Gadodiamide

Revision as of 20:19, 19 February 2015 by Kiran Singh (talk | contribs)
Jump to navigation Jump to search

Gadodiamide
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

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.

Black Box Warning

WARNING: NOT FOR INTRATHECAL USE AND NEPHROGENIC SYSTEMIC FIBROSIS (NSF) NOT FOR INTRATHECAL USE:
See full prescribing information for complete Boxed Warning.
Inadvertent intrathecal use of OMNISCAN has caused convulsions, coma, sensory and motor neurologic deficits.

NSF:

  • Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
  • Do not administer OMNISCAN to patients with:
  • Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
  • Acute kidney injury.
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g., age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • Do not exceed the recommended OMNISCAN dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration.

Overview

Gadodiamide is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

CNS (Central Nervous System)

  • OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues.

Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

  • OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space.

Dosage

CNS (Central Nervous System)

  • The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.

Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

  • For imaging the kidney, the recommended dose of OMNISCAN is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg).

Dosage Chart

This image is provided by the National Library of Medicine.

Dosing Guidelines

  • Inspect OMNISCAN visually for particulate matter and discoloration before administration, whenever solution and container permit.
  • Do not use the solution if it is discolored or particulate matter is present.
  • Draw OMNISCAN into the syringe and use immediately. Discard any unused portion of OMNISCAN Injection.
  • To ensure complete delivery of the desired volume of contrast medium, follow the injection of OMNISCAN with a 5 mL flush of 0.9% sodium chloride, as provided in the Prefill Plus needle-free system. Complete the imaging procedure within 1 hour of administration of OMNISCAN.

DOSAGE FORMS AND STRENGTHS

  • Sterile aqueous solution for intravenous injection; 287 mg/mL.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

  • OMNISCAN is contraindicated in patients with:
  • Chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2), or
  • Acute kidney injury
  • Prior hypersensitivity reaction to OMNISCAN

Warnings

WARNING: NOT FOR INTRATHECAL USE AND NEPHROGENIC SYSTEMIC FIBROSIS (NSF) NOT FOR INTRATHECAL USE:
See full prescribing information for complete Boxed Warning.
Inadvertent intrathecal use of OMNISCAN has caused convulsions, coma, sensory and motor neurologic deficits.

NSF:

  • Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
  • Do not administer OMNISCAN to patients with:
  • Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
  • Acute kidney injury.
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g., age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • Do not exceed the recommended OMNISCAN dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration.

There is limited information regarding Gadodiamide Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

  • The following adverse reactions are discussed in greater detail in other sections of the label:
  • Nephrogenic systemic fibrosis.
  • Hypersensitivity reactions.
  • Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Clinical Studies Experience (Adults)

  • In clinical studies 1160 patients were exposed to OMNISCAN. The most frequent adverse reactions were nausea, headache, and dizziness that occurred in 3% or less of the patients. The majority of these reactions were of mild to moderate intensity.
  • The following adverse reactions occurred in 1% or less of patients:
  • Application Site Disorders: Injection site reaction.
  • Autonomic Nervous System Disorders: Vasodilation.
  • Central and Peripheral Nervous System Disorders: Convulsions including grand mal, ataxia, abnormal coordination, paresthesia, tremor, aggravated multiple sclerosis (characterized by sensory and motor disturbances), aggravated migraine.
  • Hearing and Vestibular Disorders: Tinnitus.
  • Liver and Biliary System Disorders: Abnormal hepatic function.
  • Special Senses, Other Disorders: Taste loss, taste perversion.
  • Urinary System Disorders: Acute reversible renal failure.
  • Vision Disorders: Abnormal vision.

Clinical Studies Experience (Pediatrics)

  • In the 97 pediatric patients in CNS studies with OMNISCAN and the 144 pediatric patients in published literature, the adverse reactions were similar to those reported in adults.

Postmarketing Experience

  • Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • The following adverse reactions have been identified during the postmarketing use of OMNISCAN:
  • Nervous System Disorders: Inadvertent intrathecal use causes convulsions, coma, paresthesia, paresis. Convulsions have also been reported with intravenous use in patients with and without a history of convulsions or brain lesions.
  • General Disorders: Nephrogenic Systemic Fibrosis (NSF).
  • Renal and Urinary System Disorders: In patients with pre-existing renal insufficiency: acute renal failure, renal impairment, blood creatinine increased.

Drug Interactions

There is limited information regarding Gadodiamide Drug Interactions in the drug label.

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 Gadodiamide in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Gadodiamide Pharmacology in the drug label.

Mechanism of Action

Structure

File:Gadodiamide01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Gadodiamide Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Gadodiamide |?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

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Gadodiamide 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)

{{#subobject: 

 |Page Name=Gadodiamide
 |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=Gadodiamide
 |Label Name=Gadodiamide11.png

}}

{{#subobject: 

 |Label Page=Gadodiamide
 |Label Name=Gadodiamide11.png

}}

Retrieved from "https://www.wikidoc.org/index.php?title=Gadodiamide&oldid=1071354"