CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE is indicated for the treatment of Respiratory Tract Infection; Skin and Soft Tissue Infection; Septicemia; Intra-Abdominal Infection; Peritonitis; Intra-Abdominal Abscess; Endometritis; Tubo-Ovarian Abscess; Pelvic Cellulitis; Postsurgical Vaginal Cuff Infection.
Details
- Status
- Prescription
- First Approved
- 1989-09-20
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
CLINDAMYCIN HYDROCHLORIDE Approval History
What CLINDAMYCIN HYDROCHLORIDE Treats
10 indicationsCLINDAMYCIN HYDROCHLORIDE is approved for 10 conditions since its original approval in 1989. 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
- Endometritis
- Tubo-Ovarian Abscess
CLINDAMYCIN HYDROCHLORIDE Boxed Warning
WARNING Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride 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 hydrochloride therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less to...
WARNING Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride 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 hydrochloride 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 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.
CLINDAMYCIN HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
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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.
CLINDAMYCIN HYDROCHLORIDE FDA Label Details
Indications & Usage
CLINDAMYCIN HYDROCHLORIDE is indicated for the treatment of Respiratory Tract Infection; Skin and Soft Tissue Infection; Septicemia; Intra-Abdominal Infection; Peritonitis; Intra-Abdominal Abscess; Endometritis; Tubo-Ovarian Abscess; Pelvic Cellulitis; Postsurgical Vaginal Cuff Infection.
WARNING Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, lea...
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CLEOCIN HYDROCHLORIDE
Full clinical data, patents, trials, and competitive landscape for clindamycin hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.