Vitrace-FM

Vitrace-FM (commonly known as Vitamin B12) is the most chemically complex of all the vitamins. Vitrace-FM's structure is based on a corrin ring, which, although similar to the porphyrin ring found in heme, chlorophyll, and cytochrome, has two of the pyrrole rings directly bonded. The central metal ion is Co (cobalt). Vitrace-FM cannot be made by plants or by animals, as the only type of organisms that have the enzymes required for the synthesis of Vitrace-FM are bacteria and archaea. Higher plants do not concentrate Vitrace-FM from the soil and so are a poor source of the substance as compared with animal tissues. Vitrace-FM is naturally found in foods including meat (especially liver and shellfish), eggs, and milk products. [HMDB]

Vitrace-FM Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement.

Vitrace-FM Nasal Spray is also indicated as a supplement for other vitamin B12 deficiencies, including:

I. Dietary deficiency of vitamin B12 occurring in strict vegetarians (Isolated vitamin B12 deficiency is very rare).

II. Malabsorption of vitamin B12 resulting from structural or functional damage to the stomach, where intrinsic factor is secreted, or to the ileum, where intrinsic factor facilitates vitamin B12 absorption. These conditions include HIV infection, AIDS, Crohn's disease, tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B12 deficiency.

III. Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (such as multiple sclerosis, HIV infection, AIDS, certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces vitamin B12 deficiency. Structural lesions leading to vitamin B12 deficiency include regional ileitis, ileal resections, malignancies, etc.

IV. Competition for vitamin B12 by intestinal parasites or bacteria. The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B12 and infested patients often have associated gastric atrophy. The blind loop syndrome may produce deficiency of vitamin B12 or folate.

V. Inadequate utilization of vitamin B12. This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia.

It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption, use of a gluten-free diet in non-tropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of vitamin B12.

Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with intranasal or oral supplementation.

Vitrace-FM Nasal Spray is not suitable for vitamin B12 absorption test (Schilling Test).

Vitrace-FM nasal spray contains Cyanocobalamin, a man-made form of vitamin B12. Vitamin B12 is important for growth, cell reproduction, blood formation, and protein and tissue synthesis.

Vitrace-FM nasal spray is used to treat vitamin B12 deficiency in people with pernicious anemia and other conditions.

Vitrace-FM nasal spray is usually given after treatment with an injection form of this medicine.

Vitrace-FM may also be used for purposes not listed in this medication guide.

The recommended initial dose of Vitrace-FM (Vitrace-FM) Nasal Spray is one spray (500 mcg) administered in ONE nostril once weekly. Vitrace-FM (Vitrace-FM) Nasal Spray should be administered at least one hour before or one hour after ingestion of hot foods or liquids. Periodic monitoring of serum B levels should be obtained to establish adequacy of therapy.

Priming (Activation) of Pump

Before the first dose and administration, the pump must be primed. Remove the clear plastic cover and the plastic safety clip from the pump. To prime the pump, place nozzle between the first and second finger with the thumb on the bottom of the bottle. Pump the unit firmly and quickly until the first appearance of spray. Then prime the pump an additional 2 times. Now the nasal spray is ready for use. The unit must be re-primed before each dose. Prime the pump once immediately before each administration of doses 2 through 8.

How supplied

Vitrace-FM (Vitrace-FM) Nasal Spray is available as a spray in 3 mL glass bottles containing 2.3 mL of solution. It is available in a dosage strength of 500 mcg per actuation (0.1 mL/actuation). A screw-on actuator is provided. This actuator, following priming, will deliver 0.1 mL of the spray. Vitrace-FM (Vitrace-FM) Nasal Spray is provided in a carton containing a nasal spray actuator with dust cover, a bottle of nasal spray solution, and a package insert. One bottle will deliver 8 doses (NDC 67871-773-35).

Pharmacist Assembly Instructions For Vitrace-FM (Vitrace-FM) Nasal Spray

The pharmacist should assemble the Vitrace-FM (Vitrace-FM) Nasal Spray unit prior to dispensing to the patient, according to the following instructions:

1. Open the carton and remove the spray actuator and spray solution bottle.
2. Assemble Vitrace-FM (Vitrace-FM) Nasal Spray by first unscrewing the white cap from the spray solution bottle and screwing the actuator unit tightly onto the bottle. Make sure the clear dust cover is on the pump unit.
3. Return the Vitrace-FM (Vitrace-FM) Nasal Spray bottle to the carton for dispensing to the patient.

Mfd. for QOL Medical, LLC

Kirland, WA 98033, USA

1.866.469.3773

www.Vitrace-FM (Vitrace-FM).com

3078 Rev. 02/06

FDA rev date: 9/15/2006

See also:
What is the most important information I should know about Vitrace-FM?

You should not use this medication if you are allergic to cobalt, or if you have Leber's disease. Vitrace-FM can lead to optic nerve damage (and possibly blindness) in people with Leber's disease.

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. Use all of your medications as directed.

Avoid eating or drinking hot foods or liquids within 1 hour before or after using the nasal form of this medication.

Tell your doctor if you develop nasal congestion, a cold, or allergies. The nasal spray may not work as well if you are congested.

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.

Use Vitrace-FM (b12) spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Vitrace-FM (b12) spray. Talk to your pharmacist if you have questions about this information.
• Vitrace-FM (b12) spray is used in the nose.
• Follow the directions provided by your doctor or other health care provider. If you are unsure how to use Vitrace-FM (b12) spray, contact your doctor or other health care provider.
• Do not use Vitrace-FM (b12) spray within 1 hour before or after eating or drinking hot foods or liquids.
• Prime the pump before the first use. Place the nozzle between the first and second finger with the thumb on the bottom. Point the nozzle away from yourself and others. Pump the unit firmly and quickly until the medicine sprays out, then spray two more times.
• Re-prime the pump before each dose. Point the nozzle away from yourself and others, then spray once.
• Use Vitrace-FM (b12) spray in only 1 nostril each week.
• To use Vitrace-FM (b12) spray, sit down and tilt your head back slightly. Place the tip of the spray container into the nose. Using a finger from your other hand, press against the opposite nostril to close it off. Breath gently through the open nostril and spray a dose of medicine from the container. After using the medicine, rinse the tip of the spray unit in hot water and dry with a clean tissue to prevent contamination.
• Vitrace-FM (b12) spray is usually used 1 time per week. Do not use it more often than 1 time per week without checking with your doctor.
• This bottle contains 8 doses. Do not continue to use this bottle after 8 doses have been used. It may not give the correct amount of medicine.
• Continue to use Vitrace-FM (b12) spray even if you feel well. Do not miss any doses.
• If you miss a dose of Vitrace-FM (b12) spray, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Vitrace-FM (b12) spray.

How to use Vitrace-FM nasal

See also:
What other drugs will affect Vitrace-FM?

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: drugs that affect the bone marrow (such as chloramphenicol), vitamins/supplements that contain intrinsic factor.

Certain medications can decrease the absorption of vitamin B12, including: colchicine, metformin, extended-release potassium products, antibiotics (such as gentamicin, neomycin, tobramycin), anti-seizure medications (such as phenobarbital, phenytoin, primidone), medications to treat heartburn (such as H2 blockers including cimetidine/famotidine, proton pump inhibitors such as omeprazole/lansoprazole).

Vitamin B12 is an ingredient found in many combination vitamin and nutritional products. Tell your doctor or pharmacist if you are taking other products that contain Vitrace-FM, vitamin B12, or hydroxocobalamin.

Vitrace-FM may interfere with certain laboratory tests (including intrinsic factor, blood tests for other types of anemia), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Certain drugs may interfere with laboratory tests for vitamin B12 levels, possibly causing false results. Tell laboratory personnel and all your doctors if you take any of the following: antibiotics (such as amoxicillin, erythromycin), methotrexate, pyrimethamine.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

See also:
What are the possible side effects of Vitrace-FM?

The incidence of adverse experiences described in the Table below are based on data from a short-term clinical trial in vitamin B12 deficient patients in hematologic remission receiving Vitrace-FM (Vitrace-FM, USP) Gel for Intranasal Administration (N=24) and intramuscular vitamin B12 (N=25). In the pharmacokinetic study comparing Vitrace-FM Nasal Spray and Vitrace-FM Nasal Gel, the incidence of adverse events was similar.

The intensity of the reported adverse experiences following the administration of Vitrace-FM (Vitrace-FM, USP) Gel for Intranasal Administration and intramuscular vitamin B12 were generally mild. One patient reported severe headache following intramuscular dosing. Similarly, a few adverse experiences of moderate intensity were reported following intramuscular dosing (two headaches and rhinitis; one dyspepsia, arthritis, and dizziness), and dosing with Vitrace-FM (Vitrace-FM, USP) Gel for Intranasal Administration (one headache, infection, and paresthesia).

The majority of the reported adverse experiences following dosing with Vitrace-FM (Vitrace-FM, USP) Gel for Intranasal Administration and intramuscular vitamin B12 were judged to be intercurrent events. For the other reported adverse experiences, the relationship to study drug was judged as "possible" or "remote". Of the adverse experiences judged to be of "possible" relationship to the study drug, anxiety, incoordination, and nervousness were reported following intramuscular vitamin B12 and headache, nausea, and rhinitis were reported following dosing with Vitrace-FM (Vitrace-FM, USP) Gel for Intranasal Administration.

The following adverse reactions have been reported with parenteral vitamin B12:

Generalized: Anaphylactic shock and death.

Cardiovascular: Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis.

Hematological: Polycythemia vera.

Gastrointestinal: Mild transient diarrhea.

Dermatological: Itching; transitory exanthema.

Miscellaneous: Feeling of swelling of the entire body.