Iron(II) gluconate

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

• Hemodialysis – Iron deficiency anemia, during epoetin therapy.

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

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

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

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

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

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

• 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.

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

• Oral

• Intravenous

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

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

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

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

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

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

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

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

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

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

• Store at 20° to 25°C (68° to 77°F)

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

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

• FERROUS GLUCONATE®^[1]

There is limited information regarding Iron(II) gluconate Look-Alike Drug Names in the drug label.

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