Zatean-Pn Plus

TRIGEN Laboratories, Inc.

Zatean™-Pn Plus Softgels

FULL PRESCRIBING INFORMATION: CONTENTS*

• ZATEAN-PN PLUS DESCRIPTION
• ZATEAN-PN PLUS INDICATIONS AND USAGE
• ZATEAN-PN PLUS CONTRAINDICATIONS
• WARNING
• CAUTION
• PRECAUTIONS
  • General
• PATIENT INFORMATION
• INTERACTIONS
• ZATEAN-PN PLUS ADVERSE REACTIONS
• ZATEAN-PN PLUS DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

FULL PRESCRIBING INFORMATION

Rx Only

ZATEAN-PN PLUS DESCRIPTION

Zatean™ - Pn Plus is a prescription prenatal/postnatal multivitamin/ mineral softgel with an essential fatty acid. Each softgel capsule is oblong, green and imprinted with "T582" in white ink.

Supplement Facts Servings per Bottle: 30
Serving Size: 1 Softgel Capsule Each Softgel Capsule contains	%DV for Pregnant and Lactating Women
Folate (L-methylfolate, or 6(S)-5-MTHF 600 mcg) folic acid, USP 400 mcg)	1 mg	125%
Vitamin C	85 mg	142%
Vitamin D3	200 IU	50%
Vitamin E	10 IU	33%
Vitamin B6	25 mg	1000%
Vitamin B12	12 mcg	150%
Biotin	250 mcg	83%
Calcium (calcium carbonate)	140 mg	11%
Iron (ferrous fumarate)	28 mg	156%
Iodine (potassium iodide)	150 mcg	100%
Magnesium (magnesium oxide)	45 mg	10%
Docosahexaenoic Acid (DHA)	300 mg from at least 340 mg omega-3s derived from at least 390 mg purified fish oils.	Daily value not established. THIS PRODUCT CONTAINS SOY AND FISH OIL.
Eicosapentaenoic Acid (EPA)	40 mg Daily Value not established	Certified Organic

Inactive Ingredients: Caramel, Citric Acid, Ethyl Vanillin, FD&C Blue # 1, FD&C Yellow # 5, Gelatin, Glycerin, Lecithin, Natural Creamy Orange Flavor, Purified Water, Sorbitol, Titanium Dioxide, Tripotassium Citrate, Yellow Bees Wax.

ZATEAN-PN PLUS INDICATIONS AND USAGE

Zatean™ - Pn Plus is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

ZATEAN-PN PLUS CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.

WARNING

Daily ingestion of more than 3 grams 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 SOY 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

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

Zatean™ - Pn Plus 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.

ZATEAN-PN PLUS 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.

ZATEAN-PN PLUS DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Zatean™ - Pn Plus is dispensed in bottles of 30 softgels.

PRODUCT CODE 13811-582-30

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 - 30 Softgel Bottle Label

13811-582-30
R_x Only

Zatean™-Pn
Plus
Softgels

30 SOFTGELS

TRIGEN
LABORATORIES