Nascobal

DRUG DESCRIPTION

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 cyanocobalamin nasal (Nascobal)?

If you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives), stop using cyanocobalamin nasal and seek emergency medical attention:

Other, less serious side effects may be more likely to occur. Continue to use cyanocobalamin nasal and talk to your doctor if you experience

  • headache;
  • runny nose;
  • upset stomach; or
  • numbness or tingling.

Side effects other than those listed here may also occur....

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 »


Nascobal Consumer (continued)

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.

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.


Nascobal Patient Information Including Side Effects

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.

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.

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  • Nascobal
  • CaloMist Nasal Spray


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