Vol-Care Rx

TRIGEN Laboratories, Inc.

Vol-Care Rx Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• VOL-CARE RX DESCRIPTION
• VOL-CARE RX INDICATIONS AND USAGE
• VOL-CARE RX CONTRAINDICATIONS
• PRECAUTIONS
  • General
  • PATIENT INFORMATION
• INTERACTIONS
• VOL-CARE RX ADVERSE REACTIONS
• VOL-CARE RX DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

FULL PRESCRIBING INFORMATION

VOL-CARE RX DESCRIPTION

Vol-Care Rx is an orally administered prescription vitamin for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation. Vol-Care Rx is an oval, yellow tablet with "TL515" debossed on one side.

Inactive Ingredients: Microcrystalline Cellulose, Pregelatinized Starch, DiCalcium Phosphate, Polyvinyl Alcohol, Silicified Microcrystalline Cellulose, Tripotassium Citrate, Citric Acid, Titanium Dioxide, Croscarmellose Sodium, Stearic Acid, Polyethylene Glycol, Talc, FD&C Yellow #5 Lake.

VOL-CARE RX INDICATIONS AND USAGE

Vol-Care Rx is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

VOL-CARE RX CONTRAINDICATIONS

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

PRECAUTIONS

General

Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of 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). Reduced folates may be less likely than folic acid to mask vitamin B₁₂ deficiency. Folate therapy alone is inadequate for the treatment of B₁₂ deficiency.

PATIENT INFORMATION

Vol-Care Rx is a prescription vitamin for use only under the direction and supervision of a licensed physician.

INTERACTIONS

Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

Drugs which may interact with folate include:

• Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, 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 levels of this AED in the blood and allowing breakthrough seizures to occur.
• 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.
• 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.
• Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
• 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.

VOL-CARE RX ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates, including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.

VOL-CARE RX DOSAGE AND ADMINISTRATION

Before, during, and or after pregnancy, one tablet daily or as prescribed by a physician.

HOW SUPPLIED

Vol-Care Rx is supplied in bottles of 100 tablets.

PRODUCT CODE 13811-515-10

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature]. Dispense in child-resistant containers. Dispense in tight, light-resistant container as defined by the USP.

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

KEEP OUT OF REACH OF CHILDREN

Rx Only

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com

Rev. 02/13

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

13811-515-10
R_x Only

Vol-Care Rx

Tablets

100 TABLETS

TRIGEN
LABORATORIES