UROCIT-K Tablet (2021)
Βιβλιογραφική αναφορά
Συγγραφείς
Mission Pharmacal Company
Λέξεις κλειδιά
0178-0610 0178-0600 0178-0615
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1. Indications and Usage
1.1 Renal tubular acidosis (RTA) with calcium stones Potassium citrate is indicated for the management of renal tubular acidosis <em>[see Clinical Studies (14.1)]</em>. 1.2 Hypocitraturic calcium oxalate ...
2. Dosage and Administration
2.1 Dosing Instructions Treatment with extended release potassium citrate should be added to a regimen that limits salt intake (avoidance of foods with high salt content and of added salt at the table) ...
3. Dosage Forms and Strengths
5 mEq tablets are uncoated, tan to yellowish in color, modified ball shaped, with MPC 600 debossed on one side and blank on the other 10 mEq tablets are uncoated, tan to yellowish in color, elliptical ...
4. Contraindications
Urocit-K is contraindicated: In patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such ...
5. Warnings and Precautions
5.1 Hyperkalemia In patients with impaired mechanisms for excreting potassium, Urocit-K administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and ...
6.1. Postmarketing Experience
Some patients may develop minor gastrointestinal complaints during Urocit-K therapy, such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These symptoms are due to the irritation ...
7. Drug Interactions
7.1 Potential Effects of Potassium citrate on Other Drugs Potassium-sparing Diuretics Concomitant administration of Urocit-K and a potassium-sparing diuretic (such as triamterene, spironolactone or amiloride) ...
8.1. Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted. It is also not known whether Urocit-K can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ...
8.3. Nursing Mothers
The normal potassium ion content of human milk is about 13 mEq/L. It is not known if Urocit-K has an effect on this content. Urocit-K should be given to a woman who is breastfeeding only if clearly needed. ...
8.4. Pediatric Use
Safety and effectiveness in children have not been established.
10. Overdosage
Treatment of Overdosage The administration of potassium salts to persons without predisposing conditions for hyperkalemia rarely causes serious hyperkalemia at recommended dosages. It is important to recognize ...
11. Description
Urocit-K is a citrate salt of potassium. Its empirical formula is K<sub>3</sub>C<sub>6</sub>H<sub>5</sub>O<sub>7</sub>•H<sub>2</sub>O, and it has the following chemical structure: Urocit-K yellowish to ...
12.1. Mechanism of Action
When Urocit-K is given orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance ...
14. Clinical Studies
The pivotal Urocit-K trials were non-randomized and non-placebo controlled where dietary management may have changed coincidentally with pharmacological treatment. Therefore, the results as presented in ...
15. References
Pak, C. (1987). Citrate and Renal Calculi. <em>Mineral and Electrolyte Metabolism</em> 13, 257-266. Pak, C. (1985). Long-Term Treatment of Calcium Nephrolithiasis with Potassium Citrate. <em>The Journal ...
16.1. How Supplied
Urocit-K 5 mEq tablets are uncoated, tan to yellowish in color, modified ball shaped, with MPC 600 debossed on one side and blank on the other, supplied in bottles as: NDC 0178-0600-01 Bottle of 100NDC ...
16.2. Storage and Handling
Store in a tight container.
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 ...