six hours depending on the severity of the infection.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.
Renal impairmentNo 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 impairmentIn 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.
Method of AdministrationOral.Clindamycin capsules should always be swallowed whole with a full glass of water. Absorption of Clindamycin is not appreciably modified by the presence of food.
Vitamin K antagonistsIncreased coagulation tests (PT/INR) and/or bleeding, have been reported in patients treated with clindamycin in combination with a vitamin K antagonist (e.g. warfarin, acenocoumarol and fluindione). Coagulation tests, therefore, should be frequently monitored in patients treated with vitamin K antagonists.
PregnancyOral and subcutaneous reproductive toxicity studies in rats and rabbits revealed no evidence of impaired fertility or harm to the fetus due to clindamycin, except at doses that caused maternal toxicity. Animal reproduction studies are not always predictive of human response.Clindamycin crosses the placenta. There are inadequate data regarding the safety of clindamycin in pregnancy. Therefore, clindamycin should only be administered to pregnant women if the potential benefit is considered to outweigh the possible risk to the foetus. After multiple doses, amniotic fluid concentrations were approximatley 30 % of maternal blood concentrations.In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.Clindamycin should be used in pregnancy only if clearly needed.
BreastfeedingOrally and parentally administered clindamycin has been reported to appear in human breast milk in ranges from 0.7 to 3.8 μg/mL. Because of the potential for serious adverse reactions in nursing infants, clindamycin should not be taken by nursing mothers.
FertilityFertility studies in rats treated orally with clindamycin revealed no effects on fertility or mating ability.
|System Organ Class||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||Not Known (cannot be estimated from available data)|
|Infections and infestations||Vaginal infection|
|Blood and Lymphatic System Disorders||Agranulocytosis Leukopenia Neutropenia Thrombocytopenia Eosinophilia|
|Immune System Disorders||Anaphylactoid reaction Drug reaction with eosinophilia and systemic symptom (DRESS)|
|Nervous System Disorders||Dysgeusia|
|Gastrointestinal Disorders||Abdominal pain Diarrhoea Pseudomembranous colitis (see section 4.4)||Nausea Vomiting||Oesophageal ulcer Oesophagitis|
|Hepatobiliary Disorders||Liver function test abnormal||Jaundice|
|Skin and Subcutaneous Tissue Disorders||Rash maculopapular Urticaria||Toxic epidermal necrolysis Stevens-Johnson syndrome Acute generalised exanthematous pustulosis (AGEP) Erythema multiforme Dermatitis exfoliative Dermatitis bullous Rash morbilliform Pruritis|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
Mode of actionClindamycin binds to the 50S subunit of the bacterial ribosome and inhibits protein synthesis. Clindamycin has a predominately bacteriostatic action.
Mechanism of resistanceResistance to clindamycin usually occurs via macrolide-lincosamide-streptogramin B (MLSB) type of resistance, which may be constitutive or inducible.
PK/PD relationshipThe efficacy mainly depends on the duration of time during which the agent level is above the minimum inhibitory concentration (MIC) of the pathogen.
BreakpointsThe minimum inhibitory concentrations (MIC) breakpoints are as follows:Staphylococci: sensitive ≤ 0.5 resistant > 0.5Streptococci ABCG and pneumoniae: sensitive ≤ 0.5 resistant > 0.5Gram positive anaerobes: sensitive ≤ 4 resistant > 4Gram negative anaerobes: ≤ 4 resistant > 4
SusceptibilityThe prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
|Susceptible Gram-positive aerobes Staphylococcus aureus* Staphylococcus epidermidis Streptococcus pneumonia Streptococcus pyogenes Streptococcus viridans Anaerobes Bacteriodes fragilis group Bacteroides melaninogenicus Bifidobacterium spp. Clostridium perfringens Eubacterium spp Fusobacterium spp. Peptococcus spp. Peptostreptococcus spp. Propionibacterium spp. Veillonella spp.|
|Resistant Clostridia spp. Enterococci Enterobacteriaceae|
General characteristics of active substanceAbout 90% of a dose of clindamycin hydrochloride is absorbed from the gastro-intestinal tract; concentrations of 2 to 3 micrograms per ml occur within one hour after a 150 mg dose of clindamycin, with average concentrations of about 0.7 micrograms per ml after 6 hours. After doses of 300 and 600 mg peak plasma concentrations of 4 and 8 micrograms per ml, respectively, have been reported. Absorption is not significantly diminished by food in the stomach but the rate of absorption may be reduced.Clindamycin is widely distributed in body fluids and tissues including bone, but it does not reach the csf in significant concentrations. It diffuses across the placenta into the fetal circulation and has been reported to appear in breast milk. High concentrations occur in bile. It accumulates in leucocytes and macrophages. Over 90% of clindamycin in the circulation is bound to plasma proteins. The half-life is 2 to 3 hours, although this may be prolonged in pre-term neonates and patients with severe renal impairment.Clindamycin undergoes metabolism, presumably in the liver, to the active N-demethyl and sulfoxide metabolites, and also some inactive metabolites. About 10% of a dose is excreted in the urine as active drug or metabolites and about 4% in the faeces; the remainder is excreted as inactive metabolites. Excretion is slow, and takes place over several days. It is not effectively removed from the blood by dialysis.
Characteristics in patientsNo special characteristics. See section 4.4 "Special warnings and special precautions for use" for further information.
Capsule fill:Anhydrous Lactose Corn starchTalcMagnesium stearate
Capsule cap and body:Titanium dioxide (E171)GelatinWaterSodium lauryl sulfatePrinting ink:ShellacDehydrated alcoholIsopropyl alcoholButyl alcoholPropylene glycol (E1520)Strong ammonia solutionBlack iron oxide (E172)Potassium hydroxidePurified water
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