Trigels-F Forte

TRIGEN Laboratories, Inc.

Trigels-F Forte

FULL PRESCRIBING INFORMATION: CONTENTS*

• TRIGELS-F FORTE DESCRIPTION
  • Inactive Ingredients
• TRIGELS-F FORTE INDICATIONS AND USAGE
• TRIGELS-F FORTE CONTRAINDICATIONS
• PRECAUTIONS
  • General
• PATIENT INFORMATION
• INTERACTIONS
• TRIGELS-F FORTE ADVERSE REACTIONS
• TRIGELS-F FORTE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - 100 Softgel Blister Pack Carton

FULL PRESCRIBING INFORMATION

TRIGELS-F FORTE DESCRIPTION

Trigels-F Forte is an orally administered vitamin for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

Inactive Ingredients

Soybean Oil, Gelatin, Glycerin, Purified Water, Yellow Beeswax, Lecithin, Ethyl Vanillin, Titanium Dioxide, FD&C Red #40, FD&C Yellow #5, FD&C Blue #1.

TRIGELS-F FORTE INDICATIONS AND USAGE

Trigels-F Forte is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

TRIGELS-F FORTE CONTRAINDICATIONS

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

THIS PRODUCT CONTAINS SOYBEAN OIL.

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

Trigels-F Forte is a prescription vitamin for use only under the direction and supervision of a licensed physician.

INTERACTIONS

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.

TRIGELS-F FORTE 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. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanococobalamin.

TRIGELS-F FORTE DOSAGE AND ADMINISTRATION

One softgel daily or as directed by a physician.

HOW SUPPLIED

Trigels-F Forte is supplied as an oblong, brown softgel, imprinted with "TL518". Trigels-F Forte is available in child-resistant blister packs of 100 softgels.

PRODUCT CODE 13811-518-10

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 side effects by calling 888 9 TRIGEN (888-987-4436).

KEEP OUT OF REACH OF CHILDREN

R_x Only

All prescriptions using this product shall be persuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician's supervision. There are no implied or explicit claims on therapeutic equivalence.

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

Rev. 05/13

PRINCIPAL DISPLAY PANEL - 100 Softgel Blister Pack Carton

13811-518-10
R_x Only

Trigels-F
Forte

Softgels

100 SOFTGELS

TRIGEN
LABORATORIES