Clindamycin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Black Box Warning
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WARNING
See full prescribing information for complete Boxed Warning.
Clostridium 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. difficle.
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 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. |
Overview
Clindamycin is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Clindamycin FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Clindamycin in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Clindamycin in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Clindamycin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Clindamycin in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Clindamycin in pediatric patients.
Contraindications
There is limited information regarding Clindamycin Contraindications in the drug label.
Warnings
|
WARNING
See full prescribing information for complete Boxed Warning.
Clostridium 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. difficle.
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 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. |
There is limited information regarding Clindamycin Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clindamycin Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Clindamycin Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Clindamycin Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Clindamycin in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Clindamycin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Clindamycin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Clindamycin in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Clindamycin in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Clindamycin in geriatric settings.
Gender
There is no FDA guidance on the use of Clindamycin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Clindamycin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Clindamycin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Clindamycin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Clindamycin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Clindamycin in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Clindamycin Administration in the drug label.
Monitoring
There is limited information regarding Clindamycin Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Clindamycin and IV administrations.
Overdosage
There is limited information regarding Clindamycin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Clindamycin Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Clindamycin Mechanism of Action in the drug label.
Structure
There is limited information regarding Clindamycin Structure in the drug label.
Pharmacodynamics
There is limited information regarding Clindamycin Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Clindamycin Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Clindamycin Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Clindamycin Clinical Studies in the drug label.
How Supplied
There is limited information regarding Clindamycin How Supplied in the drug label.
Storage
There is limited information regarding Clindamycin Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Clindamycin Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Clindamycin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Clindamycin Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Clindamycin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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| Routes of administration | Oral, topical, IV, intravaginal |
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| Pharmacokinetic data | |
| Bioavailability | 90% (oral) 4–5% (topical) |
| Protein binding | 90% |
| Metabolism | Hepatic |
| Elimination half-life | 2–3 hours |
| Excretion | Renal |
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| E number | {{#property:P628}} |
| ECHA InfoCard | {{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value). |
| Chemical and physical data | |
| Formula | C18H33ClN2O5S |
| Molar mass | 424.98 g/mol |
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WikiDoc Resources for Clindamycin |
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Media |
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Powerpoint slides on Clindamycin |
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Evidence Based Medicine |
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Clinical Trials |
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Ongoing Trials on Clindamycin at Clinical Trials.gov Clinical Trials on Clindamycin at Google
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Guidelines / Policies / Govt |
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US National Guidelines Clearinghouse on Clindamycin
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Books |
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News |
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Commentary |
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Definitions |
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Patient Resources / Community |
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Patient resources on Clindamycin Discussion groups on Clindamycin Patient Handouts on Clindamycin Directions to Hospitals Treating Clindamycin Risk calculators and risk factors for Clindamycin
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Healthcare Provider Resources |
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Causes & Risk Factors for Clindamycin |
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Continuing Medical Education (CME) |
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Experimental / Informatics |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]
Overview
Clindamycin (rINN) (IPA: Template:IPA) is a lincosamide antibiotic used in the treatment of infections caused by susceptible microorganisms. Clindamycin is a semisynthetic antibiotic derived from lincomycin by 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the lincomycin. Clindamycin is marketed under various trade names including Dalacin (Pfizer), Cleocin (Pfizer), and in a foam as Evoclin (Connetics) and Duac(Stiefel).
Indications
Clindamycin is used primarily to treat infections caused by susceptible anaerobic bacteria. Such infections might include infections of the respiratory tract, septicemia and peritonitis. In patients with hypersensitivity to penicillins, clindamycin may be used to treat infections caused by susceptible aerobic bacteria as well. It is also used to treat bone infections caused by Staphylococcus aureus. Topical application of clindamycin phosphate can be used to treat moderate to severe acne.
It is most effective against infections involving the following types of organisms:
- Aerobic gram-positive cocci, including some members of the Staphylococcus and Streptococcus (eg. pneumococcus) genera.
- Anaerobic gram-negative bacilli, including some members of the Bacteroides and Fusobacterium genera.
Clindamycin is also used occasionally in cases of suspected toxic shock syndrome in combination with a bactericidal agent such as vancomycin. The rationale for this approach is a presumed synergy between the bactericidal antibiotic, which causes the death of the bacteria by breakdown of the cell membrane, and clindamycin, which inhibits toxin synthesis.
Clindamycin has been proven to decrease the risk of preterm births in women diagnosed with bacterial vaginosis during early pregnancy to about a third of the risk of untreated women (Lamont, 2005).
Recently, clindamycin has been found to be useful in skin and soft tissue infections caused by methicillin-resistant Staphylococcus aureus (Daum, 2007).
Available forms
Clindamycin preparations for oral administration include capsules (containing clindamycin hydrochloride) and oral suspensions (containing clindamycin palmitate hydrochloride). It is also available for topical administration, in gel form and in a foam delivery system (both containing clindamycin phosphate), primarily as a prescription acne treatment.
Adverse effects
Common adverse drug reactions (ADRs) associated with clindamycin therapy—found in over 1% of patients—include: diarrhea, pseudomembranous colitis, nausea, vomiting, abdominal pain or cramps, rash, and/or itch. High intravenous doses may cause a metallic taste, and topical application may cause contact dermatitis (Rossi, 2006).
Pseudomembranous colitis is a potentially-lethal condition commonly associated with clindamycin, but which also occurs with other antibiotics. Overgrowth of Clostridium difficile, which is inherently resistant to clindamycin, results in the production of a toxin that causes a range of adverse effects, from diarrhea to colitis and toxic megacolon (Rossi, 2006).
Rarely—in less than 0.1% of patients—clindamycin therapy has been associated with anaphylaxis, blood dyscrasias, polyarthritis, jaundice, raised liver enzymes and/or hepatotoxicity (Rossi, 2006).
Pharmacology
Pharmacokinetics
Approximately 90% of an oral dose of clindamycin is absorbed from the gastrointestinal tract and it is widely distributed throughout the body, excluding the central nervous system. Adequate therapeutic concentrations can be achieved in bone. There is also active uptake into white blood cells, most importantly neutrophils. (Klempner and Styrt, 1981)
Clindamycin is extensively metabolised in the liver, with some metabolites being active, such as N-dimethyl clindamycin and clindamycin sulfoxide. The elimination half-life is 1.5 to 5 hours. Clindamycin is primarily eliminated by hepatic metabolism; after an intravenous dose of clindamycin phosphate, about 4.5% of the dose is excreted in urine as clindamycin and about 0.35% as the phosphate salt (Plaisance, 1989). The metabolites of clindamycin are excreted primarily in the urine (Klasco, 2006).
Mechanism of action
Clindamycin has a bacteriostatic effect. It interferes with bacterial protein synthesis, in a similar way to erythromycin and chloramphenicol, by binding to the 50S subunit of the bacterial ribosome. This causes antagonism if administered simultaneously and possible cross-resistance.
Veterinary use
In cats
Clindamycin has been used successfully in treating cats that are displaying symptoms of toxoplasmosis. This disease rarely causes symptoms in cats, but can do so in very young or immunocompromised kittens and cats. Toxoplasmosis is contagious to humans, and therefore cat owners, particularly pregnant women, should take precautions to prevent the spread of the disease.
References
- Daum RS (2007). "Clinical practice. Skin and soft-tissue infections caused by methicillin-resistant Staphylococcus aureus". N Engl J Med. 357 (4): 380–90. doi:10.1056/NEJMcp070747. PMID 17652653.
- Klasco RK, editor. Drugdex system, volume 128. Greenwood Village (CO): Thomson Micromedex; 2006.
- Klempner MS, Styrt B (1981). "Clindamycin uptake by human neutrophils". J. Infect. Dis. 144 (5): 472–9. PMID 6171600.
- Lamont RF (2005). "Can antibiotics prevent preterm birth--the pro and con debate". BJOG. 112 Suppl 1: 67–73. doi:10.1111/j.1471-0528.2005.00589.x. PMID 15715599.
- Plaisance KI; et al. (1989). "Pharmacokinetic evaluation of two dosage regimens of clindamycin phosphate". Antimicrob Agents Chemother. 33 (5): 618–20. PMID 2751277. PMC 172501.
- Rossi S, editor. Australian Medicines Handbook 2006. Adelaide: Australian Medicines Handbook; 2006.
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