Clindamycin in 5 Percent Dextrose 18 mg/mL
Clindamycin in 5 Percent Dextrose · INJECTION, SOLUTION · Sandoz Inc
Clindamycin in 5 Percent Dextrose is a injection, solution containing clindamycin in 5 percent dextrose at 18 mg/mL, taken intravenous. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Clindamycin in 5 Percent Dextrose
- Generic Name
- Clindamycin in 5 Percent Dextrose
- NDC Code (Product)
0781-3290- Manufacturer
- Sandoz Inc
- Strength
- 18 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA201692
- Drug Class
- Lincosamide Antibacterial [EPC]
- Marketing Start
- 02/07/2013
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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 antibacterial drug-associated pseudomembranous 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). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction with antibacterial drug 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, …
Dosage & Administration
DOSAGE AND ADMINISTRATION If diarrhea occurs during therapy, this antibacterial drug 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 Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens ): 600 to 1,200 mg/day in 2, 3 or 4 equal doses. More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens : 1,200 to 2,700 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 4,800 mg daily have been given intravenously to adults. See IV 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: Table 2. Serum Clindamycin Levels Maintained, Rapid Infusion Rate and Maintenance Infusion Rate To maintain serum clindamycin leve…
Warnings
WARNINGS See BOXED WARNING . Clostridioides difficile - Associated Diarrhea Clostridioides 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 . 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 antibacterial drug 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 antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically ind…
Contraindications
CONTRAINDICATIONS This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
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.
Adverse Reactions
ADVERSE REACTIONS The following reactions have been reported with the use of clindamycin. Infections and Infestations Clostridioides difficile colitis Gastrointestinal Antibacterial drug-associated colitis (see WARNINGS ), pseudomembranous colitis, abdominal pain, nausea, and vomiting. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS ). An unpleasant or metallic taste has been reported after intravenous administration of the higher doses of clindamycin phosphate. Hypersensitivity Reactions Maculopapular rash and urticaria have been observed during drug therapy. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions. 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, have been associated with clindamycin. Anaphylactic shock, anaphylactic reaction, hypersensitivity, and acute myocardial ischemia with or without myocardial infarction occurring as part of an allergic reaction …
Frequently Asked Questions
What is Clindamycin in 5 Percent Dextrose used for?
Clindamycin in 5 Percent Dextrose contains Clindamycin in 5 Percent Dextrose. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Clindamycin in 5 Percent Dextrose a controlled substance?
Clindamycin in 5 Percent Dextrose is not classified as a controlled substance by the DEA.
What is the generic name for Clindamycin in 5 Percent Dextrose?
The generic name for Clindamycin in 5 Percent Dextrose is Clindamycin in 5 Percent Dextrose. There are 2 other brand versions of Clindamycin in 5 Percent Dextrose.
What is the NDC code for Clindamycin in 5 Percent Dextrose 18 mg/mL?
The NDC (National Drug Code) for Clindamycin in 5 Percent Dextrose 18 mg/mL is 0781-3290, listed by Sandoz Inc.