Clindamycin In 5 Percent Dextrose
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Questions & Answers
Side Effects & Adverse Reactions
See WARNING box.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin in 5% dextrose injection, 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.
A careful inquiry should be made concerning previous sensitivities to drugs and other allergens.
Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
SERIOUS ANAPHYLACTOID REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN AND INTRAVENOUS CORTICOSTEROIDS SHOULD ALSO BE ADMINISTERED AS INDICATED.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Clindamycin in 5% dextrose injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin in 5% dextrose injection 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 antibiotic-associated pseudomembranous 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).
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
Clindamycin in 5% dextrose injection is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below:
Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus.
Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes.
Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes.
Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms.
Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes.
Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin in 5% dextrose injection and other antibacterial drugs, clindamycin in 5% dextrose injection 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.
History
There is currently no drug history available for this drug.
Other Information
Clindamycin in 5% dextrose injection in the Cryovac plastic container for intravenous use is composed of clindamycin phosphate equivalent to 300, 600 and 900 mg of clindamycin premixed with 5% dextrose as a sterile solution. Disodium edetate has been added at a concentration of 0.04 mg/mL. The pH has been adjusted with sodium hydroxide and/or hydrochloric acid. Clindamycin is a semisyntheric antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
The chemical name of clindamycin phosphate is L-threo-α-D-galacto- Octopyranoside, methyl 7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2- pyrrolidinyl) carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-.
The molecular formula is C18H34CIN208PS and the molecular weight is 504.97.
The structural formula is represented below:
The plastic container is fabricated from a specially designed multilayer plastic, M312A material. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
Sources
Clindamycin In 5 Percent Dextrose Manufacturers
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Sandoz Inc
![Clindamycin In 5 Percent Dextrose Injection, Solution [Sandoz Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Clindamycin In 5 Percent Dextrose | Sandoz Inc
If diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).
Adults: Parenteral (IV Administration): Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroidesfragilis, Peptococcus species and Clostridium species other than Clostridium perfringens):
600 to 1200 mg/day in 2, 3 or 4 equal doses.
More severe infections, particularly those due to proven or suspectedBacteroidesfragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens:
1200 to 2700 mg/day in 2, 3 or 4 equal doses.
For more serious infections, these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Infusion Rates section below.
Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:
To Maintain Serum Clindamycin Levels Rapid Infusion Rate Maintenance Infusion RateAbove 4 mcg/mL
10 mg/min for 30 min
0.75 mg/min
Above 5 mcg/mL
15 mg/min for 30 min
1 mg/min
Above 6 mcg/mL
20 mg/min for 30 min
1.25 mg/min
Neonates (less than 1 month):
15 to 20 mg/kg/day in 3 to 4 equal doses. The lower dosage may be adequate for small prematures.
Pediatric patients 1 month of age to 16 years: Parenteral (IV) administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.
Parenteral therapy may be changed to oral clindamycin palmitate hydrochloride powder for oral solution or clindamycin hydrochloride capsule when the condition warrants and at the discretion of the physician.
In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.
Infusion RatesInfusion rates for clindamycin in 5% dextrose injection should not exceed 30 mg per minute. The usual infusion rates are as follows:
Dose Strength Time300 mg/50 mL
6 mg/mL
10 min
600 mg/50 mL
12 mg/mL
20 min
900 mg/50 mL
18 mg/mL
30 min
Administration of more than 1200 mg in a single 1-hour infusion is not recommended.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
DIRECTIONS FOR USEClindamycin in 5% dextrose injection in Cryovac Plastic Container
Premixed clindamycin in 5% dextrose injection is for intravenous administration using sterile equipment. Check for minute leaks prior to use by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not add supplementary medication. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use unless solution is clear and seal is intact.
Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.
Preparation for Administration:
1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set. -
Sandoz Inc
Clindamycin In 5 Percent Dextrose | Sandoz Inc
If diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).
Adults: Parenteral (IV Administration): Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroidesfragilis, Peptococcus species and Clostridium species other than Clostridium perfringens):
600 to 1200 mg/day in 2, 3 or 4 equal doses.
More severe infections, particularly those due to proven or suspectedBacteroidesfragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens:
1200 to 2700 mg/day in 2, 3 or 4 equal doses.
For more serious infections, these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Infusion Rates section below.
Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:
To Maintain Serum Clindamycin Levels Rapid Infusion Rate Maintenance Infusion RateAbove 4 mcg/mL
10 mg/min for 30 min
0.75 mg/min
Above 5 mcg/mL
15 mg/min for 30 min
1 mg/min
Above 6 mcg/mL
20 mg/min for 30 min
1.25 mg/min
Neonates (less than 1 month):
15 to 20 mg/kg/day in 3 to 4 equal doses. The lower dosage may be adequate for small prematures.
Pediatric patients 1 month of age to 16 years: Parenteral (IV) administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.
Parenteral therapy may be changed to oral clindamycin palmitate hydrochloride powder for oral solution or clindamycin hydrochloride capsule when the condition warrants and at the discretion of the physician.
In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.
Infusion RatesInfusion rates for clindamycin in 5% dextrose injection should not exceed 30 mg per minute. The usual infusion rates are as follows:
Dose Strength Time300 mg/50 mL
6 mg/mL
10 min
600 mg/50 mL
12 mg/mL
20 min
900 mg/50 mL
18 mg/mL
30 min
Administration of more than 1200 mg in a single 1-hour infusion is not recommended.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
DIRECTIONS FOR USEClindamycin in 5% dextrose injection in Cryovac Plastic Container
Premixed clindamycin in 5% dextrose injection is for intravenous administration using sterile equipment. Check for minute leaks prior to use by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not add supplementary medication. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use unless solution is clear and seal is intact.
Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.
Preparation for Administration:
1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set.
![Clindamycin In 5 Percent Dextrose Injection, Solution [Sandoz Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1afa9f7a-944c-4e34-ba51-120f68f2fcf9&name=1afa9f7a-944c-4e34-ba51-120f68f2fcf9-02.jpg)
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