CLINDAMYCIN PALMITATE HYDROCHLORIDE- PEDIATRIC solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLINDAMYCIN PALMITATE HYDROCHLORIDE (UNII: VN9A8JM7M7) (CLINDAMYCIN - UNII:3U02EL437C)

Available from:

Aurobindo Pharma Limited

INN (International Name):

CLINDAMYCIN PALMITATE HYDROCHLORIDE

Composition:

CLINDAMYCIN 75 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin palmitate hydrochloride for oral solution (Pediatric) 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 BOXED WARNING , 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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin palmitate hydrochloride for oral solution (Pediatric) and other antibacterial drugs, clindamycin palmitate hydrochloride for oral solution (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.

Product summary:

Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) is white flavored granules and becomes colorless to off-white with cherry flavored solution after reconstitution. It is available in bottles of 100 mL.                                                                                                 Bottles of 100 mL (Glass)        NDC 65862-596-01                                                                                                 Bottles of 100 mL (HDPE)       NDC 65862-596-02 When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) - CLINDAMYCIN
PALMITATE HYDROCHLORIDE (PEDIATRIC) SOLUTION
AUROBINDO PHARMA LIMITED
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CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP (PEDIATRIC)
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
clindamycin palmitate hydrochloride for oral solution (Pediatric) and
other antibacterial
drugs, clindamycin palmitate hydrochloride for oral solution
(Pediatric) should be used
only to treat or prevent infections that are proven or strongly
suspected to be caused
by bacteria.
_Not for Injection_
WARNING
_CLOSTRIDIUM DIFFICILE _ASSOCIATED DIARRHEA (CDAD) HAS BEEN REPORTED
WITH
USE OF NEARLY ALL ANTIBACTERIAL AGENTS, INCLUDING CLINDAMYCIN 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_.
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.
_C.DIFFICILE _PRODUCES TOXINS A AND B WHICH CONTRIBUTE TO THE
DEVELOPMENT
OF CDAD. HYPERTOXIN PRODUCING STRAINS OF _C.DIFFICILE _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 _C.DIFFICILE _MAY NEED TO BE DISCONTINUED.
APPROPRIATE
FLUID AND ELECTROLYTE MANAGEMENT, PROTEIN SUPPLEMENTATION, ANTIBIOTIC
TREATMENT OF _C.DIFFICILE_, AND SURGICAL EVALUATION SHOULD BE
INSTIT