Drugs Details

Drugs Info of CaloMist, Nascobal
Drugs Details
  • Drugs Type  : Multum
  • Date : 25th Jan 2015 11:40 pm
  • Brand Name : CaloMist, Nascobal
  • Generic Name : cyanocobalamin (nasal) (Pronunciation: sye AN oh koe BAL a min)
Descriptions

Cyanocobalamin is a synthetic form of vitamin B12 with equivalent vitamin B12 activity. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide. The cobalt content is 4.35%. The molecular formula is C63H88CoN14O14P, which corresponds to a molecular weight of 1355.38 and the following structural formula:

 

Nascobal (Cyanocobalamin, USP) Structural Formula Illustration

Cyanocobalamin occurs as dark red crystals or orthorhombic needles or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly to moderately soluble in water (1:80). Its pharmacologic activity is destroyed by heavy metals (iron) and strong oxidizing or reducing agents (vitamin C), but not by autoclaving for short periods of time (15-20 minutes) at 121°C. The vitamin B12 coenzymes are very unstable in light.

Nascobal® Nasal Spray is a solution of Cyanocobalamin, USP (vitamin B12) for administration as a spray to the nasal mucosa. Each bottle of Nascobal (cyanocobalamin) Nasal Spray contains 2.3 mL of a 500 mcg / 0.1 mL solution of cyanocobalamin with sodium citrate, citric acid, glycerin and benzalkonium chloride in purified water. The spray solution has a pH between 4.5 and 5.5. The spray pump unit must be fully primed (see DOSAGE AND ADMINISTRATION) prior to initial use. After initial priming, each spray delivers an average of 500 mcg of cyanocobalamin and the 2.3 mL of spray solution contained in the bottle will deliver 8 doses of Nascobal (cyanocobalamin) Nasal Spray. The unit must be re-primed before each dose. (see DOSAGE AND ADMINISTRATION).

What are the possible side effects of nasal cyanocobalamin (CaloMist, Nascobal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain; or
  • unusual warmth, redness, or pain in an arm or leg.

Less serious side effects may include:

  • headache, dizziness, weakness;
  • nausea, upset stomach, diarrhea;
  • numbness or...

Read All Potential Side Effects and See Pictures of Nascobal »

What are the precautions when taking cyanocobalamin (Nascobal)?

Before using cyanocobalamin, tell your doctor or pharmacist if you are allergic to it; or to cobalt; or if you have any other allergies. Your doctor may recommend that you receive a smaller test dose before starting your regular dose. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low potassium blood levels (hypokalemia), gout, a certain blood disorder (polycythemia vera), a certain eye disease (Leber's disease), other vitamin/mineral deficiencies (especially folic acid and iron).

Tell your doctor if you develop a stuffy or runny nose (e.g., due to a common cold or allergies) while...

Read All Potential Precautions of Nascobal »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Nascobal (cyanocobalamin) Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement.

Nascobal (cyanocobalamin) Nasal Spray is also indicated as a supplement for other vitamin B12 deficiencies, including:

I. Dietary deficiency of vitamin B12 occurring in strict vegetarians (Isolated vitamin B12 deficiency is very rare).

II. Malabsorption of vitamin B12 resulting from structural or functional damage to the stomach, where intrinsic factor is secreted, or to the ileum, where intrinsic factor facilitates vitamin B12 absorption. These conditions include HIV infection, AIDS, Crohn's disease, tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B12 deficiency.

III. 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, HIV infection, AIDS, certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces vitamin B12 deficiency. Structural lesions leading to vitamin B12 deficiency include regional ileitis, ileal resections, malignancies, etc.

IV. Competition for vitamin B12 by intestinal parasites or bacteria. The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B12 and infested patients often have associated gastric atrophy. The ">blind loop syndrome may produce deficiency of vitamin B12 or folate.

V. Inadequate utilization of vitamin B12. This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia.

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 vitamin B12.

Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with intranasal or oral supplementation.

Nascobal (cyanocobalamin) Nasal Spray is not suitable for vitamin B12 absorption test (Schilling Test).

Dosage Administration

The recommended initial dose of Nascobal (cyanocobalamin) Nasal Spray is one spray (500 mcg) administered in ONE nostril once weekly. Nascobal (cyanocobalamin) Nasal Spray should be administered at least one hour before or one hour after ingestion of hot foods or liquids. Periodic monitoring of serum B12 levels should be obtained to establish adequacy of therapy.

Priming (Activation) of Pump

Before the first dose and administration, the pump must be primed. Remove the clear plastic cover and the plastic safety clip from the pump. To prime the pump, place nozzle between the first and second finger with the thumb on the bottom of the bottle. Pump the unit firmly and quickly until the first appearance of spray. Then prime the pump an additional 2 times. Now the nasal spray is ready for use. The unit must be re-primed before each dose. Prime the pump once immediately before each administration of doses 2 through 8.

 

Nascobal (Cyanocobalamin, USP) Priming the pump - Illustration

See LABORATORY TESTS for monitoring B12 levels and adjustment of dosage.

How Supplied

Nascobal (cyanocobalamin) Nasal Spray is available as a spray in 3 mL glass bottles containing 2.3 mL of solution. It is available in a dosage strength of 500 mcg per actuation (0.1 mL/actuation). A screw-on actuator is provided. This actuator, following priming, will deliver 0.1 mL of the spray. Nascobal (cyanocobalamin) Nasal Spray is provided in a carton containing a nasal spray actuator with dust cover, a bottle of nasal spray solution, and a package insert. One bottle will deliver 8 doses (NDC 67871-773-35).

Pharmacist Assembly Instructions For Nascobal (cyanocobalamin) Nasal Spray

The pharmacist should assemble the Nascobal (cyanocobalamin) Nasal Spray unit prior to dispensing to the patient, according to the following instructions:

  1. Open the carton and remove the spray actuator and spray solution bottle.
  2. Assemble Nascobal (cyanocobalamin) Nasal Spray by first unscrewing the white cap from the spray solution bottle and screwing the actuator unit tightly onto the bottle. Make sure the clear dust cover is on the pump unit.
  3. Return the Nascobal (cyanocobalamin) Nasal Spray bottle to the carton for dispensing to the patient.

 

Pharmacist Assembly Instructions For Nascobal Nasal Spray

Mfd. for QOL Medical, LLC
Kirland, WA 98033, USA
1.866.469.3773
www.nascobal (cyanocobalamin) .com
3078 Rev. 02/06
FDA rev date: 9/15/2006

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The incidence of adverse experiences described in the Table below are based on data from a short-term clinical trial in vitamin B12 deficient patients in hematologic remission receiving Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration (N=24) and intramuscular vitamin B12 (N=25). In the pharmacokinetic study comparing Nascobal (cyanocobalamin) Nasal Spray and Nascobal (cyanocobalamin) Nasal Gel, the incidence of adverse events was similar.

Table. Adverse Experiences by Body System, Number of Patients and Number of Occurrences by Treatment Following Intramuscular and Intranasal Administration of Cyanocobalamin.

 

    Number of Patients (Occurrences)
Body System Adverse Experience Vitamin B12
Nasal Gel,
500 mcg
N=24
Intramuscular
Vitamin B12 ,
100 mcg
N=25
Body as a Whole Asthenia 1 (1) 4 (4)
Back Pain 0 (0) 1 (1)
Generalized Pain 0 (0) 2 (3)
Headache 1 (2)* 5 (11)
Infectiona 3 (4) 3 (3)
Cardiovascular System Peripheral Vascular Disorder 0 (0) 1 (1)
Digestive System Dyspepsia 0 (0) 1 (2)
Glossitis 1 (1) 0 (0)
Nausea 1 (1)* 1 (1)
Nausea & Vomiting 0 (0) 1 (1)
Vomiting 0 (0) 1 (1)
MusculoskeletalSystem Arthritis 0 (0) 2 (2)
Myalgia 0 (0) 1 (1)
Nervous System Abnormal Gait 0 (0) 1 (1)
Anxiety 0 (0) 1 (1)*
Dizziness 0 (0) 3 (3)
Hypoesthesia 0 (0) 1 (1)
Incoordination 0 (0) 1 (2)*
Nervousness 0 (0) 1 (3)*
Paresthesia 1 (1) 1 (1)
Respiratory Dyspnea 0 (0) 1 (1)
System Rhinitis 1 (1)* 2 (2)
a Sore throat, common cold
* There may be a possible relationship between these adverse experiences and the study drugs. These adverse experiences could have also been produced by the patient's clinical state or other concomitant therapy.

The intensity of the reported adverse experiences following the administration of Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration and intramuscular vitamin B12 were generally mild. One patient reported severe headache following intramuscular dosing. Similarly, a few adverse experiences of moderate intensity were reported following intramuscular dosing (two headaches and rhinitis; one dyspepsia, arthritis, and dizziness), and dosing with Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration (one headache, infection, and paresthesia).

The majority of the reported adverse experiences following dosing with Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration and intramuscular vitamin B12 were judged to be intercurrent events. For the other reported adverse experiences, the relationship to study drug was judged as “possible” or “remote”. Of the adverse experiences judged to be of “possible” relationship to the study drug, anxiety, incoordination, and nervousness were reported following intramuscular vitamin B12 and headache, nausea, and rhinitis were reported following dosing with Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration.

The following adverse reactions have been reported with parenteral vitamin B12:

Generalized: Anaphylactic shock and death (See WARNINGS and PRECAUTIONS).

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 the entire body.

Read the Nascobal (cyanocobalamin) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Drug/Laboratory Test Interactions

Persons taking most antibiotics, methotrexate or pyrimethamine invalidate folic acid and vitamin B12 diagnostic blood assays.

Colchicine, para-aminosalicylic acid and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B12.

Read the Nascobal Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Patients with early Leber's disease (hereditary optic nerve atrophy) who were treated with vitamin B12 suffered severe and swift optic atrophy.

Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely with vitamin B12. Folic acid is not a substitute for vitamin B12 although it may improve vitamin B12-deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B12-deficient megaloblastic anemia could result in progressive and irreversible neurologic damage.

Anaphylactic shock and death have been reported after parenteral vitamin B12 administration. No such reactions have been reported in clinical trials with Nascobal (cyanocobalamin) Nasal Spray or Nascobal (cyanocobalamin) Nasal Gel.

Blunted or impeded therapeutic response to vitamin B12 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.

Precautions

General

An intradermal test dose of parenteral vitamin B12 is recommended before Nascobal (cyanocobalamin) Nasal Spray is administered to patients suspected of cyanocobalamin sensitivity. Vitamin B12 deficiency that is allowed to progress for longer than three months may produce permanent degenerative lesions of the spinal cord. Doses of folic acid greater than 0.1 mg per day may result in hematologic remission in patients with vitamin B12 deficiency. Neurologic manifestations will not be prevented with folic acid, and if not treated with vitamin B12, irreversible damage will result.

Doses of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis.

The validity of diagnostic vitamin B12 or folic acid blood assays could be compromised by medications, and this should be considered before relying on such tests for therapy.

Vitamin B12 is not a substitute for folic acid and since it might improve folic acid deficient megaloblastic anemia, indiscriminate use of vitamin B12 could mask the true diagnosis.

Hypokalemia and thrombocytosis could occur upon conversion of severe megaloblastic to normal erythropoiesis with vitamin B12 therapy. Therefore, serum potassium levels and the platelet count should be monitored carefully during therapy.

Vitamin B12 deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B12 may unmask this condition.

If a patient is not properly maintained with Nascobal® (cyanocobalamin) Nasal Spray, intramuscular vitamin B12 is necessary for adequate treatment of the patient. No single regimen fits all cases, and the status of the patient observed in follow-up is the final criterion for adequacy of therapy.

The effectiveness of Nascobal (cyanocobalamin) Nasal Spray in patients with nasal congestion, allergic rhinitis and upper respiratory infections has not been determined. Therefore, treatment with Nascobal (cyanocobalamin) Nasal Spray should be deferred until symptoms have subsided.

Laboratory Tests

Hematocrit, reticulocyte count, vitamin B12, folate and iron levels should be obtained prior to treatment. If folate levels are low, folic acid should also be administered. All hematologic parameters should be normal when beginning treatment with Nascobal® (cyanocobalamin) Nasal Spray.

Vitamin B12 blood levels and peripheral blood counts must be monitored initially at one month after the start of treatment with Nascobal® (cyanocobalamin) Nasal Spray, and then at intervals of 3 to 6 months.

A decline in the serum levels of B12 after one month of treatment with B12 nasal spray may indicate that the dose may need to be adjusted upward. Patients should be seen one month after each dose adjustment; continued low levels of serum B12 may indicate that the patient is not a candidate for this mode of administration.

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

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals to evaluate carcinogenic potential have not been done. There is no evidence from long-term use in patients with pernicious anemia that vitamin B12 is carcinogenic. 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 vitamin B12.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with vitamin B12. It is also not known whether vitamin B12 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Adequate and well-controlled studies have not been done in pregnant women. However, vitamin B12 is an essential vitamin and requirements are increased during pregnancy. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science - National Research Council for pregnant women should be consumed during pregnancy.

Nursing Mothers

Vitamin B12 appears in the milk of nursing mothers in concentrations which approximate the mother's vitamin B12 blood level. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for lactating women should be consumed during lactation.

Pediatric Use

Intake in pediatric patients should be in the amount recommended by the Food and Nutrition Board, National Academy of Science-National Research Council.

Please also see PATIENT INFORMATION

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No overdosage has been reported with Nascobal Nasal Spray, Nascobal (Cyanocobalamin, USP) Gel for Intranasal Administration or parenteral vitamin B12.

ContrainDications

Sensitivity to cobalt and/or vitamin B12 or any component of the medication is a contraindication.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

General Pharmacology And Mechanism Of Action

Vitamin B12 is essential to growth, cell reproduction, hematopoiesis, and nucleoprotein and myelin synthesis. Cells characterized by rapid division (e.g., epithelial cells, bone marrow, myeloid cells) appear to have the greatest requirement for vitamin B12. Vitamin

B12 can be converted to coenzyme B12 in tissues, and as such is essential for conversion of methylmalonate to succinate and synthesis of methionine from homocysteine, a reaction which also requires folate. In the absence of coenzyme B12, tetrahydrofolate cannot be regenerated from its inactive storage form, 5- methyltetrahydrofolate, and a functional folate deficiency occurs. Vitamin B12 also may be involved in maintaining sulfhydryl (SH) groups in the reduced form required by many SH-activated enzyme systems. Through these reactions, vitamin B12 is associated with fat and carbohydrate metabolism and protein synthesis. Vitamin B12 deficiency results in megaloblastic anemia, GI lesions, and neurologic damage that begins with an inability to produce myelin and is followed by gradual degeneration of the axon and nerve head.

Cyanocobalamin is the most stable and widely used form of vitamin B12, and has hematopoietic activity apparently identical to that of the antianemia factor in purified liver extract. The information below, describing the clinical pharmacology of cyanocobalamin, has been derived from studies with injectable vitamin B12.

Vitamin B12 is quantitatively and rapidly absorbed from intramuscular and subcutaneous sites of injection. It is bound to plasma proteins and stored in the liver. Vitamin B12 is excreted in the bile and undergoes some enterohepatic recycling. Absorbed vitamin B12 is transported via specific B12 binding proteins, transcobalamin I and II, to the various tissues. The liver is the main organ for vitamin B12 storage.

Parenteral (intramuscular) administration of vitamin B12 completely reverses the megaloblastic anemia and GI symptoms of vitamin B12 deficiency; the degree of improvement in neurologic symptoms depends on the duration and severity of the lesions, although progression of the lesions is immediately arrested.

Gastrointestinal absorption of vitamin B12 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 B12 prevents progression of neurologic damage.

The average diet supplies about 4 to 15 mcg/day of vitamin B12 in a protein-bound form that is available for absorption after normal digestion. Vitamin B12 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 B12 is bound to intrinsic factor during transit through the stomach; separation occurs in the terminal ileum in the presence of calcium, and vitamin B12 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 B12.

Colchicine, para-aminosalicylic acid, and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B12.

Pharmacokinetics

Absorption

A three way crossover study in 25 fasting healthy subjects was conducted to compare the bioavailability of the B12 nasal spray to the B12 nasal gel and to evaluate the relative bioavailability of the nasal formulations as compared to the intramuscular injection. The peak concentrations after administration of intranasal spray were reached in 1.25 +/- 1.9 hours. The average peak concentration of B12 obtained after baseline correction following administration of intranasal spray was 757.96 +/- 532.17 pg/mL. The bioavailability of the nasal spray relative to the intramuscular injection was found to be 6.1%. The bioavailability of the B12 nasal spray was found to be 10% less than the B12 nasal gel. The 90% confidence intervals for the loge-transformed AUC(0-t) and Cmax was 71.71% - 114.19% and 71.6% - 118.66% respectively.

In pernicious anemia patients, once weekly intranasal dosing with 500 mcg B12 gel resulted in a consistent increase in pre-dose serum B12 levels during one month of treatment (p < 0.003) above that seen one month after 100 mcg intramuscular dose (Figure).

Distribution

In the blood, B12 is bound to transcobalamin II, a specific B-globulin carrier protein, and is distributed and stored primarily in the liver and bone marrow.

Elimination

About 3-8 mcg of B12 is secreted into the GI tract daily via the bile; in normal subjects with sufficient intrinsic factor, all but about 1 mcg is reabsorbed. When B12 is administered in doses which saturate the binding capacity of plasma proteins and the liver, the unbound B12 is rapidly eliminated in the urine. Retention of B12 in the body is dose-dependent. About 80-90% of an intramuscular dose up to 50 mcg is retained in the body; this percentage drops to 55% for a 100 mcg dose, and decreases to 15% when a 1000 mcg dose is given.

 

View Enlarged Table

Figure. Vitamin B12 Serum Trough Levels After Intramuscular Solution (IM) of 100 mcg and Nasal Gel (IN) Administration of 500 mcg Cyanocobalamin After Weekly Doses.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients with pernicious anemia should be instructed that they will require weekly intranasal administration of Nascobal (cyanocobalamin) Nasal Spray for the remainder of their lives. Failure to do so will result in return of the anemia and in development of incapacitating and irreversible damage to the nerves of the spinal cord. Also, patients should be warned about the danger of taking folic acid in place of vitamin B12, because the former may prevent anemia but allow progression of subacute combined degeneration of the spinal cord.

(Hot foods may cause nasal secretions and a resulting loss of medication; therefore, patients should be told to administer Nascobal (cyanocobalamin) Nasal Spray at least one hour before or one hour after ingestion of hot foods or liquids).

A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any vitamin B12. Therefore, patients following such a diet should be advised to take Nascobal (cyanocobalamin) Nasal Spray weekly. The need for vitamin B12 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.

Because the nasal dosage forms of Vitamin B12 have a lower absorption than intramuscular dosage, nasal dosage forms are administered weekly, rather than the monthly intramuscular dosage. As shown in the Figure above, at the end of a month, weekly nasal administration results in significantly higher serum Vitamin B12 levels than after intramuscular administration. The patient should also understand the importance of returning for follow-up blood tests every 3 to 6 months to confirm adequacy of the therapy.

Careful instructions on the actuator assembly, removal of safety clip, priming of the actuator and nasal administration of Nascobal (cyanocobalamin) Nasal Spray should be given to the patient. Although instructions for patients are supplied with individual bottles, procedures for use should be demonstrated to each patient.

Storage Conditions

Protect from light. Keep covered in carton until ready to use. Store upright at controlled room temperature 15°C to 30°C (59°F to 86°F). Protect from freezing.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

CYANOCOBALAMIN - NASAL

 

(SYE-an-oh-koe-BAL-a-min)

 

COMMON BRAND NAME(S): Nascobal

 

USES: Cyanocobalamin is a man-made form of vitamin B12 used to treat low levels (deficiency) of this vitamin. Vitamin B12 helps your body use fat and carbohydrates for energy and make new protein. It is also important for normal blood, cells, and nerves. Most people get enough vitamin B12 in their diet, but a deficiency may occur in certain health conditions (e.g., poor nutrition, pregnancy, stomach/intestinal problems, infection, cancer). Serious vitamin B12 deficiency may result in anemia, stomach problems, and nerve damage.

 

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Refer to the illustrated instructions provided by the manufacturer for directions on how to use this device. If any of the information is unclear, consult your doctor or pharmacist.

Gently blow your nose before using this drug. Follow the instructions on how to properly prime the bottle if you are using it for the first time. The gel pump does not need to be primed after the first use. However, the spray pump must be primed with each use.

Use this medication in the nose once weekly or as directed by your doctor. Hot food or drinks may produce mucus that can wash away this medication. Therefore, avoid hot food or drinks for 1 hour before or after using this medication.

Dosage is based on your medical condition and response to treatment. Do not increase, decrease, or stop this medication without your doctor's approval. Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week. It may help to mark your calendar with a reminder.

Consumer Overview Side Effect

SIDE EFFECTS: Headache, nausea, or runny nose may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may cause low potassium levels in the blood (hypokalemia). Tell your doctor immediately if any of these unlikely but serious side effects occur: muscle cramps, weakness, irregular heartbeat.

People who have a rare blood disorder (polycythemia vera) may infrequently have symptoms related to this disorder while taking cyanocobalamin. Seek immediate medical attention if any of these rare but very serious symptoms occur: chest pain (especially with shortness of breath), weakness on one side of the body, sudden vision changes, slurred speech.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Nascobal (cyanocobalamin) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using cyanocobalamin, tell your doctor or pharmacist if you are allergic to it; or to cobalt; or if you have any other allergies. Your doctor may recommend that you receive a smaller test dose before starting your regular dose. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low potassium blood levels (hypokalemia), gout, a certain blood disorder (polycythemia vera), a certain eye disease (Leber's disease), other vitamin/mineral deficiencies (especially folic acid and iron).

Tell your doctor if you develop a stuffy or runny nose (e.g., due to a common cold or allergies) while using this medication. You may need to use another form of vitamin B12 when these symptoms are present.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Based on information from related drugs, this medication may pass into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that may affect blood cell production (e.g., chloramphenicol, anti-cancer drugs, HIV drugs), other vitamins/nutritional supplements (especially folic acid).

Certain other drugs may interfere with laboratory tests for vitamin B12 levels, possibly causing false test results. Tell laboratory personnel and all your doctors if you take any of the following: anti-infective drugs (e.g., amoxicillin, erythromycin), methotrexate, pyrimethamine.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: Overdose with this medication is very unlikely. However, if overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., serum potassium levels, complete blood count, hematocrit, vitamin B12 levels) should be performed to monitor your progress or check for side effects. Consult your doctor for more details.

This product is not a substitute for a proper diet. Remember that it is best to get your vitamins from healthy foods. Vitamin B12 is commonly found in many foods from animals, especially liver, kidney, fish and shellfish, meat, and dairy foods.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store the pump upright at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not freeze. Do not store in the bathroom. Keep track of the number of doses you use from each pump, and discard the pump after you have used the labeled number of doses on the product package. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: CaloMist, Nascobal

Generic Name: cyanocobalamin (nasal) (Pronunciation: sye AN oh koe BAL a min)

  • What is nasal cyanocobalamin (Nascobal)?
  • What are the possible side effects of nasal cyanocobalamin (Nascobal)?
  • What is the most important information I should know about nasal cyanocobalamin (Nascobal)?
  • What should I discuss with my healthcare provider before using nasal cyanocobalamin (Nascobal)?
  • How should I use nasal cyanocobalamin (Nascobal)?
  • What happens if I miss a dose (Nascobal)?
  • What happens if I overdose (Nascobal)?
  • What should I avoid while using nasal cyanocobalamin (Nascobal)?
  • What other drugs will affect nasal cyanocobalamin (Nascobal)?
  • Where can I get more information?

What is nasal cyanocobalamin (Nascobal)?

Cyanocobalamin is a man-made form of vitamin B12. Vitamin B12 is important for growth, cell reproduction, blood formation, and protein and tissue synthesis.

Cyanocobalamin is used to treat vitamin B12 deficiency in people with pernicious anemia and other conditions.

Cyanocobalamin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of nasal cyanocobalamin (Nascobal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain; or
  • unusual warmth, redness, or pain in an arm or leg.

Less serious side effects may include:

  • headache, dizziness, weakness;
  • nausea, upset stomach, diarrhea;
  • numbness or tingling;
  • runny nose, sneezing, sore throat, swollen tongue;
  • fever;
  • joint pain; or
  • itching or rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Nascobal (cyanocobalamin) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about nasal cyanocobalamin (Nascobal)?

You should not use this medication if you are allergic to cobalt, or if you have Leber's disease. Cyanocobalamin can lead to optic nerve damage (and possibly blindness) in people with Leber's disease.

To treat pernicious anemia, you will have to use this medication on a regular basis for the rest of your life. Not using the medication can lead to irreversible nerve damage in your spinal cord.

Pernicious anemia is also treated with folic acid to help maintain red blood cells. However, folic acid will not treat Vitamin B12 deficiency and will not prevent possible damage to the spinal cord. Use all of your medications as directed.

Avoid eating or drinking hot foods or liquids within 1 hour before or after using the nasal form of this medication.

Tell your doctor if you develop nasal congestion, a cold, or allergies. The nasal spray may not work as well if you are congested.

Your dose needs may change if you become pregnant, if you breast-feed, or if you eat a vegetarian diet. Tell your doctor about any changes in your diet or medical condition.

Side Effects Centers
  • Nascobal

Patient Detailed How Take

What should I discuss with my healthcare provider before using nasal cyanocobalamin (Nascobal)?

You should not use this medication if you are allergic to cobalt, or if you have Leber's disease. Cyanocobalamin can lead to optic nerve damage (and possibly blindness) in people with Leber's disease.

Before using cyanocobalamin, tell your doctor if you have:

  • any type of infection;
  • iron or folic acid deficiency;
  • kidney or liver disease; or
  • if you are receiving any medication or treatment that affects bone marrow.

Tell your doctor if you develop nasal congestion, a cold, or allergies. Nasal cyanocobalamin may not work as well if your nose is congested.

FDA pregnancy category C. It is not known whether this medication can harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Cyanocobalamin passes into breast milk, but it is not known whether cyanocobalamin could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use nasal cyanocobalamin (Nascobal)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your dose needs may change if you become pregnant, if you breast-feed, or if you eat a vegetarian diet. Tell your doctor about any changes in your diet or medical condition.

To use nasal cyanocobalamin.

  • Gently blow your nose to clear any mucus.
  • Prime the nasal gel pump before your first use and whenever it has been longer than 2 days between uses. Pump the gel unit several times until a gel droplet appears at the tip, then pump 2 more times.
  • Prime the nasal spray before your first use by pumping the spray a few times until a fine mist appears. Prime the pump 1 time before each use thereafter.
  • Insert the tip of the nasal pump about half an inch into your nostril, pointing it toward the back of the nose.
  • Gently press your other nostril closed with your finger, and tilt your head forward. Pump and sniff gently at the same time. Return your head to an upright position.
  • Remove the pump from your nose. Rub your nostril gently for a few seconds.
  • Clean the tip of the spray or gel pump with a clean tissue and recap.

To be sure this medication is helping your condition, your blood will need to be tested every 3 to 6 months. This will help your doctor determine the correct dose and how long to treat you with cyanocobalamin. Do not miss any scheduled appointments.

To treat pernicious anemia, you will have to use this medication on a regular basis for the rest of your life. Not using the medication can lead to irreversible nerve damage in your spinal cord.

Pernicious anemia is also treated with folic acid to help maintain red blood cells. However, folic acid will not treat Vitamin B12 deficiency and will not prevent possible damage to the spinal cord. Use all of your medications as directed.

Store this medication at room temperature away from moisture, heat, and light. Keep the nasal gel in the prescription vial when not in use. Store the nasal spray upright.

Side Effects Centers
  • Nascobal

Patient Detailed Avoid Taking

What happens if I miss a dose (Nascobal)?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Nascobal)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of cyanocobalamin is not likely to cause life-threatening symptoms.

What should I avoid while using nasal cyanocobalamin (Nascobal)?

Do not drink hot liquid or eat hot food within 1 hour before or after you use nasal cyanocobalamin.

Avoid drinking large amounts of alcohol while you are being treated with cyanocobalamin.

Avoid using any other nasal medications that your doctor has not recommended or prescribed.

What other drugs will affect nasal cyanocobalamin (Nascobal)?

Before using cyanocobalamin, tell your doctor if you are taking any of the following medications:

  • antibiotics;
  • methotrexate (Rheumatrex);
  • pyrimethamine (Daraprim);
  • colchicine; or
  • if you drank a lot of alcohol within the past 2 weeks.

This list is not complete and there may be other drugs that can interact with cyanocobalamin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about nasal cyanocobalamin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.04. Revision date: 12/15/2010.

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