Addressing elevated homocysteine related diseases & conditions : Pamlab L.L.C.
Product Resources
Foltx® Prescribing Information
FOLTX® Tablets
A medical food for the dietary management of hyperhomocysteinemia.
Description
Each round coated beige colored tablet contains:
| Active Ingredients | |
|---|---|
| Folacin (Folic Acid) | 2.5 mg |
| Pyridoxine (B6) | 25 mg |
| Cyanocobalamin (B12) | 2 mg |
| Inactive Ingredients: |
|---|
| Dibasic Calcium Phosphate Dihydrate, Microcrystalline Cellulose, Opadry II Beige 40L174427 (Titanium Dioxide, Polydextrose, Hypromellose 3cP, Hypromellose 6cP, Triacetin, Hypromellose 50cP, Polyethylene Glycol 8000, FD&C Yellow #6-Lake, FD&C Blue #2-Lake, FD&C Red #40-Lake), Crospovidone, Croscarmellose Sodium, Magnesium Stearate (Vegetable Source), Opadry II Clear #Y-19-7483 (Hypromellose 6cP, Maltodextrin, Hypromellose 3cP, PEG 400, Hypromellose 50cP). |
FOLTX® tablets do not contain sugar, lactose, or dye.
Indication and Usage
FOLTX® tablets are indicated for the distinct nutritional requirements of individuals under a physician's treatment for hyperhomocysteinemia; with particular emphasis for individuals with or at risk for atherosclerotic vascular disease in the coronary1, peripheral2, or cerebral3 vessels, or vitamin B12 deficiency4
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 occur while neurological manifestations remain progressive. The 2 mgs of cyanocobalamin contained in FOLTX® has been shown to provide an adequate amount of cyanocobalamin to address this precaution5. Unmetabolized folic acid has been shown in one study of 105 postmenopausal women (50-75yrs) to have the potential to reduce natural killer cells' cytotoxicity, which may result in an impaired immune response6
Adverse Reactions
Allergic sensitization has been reported following both oral and parenteral administration of folacin (folic acid). Paresthesia, somnolence, nausea and headaches 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.
Contraindications
Known hypersensitivity to any of the components in the product is a contraindication.
Drug Interactions
Pyridoxine supplements should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine. However, pyridoxine 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.
Patient Information
FOLTX® tablets are a medical food, for use only under the direction and supervision of a licensed physician.
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 beige colored tablet. Debossed with "PAL" on one side and "♥" (heart outline) on the other. Supplied in bottles of 90 tablets.
Store at controlled room temperature between 15°-30° C (59°-86° F) (See USP). Protect from light and moisture. Dispense in original light-resistant container with child-resistant closure.
NDC# 00525-0906-90
RX ONLY
Some or all of the following patents may apply:
U.S. Patent No. 4,940,658 U.S. Patent No. 6,207,651 U.S. Patent No. 5,563,126 U.S. Patent No. 6,297,224 U.S. Patent No. 5,795,873 U.S. Patent No. 6,528,496
and other pending patent applications.
References
1, 2: Eilelboom JW, Lonna Eva, Genest Jr Jaques, Hankey Graeme, Yusuf Salim: Homocysteine and Cardiovascular Disease: A Critical Review of the Epidemiologic Evidence. Ann Intern Me. 1999; 131:363-375.
3: The Homocysteine Studies Collaboration: Homocysteine and Risk of Ischemic Heart Disease and Stroke. JAMA 2002; Vol 288, No. 16:2015-2002.
4: RefsumHelga, Smith A. David, Ueland Per M, Nexo Ebba, Clarke Robert, McPartlin Joseph, Johnston Carole, Engbaek Frode, Scheede Jorn, McPartlin Catherime, and Scott John M.: Facts and Recommendations about Total Homocysteine Determinations: An Expert Opinion. Clinical Chemistry 2004; 50:1 3-32.
5: Kuzminski AM, Del Giacco EJ, Allen RH, et al: Effective Treatment Of Cobalamin Deficiency With Oral Cobalamin. Blood 1998; 92:1191-1198.
6: Troen AM, Mitchell B, Sorensen B, Wener MH, Johnston A, Wood B Selhub J, McTierman A, Yasui Y, Oral E, Potter JD, and Ulich CM: Unmetabloized Folic "Acid in Plasma is Asssociated with Reduced Natural Killer Cell Cytoxicity among Postmenopausal Women." Journal of Nutrition 2006 Jan; 136(1): 189-194.
Manufactured for:
PAMLAB, L.L.C. Covington, LA 70433
PC0013-03
Revised 03/07
- Metanx®: The active, natural occurring B-vitamins in Metanx® are directly associated with metabolizing homocysteine, a risk factor for vascular disease, and improving the overall health of the blood vessels.
- Diatx®Zn is a medical food indicated for the distinct nutritional requirements of patients under a physician's treatment for hyperhomocysteinemia with particular emphasis for those individuals diagnosed with chronic kidney disease (CKD), end stage renal disease (ESRD) or dialysis.