Polycitra

Uses

Citric Acid Monohydrate contains the active ingredient Citric Acid Monohydrate which helps to reduce the dry cough and soothes the throat from any related discomfort and pain. Citric Acid is a demulcent which relieves irritation of the mucous membrane in the throat by forming a protective film. Citric Acid is absorbed after oral administration. It is found naturally in the body and is widely distributed.

Renal Tubular Acidosis (RTA) With Calcium Stones: Potassium citrate is used for the management of renal tubular acidosis

Hypocitraturic Calcium Oxalate Nephrolithiasis Of Any Etiology: Potassium citrate is used for the management of Hypocitraturic calcium oxalate nephrolithiasis

Uric Acid Lithiasis With Or Without Calcium Stones: Potassium citrate is used for the management of Uric acid lithiasis with or without calcium stones

Sodium citrate is an ingredient used for the anticoagulation of whole blood as part of automated apheresis procedures.

Used as an anticoagulant during plasmophoresis as well as a neutralizing agent in the treatment of upset stomach and acidic urine .

Polycitra is also used to associated treatment for these conditions: Acidosis, Catheter site calcification caused by appetite, Catheter site calcification caused by struvite, Gouty Arthritis, Headache, Heartburn, Kidney Stones, Metabolic Acidosis, Blood Specimen Collection, Blood sample storage, Bowel preparation therapy, Chemical contraception, Potassium placement, Urine alkalinization therapy, Cleansing of the colon as a preparation for colonoscopy, Oral antisepsisAcidosis, Renal Tubular, Bowel preparation therapy, Constipation, Hypocitraturic calcium oxalate nephrolithiasis, Kidney Stones, Metabolic Acidosis, Uremia, Uric Acid Nephrolithiasis, Chronic metabolic acidosis, Uric acid lithiasis, LaxativeAcidosis, Allergic cough, Allergies, Asthma, Asthma Chronic, Cough, Common Cold, Cough, Coughing caused by Bronchitis, Dehydration, Gouty Arthritis, Heartburn, Metabolic Acidosis, Phlegm, Airway secretion clearance therapy, Oral rehydration therapy, Plasmapheresis, Urine alkalinization therapy, Fluid and electrolyte maintenance therapy, Irrigation during surgical procedures, Irrigation of the ocular surface therapy

How Polycitra works

After oral administration of potassium citrate, its metabolism yields alkaline load. Potassium Citrate therapy appears to increase urinary citrate mainly by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate. In addition to raising urinary pH and citrate, Potassium Citrate increases urinary potassium by approximately the amount contained in the medication. In some patients, Potassium Citrate causes a transient reduction in urinary calcium.

Citrate chelates free calcium ions preventing them from forming a complex with tissue factor and coagulation factor VIIa to promote the activation of coagulation factor X . This inhibits the extrinsic initiation of the coagulation cascade. Citrate may also exert an anticoagulant effect via a so far unknown mechanism as restoration of calcium concentration does not fully reverse the effect of citrate . Citrate is a weak base and so reacts with hydrochloric acid in the stomach to raise the pH. It it further metabolized to bicarbonate which then acts as a systemic alkalizing agent, raising the pH of the blood and urine . It also acts as a diuretic and increases the urinary excretion of calcium.

Dosage

Polycitra dosage

Age Dose Dose frequency

1-5 years 5 ml Upto 4 times daily

6-12 years 10 ml Upto 4 times daily

>12 years & Adults 20 ml 3-4 times daily

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) and encourages high fluid intake (urine volume should be at least two liters per day). Theobjectiveof treatment with Potassium Citrate is to provide Potassium Citrate in sufficient dosage 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 or 7.0.

Monitor serum electrolytes (sodium, potassium, chloride andcarbon dioxide), serum creatinine and complete blood counts every four months and more frequently in patients with cardiac disease, renal disease or acidosis. Perform electrocardiograms periodically. Treatment should be discontinued if there ishyperkalemia, a significant rise in serum creatinine or a significant fall in blood hemocrit orhemoglobin.

Severe Hypocitraturia: In patients with severe hypocitraturia (urinary citrate <150 mg/day), therapy should be initiated at a dosage of 60 mEq/day (30 mEq two times/day or 20 mEq three times/day with meals or within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. In addition, urinary citrate and/or pH should be measured every four months. Doses of Potassium Citrate greater than 100 mEq/day have not been studied and should be avoided.

Mild To Moderate Hypocitraturia: In patients with mild to moderate hypocitraturia (urinary citrate > 150 mg/day) therapy should be initiated at 30 mEq/day (15 mEq two times/day or 10 mEq three times/day within 30 minutes after meals or bedtime snack). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change. Doses of Potassium Citrate greater than 100 mEq/day have not been studied and should be avoided.

Side Effects

There are no known side effects from using this medicine when used as directed. If taken excessively above the stated dose, glycerol present in the medicine may cause headache, stomach upset and diarrhea.

Nausea, vomiting, diarrhea, and stomach pain may occur. Taking it after meals will help prevent these side effects. An empty tablet shell may appear in your stool. This is harmless because your body has already absorbed the medication.

This drug may cause serious stomach or intestinal problems (e.g., bleeding, blockage, puncture). This medication may cause high potassium levels in the blood (hyperkalemia). A very serious allergic reaction to this drug is rare.

Toxicity

ORAL (LD50): Acute: 5040 mg/kg [Mouse]. 3000 mg/kg [Rat].

LD50 (dog): Intravenous 176 mg/kg.

Overdose toxicity is mainly due to alkalosis as well as tetany or depressed heart function due to lack of free calcium .

Precaution

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medication should not be used ifpatient have (Addison's disease), current bladder infection, uncontrolled diabetes, severe heart disease (e.g., recent heart attack, heart damage), certain stomach/intestinal problems (diabetic gastroparesis, conditions decreasing gut movement, peptic ulcer, blockage), severe kidney disease (e.g., inability to make urine), potassium-restricted diet, high potassium levels, severe loss of body water (dehydration).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low calcium levels, severe diarrhea, heart problems (e.g., irregular heartbeat, heart failure), kidney disease, stomach/gut problems (e.g., irritable bowel), severe tissue damage (e.g., severe burns). Before having surgery, tell your doctor or dentist that you are taking this medication.

Volume of Distribution

19-39L .

Elimination Route

Tmax of 98-130min .

Half Life

18-54 min

Clearance

Total clearance of 313-1107mL/min .

Elimination Route

Urinary; less than 5% unchanged.

Largely eliminated through hepatic metabolism with very little cleared by the kidneys .

Pregnancy & Breastfeeding use

There are no or limited amount of data from the use of Citric Acid Monohydrate in pregnant women. There is insufficient information on the excretion of Citric Acid Monohydrate & its metabolites in human milk.

Pregnancy Category C. Animal reproduction studies have not been conducted. It is also not known whether Potassium Citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Citrate should be given to a pregnant woman only if clearly needed.

Nursing Mothers: The normal potassium ion content of human milk is about 13 mEq/L. It is not known if Potassium Citrate has an effect on this content. Potassium Citrate should be given to a woman who is breast feeding only if clearly needed.

Contraindication

Potassium Citrate 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 conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride).
• In patients in 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, or those taking anticholinergic medication.
• In patients with peptic ulcer disease because of its ulcerogenic potential.
• In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones). The ability of Potassium Citrate to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from Potassium Citrate therapy might promote further bacterial growth.
• In patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia.

Special Warning

Pediatric Use: Safety and effectiveness in children have not been established.

Acute Overdose

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 that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic electrocardiographic changes (peaking of T-wave, loss of P-wave, depression of S-T segment and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest.

Treatment measures for hyperkalemia include the following:

• Patients should be closely monitored for arrhythmias and electrolyte changes.
• Elimination of medications containing potassium and of agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements and many others.
• Elimination of foods containing high levels of potassium such as almonds, apricots, bananas, beans (lima, pinto, white), cantaloupe, carrot juice (canned), figs, grapefruit juice, halibut, milk, oat bran, potato (with skin), salmon, spinach, tuna and many others.
• Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.
• Intravenous administration of 300-500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
• Correction of acidosis, if present, with intravenous sodium bicarbonate.
• Hemodialysis or peritoneal dialysis.
• Exchange resins may be used. However, this measure alone is not sufficient for the acute treatment of hyperkalemia.

Lowering potassium levels too rapidly in patients taking digitalis can produce digitalis toxicity.

Storage Condition

Keep in a cool and dry place, away from light. Keep out of the reach of children.

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