Calomist

Cyanocobalamin nasal spray is used for maintaining normal vitamin B12 blood levels in patients with pernicious anemia. This is used after patients have received initial therapy with vitamin B12 injection and do not have nervous system problems.

Cyanocobalamin is a man-made form of vitamin B12. This medicine is also used to prevent or treat vitamin B12 deficiency that is caused by the following conditions: persons who are strict vegetarians, malabsorption of vitamin B12 in the ileum, or not properly utilized vitamin B12.

This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

• Gel/Jelly
• Spray

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:

1. 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.

2. Pediatric Population:
Normal daily requirements of vitamin B12 vary according to age.

3. Geriatric Population:
No information is available on the relationship of age to the effects of cyanocobalamin nasal spray in geriatric patients.

4. Pregnancy:
Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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

6. 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

7. 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.

8. 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
• Hay fever
• Upper respiratory infection—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
• Folic acid deficiency
• Iron deficiency
• Leber's disease (genetic eye disease)
• Uremia (high urea in the blood)—Use with caution. May make these conditions worse.
• Megaloblastic anemia—May increase risk for hypokalemia.
• Polycythemia vera (bone marrow disorder)—Using this medicine may mask or hide the signs of polycythemia vera.

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

This medicine is only used in the nose. Do not get it in 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 liquid or eat a hot meal for at least 1 hour before or 1 hour after using this medicine.

To use the nasal spray:

• Before each use of this medicine, you must prime the pump. To prime the spray, hold the bottle with the nozzle between two fingers and your thumb on the bottom of the bottle. Pump the bottle until the spray or gel appears, and then pump 2 more times. Now the medicine is ready to use.
• Gently blow your nose to clear the nostrils before you use this medicine.
• After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.

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

It is very important that your doctor check the progress of you or your child 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.

Avoid drinking a lot of alcohol for longer than 2 weeks while using this medicine. This can lower your blood levels of vitamin B12 and may make your condition worse.

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.

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

• Abdominal or Stomach bloating, burning, cramping, or pain
• Belching
• Bloody or Black, tarry stools
• Cloudy urine
• Constipation
• Decrease in urine output or decrease in urine-concentrating ability
• Diarrhea
• Dizziness
• Feeling of indigestion
• Headache
• Increased bleeding time
• Itching skin or rash
• Loss of appetite
• Nausea and Vomiting
• Pain in the chest below the breastbone
• Pale skin
• Severe stomach pain
• Swelling
• Troubled breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting of blood or material that looks like coffee grounds
• Weight loss

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation
• Blurred vision
• Change in consciousness
• Change in the ability to see colors, especially blue or yellow
• Confusion
• Depression
• Difficult or troubled breathing
• Hives
• Hostility
• Irregular, Fast or Slow, or Shallow breathing
• Irritability
• Loss of consciousness
• Muscle twitching
• Nervousness
• Pain or Discomfort in the chest, upper stomach, or throat
• Pale or Blue lips, fingernails, or skin
• Puffiness or Swelling of the eyelids or around the eyes, face, lips, or tongue
• Rapid weight gain
• Seizures
• Sleepiness
• Slow or Fast heartbeat
• Stupor
• Swelling of the face, ankles, or hands
• Tightness in the chest
• Trouble sleeping
• Unusual drowsiness, dullness, or feeling of sluggishness

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:

More common

• Continuing ringing or buzzing or other unexplained noise in the ears
• Excess air or gas in the stomach or intestines
• Hearing loss
• Lack or Loss of strength
• Passing gas

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.