Tetraferric tricitrate decahydrate: Difference between revisions

Tetraferric tricitrate decahydrate
	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

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Revision as of 17:02, 24 April 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Tetraferric tricitrate decahydrate is a phosphate binder that is FDA approved for the treatment of serum phosphorus levels in patients with chronic kidney disease on dialysis. Common adverse reactions include diarrhea, discolored feces, constipation, nausea, and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Auryxia (ferric citrate) is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

Dosage

The recommended starting dose is 2 tablets orally 3 times per day with meals. Serum phosphorus levels should be monitored and the dose of Auryxia titrated in decrements or increments of 1 to 2 tablets per day as needed to maintain serum phosphorus at target levels, up to a maximum dose of 12 tablets daily. Dose can be titrated at 1-week or longer intervals.

In a clinical trial conducted in the United States, patients required an average of 8 to 9 tablets a day to control serum phosphorus levels.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Tetraferric tricitrate decahydrate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Condition1

Warnings

Description

Precautions

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Tetraferric tricitrate decahydrate 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 Tetraferric tricitrate decahydrate 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 Tetraferric tricitrate decahydrate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Tetraferric tricitrate decahydrate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Tetraferric tricitrate decahydrate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Tetraferric tricitrate decahydrate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Tetraferric tricitrate decahydrate with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

There is no FDA guidance on the use of Tetraferric tricitrate decahydrate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Tetraferric tricitrate decahydrate in patients with hepatic impairment.

Females of Reproductive Potential and Males

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

Immunocompromised Patients

There is no FDA guidance one the use of Tetraferric tricitrate decahydrate in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Tetraferric tricitrate decahydrate in the drug label.

Description

IV Compatibility

There is limited information regarding IV Compatibility of Tetraferric tricitrate decahydrate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Tetraferric tricitrate decahydrate in the drug label.

Pharmacology

There is limited information regarding Tetraferric tricitrate decahydrate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Tetraferric tricitrate decahydrate01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Tetraferric tricitrate decahydrate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Tetraferric tricitrate decahydrate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Tetraferric tricitrate decahydrate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Tetraferric tricitrate decahydrate in the drug label.

How Supplied

Storage

There is limited information regarding Tetraferric tricitrate decahydrate Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Tetraferric tricitrate decahydrate in the drug label.

Precautions with Alcohol

Alcohol-Tetraferric tricitrate decahydrate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

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

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[1]

[2]

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