Description and Brand Names

US Brand Name

  1. CaloMist
  2. Nascobal

Descriptions


Cyanocobalamin nasal spray is used to maintain normal vitamin B12 blood levels in patients with pernicious anemia who have achieved healthy vitamin B12 levels after receiving vitamin B12 shots and do not have nervous system problems.

Cyanocobalamin is also used to prevent vitamin B12 deficiency in adults who require higher amounts of vitamin B12. It is also used to treat vitamin B12 deficiency caused by certain food limitations (eg, strict vegetarians), medicines, or malabsorption-related problems. Cyanocobalamin is a man-made form of vitamin B12.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Spray

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of cyanocobalamin nasal spray in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of cyanocobalamin nasal spray have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Chloramphenicol

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergic rhinitis or hay fever (unexplained runny nose or sneezing) or
  • Nasal congestion (stuffy nose) or
  • Upper respiratory tract infection (eg, chills, fever, difficulty breathing)—Cyanocobalamin may not be effective when used in patients with these conditions.
  • Allergy to cobalt—Should not be used in patients with this condition.
  • Bone marrow problems or
  • Folic acid deficiency or
  • Iron deficiency—Use with caution. May make these conditions worse.
  • Leber's disease (genetic eye disease)—Use is not recommended in patients with this condition.
  • Megaloblastic anemia, severe—May increase risk for hypokalemia (low potassium level in the blood) or thrombocytosis (excess number of platelets in the blood).
  • Polycythemia vera (bone marrow disorder)—Using this medicine may mask or hide the signs of polycythemia vera.

Proper Use

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is only used in the nose. Do not get it into your eyes or on your skin. If it does get on these areas, rinse it off right away and call your doctor.

Some patients may need a test dose of vitamin B12 injection before using Nascobal® nasal spray. This is to check if you have an allergic reaction to cyanocobalamin.

Carefully follow your doctor's instructions about diet and oral vitamin supplements (pills).

If you are using this medicine to treat pernicious anemia, you will need to use the medicine for the rest of your life.

Do not drink hot liquids or eat a hot meal for at least 1 hour before or 1 hour after using this medicine.

This medicine contains only 1 spray. Use each nasal spray device only one time. You do not need to prime the device before using it.

To use the nasal spray:

  • Gently blow your nose to clear the nostrils before you use this medicine.
  • Hold the nasal spray device with your thumb on the bottom and your pointer finger and middle finger on either side of the nozzle.
  • Close 1 nostril with your other index finger, then insert the nozzle into the open nostril about half an inch or as far as it feels comfortable. Tilt your head slightly forward.
  • Breathe in gently through your nose, close your mouth, and at the same time press the plunger firmly upwards with your thumb.
  • Remove the nozzle from your nostril. At the same time, keep your head straight for 10 to 20 seconds while gently breathing in through your nose and breathing out through your mouth.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For nasal dosage form (spray):
    • For pernicious anemia and vitamin B12 deficiency:
      • Adults—One spray into one nostril once a week. Each spray contains 500 micrograms (mcg). Your doctor may adjust your dose as needed.
      • Children—Dose must be determined by your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in its original container until you are ready to use it.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly. Blood and other laboratory tests may be needed to check for unwanted effects.

Do not use folic acid in place of cyanocobalamin to treat your condition.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Fever
  2. chills
  3. cough
  4. hoarseness
  5. lower back or side pain
  6. painful or difficult urination

Less common

  1. Runny nose
  2. sneezing
  3. sore throat
  4. stuffy nose

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  1. Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  2. headache
  3. lack or loss of strength
  4. nausea
  5. redness, swelling, or soreness of the tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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