B-12

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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.

Do not swallow a lozenge or sublingual tablet whole. Allow it to dissolve in your mouth without chewing.

The sublingual tablet should be placed under your tongue where it will dissolve.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Take the extended-release tablet with a full glass of water.

To be sure cyanocobalamin 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.

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. Take all of your medications as directed.

Store at room temperature away from moisture, heat, and light.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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

Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• chest pain; or

• unusual warmth, redness, or pain in an arm or leg.

Common side effects may include:

• headache, dizziness, weakness;

• nausea, upset stomach, diarrhea;

• numbness or tingling;

• fever;

• joint pain;

• swollen tongue; or

• itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to cyanocobalamin: intramuscular solution

Other dosage forms:

• nasal gel/jelly, nasal spray

Along with its needed effects, cyanocobalamin (the active ingredient contained in B-12) 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 or nurse immediately if any of the following side effects occur while taking cyanocobalamin:

• Abdominal or stomach pain
• bleeding from the gums or nose
• blue lips and fingernails
• chest pain
• cough
• coughing that sometimes produces a pink frothy sputum
• decreased urine output
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty with swallowing
• dilated neck veins
• dizziness
• extreme fatigue
• eye pain
• fast heartbeat
• headache
• hives, itching, or skin rash
• increased sweating
• irregular breathing
• irregular heartbeat
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• ringing in the ears
• swelling of the face, fingers, feet, or lower legs
• tightness in the chest
• unusual tiredness or weakness
• weight gain

Some side effects of cyanocobalamin 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:

• Diarrhea
• skin rash with a general disease

0.5 to 3 mcg daily

Administration advice:
-Avoid intravenous administration: almost all of the vitamin will be lost in the urine.
-Warm parenteral solution to body temperature before administration for patient comfort.

Monitoring:
-Pernicious anemia: monitor serum potassium closely during the first 48 hours of treatment and replace potassium if needed.

Patient advice:
-Patients with pernicious anemia will require B12 for the rest of their lives; failure to do so will cause anemia to return, which could lead to incapacitating and irreversible damage to the nerves and spinal cord.
-Taking folic acid instead of B12 may prevent anemia, but allow degeneration of the spinal cord.