A medical food for the dietary management of hyperhomocysteinemia, homocystinuria, or nutrient malabsorption.

DESCRIPTION

Each round coated peach colored tablet contains:

Active Ingredients:

Folacin (Folic Acid) ............................................. 2.5 mg

Pyridoxine (B6) ...................................................  25 mg

Cyanocobalamin (B12) ........................................    2 mg

Inactive Ingredients:
Dibasic Calcium Phosphate, Microcrystalline Cellulose, Opadry II Flesh # Y-22-13577, Croscamellose Sodium, Crospovidone, Magnesium Stearate, Hydroxypropyl Methylcellulose.


FOLTX  tablets do not conatin sugar, lactose, or dye.

INDICATIONS AND USAGE

FOLTX  tablets are indicated for the distinct nutritional requirements of individuals under physician's treatment for hyperhomocysteinemia, homocystinuria, or nutrient malabsorption; with particular emphasis for individuals with or at risk for: cardiovascular disease, cerebrovascular disease, peripheral vascular disease, atherosclerotic vascular disease, neurological disorders, renal disease, and vitamin B12 deficiency.

CONTRAINDICATIONS

Known hypersensitivity to any of the components in the product is a contraindication.

PRECAUTIONS

Folacin (folic acid) when administered as a single agent in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occure while neurological manifestations remain progressive.  The 2mgs of cyanocobalamin contained in FOLTX  has been shown to provide an adequate amount of cyanocobalamin to address this precaution. 

PATIENT INFORMATION

FOLTX  tablets are a medical food, for use only under the direction and supervision of a licensed physician.

DRUG INTERACTIONS

Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine.  However, pyrodoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.  Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folacin (folic acid).  Paresthesia and somnolence have been reported with pyridoxine.  Mild transient diarrhea, polycythemia vera, itching transitory exanthema, and the feeling of swelling of the entire body has been associated with cyanocobalamin.

DOSAGE AND ADMINISTRATION

Usual adult dose is one to two tablets daily or as directed by a physician.

HOW SUPPLIED

Available as a round coated peach colored tablet.  Debossed with "PAL" on one side and a (heart shape) on the other. 

Supplied in bottles of 30      NDC 54868-5096-0
Supplied in bottles of 90      NDC 54868-5096-2

STORAGE

Store at controlled room temperature 15°C to 30°C (59°F to 86°F) (See USP).

Protect from light and moisture.

Dispense in original light-resistant container with child-resistant closure.

Rx ONLY

Some or all of the following patents may apply:

U.S. Patent No. 4,940,658
U.S. Patent No. 5,563,126
U.S. Patent No. 5,795,873
U.S. Patent No. 6,207,651
U.S. Patent No. 6,297,224
U.S. Patent No. 6,528,496
and other pending patent applications.

Manufactured for:
PAMLAB, L.L.C.
Covington, LA  70433

1  Kuzminski AM, Del Giacco EJ, Allen RH, et al.: Effective Treatment of Cobalamin Deficiency With Oral Cobalamin.
Blood 1998; 92:1191-1198
#6795             Rev. 05/04

Distributed and Repackaged by:
Physicians Total Care, Inc.
Tulsa, Oklahoma       74146

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