Iron Dextran

Overview

Iron dextran is a dark brown, slightly viscous liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Iron Dextran is used for the treatment of patients with documented iron deficiency in which oral administration is unsatisfactory or impossible.

Indication

For treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible. Also used to replenish body iron stores in Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) patients receiving or not receiving erythropoietin and in Hemodialysis Dependent (HDD-CKD) and Peritoneal Dialysis Dependent (PDD-CKD) - Chronic Kidney Disease patients receiving an erythropoietin.

Associated Conditions

Iron Deficiency (ID)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Effect of Intravenous Iron Repletion on Renal Function in Patients With Iron Deficiency and Acute Kidney Injury	2023/07/25	NCT05960227	Phase 2	Completed	Hospital Civil de Guadalajara
Practical Anemia Bundle for SusTained Blood Recovery	2021/12/22	NCT05167734	Phase 2	Completed	Mayo Clinic
Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia	2021/09/17	NCT05047211	Phase 4	Completed	The University of Texas Medical Branch, Galveston
Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial	2018/02/19	NCT03438227	Phase 4	Completed	Indiana University
Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women	2017/07/11	NCT03212781	Phase 3	Completed	Assiut University
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia	2008/06/24	NCT00704028	Phase 3	Completed	American Regent, Inc.
Trial Comparing the Safety of Two Different Intravenous Iron Formulations	2008/01/15	NCT00593619	Phase 4	Suspended	London Health Sciences Centre

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
IRON DEXTRAN	HF Acquisition Co LLC, DBA HealthFirst	51662-1441	INTRAMUSCULAR, INTRAVENOUS	50 mg in 1 mL	2/22/2020
PureVit DualFe Plus	PureTek Corporation	59088-112	ORAL	53 mg in 1 1	1/11/2023
INFED	Henry Schein, Inc.	0404-9879	INTRAMUSCULAR, INTRAVENOUS	50 mg in 1 mL	1/11/2022
Niferex	Avion Pharmaceuticals, LLC	75854-321	ORAL	100 mg in 1 1	1/7/2021
INFeD	Allergan, Inc.	0023-6082	INTRAMUSCULAR, INTRAVENOUS	50 mg in 1 mL	2/23/2024
Uniferon 200	Pharmacosmos, Inc	42552-741	INTRAMUSCULAR	200 mg in 1 mL	4/9/2025
INFED	General Injectables & Vaccines, Inc.	52584-086	INTRAMUSCULAR, INTRAVENOUS	50 mg in 1 mL	12/22/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Higher Ferritin Threshold of 25µg/L Proves Cost-Effective for Iron Deficiency Screening in Women

7 months ago

New research demonstrates that screening for iron deficiency using a ferritin threshold of 25µg/L is more cost-effective than the current WHO guideline of 15µg/L, generating better health outcomes and economic value.

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