Hydroxocobalamin

What is Hydroxocobalamin?

• Hydroxocobalamin is a vitamin found in food and used as a dietary supplement.
• As a supplement it is used to treat vitamin B12 deficiency including pernicious anemia.
• Other uses include treatment for cyanide poisoning, Leber's optic atrophy, and toxic amblyopia.

Hydroxocobalamin

Hydroxocobalamin ball-and-stick animation

Hydroxocobalamin Injection

What are the uses of this medicine?

Hydroxocobalamin is used in the treatment of:

• Pernicious anemia, both uncomplicated and accompanied by nervous system involvement.
• Dietary deficiency of Vitamin B12, occurring in strict vegetarians and in their breast-fed infants.
• Malabsorption of vitamin B12, resulting from structural or functional damage to the stomach.
• Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa.
• Structural lesions leading to vitamin B12 deficiency include regional ileitis, ileal resections, malignancies, etc.
• Competition for Vitamin B12 by intestinal parasites or bacteria.
• Inadequate utilization of vitamin B12.
• For the Schilling Test.

How does this medicine work?

• Vitamin B12 is essential to growth, cell reproduction, hematopoiesis, nucleoprotein and myelin synthesis.
• Fifty percent of the administered dose of hydroxocobalamin disappears from the injection site in 2.5 hours.
• Hydroxocobalamin is bound to plasma proteins and stored in the liver.
• It is excreted in the bile and undergoes some enterohepatic recycling.
• Within 72 hours after injection of 500 to 1000 mcg of hydroxocobalamin, 16 to 66 percent of the injected dose may appear in the urine.
• The major portion is excreted within the first 24 hours.

Who Should Not Use this medicine ?

This medicine cannot be used:

• Hypersensitivity to any component of this medication.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Hydroxocobalamin was first isolated in 1949.
• It is on the World Health Organization's List of Essential Medicines.
• Hydroxocobalamin is available as a generic medication.

How should this medicine be used?

Recommended dosage: Treatment of Vitamin B12 Deficiency:

• Thirty mcg daily for 5 to 10 days followed by 100 to 200 mcg monthly injected intramuscularly.
• If the patient is critically ill, or has neurologic disease, an infectious disease or hyperthyroidism, considerably higher doses may be indicated.
• Children may be given a total of 1 to 5 mg over a period of 2 or more weeks in doses of 100 mcg, then 30 to 50 mcg every 4 weeks for maintenance.
• Patients who have normal intestinal absorption may be treated with an oral therapeutic multivitamin preparation, containing 15 mcg vitamin B12 daily.

Schilling Test:

• The flushing dose is 1000 mcg.

Administration:

• Hydroxocobalamin injection should be given only intramuscularly.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Hydroxocobalamin Injection USP, 1000 mcg/mL is available in a 30 mL multiple dose vial, individually boxed.

This medicine is available in fallowing brand namesː

• alpharedisol

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• itching
• transitory exanthema
• feeling of swelling of entire body
• anaphylaxis

What special precautions should I follow?

• Avoid the intravenous route.
• Folic acid is not a substitute for vitamin B12 although it may improve vitamin B12 deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B12 deficient megaloblastic anemia could result in progressive and irreversible neurologic damage.
• Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic to normal erythropoiesis with B12 therapy. Therefore, serum potassium levels and the platelet count should be monitored carefully during therapy.
• Vitamin B12 deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B12 may unmask this condition.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• It is also not known whether hydroxocobalamin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hydroxocobalamin should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness for pediatric patients have been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• HYDROXOCOBALAMIN ACETATE

Inactive Ingredients:

• SODIUM ACETATE ANHYDROUS
• ACETIC ACID
• SODIUM CHLORIDE
• METHYLPARABEN
• PROPYLPARABEN
• WATER

Who manufactures and distributes this medicine?

Manufactured by:

• Hikma Farmaceutica (Portugal)
• S.A. Terrugem SNT, Portugal

Distributed by:

• Actavis Pharma, Inc.
• Parsippany, NJ USA

What should I know about storage and disposal of this medication?

• Store at 20°-25°C (68°-77°F).

• Dailymed label info on Hydroxocobalamin
• FDA Hydroxocobalamin

Vitamins A Vitamin A B Biotin Vitamin B1 (see Thiamin) Vitamin B12 Vitamin B6 C Calcium Choline Chromium Copper Vitamin C D Vitamin D

E Energy Drinks Exercise and Athletic Performance Vitamin E F Fluoride Folate I Iodine Iron K Vitamin K

M Magnesium Multivitamin/mineral Supplements N Niacin P Pantothenic Acid Phosphorus Potassium Primary Mitochondrial Disorders R Riboflavin

S Selenium T Thiamin V Vitamin A Vitamin B1 (see Thiamin) Vitamin B12 Vitamin B6 Vitamin C Vitamin D Vitamin E Vitamin K Z Zinc