Clindamycin phosphate (gel): Difference between revisions

Jump to navigation Jump to search
VisualWikitext
No edit summary
No edit summary
Line 17: Line 17:
|fdaLIADAdult=Indication
|fdaLIADAdult=Indication
ClindaMax® (Clindamycin Phosphate Gel) is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate.
ClindaMax® (Clindamycin Phosphate Gel) is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate.
 
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
|offLabelAdultGuideSupport=
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Pediatric Indications and Dosage-->
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


<!--Off-Label Use and Dosage (Pediatric)-->
<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport=
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
<!--Contraindications-->
Line 56: Line 47:
Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.
Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.
|clinicalTrials=In 18 clinical studies of various formulations of Clindamycin Phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below].
|clinicalTrials=In 18 clinical studies of various formulations of Clindamycin Phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below].
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
: [[File:Clindamycin gel AE 01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally.
Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally.


Line 63: Line 54:
Abdominal pain and gastrointestinal disturbances as well as gram-negative folliculitis have also been reported in association with the use of topical formulations of clindamycin.
Abdominal pain and gastrointestinal disturbances as well as gram-negative folliculitis have also been reported in association with the use of topical formulations of clindamycin.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|drugInteractions=* Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore it should be used with caution in patients receiving such agents.
|drugInteractions=* Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore it should be used with caution in patients receiving such agents.
|FDAPregCat=B
|FDAPregCat=B
Line 72: Line 61:
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing= It is not known whether clindamycin is excreted in human milk following use of clindamycin phosphate. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
|useInNursing=It is not known whether clindamycin is excreted in human milk following use of clindamycin phosphate. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
Line 93: Line 82:
<!--Overdosage-->
<!--Overdosage-->
|overdose=Topically applied clindamycin topical solution can be absorbed in sufficient amounts to produce systemic effects.
|overdose=Topically applied clindamycin topical solution can be absorbed in sufficient amounts to produce systemic effects.
|drugBox={{Drugbox2
|drugBox={{Drugbox2
| Verifiedfields = changed
| Verifiedfields = changed
Line 159: Line 147:
<!--Structure-->
<!--Structure-->
|structure=[[File:clindamycin structure.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|structure=[[File:clindamycin structure.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


Line 182: Line 169:
30 gram tube NDC 0462-0390-30                    60 gram tube NDC 0462-0390-60
30 gram tube NDC 0462-0390-30                    60 gram tube NDC 0462-0390-60
|storage=Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.
|storage=Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.
|packLabel=[[File:XXXXX.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|packLabel=[[File:Clinda gel 02.jpg|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:XXXXX.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:Clinda gel 03.jpg|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:XXXXX.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:Clinda gel 04.jpg|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:XXXXX.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:Clinda gel 05.jpg|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:XXXXX.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:DailyMed CLINDAMAX clindamycin phosphate gel.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


Revision as of 06:46, 25 May 2015

Clindamycin phosphate (gel)
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: Ammu Susheela, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Clindamycin phosphate (gel) is an antibiotic that is FDA approved for the treatment of acne vulgaris. Common adverse reactions include abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting, and diarrhea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indication ClindaMax® (Clindamycin Phosphate Gel) is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Clindamycin phosphate (gel) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Clindamycin phosphate (gel) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Clindamycin phosphate (gel) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Clindamycin phosphate (gel) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Clindamycin phosphate (gel) in pediatric patients.

Contraindications

  • ClindaMax® (Clindamycin Phosphate Gel) is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

Warnings

  • Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.

Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea.

Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile. The usual adult dosage is 500 mg to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days. Cholestyramine or colestipol resins bind vancomycin in vitro. If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug.

Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

Adverse Reactions

Clinical Trials Experience

In 18 clinical studies of various formulations of Clindamycin Phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below].

This image is provided by the National Library of Medicine.

Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally.

Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin.

Abdominal pain and gastrointestinal disturbances as well as gram-negative folliculitis have also been reported in association with the use of topical formulations of clindamycin.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Clindamycin phosphate (gel) in the drug label.

Drug Interactions

  • Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore it should be used with caution in patients receiving such agents.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B

  • Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin ranging from 100 to 600 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to clindamycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Clindamycin phosphate (gel) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Clindamycin phosphate (gel) during labor and delivery.

Nursing Mothers

It is not known whether clindamycin is excreted in human milk following use of clindamycin phosphate. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

There is no FDA guidance on the use of Clindamycin phosphate (gel) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Clindamycin phosphate (gel) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Clindamycin phosphate (gel) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Clindamycin phosphate (gel) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Clindamycin phosphate (gel) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Clindamycin phosphate (gel) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Clindamycin phosphate (gel) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Clindamycin phosphate (gel) in patients who are immunocompromised.

Administration and Monitoring

Administration

Monitoring

There is limited information regarding Monitoring of Clindamycin phosphate (gel) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Clindamycin phosphate (gel) in the drug label.

Overdosage

Topically applied clindamycin topical solution can be absorbed in sufficient amounts to produce systemic effects.

Pharmacology

Template:Px
Template:Px
Clindamycin phosphate (gel)
Systematic (IUPAC) name
methyl 7-chloro-6,7,8-trideoxy-6-{[(4R)-1-methyl-4-propyl-L-prolyl]amino}-1-thio-L-threo-α-D-galacto-octopyranoside
Identifiers
CAS number 18323-44-9
ATC code J01FF01 D10AF01 (WHO) G01AA10 (WHO)
PubChem 446598
DrugBank DB01190
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 424.98 g/mol
SMILES eMolecules & PubChem
Synonyms 7-chloro-lincomycin
7-chloro-7-deoxylincomycin
Pharmacokinetic data
Bioavailability 90% (oral)
4–5% (topical)
Protein binding 95%
Metabolism Hepatic
Half life 2–3 hours
Excretion Biliary and renal (around 20%)
Therapeutic considerations
Licence data

US

Pregnancy cat.

A(AU) B(US)

Legal status

Prescription Only (S4)(AU) POM(UK) [[Prescription drug|Template:Unicode-only]](US)

Routes Oral, topical, IV, intravaginal

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Clindamycin phosphate (gel) in the drug label.

Pharmacokinetics

Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Cross resistance has been demonstrated between clindamycin and lincomycin.

Antagonism has been demonstrated between clindamycin and erythromycin.

Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0-3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin.

Clindamycin activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of Clindamycin Phosphate Topical Solution for 4 weeks was 597 mcg/g of comedonal material (range 0 - 1490). Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0.4 mcg/mL). Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following application of clindamycin.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Clindamycin phosphate (gel) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Clindamycin phosphate (gel) in the drug label.

How Supplied

  • ClindaMax® Gel (Clindamycin Phosphate Gel USP, 1%) containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes:

30 gram tube NDC 0462-0390-30 60 gram tube NDC 0462-0390-60

Storage

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

Images

Drug Images

{{#ask: Page Name::Clindamycin phosphate (gel) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

{{#ask: Label Page::Clindamycin phosphate (gel) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Clindamycin phosphate (gel) in the drug label.

Precautions with Alcohol

  • Alcohol-Clindamycin phosphate (gel) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

There is limited information regarding Clindamycin phosphate (gel) 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.

  1. ↑ "CLINDAMAX- clindamycin phosphate gel".

{{#subobject: 

 |Page Name=Clindamycin phosphate (gel)
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject: 

 |Label Page=Clindamycin phosphate (gel)
 |Label Name=Clindamycin phosphate (gel)11.png

}}

{{#subobject: 

 |Label Page=Clindamycin phosphate (gel)
 |Label Name=Clindamycin phosphate (gel)11.png

}}

Retrieved from "https://www.wikidoc.org/index.php?title=Clindamycin_phosphate_(gel)&oldid=1101811"