Overview
Clindamycin is a semi-synthetic lincosamide antibiotic used in the treatment of a variety of serious infections due to susceptible microorganisms as well as topically for acne vulgaris. It has a relatively narrow spectrum of activity that includes anaerobic bacteria as well as gram-positive cocci and bacilli and gram-negative bacilli. Interestingly, clindamycin appears to carry some activity against protozoans, and has been used off-label in the treatment of toxoplasmosis, malaria, and babesiosis. Clindamycin is derived from, and has largely replaced, lincomycin, a naturally occurring lincosamide and the eponymous member of this antibiotic class, due to its improved properties over the parent compound. The name lincomycin is derived from Lincoln, Nebraska, where it was first isolated from Streptomyces lincolnensis found in a soil sample.
Background
Clindamycin is a semi-synthetic lincosamide antibiotic used in the treatment of a variety of serious infections due to susceptible microorganisms as well as topically for acne vulgaris. It has a relatively narrow spectrum of activity that includes anaerobic bacteria as well as gram-positive cocci and bacilli and gram-negative bacilli. Interestingly, clindamycin appears to carry some activity against protozoans, and has been used off-label in the treatment of toxoplasmosis, malaria, and babesiosis. Clindamycin is derived from, and has largely replaced, lincomycin, a naturally occurring lincosamide and the eponymous member of this antibiotic class, due to its improved properties over the parent compound. The name lincomycin is derived from Lincoln, Nebraska, where it was first isolated from Streptomyces lincolnensis found in a soil sample.
Indication
In oral and parenteral formulations, clindamycin is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria, as well as susceptible staphylococci, streptococci, and pneumococci. Used topically, it is indicated for the treatment of acne vulgaris and is available in combination with benzoyl peroxide or tretinoin for this purpose, or as a triple combination therapy with benzoyl peroxide and adapalene. Clindamycin is also indicated as a vaginal cream, suppository, or gel for the treatment of bacterial vaginosis in non-pregnant females. Clindamycin is used for antimicrobial prophylaxis against Viridans group streptococcal infections in susceptible patients undergoing oral, dental, or upper respiratory surgery, and may be used for prophylaxis against bacterial endocarditis in penicillin-allergic patients at high risk of these infections.
Associated Conditions
- Abscess, Intra-Abdominal caused by Anaerobic Bacterial Infection
- Acne Vulgaris
- Babesiosis
- Bacterial Endocarditis
- Bacterial Vaginosis (BV)
- Bloodstream Infections caused by Anaerobic Bacterial Infection
- Bone and Joint Infections caused by susceptible Staphylococcus
- Empyema caused by Anaerobic Bacterial Infection
- Endometritis caused by Anaerobic Bacterial Infection
- Lung Abscess caused by Anaerobic Bacterial Infection
- Malaria caused by Plasmodium falciparum
- Mixed Vaginal Infections
- Pelvic cellulitis caused by Anaerobic Bacterial Infection
- Peritonitis caused by Anaerobic Bacterial Infection
- Pneumocystis Jirovecii Pneumonia
- Pneumonitis caused by Anaerobic Bacterial Infection
- Respiratory Tract Infections (RTI) caused by susceptible Staphylococcus
- Respiratory Tract Infections (RTI) caused by susceptible pneumococci
- Respiratory Tract Infections (RTI) caused by susceptible streptococci
- Septicemia caused by susceptible Staphylococcus
- Septicemia caused by susceptible streptococci
- Skin Structures and Soft Tissue Infections caused by Anaerobic Bacterial Infection
- Skin Structures and Soft Tissue Infections caused by susceptible Staphylococcus
- Skin Structures and Soft Tissue Infections caused by susceptible streptococci
- Toxoplasmosis
- Tubo-ovarian abscess caused by Anaerobic Bacterial Infection
- Vaginal Candidiasis
- Vaginal Mycosis
- Chronic Bone and Joint Infections caused by Susceptible infections
- Moderate Acne vulgaris
- Post-surgical vaginal cuff infection caused by Anaerobic Bacterial Infection
- Viridans group streptococci
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/11/22 | Not Applicable | Not yet recruiting | Leiden University Medical Center | ||
2024/11/05 | Phase 1 | Completed | |||
2024/07/10 | Phase 4 | Recruiting | |||
2024/05/20 | Phase 4 | Not yet recruiting | |||
2023/12/15 | Phase 4 | Recruiting | Leiden University Medical Center | ||
2023/11/13 | N/A | Active, not recruiting | |||
2023/11/07 | Phase 2 | Recruiting | |||
2023/10/05 | Not Applicable | Completed | |||
2023/07/03 | Phase 2 | Completed | |||
2023/06/12 | Phase 4 | Recruiting | Frieder Schaumburg |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Sincerus Florida, LLC | 72934-1017 | TOPICAL | 1 g in 100 g | 4/23/2019 | |
DIRECT RX | 61919-057 | ORAL | 150 mg in 1 1 | 1/20/2020 | |
Viona Pharmaceuticals Inc | 72578-084 | TOPICAL | 10 mg in 1 mL | 10/5/2022 | |
NorthStar RxLLC | 16714-984 | TOPICAL | 10 mg in 1 g | 6/28/2019 | |
Pharmacia & Upjohn Company LLC | 0009-0395 | ORAL | 300 mg in 1 1 | 11/9/2022 | |
Aidarex Pharmaceuticals LLC | 33261-159 | ORAL | 150 mg in 1 1 | 12/18/2013 | |
STAT Rx USA LLC | 42549-532 | ORAL | 150 mg in 1 1 | 4/2/2012 | |
Solaris Pharma Corporation | 73473-300 | TOPICAL | 10 mg in 1 g | 8/11/2023 | |
Asclemed USA, Inc. | 76420-615 | ORAL | 75 mg in 1 1 | 9/14/2023 | |
Preferred Pharmaceuticals, Inc. | 68788-7753 | ORAL | 150 mg in 1 1 | 3/3/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
DALACIN T TOPICAL GEL 1% | SIN09700P | GEL | 1% | 4/6/1998 | |
DALACIN C INJECTION 150 mg/ml | SIN01502P | INJECTION | 150 mg/ml | 5/25/1988 | |
CLIDACIN PRESERVATIVE FREE Solution for injection or infusion 150mg/ml | SIN15960P | INJECTION, SOLUTION | 150mg/ml | 6/19/2020 | |
TIDACT INJECTION 150 mg/ml | SIN07759P | INJECTION | 150 mg/ml | 7/1/1994 | |
Clindamycin-hameln Solution for Injection 150mg/ml | SIN14599P | INJECTION, SOLUTION | 150 mg/ml | 9/3/2014 | |
CLIMADAN CAPSULE 150 mg | SIN11414P | CAPSULE | 150 mg | 10/27/2000 | |
T3 MYCIN Lotion 1% w/v | SIN13047P | LOTION | 1% w/v | 2/1/2005 | |
DALACIN T LOTION 1% | SIN07338P | LOTION | 1% | 2/11/1993 | |
TIDACT CAPSULE 150 mg | SIN10164P | CAPSULE | 150 mg | 10/5/1998 | |
DALACIN C CAPSULE 150 mg | SIN02170P | CAPSULE | 150 mg | 6/28/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Clindamycin Hydrochloride tablets | 国药准字H20070303 | 化学药品 | 片剂 | 10/28/2022 | |
Clindamycin Hydrochloride Injection | 国药准字H20066848 | 化学药品 | 注射剂 | 1/14/2021 | |
Clindamycin Hydrochloride Injection | 国药准字H20045883 | 化学药品 | 注射剂 | 2/25/2022 | |
Clindamycin Hydrochloride Injection | 国药准字H20059535 | 化学药品 | 注射剂(注射液) | 12/2/2020 | |
Clindamycin Hydrochloride Injection | 国药准字H20058608 | 化学药品 | 注射剂 | 6/10/2020 | |
Clindamycin Hydrochloride Injection | 国药准字H20103819 | 化学药品 | 注射剂 | 12/11/2020 | |
Clindamycin Hydrochloride Injection | 国药准字H20045539 | 化学药品 | 注射剂 | 9/22/2020 | |
Clindamycin Hydrochloride Injection | 国药准字H20053587 | 化学药品 | 注射剂 | 6/18/2020 | |
Clindamycin Hydrochloride Injection | 国药准字H20064327 | 化学药品 | 注射剂(注射液) | 11/10/2020 | |
Clindamycin Hydrochloride Injection | 国药准字H20059190 | 化学药品 | 注射剂 | 6/17/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
ZANIFAR GEL 1% | N/A | N/A | N/A | 2/11/2006 | |
FUJIRIS TOPICAL SOLUTION 1%W/V | N/A | N/A | N/A | 11/10/2005 | |
DUAC ONCE DAILY GEL (UNITED KINGDOM) | N/A | N/A | N/A | 9/25/2013 | |
EUROTECH ACNE GEL 1% | N/A | N/A | N/A | 12/11/2006 | |
BIBI GEL 1% W/W | N/A | N/A | N/A | 9/28/2017 | |
AMERRA GEL 1% | N/A | N/A | N/A | 2/11/2006 | |
DALACIN C CAP 150 MG | N/A | N/A | N/A | 8/15/1978 |