Hydroxocobalamin
1000 ug/mL · Injection, Solution
- Prescription only
- Antidote
- Active substance
- Hydroxocobalamin
- Made by
- Actavis Pharma, Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2017-01-31
Pharmacies may have trouble getting it. Your pharmacist can suggest what to do. · Updated 2026-10-01 FDA drug shortages
Antidote
- Pernicious anemia, both uncomplicated and accompanied by nervous system involvement.
A diagnostic trial utilizing physiologic doses of vitamin B 12 (1 mcg daily) and observing daily reticulocyte counts after establishing a baseline may also be performed.
Full directions ↓CONTRAINDICATION Hypersensitivity to any component of this medication.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Pernicious anemia, both uncomplicated and accompanied by nervous system involvement.
- Dietary deficiency of Vitamin B 12 , occurring in strict vegetarians and in their breast-fed infants.
- (Isolated vitamin B 12 deficiency is very rare).
- Malabsorption of vitamin B 12 , resulting from structural or functional damage to the stomach, where intrinsic factor is secreted or to the ileum, where intrinsic factor facilitates vitamin B 12 absorption.
- These conditions include tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy).
- Folate deficiency in these patients is usually more severe than vitamin B 12 deficiency.
- Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (such as multiple sclerosis, certain endocrine disorders, iron deficiency, and subtotal gastrectomy).
- Total gastrectomy always produces vitamin B 12 deficiency.
- Structural lesions leading to vitamin B 12 deficiency include regional ileitis, ileal resections, malignancies, etc.
- Competition for Vitamin B 12 by intestinal parasites or bacteria.
- The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B 12 and infested patients often have associated gastric atrophy.
- The blind-loop syndrome may produce deficiency of Vitamin B 12 or folate.
- Inadequate utilization of vitamin B 12 .
- This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia.
- For the Schilling Test.
From the official label · 2017-01-31 · DailyMed
How it works
From this product’s own US prescribing label.
Vitamin B 12 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.
It is excreted in the bile and undergoes some enterohepatic recycling.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2017-01-31
Do not take it if
CONTRAINDICATION Hypersensitivity to any component of this medication.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Protect from light.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
- Hydroxocobalamin injection should be given only intramuscularly.
- In patients with Addisonian Pernicious Anemia, parenteral therapy with vitamin B 12 is the recommended method of treatment and will be required for the remainder of the patient’s life.
- Oral therapy is not dependable.
- In other patients with vitamin B 12 deficiency, the duration of therapy and route of administration will depend upon the cause and whether or not it is reversible.
- Confirmatory diagnostic studies should be performed prior to initiating therapy, if possible, and the patient should be followed with appropriate studies to demonstrate hematologic improvement (Hgb, hematocrit, RBC, reticulocyte count).
- A diagnostic trial utilizing physiologic doses of vitamin B 12 (1 mcg daily) and observing daily reticulocyte counts after establishing a baseline may also be performed.
- The observation of reticulocytosis which usually occurs between the third and tenth day of therapy confirms the diagnosis of vitamin B 12 deficiency.
- In seriously ill patients it may be advisable to administer both vitamin B 12 and folic acid while awaiting the results of distinguishing laboratory studies.
- It is not necessary to withhold vitamin B 12 therapy until the precise cause of B 12 deficiency is established since absorption studies can be performed at any time.
- Serum potassium should be closely observed the first 48 hours and potassium should be administered if necessary.
- Treatment of Vitamin B 12 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.
- However, current data indicate that the optimum obtainable neurologic response may be expected with a dosage of vitamin B 12 sufficient to produce good hematologic response.
- 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 B 12 daily.
- Schilling Test The flushing dose is 1000 mcg.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Avoid the intravenous route.
- Folic acid is not a substitute for vitamin B 12 although it may improve vitamin B 12 deficient megaloblastic anemia.
- Exclusive use of folic acid in treating vitamin B 12 deficient megaloblastic anemia could result in progressive and irreversible neurologic damage.
- Blunted or impeded therapeutic response to vitamin B 12 may be due to such conditions as infection, uremia, drugs having bone marrow suppressant properties such as chloramphenicol, and concurrent iron or folic acid deficiency.
- General The validity of diagnostic vitamin B 12 or folic acid blood assays could be compromised by medications, and this should be considered before relying on such tests for therapy.
- Vitamin B 12 is not a substitute for folic acid and since it might improve folic acid deficient megaloblastic anemia, indiscriminate use of vitamin B 12 could mask the true diagnosis.
- Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic to normal erythropoiesis with B 12 therapy.
- Therefore, serum potassium levels and the platelet count should be monitored carefully during therapy.
- Vitamin B 12 deficiency may suppress the signs of polycythemia vera.
- Treatment with vitamin B 12 may unmask this condition.
- Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of carcinogenicity, mutagenesis, or impairment of fertility have not been performed with hydroxocobalamin.
- Pregnancy Teratogenic Effects:
- General The validity of diagnostic vitamin B 12 or folic acid blood assays could be compromised by medications, and this should be considered before relying on such tests for therapy.
- Vitamin B 12 is not a substitute for folic acid and since it might improve folic acid deficient megaloblastic anemia, indiscriminate use of vitamin B 12 could mask the true diagnosis.
- Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic to normal erythropoiesis with B 12 therapy.
- Therefore, serum potassium levels and the platelet count should be monitored carefully during therapy.
- Vitamin B 12 deficiency may suppress the signs of polycythemia vera.
- Treatment with vitamin B 12 may unmask this condition.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Teratogenic Effects:
- Pregnancy Category C:
- Animal reproduction studies have not been conducted with hydroxocobalamin.
- 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.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
The intravenous LD 50 of hydroxocobalamin in mice is greater than 50 mL/kg.
Quoted from the official label, section “Overdosage”.
Side effects
- Mild transient diarrhea, itching, transitory exanthema, feeling of swelling of entire body, and anaphylaxis.
- A few patients may experience pain after injection of hydroxocobalamin.
- To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- Hydroxocobalamin Injection USP, 1000 mcg/mL is available in a 30 mL multiple dose vial, individually boxed.
- Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] PROTECT FROM LIGHT.
- Literature revised:
- January 2017 Manufactured by:
- Hikma Farmaceutica (Portugal) S.A. 2705-906 Terrugem SNT, Portugal Distributed by:
- Actavis Pharma, Inc.
- Parsippany, NJ 07054 USA PIN229-WAT/2
Quoted from the official label, section “How Supplied”.
How to store it
- Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] PROTECT FROM LIGHT.
- Literature revised:
- January 2017 Manufactured by:
- Hikma Farmaceutica (Portugal) S.A. 2705-906 Terrugem SNT, Portugal Distributed by:
- Actavis Pharma, Inc.
- Parsippany, NJ 07054 USA PIN229-WAT/2
Quoted from the official label, section “Storage and Handling”.
What is in it
- Hydroxocobalamin injection is a sterile solution of hydroxocobalamin for intramuscular administration.
- Each mL contains:
- Hydroxocobalamin Acetate equivalent to 1000 mcg Hydroxocobalamin, Sodium Acetate Anhydrous 0.2 mg, Glacial Acetic Acid 0.442 mg, Sodium Chloride 8.2 mg, with Methylparaben 1.5 mg and Propylparaben 0.2 mg as preservatives, in Water for Injection q.s.
- Additional Glacial Acetic Acid and/or Sodium Acetate may have been used to adjust pH. pH range is 3.5 to 5.0.
- Hydroxocobalamin appears as dark red orthorhombic needles or as an amorphous or crystalline red powder.
- It is very hygroscopic in the anhydrous form, and moderately soluble in water.
- It has a molecular weight of 1346.37.
- The vitamin B 12 coenzymes are very unstable in light.
- Hydroxocobalamin shares the cobalamin molecular structure with cyanocobalamin.
- The chemical name is α-(5,6-dimethylbenzimidazoly) hydroxocobamide.
- The empirical formula is C 62 H 89 CoN 13 O 15 P and its structural formula is:
- The cobalt content is 4.34%.
- Hydroxocobalamin Structural Formula
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | Actavis Pharma, Inc. |
|---|---|
| Active substance | Hydroxocobalamin |
| Used in | Everything that fits nowhere else, such as contrast media |
| Strength | 1000 ug/mL |
| Form | Injection, Solution |
| Route | Intramuscular |
| Packs | 1 VIAL, MULTI-DOSE in 1 CARTON / 30 mL in 1 VIAL, MULTI-DOSE |
| NDC | 0591-2888 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Injection, Solution1 products
- 1000 ug/mL
- Injection1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.