Pocitrin Tab

Pocitrin Tab

Manufacturer:

Nihon Pharmaceutical Industry

Distributor:

Ouiheng International Healthcare
Full Prescribing Info
Contents
Potassium citrate, sodium citrate.
Description
Each tablet contains potassium citrate 231.5 mg and sodium citrate 195 mg.
Potassium citrate is tripotassium-2-hydroxy-1,2,3-propanetricarboxylate hydrate. The molecular formula is C6H5K3O7·H2O and molecular weight of 324.41. It occurs as colorless crystals or white crystalline powder. It is odorless and has salty taste. It is very soluble in water, sparingly soluble in glacial acetic acid and practically insoluble in ethanol, acetone, ether and hexane.
Sodium citrate is trisodium-2-hydroxy-1,2,3-propanetricarboxylate dihydrate. The molecular formula is C6H5Na3O7·2H2O and molecular weight of 294.1. It is colorless crystal or white crystalline powder. It is odorless and has refreshingly salty taste. It is freely soluble in water and practically insoluble in ethanol or ether.
Action
Pharmacology: The action of Xitrin is considered to be based mainly on the action of bicarbonate (HCO3-) of the metabolite as base in the body.
Effect on Improvement of Acidic Urine: Xitrin showed dose-dependent preventive effect and therapeutic effect for acidic urine in rats with ammonium chloride-induced acidic urine. It inhibited the deposition in the renal tissue of uric acid, in which the solubility of uric acid decreased in the acidic condition in the rats.
Effect on Improvement of Acidosis: Xitrin increased dose-dependently the lowered blood pH, bicarbonate concentration and base excess in rats with maleic acid-induced acidosis.
Pharmacokinetics: Potassium citrate and sodium citrate are oxidized in the body to form bicarbonate. When oxidative activity is intact, oxidation of citrate salts is essentially complete and <5% of the drug is excreted in urine unchanged. Following a single oral dose of 6 tabs to healthy adults, it attains a peak of 30 mcg/mL in blood 48 min after administration. Serum half-life is approximately 2.3 hrs.
Indications/Uses
Alkalinization of acidic urine in gout and hyperuricemia patients.
Treatment of metabolic acidosis.
Dosage/Direction for Use
Alkalinization of Acidic Urine in Patients with Gout and Hyperuricemia: Adults: Usually 2 tabs 3 times a day is given orally. Dosage should be adjusted so that urine pH may be maintained in a range 6.2-6.8 by urinalysis.
Treatment of Metabolic Acidosis: Adults: As a rule, 12 tabs a day divided into 3 or 4 dosages is given orally. However, the dosage should be increased or decreased depending on the condition of patients, taking into consideration the age, body weight, results of blood-gas analysis and others.
Overdosage
Excessive administration of Xitrin may lead to hyperkalemia and metabolic alkalosis, especially in patients with impaired renal function.
Symptoms: Mood changes, tiredness, shortness of breath, muscle weakness and irregular heartbeat.
Treatment: Consists mainly of appropriate correction of fluid and electrolyte balance.
Contraindications
Hypersensitivity to sodium citrate, potassium citrate or any component of Xitrin. Severe renal insufficiency, sodium-restricted diet, metabolic or respiratory alkalosis, hypocalcemia or hypochlorhydria.
Special Precautions
Careful Administration: Patients with severe renal disorder, because serum potassium may be elevated; patients with hepatic disease, because the symptom may be worsened.
As calcium phosphate is known to become insoluble in alkaline condition, excessive urine alkalinization should be avoided for prevention of calculus.
Use in pregnancy & lactation: Use caution with toxemia of pregnancy.
Use in the elderly: As the physiological functions are weakened in elderly patients and adverse reactions are liable to occur in these patients, Xitrin should be administered with caution such as a reduction in dosage.
Use In Pregnancy & Lactation
Use caution with toxemia of pregnancy.
Adverse Reactions
Out of 13,226 patients examined for Uralyt-U [in clinical trials for new drug application (NDA) and post-marketing studies for re-evaluation] and Xitrin (in clinical trials for NDA), adverse reactions (including abnormal changes of laboratory test values) were observed in 192 (1.45%) patients. Most frequently reported adverse reactions were gastrointestinal symptoms (0.6%) eg, diarrhea and loose stools (20 events); stomach discomfort (15 events); and nausea (10 events). Main abnormal changes in laboratory test value were serum potassium elevation (28 events); GPT elevation (23 events); and GOT elevation (18 events).
Incidence of adverse reactions:
Abnormality of Metabolism: 0.1-1%: Hyperkalemia*.
Liver*: 0.1-1%: Increased GOT, GPT. <1%: Increased ALP, γ-GPT, LDH.
Kidney: <1%: Increased blood creatinine, BUN.
Digestive Tract: 0.1-1%: Stomach discomfort, diarrhea. <1%: Anorexia, retching, nausea, vomiting, heartburn, stomatitis, abdominal distention.
Skin: <1%: Rash, itching.
Urinary Tract: <1%: Urinary disorder. The cause is incarceration of shrunk calculus into the urinary duct. In such case, an appropriate measure including surgical measure should be taken.
Others: <1%: Tachycardia, feeling of residual urine, sleepiness, anemia, malaise.
*Careful monitoring should be performed during treatment and if any abnormality was observed; appropriate measure eg, a decrease in dosage or Xitrin discontinuation should be considered.
Drug Interactions
Acidic Drugs eg, Salicylates and Barbiturates: Alkalinization of the urine by bicarbonate or bicarbonate precursors leads to increased renal clearance and decreased effect of Xitrin.
Aluminium Hydroxide: Citrate salts can enhance the absorption of aluminium. Therefore, at the time of concomitant use, the period of ≥2 hrs should be put between both drugs. Patients with renal failure taking aluminium-containing compounds should avoid Xitrin.
Angiotensin-Converting Enzyme (ACE) Inhibitors and Potassium-Sparing Diuretics: May lead to development of hyperkalemia.
Storage
Store below 30°C, in airtight container.
ATC Classification
G04BX - Other urologicals ; Used in the treatment of urological problems.
Presentation/Packing
Tab (plain, white with cut-line and imprinted identification code with NCP and U in the front) 10 x 10's.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in