Palmitate

• Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) (clindamycin palmitate HCl) 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.

• This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.contraindicated

If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see BOXED WARNING ). Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate HCl contained in clindamycin palmitate hydrochloride for oral solution (Pediatric) flavored granules. Serious infections: 8-12 mg/kg/day (4-6 mg/lb/day) divided into 3 or 4 equal doses. Severe infections: 13-16 mg/kg/day (6.5-8 mg/lb/day) divided into 3 or 4 equal doses. More severe infections: 17-25 mg/kg/day (8.5-12.5 mg/lb/day) divided into 3 or 4 equal doses. In pediatric patients weighing 10 kg or less, ½ teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose. Clindamycin should be dosed based on total body weight regardless of obesity. Serious infections due to anaerobic bacteria are usually treated with clindamycin injection. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin palmitate hydrochloride for oral solution (Pediatric). NOTE: In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days. Reconstitution Instructions: When reconstituted with water as follows, each 5 mL (teaspoon) of solution contains clindamycin palmitate HCl equivalent to 75 mg clindamycin. Reconstitute bottles of 100 mL with 75 mL of water. Add a large portion of the water and shake vigorously; add the remainder of the water and shake until the solution is uniform.

See BOXED WARNING. Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cindamycin palmitate hydrochloride for oral solution (Pediatric), 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 . 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 instituted as clinically indicated. Anaphylactic and Severe Hypersensitivity Reactions Anaphylactic shock and anaphylactic reactions have been reported (see ADVERSE REACTIONS ).

The following reactions have been reported with the use of clindamycin. Infections and infestations: Clostridium difficile colitis Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting and diarrhea (see BOXED WARNING ). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS ) . 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. Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy. Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported (See WARNINGS ). Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction and hypersensitivity have also been reported. Skin and Mucous Membranes: Pruritus, vaginitis, angioedema, and rare instances of exfoliative dermatitis have been reported. (See Hypersensitivity Reactions .) Liver : Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. 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. Hematopoietic : Transient neutropenia (leukopenia) and eosinophilia have been reported.

Pregnancy: Teratogenic Effects 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. Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. 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.

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. In the mice, convulsions and depression were observed. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

• May 18, 1949NDANDA006823Casper Pharma Llc
• Apr 7, 1986ANDAANDA062644Pfizer
• Feb 21, 2001NDANDA021265Sandoz Canada Inc
• Jul 31, 2009NDANDA022264Janssen Pharms
• Aug 28, 2012ANDAANDA201821Rising
• Apr 30, 2013ANDAANDA202409Aurobindo Pharma Ltd
• May 18, 2015NDANDA207946Janssen Pharms
• Jul 26, 2024NDANDA216352Luye Innomind Pharma

1. 1Off Label Use3,20210%
2. 2Drug Ineffective2,2447.0%
3. 3Hospitalisation1,7775.6%
4. 4Weight Increased1,6345.1%
5. 5Drug Dose Omission1,4174.4%
6. 6Product Dose Omission Issue1,3834.3%
7. 7Schizophrenia1,1043.5%
8. 8Gynaecomastia1,0853.4%
9. 9Condition Aggravated1,0483.3%
10. 10Treatment Noncompliance9342.9%
11. 11Blood Prolactin Increased9272.9%
12. 12Psychotic Disorder8942.8%
13. 13Incorrect Dose Administered8752.7%
14. 14Inappropriate Schedule Of Drug Administration7852.5%
15. 15Therapeutic Response Decreased7502.3%

Recent PubMed references pinned to Palmitate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Direct or indirect: the crucial role of N-palmitate in hedgehog signaling.
  Biochemical Society transactions · 2026 · Puschmann J, Grobe K
  PMID 42138130DOI 10.1042/BST20260268
• Growth and Neurodevelopment to 18 Months in Infant With Varying sn-2 Palmitate Levels in Formula: An Observational Study.
  Pediatrics international : official journal of the Japan Pediatric Society · 2026 · Arai H, Shoji H, Kakiuchi S, et al.
  PMID 42130284DOI 10.1111/ped.70434
• ACOT8-mediated palmitate accumulation promotes M1 macrophage polarization in renal ischemia-reperfusion injury via activation of the cGAS-STING pathway.
  International immunopharmacology · 2026 · Zhang H, Liu X, Ji X, et al.
  PMID 41905213DOI 10.1016/j.intimp.2026.116558
• Palmitate-induced mitochondrial damage restricts histone acetylation in CD8 T cells to impair antitumor immunity.
  Science immunology · 2026 · Tiberti S, Gennari S, Romeo M, et al.
  PMID 41894555DOI 10.1126/sciimmunol.aeb1459
• Short-Chain Fatty Acids and Palmitate Induce Distinct Metabolic and Phenotypic Signatures in Normal and Ischemic Skeletal Muscle Microvascular Endothelial Cells.
  Cells · 2026 · Guilfoyle-Speese A, Patel K, Ghanwat AH, et al.
  PMID 41892284DOI 10.3390/cells15060493
• Effects of infant formula supplied with medium- and long-chain triacylglycerols and sn-2 palmitate on fecal lipid metabolome and microbiota profiles in healthy term infants: a parallel-controlled study.
  Food & function · 2026 · Yu J, Liu Z, Yang M, et al.
  PMID 41874534DOI 10.1039/d5fo04757a
• Loss of HuD Sensitizes Neuroblastoma Cells to Palmitate-Driven Stress-Induced Premature Senescence via PPARα Downregulation and FAO Impairment.
  Cells · 2026 · Ryu S, Seo J, Sim YE, et al.
  PMID 41744759DOI 10.3390/cells15040316
• Impact of medium- and long-chain triacylglycerols and sn-2 palmitate on temperament development in term infants: potential role of gut Bifidobacterium.
  Food & function · 2026 · Qiu YZ, Yang MT, Liu Z, et al.
  PMID 41705972DOI 10.1039/d5fo03451e

The 10 most recently updated of 283 ClinicalTrials.gov registrations naming Palmitate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• PANDORA: Paravertebral AdjuNctive DexamethasOne Palmitate Reducing Chronic Pain After Caridiac Surgery
  Completed · Interventional · 562 enrolled · Xijing Hospital
  NCT05920967updated 2026-05-28
• Study Comparing Antipsychotic Dose Reduction vs. Maintenance Treatment in Patients With Schizophrenia Spectrum Disorder: a Personalized Medicine Approach
  Not yet recruiting · Phase 2 · Interventional · 288 enrolled · University Hospital, Strasbourg, France
  NCT07152184updated 2026-05-26
• Effect of Vitamin A Supplementation on Idiopathic Scoliosis
  Recruiting · Interventional · 140 enrolled · Second Affiliated Hospital of Wenzhou Medical University
  NCT07335991updated 2026-05-15
• Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR.
  Active not recruiting · Phase 4 · Interventional · 84 enrolled · Dr. Stavroula Rakitzi
  NCT07047651updated 2026-05-01
• Ozonated Oil Emulsion for Seborrhea in Women
  Completed · Interventional · 66 enrolled · Chadi Khatib
  NCT07559617updated 2026-04-30
• Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain
  Recruiting · Early phase 1 · Interventional · 80 enrolled · Carilion Clinic
  NCT07260656updated 2026-04-20
• Risk of Breakthrough Symptoms With Long-Acting Injectable Medications
  Completed · Observational · 51 enrolled · Centre for Addiction and Mental Health
  NCT05473741updated 2026-04-14
• Dinner Time for Obesity and Prediabetes
  Recruiting · Interventional · 32 enrolled · Johns Hopkins University
  NCT05745441updated 2026-04-13
• "Extended" (Alternate Day) Antipsychotic Dosing
  Recruiting · Phase 4 · Interventional · 120 enrolled · Centre for Addiction and Mental Health
  NCT04478838updated 2026-04-13
• Dexamethasone Palmitate for Postoperative Pain
  Not yet recruiting · Interventional · 446 enrolled · Beijing Tiantan Hospital
  NCT07341854updated 2026-04-08

Frequently asked questions

What is Palmitate used for?

According to FDA labeling, Palmitate carries indications including: Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) (clindamycin palmitate HCl) 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Palmitate?

Palmitate labeling lists contraindications including: This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.. Always consult the full prescribing information and a clinician.