CLEOCIN HYDROCHLORIDE (clindamycin hydrochloride)
CLEOCIN HYDROCHLORIDE is indicated for the treatment of Respiratory Tract Infection; Skin and Soft Tissue Infection; Septicemia; Intra-abdominal Infection; Peritonitis; Intra-abdominal Abscess; Infection of the Female Pelvis; Infection of the Female Genital Tract; Endometritis; Tubo-ovarian Abscess; Pelvic Cellulitis; Postsurgical Vaginal Cuff Infection; Empyema; Anaerobic Pneumonitis; Lung Abscess.
How CLEOCIN HYDROCHLORIDE Works
Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the bacterial ribosome. This mechanism of action is primarily bacteriostatic.
Details
- Status
- Prescription
- First Approved
- 1970-02-22
- Routes
- ORAL
- Dosage Forms
- CAPSULE
CLEOCIN HYDROCHLORIDE Approval History
What CLEOCIN HYDROCHLORIDE Treats
15 indicationsCLEOCIN HYDROCHLORIDE is approved for 15 conditions since its original approval in 1970. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Respiratory Tract Infection
- Skin and Soft Tissue Infection
- Septicemia
- Intra-abdominal Infection
- Peritonitis
- Intra-abdominal Abscess
- Infection of the Female Pelvis
- Infection of the Female Genital Tract
CLEOCIN HYDROCHLORIDE Boxed Warning
WARNING Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN HCl 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 CLEOCIN HCl therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are ...
WARNING Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN HCl 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 CLEOCIN HCl 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.
CLEOCIN HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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.
CLEOCIN HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)CLEOCIN HYDROCHLORIDE is indicated for the treatment of Respiratory Tract Infection; Skin and Soft Tissue Infection; Septicemia; Intra-abdominal Infection; Peritonitis; Intra-abdominal Abscess; Infection of the Female Pelvis; Infection of the Female Genital Tract; Endometritis; Tubo-ovarian Abscess; Pelvic Cellulitis; Postsurgical Vaginal Cuff Infection; Empyema; Anaerobic Pneumonitis; Lung Abscess.
WARNING Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN HCl and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgr...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.