Hydroxocobalamin

Overview

Hydroxocobalamin, also known as vitamin B12a and hydroxycobalamin, is an injectable form of vitamin B 12 that has been used therapeutically to treat vitamin B 12 deficiency. It is also used in cyanide poisoning, Leber's optic atrophy, and toxic amblyopia.

Indication

For treatment of pernicious anemia and the prevention and treatment of vitamin B12 deficiency arising from alcoholism, malabsorption, tapeworm infestation, celiac, hyperthyroidism, hepatic-biliary tract disease, persistent diarrhea, ileal resection, pancreatic cancer, renal disease, prolonged stress, vegan diets, macrobiotic diets or other restrictive diets. Also for the treatment of known or suspected cyanide poisoning.

Associated Conditions

Anemia, Pernicious
Cyanide Poisoning
Vitamin B complex deficiency
Vitamin B12 Deficiency

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Prophylactic Use of Hydroxycobolamin in Vasoplegic Syndrome in Adult Patients Undergoing Cardiopulmonary Bypass	2023/12/07	NCT06160219	Phase 2	Completed	Ain Shams University
Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy	2022/09/13	NCT05536596	Phase 2	Not yet recruiting	Universitat Internacional de Catalunya
Do Iron And Vitamin B12 Injections Given Together, Improve Hemoglobin In Patients On Hemodialysis?	2020/11/13	NCT04627181	Phase 4	UNKNOWN	Christian Medical College, Vellore, India
Hydroxocobalamin Approach for Reducing of Calprotectin With Butyrate for Ulcerative Colitis Remission	2020/02/06	NCT04259060	Phase 2	Withdrawn	Joshua Korzenik
Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients	2019/08/13	NCT04054999	Phase 4	Completed	Mayo Clinic
A Trial of Vitamin B12 in Septic Shock	2018/12/20	NCT03783091	Phase 2	Completed	Medical College of Wisconsin
Vitamin B12a Vasoplegic Syndrome	2018/11/08	NCT03735316	Phase 2	Terminated	Mayo Clinic
Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia During Cardiac Surgery	2018/02/27	NCT03446599	Phase 2	Withdrawn	Dartmouth-Hitchcock Medical Center
Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia	2017/12/13	NCT03372447	Phase 4	Completed	Hospital Universitario Dr. Jose E. Gonzalez
Vitamin Deficiencies and Suppletion in Morbid Obesity	2014/10/21	NCT02270749	Phase 4	Completed	Rijnstate Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cyanokit	Meridian Medical Technologies, Inc.	11704-370	INTRAVENOUS	5 g in 250 mL	10/15/2021
Cyanokit	BTG INTERNATIONAL INC.	50633-310	INTRAVENOUS	5 g in 250 mL	5/31/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Cyanokit	SERB SA,Avenue Louise 480,1050 Brussels,Belgium	Authorised	11/23/2007

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
HEPATOSWISS FOR IV INFUSION INJ	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	11/12/1982
HEPATOSWISS IM INJ	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	8/13/1982
HYCOBAL INJ 5MG/2ML	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	8/13/1982

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Adrenal Adapt	444375	Vitality Supplements Pty Ltd	Medicine	A	3/25/2024
ORGANIC Iron COMPLETE	372450	bWellness Pty Ltd	Medicine	A	8/9/2021
Hydroxy B12 100 drops	448450	RN Labs Pty Ltd	Medicine	A	5/13/2024
Preconception Multi for Women	476988	NRC Nutrition Pty Ltd	Medicine	A	1/29/2025
Pure Children’s Essentials	371280	Bio Concepts Pty Ltd	Medicine	A	7/19/2021
Iron & Brain Support	446232	NRC Nutrition Pty Ltd	Medicine	A	4/23/2024
Prenatal Trimester 2 & 3 Plus Breastfeeding	456175	NRC Nutrition Pty Ltd	Medicine	A	7/24/2024
BioActive B-Complex	488900	RN Labs Pty Ltd	Medicine	A	5/15/2025
Total B Folinic	432050	RN Labs Pty Ltd	Medicine	A	1/2/2024
FOREST PHARMA WITH AMINO ACIDS capsule carton	51067	Forest Pharmatech Pty Limited	Medicine	A	12/7/1994

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CYANOKIT	serb s.a.	02375370	Powder For Solution - Intravenous	5 G / VIAL	10/19/2012
HYDRO COBEX INJ 1000MCG/ML	kripps pharmacy ltd.	00463477	Liquid - Intramuscular	1 MG / ML	12/31/1979
HYDROXY COBAL INJ 1000MCG/ML	MERIT PHARMACEUTICALS	00623857	Liquid - Intramuscular	1 MG / ML	12/31/1984
CYANOKIT	emd serono, a division of emd inc., canada	02360721	Powder For Solution - Intravenous	2.5 G / VIAL	4/7/2011
HYDROXOCOBALAMIN INJ 1000MCG/ML	e l stickley and co ltd.	00230375	Liquid - Intramuscular	1 MG / ML	12/31/1968

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.

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