PRODUCT OVERVIEW

Key Facts:    Prelief is AkPharma's brand name for calcium glycerophosphate which has a number of important uses. These fields include:

Urinary :    As a palliative in interstitial cystitis, prostatitis, overactive bladder.

Intestinal :    As a symptoms reducer in irritable bowel syndrome.

Prelief is taken in periodic dosages, regardless of meals or foods eaten. Clinical studies demonstrate that such use greatly reduces urinary pain and urgency in overactive bladder. Prelief is also used beneficially in terms of pain and urgency with interstitial cystitis and prostatitis. A pilot clinical study suggests beneficial use by persons with diarrhea-predominant irritable bowel syndrome (IBS) and a clinical study to confirm this is nearing completion. Clinical studies are also underway to confirm cellular effects in interstitial cystitis.

Safety Information:    Prelief is made from an FDA Generally Recognized as Safe (GRAS) 1 mineral and is also listed in the Food Chemicals Codex (FCC). 2

PRODUCT INFORMATION

Description:

Prelief Tablets :   Each tablet contains 345 mg calcium glycerophosphate (65 mg of elemental calcium). The tablets also contain 0.25% magnesium stearate as a processing aid. Two tablets are equivalent to 690 mg calcium glycerophosphate (130mg of elemental calcium).

Prelief Powder :   Each ¼ teaspoon usage of powder is comparable to two tablets. The powder dissolves rapidly in food or non-alcoholic beverages. Tablets are recommended for taking with alcoholic beverages.

Two tablets or about ¼ teaspoon of powder provides 15% (130 mg) of the FDA Recommended Daily Intake (RDI) for calcium and 10% (100 mg) of the FDA RDI for phosphorus. No sodium; no aluminum; no sugar; no potassium.

Reasons for Use:    Prelief is used as an intervention in certain identifiable urinary and intestinal problems such as interstitial cystitis, prostatitis, overactive bladder and irritable bowel syndrome.

Action:    Through a mechanism not fully elucidated, Prelief appears to reduce cellular inflammation in the urinary bladder. It also appears to non-irritatively encourage cellular reproduction. This is possibly a result of Prelief's uniquely free calcium ion and/or the glycerophosphate moiety, working singly or together. In addition, Prelief neutralizes the acid found in a large number of foods which many people find cause them discomfort.

Usage:

Tablets:   2-3 tablets, 2 times a day.

Powder:   ¼ teaspoon of powder 2 times a day. More can be used when needed.

Kosher:    Prelief is Kosher and Parve.

How Supplied:

Tablets:   60, 120 and 300-tablet bottles.

Powder:   Portable 20-use (correspondent to 40 tablets) squeeze bottle and 150-serving shaker.

Use Limitations:    None, except as may apply below.

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.

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Adverse Reactions:    None known.

Toxicity:    None known.

Interactions with Drugs:    Calcium may interfere with the availability of some antibiotics. Check with drug publications.

Precautions:    None, except for people who have been advised by their physician not to take calcium, phosphorus or glycerin/glycerol.


1 21 CFR §184.1201
2 Food Chemicals Codex, 4th Edition, pp 60-61

For more information, please write or call toll-free 1-800-994-4711.

AkPharma Inc.

P.O. Box 111

Pleasantville, NJ 08232-0111

2004-2005© AkPharma Inc. All rights reserved.



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