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.
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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.
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NEWS HIGHLIGHTS RELATED TO CLEOCIN PEDIATRIC
Published Studies Related to Cleocin Pediatric (Clindamycin)
An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% for the once-daily treatment of moderate to severe acne vulgaris: assessment of efficacy and safety in 2813 patients. [2008.11]
OBJECTIVE: We sought to evaluate efficacy, safety, and tolerability of a combination of clindamycin [generic for Cleocin Pediatric] phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) aqueous gel in moderate to severe acne vulgaris... CONCLUSIONS: Clindamycin-BPO 2.5% provides statistically significant greater efficacy than individual active ingredients and vehicle with a highly favorable safety and tolerability profile.
A novel gel formulation of clindamycin phosphate-tretinoin is not associated with acne flaring. [2008.08]
Concern exists about using topical retinoids on patients with inflammatory acne lesions, fearing that a flare in inflammation will occur. In 3 multicenter, double-blind, randomized, phase 3 trials of a clindamycin [generic for Cleocin Pediatric] phosphate 1.2%-tretinoin 0.025% gel (CLIN/RA), clinical evaluations after 2 weeks of treatment determined if flaring occurred in participants treated with tretinoin gel 0.025% (RA) monotherapy, and the difference in inflammation when treated with the combination formulation.
Cefepime/clindamycin vs. ceftriaxone/clindamycin for the empiric treatment of poisoned patients with aspiration pneumonia. [2008.08]
Different antimicrobial treatments have proved to be effective in patients with aspiration pneumonia. However, resistant bacterial strains are commonly observed in hospital settings challenging the empirical treatment of these patients... In conclusion, efficacy of empiric treatment of poisoned patients with aspiration pneumonia with ceftriaxone/clindamycin [generic for Cleocin Pediatric] was comparable to treatment with cefepime/clindamycin.
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]
BACKGROUND: The primary objective of this study was to investigate if supplementary lactobacilli treatment could improve the initial cure rate after vaginal clindamycin [generic for Cleocin Pediatric] therapy, and secondly, if lactobacilli as repeated adjunct treatment during 3 menstrual cycles could lengthen the time to relapse after initial cure... CONCLUSION: The study shows that supplementary treatment combining two different strains of probiotic lactobacilli does not improve the efficacy of BV therapy during the first month of treatment, but for women initially cured, adjunct treatment of lactobacilli during 3 menstrual cycles lengthens the time to relapse significantly in that more women remained BV free at the end of the 6-month follow up. TRIAL REGISTRATION NUMBER: ISRCTN62879834.
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]
OBJECTIVE: At the present the clinical treatment of choice of bacterial vaginosis (BV) is the use of systemic or local metronidazole or clindamycin [generic for Cleocin Pediatric]. Aim of the study was to evaluate the efficacy and tolerability of a single dose of gynaecologic solution, Polyhexamethylene Biguanide (PHMB), Monogin, in the treatment of BV in comparison to a 7-days treatment with clindamycin vaginal cream... CONCLUSIONS: A single dose, of PHMB gynaecologic solution (Monogin) is equivalent in safety and efficacy to a 7-dose regimen of Clindamycin vaginal cream in the treatment of bacterial vaginosis. Futhermore the compliance as been reported to be higher for the single-dose treatment with PHMB than with 7-days treatment with Clindamycin.
Clinical Trials Related to Cleocin Pediatric (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]
To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine
and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients
with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most
frequent cause of focal central nervous system infection in patients with AIDS. If untreated,
the encephalitis is fatal. At present, it is standard practice to give a combination of
pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of
sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of
therapy difficult. There is some information that high doses of parenteral (such as by
injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus
sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients
with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however,
is costly, requires hospitalization, and is inconvenient for the patient. There is some
indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral
clindamycin may be effective. Leucovorin calcium is useful in preventing
pyrimethamine-associated bone marrow toxicity.
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]
Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative
for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a
combination product including these actives for the treatment of acne vulgaris.
You may be suitable to take part in this study because you have acne vulgaris on your face.
Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms,
legs, and back.
Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin [Completed]
Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic
that has been shown to be effective against malaria, although it cannot achieve a total cure
in all patients. A previous small study has shown that in combination with clindamycin, an
commonly used antibiotic, it is highly effective and safe, in asymptomatic carriers of
malaria parasites. The current study will evaluate the efficacy and safety of the combination
given for three days in children with uncomplicated malaria in Gabon.
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Page last updated: 2009-02-07
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