MedPath

Clindamycin

Generic Name
Clindamycin
Brand Names
Acanya, Benzaclin, Biacna, Cabtreo, Cleocin, Cleocin-T, Clindacin, Clindagel, Clindesse, Clindoxyl, Dalacin, Dalacin C, Duac, Evoclin, Neuac, Onexton, Veltin, Xaciato, Ziana
Drug Type
Small Molecule
Chemical Formula
C18H33ClN2O5S
CAS Number
18323-44-9
Unique Ingredient Identifier
3U02EL437C

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.

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
No NMPA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
BIACNA TOPICAL GEL
bausch health, canada inc.
02359685
Gel - Topical
1.2 % / W/W
5/16/2011
CLINDAMYCIN PHOSPHATE INJECTION USP LIQ
lyphomed, division of fujisawa canada inc.
02051826
Liquid - Intramuscular ,  Intravenous
150 MG / ML
12/31/1994
CABTREO
bausch health, canada inc.
02550423
Gel - Topical
1.2 % / W/W
10/7/2024

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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