CLEOCIN PHOSPHATE (clindamycin phosphate) · Pfizer
Cleocin Phosphate is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria, as well as strains of streptococci, pneumococci, and staphylococci. Its use is generally reserved for penicillin-allergic patients or cases where penicillin is inappropriate. Due to a significant risk of antibacterial drug-associated pseudomembranous colitis (as noted in its Boxed Warning), clinicians should consider less toxic alternatives before prescribing. Specific clinical applications include lower respiratory tract infections (pneumonia, empyema, lung abscess), skin and skin structure infections, gynecological infections (endometritis, pelvic cellulitis), intra-abdominal infections (peritonitis, abscess), septicemia, and bone and joint infections (osteomyelitis).
How CLEOCIN PHOSPHATE Works
Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the bacterial ribosome. This action interferes with the assembly of the ribosome and the translation process. Clindamycin is typically classified as bacteriostatic.
Details
- Status
- Prescription
- First Approved
- 1972-10-02
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CLEOCIN PHOSPHATE Approval History
What CLEOCIN PHOSPHATE Treats
18 indicationsCLEOCIN PHOSPHATE is approved for 18 conditions since its original approval in 1972. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anaerobic Bacterial Infection
- Streptococcal Infection
- Lower Respiratory Tract Infection
- Pneumonia
- Empyema
- Lung Abscess
- Skin and Skin Structure Infection
- Gynecological Infection
- Endometritis
- Tubo-Ovarian Abscess
- Pelvic Cellulitis
- Vaginal Cuff Infection
- Intra-Abdominal Infection
- Peritonitis
- Intra-Abdominal Abscess
- Septicemia
- Bone and Joint Infection
- Osteomyelitis
CLEOCIN PHOSPHATE Boxed Warning
WARNING Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN PHOSPHATE 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 PHOSPHATE therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial...
WARNING Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN PHOSPHATE 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 PHOSPHATE 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 PHOSPHATE 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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Pfizer's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
CLEOCIN PHOSPHATE FDA Label Details
Indications & Usage
FDA Label (PDF)CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. CLEOCIN PHOSPHATE 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 , before selecting clindamycin the physician should...
WARNING Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN PHOSPHATE and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to o...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.