Hydroxocobalamin
Actavis Pharma, Inc.
Human Prescription Drug
NDC 0591-2888Hydroxocobalamin is a human prescription drug labeled by 'Actavis Pharma, Inc.'. National Drug Code (NDC) number for Hydroxocobalamin is 0591-2888. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Hydroxocobalamin drug includes Hydroxocobalamin Acetate - 1000 ug/mL . The currest status of Hydroxocobalamin drug is Active.
Drug Information:
| Drug NDC: | 0591-2888 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Hydroxocobalamin |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Hydroxocobalamin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Actavis Pharma, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYDROXOCOBALAMIN ACETATE - 1000 ug/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 12 Nov, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 28 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA085998 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Actavis Pharma, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 317106
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | S535M27N3Q
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Antidote [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0591-2888-30 | 1 VIAL, MULTI-DOSE in 1 CARTON (0591-2888-30) / 30 mL in 1 VIAL, MULTI-DOSE | 12 Nov, 2010 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Hydroxocobalamin hydroxocobalamin hydroxocobalamin acetate hydroxocobalamin sodium acetate anhydrous acetic acid sodium chloride methylparaben propylparaben water
Indications and Usage:
Indications and usage 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). to
Read more...tal 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.
Warnings:
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 Precautions:
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.
Dosage and Administration:
Dosage and administration 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 patientâs 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 reticuloc
Read more...yte 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.
Contraindications:
Contraindication hypersensitivity to any component of this medication.
Adverse Reactions:
Adverse reactions 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.
Use in Pregnancy:
Pregnancy 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.
Overdosage:
Overdosage the intravenous ld 50 of hydroxocobalamin in mice is greater than 50 ml/kg.
Description:
Description 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
Clinical Pharmacology:
Clinical pharmacology 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. 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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility studies of carcinogenicity, mutagenesis, or impairment of fertility have not been performed with hydroxocobalamin.
How Supplied:
How supplied 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
Package Label Principal Display Panel:
Principal display panel ndc 0591-2888-30 30 ml sterile multiple dose vial hydroxocobalamin injection usp 30,000 mcg/30 ml (1,000 mcg/ml) for intramuscular use only actavis rx only ndc 0591-2888-30