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Cleocin Pediatric (Clindamycin Palmitate Hydrochloride) - Summary

 
 



WARNING

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening.

Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Because clindamycin 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.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis".

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis.

Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy with clindamycin.

 

SUMMARY

Cleocin Pediatric®
(clindamycin palmitate hydrochloride
for oral solution, USP)

Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.

CLEOCIN PEDIATRIC (clindamycin palmitate HCl) is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.

Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).

Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection.

Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.

Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.

Pneumococci: Serious respiratory tract infections.

Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.

In Vitro Susceptibility Testing

A standardized disk testing procedure2 is recommended for determining susceptibility of aerobic bacteria to clindamycin. A description is contained in the CLEOCIN Susceptibility Disk (clindamycin) insert. Using this method, the laboratory can designate isolates as resistant, intermediate, or susceptible. Tube or agar dilution methods may be used for both anaerobic and aerobic bacteria. When the directions in the CLEOCIN Susceptibility Powder insert are followed, an MIC (minimal inhibitory concentration) of 1.6 mcg/mL may be considered susceptible; MICs of 1.6 to 4.8 mcg/mL may be considered intermediate and MICs greater than 4.8 mcg/mL may be considered resistant.

CLEOCIN Susceptibility Disks 2 mcg. See package insert for use.

CLEOCIN Susceptibility Powder 20 mg. See package insert for use.

For anaerobic bacteria the minimal inhibitory concentration (MIC) of clindamycin can be determined by agar dilution and broth dilution (including microdilution) techniques. If MICs are not determined routinely, the disk broth method is recommended for routine use. THE KIRBY-BAUER DISK DIFFUSION METHOD AND ITS INTERPRETIVE STANDARDS ARE NOT RECOMMENDED FOR ANAEROBES.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN PEDIATRIC and other antibacterial drugs, CLEOCIN PEDIATRIC should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.


See all Cleocin Pediatric indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Cleocin Pediatric (Clindamycin)

Clindamycin versus trimethoprim-sulfamethoxazole for uncomplicated skin infections. [2015]
community-acquired methicillin-resistant Staphylococcus aureus (MRSA) is unclear... CONCLUSIONS: We found no significant difference between clindamycin and TMP-SMX,

Efficacy of clindamycin in reducing pain following tonsillectomy in adults: a double-blind, randomised trial. [2013]
reducing throat pain after tonsillectomy in adult patients... CONCLUSION: Topical clindamycin was not demonstrated to be more effective than

Topical 4% nicotinamide vs. 1% clindamycin in moderate inflammatory acne vulgaris. [2013]
Nicotinamide and clindamycin gels are two popular topical medications for acne vulgaris... Skin type is a significant factor in choosing between topical nicotinamide and clindamycin in patients with acne vulgaris.

Fitzpatrick skin types and clindamycin phosphate 1.2%/benzoyl peroxide gel: efficacy and tolerability of treatment in moderate to severe acne. [2012]
efficacy of acne medications in skin of color... CONCLUSIONS: Acne subjects with Fitzpatrick skin types IV-VI were not found to be

Treatment of moderate to severe acne vulgaris in a Hispanic population: a post-hoc analysis of efficacy and tolerability of clindamycin phosphate 1.2%/benzoyl peroxide 2.5% gel. [2012]
in Hispanics... CONCLUSIONS: Overall efficacy and tolerability with clindamycin phosphate

more studies >>


Page last updated: 2015-08-10

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