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Clindamycin Palmitate Hydrochloride Granules

Pronunciation

Dosage Form: granules for oral solution

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin Palmitate Hydrochloride for Oral Solution and other antibacterial drugs, Clindamycin Palmitate Hydrochloride for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Not for Injection

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.difficileproduces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C.difficilecause 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.difficilemay 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.

Clindamycin Palmitate Hydrochloride Granules 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 contains clindamycin palmitate hydrochloride for reconstitution. Each 5 mL contains the equivalent of 75 mg clindamycin. Inactive ingredients: artificial cherry flavor, dextrin, ethylparaben, poloxamer 188, simethicone, sucrose.

Clindamycin Palmitate Hydrochloride Granules - Clinical Pharmacology

Microbiology

Mechanism of Action

Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic.

Mechanism of Resistance

Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibiotics overlap, cross-resistance is sometimes observed among lincosamides, macrolides and streptogram B. Macrolide-inducible resistance to clindamycin occurs in some ioslates of macrolide-resistant bacteria. Macrolide-resistant isolates of staphylococci and beta-hemolytic streptococci should be screened for clindamycin inducible resistance using the D-zone test.

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.

Gram-positive Aerobes

Staphylococcus aureus (Methicillin-susceptible strains)

Streptococcus pneumoniae (penicillin-susceptible strains)

Streptococcus pyogenes

Anaerobes

Clostridium perfringens

Fusobacteriumnecrophorum

Fusobacteriumnucleatum

Peptostreptococcusanaerobius

Prevotellamelaninogenica

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 to those shown in Table 1. However, the efficacy of clindamycin in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials.

Gram-positive aerobes

Staphylococcus epidermidis (methicillin-susceptible strains)

Streptococcus agalactiae

Streptococcus anginosus

Streptococcus mitis

Streptococcus oralis

Anaerobes

Actinomycesisraelii

Clostridium clostridioforme

Eggerthellalentum

Finegoldia (Peptostreptococcus) magna

Micromonas (Peptostreptococcus) micros

Prevotellabivia

Prevotellaintermedia

Propionibacteriumacnes

Susceptibility Testing Methods

When available, the clinical microbiology laboratory should provide cumulative in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial.

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure based on dilution methods (broth, agar or microdilution)2,3  or equivalent using standardized inoculum and concentrations of clindamycin. The MIC values should be interpreted according to the criteria provided in Table 1.

Diffusion Techniques

Quantitative methods that require the measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized method2,4. This procedure uses paper disks impregnated with 2 mcg of clindamycin to test the susceptibility of bacteria to clindamycin. The disk diffusion breakpoints are provided in Table 1.

Anaerobic Techniques

For anaerobic bacteria, the susceptibility to clindamycin can be determined by a method2,5. The MIC values obtained should be interpreted according to the criteria provided in Table 1.

Table 1. Susceptibility Interpretive Criteria for Clindamycin

Pathogen

 
Susceptibility Interpretive Criteria
 
Minimal Inhibitory Concentrations
 
(MIC in mcg/mL)
 
Disk Diffusion
 
(Zone Diameters in mm)
 
Staphylococcus spp.
 
S
 
≤ 0.5
 
I
 
1–2
 
R
 
≥4
 
S
 
≥21
 
I
 
15–20
 
R
 
≤14

Streptococcus pneumoniae and other

Streptococcus spp.

 
≤0.25
 
0.5
 
≥1
 
≥19
 
16–18
 
≤15

Anaerobic Bacteria

 
≤2
 
4
 
≥8
 
NA
 
NA
 
NA
 
NA=not applicable

A report of Susceptible (S) indicates that the antimicrobial drug is likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the site of infection. A report of Intermediate (I) indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone that prevents small, uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant (R) indicates that the antimicrobial drug reaches the concentrations usually achievable at the infection site; other therapy should be selected.

Quality Control

Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test.2,3,4,5Standard clindamycin powder should provide the MIC ranges in Table 2. For the disk diffusion technique using the 2 mcg clindamycin disk the criteria provided in Table 2 should be achieved.

Table 2. Acceptable Quality Control Ranges for Clindamycin to be Used in Validation of Susceptibility Test Results

Acceptable Quality Control Ranges

QC Strain

Minimum Inhibitory Concentration Range (mcg/mL)

Disk Diffusion Range (Zone Diameters in mm)

Enterococcus faecalis1

ATCC 29212

4-16

NA

Staphylococcus aureus

ATCC 29213

0.06-0.25

NA

Staphylococcus aureus

ATCC 25923

NA

24-30

Streptococcus pneumoniae

ATCC 49619

0.03-0.12

19-25

Bacteroidesfragilis

ATCC 25285

0.5-2

NA

Bacteroidesthetaiotaomicron

ATCC 29741

2-8

NA

Clostridium difficile

ATCC 7000572

2-8

Eggerthellalenta

ATCC 43055

0.06-0.25

NA

 
1 Enterococcus faecalis has been included in this table for quality control purposes only.
 
2 Quality control for C. difficile is performed using the agar dilution method only, all other obligate anaerobes may be tested by either broth microdilution or agar diffusion methods
 
NA=Not applicable
 
ATCC® is a registered trademark of the American Type Culture Collection

Human Pharmacology:

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.

Clindamycin is widely distributed in body fluids and tissues (including bones). Approximately 10% of the biological activity is excreted in the urine. The average serum half-life after doses of Clindamycin Palmitate Hydrochloride for Oral Solution is approximately two hours in pediatric patients.

Serum half-life of clindamycin is increased slightly in patients with markedly reduced renal function. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

Serum level studies with clindamycin palmitate HCl 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. By the fifth dose, the 6-hour serum concentration had reached equilibrium. 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. Serum levels have been uniform and predictable from person to person and dose to dose. 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 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.

No significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges.

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. After oral administration of clindamycin hydrochloride, elimination half-life is increased to approximately 4.0 hours (range 3.4 to 5.1 h) in the elderly compared to 3.2 hours (range 2.1 to 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. 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.

Indications and Usage for Clindamycin Palmitate Hydrochloride Granules

Clindamycin Palmitate Hydrochloride for Oral Solution, USP 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 WARNING box, 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.

In Vitro Susceptibility Testing:

A standardized disk testing procedure6 is recommended for determining susceptibility of aerobic bacteria to clindamycin.

For anaerobic bacteria the minimal inhibitory concentration (MIC) of clindamycin can be determined by agar dilution and broth dilution (including microdilution) techniques. If MICs are not determined routinely, the disk broth method is recommended for routine use. THE KIRBY-BAUER DISK DIFFUSION METHOD AND ITS INTERPRETIVE STANDARDS ARE NOT RECOMMENDED FOR ANAEROBES.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin Palmitate Hydrochloride for Oral Solution, USP and other antibacterial drugs, Clindamycin Palmitate Hydrochloride for Oral Solution, USP 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.

Contraindications

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

Warnings

See WARNING box.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Clindamycin Palmitate Hydrochloride for Oral Solution, 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.difficileproduces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C.difficilecause 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.difficilemay 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.

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.

Precautions

General

Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency.

Clindamycin Palmitate Hydrochloride for Oral Solution should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin Palmitate Hydrochloride for Oral Solution should be prescribed with caution in atopic individuals.

Indicated surgical procedures should be performed in conjunction with antibiotic therapy.

The use of Clindamycin Palmitate Hydrochloride for Oral Solution occasionally results in overgrowth of non-susceptible organisms-particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.

Clindamycin dosage modification may not be necessary in patients with renal disease. In patients with moderate to severe liver disease, prolongation of clindamycin half-life has been found. However, it was postulated from studies that when given every eight hours, accumulation should rarely occur. Therefore, dosage modification in patients with liver disease may not be necessary. However, periodic liver enzyme determinations should be made when treating patients with severe liver disease.

Prescribing Clindamycin Palmitate Hydrochloride for Oral Solution in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information For Patients

Patients should be counseled that antibacterial drugs including Clindamycin Palmitate Hydrochloride for Oral Solution 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 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 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.

Laboratory Tests

During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed.

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.

Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative.

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.

Pregnancy: Teratogenic Effects

Pregnancy Category B

Reproduction studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (2.3 and 1.6 times the highest recommended adult human oral 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 oral dose based on mg/m2, respectively) revealed no evidence of teratogenicity.

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

Nursing Mothers

Clindamycin has been reported to appear in breast milk in the range of 0.7 to 3.8 mcg/mL.

Pediatric Use

When Clindamycin Palmitate Hydrochloride for Oral Solution is administered to the pediatric population (birth to 16 years), appropriate monitoring of organ system functions is desirable.

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.

Adverse Reactions

The following reactions have been reported with the use of clindamycin.

Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting and diarrhea (see WARNING box). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS).

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. Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, and a few cases of anaphylactoid reactions have also been reported.

Skin and Mucous membranes: Pruritus, vaginitis, 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 in rare instances.

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.

Musculoskeletal: Rare instances of polyarthritis have been reported.

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.

Clindamycin Palmitate Hydrochloride Granules Dosage and Administration

If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate hydrochloride contained in Clindamycin Palmitate Hydrochloride for Oral Solution.

Serious infections: 8 to 12 mg/kg/day (4 to 6 mg/lb/day) divided into 3 or 4 equal doses.

Severe infections: 13 to 16 mg/kg/day (6.5 to 8 mg/lb/day) divided into 3 or 4 equal doses.

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 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 Phosphate Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with Clindamycin Palmitate Hydrochloride for Oral Solution.

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 hydrochloride 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 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

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.

How is Clindamycin Palmitate Hydrochloride Granules Supplied

Clindamycin Palmitate Hydrochloride for Oral Solution, USP is available in bottles of 100 mL (NDC 0574-0129-01).

When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL.

Animal Toxicology

One year oral toxicity studies in Spartan Sprague-Dawley rats and beagle dogs at dose levels up to 300 mg/kg/day (approximately 1.6 and 5.4 times the highest recommended adult human oral dose based on mg/m2, respectively) have shown clindamycin to be well tolerated. No appreciable difference in pathological findings has been observed between groups of animals treated with clindamycin and comparable control groups. Rats receiving clindamycin hydrochloride at 600 mg/kg/day (approximately 3.2 times the highest recommended adult human oral dose based on mg/m2) for 6 months tolerated the drug well; however, dogs dosed at this level (approximately 10.8 times the highest recommended adult human oral dose based on mg/m2) vomited, would not eat, and lost weight.

Rx only

References

1.
Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and CLEOCIN Phosphate in an Aged Population. Upjohn TR 8147-82-9122-021, December 1982.
2.
CLSI. Performance Standards for Antimicrobial Susceptibility Testing: Twenty-sixth Informational Supplement. CLSI document M 100-S26. Wayne, PA: Clinical and Laboratory Standards Institute; 2016.
3.
CLSI. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition. CLSI document M07-A10. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.
4.
CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - Twelth Edition. CLSI document M02-A12. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.
5.
CLSI. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition. CLSI document M11-A8. Wayne, PA: Clinical and Laboratory Standards Institute; 2012.
6.
Bauer AW, Kirby WMM, Sherris JC, Turck M: Antibiotic susceptibility testing by a standardized single disk method. Am, J. Clin. Path., 45:493-496, 1966. Standardized D Susceptibility Test, Federal Register, 37:20527-29, 1972.

Manufactured By

Perrigo®

Minneapolis, MN 55427

2202098

04-16 C

3G200 RC J2

PRINCIPAL DISPLAY PANEL - Carton

Rx Only

NDC 0574-0129-01

Clindamycin Palmitate Hydrochloride for Oral Solution, USP 75 mg

When reconstituted each 5 mL contains

Cherry Flavored

100 mL

(when mixed)

PRINCIPAL DISPLAY PANEL - Label

Rx Only

NDC 0574-0129-01

Clindamycin Palmitate Hydrochloride for Oral Solution, USP

75 mg

When reconstituted each 5 mL contains

WARNING: NOT FOR INJECTION

DO NOT REFRIGERATE SOLUTION

Cherry Flavored

100 mL (when mixed)

CLINDAMYCIN PALMITATE HYDROCHLORIDE 
clindamycin palmitate hydrochloride granule, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0574-0129
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PALMITATE HYDROCHLORIDE (Clindamycin) Clindamycin 75 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
ETHYLPARABEN  
POLOXAMER 188  
SUCROSE  
ICODEXTRIN  
DIMETHICONE  
SILICON DIOXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0574-0129-01 1 BOTTLE, GLASS in 1 CARTON
1 100 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090902 01/21/2010
Labeler - Paddock Laboratories, LLC (967694121)
Registrant - L. Perrigo Company (006013346)
Establishment
Name Address ID/FEI Operations
Paddock Laboratories, LLC. 967694121 MANUFACTURE(0574-0129)
Revised: 05/2016
 
Paddock Laboratories, LLC
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