Capreomycin sulfate: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{KS}}
|authorTag={{KS}}
|aOrAn=a
|aOrAn=an
|drugClass=antitubercular drug
|indicationType=treatment
|indication=pulmonary tuberculosis, in combination with other antituberculosis agents, as second-line therapy
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=drug-induced [[eosinophilia]], [[Ototoxicity]], raised serum blood urea nitrogen
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=WARNINGS
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=* The use of Capastat® Sulfate (Capreomycin for Injection, USP) in patients with renal insufficiency or preexisting auditory impairment must be undertaken with great caution, and the risk of additional cranial nerve VIII impairment or renal injury should be weighed against the benefits to be derived from therapy.


* Content
* Since other parenteral antituberculosis agents (streptomycin, viomycin) also have similar and sometimes irreversible toxic effects, particularly on cranial nerve VIII and renal function, simultaneous administration of these agents with Capastat Sulfate is not recommended. Use with nonantituberculosis drugs (polymyxin A sulfate, colistin sulfate, amikacin, gentamicin, tobramycin, vancomycin, kanamycin, and neomycin) having ototoxic or nephrotoxic potential should be undertaken only with great caution.


<!--Adult Indications and Dosage-->
* '''Usage in Pregnancy''': The safety of the use of Capastat Sulfate in pregnancy has not been determined.


<!--FDA-Labeled Indications and Dosage (Adult)-->
* '''Pediatric Usage''': Safety and effectiveness in pediatric patients have not been established.
|fdaLIADAdult======Condition1=====
|fdaLIADAdult===Indications==


* Dosing Information
* Capastat Sulfate, which is to be used concomitantly with other appropriate antituberculosis agents, is indicated in pulmonary infections caused by capreomycin-susceptible strains of M. tuberculosis when the primary agents (isoniazid, rifampin, ethambutol, aminosalicylic acid, and streptomycin) have been ineffective or cannot be used because of toxicity or the presence of resistant tubercle bacilli.


:* Dosage
* Susceptibility studies should be performed to determine the presence of a capreomycin-susceptible strain of M. tuberculosis.


=====Condition2=====


* Dosing Information


:* Dosage


=====Condition3=====
* Dosing Information
:* Dosage
=====Condition4=====
* Dosing Information
:* Dosage
<!--Off-Label Use and Dosage (Adult)-->
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====


Revision as of 20:07, 17 February 2015

Capreomycin sulfate
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]

Disclaimer

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Black Box Warning

WARNINGS
See full prescribing information for complete Boxed Warning.
* The use of Capastat® Sulfate (Capreomycin for Injection, USP) in patients with renal insufficiency or preexisting auditory impairment must be undertaken with great caution, and the risk of additional cranial nerve VIII impairment or renal injury should be weighed against the benefits to be derived from therapy.
  • Since other parenteral antituberculosis agents (streptomycin, viomycin) also have similar and sometimes irreversible toxic effects, particularly on cranial nerve VIII and renal function, simultaneous administration of these agents with Capastat Sulfate is not recommended. Use with nonantituberculosis drugs (polymyxin A sulfate, colistin sulfate, amikacin, gentamicin, tobramycin, vancomycin, kanamycin, and neomycin) having ototoxic or nephrotoxic potential should be undertaken only with great caution.
  • Usage in Pregnancy: The safety of the use of Capastat Sulfate in pregnancy has not been determined.
  • Pediatric Usage: Safety and effectiveness in pediatric patients have not been established.

Overview

Capreomycin sulfate is an antitubercular drug that is FDA approved for the treatment of pulmonary tuberculosis, in combination with other antituberculosis agents, as second-line therapy. There is a Black Box Warning for this drug as shown here. Common adverse reactions include drug-induced eosinophilia, Ototoxicity, raised serum blood urea nitrogen.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • Capastat Sulfate, which is to be used concomitantly with other appropriate antituberculosis agents, is indicated in pulmonary infections caused by capreomycin-susceptible strains of M. tuberculosis when the primary agents (isoniazid, rifampin, ethambutol, aminosalicylic acid, and streptomycin) have been ineffective or cannot be used because of toxicity or the presence of resistant tubercle bacilli.
  • Susceptibility studies should be performed to determine the presence of a capreomycin-susceptible strain of M. tuberculosis.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Capreomycin sulfate in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Capreomycin sulfate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Capreomycin sulfate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Capreomycin sulfate in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Capreomycin sulfate in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNINGS
See full prescribing information for complete Boxed Warning.
* The use of Capastat® Sulfate (Capreomycin for Injection, USP) in patients with renal insufficiency or preexisting auditory impairment must be undertaken with great caution, and the risk of additional cranial nerve VIII impairment or renal injury should be weighed against the benefits to be derived from therapy.
  • Since other parenteral antituberculosis agents (streptomycin, viomycin) also have similar and sometimes irreversible toxic effects, particularly on cranial nerve VIII and renal function, simultaneous administration of these agents with Capastat Sulfate is not recommended. Use with nonantituberculosis drugs (polymyxin A sulfate, colistin sulfate, amikacin, gentamicin, tobramycin, vancomycin, kanamycin, and neomycin) having ototoxic or nephrotoxic potential should be undertaken only with great caution.
  • Usage in Pregnancy: The safety of the use of Capastat Sulfate in pregnancy has not been determined.
  • Pediatric Usage: Safety and effectiveness in pediatric patients have not been established.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Capreomycin sulfate in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Capreomycin sulfate in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

There is no FDA guidance on use of Capreomycin sulfate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Capreomycin sulfate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Capreomycin sulfate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Capreomycin sulfate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Capreomycin sulfate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Capreomycin sulfate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Capreomycin sulfate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Capreomycin sulfate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Capreomycin sulfate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Capreomycin sulfate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Capreomycin sulfate in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Capreomycin sulfate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Capreomycin sulfate in the drug label.

Pharmacology

There is limited information regarding Capreomycin sulfate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Capreomycin sulfate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Capreomycin sulfate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Capreomycin sulfate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Capreomycin sulfate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Capreomycin sulfate in the drug label.

How Supplied

Storage

There is limited information regarding Capreomycin sulfate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Capreomycin sulfate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Capreomycin sulfate in the drug label.

Precautions with Alcohol

  • Alcohol-Capreomycin sulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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