The once-a-day prescription formula to support overall prostate health in patients 35 and older.

Udamin^™ - caplets: Detailed Product Information

Description

Clinical Pharmacology/ Discussion*

UDAMIN^™ is a prescription only dietary supplement intended for oral administration. Each caplet contains ingredients from the following classes: vitamins, micronutrients, minerals, and cartinoids. This product’s unique formulation is designed to help support a healthy prostate and a healthy cardiovascular system.

Indications*

UDAMIN^™ is indicated for patients of advancing age, improper food intake and/or poor dietary habits that may need additional supplementation of key vitamins, minerals and micronutrients.

Contraindications

UDAMIN^™ is contraindicated in patients with a known hypersensitivity to any of its ingredients.

Warnings

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

Precautions

General

Folic acids in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 500mcg of Vitamin B12 (as cyanocobalamin) contained in each caplet of UDAMIN^™ should address this precaution.

Adverse Reactions

Allergic sensitization has been reported following both oral and parental administration of folic acid. Paresthesia, somnolence have been reported with pyridoxine HCl.

Drug Interactions

Pyridoxine daily can decrease the efficacy of levodopa in the treatment of Parkinsonism. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness.

Information for Patients

Because toxic reactions have been reported with injudicious use of certain vitamins and minerals, patients should be instructed to follow physician's dosage regimen.

Dosage and Administration

Adults: One caplet daily or as directed by a physician. UDAMIN^™ is not recommended for children.

How supplied

Light yellow film-coated, capsule-shaped tablet-supplied in bottles of 100. Debossed with “PE220.” Store at controlled room temperature between 59°-86° F (15° - 30° C).

Manufactured for:
ProEthic Pharmaceuticals, LLC.
Montgomery, AL
36116

Protected by U.S. Patent #7,022,350 and other patents pending.

Revised 4/04

NDC#: 66869-220-10

Rx Only

References

1. Helzlsouer KJ, Huang H, Alberg AJ et al, Association between alpha-tocopherol, gamma-tocopherol, selenium, and subsequent prostate cancer. J Natl Cancer Inst 92: 2018-2023, 2000.

2. Moyad MA, Brumfield SK, Pienta KJ, Vitamin E, alpha- and gamma-tocopherol, and prostate cancer. Seminars in Urologic Oncol 17(2):85-90, 1999.

3. Kline, E.A. et al, The Selenium and Vitamin E Cancer Prevention Trial. World J Urology 21: 21-27, 2003.

4. L.C. Clark, B. Dalkin, et al, Decreased incidence of prostate cancer with selenium supplementation: results of a double-blind cancer prevention trial. British Journal of Urology 81: 730-734, 1998.

5. DePrimo, Samuel E., Shinghal, Rajesh, et al, Prostate Cancer. Hematology/oncology Clinics of North America 15: Number 3, 2001.

6. Omer Kucuk, Faziul H. Sarkar, et al, Phase II Randomized Clinical Trial of Lycopene Supplementation before Radical Prostatectomy. Cancer Epidemiology, Biomarkers & Prevention 10: 861-868, 2001.

7. Lederle FA. Oral cobalamin for pernicious anemia: Medicine's best kept secret? JAMA 265: 94-95, 1991.

* The Food and Drug Administration has not evaluated these statements. This product is not intended to diagnose, treat, cure, or prevent any disease.