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VP-GGR-B6

Generic Name: pyridoxine hydrochloride, folic acid, calcium phosphate, dibasic, anhydrous, tricalcium phosphate and ginger
Dosage Form: tablet

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.

VP-GGR-B6
Tablets

Product Code: 76439-233-60

Rx

PRENATAL
Prescription Folate

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:

*
Ginger root powder extract is concentrated. Equivalent to 500 mg ginger root powder.
Vitamin B6 (pyridoxine HCl) 40 mg
Folic Acid 1.2 mg
Calcium (as dicalcium phosphate and tricalcium phosphate) 124.1 mg
Ginger (zingiber officinale) root powder extract 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:

 
Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription.

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).

1
It is not known whether or not l-methylfolate can obscure pernicious anemia above 0.1 mg doses, so caution is advised also with this form of folate.

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:

  • Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate.
  • Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin and other anticonvulsants.
  • Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
  • Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
  • Colestipol: Reduces folic acid absorption and reduces serum folate levels.
  • Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
  • Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
  • Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
  • Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.
  • L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels.
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs):
  • NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments.
  • NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.
  • Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
  • Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
  • Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts, such as pancreatin and pancrelipase.
  • Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
  • Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine.
  • Smoking and Alcohol: Reduced serum folate levels have been noted.
  • Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
  • Metformin treatment in patients with type 2 diabetes decreases serum folate.
  • Warfarin can produce significant impairment in folate status after a 6-month therapy.
  • Heme-iron: Can compete for transport and reduce folate absorption. Ensure adequate medical supervision to ensure proper iron levels.
  • Folinic acid may enhance the toxicity of fluorouracil.
  • Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate.
  • Caution should be exercised with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.

** 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:

  • Vitamin B6 should not be given to patients receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
  • Isoniazid can produce a vitamin B6 deficiency.

Drugs which interact with calcium:

  • Calcium may interfere with the absorption of iron. Consult your healthcare practitioner for advice.
  • Calcium may interfere with blood pressure medications in certain situations. Consult your healthcare practitioner for advice.

PREGNANCY and NURSING MOTHERS: VP-GGR-B6 is intended for use as a prescription PRENATAL folate during pregnancy.

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

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

76439-233-60

VP-GGR-B6

PRENATAL

Prescription Folate

Rx
60 Tablets

VP-GGR-B6 
pyridoxine hydrochloride, folic acid, calcium phosphate, dibasic, anhydrous, tricalcium phosphate and ginger tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-233
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 40 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1.2 mg
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 62.05 mg
TRICALCIUM PHOSPHATE (CALCIUM CATION) CALCIUM CATION 62.05 mg
GINGER (GINGER) GINGER 100 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA  
CITRIC ACID MONOHYDRATE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
FD&C RED NO. 40  
HYPROMELLOSES  
POLYETHYLENE GLYCOLS  
POLYVINYL ALCOHOL  
TALC  
TITANIUM DIOXIDE  
POVIDONES  
STEARIC ACID  
POTASSIUM CITRATE ANHYDROUS  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 12mm
Flavor Imprint Code V233
Contains         
Packaging
# Item Code Package Description
1 NDC:76439-233-60 60 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/13/2013
Labeler - Virtus Pharmaceuticals (969483143)
Establishment
Name Address ID/FEI Operations
Viva Pharmaceutical Inc. 253288898 MANUFACTURE(76439-233)
Revised: 06/2014
 
Virtus Pharmaceuticals



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