Clindamycin Palmitate Hydrochloride Granule
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Questions & Answers
Side Effects & Adverse Reactions
See WARNING box.
Clostridium difficileassociated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Clindamycin Palmitate Hydrochloride for Oral Solution, 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.difficileproduces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C.difficilecause 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.difficilemay 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.
Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
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Uses
Clindamycin Palmitate Hydrochloride for Oral Solution, USP 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).
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.
Serious respiratory tract infections; serious skin and soft tissue infections.
Serious respiratory tract infections; serious skin and soft tissue infections.
Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
A standardized disk testing procedure2 is recommended for determining susceptibility of aerobic bacteria to clindamycin.
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 Clindamycin Palmitate Hydrochloride for Oral Solution, USP and other antibacterial drugs, Clindamycin Palmitate Hydrochloride for Oral Solution, USP 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.
History
There is currently no drug history available for this drug.
Other Information
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. The structural formula is represented below:
The chemical name for clindamycin palmitate hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-palmitate monohydrochloride.
Clindamycin Palmitate Hydrochloride for Oral Solution, USP contains clindamycin palmitate hydrochloride for reconstitution. Each 5 mL contains the equivalent of 75 mg clindamycin. Inactive ingredients: artificial cherry flavor, dextrin, ethylparaben, poloxamer 188, simethicone, sucrose.
Sources
Clindamycin Palmitate Hydrochloride Granule Manufacturers
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Paddock Laboratories, Llc
![Clindamycin Palmitate Hydrochloride Granule, For Solution [Paddock Laboratories, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Clindamycin Palmitate Hydrochloride Granule | Paddock Laboratories, Llc
If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).
Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate hydrochloride contained in Clindamycin Palmitate Hydrochloride for Oral Solution.
Serious infections: 8 to 12 mg/kg/day (4 to 6 mg/lb/day) divided into 3 or 4 equal doses.
Severe infections: 13 to 16 mg/kg/day (6.5 to 8 mg/lb/day) divided into 3 or 4 equal doses.
More severe infections: 17 to 25 mg/kg/day (8.5 to 12.5 mg/lb/day) divided into 3 or 4 equal doses.
In pediatric patients weighing 10 kg or less, ½ teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.
Serious infections due to anaerobic bacteria are usually treated with Clindamycin Phosphate Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with Clindamycin Palmitate Hydrochloride for Oral Solution.
NOTE: In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.
Reconstitution Instructions:When reconstituted with water as follows, each 5 mL (teaspoon) of solution contains clindamycin palmitate hydrochloride equivalent to 75 mg clindamycin.
Reconstitute bottles of 100 mL with 75 mL of water. Add a large portion of the water and shake vigorously; add the remainder of the water and shake until the solution is uniform.
Storage Conditions:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]
Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. The solution is stable for 2 weeks at room temperature.
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