cyanocobalamin 1000 ug/mL
cyanocobalamin · INJECTION, SOLUTION · Zydus Pharmaceuticals USA Inc.
cyanocobalamin is a injection, solution containing cyanocobalamin at 1000 ug/mL, taken intramuscular. Manufactured by Zydus Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- cyanocobalamin
- Generic Name
- cyanocobalamin
- NDC Code (Product)
70710-1664- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Strength
- 1000 ug/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA214655
- Drug Class
- Vitamin B12 [EPC]
- Marketing Start
- 05/05/2022
Recall History
Isomeric Pharmacy Solution, LLC
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Aidapak Services, LLC
Labeling: Label Mixup:CYANOCOBALAMIN, Tablet, 500 mcg was mislabled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002859, EXP: 6/7/2014. and may have potentially been mislabeled as one of the following drugs: VITAMIN B COMPLEX W/C, Tablet, 0, NDC 00536730001, Pedigree: AD52993_7, EXP: 5/20/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD30180_22, EXP:
Accord Healthcare, Inc.
Subpotent drug: out of specification results
Green Valley Drugs
Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.
TMC Acquisition LLC dba Tailor Made Compounding
Lack of Assurance of Sterility
American Health Packaging
Subpotent Drug: Out of specification for assay.
AEQUITA PHARMACY
Lack of Processing Controls.
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Lack of Assurance of Sterility
Fresenius Kabi USA, LLC
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
AEQUITA PHARMACY
Lack of Processing Controls.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Cyanocobalamin is indicated for vitamin B 12 deficiencies due to malabsorption which may be associated with the following conditions: Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic acid deficiency It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions ), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of vitamin B 12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin Injection is also suitable for the vitamin B 12 absorption test ( Schilling Test ).
Dosage & Administration
DOSAGE AND ADMINISTRATION Avoid using the intravenous route. Use of this product intravenously will result in almost all of the vitamin being lost in the urine. Pernicious Anemia Parenteral vitamin B 12 is the recommended treatment and will be required for the remainder of the patient's life. The oral form is not dependable. A dose of 100 mcg daily for 6 or 7 days should be administered by intramuscular or deep subcutaneous injection. If there is clinical improvement and if a reticulocyte response is observed, the same amount may be given on alternate days for seven doses, then every 3 to 4 days for another 2 to 3 weeks. By this time hematologic values should have become normal. This regimen should be followed by 100 mcg monthly for life. Folic acid should be administered concomitantly if needed. Patients with Normal Intestinal Absorption Where the oral route is not deemed adequate, initial treatment similar to that for patients with pernicious anemia may be indicated depending on the severity of the deficiency. Chronic treatment should be with an oral B 12 preparation. If other vitamin deficiencies are present, they should be treated. Schilling Test The flushing dose is 1,000 mcg.…
Warnings
WARNINGS Patients with early Leber's disease (hereditary optic nerve atrophy) who were treated with cyanocobalamin suffered severe and swift optic atrophy. Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely. Anaphylactic shock and death have been reported after parenteral vitamin B 12 administration. An intradermal test dose is recommended before cyanocobalamin injection is administered to patients suspected of being sensitive to this drug. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system an…
Contraindications
CONTRAINDICATIONS Sensitivity to cobalt and/or vitamin B 12 is a contraindication.
Adverse Reactions
ADVERSE REACTIONS Generalized: Anaphylactic shock and death have been reported with administration of parenteral vitamin B 12 (see WARNINGS ). Cardiovascular: Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis Hematological: Polycythemia vera Gastrointestinal: Mild transient diarrhea Dermatological: Itching; transitory exanthema Miscellaneous: Feeling of swelling of entire body To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Frequently Asked Questions
What is cyanocobalamin used for?
cyanocobalamin contains cyanocobalamin. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is cyanocobalamin a controlled substance?
cyanocobalamin is not classified as a controlled substance by the DEA.
What is the generic name for cyanocobalamin?
The generic name for cyanocobalamin is cyanocobalamin. There are 7 other brand versions of cyanocobalamin.
What is the NDC code for cyanocobalamin 1000 ug/mL?
The NDC (National Drug Code) for cyanocobalamin 1000 ug/mL is 70710-1664, listed by Zydus Pharmaceuticals USA Inc..