Triveen-PRx

TRIGEN Laboratories, Inc.

Triveen™-PRx RNF Capsules

FULL PRESCRIBING INFORMATION: CONTENTS*

• TRIVEEN-PRX DESCRIPTION
  • Inactive Ingredients
• INDICATIONS
• TRIVEEN-PRX CONTRAINDICATIONS
• WARNINGS
• CAUTION
• PRECAUTIONS
  • General
  • PATIENT INFORMATION
  • INTERACTIONS
• TRIVEEN-PRX ADVERSE REACTIONS
• TRIVEEN-PRX DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
  • STORAGE
• PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

R_x Only

TRIVEEN-PRX DESCRIPTION

Triveen™-PRx RNF is a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish oil-based DHA. Triveen™-PRx RNF is supplied as an oblong, maroon softgel capsule with "T558" imprinted on one side.

Inactive Ingredients

Gelatin, Glycerin, Soybean Oil, Purified water, Lecithin, Yellow Beeswax, Natural Creamy Orange Flavor, FD&C Red #40, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #6, FD&C Blue #1.

INDICATIONS

Triveen™-PRx RNF is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

TRIVEEN-PRX CONTRAINDICATIONS

Triveen™-PRx RNF capsules is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

WARNINGS

Daily ingestion of more than 3 g per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids – including DHA, should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.

This product contains soybean oil and fish oil.

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

PRECAUTIONS

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 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

Triveen™-PRx RNF 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 level 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.

TRIVEEN-PRX 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.

TRIVEEN-PRX DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, one softgel capsule daily or as directed by a physician.

HOW SUPPLIED

Bottles of 30 softgel capsules.

NDC 13811-558-30

Bottles of 60 softgel capsules.

NDC 13811-558-60

STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature].

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

KEEP THIS AND ALL DRUGS OUT OF THE 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 equivalence.

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

Rev. 08/11

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 13811-558-30
R_x Only

Triveen™-PRx
RNF
Capsules

30 CAPSULES

TRIGEN
LABORATORIES