Clindamycin: Difference between revisions

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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.
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.
|offLabelAdultGuideSupport===Indications and Dosing==
|offLabelAdultGuideSupport===Indications and Dosing==
due to risk of severe colitis, reserve use of clindamycin for serious infections when other options are inappropriate [1]
* Due to risk of severe colitis, reserve use of clindamycin for serious infections when other options are inappropriate.
Babesiosis: 600 mg ORALLY every 8 hours plus quinine 650 mg ORALLY every 6 to 8 hours for 7 to 10 days [2]
* Babesiosis: 600 mg ORALLY every 8 hours plus quinine 650 mg ORALLY every 6 to 8 hours for 7 to 10 days.
Bacterial endocarditis; Prophylaxis: (high-risk patients; dental, respiratory, or infected skin/skin structure or musculoskeletal tissue procedures) 600 mg ORALLY 30 to 60 minutes prior to procedure [3]
* Bacterial endocarditis; Prophylaxis: (high-risk patients; dental, respiratory, or infected skin/skin structure or musculoskeletal tissue procedures) 600 mg ORALLY 30 to 60 minutes prior to procedure.
Bacterial infectious disease (Severe), Susceptible infections due to anaerobic organisms, staphylococci, streptococci, pneumococci: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections (manufacturer dosing) [4]; (MRSA-associated) 300 to 450 mg ORALLY 3 times daily for cellulitis and 600 mg ORALLY 3 times daily for complicated skin and soft tissue infections (cSSTIs), pneumonia, and bone and joint infections; duration is 5 to 10 days for cellulitis, 7 to 14 days for hospital-associated cSSTIs, 7 to 21 days for pneumonia, 8 weeks for osteomyelitis, and 3 to 4 weeks for septic arthritis (guideline dosing) [5]
* Bacterial infectious disease (Severe), Susceptible infections due to anaerobic organisms, staphylococci, streptococci, pneumococci: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections (manufacturer dosing); (MRSA-associated) 300 to 450 mg ORALLY 3 times daily for cellulitis and 600 mg ORALLY 3 times daily for complicated skin and soft tissue infections (cSSTIs), pneumonia, and bone and joint infections; duration is 5 to 10 days for cellulitis, 7 to 14 days for hospital-associated cSSTIs, 7 to 21 days for pneumonia, 8 weeks for osteomyelitis, and 3 to 4 weeks for septic arthritis (guideline dosing).
Bacterial vaginosis: 300 mg ORALLY twice daily for 7 days [6]
* Bacterial vaginosis: 300 mg ORALLY twice daily for 7 days.
HIV infection - Pneumocystis pneumonia: 300 to 450 mg ORALLY every 6 to 8 hours, in combination with primaquine 15 to 30 mg (base) ORALLY once daily for 21 days [7]
* HIV infection - Pneumocystis pneumonia: 300 to 450 mg ORALLY every 6 to 8 hours, in combination with primaquine 15 to 30 mg (base) ORALLY once daily for 21 days.
HIV infection - Toxoplasmosis: (encephalitis) alternative therapy, 600 mg ORALLY every 6 hours, in combination with pyrimethamine 200 mg ORALLY for 1 dose, then 50 mg (less than 60 kg) or 75 mg (60 kg or greater) ORALLY daily plus leucovorin 10 to 25 mg (can increase to 50 mg) ORALLY daily for at least 6 weeks [7]
* HIV infection - Toxoplasmosis: (encephalitis) alternative therapy, 600 mg ORALLY every 6 hours, in combination with pyrimethamine 200 mg ORALLY for 1 dose, then 50 mg (less than 60 kg) or 75 mg (60 kg or greater) ORALLY daily plus leucovorin 10 to 25 mg (can increase to 50 mg) ORALLY daily for at least 6 weeks.
HIV infection - Toxoplasmosis; Prophylaxis: secondary prophylaxis (alternative regimen), 600 mg ORALLY every 8 hours, in combination with pyrimethamine 25 to 50 mg ORALLY daily plus leucovorin 10 to 25 mg ORALLY daily [7]
* HIV infection - Toxoplasmosis; Prophylaxis: secondary prophylaxis (alternative regimen), 600 mg ORALLY every 8 hours, in combination with pyrimethamine 25 to 50 mg ORALLY daily plus leucovorin 10 to 25 mg ORALLY daily.
Impetigo: (Staphylococcus and Streptococcus species) 300 to 400 mg ORALLY 4 times daily for 7 days, depending on clinical response (guideline dosing) [8]
* Impetigo: (Staphylococcus and Streptococcus species) 300 to 400 mg ORALLY 4 times daily for 7 days, depending on clinical response (guideline dosing).
Infection of skin AND/OR subcutaneous tissue (Severe): 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections (manufacturer dose) [4]; MRSA-associated, 300 mg to 450 mg ORALLY 3 times daily for 5 to 10 days (purulent and nonpurulent cellulitis) or 600 mg ORALLY 3 times daily (complicated skin and soft tissue infections [cSSTIs]), generally for 7 to 14 days for hospital-associated cSSTIs; individualize to patient response [5]
* Infection of skin AND/OR subcutaneous tissue (Severe): 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections (manufacturer dose) [4]; MRSA-associated, 300 mg to 450 mg ORALLY 3 times daily for 5 to 10 days (purulent and nonpurulent cellulitis) or 600 mg ORALLY 3 times daily (complicated skin and soft tissue infections [cSSTIs]), generally for 7 to 14 days for hospital-associated cSSTIs; individualize to patient response.
Infection of skin AND/OR subcutaneous tissue (Severe): Methicillin-susceptible Staphylococcus aureus or MRSA, 300 to 450 mg ORALLY 3 or [5] 4 times daily [8]; for purulent or nonpurulent cellulitis continue treatment for 5 to 10 days [5]
* Infection of skin AND/OR subcutaneous tissue (Severe): Methicillin-susceptible Staphylococcus aureus or MRSA, 300 to 450 mg ORALLY 3 or [5] 4 times daily [8]; for purulent or nonpurulent cellulitis continue treatment for 5 to 10 days.
Infection of skin AND/OR subcutaneous tissue (Severe): MRSA, complicated skin and soft tissue infections (cSSTIs), 600 mg ORALLY 3 times daily, generally for 7 to 14 days for hospital-associated cSSTIs; individualize to patient response (guideline dose) [5]
* Infection of skin AND/OR subcutaneous tissue (Severe): MRSA, complicated skin and soft tissue infections (cSSTIs), 600 mg ORALLY 3 times daily, generally for 7 to 14 days for hospital-associated cSSTIs; individualize to patient response (guideline dose).
Infectious disease of abdomen: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections [4]
* Infectious disease of abdomen: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections.
Lower respiratory tract infection (Severe), Empyema, abscess, pneumonitis: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections [4]
* Lower respiratory tract infection (Severe), Empyema, abscess, pneumonitis: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections.
Pelvic inflammatory disease: 900 mg IV every 8 hours plus gentamicin (IV or IM) loading dose of 2 mg/kg, followed by 1.5 mg/kg every 8 hours (single daily dosing of gentamicin 3 to 5 mg/kg may be substituted); discontinue IV/IM therapy 24 hours after clinical improvement and continue on clindamycin 450 mg ORALLY 4 times daily or doxycycline 100 mg ORALLY twice daily to complete a total of 14 days of therapy (guideline dosing) [6]
* Pelvic inflammatory disease: 900 mg IV every 8 hours plus gentamicin (IV or IM) loading dose of 2 mg/kg, followed by 1.5 mg/kg every 8 hours (single daily dosing of gentamicin 3 to 5 mg/kg may be substituted); discontinue IV/IM therapy 24 hours after clinical improvement and continue on clindamycin 450 mg ORALLY 4 times daily or doxycycline 100 mg ORALLY twice daily to complete a total of 14 days of therapy (guideline dosing).
Pelvic inflammatory disease: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections (manufacturer dosing) [4]
* Pelvic inflammatory disease: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections (manufacturer dosing) .
Septicemia: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections [4]
* Septicemia: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections.
Streptococcal pharyngitis: (penicillin-allergic patients) 20 mg/kg/day ORALLY in 3 divided doses (MAX 1.8 g/day)
* Streptococcal pharyngitis: (penicillin-allergic patients) 20 mg/kg/day ORALLY in 3 divided doses (MAX 1.8 g/day).
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Clindamycin in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Clindamycin in adult patients.
|offLabelPedGuideSupport=due to risk of severe colitis, reserve use of clindamycin for serious infections when other options are inappropriate [1]
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Clindamycin in pediatric patients.
Acute otitis media: 30 to 40 mg/kg/day ORALLY in 3 divided doses for 5 to 7 days (6 years or older with mild to moderate illness), 7 days (2 to 5 years with mild to moderate illness), or 10 days (younger than 2 years or with severe illness) [10]
Babesiosis: 7 to 10 mg/kg ORALLY every 6 to 8 hours (MAX 600 mg/dose) plus quinine 8 mg/kg ORALLY every 8 hours (MAX 650 mg/dose) for 7 to 10 days
Bacterial endocarditis; Prophylaxis: (high-risk patients; dental, respiratory, or infected skin/skin structure or musculoskeletal tissue procedures) 20 mg/kg ORALLY 30 to 60 minutes prior to procedure
Bacterial infectious disease (Severe), Susceptible infections due to anaerobic organisms, staphylococci, streptococci, pneumococci: 8 to 16 mg/kg/day ORALLY divided every 6 to 8 hours; use 16 to 20 mg/kg/day ORALLY divided every 6 to 8 hours for more severe infections ; (MRSA-associated infections) 40 mg/kg/day orally divided every 6 to 8 hours (guideline dosing)
HIV infection - Toxoplasmosis: (congenital toxoplasmosis) 5 to 7.5 mg/kg/dose (MAX 600 mg/dose) ORALLY 4 times daily plus pyrimethamine 2 mg/kg ORALLY once daily for 2 days, then 1 mg/kg ORALLY once daily for 2 to 6 months, then 1 mg/kg ORALLY 3 times weekly plus leucovorin 10 mg ORALLY or IM with each dose of pyrimethamine; total treatment duration is 12 months
HIV infection - Toxoplasmosis: (acquired toxoplasmosis) 5 to 7.5 mg/kg/dose (MAX 600 mg/dose) ORALLY 4 times daily plus pyrimethamine 2 mg/kg (MAX 50 mg) ORALLY once daily for 3 days, then 1 mg/kg (MAX 25 mg) ORALLY once daily plus leucovorin 10 to 25 mg ORALLY daily; continue for at least 6 weeks, followed by secondary prophylaxis
HIV infection - Toxoplasmosis; Prophylaxis: secondary prophylaxis (alternative regimen), 20 to 30 mg/kg/day ORALLY divided into 3 to 4 doses plus pyrimethamine 1 mg/kg or 15 mg/m(2) (MAX 25 mg) ORALLY daily plus leucovorin 5 mg ORALLY every 3 days
Impetigo: (Staphylococcus and Streptococcus species) 20 mg/kg/day ORALLY in 3 divided doses for 7 days, depending on clinical response (guideline dosing)
Infection of skin AND/OR subcutaneous tissue (Severe): 8 to 16 mg/kg/day ORALLY divided every 6 to 8 hours; use 16 to 20 mg/kg/day ORALLY divided every 6 to 8 hours for more severe infections (manufacturer dose)
Infection of skin AND/OR subcutaneous tissue (Severe): Methicillin-susceptible Staphylococcus aureus, 25 to 30 mg/kg/day ORALLY in 3 divided doses (guideline dose)
Infection of skin AND/OR subcutaneous tissue (Severe): MRSA, 30 to [8] 40 mg/kg/day [8][5] ORALLY in 3  or 4 divided doses (guideline dose)
Infectious disease of abdomen: 8 to 16 mg/kg/day ORALLY divided every 6 to 8 hours; use 16 to 20 mg/kg/day ORALLY divided every 6 to 8 hours for more severe infections
Lower respiratory tract infection (Severe), Empyema, abscess, pneumonitis: 8 to 16 mg/kg/day ORALLY divided every 6 to 8 hours; use 16 to 20 mg/kg/day ORALLY divided every 6 to 8 hours for more severe infections
Lower respiratory tract infection (Severe), Empyema, abscess, pneumonitis: community-acquired pneumonia (older than 3 months) 30 to 40 mg/kg/day ORALLY in 3 to 4 divided doses (guideline dosing) [
Pelvic inflammatory disease: 8 to 16 mg/kg/day ORALLY divided every 6 to 8 hours; use 16 to 20 mg/kg/day ORALLY divided every 6 to 8 hours for more severe infections
Septicemia: 8 to 16 mg/kg/day ORALLY divided every 6 to 8 hours; 16 to 20 mg/kg/day ORALLY divided every 6 to 8 hours for more severe infections
Streptococcal pharyngitis: (penicillin-allergic patients) 20 mg/kg/day ORALLY in 3 divided doses (MAX 1.8 g/day)
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Clindamycin in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Clindamycin in pediatric patients.
|alcohol=Alcohol-Clindamycin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=Alcohol-Clindamycin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
}}
}}
{{drugbox |
|image=Clindamycin skeletal.svg
|IUPAC_name = (2''S'',4''R'')-''N''-((1''R'')-2-chloro-<br />1-((3''R'',4''R'',5''S'',6''R'')-3,4,5-trihydroxy-<br />6-(methylthio)-tetrahydro-2''H''-pyran-2-yl)propyl)-<br />1-methyl-4-propylpyrrolidine-2-carboxamide
|CAS_number = 18323-44-9
| ATC_prefix=J01
| ATC_suffix=FF01
| ATC_supplemental={{ATC|G01|AA10}}
| PubChem=29029
| DrugBank=APRD00566
| C=18 | H=33 | Cl=1 | N=2 | O=5 | S=1
|molecular_weight = 424.98 g/mol
|bioavailability = 90% (oral)<br />4–5% (topical)
|metabolism = [[Liver|Hepatic]]
|protein_bound = 90%
|elimination_half-life = 2–3 hours
|excretion = [[Kidney|Renal]]
|pregnancy_US = B
|pregnancy_AU = A
|legal_status = Schedule 4 ([[Australia|Aust]])<br />POM ([[United Kingdom|UK]])<br />Prescription only ([[U.S.]])
|routes_of_administration = Oral, [[topical]], [[intravenous|IV]], [[pessary|intravaginal]]
}}
{{SI}}
__NOTOC__
{{See also|Clindamycin hydrochloride|Clindamycin palmitate hydrochloride|Clindamycin phosphate}}
{{CMG}}
==Overview==
'''Clindamycin''' ([[International Nonproprietary Name|rINN]]) ([[International Phonetic Alphabet|IPA]]: {{IPA|[klɪndəˈmaɪsən]}}) is a [[lincomycin|lincosamide]] [[antibiotic]] used in the treatment of [[infection]]s caused by susceptible [[microorganism]]s. 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 name]]s 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 organism|anaerobic]] [[bacteria]]. Such infections might include infections of the [[respiratory tract]], [[septicemia]] and [[peritonitis]]. In patients with [[hypersensitivity]] to [[penicillin]]s, clindamycin may be used to treat infections caused by susceptible [[aerobic organism|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]]) [[genus|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 [[lysis|breakdown of the cell membrane]], and clindamycin, which inhibits toxin synthesis.
Clindamycin has been proven to decrease the risk of [[preterm birth]]s 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|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 reaction]]s (ADRs) associated with clindamycin therapy—found in over 1% of patients—include: [[diarrhea]], [[pseudomembranous colitis]], [[nausea]], [[vomiting]], [[abdomen|abdominal]] pain or [[cramp]]s, [[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 [[antibiotic resistance|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 [[dyscrasia]]s, [[polyarthritis]], [[jaundice]], [[elevated transaminases|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 cell]]s, most importantly [[neutrophil granulocyte|neutrophil]]s. (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 ==
*{{cite journal |author=Daum RS |title=Clinical practice. Skin and soft-tissue infections caused by methicillin-resistant Staphylococcus aureus |journal=N Engl J Med |volume=357 |issue=4 |pages=380–90 |year=2007 |pmid=17652653 |doi=10.1056/NEJMcp070747}}
* Klasco RK, editor. Drugdex system, volume 128. Greenwood Village (CO): Thomson Micromedex; 2006.
* {{cite journal |author=Klempner MS, Styrt B |title=Clindamycin uptake by human neutrophils |journal=J. Infect. Dis. |volume=144 |issue=5 |pages=472–9 |year=1981 |pmid=6171600 |doi=}}
* {{cite journal |author=Lamont RF |title=Can antibiotics prevent preterm birth--the pro and con debate |journal=BJOG |volume=112 Suppl 1 |issue= |pages=67–73 |year=2005 |pmid=15715599 |doi=10.1111/j.1471-0528.2005.00589.x}}
* {{cite journal |author=Plaisance KI ''et al.'' |title=Pharmacokinetic evaluation of two dosage regimens of clindamycin phosphate |journal=Antimicrob Agents Chemother |volume=33 |issue=5 |pages=618–20 |year=1989 |pmid=2751277 |doi=}} {{PMC|172501}}.
* Rossi S, editor. [[Australian Medicines Handbook]] 2006. Adelaide: Australian Medicines Handbook; 2006.
[[Category:Antibiotics]]
[[Category:Wikinfect]]

Revision as of 18:45, 10 December 2014

Clindamycin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

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

Indications and Dosing

  • Due to risk of severe colitis, reserve use of clindamycin for serious infections when other options are inappropriate.
  • Babesiosis: 600 mg ORALLY every 8 hours plus quinine 650 mg ORALLY every 6 to 8 hours for 7 to 10 days.
  • Bacterial endocarditis; Prophylaxis: (high-risk patients; dental, respiratory, or infected skin/skin structure or musculoskeletal tissue procedures) 600 mg ORALLY 30 to 60 minutes prior to procedure.
  • Bacterial infectious disease (Severe), Susceptible infections due to anaerobic organisms, staphylococci, streptococci, pneumococci: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections (manufacturer dosing); (MRSA-associated) 300 to 450 mg ORALLY 3 times daily for cellulitis and 600 mg ORALLY 3 times daily for complicated skin and soft tissue infections (cSSTIs), pneumonia, and bone and joint infections; duration is 5 to 10 days for cellulitis, 7 to 14 days for hospital-associated cSSTIs, 7 to 21 days for pneumonia, 8 weeks for osteomyelitis, and 3 to 4 weeks for septic arthritis (guideline dosing).
  • Bacterial vaginosis: 300 mg ORALLY twice daily for 7 days.
  • HIV infection - Pneumocystis pneumonia: 300 to 450 mg ORALLY every 6 to 8 hours, in combination with primaquine 15 to 30 mg (base) ORALLY once daily for 21 days.
  • HIV infection - Toxoplasmosis: (encephalitis) alternative therapy, 600 mg ORALLY every 6 hours, in combination with pyrimethamine 200 mg ORALLY for 1 dose, then 50 mg (less than 60 kg) or 75 mg (60 kg or greater) ORALLY daily plus leucovorin 10 to 25 mg (can increase to 50 mg) ORALLY daily for at least 6 weeks.
  • HIV infection - Toxoplasmosis; Prophylaxis: secondary prophylaxis (alternative regimen), 600 mg ORALLY every 8 hours, in combination with pyrimethamine 25 to 50 mg ORALLY daily plus leucovorin 10 to 25 mg ORALLY daily.
  • Impetigo: (Staphylococcus and Streptococcus species) 300 to 400 mg ORALLY 4 times daily for 7 days, depending on clinical response (guideline dosing).
  • Infection of skin AND/OR subcutaneous tissue (Severe): 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections (manufacturer dose) [4]; MRSA-associated, 300 mg to 450 mg ORALLY 3 times daily for 5 to 10 days (purulent and nonpurulent cellulitis) or 600 mg ORALLY 3 times daily (complicated skin and soft tissue infections [cSSTIs]), generally for 7 to 14 days for hospital-associated cSSTIs; individualize to patient response.
  • Infection of skin AND/OR subcutaneous tissue (Severe): Methicillin-susceptible Staphylococcus aureus or MRSA, 300 to 450 mg ORALLY 3 or [5] 4 times daily [8]; for purulent or nonpurulent cellulitis continue treatment for 5 to 10 days.
  • Infection of skin AND/OR subcutaneous tissue (Severe): MRSA, complicated skin and soft tissue infections (cSSTIs), 600 mg ORALLY 3 times daily, generally for 7 to 14 days for hospital-associated cSSTIs; individualize to patient response (guideline dose).
  • Infectious disease of abdomen: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections.
  • Lower respiratory tract infection (Severe), Empyema, abscess, pneumonitis: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections.
  • Pelvic inflammatory disease: 900 mg IV every 8 hours plus gentamicin (IV or IM) loading dose of 2 mg/kg, followed by 1.5 mg/kg every 8 hours (single daily dosing of gentamicin 3 to 5 mg/kg may be substituted); discontinue IV/IM therapy 24 hours after clinical improvement and continue on clindamycin 450 mg ORALLY 4 times daily or doxycycline 100 mg ORALLY twice daily to complete a total of 14 days of therapy (guideline dosing).
  • Pelvic inflammatory disease: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections (manufacturer dosing) .
  • Septicemia: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections.
  • Streptococcal pharyngitis: (penicillin-allergic patients) 20 mg/kg/day ORALLY in 3 divided doses (MAX 1.8 g/day).

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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