Diatx®Zn Package Insert
Diatx®Zn Tablets
A medical food for the dietary management of hyperhomocysteinemia.
Description
Each round, coated, yellow colored tablet contains:
Diatx®Zn tablets
| Dietary Ingredients: | |
|---|---|
| Folacin (Folic Acid) | 5mg |
| Thiamine (B1) | 1.5mg |
| Riboflavin (B2) | 1.5mg |
| Niacinamide (B3) | 20mg |
| Pantothenic acid (B5) | 10mg |
| Pyridoxine (B6) | 50mg |
| Cyanocobalamin (B12) | 2mg |
| Ascorbic Acid (Vitamin C) | 60mg |
| D-biotin | 300mcg |
| Zinc (as Zinc Oxide) | 25mg |
| Copper (as Copper Gluconate) | 1.5mg |
Other Ingredients:
Microcrystalline Cellulose, Dicalcium Phosphate, Mono- and Di-glycerides, Sodium Starch Glycolate, Opadry II Yellow (Titanium Dioxide, Polydextrose, Hypromellose, Triacetin, Polyethylene Glycol 8000, Yellow 5 Lake, Yellow
6 Lake, Blue 2 Lake), Opadry II Clear (Hypromellose, Maltodextrin, Polyethylene Glycol 400), Calcium Stearate, Silicon Dioxide, Hypermellose, and Carnauba Wax.
Diatx®Zn tablets do not contain sugar, lactose, yeast, or gluten.
Indication and Usage
Diatx®Zn tablets are 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 disease1, 2 (CKD), end stage renal disease3 (ESRD), or dialysis4.
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 2mg of cyanocobalamin contained in Diatx®Zn has been shown to provide an adequate amount of cyanocobalamin to address this precaution5. A safe upper limit of 100mg per day has been established for the unsupervised medical use of pyridoxine. Consider all sources of pyridoxine supplementation when prescribing Diatx®Zn.
Adverse Reactions
Allergic sensitization has been reported following both oral and parenteral administration of 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 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
Diatx®Zn 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 tablet daily or as directed by a physician. For dialysis patients, Diatx®Zn should be taken after dialysis treatment.
How Supplied
Available as a round, coated, yellow colored tablet. Debossed with "PAL" on one side and "D" on the other. Commercial product is supplied in bottles of 90 tablets. Sample product is supplied in a carton containing five blisters with one tablet in each blister.
Storage
Diatx®Zn bottle
Store both commercial and sample Diatx®Zn at controlled room temperature between 15°-30° C (59°-86° F)(See USP). Protect from light and moisture. Dispense commercial product in original light-resistant container with child-resistant closure. Dispense sample product in original blister.
Commercial Product (90 tablets)
PRO-0035
0525-4281-90
Rx Only
Sample Product (5 tablets)
PRO-0034
0525-4281-05
Professional Samples - Not for sale.
Patents
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.
References
1. Ninomiya T, Kiyohara Y, Kubo M, Tanizaki Y, Tanaka K, Okubo K, Nakamura H, Hata J, Oishi Y, Kato I, Hirakata H, and Iida M: Hyperhomocysteinemia and the Development of Chronic Kidney Disease in a General Population: The Hisayama Study. American Journal of Kidney Diseases 2004; Vol 44, NO 3:437-445.
2. Frances ME, Eggers PW, Hostetter TH, and Briggs JP: Association between serum homocysteine and markers of impaired kidney function in adults in the United States. Kidney International 2004; Vol 66:303-312.
3. Stanford JL, Molina H, Phillips J, Kohlman-Trigoboff D, Moore J, and Smith BM: Oral folate reduces plasma homocyst(e)ine levels in hemodialysis patients with cardiovascular disease. Cardiovascular Surgery 2000; Vol 8, NO 7:567-571.
4. Mallamaci F, Zoccali C, Tripepi G, Fermo I, Benedetto FA, Cataliotti A, Bellanuova I, Malatino LS, and Soldarini A: Hyperhomocysteinemia predicts cardiovascular outcomes in hemodialysis patients. Kidney International 2002; Vol 61:609-614.
5. Kuzminski AM, Del Giacco EJ, Allen RH, etal: Effective Treatment Of Cobalamin Deficiency With Oral Cobalamin. Blood 1998; 92:1191-1198.
Manufactured for
PAMLAB, L.L.C. Covington, LA 70433
Rev. 06/06
DiatxZn.com © 2008