CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER (clindamycin phosphate) · Novartis
Clindamycin phosphate in 5% dextrose is an intravenous antibacterial indicated for the treatment of serious infections caused by susceptible anaerobic bacteria, staphylococci, streptococci, and pneumococci. Its use is typically reserved for serious cases where less toxic alternatives are inappropriate due
How CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER Works
The specific process by which this medication works to clear acne vulgaris is currently unknown. It is used to address the condition even though the underlying biological mechanism has not been identified.
Details
- Status
- Prescription
- First Approved
- 2012-05-31
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER Approval History
What CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER Treats
1 indicationsCLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER Boxed Warning
WARNING Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Clindamycin Injection USP in 5% Dextrose 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 Injection USP in 5% Dextrose therapy has been associated with severe colitis which may end fatally, it should be reserved for ser...
WARNING Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Clindamycin Injection USP in 5% Dextrose 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 Injection USP in 5% Dextrose 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 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 indicated.
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER Competitive Set
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Indication competitors
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04469075 | 19-342 | Ph 2 | active not recruiting | Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields |
| NCT04321070 | CLPL 1907 | Ph 1 | completed | Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris |
| NCT00616330 | CBC-302-602-622467 | Ph 3 | completed | Vaginal Infection Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
Clindamycin Injection USP in 5% Dextrose products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection USP in 5% Dextrose products are 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 , bef...
WARNING Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Clindamycin Injection USP in 5% Dextrose and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.