Chemical formula: C₁₈H₃₃ClN₂O₅S Molecular mass: 424.98 g/mol PubChem compound: 446598
Clindamycin interacts in the following cases:
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.
Increased 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.
Antibiotics can reduce the efficacy of the combined oral contraceptive pill. Additional contraceptive precautions should be taken during treatment and for up to seven days after stopping treatment.
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. It should be used with caution, therefore, in patients receiving such agents.
Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, the two drugs should not be administered concurrently.
Care should be observed in the use of clindamycin in atopic individuals, particularly those with asthma.
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.
Studies indicate a toxin(s) produced by clostridia (especially Clostridium difficile) is the principal direct cause of antibiotic-associated colitis. These studies also indicate that this toxigenic clostridium is usually sensitive in vitro to vancomycin. When 125mg to 500mg of vancomycin are administered orally four times a day for 7-10 days, there is a rapid observed disappearance of the toxin from faecal samples and a coincident clinical recovery from the diarrhoea (where the patient is receiving cholestyramine in addition to vancomycin, consideration should be given to separating the times of administration).
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 Clostridium difficile.
Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile.
Clostridium difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of Clostridium difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 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.
Oral and subcutaneous reproductive toxicity studies in rats and rabbits revealed no evidence of impaired fertility or harm to the foetus due to clindamycin, except at doses that caused maternal toxicity. Animal reproduction studies are not always predictive of human response.
Safety for use in pregnancy has not been established. Animal studies do not indicate reproductive toxicity.
There are no adequate and well-controlled studies in pregnant women during the first trimester. A moderate amount of data from clinical trials in pregnant women (between 300-1000 pregnancy outcomes) during the second and third trimesters indicates systemic administration of clindamycin has not been associated with an increased frequency of congenital abnormalities or feto/neonatal toxicity. Animal reproductive toxicity studies revealed no evidence of impaired fertility or harm to the foetus due to clindamycin, except at doses that caused maternal toxicity. Animal reproduction studies are not always predictive of human response.
Clindamycin topical solution should be used during pregnancy only if clearly needed.
There are no adequate and well-controlled studies in pregnant women during their first trimester. There was evidence of maternal toxicity and embryofetal toxicity in animal studies. Because animal reproduction studies are not always predictive of human response, this drug should be used during the first trimester of pregnancy only if clearly needed.
In a clinical trial in pregnant women during the second trimester, clindamycin cream was effective in treating bacterial vaginosis, and no drug-related medical events were reported in the neonates. However, as with any drug used during pregnancy, a careful risk-benefit assessment should take place beforehand.
Clindamycin is excreted in breast milk. Orally and parenterally 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
Clindamycin is excreted in human milk. Caution should be exercised when clindamycin 150mg/ml solution for injection and infusion is administered to a nursing mother. It is unlikely that a nursing infant can absorb a significant amount of clindamycin from its gastro-intestinal tract.
It is not known whether clindamycin is excreted in human milk following use of topical solution. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. As a general rule, breast-feeding should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.
It is not known if clindamycin is excreted in breast milk following the use of vaginally administered clindamycin phosphate. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Therefore, a full assessment of benefit-risk should be made when consideration is given to using vaginal clindamycin phosphate in a nursing mother.
In animal studies, clindamycin had no effect on fertility or mating ability.
Clindamycin has no or negligible influence on the ability to drive and use machines.
None known.
The effect of clindamycin on the ability to drive or operate machinery has not been systematically evaluated.
The adverse reactions listed below were identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. 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.
Common: Pseudomembranous colitis*
Not Known: Clostridium difficile colitis*, vaginal infection*
Not Known: Agranulocytosis*, neutropenia*, thrombocytopenia*, leukopenia*, eosinophilia
Not Known: Anaphylactic shock*, anaphylactoid reaction*, anaphylactic reaction*, hypersensitivity*
Not Known: Dysgeusia
Common: Diarrhoea, abdominal pain
Uncommon: Vomiting, nausea
Not Known: Oesophageal ulcer*, oesophagitis*
Not Known: Jaundice*
Uncommon: Rash maculopapular, urticaria
Not Known: Toxic epidermal necrolysis (TEN), Stevens Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP, angioedema*, dermatitis exfoliative*, dermatitis bullous*, erythema multiforme*, pruritus, rash morbilliform*
Common: Liver function test abnormal
* ADR identified post-marketing.
The frequency of undesirable effects listed below 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), Not known (cannot be estimated from the available data).
Not Known: Transient neutropenia (leucopenia), eosinophilia, agranulocytosis and thrombocytopenia
Not Known: Cardiopulmonary arrest and hypotension have been reported following too rapid intravenous administration
Not Known: Jaundice and abnormalities in liver function
Not Known: Anaphylactoid reactions
Not known: Dysgeusia have been observed upon systemic administration of clindamycin using injectables (IM or IV), capsules or oral granulate solutions
Not Known: Oesophageal ulcers, oesophagitis with oral preparations, nausea, vomiting, abdominal pain and diarrhoea
Not Known: Local irritation, pain, abscess formation have been observed in conjunction with IM injection. These reactions can be minimised by deep IM injection and avoiding the use of an indwelling catheter, thrombophlebitis has been reported with IV injection
Not Known: Generalised mild to moderate morbilliform-like skin rashes, Erythema multiforme resembling Stevens-Johnson syndrome, exfoliative and vesiculobullous dermatitis, toxic epidermal necrolysis, Maculopapular rash, urticaria, Pruritus, Serious cutaneous adverse reaction (SCAR)
Not Known: Vaginitis
The adverse reactions listed below were identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. 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 (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions possibly or probably related to Clindamycin Phosphate Topical Solution based on clinical trial experience and post-marketing surveillance:
Frequency Not Known: Gram-negative folliculitis, Pseudomembranous colitis
Frequency Not Known: Stinging of the eye
Uncommon: Gastrointestinal disturbances
Frequency Not Known: Abdominal pain
Very Common: Skin dryness, Skin irritation, Urticaria
Common: Skin oiliness
Frequency Not Known: Contact dermatitis
The safety of clindamycin vaginal cream was evaluated in both non pregnant patients and patients during their second and third trimesters of pregnancy.
Very common: Cervicitis
Common: Vaginal candidiasis, vulvovaginitis
Uncommon: Vaginitis/vaginal infection, urinary tract infection, candidiasis (body), fungal infection
Not known: Trichomonal vaginitis, bacterial infection, upper respiratory infection, candidiasis (skin)
Uncommon: Allergic reaction
Not known: Hyperthyroidism
Uncommon: Taste perversion
Uncommon: Headache, dizziness
Uncommon: Vertigo
Uncommon: Epistaxis
Common: Abdominal cramps
Uncommon: Abdominal pain, halitosis, diarrhoea, nausea, vomiting, constipation, dyspepsia, flatulence
Not known: Generalised abdominal pain, localised abdominal pain, abdominal distension, pseudomembranous colitis
Common: Pruritus (non-application site)
Uncommon: Rash, erythema, urticaria
Not known: Maculopapular rash
Not known: Back pain
Uncommon: Dysuria, glycosuria, proteinuria
Common: Vulvovaginal disorder, vulvovaginal discomfort, vaginal discharge
Uncommon: Vaginal pain
Not known: Menstrual disorder, metrorrhagia, endometriosis, pelvic pain
Not known: Abnormal labour
Not known: Inflammatory swelling, generalised pain
Not known: Abnormal microbiological test
† Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Not known (frequency cannot be estimated from the available data)
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
