VP-ZEL tablets

VP-ZEL Tabs is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. VP-ZEL Tabs should be administered under the supervision of a licensed medical practitioner.

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-ZEL Tabs is a prescription dietary supplement 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.

Drugs which may interact with nicotinamide:

• The clearance of primidone and carbamazepine may be reduced with the concomitant use of nicotinamide.

Drugs which may interact with zinc oxide:

• The absorption of quinolones or tetracycline may be decreased with the concomitant use of zinc.

Drugs which may interact with cupric oxide:

• Concomitant use of penicillamine and copper can cause decreased absorption of both substances.

PREGNANCY and NURSING MOTHERS

VP-ZEL Tabs is not intended for use as a prenatal/ postnatal multivitamin for lactating and nonlactating mothers. Talk with your medical practitioner before using if pregnant or lactating.

Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate.

Usual adult dose is one or two tablets taken once or twice a day with or without food or as directed by a licensed medical practitioner.

VP-ZEL Tabs tablets are coated, purple colored, oval-shaped tablets debossed on one side with "V221", and are supplied in bottles of 60 tablets.

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.

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 licensed medical practitioner about side effects.

You may report side effects by calling 813-283-1344.

NDC2: 76439-221-60

VP-ZEL Tabs
Tablets
60ct Bottle
Rx
Prescription Dietary Supplement

Manufactured for:
Virtus Pharmaceuticals
Tampa, FL 33619
MADE IN USA

Rev. 12/11