Taron Bc Prenatal

TRIGEN Laboratories, Inc.

Taron Bc

FULL PRESCRIBING INFORMATION: CONTENTS*

• TARON BC PRENATAL DESCRIPTION
• INDICATIONS
• TARON BC PRENATAL CONTRAINDICATIONS
• PRECAUTION
  • General:
  • PATIENT INFORMATION
  • INTERACTIONS
• TARON BC PRENATAL ADVERSE REACTIONS
• TARON BC PRENATAL DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - 30 TABLETS/60 B TABLETS Label

FULL PRESCRIBING INFORMATION

TARON BC PRENATAL DESCRIPTION

Taron ^TM -Bc is a prescription prenatal multivitamin/mineral tablet with a high level of B₆, along with two vitamin B₆ tablets. Taron^TM-Bc multivitamin/mineral prenatal tablets are white-coated, oval tablets with “T569” debossed on one side. Taron™-Bc vitamin B₆ tablets are white, round tablets debossed “B6” on one side.

Inactive Ingredients (Prenatal tablet):Microcrystalline Cellulose, TriPotassium Citrate, Hypromellose, Citric Acid, Acacia, Titanium Dioxide, Povidone K30, Polyvinyl Alcohol, Croscarmellose Sodium, Polyethylene Glycol, Magnesium Stearate, Stearic Acid, Talc, Fumed Silica.

Inactive Ingredients (B6 tablet):Microcrystalline Cellulose, Di Cal Phosphate, Silicon Dioxide, Stearic Acid, Ethyl Vanillin.

INDICATIONS

Taron ^TM Bc is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers. Taron ^TM-Bc may be used in conjunction with a physician prescribed regimen to help minimize pregnancy related nausea and vomiting.

TARON BC PRENATAL CONTRAINDICATIONS

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

PRECAUTION

General:

Folic acid, 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 hematologic 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. Folates therapy alone is inadequate for the treatment of B₁₂ deficiency.

PATIENT INFORMATION

Taron^TM 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 occured 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.

TARON BC PRENATAL 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.

TARON BC PRENATAL DOSAGE AND ADMINISTRATION

Three (3) tablets per day: One (1) tablet every eight hours beginning with the multivitamin (white-coated, oval tablet debossed with “T569”) followed by the vitamin B₆ tablets (white, round tablets debossed with “B6”).

HOW SUPPLIED

Taron^TM is supplied in child-resistant 6 blister cards. Each card contains 5 doses of one (1) multivitamin/mineral tablet asnd two (2) vitamin B₆ tablets.

PRODUCT CODE 13811-569-30

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature]. Contact with moisture can discolor or erode tablets.

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

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

R_x 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 equivalences.

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

Rev. 06/13

PRINCIPAL DISPLAY PANEL - 30 TABLETS/60 B TABLETS Label

13811-569-30
R_x Only

Taron^TM - Bc
Tablets

30 TABLETS/60 B₆ TABLETS

TRIGEN
LABORATORIES