Neuroforte-R

Name: Neuroforte-R

Side Effects of Neuroforte-R

Serious side effects have been reported with cyanocobalamin. See the “Cyanocobalamin Precautions” section.

Common side effects of cyanocobalamin include the following:

  • diarrhea
  • feeling as if your entire body is swollen
  • itching
  • eruption of the skin
  • diarrhea

This is not a complete list of cyanocobalamin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Neuroforte-R Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • antibiotics such as chloramphenicol (Chloromycetin, Mychel-S)
  • colchicine (Colcrys)
  • folic acid
  • methotrexate (Rheumatrex, Trexall)
  • para-aminosalicylic acid (Paser)
  • pyrimethamine (Daraprim)

Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

This is not a complete list of cyanocobalamin drug interactions. Ask your doctor or pharmacist for more information.

Neuroforte-R Precautions

Serious side effects have been reported with cyanocobalamin including the following:

  • Hypokalemia and sudden death may occur in severe megaloblastic anemia.
  • Anaphylactic shock and death. Anaphylactic shock and death have been reported after cyanocobalamin administration.
  • "Gasping Syndrome" in premature infants. This product contains Benzyl Alcohol. Benzyl Alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.
  • Aluminum toxicity. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged administration in patients with impaired kidney function.
  • Congestive heart failure. Tell your healthcare provider right away if you experience any of the following symptoms of CHF:
    • sudden weight gain
    • worsening shortness of breath
    • increased swelling of your feet, legs, or abdomen
    • needing to use more pillows to go to sleep or sleeping in a recliner
    • waking from sleep to catch your breath
    • a cough that does not go away
    • new or increasing irregularities in your heart rate
  • Production of too many red blood cells.

Do not take cyanocobalamin if you:

  • are allergic to cyanocobalamin or to any of its ingredients
  • have sensitivity to cobalt

Neuroforte-R and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Cyanocobalamin falls into category C.There are no well-controlled studies that have been done in pregnant women. Cyanocobalamin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

However, vitamin B12 is an essential vitamin and requirements are increased during pregnancy. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for pregnant women (4 mcg daily) should be consumed during pregnancy.

Neuroforte-R and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

Cyanocobalamin has been detected in human breast milk.

Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for lactating women (4 mcg daily) should be consumed during lactation.

 

Neuroforte-R Usage

Take Cyanocobalamin exactly as prescribed.

This medication is available in an injectable form to be given directly into the muscle (IM) or under the skin by a healthcare professional.

Patients with pernicious anemia will require monthly injections of vitamin B12 for the remainder of their lives.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of cyanocobalamin at the same time.

Uses For Neuroforte-R

Cyanocobalamin injection is used to treat or prevent vitamin B12 deficiency caused by the following conditions:

  • Addisonian (pernicious) anemia
  • Stomach or bowel problems
  • Worm infestation
  • Pancreas or bowel cancer
  • Folic acid deficiency.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using Neuroforte-R

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

Normal daily requirements of vitamin B12 vary according to age.

Geriatric

No information is available on the relationship of age to the effects of cyanocobalamin injection in geriatric patients.

Pregnancy

Pregnancy Category Explanation
All Trimesters 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.

Breast Feeding

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

Interactions with Medicines

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.

Interactions with Food/Tobacco/Alcohol

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:

  • Allergy to cobalt—Should not be used in patients with this condition.
  • Kidney disease—Use with caution. May increase risk for more serious side effects.
  • Megaloblastic anemia, severe—May increase risk for hypokalemia.

For the Consumer

Applies to cyanocobalamin: intramuscular solution

Other dosage forms:

  • nasal gel/jelly, nasal spray

Along with its needed effects, cyanocobalamin (the active ingredient contained in Neuroforte-R) 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:

Incidence not known
  • 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:

Incidence not known
  • Diarrhea
  • skin rash with a general disease

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