potassium citrate 10 MEQ Extended Release Oral Tablet

1 INDICATIONS AND USAGE Potassium citrate extended-release tablet is a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium stones (1.1) Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2) Uric acid lithiasis with or without calcium stones (1.3) 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)]. 1.3 Uric Acid Lithiasis with or without Calcium Stones Potassium citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)].

Zydus Pharmaceuticals (USA) Inc.

FDA Reported Adverse Reactions
`[1] fatigue` `[2] drug ineffective` `[3] pain` `[4] off label use` `[5] nausea` `[6] arthralgia` `[7] toxicity to various agents` `[8] rheumatoid arthritis` `[9] rash` `[10] headache`

4 years ago

OVAL YELLOW 537

16 HOW SUPPLIED/STORAGE AND HANDLING

POTASSIUM CITRATE Extended-release Tablets USP, 5 mEq are tan to yellowish color, round shaped, biconvex uncoated tablets debossed with "536" on one side and plain on the other side and are supplied as follows: NDC 68382-536-06 in bottle of 30 tablets with child-resistant closure NDC 68382-536-16 in bottle of 90 tablets with child-resistant closure NDC 68382-536-01 in bottle of 100 tablets with child-resistant closure NDC 68382-536-05 in bottle of 500 tablets NDC 68382-536-10 in bottle of 1,000 tablets NDC 68382-536-30 in unit-dose blister cartons of 100 (10×10) unit dose tablets

POTASSIUM CITRATE Extended-release Tablets USP, 10 mEq are tan to yellowish color, oval shaped, biconvex uncoated tablets debossed with "537" on one side and plain on the other side and are supplied as follows: NDC 68382-537-06 in bottle of 30 tablets with child-resistant closure NDC 68382-537-16 in bottle of 90 tablets with child-resistant closure NDC 68382-537-01 in bottle of 100 tablets with child-resistant closure NDC 68382-537-05 in bottle of 500 tablets NDC 68382-537-10 in bottle of 1,000 tablets NDC 68382-537-30 in unit-dose blister cartons of 100 (10×10) unit dose tablets

POTASSIUM CITRATE Extended-release Tablets USP, 15 mEq are tan to yellowish color, oblong shaped, biconvex uncoated tablets debossed with "538" on one side and plain on the other side and are supplied as follows: NDC 68382-538-06 in bottle of 30 tablets with child-resistant closure NDC 68382-538-16 in bottle of 90 tablets with child-resistant closure NDC 68382-538-01 in bottle of 100 tablets with child-resistant closure NDC 68382-538-05 in bottle of 500 tablets NDC 68382-538-10 in bottle of 1,000 tablets NDC 68382-538-30 in unit-dose blister cartons of 100 (10×10) unit dose tablets Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.

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