B-12 Vitamin Injection Cyanocobalamin 1000MCG MDV/ml 25/Pack

NDC: 72603-650-25

Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x 1 mL Multiple-Dose Vials — NorthStar Rx

Active ingredient	Cyanocobalamin 1,000 mcg/mL
Dosage form	Injection, solution, multiple-dose vial (contains benzyl alcohol 1.5% as preservative; contains no more than 625 mcg/L aluminum)
Route	Intramuscular, Subcutaneous
Size	25 x 1 mL multiple-dose vials
Manufacturer	Manufactured by Mankind Pharma Limited; manufactured for NorthStar Rx LLC
NDC	72603-650-25

Indications and Usage

Indicated for vitamin B12 deficiencies due to malabsorption, which may be associated with pernicious (Addisonian) anemia, gastrointestinal pathology/dysfunction/surgery (including gluten enteropathy, small bowel bacterial overgrowth, total or partial gastrectomy), fish tapeworm infestation, malignancy of the pancreas or bowel, or folic acid deficiency. Also suitable for use in the vitamin B12 absorption test (Schilling test).

Dosage and Administration

Avoid intravenous administration; the vitamin is nearly completely lost in the urine via this route. For pernicious anemia: 100 mcg intramuscularly or by deep subcutaneous injection daily for 6–7 days, then on alternate days for 7 doses, then every 3–4 days for 2–3 weeks, followed by 100 mcg monthly for life. For the Schilling test, the flushing dose is 1,000 mcg. Inspect visually for particulate matter and discoloration prior to administration.

Warnings and Precautions

• Contains benzyl alcohol, which has been associated with fatal "Gasping Syndrome" in premature infants
• Contains aluminum, which may reach toxic levels with prolonged parenteral use in patients with impaired kidney function, including premature neonates
• Anaphylactic shock and death have been reported with parenteral vitamin B12 administration; an intradermal test dose is recommended in patients suspected of sensitivity
• Patients with early Leber's disease (hereditary optic nerve atrophy) have suffered severe and swift optic atrophy following cyanocobalamin treatment
• Hypokalemia and sudden death may occur during intensive treatment of severe megaloblastic anemia; serum potassium should be monitored closely during the first 48 hours of treatment
• Folic acid should not be substituted for vitamin B12; doing so may mask hematologic improvement while allowing irreversible neurologic damage to progress
• Patients with pernicious anemia have approximately 3 times the incidence of gastric carcinoma versus the general population; appropriate testing should be performed when indicated

Contraindications

Contraindicated in patients with known sensitivity to cobalt and/or vitamin B12.

Adverse Reactions

Reported reactions include anaphylactic shock and death (parenteral administration); pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis; polycythemia vera; mild transient diarrhea; itching and transitory exanthema; and generalized feeling of body swelling.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

How Supplied

Supplied as a red solution in 1 mL multiple-dose vials, packaged 25 vials per carton.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.