Clindamycin Hydrochloride, Clindamycin Palmitate Hydrochloride, Clindamycin Phosphate: Cautions
GI Effects
Adverse GI effects frequently occur with oral, IM, or IV clindamycin and may be severe enough to necessitate discontinuance of the drug. Adverse GI effects of clindamycin include nausea, vomiting, diarrhea, abdominal pain, and tenesmus. In addition, flatulence, bloating, anorexia, weight loss, and esophagitis have occurred. An unpleasant or metallic taste has occurred occasionally following IV administration of high doses of the drug. Nonspecific colitis and diarrhea, as well as potentially fatal Clostridium difficile-associated diarrhea and colitis (also known as antibiotic-associated pseudomembranous colitis), have also occurred in patients receiving clindamycin.
Diarrhea and Colitis
C. difficile-associated diarrhea and colitis induced by clindamycin is usually characterized by severe diarrhea and abdominal cramps and/or distension and may be associated with the passage of blood or mucus; endoscopic examination is necessary to reveal the presence of pseudomembranes. This diarrhea and colitis frequently is accompanied by fever and leukocytosis; rarely, reactive polyarthritis and protein-losing enteropathy (in geriatric patients) have been reported in patients with pseudomembranous colitis.
Data from animal and clinical studies indicate that C. difficile-associated diarrhea and colitis is caused by toxin-producing clostridia resistant to the antibiotic being administered. Although the role of these bacteria in antibiotic-associated diarrhea in the absence of colitis is unclear, some evidence suggests that the organism may be the principal pathogen in 15-25% of cases of diarrhea associated with anti-infective use.
Antibiotic-associated diarrhea of unknown cause is far more common than C. difficile-associated diarrhea and/or colitis. If colitis occurs, symptoms usually develop 2-9 days following initiation of clindamycin therapy, but may not occur until several weeks after the drug has been discontinued. C. difficile-associated diarrhea and colitis occurs predominately in institutionalized patients, principally in hospitals, as the result of nosocomial transmission. The infection rarely occurs in a community (outpatient) setting.
The principal reservoirs for the infection are infected humans, both those who are symptomatic and those who are asymptomatic carriers. Patients with symptomatic intestinal infections probably serve as the principal reservoir, but asymptomatic colonization appears to be common in institutions with a high prevalence of symptomatic disease. Health-care workers do not appear to provide a major reservoir for the infection but contribute to transmission because of transient hand carriage of the organism. Environmental surface contamination with, and persistence of, C. difficile spores (which can be highly resistant to cleaning and disinfection measures) have been well documented in hospitals, although the extent to which such contamination contributes to transmission is unclear.
Direct patient exposure to contaminated items (e.g., commodes, bedpans, rectal thermometers, enteral feedings) within the hospital also appears to contribute to transmission. As a result, infection control procedures aimed at reducing horizontal spread of the infection may be important in managing an institutional outbreak.
However, in one reported institutional outbreak, educational measures, enforcement of barrier precautions, and increased attention to environmental cleaning did not affect the rate of C. difficile-associated diarrhea and colitis; only after clindamycin use within the hospital was restricted did the outbreak resolve. Patients admitted to a hospital generally are considered at negligible risk of developing C. difficile-associated diarrhea and colitis until they are exposed to anti-infective therapy; thus, while they may be continually at risk of exposure to the organism while hospitalized, they appear to become vulnerable only after exposure to anti-infective therapy. Exposure to a single prophylactic surgical dose of an anti-infective may be sufficient to place a patient at risk.
The risk of becoming infected with C. difficile increases with an increasing duration of stay within a hospital. Mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance of the drug alone, but diagnosis and management of moderate to severe cases should include appropriate bacteriologic and other (e.g., identification of clostridial toxins) studies, and treatment with fluid, electrolyte, and protein supplementation as indicated; sigmoidoscopy (or other appropriate endoscopic examination) usually is reserved for special situations. Isolation of the patient may also be advisable.
Other causes of colitis should be considered. If C. difficile-associated diarrhea and colitis is moderate to severe or is not relieved by discontinuance of clindamycin, appropriate anti-infective therapy (e.g., oral metronidazole or oral vancomycin) should be administered. Most experts and clinicians state that in order to decrease the incidence of vancomycin-resistant enterococci, metronidazole therapy should be used first in patients with C. difficile-associated diarrhea and colitis, reserving vancomycin therapy for seriously ill patients (i.e., those with severe or potentially life-threatening colitis), patients in whom metronidazole-resistant C. difficile is suspected, patients in whom metronidazole therapy is contraindicated or not tolerated, or those who do not respond to metronidazole. Oral metronidazole therapy also generally is preferred because of cost considerations.
Cholestyramine and colestipol hydrochloride have been shown to bind clostridia-produced toxin(s) in vitro; however, an established benefit of this approach is lacking, and the resins have also been shown to bind vancomycin in vitro. The manufacturers state that systemic corticosteroids and corticosteroid retention enemas may help relieve colitis; however, antiperistaltic and antidiarrheal agents such as opiates and diphenoxylate may prolong and/or worsen the condition. For additional information on the management of this colitis, see Uses: C. difficile-associated Diarrhea and Colitis in Metronidazole 8:30.04.
Dermatologic and Sensitivity Reactions
Generalized mild to moderate morbilliform rash is the most frequently reported adverse reaction to clindamycin. Maculopapular rash, urticaria, pruritus, fever, hypotension, and rarely polyarthritis have also occurred. A few anaphylactoid reactions have been reported in patients receiving clindamycin. Rarely, erythema multiforme, sometimes resembling Stevens-Johnson syndrome, has occurred with the drug.
Local Effects
Thrombophlebitis, erythema, and pain and swelling have occurred with IV administration of clindamycin. IM administration of clindamycin has caused pain, induration, sterile abscess, and reversible increases in serum creatine kinase (CK, creatine phosphokinase, CPK) concentrations. Local reactions can be minimized by giving deep IM injections or avoiding the prolonged use of indwelling IV catheters.
Other Adverse Effects
Other reported adverse effects of clindamycin include transient increases in serum bilirubin, alkaline phosphatase, and AST (SGOT) concentrations; transient leukopenia; neutropenia; eosinophilia; thrombocytopenia; and agranulocytosis.
The relationship of liver function and hematologic abnormalities to clindamycin is not known. Polyarthritis has been reported rarely, and rare occurrences of cardiopulmonary arrest and hypotension have been reported following too rapid IV administration of the drug. Although renal damage has not been directly attributed to clindamycin, renal dysfunction manifested as azotemia, oliguria, and/or proteinuria has been observed rarely in patients receiving the drug. Polyarthritis also has been reported rarely with clindamycin.
Precautions and Contraindications
If clinically important or persistent diarrhea occurs during clindamycin therapy, the drug should be discontinued or, if necessary, continued only with close observation of the patient. Appropriate therapy should be instituted if necessary. (See Cautions: GI Effects.) In addition to antibiotic-associated pseudomembranous colitis, other causes of colitis should be considered in these patients. Experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well than other patients; when clindamycin is indicated in such patients, they should be monitored carefully for changes in bowel movement and/or frequency.
During prolonged clindamycin therapy, liver and renal function tests and blood cell counts should be performed periodically. The use of clindamycin may cause overgrowth of nonsusceptible organisms, particularly fungi. If superinfection occurs, appropriate measures should be taken. Patients receiving the drug who have a preexisting Candida infection should receive concomitant antifungal treatment. If a hypersensitivity reaction occurs during clindamycin therapy, the drug should be discontinued and appropriate therapy (e.g. antihistamines, epinephrine, oxygen, corticosteroids) instituted as necessary.
Cleocin HCl® 75- and 150-mg capsules contain the dye tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals. Although the incidence of tartrazine sensitivity is low, it frequently occurs in patients who are sensitive to aspirin. Clindamycin should be used with caution in patients with a history of GI disease, particularly colitis.
Clindamycin should be used with caution in patients with severe renal and/or hepatic impairment; serum clindamycin concentrations should be monitored during high-dose therapy in these patients. Clindamycin should be used with caution in atopic individuals and is contraindicated in patients who are hypersensitive to either clindamycin or lincomycin. Because clindamycin does not distribute adequately into the CNS, the drug should not be administered systemically for the treatment of CNS infections.
Pediatric Precautions
When clindamycin is administered to pediatric patients 16 years of age, organ system functions should be monitored. Each mL of clindamycin phosphate injection contains 9.45 mg of benzyl alcohol. Although a causal relationship has not been established, administration of injections preserved with benzyl alcohol has been associated with toxicity in neonates. Toxicity appears to have resulted from administration of large amounts (i.e., about 100-400 mg/kg daily) of benzyl alcohol in these neonates. Although use of drugs preserved with benzyl alcohol should be avoided in neonates whenever possible, the American Academy of Pediatrics (AAP) states that the presence of small amounts of the preservative in a commercially available injection should not proscribe its use when indicated in neonates.
Geriatric Precautions
Clinical studies of clindamycin did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently from younger patients. Clinical experience indicates that C. difficile-associated diarrhea and colitis seen in association with anti-infective agent therapy may occur more frequently and be more severe in geriatric patients (i.e., patients older than 60 years of age).
Therefore, geriatric patients receiving clindamycin should be carefully monitored for the development of diarrhea (e.g., changes in bowel frequency). Studies to date have not revealed any clinically important differences in the pharmacokinetics of oral or parenteral clindamycin between younger adults and geriatric patients with normal hepatic function and normal (age-adjusted) renal function.
Mutagenicity and Carcinogenicity
Clindamycin was not mutagenic in a rat micronucleus test or the Ames Salmonella reversion test. Long-term studies in animals have not been performed to date to evaluate the carcinogenic potential of clindamycin.
Pregnancy, Fertitlity and Lactation
Safe use of clindamycin in pregnant women has not been established. Reproduction studies in rats and mice using oral and parenteral dosages of clindamycin up to 600 mg/kg daily (2.1 and 1.1 times, respectively, the maximum recommended human parenteral dosage or 3.2 and 1.6 times, respectively, the maximum human oral dosage on a mg/m2 basis) or subcutaneous doses of clindamycin up to 250 mg/kg daily (0.9-1.3 and 0.5-0.7 times, respectively, the maximum recommended human dosage on a mg/m2 basis) have not revealed evidence of harm to the fetus. While cleft palates were observed in fetuses in one mouse strain, this was considered to be a strain-specific effect since it was not observed in other mouse strains or in other species studied. There are no adequate and controlled studies to date using clindamycin in pregnant women.
Because animal reproduction studies are not always predictive of human response, clindamycin should be used during pregnancy only when clearly needed. The US Centers for Disease Control and Prevention (CDC) recommends that screening and/or treatment for bacterial vaginosis in pregnant women as clinically indicated (see Bacterial Vaginosis: Pregnant Women, under Uses in Metronidazole 8:30.04) should be conducted at the first prenatal visit.
For the treatment of bacterial vaginosis and reduction in the incidence of adverse pregnancy outcomes associated with bacterial vaginosis (e.g., preterm birth), particularly in pregnant women at high risk for complications of pregnancy, a 7-day regimen of oral metronidazole or a 7-day course of oral clindamycin is recommended. Fertility studies in rats treated with oral clindamycin doses up to 300 mg/kg daily (about 1.1-1.6 times the maximum recommended human dose on a mg/m2 basis) have not revealed evidence of impaired fertility or mating ability. Clindamycin is distributed into milk, achieving breast milk concentrations of 0.7-3. mcg/mL at dosages of 150 mg orally to 600 mg IV. Because of the potential for serious adverse reactions from clindamycin in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
Drug Interactions
Neuromuscular Blocking Agents
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the neuromuscular blocking action of other agents (e.g., ether, tubocurarine, pancuronium). Clindamycin should be used with caution in patients receiving such agents, and such patients should be observed for prolongation of neuromuscular blockade.
Aminoglycosides
Clindamycin has been reported to antagonize the bactericidal activity of aminoglycosides in vitro, and some clinicians recommend that these drugs not be used concomitantly. However, in vivo antagonism has not been demonstrated, and clindamycin has been administered successfully in conjunction with an aminoglycoside with no apparent decrease in activity.
Other Drugs
Antagonism of bactericidal activity has been observed between erythromycin and clindamycin in vitro.
Acute Toxcicity
The manufacturer does not report any information to date on overdosage of clindamycin in humans. Convulsions, depression, and death have been reported in mice receiving IV administration of 855-mg/kg doses of clindamycin; death has been reported in rats receiving oral or subcutaneous administration of 2618-mg/kg doses of clindamycin. Clindamycin is not removed by hemodialysis or peritoneal dialysis.
Mechanism of Action
Clindamycin may be bacteriostatic or bactericidal in action, depending on the concentration of the drug attained at the site of infection and the susceptibility of the infecting organism. Clindamycin palmitate hydrochloride and clindamycin phosphate are inactive until hydrolyzed to free clindamycin. This hydrolysis occurs rapidly in vivo. Clindamycin appears to inhibit protein synthesis in susceptible organisms by binding to 50S ribosomal subunits; the primary effect is inhibition of peptide bond formation. The site of action appears to be the same as that of erythromycin, chloramphenicol, lincomycin, oleandomycin, and troleandomycin.
| Dosage forms of Clindamycin: | |||
|---|---|---|---|
| Apo-Clindamycin 300 mg Capsule | Mylan-Clindamycin 300 mg Capsule | Novo-Clindamycin 300 mg Capsule | Dalacin C 150 mg Capsule |
| Clindets 1% pledgets | Clindamycin hcl 150 mg capsule | Clindamycin 2% vaginal cream | Clindamax 2% vaginal cream |
| Clindamycin ph 300 mg/2 ml vial | Cleocin t 1% gel | Cleocin phos 150 mg/ml vial | Cleocin 2% vaginal cream |
| Clindamycin 150 mg/ml addvan | Dalacin C 300 mg Capsule | Cleocin hcl 75 mg capsule | Cleocin hcl 150 mg capsule |
| Clindamycin (60 & 120 Ml) 150 mg/ml | Clindamycin 150 mg/ml | Clindamycin phosphate 1% foam | Clindamycin hcl 300 mg capsule |
| Dalacin C Phosphate 150 mg/ml | Cleocin 150 mg capsule | Clindagel 1% gel | Evoclin 1% foam |
| Clindamycin phos crystals | Cleocin hcl 300 mg capsule | Clindamycin Phosphate 1% Solution 30ml Bottle | Clindamycin phosphate powdr |
| Clindamycin Phosphate 1% Solution 60ml Bottle | Clindamycin Phosphate 1% Gel 30 gm Tube | Clindesse 2% vaginal cream | Clindamycin Phosphate 1% Lotion 60ml Bottle |
| Clindamycin Phosphate 60 1% Swab Box | Clindamycin Phosphate 2% Cream 40 gm Tube | Cleocin-T 1% Gel 30 gm Tube | Cleocin-T 1% Solution 60ml Bottle |
| Clindamycin Phosphate 1% Gel 60 gm Tube | Clindamycin hcl crystals | Cleocin 75 mg/5ml Solution 100ml Bottle | Cleocin 3 100 mg Suppository Box |
| Cleocin 2% Cream 40 gm Tube | Cleocin-T 60 1% Swab Box | Cleocin-T 1% Lotion 60ml Bottle | Cleocin-T 1% Gel 60 gm Tube |
| Clindamycin Phos-Benzoyl Perox 1-5% Gel 50 gm Jar | Clindamycin Phosphate 1% Foam 50 gm Can | Clindagel 1% Gel 40ml Bottle | Evoclin 1% Foam 50 gm Can |
| Clindamycin Phosphate 1% Foam 100 gm Can | Evoclin 1% Foam 100 gm Can | Clindagel 1% Gel 75ml Bottle | Dalacin C Palmitate 15 mg/ml Solution |
| Cleocin 600 mg-d5w-galaxy | Cleocin 900 mg-d5w-galaxy | Clinda-derm 1% solution | Apo-Clindamycin 150 mg Capsule |
| Mylan-Clindamycin 150 mg Capsule | Novo-Clindamycin 150 mg Capsule | Clindamycin ph 9 g/60 ml vial | |
Synonyms of Clindamycin:
Clindamicina [INN-Spanish], Clindamycin, Clindamycin Hcl, Clindamycin Hydrochloride, Clindamycin Phosphate, Clindamycine [French], Clindamycine [INN-French], Clindamycinum [INN-Latin]
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Therapeutic classes of Clindamycin:
Anti-Bacterial Agents, Lincomycins, Protein Synthesis Inhibitors
Delivery
Australia, Canada, Mexico, New Zealand, USA, Europe [Belgium, France, Norway, Holland, Ireland, Spain, Switzerland, Great Britain (UK), Italy] and etc.