Iron(II) gluconate

Iron(II) gluconate
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]

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Overview

Iron(II) gluconate is a mineral that is FDA approved for the treatment of iron deficiency anemia. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Hemodialysis - Iron deficiency anemia, during epoetin therapy.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Iron(II) gluconate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Iron(II) gluconate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Iron(II) gluconate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Iron(II) gluconate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Iron(II) gluconate in pediatric patients.

Contraindications

There is limited information regarding Iron(II) gluconate Contraindications in the drug label.

Warnings

• Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
• Do not take within 2 hours of taking oral tetracycline antibiotics, since oral iron products tend to interfere with absorption of tetracycline. May cause gastrointestinal discomfort, nausea, constipation or diarrhea. If you are pregnant or nursing a baby, seek advice of a health professional before using this product. U.S. Consumer Product Safety Commission requires that iron-containing medicines and vitamins with iron be packaged in child-resistant closures. Parents should always properly resecure safety closures.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Iron(II) gluconate in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Iron(II) gluconate in the drug label.

Drug Interactions

There is limited information regarding Iron(II) gluconate 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 Iron(II) gluconate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Iron(II) gluconate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Iron(II) gluconate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Iron(II) gluconate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Iron(II) gluconate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Iron(II) gluconate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Iron(II) gluconate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Iron(II) gluconate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Iron(II) gluconate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Iron(II) gluconate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Iron(II) gluconate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Iron(II) gluconate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Iron(II) gluconate in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Iron(II) gluconate in the drug label.

Pharmacology

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Template:Chembox header2 | Iron(II) gluconate
Identifiers
CAS Number	299-29-6 N
3D model (JSmol)	Interactive image
ChemSpider	19953133 Y
ECHA InfoCard
PubChem CID	9291
InChI InChI=1S/2C6H12O7.Fe/c2*7-1-2(8)3(9)4(10)5(11)6(12)13;/h2*2-5,7-11H,1H2,(H,12,13);/q;;+2/p-2/t2*2-,3-,4+,5-;/m11./s1 Y Key: VRIVJOXICYMTAG-IYEMJOQQSA-L Y InChI=1/2C6H12O7.Fe/c2*7-1-2(8)3(9)4(10)5(11)6(12)13;/h2*2-5,7-11H,1H2,(H,12,13);/q;;+2/p-2/t2*2-,3-,4+,5-;/m11./s1 Key: VRIVJOXICYMTAG-QFKJHGNTBV
SMILES [Fe+2].O[C@H]([C@@H](O)C([O-])=O)[C@H](O)[C@H](O)CO.[O-]C(=O)[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO
Properties
Chemical formula	C12H22FeO14
Molar mass	446.14 g·mol−1
Template:Chembox header2 | Except where noted otherwise, data are given for materials in their standard state (at 25 °C, 100 kPa) Infobox disclaimer and references

Mechanism of Action

There is limited information regarding Iron(II) gluconate Mechanism of Action in the drug label.

Structure

File:Iron(II) gluconate01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Iron(II) gluconate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Iron(II) gluconate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Iron(II) gluconate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Iron(II) gluconate in the drug label.

How Supplied

There is limited information regarding Iron(II) gluconate How Supplied in the drug label.

Storage

• Store at 20° to 25°C (68° to 77°F)

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Iron(II) gluconate in the drug label.

Precautions with Alcohol

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

Brand Names

• FERROUS GLUCONATE®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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