POTASSIUM CITRATE EXTENDED RELEASE: 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.

15 REFERENCES

1. Pak, C. (1987). Citrate and Renal Calculi. Mineral and Electrolyte Metabolism 13 , 257-266.

2. Pak, C. (1985). Long-Term Treatment of Calcium Nephrolithiasis with Potassium Citrate. The Journal of Urology 134 , 11-19.

3. Preminger, G.M., K. Sakhaee, C. Skurla and C.Y.C. Pak. (1985). Prevention of Recurrent Calcium Stone Formation with Potassium Citrate therapy in Patients with Distal Renal Tubular Acidosis. The Journal of Urology 134 , 20-23.

4. Pak, C.Y.C., K. Sakhaee and C. Fuller. (1986). Successful Management of Uric Acid Nephrolithiasis with Potassium Citrate. Kidney International 30 , 422-428.

5. Hollander-Rodriguez, J et al. (2006). Hyperkalemia, American Family Physician , Vol.73/No. 2.

6. Greenberg, A et al. (1998). Hyperkalemia: treatment options. Semen Nephrol. Jan; 18 (1): 46-57.

16 HOW SUPPLIED/STORAGE AND HANDLING

Potassium citrate extended-release tablets USP 5 mEq are uncoated, pale yellow colored, round shaped, bi-Convex, debossed with ‘S406’ on one side and plain on the other side, supplied in bottles as:

NDC 42543-406-01 Bottle of 100 tablets

Potassium citrate extended-release tablets USP 10 mEq are uncoated, pale yellow colored, caplet shaped, bi-Convex, debossed with ‘S407’ on one side and plain on the other side, supplied in bottles as:

NDC 42543-407-01 Bottle of 100 tablets

Potassium citrate extended-release tablets USP 15 mEq are uncoated, pale yellow colored, caplet shaped, bi-Convex, debossed with ‘S408’ on one side and plain on the other side, supplied in bottles as:

NDC 42543-408-01 Bottle of 100 tablets

Storage: Store in a tight container at 20°–25°C (68°–77°F), Excursions permitted between 15° and 30°C (59° and 86°F) [See USP controlled room temperature].

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.

Manufactured by:

Strides Pharma Science Ltd.

Puducherry – 605014, India

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised: 01/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label — Principle Display Panel — 100 — Count Bottle, 5 mEq (540 mg)Tablets

NDC 42543-406 -01

100 Tablets

Potassium Citrate Extended-Release Tablets, USP

5 mEq (540 mg)per tablet

Rx only

Strides Pharma Inc.

Package Label — Principle Display Panel — 100 — Count Bottle, 10 mEq (1080 mg)Tablets

NDC 42543-407 -01

100 Tablets

Potassium Citrate Extended-Release Tablets, USP

10 mEq (1080 mg)per tablet

Rx only

Strides Pharma Inc.

Package Label — Principle Display Panel — 100 — Count Bottle, 15 mEq (1620 mg)Tablets

NDC 42543-408 -01

100 Tablets

Potassium Citrate Extended-Release Tablets, USP

15 mEq (1620 mg)per tablet

Rx only

Strides Pharma Inc.

POTASSIUM CITRATE EXTENDED RELEASE potassium citrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42543-406 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM CITRATE (ANHYDROUS CITRIC ACID) POTASSIUM CITRATE 5 meq

Inactive Ingredients Ingredient Name Strength CARNAUBA WAX STEARIC ACID MAGNESIUM STEARATE

Product Characteristics Color YELLOW (PALE YELLOW) Score no score Shape ROUND (ROUND SHAPED) Size 10mm Flavor Imprint Code S;406 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42543-406-01 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206813 11/01/2017

POTASSIUM CITRATE EXTENDED RELEASE potassium citrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42543-407 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM CITRATE (ANHYDROUS CITRIC ACID) POTASSIUM CITRATE 10 meq

Inactive Ingredients Ingredient Name Strength CARNAUBA WAX STEARIC ACID MAGNESIUM STEARATE

Product Characteristics Color YELLOW (PALE YELLOW) Score no score Shape CAPSULE (CAPLET SHAPED) Size 19mm Flavor Imprint Code S;407 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42543-407-01 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206813 11/01/2017

POTASSIUM CITRATE EXTENDED RELEASE potassium citrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42543-408 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM CITRATE (ANHYDROUS CITRIC ACID) POTASSIUM CITRATE 15 meq

Inactive Ingredients Ingredient Name Strength CARNAUBA WAX STEARIC ACID MAGNESIUM STEARATE

Product Characteristics Color YELLOW (PALE YELLOW) Score no score Shape CAPSULE (CAPLET SHAPED) Size 22mm Flavor Imprint Code S;408 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42543-408-01 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206813 11/01/2017

Labeler — Strides Pharma Inc. (078310501)

Establishment
Name	Address	ID/FEI	Operations
Strides Pharma Science Limited		871402375	ANALYSIS (42543-406), ANALYSIS (42543-407), ANALYSIS (42543-408), MANUFACTURE (42543-406), MANUFACTURE (42543-407), MANUFACTURE (42543-408), PACK (42543-406), PACK (42543-407), PACK (42543-408)

Revised: 01/2022 Strides Pharma Inc.