Clindamycin Palmitate Hydrochloride (Cleocin Pediatric)

Trade Name : Cleocin Pediatric

Pharmacia and Upjohn Company LLC

GRANULE, FOR SOLUTION

Strength 75 mg/5mL

CLINDAMYCIN PALMITATE HYDROCHLORIDE Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Clindamycin Palmitate Hydrochloride (Cleocin Pediatric) which is also known as Cleocin Pediatric and Manufactured by Pharmacia and Upjohn Company LLC. It is available in strength of 75 mg/5mL per ml. Read more

Clindamycin Palmitate Hydrochloride (Cleocin Pediatric) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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 bacteria.
  • Not for Injection
  • Clostridium difficilen- C.difficile
  • 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 section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of 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 may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
  • 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--4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L--u03b1-D--octopyranoside 2-palmitate monohydrochloride.
  • CLEOCIN PEDIATRIC Flavored Granules contain clindamycin palmitate hydrochloride for reconstitution. Each 5 mL contains the equivalent of 75 mg clindamycin. Inactive ingredients: artificial cherry flavor, ethylparaben, pluronic F68, simethicone, sucrose.
  • No data
  • 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 , before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
  • Anaerobes:
  • Streptococci:
  • Staphylococci:
  • Pneumococci:
  • 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.
  • This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
  • See .
  • No data
  • The following reactions have been reported with the use of clindamycin.
  • Infections and infestations: Clostridium difficile
  • Gastrointestinal:n- Arrayn- Array
  • Hypersensitivity Reactions:n- Array
  • Skin and Mucous Membranes:n- Array
  • Liver:
  • Renal:
  • Hematopoietic:
  • Immune system
  • Musculoskeletal:
  • Significant mortality was observed in mice at an intravenous dose of 855 mg/kg and in rats at an oral or subcutaneous dose of approximately 2618 mg/kg. In the mice, convulsions and depression were observed. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.
  • If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see ).
  • Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate HCl contained in CLEOCIN PEDIATRIC Flavored Granules.
  • Serious infections: 8u201312 mg/kg/day (4u20136 mg/lb/day) divided into 3 or 4 equal doses.
  • Severe infections: 13u201316 mg/kg/day (6.5u20138 mg/lb/day) divided into 3 or 4 equal doses.
  • More severe infections: 17u201325 mg/kg/day (8.5u201312.5 mg/lb/day) divided into 3 or 4 equal doses.
  • In pediatric patients weighing 10 kg or less, u00bd teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose. Clindamycin should be dosed based on total body weight regardless of obesity.
  • Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with CLEOCIN PEDIATRIC.
  • NOTE:
  • Reconstitution Instructions:
  • Reconstitute bottles of 100 mL with 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:
  • Do 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.
  • CLEOCIN PEDIATRIC Flavored Granules for oral solution is available in bottles of 100 mL (NDC 0009-0760-04).
  • When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL.
  • Rx only
  • No data
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
  • LAB-0041-22.0
  • Revised: 2/2020
  • NDC 0009-0760-04
  • Pfizer
  • Cleocin Pediatric
  • When reconstituted each 5 mL contains
  • 75 mg*
  • 100 mL (when mixed)n n
  • NDC 0009-0760-04
  • Pfizer
  • CleocinPediatric
  • When reconstituted each5 mL contains
  • 75 mg*
  • 100 mL (when mixed)n n

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