Zatean-CH

calcium citrate, iron, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium and doconexent

Dosage Form: capsule
Zatean™-CH

Softgel Capsule

Rx Only

Zatean-CH Description

Zatean™-CH is an orally administered prenatal prescription vitamin. Zatean™-CH is a purple, oblong soft gelatin capsule imprinted with "T583".

Each capsule contains the following Ingredients:
* Folates– including reduced folates, are variant forms of Vitamin B9, or Folic Acid. † Derived from at least 281.7 mg omega-3s from at least 396.8 mg purified fish oil.
Calcium (Calcium citrate)	100 mg
Iron (Carbonyl iron)	27 mg
Vitamin D3 (Cholecalciferol)	400 IU
Vitamin E (dl-alpha tocopheryl acetate)	30 IU
Vitamin B6 (Pyridoxine HCl)	25 mg
Folate*	1 mg
Docusate Sodium	50 mg
Docosahexaenoic Acid (DHA)	250 mg†

Inactive Ingredients

Lecithin, Soybean Oil, Yellow Beeswax, Natural Creamy Orange Flavor, Gelatin, Glycerin, Titanium Dioxide, FD&C Red #40, FD&C Blue #1, Ethyl Vanillin, Purified Water, and other trace excipients.

INDICATIONS

Zatean™-CH 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.

Contraindications

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

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.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

This product contains fish oil and soy products.

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™-CH is a prescription prenatal vitamin for use only under medical supervision and direction.

INTERACTIONS

Drugs which may interact with folate include

• First generation anticonvulsants: High dose folic acid may result in decreased serum levels for first generation anticonvulsants (carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate). This may possibly reduce the effectiveness of first generation anticonvulsants and/or increase the frequency of seizures in susceptible patients. Caution should be used when prescribing folates among patients who are receiving treatment with first generation anticonvulsants.


• Second-generation anticonvulsants: Information on the effect of second-generation anticonvulsants (including, but not limited to, lamotrigine) on folate levels is limited and cannot be ruled out.


• 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.


• Colchicine: Colchicine may decrease folate plasma levels.


• L-dopa: L-dopa may decrease folate plasma 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. Caution should be exercised when using folate with folate antagonists. Patients, typically, should not be given folate simultaneously with a folate antagonist, for the purpose of reducing or preventing clinical toxicity, as the therapeutic effect of the antagonist may be nullified.


• 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, including, but not limited to pancreatin and pancrelipase: 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.


• Folate may enhance the toxicity of fluorouracil.


• Concurrent administration of chloramphenicol and folate in folate-deficient patients may result in antagonism of the haematopoietic response to folate.


• Caution should be exercised with the concomitant use of folate and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.

Drugs which may interact with pyridoxine hydrochloride include

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.

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.

Zatean-CH Dosage and Administration

One capsule daily or as directed by a physician.

How is Zatean-CH Supplied

Zatean™-CH is supplied in bottles of 30 capsules each.

NDC 13811-583-30

STORAGE

Store at controlled room temperature 15°-30°C (59°-86°F). [See USP]. Contact with moisture can discolor or erode the capsule.

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

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

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.

Rx Only

Manufactured For:

TRIGEN Laboratories, Inc., Sayreville, NJ 08872

www.trigenlab.com

MADE IN CANADA

Rev. 10/10

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 13811-583-30

Rx Only

Zatean™-CH

Softgel Capsule

30 CAPSULES

TRIGEN

LABORATORIES

Zatean-CH  calcium citrate, iron, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13811-583 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calcium Citrate (Calcium Cation) Calcium Citrate 100 mg Iron (Iron) Iron 27 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU] .Alpha.-Tocopherol Acetate, DL- (.Alpha.-Tocopherol Acetate, DL-) .Alpha.-Tocopherol Acetate, DL- 30 [iU] Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg Folic Acid (Folic Acid) Folic Acid 1 mg Docusate Sodium (Docusate) Docusate Sodium 50 mg Doconexent (Doconexent) Doconexent 250 mg

Inactive Ingredients Ingredient Name Strength Soybean Oil   Yellow Wax   Gelatin   Glycerin   Titanium Dioxide   FD&C Red No. 40   FD&C Blue No. 1   Ethyl Vanillin   Water

Product Characteristics Color PURPLE Score no score Shape CAPSULE (oblong) Size 25mm Flavor ORANGE (Creamy Orange) Imprint Code T583 Contains

Packaging # NDC Package Description Multilevel Packaging 1 13811-583-30 30 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		11/01/2010

Labeler - TRIGEN Laboratories, Inc. (830479668)

Revised: 09/2011TRIGEN Laboratories, Inc.

More Zatean-CH resources

• Zatean-CH Side Effects (in more detail)
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• Zatean-CH Support Group
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