VP-GSTN

Virtus Pharmaceuticals

VP-GSTN Capsules

FULL PRESCRIBING INFORMATION: CONTENTS*

• VP-GSTN DESCRIPTION
• VP-GSTN INDICATIONS AND USAGE
• VP-GSTN CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • PATIENT INFORMATION
  • DRUG INTERACTIONS
• VP-GSTN ADVERSE REACTIONS
• VP-GSTN DOSAGE AND ADMINISTRATION
• STORAGE
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 60 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

Bottle (60 ct.)
Medical Food

VP-GSTN DESCRIPTION

VP-GSTN is an orally administered medical food dispensed by prescription specifically formulated for the dietary management of individuals with unique nutritional needs, and are in need of supplementation as determined by a licensed medical practitioner.

VP-GSTN may be dispensed by prescription, and should be administered only under the supervision of a licensed medical practitioner.

Each OBLONG, WHITE-colored capsule contains the following dietary ingredients:

Other Ingredients: Dicalcium Malate, Fumed Silica, Magnesium Oxide, Magnesium Stearate, Microcrystalline Cellulose, Black Ink (Black Iron Oxide, FD&C Blue #1 Lake, FD&C Blue #2 Lake, FD&C Red #40 Lake, D&C Yellow #10 Lake, Shellac Glaze), Capsule (Gelatin, Purified Water, and Titanium Dioxide).

This product contains soy.

VP-GSTN INDICATIONS AND USAGE

VP-GSTN is indicated for the distinctive nutritional requirements of individuals in need of dietary supplementation as determined by a licensed medical practitioner.

VP-GSTN should be administered only under the supervision of a licensed medical practitioner.

VP-GSTN CONTRAINDICATIONS

VP-GSTN is contraindicated in individuals with a known hypersensitivity to any of the ingredients.

VP-GSTN is contraindicated in pregnant and lactating women. Women capable of becoming pregnant should use appropriate contraception when taking VP-GSTN.

VP-GSTN is also contraindicated in patients with a history of breast cancer and/or cancer affecting the reproductive organs. Caution is advised among women who have first degree female relatives with a history of cancer of the breast and/or reproductive organs (see Warnings).

WARNINGS

This product contains genistein. Animal studies of genistein suggest that genistein may produce developmental abnormalities of the male and female genital tract if consumed during pregnancy. This product is contraindicated in pregnant and lactating women (see Contraindications).

Caution is advised among women who have first degree female relatives with a history of cancer of the breast and/or reproductive organs.

PRECAUTIONS

This product contains 4 mg of elemental zinc per capsule. Zinc is considered acutely toxic at 200 mg of elemental zinc per day (the equivalent of 50 VP-GSTN capsules per day). Patients on long-term zinc supplementation should be monitored for zinc and copper status. Consult your healthcare practitioner before taking any other products that may contain zinc as zinc toxicity (and an associated induced copper deficiency) can occur.

This product contains cholecalciferol (vitamin D₃). Patients prone to hypercalcemia and/or hypercalciuria should consult their licensed medical practitioner before taking any products with vitamin D. Regular monitoring of urine and serum calcium may be indicated in this population.

VP-GSTN is not intended for use as a general multivitamin/mineral supplement or as a supplement to treat a specific vitamin deficiency. Consult your healthcare practitioner to ensure adequate supplementation of calcium, vitamin D, and other vitamins/minerals.

VP-GSTN has not been studied or tested for its effect on bone in human males.

VP-GSTN has not been studied or tested in pediatric patients.

PATIENT INFORMATION

VP-GSTN is a medical food to be used only under licensed medical supervision.

DRUG INTERACTIONS

Drugs which may interact with vitamin D₃:

• Certain thiazide diuretics, such as hydrochlorothiazide, as well as antacids, bile acid sequestrants (such as cholestyramine), mineral oil, orlistat, olestra, cimetidine, and anticonvulsant medications may reduce the absorption or increase the catabolism of vitamin D.
• Vitamin D supplementation should not be given with calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

Drugs which may interact with zinc:

• Concomitant administration of zinc supplements and certain antibiotics, specifically tetracyclines and quinolones, may decrease absorption of the antibiotic and potentially reduce its efficacy.
• Iron may reduce zinc absorption.

VP-GSTN ADVERSE REACTIONS

Gastrointestinal symptoms, including abdominal pain and epigastric pain, dyspepsia, vomiting and constipation have been reported in a study with genistein.

VP-GSTN DOSAGE AND ADMINISTRATION

One capsule twice daily, approximately 12 hours apart, or as directed by a licensed medical practitioner. VP-GSTN may be taken with or without food. If gastrointestinal upset occurs, taking VP-GSTN with food may reduce or eliminate these symptoms. There are no postural limitations.

VP-GSTN is contraindicated in pregnant and/or lactating women. Women capable of becoming pregnant should use appropriate contraception when taking VP-GSTN.

VP-GSTN is also contraindicated in patients with a history of breast cancer and/or cancer affecting the reproductive organs. Please see Contraindications and Warnings for more information.

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-GSTN is supplied as oblong, white-colored capsules imprinted with "V222", dispensed in bottles of 60 capsules.

76439-222-60

This product is marketed as a medical food to indicate administration by a licensed medical practitioner. As such, this product requires licensed medical supervision.

Call your medical practitioner about side effects. You may report side effects by calling (813) 283-1344.

KEEP THIS OUT OF REACH OF CHILDREN.

Dispense by Prescription

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

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619

Made in Canada
Rev. 3/2012

PRINCIPAL DISPLAY PANEL - 60 Capsule Bottle Label

VIRTUS
PHARMACEUTICALS

76439-222-60
VP-GSTN

Medical Food

Dispense by Prescription
60 Capsules