Neuroforte-R

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose of cyanocobalamin for the treatment of pernicious anemia is 100 mcg a day. A dose of 100 mcg daily for 6 or 7 days should be administered. If there is clinical improvement the same amount may be given on alternate days for seven doses, then every 3 to 4 days for another 2 to 3 weeks. The regimen will depend on you respond to cyanocobalamin.

This regimen should be followed by 100 mcg monthly for life.

In the U.S.

• Cobal
• LA-12
• Neuroforte-R
• Vita #12
• Vitabee 12

In Canada

• Bedoz

Available Dosage Forms:

• Solution

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin B (class)

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 or nurse immediately if any of the following side effects occur:

• 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 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

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.

Applies to cyanocobalamin: compounding powder, injectable solution, intramuscular solution, nasal gel, nasal spray, oral tablet, oral tablet extended release, sublingual lozenge, sublingual tablet

Cardiovascular

Frequency not reported: Congestive heart failure, peripheral vascular thrombosis, cardiac arrest, low blood pressure[Ref]

Hypersensitivity

Patients sensitized to the injectable product are often able to tolerate the oral route without problems.[Ref]

Frequency not reported: Anaphylactic shock and death, allergic hypersensitivity reactions[Ref]

Gastrointestinal

Frequency not reported: Mild transient diarrhea, prolonged abdominal pain, prolonged nausea or vomiting[Ref]

Nervous system

Frequency not reported: Severe dizziness, drowsiness, muscular paralysis, loss of consciousness[Ref]

Dermatologic

Frequency not reported: Itching, transitory exanthema, acneiform eruptions, bullous eruptions[Ref]

Respiratory

Frequency not reported: Pulmonary edema[Ref]

Metabolic

Frequency not reported: Hypokalemia[Ref]

Oncologic

Frequency not reported: Polycythemia vera[Ref]

Ocular

Frequency not reported: Vision problems[Ref]

Other

Frequency not reported: Feeling of swelling of entire body[Ref]

Some side effects of Neuroforte-R may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.