VP-GGR-B6- pyridoxine hydrochloride, folic acid, calcium phosphate, dibasic, anhydrous, tricalcium phosphate and ginger tablet
Virtus Pharmaceuticals
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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DESCRIPTION: VP-GGR-B6 is an orally administered PRENATAL prescription folate specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels.
VP-GGR-B6 should be administered under the supervision of a licensed medical practitioner.
Each round, pink tablet contains the following dietary ingredients:
|
|
Vitamin B6 (pyridoxine HCl) |
40 mg |
Folic Acid |
1.2 mg |
Calcium (as dicalcium phosphate and tricalcium phosphate) |
124.1 mg |
|
100 mg* |
Other Ingredients: Acacia, Citric Acid, Magnesium Stearate, Microcrystalline Cellulose, Pink Coating (FD&C Red#40 Lake, Hydroxypropylmethyl Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Talc, Titanium Dioxide), Polyvinylpyrrolidone, Silicified Microcrystalline Cellulose, Stearic Acid, and TriPotassium Citrate
Since colors, flavors of natural origin vary from batch to batch in consistency - it may be necessary to substitute excipients as needed to ensure the highest therapeutic target, safety and quality.
Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.
FOLATE REGULATION: The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, l-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate.
Individuals with genetic polymorphisms for the genes coding methylenetetrahydrofolate reductase (MTHFR) may not be capable of utilizing or metabolizing folic acid adequately for the vitamin B12 dependent methylation cycle.
Folic acid, including reduced forms1 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision of a licensed medical practitioner.
The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern while establishing that increased folate was proper therapy in megaloblastic anemias - specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that:
Folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345).
INDICATIONS AND USAGE: VP-GGR-B6 is indicated for the distinct nutritional requirements of patients in need of PRENATAL dietary supplementation as determined by a licensed medical practitioner.
VP-GGR-B6 should be administered under the supervision of a licensed medical practitioner.
CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNINGS: VP-GGR-B6 contains ginger. Ginger may increase the risk of bleeding in certain situations. Individuals with bleeding disorders and/or those receiving anti-coagulant therapy or anti-platelet therapy should ask their licensed medical practitioner before using this product. In addition, those individuals undergoing surgery should seek advice of their medical practitioner.
Individuals with cardiac conditions, gallstones, diabetes and/or hypoglycemia should consult their medical practitioner before taking this product.
See product ingredients. Please consult your healthcare practitioner or pharmacist for more information.
PRECAUTIONS: General: Folate, when administered as a single agent in doses about 0.1 mg daily, may obscure the detection of vitamin B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Folate therapy alone is inadequate for treatment of a vitamin B12 deficiency.
PATIENT INFORMATION: VP-GGR-B6 is a PRENATAL prescription folate to be used only under licensed medical supervision.
DRUG INTERACTIONS: Drugs which may interact with folate** include:
** Folate is a broad term that includes folic acid and all reduced forms including l-methylfolate and folinic acid. VP-GGR-B6 does not contain l-methylfolate or folinic acid but these warnings are included as general folate information.
Drugs which interact with vitamin B6:
Drugs which interact with calcium:
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate. Paresthesia, somnolence, nausea and headaches have been reported with vitamin B6. Gas, bloating, heartburn, and nausea have been associated with ginger, but normally with high doses.
DOSAGE AND ADMINISTRATION: One or two tablets daily, in divided doses, or as directed by a licensed medical practitioner.
STORAGE: Store at Controlled Room Temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.
HOW SUPPLIED: VP-GGR-B6 is supplied as round, pink tablets debossed on one side with “V233”, dispensed in bottles of 60 tablets.
Product Code: 76439-233-60
*This product is a PRENATAL prescription folate that contains folate in an amount higher than 0.1 mg, and has an increased risk associated with masking of vitamin B12 deficiency and must be administered under a physician’s supervision (AUG 3 1973 FR 20750).
This product requires licensed medical supervision, and an Rx status, as required by pedigree reporting requirements.
KEEP THIS OUT OF REACH OF CHILDREN.
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Call your medical practitioner about side effects. You may report side effects by calling (813) 283-1344.
Rx
Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619
MADE IN CANADA
Rev. 5/2012
VIRTUS
PHARMACEUTICALS
VP-GGR-B6
pyridoxine hydrochloride, folic acid, calcium phosphate, dibasic, anhydrous, tricalcium phosphate and ginger tablet |
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Labeler - Virtus Pharmaceuticals (969483143) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Viva Pharmaceutical Inc. | 253288898 | MANUFACTURE(76439-233) |