Anaphylactic and Severe Hypersensitivity Reactions bacterial stomach or intestine infection due to anthrax, treatment to prevent anthrax after exposure to disease, blood poisoning caused by anaerobic bacteria, a systemic inflammatory response called sepsis due to an infection with bacteria, an infection by Actinomyces bacteria called actinomycosis, falciparum malaria resistant to the drug chloroquine, encephalitis due to the parasite Toxoplasma gondii, infection due to the parasite Toxoplasma gondii, pneumonia with a fungus called Pneumocystis jirovecii, acute sinusitis caused by Streptococcus pneumoniae, acute Streptococcus pyogenes bacteria sinus infection, acute sinus infection caused by Staphylococcus bacteria, inflammation of the tissue lining the sinuses, bacterial pneumonia caused by Streptococcus pneumoniae, bacterial pneumonia caused by Streptococcus, bacterial pneumonia caused by Staphylococcus, pneumonia caused by an anaerobic bacteria, abscess of the lung caused by anaerobic bacteria, anaerobic bacteria infection of abdominal cavity lining, abscess within the abdomen caused by anaerobic bacteria, fallopian tube & ovary abscess due to anaerobic bacteria, inflammation in pelvic area caused by anaerobic bacteria, an infection of the female reproductive organs called pelvic inflammatory disease, infection of tissues of the uterus caused by Bacteroides, inflammation of the vagina caused by bacteria, anaerobic infection following vaginal cuff surgery, an infection of the skin and the tissue below the skin, skin infection due to Staphylococcus aureus bacteria, skin infection due to Streptococcus pyogenes bacteria, diabetic with foot infection due to a specific bacteria, FDA Labeling for clindamycin (PEDIATRIC) on RxList. Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and CLEOCIN Phosphate in an Aged Population. being unable to get an erection at any time. 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. 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. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin palmitate HCl, and may range in severity from mild diarrhea to fatal colitis. Serum level studies with clindamycin palmitate HCl in normal pediatric patients weighing 50-100 lbs given 2, 3 or 4 mg/kg every 6 hours (8, 12 or 16 mg/kg/day) demonstrated mean peak clindamycin serum levels of 1.24, 2.25 and 2.44 mcg/mL respectively, one hour after the first dose. The structural formula is represented below: Cross-resistance between clindamycin and lincomycin is complete. 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. Available for Android and iOS devices. Serious respiratory tract infections. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. Upjohn TR 8147-82-9122-021, December 1982. Infections and Infestations: Clostridioidesdifficile colitis. Monitor the breast-fed infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis. Do not use a household spoon because you may not get the correct dose. CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC)- clindamycin palmitate hydrochloride (pediatric)solution 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. Anaphylactic shock and anaphylactic reactions have been reported (see ADVERSE REACTIONS). Clindamycin is widely distributed in body fluids and tissues (including bones). Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin palmitate HCl. Children weighing 10 kg or lessDose is . Hematopoietic: Transient neutropenia (leukopenia) and eosinophilia have been reported. 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). 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 be active against most of the isolates of the following microorganisms, both in vitro and in clinical infections, as described in the INDICATIONS AND USAGE section. Greenstone LLC. In patients with moderate to severe liver disease, prolongation of clindamycin half-life has been found. Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin. 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 (Pediatric) in adults and pediatric patients. DESCRIPTION Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. Clindamycin phosphate is soluble 1:2.5 in water, slightly soluble in dehydrated alcohol . Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Pharmacokinetic studies in elderly volunteers (61 to 79 years) and younger adults (18 to 39 years) indicate that age alone does not alter clindamycin pharmacokinetics (clearance, elimination half-life, volume of distribution, and area under the serum concentration-time curve) after IV administration of clindamycin phosphate. The elimination half-life of clindamycin is increased slightly in patients with markedly reduced renal or hepatic function. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. Obese Pediatric Patients Aged 2 to Less than 18 Years and Obese Adults Aged 18 to 20 Years Patients should be counseled that antibacterial drugs including clindamycin palmitate hydrochloride for oral solution (Pediatric) should only be used to treat bacterial infections. For the best effect, take this antibiotic at evenly spaced times. When clindamycin palmitate HCl 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. Manufactured by: This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. Renal: Acute kidney injury (See WARNINGS). 75 mg*/5 mL 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. An unpleasant or metallic taste has been reported after oral administration. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.difficile may need to be discontinued. All rights reserved. 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. Symptoms of ED include. Usage in Meningitis: Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis. 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 (when mixed) Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Carcinogenesis, Mutagenesis, Impairment of Fertility. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing. Select a condition to view a list of medication options. when reconstituted 75 mg*/5 mL Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy. Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. Microbiology. It will not work for viral infections (such as common cold, flu). Inactive ingredients: artificial cherry flavor, dextrin, ethylparaben, poloxamer, simethicone, compressible sugar. What is the best antibiotic to treat strep throat? Clindamycin dosage modification may not be necessary in patients with renal disease. Older adults may be more sensitive to the side effects of this drug, especially diarrhea. However, periodic liver enzyme determinations should be made when treating patients with severe liver disease. In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4. Serum levels have been uniform and predictable from person to person and dose to dose. Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Prevotella intermedia Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. 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. CLINDAMYCIN PALMITATE HYDROCHLORIDE- clindamycin palmitate hydrochloridesolution Long term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential. When reconstituted with water as follows, each 5 mL (teaspoon) of solution contains clindamycin palmitate HCl equivalent to 75 mg clindamycin. Anaerobic Bacteria 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. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. It is very soluble in dimethylformamide. Clindamycin palmitate hydrochloride for oral solution, USP is available in bottles of 100 mL (NDC 67787-515-71). Hydrochloride for Oral Solution, USP (Pediatric) A very serious allergic reaction to this drug is rare. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin palmitate hydrochloride for oral solution. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Peak serum concentrations after this time would be about 2.46, 2.98 and 3.79 mcg/mL with doses of 8, 12 and 16 mg/kg/day, respectively. No significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges. Each 5 mL contains the equivalent of 75 mg clindamycin. Alembic Labs LLC C. difficile produces toxins A and B which contribute to the development of CDAD. In the mice, convulsions and depression were observed. . 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. The structural formula is represented below: Do not use it later for another infection unless your doctor tells you to. When reconstituted with water as follows, each 5 mL (teaspoon) of solution contains clindamycin palmitate hydrochloride equivalent to 75 mg clindamycin. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. 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 case of such an anaphylactic or severe hypersensitivity reaction, discontinue treatment permanently and institute appropriate therapy. Clindamycin is a semisynthetic antibiotic produced by a 7(S) Chloro- substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The average serum half-life after doses of clindamycin palmitate hydrochloride for oral solution (Pediatric) is approximately two hours in pediatric patients. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from 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). With prolonged use, lab and/or medical tests (such as kidney/liver function, blood counts) should be done while you are taking this medication. 4 equal doses a severe intestinal condition due to a bacteria called C. difficile into 3 or equal... 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