(See Hypersensitivity Reactions.). Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Several FDA-approved drug labels may be available for clindamycin. Approximately 10% of the bioactivity is excreted in the urine and 3.6% in the feces; the remainder is excreted as bioinactive metabolites. In Canada - Call your doctor for medical advice about side effects. Antimicrobial Activity Infections and infestations: Clostridium difficile colitis. The solution is stable for 2 weeks at room temperature. Clindamycin palmitate hydrochloride for oral solution is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness. Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting and diarrhea (see BOXED WARNING). Immune system: Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported. Fertility studies in rats treated orally with up to 300 mg/kg/day (approximately 1.6 times the highest recommended adult human oral dose based on mg/m2) revealed no effects on fertility or mating ability. 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 onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS). Clindamycin Palmitate Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: sore/painful throat, joint pain/swelling, yellowing eyes or skin, signs of kidney problems (such as change in the amount of urine).Use of this medication for prolonged or repeated periods may result in o. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Clostridium perfringens Distributed by: C. difficile produces toxins A and B which contribute to the development of CDAD. Serum levels exceed the MICs for most indicated organisms for at least six hours following administration of the usually recommended doses of clindamycin palmitate HCl in adults and pediatric patients. CLINICAL PHARMACOLOGY Human Pharmacology - Absorption - Blood level studies comparing clindamycin palmitate HCl with clindamycin hydrochloride show that both drugs reach their peak active serum levels at the same . To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin palmitate HCl and other antibacterial drugs, clindamycin palmitate HCl should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. Clindamycin palmitate hydrochloride for oral solution (Pediatric) should be prescribed with caution in atopic individuals. Reconstitute bottles of 100 mL with 75 mL of water. Store at 20 to 25C (68 to 77F). C.difficile produces toxins A and B which contribute to the development of CDAD. Clindamycin palmitate hydrochloride is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin [1] . Skin and Mucous Membranes: Pruritus, vaginitis, angioedema, and rare instances of exfoliative dermatitis have been reported. Actinomyces israelii Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of theester of clindamycin and palmitic acid. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora. Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Reports of agranulocytosis and thrombocytopenia have been made. 279 Princeton-Hightstown Road East Windsor, NJ 08520 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. Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting and diarrhea (see BOXED WARNING). Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Fertility studies in rats treated orally with up to 300 mg/kg/day (approximately 1.6 times the highest recommended adult human oral dose based on mg/m2) revealed no effects on fertility or mating ability. Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. 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. Can I take clindamycin if I am allergic to penicillin? Clindamycin is bacteriostatic. Clindamycin phosphate is soluble 1:2.5 in water, slightly soluble in dehydrated alcohol . In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Both tests were negative. Clindamycin should be dosed based on total body weight regardless of obesity. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. 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. No significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges. being able to get an erection, but not having it last long enough for sex. Rx only 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. What are the best antibiotics for a tooth infection? Manufactured for: (when mixed) An unpleasant or metallic taste has been reported after oral administration. 2The structural formula is represented below: However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever that doesn't go away, new or worsening lymph node swelling, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Clindamycin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Reports of agranulocytosis and thrombocytopenia have been made. Clindamycin palmitate hydrochloride is freely soluble in water, in chloroform, in ether, and in benzene. 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. In vitro studies in human liver and intestinal microsomes indicated that clindamycin is predominantly metabolized by Cytochrome P450 3A4 (CYP3A4), with minor contribution from CYP3A5, to form clindamycin sulfoxide and a minor metabolite, N-desmethylclindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. In case of such an anaphylactic or severe hypersensitivity reaction, discontinue treatment permanently and institute appropriate therapy. However, it was postulated from studies that when given every eight hours, accumulation should rarely occur. Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate HCl contained in clindamycin palmitate hydrochloride Flavored Granules. Clindamycin palmitate hydrochloride for oral solution (Pediatric) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. 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. How it works Clindamycin is an antibiotic that may be used to treat a wide range of infections including those involving gram-positive and anaerobic bacteria (anaerobic means living without air). Store at controlled room temperature 20 to 25C (68 to 77F) [see USP]. Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE Sterile Solution. Immune system: Drug reaction with eosinophilia and systemic symptoms (DRESS)cases have been reported. 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. Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. However, periodic liver enzyme determinations should be made when treating patients with severe liver disease. Consult your doctor before breast-feeding. Usage in Meningitis: Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis. Long term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential. The use of clindamycin palmitate hydrochloride for oral solution (Pediatric) occasionally results in overgrowth of nonsusceptible organisms-particularly yeasts. Inactive ingredients: artificial cherry flavor, ethylparaben, pluronic F68, simethicone, sucrose. During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed. 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. Therefore inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. Clostridioidesdifficile-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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin palmitate HCl and other antibacterial drugs, clindamycin palmitate HCl should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. In vitro studies in human liver and intestinal microsomes indicated that clindamycin is predominantly metabolized by Cytochrome P450 3A4 (CYP3A4), with minor contribution from CYP3A5, to form clindamycin sulfoxide and a minor metabolite, N- desmethylclindamycin. When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency. The average serum half-life after doses of clindamycin palmitate hydrochloride for oral solution (Pediatric) is approximately two hours in pediatric patients. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Hypersensitivity Reactions: Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions. Serious infections due to anaerobic bacteria are usually treated with clindamycin injection. If you notice other effects not listed above, contact your doctor or pharmacist. Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Canada residents can call a provincial poison control center. Clindamycin palmitate hydrochloride, USP for oral solution was available in 100 mL bottles and was prepared in the pharmacy at each site based on the reconstitution recommendation in the package insert. 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. Reports of agranulocytosis and thrombocytopenia have been made. clindamycin or from the underlying maternal condition. The structural formula is represented below: The chemical name for clindamycin palmitate 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 2-palmitate monohydrochloride. Serious respiratory tract infections; serious skin and soft tissue infections. ], 1. Serious infections due to anaerobic bacteria are usually treated with clindamycin injection. Peptostreptococcus anaerobius Anaphylactic shock and anaphylactic reactions have been reported (see ADVERSE REACTIONS). Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. Cross-resistance between clindamycin and lincomycin is complete. Prevotella melaninogenica Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Hydrochloride for Oral The purpose of this study is to better understand how clindamycin works in children who fall in the 85th percentile or higher for body mass index (BMI - a ratio of weight to height). If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.difficile may need to be discontinued. 75 mg*, Set id: e17229b3-7246-4886-abe6-58e39c4e47ef, Clindamycin palmitate hydrochloride for oral solution, USP, Infections and Infestations: Clostridioidesdifficile, clindamycin palmitate hydrochloride solution, 100 mL in 1 BOTTLE; Type 0: Not a Combination Product, ANALYSIS(59762-0016) , MANUFACTURE(59762-0016), ANALYSIS(59762-0016) , API MANUFACTURE(59762-0016) , PACK(59762-0016) , LABEL(59762-0016). Can clindamycin be used to treat chlamydia. 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. The structural formula is represented below: However, it was postulated from studies that when given every eight hours, accumulation should rarely occur. Storage Conditions: Store at controlled room temperature 20 to 25C (68 to 77F) [see USP]. Molecular Weight: 504.9656. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Consult your doctor or pharmacist for details and an appropriate treatment plan. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. The solution is stable for 2 weeks at room temperature. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. However, periodic liver enzyme determinations should be made when treating patients with severe liver disease. Clindamycin is widely distributed in body fluids and tissues (including bones). Clindamycin palmitate hydrochloride for oral solution should be prescribed with caution in atopic individuals. Blood level studies comparing clindamycin palmitate HCl 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. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. 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. In the mice, convulsions and depression were observed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. ED is often a symptom of another health problem or health-related factor. 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. Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction and hypersensitivity have also been reported. 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. Serum level studies with clindamycin palmitate HCI in normal pediatric patients weighing 50 to 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. Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. 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