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Clindamycin (Clindamycin Hydrochloride) - Warnings and Precautions

 
 



Boxed Warning Section

Clostridium difficile

associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of

C. difficile

.

Because clindamycin hydrochloride therapy has been asso­ciated with severe colitis which may end fatally, it should be reserved for serious infec­tions where less toxic antimicrobial agents are inappropriate, as described in the

INDICA­TIONS AND USAGE

section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. 

 

C. difficile

produces toxins A and B, which contribute to the development of CDAD.  Hypertoxin producing strains of

C. 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 diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

 

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against

C. difficile

may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of

C. difficile

, and surgical evaluation should be instituted as clinically indicated.

 

 

Warnings Section

See

WARNING

box.

 

Clostridium difficile

associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of

C. difficile

.



C. difficile

produces toxins A and B, which contribute to the development of CDAD.  Hypertoxin producing strains of

C. 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 diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. 

 

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against

C. difficile

may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of

C. difficile

, and surgical evaluation should be instituted as clinically indicated.

A careful inquiry should be made concerning previous sensitivities to drugs and other allergens.

 

Usage in Meningitis 

 

Since clindamycin does not dif­fuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.

 

Precautions Section

Review of experience to date suggests that a sub­group of older patients with associated severe illness may tolerate diarrhea less well. When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency.

 

Clindamycin hydrochloride should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

 

Clindamycin hydrochloride should be prescribed with caution in atopic individuals.

 

Indicated surgical procedures should be performed in conjunction with antibiotic therapy.

 

The use of clindamycin hydrochloride occasionally results in over­growth of nonsusceptible organisms—particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.

 

Clindamycin dosage modification may not be neces­sary in patients with renal disease. In patients with mod­erate to severe liver disease, prolongation of clindamycin half-life has been found. However, it was postulated from studies that when given every eight hours, accumulation should rarely occur. Therefore, dosage modification in patients with liver disease may not be necessary. However, periodic liver enzyme deter­minations should be made when treating patients with severe liver disease.

 

Prescribing clindamycin hydrochloride in the absence of a proven or strongly suspected bacterial infection or a prophylac­tic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resis­tant bacteria.

 

Patients should be counseled that antibacterial drugs, including clindamycin hydrochloride, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When clindamycin hydrochloride is pre­scribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effec­tiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by clindamycin hydrochloride or other antibacte­rial drugs in the future.

 

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

 

During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed.

 

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

 

Antagonism has been demonstrated between clindamycin and erythromycin

in vitro

. Because of possible clinical significance, these two drugs should not be administered concurrently.

 

Long-term studies in animals have not been per­formed with clindamycin to evaluate carcinogenic poten­tial. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative.

 

Fertility studies in rats treated orally with up to 300 mg/kg/day (approximately 1.6 times the highest rec­ommended adult human dose based on mg/m

2

) revealed no effects on fertility or mating ability.

 

Pregnancy Category B

 

Reproduction studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (3.2 and 1.6 times the highest recommended adult human dose based on mg/m

2

, respectively) or subcuta­neous doses of clindamycin up to 250 mg/kg/day (1.3 and 0.7 times the highest recommended adult human dose based on mg/m

2

, respectively) revealed no evi­dence of teratogenicity.

 

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduc­tion studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed.

 

Clindamycin has been reported to appear in breast milk in the range of 0.7 to 3.8 mcg/mL.

 

When clindamycin hydrochloride is administered to the pediatric population (birth to 16 years), appropriate monitoring of organ system functions is desirable.

 

Clinical studies of clindamycin did not include suffi­cient numbers of patients age 65 and over to determine whether they respond differently from younger patients. However, other reported clinical experience indicates that antibiotic-associated colitis and diarrhea (due to

Clostridium difficile

) seen in association with most anti­biotics occur more frequently in the elderly (>60 years) and may be more severe. These patients should be carefully monitored for the development of diarrhea.

 

Pharmacokinetic studies with clindamycin have shown no clinically important differences between young and elderly subjects with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration.

 

Page last updated: 2014-05-19

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