Potassium-cit: Package Insert and Label Information (Page 2 of 2)
14.3 Uric Acid Lithiasis with or without Calcium Stones
A long-term non-randomized, non-placebo controlled clinical trial with eighteen adult patients with uric acid lithiasis participated in the study. Six patients formed only uric acid stones, and the remaining 12 patients formed mixed stones containing both uric acid and calcium salts or formed both uric acid stones (without calcium salts) and calcium stones (without uric acid) on separate occasions.
Eleven of the 18 patients received potassium citrate alone. Six of the 7 other patients also received allopurinol for hyperuricemia with gouty arthritis, symptomatic hyperuricemia, or hyperuricosuria. One patient also received hydrochlorothiazide because of unclassified hypercalciuria. The main inclusion criterion was a history of stone passage or surgical removal of stones during the 3 years prior to initiation of potassium citrate therapy. All patients received potassium citrate at a dosage of 30-80 mEq/day in three-to-four divided doses and were followed every four months for up to 5 years.
While on potassium citrate treatment, urinary pH rose significantly from a low value of 5.3 ± 0.3 to within normal limits (6.2 to 6.5). Urinary citrate which was low before treatment rose to the high normal range and only one stone was formed in the entire group of 18 patients.
16 HOW SUPPLIED/STORAGE AND HANDLING
Potassium Citrate Extended-release Tablets USP, 10 mEq tablets are uncoated, tan to yellowish speckled in color, elliptical shaped, with E35 debossed on one side and plain on the other side, supplied in bottles as:
NDC: 70518-3328-00
PACKAGING: 100 in 1 BOTTLE PLASTIC
Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store in a tight container.
Unit-of-use package. Dispense in this container without repackaging.
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
17 PATIENT COUNSELING INFORMATION
17.1 Administration of Drug
Tell patients to take each dose without crushing, chewing or sucking the tablet.
Tell patients to take this medicine only as directed. This is especially important if the patient is also taking both diuretics and digitalis preparations.
Tell patients to check with the doctor if there is trouble swallowing tablets or if the tablet seems to stick in the throat.
Tell patients to check with the doctor at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.
Tell patients that their doctor will perform regular blood tests and electrocardiograms to ensure safety.
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
DRUG: Potassium-cit
GENERIC: potassium-cit
DOSAGE: TABLET, EXTENDED RELEASE
ADMINSTRATION: ORAL
NDC: 70518-3328-0
COLOR: yellow
SHAPE: OVAL
SCORE: No score
SIZE: 19 mm
IMPRINT: E35
PACKAGING: 100 in 1 BOTTLE, PLASTIC
ACTIVE INGREDIENT(S):
- POTASSIUM CITRATE 10meq in 1
INACTIVE INGREDIENT(S):
- MAGNESIUM STEARATE
- CARNAUBA WAX
| POTASSIUM-CIT potassium-cit tablet, extended release | ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| Labeler — REMEDYREPACK INC. (829572556) |
Revised: 01/2022 REMEDYREPACK INC.
DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.