VP-ZEL Tabs

Azelaic acid is an organic compound with the formula (CH2)7(CO2H)2 [or also as C9H16O4], and has CAS number 123-99-9. It is in the dicarboxylic acid (saturated) group, and is occurs naturally in wheat, rye, and barley.

DESCRIPTION: VP-ZEL Tabs is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels and nutritional supplementation.

VP-ZEL Tabs should be administered under the supervision of a licensed medical practitioner.

Each coated, purple colored, oval-shaped tablet contains the following dietary ingredients:

DOSAGE AND ADMINISTRATION: Usual adult dose is one or two tablets taken once or twice a day with or without food or as prescribed by a licensed medical practitioner.

Prescription Dietary Supplement

Rx

Made in USA

STORAGE: Store at Controlled Room Temperature 15(0)-30(0)C (59(0)-86(0)F). [See USP]. Protect from light and moisture.

Dispense in a tight, light-resistant container.

If you are pregnant or nursing a baby, please ask a health professional.

KEEP THIS OUT OF REACH OF CHILDREN.

This is not an Orange Book product.

Call your licensed medical practitioner about side effects.

NDC+: 76439-221-60 +See insert for more information about National Drug Codes (NDC).

Rev. 09/12

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

PATIENT INFORMATION: VP-ZEL Tabs is a prescription dietary supplement to be used only under licensed medical supervision.

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 polymorphorisms 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 forms* 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).

INDICATIONS AND USAGE: 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.

WARNINGS: Caution is recommended in patients with a history of bipolar illness.

*These products are dietary supplements that - due to increased folate levels (AUG 3 1973 FR 20750), require an Rx on the label because of increased risk associated with masking of B12 deficiency. As such this product requires licensed medical supervision, an Rx status, and a national drug code (NDC) as required by pedigree reporting requirements.

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.

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.

HOW SUPPLIED: 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.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

V Virtus PHARMACEUTICALS

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.

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.