Nascobal 500 ug/1

cyanocobalamin · SPRAY · Par Health USA, LLC

No Recall History

Plain English

Nascobal is a spray containing cyanocobalamin at 500 ug/1, taken nasal. Manufactured by Par Health USA, LLC.

Key Facts

Brand Name: Nascobal
Generic Name: cyanocobalamin
NDC Code (Product): 49884-270
Manufacturer: Par Health USA, LLC
Strength: 500 ug/1
Dosage Form: SPRAY
Route: NASAL
Marketing Status
Application #: NDA021642
Drug Class: Vitamin B12 [EPC]
Marketing Start: 08/13/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue3,217 reports

nausea2,646 reports

off label use2,352 reports

headache2,313 reports

diarrhoea2,155 reports

pain2,146 reports

drug ineffective2,094 reports

dyspnoea2,036 reports

vomiting1,736 reports

arthralgia1,709 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE NASCOBAL is indicated for: Vitamin B 12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B 12 therapy and who have no nervous system involvement Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B 12 deficiency not due to pernicious anemia Prevention of vitamin B 12 deficiency in adult patients with vitamin B 12 requirements in excess of normal Limitations of Use NASCOBAL should not be used for the vitamin B 12 absorption test (Schilling test). In patients with correctible or temporary causes of vitamin B 12 deficiency, the benefit of continued long-term use of NASCOBAL following adequate correction of vitamin B 12 deficiency and underlying disease has not been established. The effectiveness of NASCOBAL in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined. Treatment with NASCOBAL should be deferred until symptoms have subsided. NASCOBAL is a vitamin B 12 indicated for: Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscula…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Prior to treatment, obtain hematocrit, reticulocyte count, vitamin B 12 , folate, and iron levels. (2.1) The recommended initial dose is one spray (500 mcg) in one nostril once weekly. (2.2) Administer at least one hour before or one hour after ingestion of hot foods or liquids. (2.2) Monitor serum B12 levels periodically.Obtain a serum B12 level and peripheral blood count one month after treatment initiation, then subsequently at intervals of 3 to 6 months. (2.3) If serum levels of B12 decline after one month of treatment, consider increasing the dose. Assess serum B12 level one month after each dose adjustment.If serum B12 levels are persistently low, consider alternative therapy (e.g., intramuscular or subcutaneous vitamin B12 therapy). (2.3) See Full Prescibing Information to see what other therapies should be administered with NASCOBAL. (2.4) 2.1 Testing and Other Considerations Prior to Dosing Prior to treatment, obtain hematocrit, reticulocyte count, vitamin B 12 , folate, and iron levels [see Dosage and Administration (2.4) ] . Consider the potential for concomitant drugs to interfere with vitamin B 12 and folate diagnostic blood assays [see Drug…

Contraindications

4 CONTRAINDICATIONS NASCOBAL is contraindicated in patients with hypersensitivity to cobalt and/or vitamin B 12 or any of its excipients [see Warnings and Precautions (5.2) ] . Anaphylactic shock and death have been reported after parenteral vitamin B12 administration in sensitive patients. • Hypersensitivity to cobalt, vitamin B 12 or any excipients (4)

Drug Interactions

7 DRUG INTERACTIONS Chloramphenicol may decrease the efficacy of NASCOBAL when used for treatment of anemia. If NASCOBAL is used for the treatment of anemia concomitantly with chloramphenicol, monitor for reduced efficacy and if needed, consider an alternative therapy

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Severe Optic Atrophy in Patients with Leber’s Disease [see Warnings and Precautions (5.1) ] . Anaphylactic Reactions [see Warnings and Precautions (5.2) ] . Hypokalemia and Thrombocytosis Due to Intense Treatment of Megaloblastic Anemia [see Warnings and Precautions (5.4) ] . The most common adverse reactions (≥ 4%) were infection, headache, glossitis, paresthesia, asthenia, nausea and rhinitis (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reactions described in Table 1 below are based on data from an eight week cross over trial in which vitamin B12 deficient patients in hematologic remission received one vitamin B12 intramuscu…

Frequently Asked Questions

What is Nascobal used for?

Nascobal contains cyanocobalamin. It is a spray taken nasal. Consult your doctor for specific uses.

Is Nascobal a controlled substance?

Nascobal is not classified as a controlled substance by the DEA.

What is the generic name for Nascobal?

The generic name for Nascobal is cyanocobalamin. There are 11 other brand versions of cyanocobalamin.

What is the NDC code for Nascobal 500 ug/1?

The NDC (National Drug Code) for Nascobal 500 ug/1 is 49884-270, listed by Par Health USA, LLC.

Product NDC

49884-270

Package NDC

49884-270-82

Other Cyanocobalamin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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