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Cleocin (Clindamycin Hydrochloride) - Summary

 


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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 over-growth 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.

 

CLEOCIN SUMMARY

Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.

Clindamycin 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 (eg, 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 tuboovarian 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 procedure * is recommended for determining susceptibility of aerobic bacteria to clindamycin. A description is contained in the CLEOCIN® Susceptibility Disk 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 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.


*Bauer AW, Kirby WMM, Sherris JC, et al: Antibiotic susceptibility testing by a standardized single disc method. Am J Clin Pathol 45:493-496, 1966. Standardized disc susceptibility test. Federal Register 37:20527-29, 1972.

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 HCl and other antibacterial drugs, CLEOCIN HCl 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 indications & dosage >>

CLEOCIN NEWS HIGHLIGHTS

Published Studies Related to Cleocin (Clindamycin)

A novel gel formulation of clindamycin phosphate-tretinoin is not associated with acne flaring. [2008.08]

Cefepime/clindamycin vs. ceftriaxone/clindamycin for the empiric treatment of poisoned patients with aspiration pneumonia. [2008.08]

Human lactobacilli as supplementation of clindamycin to patients with bacterial vaginosis reduce the recurrence rate; a 6-month, double-blind, randomized, placebo-controlled study. [2008.01.15]

The efficacy and safety of a single dose of polyhexamethylene biguanide gynaecologic solution versus a seven-dose regimen of vaginal clindamycin cream in patients with bacterial vaginosis. [2008.01]

Pharmacokinetics and bioequivalence study of clindamycin hydrochloride formulations after single-dose administration in healthy Chinese male volunteers. [2008]

more >>

Clinical Trials Related to Cleocin (Clindamycin)

Dalacin-T Gel Post Approval Study [Completed]

A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS [Completed]

The Safety and Efficacy of Clindamycin and Primaquine in the Treatment of Mild - Moderate Pneumocystis Carinii Pneumonia in Patients With AIDS [Completed]

Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne [Recruiting]

Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin [Completed]

more >>

CLEOCIN PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Cleocin has an overall score of 2. The effectiveness score is 8 and the side effect score is 2. The scores are on ten point scale: 10 - best, 1 - worst.
 

Cleocin review by 61 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   infection in mandible
Dosage & duration:   150 mg taken 4 times a day for the period of 6 weeks
Other conditions:   asthma
Other drugs taken:   benadryl
  
Reported Results
Benefits:   Eradicated the infection.
Side effects:   Severe pruritis, bruising, hives.
Comments:   Received IV in hospital x5 days for a very severe abscessed tooth leading to bone infection; developed hives with first dose, so they gave me benadryl every 6 hours. After being discharged, I took the oral Cleocin for about 5-6 weeks, along with benadryl. I developed severe itching (mostly in the legs and back, some in the neck area) and severe bruising as a result of trying to relieve the itch. The itching, hives and bruising dissipated about 2-4 weeks after final dose.

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Page last updated: 2008-11-02

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