Serum levels have been uniform and predictable from person to person and dose to dose. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Clostridioides difficile-Associated Diarrhea. Package insert / product label Generic name: clindamycin phosphate Dosage form: vaginal cream Drug classes: Topical acne agents, Vaginal anti-infectives Medically reviewed by Drugs.com. When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency. Clindamycin is a semisynthetic antibiotic produced by a . when reconstituted Clindamycin Palmitate Hydrochloride Granules, MANUFACTURE(68462-142, 68462-143, 68462-144), ANALYSIS(68462-142, 68462-143, 68462-144). CLINICAL PHARMACOLOGY Toll No: 1-800-206-7821 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India. Clindamycin Hydrochloride Capsules, USP 300 mg are size 0 hard gelatin capsules with a light blue opaque cap and a light blue opaque body, imprinted with G on the cap and 144 on the body with black ink and filled with white to off-white powder. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Clindamycin is widely distributed in body fluids and tissues (including bones). In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities. Macrolide-resistant isolates of staphylococci and beta-hemolytic streptococci should be screened for induction of clindamycin resistance using the D-zone test. CLINICAL PHARMACOLOGY Absorption Clindamycin hydrochloride is rapidly absorbed from the canine gastrointestinal tract. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness. ], 1. Adults: Serious infections 150 to 300 mg every 6 hours. Anaphylactic and Severe Hypersensitivity Reactions. Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. Clostridium difficile-associated disease (CDAD) Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including clindamycin phosphate. Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate HCl contained in clindamycin palmitate hydrochloride flavored granules. Obese Pediatric Patients Aged 2 to Less than 18 Years and Obese Adults Aged 18 to 20 years. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. Multiple-dose studies in neonates and infants up to 6 months of age show that the drug does not accumulate in the serum and is excreted rapidly. Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction and hypersensitivity have also been reported. Children weighing 10 kilograms (kg) or moreDose is based on body weight and must be determined by your doctor. Long term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential. Vhody smoothies zvisia od toho, o do nich dte. Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. WARNING Streptococcus mitis The following in vitro data are available, but their clinical significance is unknown. Fusobacterium nucleatum Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and CLEOCIN Phosphate in an Aged Population. Clindamycin is widely distributed in body fluids and tissues (including bones). However, other reported clinical experience indicates that antibiotic-associated colitis and diarrhea (due to Clostridium difficile) seen in association with most antibiotics occur more frequently in the elderly (>60 years) and may be more severe. However, the efficacy of clindamycin in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride and other antibacterial drugs, clindamycin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported (See WARNINGS). Sterile Solution is for Intramuscular and Intravenous Use Warning Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. 10. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. More severe infections: 1725 mg/kg/day (8.512.5 mg/lb/day) divided into 3 or 4 equal doses. Photo: Andreas Neumann. When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL. Reconstitute bottles of 100 mL with 75 mL of water. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules. Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Skin and Mucous Membranes: Pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported (see Hypersensitivity Reactions). Therefore, it should be used with caution in patients receiving such agents. East Brunswick, NJ 08816. Therefore, it should be used with caution in patients receiving such agents. Hypertoxin producing strains of C.difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. Musculoskeletal: Cases of polyarthritis have been reported. These patients should be carefully monitored for the development of diarrhea. Reconstitute bottles of 100 mL with 75 mL of water. Microbiology Although clindamycin palmitate HCl is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin. Therefore inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. Can I take clindamycin if I am allergic to penicillin? Un programa que dej de tener gracia cuando se. Patients should be counseled that antibacterial drugs including clindamycin palmitate hydrochloride for oral solution (Pediatric) should only be used to treat bacterial infections. Clindamycin Hydrochloride Capsules, USP are available in the following strengths, colors and sizes: Clindamycin Hydrochloride Capsules, USP 75 mg are size 3 hard gelatin capsules with a light green opaque cap and a light opaque green body, imprinted with G on the cap and 142 on the body with black ink and filled with white to off-white powder. Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and CLEOCIN Phosphate in an Aged Population. Staphylococci: Serious respiratory tract infections; serious skin and soft tissues infections. However, periodic liver enzyme determinations should be made when treating patients with severe liver disease. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Clindamycin has been shown to have in vitro activity against isolates of the following organisms: Aerobic gram positive cocci, including: Indicated surgical procedures should be performed in conjunction with antibiotic therapy. C.difficile produces toxins A and B which contribute to the development of CDAD. Therefore inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. 100 mL (when mixed) Clindamycin palmitate hydrochloride for oral solution Flavored Granules contain clindamycin palmitate hydrochloride for reconstitution. Therefore, dosage modification in patients with liver disease may not be necessary. In the mice, convulsions and depression were observed. Cleft palates were observed in fetuses from one Reproduction studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (3.2 and 1.6 times the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (1.3 and 0.7 times the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity. During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed. Clindamycin palmitate hydrochloride for oral solution (Pediatric) should be prescribed with caution in atopic individuals. Serum concentrations exceed the MIC (minimum inhibitory concentration) for most indicated organisms for at least six hours following administration of the usually recommended doses. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Clindamycin should be used during the first trimester of pregnancy only if clearly needed. M.L.No. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Clinical studies of clindamycin did not include sufficient numbers of patients age 65 and over to determine whether they respond differently from younger patients. Clindamycin hydrochloride, USP is the hydrated hydrochloride salt of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. Hypersensitivity Reactions: Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. Clindamycin is potentially nephrotoxic and cases with acute kidney injury have been reported. If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see BOXED WARNING). Limited published data based on breast milk sampling reports that clindamycin appears in human breast milk in the range of less than 0.5 to 3.8 mcg/mL. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. However, other reported clinical experience indicates that antibiotic-associated colitis and diarrhea (due to Clostridioides difficile) seen in association with most antibiotics occur more frequently in the elderly (>60 years) and may be more severe. Clindamycin should be dosed based on total body weight regardless of obesity. Streptococcus pneumoniae (penicillin-susceptible strains) For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC. Clindamycin is bacteriostatic. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. No significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges. When clindamycin palmitate hydrochloride for oral solution (Pediatric) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS). Therefore, dosage modification in patients with liver disease may not be necessary. To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water. By the fifth dose, the 6-hour serum concentration had reached equilibrium. Patients should be counseled that antibacterial drugs including clindamycin palmitate hydrochloride for oral solution should only be used to treat bacterial infections. 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