Potassium Citrate (Urocit-K)

Trade Name : UROCIT-K

Mission Pharmacal Company

TABLET, EXTENDED RELEASE

Strength 5 meq/1

POTASSIUM CITRATE Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Potassium Citrate (Urocit-K) which is also known as UROCIT-K and Manufactured by Mission Pharmacal Company. It is available in strength of 5 meq/1 per ml. Read more

Potassium Citrate (Urocit-K) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Urocitn n n n n n n n n n n n -K is a citrate salt of potassium indicated for the management of:n nn n nn n nn n nn
  • Renal tubular acidosis (RTA) with calcium stones (n n n n n n n n n n n n )n n n n n n n n n n n n
  • Hypocitraturic calcium oxalate nephrolithiasis of any etiology (n n n n n n n n n n n n )n n n n n n n n n n n n
  • Uric acid lithiasis with or without calcium stones (n n n n n n n n n n n n )n n n n n n n n n n n n
  • Objective: To restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 to 7.0.
  • Severe hypocitraturia (urinary citrate < 150 mg/day): therapy should be initiated at 60 mEq per day; a dose of 30 mEq two times per day or 20 mEq three times per day with meals or within 30 minutes after meals or bedtime snack (n n n n n n n n n n n n )n n n n n n n n n n n n
  • Mild to moderate hypocitraturia (urinary citrate >150 mg/day): therapy should be initi-ated at 30 mEq per day; a dose of 15 mEq two times per day or 10 mEq three times -per day with meals or within 30 minutes after meals or bedtime snack (n n n n n n n n n n n n )n n n n n n n n n n n n
  • Tablets: 5 mEq, 10 mEq and 15 mEq (3)
  • Urocitn n n n n n n n n n n n -K is contraindicated:n nn n nn n nn n nn
  • Patients with hyperkalemia (or who have conditions predisposing them to hyperkalemia). Such conditions include chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown (n n n n n n n n n n n n )n n n n n n n n n n n n
  • Patients for whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture (n n n n n n n n n n n n )n n n n n n n n n n n n
  • Patients with peptic ulcer disease (n n n n n n n n n n n n )n n n n n n n n n n n n
  • Patients with active urinary tract infection (n n n n n n n n n n n n )n n n n n n n n n n n n
  • Patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min) (n n n n n n n n n n n n )n n n n n n n n n n n n
  • No data
  • Hyperkalemia: In patients with impaired mechanisms for excreting potassium, Urocitn n n n n n n n n n n n -K administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Urocitn n n n n n n n n n n n -K in patients with chronic renal failure, or any other condition which impairs potassium excretion such as severe myocardial damage or heart failure, should be avoided (n n n n n n n n n n n n )n n n n n n n n n n n n
  • Gastrointestinal lesions: if there is severe vomiting, abdominal pain or gastrointestinal bleeding, Urocitn n n n n n n n n n n n -K should be discontinued immediately and the possibility of bowel perforation or obstruction investigated (n n n n n n n n n n n n )n n n n n n n n n n n n
  • Some patients may develop minor gastrointestinal complaints during Urocitn n n n n n n n n n n n -K therapy, such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These symptoms are due to the irritation of the gastrointestinal tract, and may be alleviated by taking the dose with meals or snacks, or by reducing the dosage. Patients may find intact matrices in their feces.n nn n nn n nn n nn
  • Some patients may develop minor gastrointestinal complaints such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These may be alleviated by taking the dose with meals or snacks or by reducing the dosage (n n n n n n n n n n n n )n nn n nn n nn n nn
  • The following drug interactions may occur with potassium citrate:
  • Potassium-sparing diuretics: concomitant administration should be avoided since the simultaneous administration of these agents can produce severe hyperkalemia (n n n n n n n n n n n n )n n n n n n n n n n n n
  • Drugs that slow gastrointestinal transit time: These agents (such as anticholinergics) can be expected to increase the gastrointestinal irritation produced by potassium salts (n n n n n n n n n n n n )n n n n n n n n n n n n
  • No data
  • Pregnant women: Pregnancy Category C; animal reproduction studies have not been conducted. It is not known whether Urocit n -K can cause fetal harm when administered -to a pregnant woman or can affect reproduction capacity. Urocit n -K should be given to a pregnant woman only if clearly needed ( n )n
  • Nursing mothers: The normal potassium ion content of human milk is about 13 mEq/L. It is not known if Urocit n -K has an effect on this content. Urocit n -K should be given to a woman who is breast feeding only if clearly needed ( n )n
  • Pediatric Use: Safety and effectiveness in children have not been established ( n )n
  • Treatment of Overdosage:
  • Treatment measures for hyperkalemia include the following:
  • Lowering potassium levels too rapidly in patients taking digitalis can produce digitalis toxicity.
  • Urocitn n n n n n n n n n n n -K is a citrate salt of potassium. Its empirical formula is Kn n n n n n n n n n n n Cn n n n n n n n n n n n Hn n n n n n n n n n n n On n n n n n n n n n n n u2022 Hn n n n n n n n n n n n O, and it has the following chemical structure:n nn n nn n nn n nn
  • Urocitn -K yellowish to tan, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate and 15 mEq (1620 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate.n Urocitn n n n n n n n n n n n -K yellowish to tan, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate and 15 mEq (1620 mg) potassium citrate each. Inactive ingredients include carnauba wax and magnesium stearate.n nn n nn n nn n nn
  • When Urocitn n n n n n n n n n n n -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 without measurably altering ultrafilterable serum citrate. Thus, Urocitn n n n n n n n n n n n -K therapy appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate. The increased filtered load of citrate may play some role, however, as in small comparisons of oral citrate and oral bicarbonate, citrate had a greater effect on urinary citrate.n nn n nn n nn n nn
  • In addition to raising urinary pH and citrate, Urocitn n n n n n n n n n n n -K increases urinary potassium by approximately the amount contained in the medication. In some patients, Urocitn n n n n n n n n n n n -K causes a transient reduction in urinary calcium.n nn n nn n nn n nn
  • The changes induced by Urocitn n n n n n n n n n n n -K produce urine that is less conducive to the crystallization of stone-forming salts (calcium oxalate, calcium phosphate and uric acid). Increased citrate in the urine, by complexing with calcium, decreases calcium ion activity and thus the saturation of calcium oxalate. Citrate also inhibits the spontaneous nucleation of calcium oxalate and calcium phosphate (brushite).n nn n nn n nn n nn
  • The increase in urinary pH also decreases calcium ion activity by increasing calcium complexation to dissociated anions. The rise in urinary pH also increases the ionization of uric acid to the more soluble urate ion.
  • Urocitn n n n n n n n n n n n -K therapy does not alter the urinary saturation of calcium phosphate, since the effect of increased citrate complexation of calcium is opposed by the rise in pH-dependent dissociation of phosphate. Calcium phosphate stones are more stable in alkaline urine.n nn n nn n nn n nn
  • In the setting of normal renal function, the rise in urinary citrate following a single dose begins by the first hour and lasts for 12 hours. With multiple doses the rise in citrate excretion reaches its peak by the third day and averts the normally wide circadian fluctuation in urinary citrate, thus maintaining urinary citrate at a higher, more constant level throughout the day. When the treatment is withdrawn, urinary citrate begins to decline toward the pre-treatment level on the first day.
  • The rise in citrate excretion is directly dependent on the Urocitn n n n n n n n n n n n -K dosage. Following long-term treatment, Urocitn n n n n n n n n n n n -K at a dosage of 60 mEq/day raises urinary citrate by approximately 400 mg/day and increases urinary pH by approximately 0.7 units.n nn n nn n nn n nn
  • In patients with severe renal tubular acidosis or chronic diarrheal syndrome where urinary citrate may be very low (<100 mg/day), Urocitn n n n n n n n n n n n -K may be relatively ineffective in raising urinary citrate. A higher dose of Urocitn n n n n n n n n n n n -K may therefore be required to produce a satisfactory citraturic response. In patients with renal tubular acidosis in whom urinary pH may be high, Urocitn n n n n n n n n n n n -K produces a relatively small rise in urinary pH.n nn n nn n nn n nn
  • The pivotal Urocitn n n n n n n n n n n n -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 the following sections may overstate the effectiveness of the product.n nn n nn n nn n nn
  • No data
  • Urocitn n n n n n n n n n n n -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:n nn n nn n nn n nn
  • NDC 0178-0600-01u00a0u00a0u00a0u00a0 Bottle of 100NDC 0178-0600-01u00a0u00a0u00a0u00a0 Bottle of 100
  • Urocitn -K 10 mEq tablets are uncoated, tan to yellowish in color, elliptical shaped, with MPC 610 debossed on one side and MISSION on the other, supplied in bottles as:n Urocitn n n n n n n n n n n n -K 10 mEq tablets are uncoated, tan to yellowish in color, elliptical shaped, with MPC 610 debossed on one side and MISSION on the other, supplied in bottles as:n nn n nn n nn n nn
  • NDC 0178-0610-01u00a0u00a0u00a0u00a0 Bottle of 100NDC 0178-0610-01u00a0u00a0u00a0u00a0 Bottle of 100
  • Urocitn -K 15 mEq tablets are uncoated, tan to yellowish in color, modified rectangle shaped, with M15 debossed on one side and blank on the other, supplied in bottles as:n Urocitn n n n n n n n n n n n -K 15 mEq tablets are uncoated, tan to yellowish in color, modified rectangle shaped, with M15 debossed on one side and blank on the other, supplied in bottles as:n nn n nn n nn n nn
  • NDC 0178-0615-01u00a0u00a0u00a0u00a0 Bottle of 100NDC 0178-0615-01u00a0u00a0u00a0u00a0 Bottle of 100
  • Storage:
  • 17.1 Administration of Drugn n nTell patients to take each dose without crushing, chewing or suckingn n nthe tablet.n n nTell patients to take this medicine only as directed. This is especiallyn n nimportant if the patient is also taking both diuretics and digitalis preparations.n n nTell patients to check with the doctor if there is trouble swallowingn n ntablets or if the tablet seems to stick in the throat.n n nTell patients to check with the doctor at once if tarry stools or othern n nevidence of gastrointestinal bleeding is noticed.n n nTell patients that their doctor will perform regular blood tests and electrocardiogramsn n nto ensure safety.n
  • 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.
  • MISSION PHARMACAL COMPANY, SAN ANTONIO, TX USA 78230 1355
  • PRINCIPAL DISPLAY PANEL - 5 mEq Bottle Label
  • NDC
  • UROCITn n n n n n n n n n n n -Kn n n n n n n n n n n n
  • 5 mEq
  • (Potassium Citrate)
  • 5 mEq (540 mg) per tablet
  • Rx only
  • 100 Tablets
  • Missionn n n n n n n n n n n n Pharmacaln nn n nn n nn n nn
  • PRINCIPALnDISPLAY PANEL - 10 mEq Bottle Label
  • NDC
  • UROCITn n n n n n n n n n n n -Kn n n n n n n n n n n n
  • 10 mEq
  • (Potassium Citrate)
  • 10 mEq (1080 mg) per tablet
  • Rx only
  • 100 Tablets
  • Missionn n n n n n n n n n n n Pharmacaln nn n nn n nn n nn
  • PRINCIPALnDISPLAY PANEL - 15 mEq Bottle Label
  • NDC
  • UROCITn n n n n n n n n n n n -Kn n n n n n n n n n n n
  • 15 mEq
  • (Potassium Citrate)
  • 15 mEq (1620 mg) per tablet
  • Rx only
  • 100 Tablets
  • Missionn n n n n n n n n n n n Pharmacaln nn n nn n nn n nn
  • No data

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