Serum half-life of clindamycin is increased slightly in patients with markedly reduced renal function. Severe infections: 13 to 16 mg/kg/day (6.5 to 8 mg/lb/day) divided into 3 or 4 equal doses. An average peak serum concentration of 2.50 mcg/mL was reached in 45 minutes; serum concentration averaged 1.51 mcg/mL at 3 hours and 0.70 mcg/mL at 6 hours. Approximately 10% of the bioactivity is excreted in the urine and 3.6% in the feces; the remainder is excreted as bioinactive metabolites. 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. When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.difficile may need to be discontinued. Serious infections: 8 to 12 mg/kg/day (4 to 6 mg/lb/day) divided into 3 or 4 equal doses. Clindamycin hydrochloride should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Clindamycin has been shown to have in vitro activity against isolates of the following organisms: Aerobic gram positive cocci, including: Clindamycin is widely distributed in body fluids and tissues (including bones). Staphylococcus epidermidis (methicillin-susceptible strains). However, the extent of absorption is not different between age groups and no dosage alteration is necessary for the elderly with normal hepatic function and normal (age-adjusted) renal function1. Store at 20 to 25C (68 to 77F). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. 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. Mechanism of Action For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: http://www.fda.gov/STIC. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing. Pneumococci:Serious respiratory tract infections. Last updated on Jun 1, 2022. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.difficile, and surgical evaluation should be instituted as clinically indicated. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing. Clindamycin is widely distributed in body fluids and tissues (including bones). CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC)- clindamycin palmitate hydrochloride (pediatric)solution Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Hematopoietic: Transient neutropenia (leukopenia) and eosinophilia have been reported. 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. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. 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. Anaphylactic shock and anaphylactic reactions have been reported (see ADVERSE REACTIONS). Medically reviewed by Drugs.com. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin palmitate hydrochloride for oral solution (Pediatric). In patients with moderate to severe liver disease, prolongation of clindamycin half-life has been found. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for clindamycin against isolates of a similar genus or organism group. Approximately 10% of the bioactivity is excreted in the urine and 3.6% in the feces; the remainder is excreted as bioinactive metabolites. Blood level studies comparing clindamycin palmitate HCl with clindamycin hydrochloride show thatboth drugs reach their peak active serum levels at the same time, indicating a rapid hydrolysis of the palmitate to the clindamycin. The following in vitro data are available, but their clinical significance is unknown. Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. By the fifth dose, the 6-hour serum concentration had reached equilibrium. Package insert / product label Generic name: clindamycin phosphate Dosage form: gel Drug classes: Topical acne agents, Vaginal anti-infectives Medically reviewed by Drugs.com. Therefore, inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride and may range in severity from mild diarrhea to fatal colitis. 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. Generic name: clindamycin hydrochloride Fertility studies in rats treated orally with up to 300 mg/kg/day (approximately 1.6 times the highest recommended adult human dose based on mg/m2) revealed no effects on fertility or mating ability. The product is distributed in a single package with assigned NDC . Consider monitoring of renal function particularly in patients with pre-existing renal dysfunction or those taking concomitant nephrotoxic drugs. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Clostridium difficile Associated Diarrhea. Staphylococcus aureus (methicillin-susceptible strains), Streptococcus pneumoniae (penicillin-susceptible strains). This same study revealed that average peak serum concentrations of clindamycin occur 1 hour and 15 minutes after oral dosing. Blood level studies comparing clindamycin palmitate hydrochloride with clindamycin hydrochloride show that both drugs reach their peak active serum levels at the same time, indicating a rapid hydrolysis of the palmitate to the clindamycin. On This Page Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Warnings and Precautions Staphylococcus epidermidis (methicillin-susceptible strains) In case of such an anaphylactic or severe hypersensitivity reaction, discontinue treatment permanently and institute appropriate therapy. Severe hypersensitivity reactions, including severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome (SJS), some with fatal outcome, have been reported(see ADVERSE REACTIONS). 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). The extent of absorption, however, is not different between age groups and no dosage alteration is necessary for the elderly with normal hepatic function and normal (age-adjusted) renal function1. Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. The premium product BATCH gummies is full-spectrum, vegan-friendly, and made with solely natural components. 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. When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL. Macrolide-resistant isolates of staphylococci and beta-hemolytic streptococci should be screened for induction of clindamycin resistance using the D-zone test. The elimination half-life of clindamycin is increased slightly in patients with markedly reduced renal or hepatic function. What are the best antibiotics for a tooth infection? These patients should be carefully monitored for the development of diarrhea. Cross-resistance between clindamycin and lincomycin is complete. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin palmitate hydrochloride for oral solution (Pediatric), and may range in severity from mild diarrhea to fatal colitis. Renal:Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed. However, periodic liver enzyme determinations should be made when treating patients with severe liver disease. The first look at the 'middle aged Love Island' set has been released, which has already been nicknamed the 'Viagra House' by locals after single parents searched for love 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Not for Injection. Reconstitution Instructions: When reconstituted with water as follows, each 5 mL (teaspoon) of solution contains clindamycin palmitate HCl equivalent to 75 mg clindamycin. ], 1. Serum levels at or above 0.5 g/mL can be maintained by oral dosing at a rate of 2.5 mg/lb of clindamycin hydrochloride every 12 hours. (See Hypersensitivity Reactions.). 2) and have revealed no evidence of harm to the fetus due to clindamycin. Reports of agranulocytosis and thrombocytopenia have been made. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.difficile. Last updated on Nov 1, 2022. Clindamycin should be used during the first trimester of pregnancy only if clearly needed. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. Obese Pediatric Patients Aged 2 to Less than 18 Years and Obese Adults Aged 18 to 20 years. Pregnancy: Teratogenic Effects Cross-resistance between clindamycin and lincomycin is complete. Adults: Serious infections 150 to 300 mg every 6 hours. This medicine contains alcohol and is flammable. Pneumococci: Serious respiratory tract infections. Serum half-life of clindamycin is increased slightly in patients with markedly reduced renal function. It is not known whether clindamycin is excreted in human milk following use of CLEOCIN T. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Can clindamycin be used to treat chlamydia? The 75 mg and 150 mg capsules contain FD&C yellow no. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Clindamycin palmitate hydrochloride for oral solution (Pediatric) should be prescribed with caution in atopic individuals. Renal: Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed. Drug class: Lincomycin derivatives. More severe infections 16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses. The product's dosage form is granule, for solution and is administered via oral form. CLINDAMYCIN PALMITATE HYDROCHLORIDE- clindamycin palmitate hydrochloridegranule, for solution Orally and parenterally administered clindamycin has been reported to appear in human breast milk in ranges from <0.5 to 3.8 g/ml. Reproduction studies have been performed in rats and mice using oral and parenteral doses of clindamycin up to 600 mg/kg/day (62 and 25 times, respectively, the maximum human exposure based on body surface area) and have revealed no evidence of harm to the fetus due to clindamycin. 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. 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. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Cleft palates were observed in fetuses from one Clindamycin is potentially nephrotoxic and cases with acute kidney injury have been reported. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL. Clindamycin Hydrochloride Capsules, USP contain clindamycin hydrochloride, USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin. Serum concentrations exceed the MIC (minimum inhibitory concentration) for most indicated organisms for at least six hours following administration of the usually recommended doses. Each 5 mL contains the equivalent of 75 mg clindamycin. Last updated on May 1, 2022. Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. However, it was postulated from studies that when given every eight hours, accumulation should rarely occur. Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE Sterile Solution. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6- (1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo--D-galacto-octopyranoside monohydrochloride. Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting and diarrhea(see BOXED WARNING). It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) is whiteflavored granules and becomes colorless to off-white with cherry flavored solution after reconstitution. Trademarks are the property of their respective owners. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Therefore, dosage modification in patients with liver disease may not be necessary. Hydrochloride for Oral Solution, USP (Pediatric) Children weighing 10 kilograms (kg) or moreDose is based on body weight and must be determined by your doctor. Both tests were negative. In the mice, convulsions and depression were observed. On This Page Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Warnings and Precautions This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin. They are supplied as follows: Bottles of 100 Capsules, NDC 68462-142-01. Immune System: Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported. Upjohn TR 8147-82-9122-021, December 1982. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for clindamycin and any potential adverse effects on the breast-fed child from clindamycin or from the underlying maternal condition. Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see BOXED WARNING). 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 inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. An unpleasant or metallic taste has been reported after oral administration.. Hypersensitivity Reactions:Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions. Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate HCl contained in clindamycin palmitate hydrochloride flavored granules. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see BOXED WARNING). Last updated on Sep 21, 2022. Photo: Andreas Neumann. Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections. Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Clindamycin hydrochloride should be prescribed with caution in atopic individuals. At least 90% of the microorganisms listed below exhibit in vitro minimum inhibitory concentrations (MICs) less than or equal to the clindamycin susceptible MIC breakpoint for organisms of a similar type. FDA approved dissolution test specifications differ from USP. 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. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. NORTHSTAR, Set id: b35e3714-44d1-4e6a-a124-555ad259fec1, 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, clindamycin palmitate hydrochloride (pediatric) solution, 100 mL in 1 BOTTLE; Type 0: Not a Combination Product, 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product, ANALYSIS(16714-483) , MANUFACTURE(16714-483). The average biological half-life is 2.4 hours. Both tests were negative. Serum levels have been uniform and predictable from person to person and dose to dose. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. NorthStar Rx LLC, 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. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. DESCRIPTION Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. Distributed By If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by clindamycin palmitate hydrochloride for oral solution (Pediatric) or other antibacterial drugs in the future. Clindamycin hydrochloride, USP is the hydrated hydrochloride salt of clindamycin. After oral administration of clindamycin hydrochloride, elimination half-life is increased to approximately 4.0 hours (range 3.4-5.1 h) in the elderly compared to 3.2 hours (range 2.1 - 4.2 h) in younger adults. These CBD candies offer a simple and flexible . Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. The molecular formula is C 18 H 34 ClN 2 O 8 PS and the molecular weight is 504.97. Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. Serum levels exceed the MICs for most indicated organisms for at least six hours following administration of the usually recommended doses of clindamycin palmitate hydrochloride for oral solution in adults and pediatric patients. Napumpujte ho antioxidantmi a vitamnmi! Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. An analysis of pharmacokinetic data in obese pediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years demonstrated that clindamycin clearance and volume of distribution, normalized by total body weight, are comparable regardless of obesity. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.difficile, and surgical evaluation should be instituted as clinically indicated. 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. 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). Antimicrobial Activity If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. C.difficile produces toxins A and B which contribute to the development of CDAD. 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. However, the efficacy of clindamycin in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials. More severe infections 300 to 450 mg every 6 hours. 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. Clindamycin has been shown to have in vitro activity against isolates of the following organisms: Aerobic gram positive cocci, including: Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting, and diarrhea (see BOXED WARNING). Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Skin and Mucous Membranes: Pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported (see Hypersensitivity Reactions). Because the binding sites for these antibacterial drugs overlap, cross-resistance is sometimes observed among lincosamides, macrolides and streptogramin B. Macrolide-inducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria. During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed. After oral administration of clindamycin hydrochloride, elimination half-life is increased to approximately 4.0 hours (range 3.4-5.1 h) in the elderly compared to 3.2 hours (range 2.1-4.2 h) in younger adults; administration of clindamycin palmitate HCl resulted in a similar elimination half-life value of about 4.5 hours in elderly subjects. Patients should be counseled that antibacterial drugs, including clindamycin hydrochloride capsules, should only be used to treat bacterial infections. What is the best antibiotic to treat strep throat? Severe hypersensitivity reactions, including severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome (SJS), some with fatal outcome, have been reported (see ADVERSE REACTIONS). 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