cyanocobalamine

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Overview

What is cyanocobalamine?

Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection.

Each mL contains 1,000 mcg cyanocobalamin, Sodium Chloride 0.9%. Benzyl Alcohol 1.5% is present as a preservative. Sodium acetate and Glacial acetic acid are present as buffer. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5 to 7.0).

Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder or purplish crystalline powder. Sparingly soluble in water and soluble in alcohol, practically insoluble in acetone, in chloroform and in either. It is stable to autoclaving for short periods at 121°C. The vitamin B coenzymes are very unstable in light.

The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is CHCoNOP. The cobalt content is 4.34%. The molecular weight is 1355.4.

The structural formula is represented below.

What does cyanocobalamine look like?

What are the available doses of cyanocobalamine?

Sorry No records found.

What should I talk to my health care provider before I take cyanocobalamine?

Sorry No records found

How should I use cyanocobalamine?

Cyanocobalamin is indicated for vitamin B deficiencies due to malabsorption which may be associated with the following conditions:

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 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 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, USP is also suitable for the vitamin B absorption test (Schilling test).

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:

Patients with Normal Intestinal Absorption:

Schilling Test:

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

What interacts with cyanocobalamine?

Sensitivity to cobalt and/or vitamin B is a contraindication.

What are the warnings of cyanocobalamine?

If isosorbide mononitrate is used in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.

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 administration. An intradermal test dose is recommended before Cyanocobalamin Injection, USP 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 and bone toxicity.

Tissue loading may occur at even lower rates of administration.

What are the precautions of cyanocobalamine?

General Precautions

Doses of cyanocobalamin exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis.

Information for Patients:

A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any vitamin B. Patients following such a diet should be advised to take oral vitamin B regularly. The need for vitamin B is increased by pregnancy and lactation. Deficiency has been recognized in infants of vegetarian mothers who were breast fed, even though the mothers had no symptoms of deficiency at the time.

Laboratory Tests:

Hematocrit, reticulocyte count, vitamin B, folate and iron levels should be obtained prior to treatment. Hematocrit and reticulocyte counts should be repeated daily from the fifth to seventh days of therapy and then frequently until the hematocrit is normal. If folate levels are low, folic acid should also be administered. If reticulocytes have not increased after treatment or if reticulocyte counts do not continue at least twice normal as long as the hematocrit is less than 35%, diagnosis or treatment should be reevaluated. Repeat determinations of iron and folic acid may reveal a complicating illness that might inhibit the response of the marrow.

Patients with pernicious anemia have about 3 times the incidence of carcinoma of the stomach as the general population, so appropriate tests for this condition should be carried out when indicated.

Drug/Laboratory Test Interactions:

Colchicine para-aminosalicylic acid and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Pernicious anemia is associated with an increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with cyanocobalamin.

Pregnancy: Teratogenic Effects. Pregnancy Category C:

Nursing Mothers:

Pediatric Use:

What are the side effects of cyanocobalamine?

Generalized:

Cardiovascular:

Hematological:

Gastrointestinal:

Dermatological:

Miscellaneous:

To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1 877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

What should I look out for while using cyanocobalamine?

Sensitivity to cobalt and/or vitamin B is a contraindication.

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 administration. An intradermal test dose is recommended before Cyanocobalamin Injection, USP 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 and bone toxicity.

Tissue loading may occur at even lower rates of administration.

What might happen if I take too much cyanocobalamine?

No overdosage has been reported with this drug.

How should I store and handle cyanocobalamine?

Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows:10 mL Multiple Dose Vial, Box of 1 vial.10 mL Multiple Dose Vial, Box of 25 vials.30 mL Multiple Dose Vial,Box of 1 vial.30 mL Multiple Dose Vial,Box of 5 vials.Store at 20to 25C (68to 77F). [See USP Controlled Room Temperature.]PROTECT FROM LIGHT. Manufactured for:Mylan Institutional LLCRockford, IL 61103 U.S.A.Manufactured by:Mylan Laboratories LimitedBangalore, IndiaMAY 2016

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Vitamin B is essential to growth, cell reproduction, hematopoiesis, and nucleoprotein and myelin synthesis.

Cyanocobalamin is quantitatively and rapidly absorbed from intramuscular and subcutaneous sites of injection; the plasma level of the compound reaches its peak within 1 hour after intramuscular injection. Absorbed vitamin B is transported via specific B binding proteins, transcobalamin I and II to the various tissues. The liver is the main organ for vitamin B storage.

Within 48 hours after injection of 100 or 1,000 mcg of vitamin B, 50 to 98% of the injected dose may appear in the urine. The major portion is excreted within the first eight hours. Intravenous administration results in even more rapid excretion with little opportunity for liver storage.

Gastrointestinal absorption of vitamin B depends on the presence of sufficient intrinsic factor and calcium ions. Intrinsic factor deficiency causes pernicious anemia, which may be associated with subacute combined degeneration of the spinal cord. Prompt parenteral administration of vitamin B prevents progression of neurologic damage.

The average diet supplies about 5 to 15 mcg/day of vitamin B in a protein-bound form that is available for absorption after normal digestion. Vitamin B is not present in foods of plant origin, but is abundant in foods of animal origin. In people with normal absorption, deficiencies have been reported only in strict vegetarians who consume no products of animal origin (including no milk products or eggs).

Vitamin B is bound to intrinsic factor during transit through the stomach; separation occurs in the terminal ileum in the presence of calcium, and vitamin B enters the mucosal cell for absorption. It is then transported by the transcobalamin binding proteins. A small amount (approximately 1% of the total amount ingested) is absorbed by simple diffusion, but this mechanism is adequate only with very large doses. Oral absorption is considered too undependable to rely on in patients with pernicious anemia or other conditions resulting in malabsorption of vitamin B.

Cyanocobalamin is the most widely used form of vitamin B, and has hematopoietic activity apparently identical to that of the antianemia factor in purified liver extract. Hydroxycobalamin is equally as effective as cyanocobalamin, and they share the cobalamin molecular structure.

Non-Clinical Toxicology

Sensitivity to cobalt and/or vitamin B is a contraindication.

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 administration. An intradermal test dose is recommended before Cyanocobalamin Injection, USP 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 and bone toxicity.

Tissue loading may occur at even lower rates of administration.

Concomitant use of isosorbide mononitrate with phosphodiesterase inhibitors in any form is contraindicated (see CONTRAINDICATIONS).

Concomitant use of isosorbide mononitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see CONTRAINDICATIONS).

The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.

General Precautions

Doses of cyanocobalamin exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis.

Information for Patients:

A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any vitamin B. Patients following such a diet should be advised to take oral vitamin B regularly. The need for vitamin B is increased by pregnancy and lactation. Deficiency has been recognized in infants of vegetarian mothers who were breast fed, even though the mothers had no symptoms of deficiency at the time.

Laboratory Tests:

Hematocrit, reticulocyte count, vitamin B, folate and iron levels should be obtained prior to treatment. Hematocrit and reticulocyte counts should be repeated daily from the fifth to seventh days of therapy and then frequently until the hematocrit is normal. If folate levels are low, folic acid should also be administered. If reticulocytes have not increased after treatment or if reticulocyte counts do not continue at least twice normal as long as the hematocrit is less than 35%, diagnosis or treatment should be reevaluated. Repeat determinations of iron and folic acid may reveal a complicating illness that might inhibit the response of the marrow.

Patients with pernicious anemia have about 3 times the incidence of carcinoma of the stomach as the general population, so appropriate tests for this condition should be carried out when indicated.

Drug/Laboratory Test Interactions:

Colchicine para-aminosalicylic acid and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Pernicious anemia is associated with an increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with cyanocobalamin.

Pregnancy: Teratogenic Effects. Pregnancy Category C:

Nursing Mothers:

Pediatric Use:

Generalized:

Cardiovascular:

Hematological:

Gastrointestinal:

Dermatological:

Miscellaneous:

To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1 877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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