CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) 75 mg/5mL Granule, For Solution, 100 mL
Other active recalls for Clindamycin Palmitate Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Lincosamide Antibacterial class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Clindamycin is used to treat certain types of bacterial infections. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria. Antibiotics such as clindamycin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Read the full MedlinePlus article ↗- Clindamycin is used for serious bacterial infections — things like deep skin infections, lung abscesses, pelvic infections, and abdominal infections. It's often chosen when penicil...
- What kinds of infections is clindamycin actually used for?
- You don't have to eat with it — food doesn't meaningfully change how it's absorbed. But the most important thing is to take each capsule with a full, large glass of water, and stay...
- Do I need to take clindamycin with food?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 14255EXE39
Ethylparaben is a preservative, a chemical that stops bacteria and mold from growing in the medicine. It keeps the product safe and effective throughout its shelf life.
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UNII LQA7B6G8JG
A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clindamycin Palmitate Hydrochloride (Pediatric) 75 mg/5mL 16714-0483-01 | NorthStar | 1 bottle | $0.129 | AA | Availability likely | — |
| clindamycin palmitate hydrochloride 75 mg/5mL 23155-0603-51 | Heritage | 1 bottle | $0.129 | AA | Availability likely | — |
| Clindamycin Palmitate Hydrochloride (Pediatric) 75 mg/5mL 53746-0468-19 | Amneal | 1 bottle | $0.129 | — | Availability likely | — |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) 75 mg/5mL 64980-0511-10 | Rising | 100 ml | $0.129 | AA | Availability likely | — |
| Clindamycin Palmitate Hydrochloride (Pediatric) 75 mg/5mL 65162-0468-19 | Amneal | 1 bottle | $0.129 | — | Availability likely | — |
| Clindamycin Palmitate Hydrochloride (Pediatric) 75 mg/5mL 65862-0596-01 | Aurobindo | 1 bottle | $0.129 | AA | Availability likely | — |
| Cleocin Pediatric 75 mg/5mL 00009-0760-04 | Pharmacia | 1 bottle | — | AA | Discontinued | — |
| Clindamycin Palmitate Hydrochloride 75 mg/5mL 62135-0926-01 | Chartwell | 100 ml | — | AA | FDA listed | — |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) 75 mg/5mLthis 63629-2391-01 | Bryant | 100 ml | — | AA | FDA listed | — |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) 75 mg/5mL 72162-1809-01 | Bryant | 100 ml | — | AA | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63629-2391-01 You're viewing this | 100 mL in 1 BOTTLE (63629-2391-1) | 2021-02-23 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING 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. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.difficile. 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.
It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. 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.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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. 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). 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.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. 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. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION 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.
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.
Storage Conditions: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. The solution is stable for 2 weeks at room temperature.
⛔ Contraindications ▾
CONTRAINDICATIONS This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
⚠️ Warnings ▾
WARNINGS 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 ). 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 ). In case of such an anaphylactic or severe hypersensitivity reaction, discontinue treatment permanently and institute appropriate therapy.
A careful inquiry should be made concerning previous sensitivities to drugs and other allergens. Usage in Meningitis Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
🤒 Adverse Reactions ▾
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.
Reports of agranulocytosis and thrombocytopenia have been made. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing. Immune system: Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.
Musculoskeletal : Cases of polyarthritis have been reported. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc. at 1-866-562-4597 or FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.
🔄 Drug Interactions ▾
Drug Interactions Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin.
Therefore inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.
In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects 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.
🧒 Pediatric Use ▾
Pediatric Use When clindamycin palmitate hydrochloride for oral solution (Pediatric) is administered to the pediatric population (birth to 16 years), appropriate monitoring of organ system functions is desirable.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of clindamycin did not include sufficient numbers of patients age 65 and over to determine whether they respond differently from younger patients. 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. These patients should be carefully monitored for the development of diarrhea.
Pharmacokinetic studies with clindamycin have shown no clinically important differences between young subjects (18 to 39 years) and elderly subjects (61 to 79 years) with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration.
🆘 Overdosage ▾
OVERDOSAGE 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.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) flavored granules is available in bottles of 100 mL (NDC 63629-2391-1). When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL. Rx only Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
DESCRIPTION Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. 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 -α-D- galacto -octopyranoside 2-palmitate monohydrochloride.
Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) flavored granules contain clindamycin palmitate hydrochloride for reconstitution. Each 5 mL contains the equivalent of 75 mg clindamycin. Inactive ingredients: natural cherry flavor, dextrin, ethylparaben, poloxamer 188, simethicone, sucrose.
💬 Information for Patients ▾
Information for Patients Patients should be counseled that antibacterial drugs including clindamycin palmitate hydrochloride for oral solution (Pediatric) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). 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.
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. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. 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.
If this occurs, patients should contact their physician as soon as possible.