Potassium Citrate

Potassium Citrate has been approved for relieving symptoms as well as for the treatment and maintenance of episodes of renal tubular acidosis, hypocitraturia calcium oxalate nephrolithiasis, uric acid lithiasis with or without calcium stones, and hypokalemia.

Potassium Citrate is found to be absorbed, and the citrate is metabolized to bicarbonate. Oxidation of potassium citrate is found to be virtually complete, so <5% is excreted in the urine unchanged.

The common side effects of Potassium Citrate include numbness or tingling in the hands, feet, or lips, shortness of breath, abdominal or stomach pain, difficulty breathing, irregular heartbeat, and weakness or heaviness of the legs.

Potassium Citrate is found to be available in the form of tablets, Extended-release Tablets, Extended release capsules,oral solution , oral packet, I.V. premix

Potassium Citrate is available in the U.S., Canada, E.U., India, Australia, and Japan.

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

Potassium Citrate had been approved for relieving symptoms as well as also for the treatment and maintenance of episodes of renal tubular acidosis, hypocitraturia calcium oxalate nephrolithiasis, uric acid lithiasis with or without calcium stones, and hypokalemia.

The onset of action of Potassium Citrate is said to be within an hour. The duration of action of Potassium citrate is several hours.

Potassium Citrate is available in tablets, Extended-release Tablets, Extended release capsules, oral solution , oral packet, I.V. premix.

Potassium Citrate can be used in the treatment of the following conditions:

• Renal tubular acidosis
• Uric acid lithiasis with or without calcium stones
• Hypocitraturic calcium oxalate nephrolithiasis
• Hypokalemia

Potassium Citrate can help to relieve symptoms and also for the treatment and maintenance of renal tubular acidosis, hypocitraturia, calcium oxalate nephrolithiasis, uric acid lithiasis with or without calcium stones, and hypokalemia.

Potassium Citrate is approved for the treatment in the following clinical indications/conditions:

• Renal tubular acidosis
• Uric acid lithiasis with or without calcium stones
• Hypocitraturic calcium oxalate nephrolithiasis
• Hypokalemia

Tablets, Extended-release Tablets, Extended release capsules, oral solution , oral packet

To be swallowed as a whole with water

I.V. premix: To be administered by a registered medical practitioner.

Tablet: 20mEq

Extended-release tablet: 8mEq, 10mEq ,15mEq ,20mEq

Oral Solution: 20mEq/15mL, 40mEq/15mL

Oral Packet: 20mEq

Extended-release capsules: 8mEq, 10mEq

IV premix in plastic container: 10mEq, 20mEq, 30mEq ,40mEq

Tablet, Extended-release Tablets, Extended release capsules,oral solution , oral packet, I.V. premix.

• Dosage Adjustments in Kidney Patients

The use of Potassium Citrate is contraindicated in patients with renal insufficiency (GFR <0.7 mL/kg/minute) or chronic renal failure.

Smoking cessation and maintaining health are a must.

Caffeine should be avoided or limited to use as it might lead to the risk of nausea, palpitations, nervousness, rapid heartbeat, etc.

Alcohol intake should be avoided in patients, especially those with an underlying liver disorder or liver dysfunction.

A diet containing citrus-containing food should be avoided while on potassium citrate medication.

The dietary restrictions should be individualized as per the patient's requirements.

Potassium Citrate may be contraindicated under the following conditions:

• In patients suffering from hyperkalemia or who have conditions predisposing them to hyperkalemia, a further rise in the serum potassium concentration might produce cardiac arrest. Such conditions include acute dehydration, chronic renal failure, uncontrolled diabetes mellitus, strenuous physical exercise in unconditioned individuals, extensive tissue breakdown,adrenal insufficiency, or the administration of a potassium-sparing agent ex: triamterene, spironolactone, or amiloride.
• In patients with arrest or delay in tablet passage through the gastrointestinal tract, such as those who are suffering from delayed esophageal compression, gastric emptying, intestinal obstruction or stricture, as well as those taking anticholinergic medication.
• In patients suffering from peptic ulcer disease because of its ulcerogenic potential.
• In the patients suffering from active urinary tract infection , with either urea-splitting or other organisms, also in association with either the calcium or struvite stones
• The ability of Potassium Citrate to increase urinary citrate might be attenuated by the bacterial enzymatic degradation of the citrate. Moreover, the rise in the urinary pH resulting from Potassium Citrate therapy might further promote bacterial growth.
• In the patients with renal insufficiency such as glomerular filtration rate is found to be of less than 0.7 ml/kg/min, as there might be danger of soft tissue calcification and also increased risk for the development of hyperkalemia.

The physician should closely monitor the patients and keep pharmacovigilance as follows:

Hyperkalemia

In patients suffering with impaired mechanisms for excreting potassium, Potassium Citrate administration might produce hyperkalemia as well as cardiac arrest. Potentially fatal hyperkalemia might develop rapidly and be asymptomatic. The use of Potassium Citrate in patients with chronic renal failure or any other condition which impairs the potassium excretion, such as severe myocardial damage or condition such as heart failure, should be avoided. Hence , patients should be closely monitored for signs and symptoms of hyperkalemia with periodic blood tests and ECGs.

Gastrointestinal Lesions

As the reports of upper gastrointestinal mucosal lesions following administration of potassium-chloride, an endoscopic examination of the upper gastrointestinal mucosa had been performed in 30 normal volunteers after which they had taken glycopyrrolate 2 mg p.o. t.i.d Potassium Citrate about 95 mEq/day, wax-matrix potassium chloride about 96 mEq/day, or wax-matrix placebo, in the thrice daily schedule in the fasting state for one week.Potassium Citrate and the wax-matrix formulation of potassium chloride had an indistinguishable, but both were significantly more irritating than the wax-matrix placebo. In a subsequent similar study, the lesions were found to be less severe when glycopyrrolate had been omitted. Solid dosage forms of potassium chlorides had produced stenotic and/or ulcerative lesions of the small bowel and deaths. These lesions are caused due to the high local concentration of the potassium ions in the region of the dissolving tablets, which as well injures the bowel. Perhaps as wax-matrix preparations are not enteric-coated and release some of their potassium content in the stomach, there have been reports of the upper gastrointestinal bleeding which is associated with these products. The frequency of the gastrointestinal lesions with the wax-matrix potassium chloride products is estimated to be one per 100,000 patient years. Experience with Potassium Citrate is limited, but a similar frequency of gastrointestinal lesions should be expected if there is severe vomiting, abdominal pain, and also gastrointestinal bleeding. Potassium Citrate Should be discontinued immediately, and the possibility of bowel perforation or obstruction should be investigated.

Avoid alcohol usage while on Potassium Citrate medication, as alcohol can worsen the effects of any underlying disease condition, including conditions such as dizziness, blurred vision, etc.

It is reported that the normal potassium ion content of human milk is found to be about 13 mEq/L. It is unknown if Potassium Citrate has any effect on this content. Potassium Citrate should be stricter for those on anticholinergic medication, given to a woman who is breastfeeding only if clearly needed.

Pregnancy Category C

Animal reproduction studies had not been conducted. It is also unknown whether Potassium Citrate can cause any fetal harm when it is administered to a pregnant woman or it can affect the reproduction capacity.Potassium Citrate should be given to pregnant women only if clearly needed.

No sufficient scientific evidence is traceable regarding the use and safety of Potassium Citrate in concurrent use with any particular food.

The adverse reactions related to Potassium Citrate can be categorized as follows:

Common

• Diarrhea
• Nausea
• Vomiting
• Stomach pain or upset

Rare

• Leg discomfort
• Muscle weakness or limp feeling
• Severe stomach pain
• Diarrhea
• Confusion
• Anxiety
• Uneven heartbeat
• Extreme thirst
• Increased urination
• Vomiting
• Black, bloody, or tarry stools
• Coughing or vomiting the blood that looks like coffee grounds

The common side effects of Potassium Citrate include the following:

• Numbness or tingling sensation in the hands, feet, or lips.
• Shortness of breath.
• Abdominal or stomach pain.
• Difficult breathing.
• Irregular heartbeat.
• Weakness or heaviness of the legs.

Pregnancy

Pregnancy Category C

Animal reproduction studies had not been conducted. It is also unknown whether Potassium Citrate can cause any fetal harm when it is administered to a pregnant woman or it can affect the reproduction capacity.Potassium Citrate should be given to pregnant women only if clearly needed.

Nursing Mothers

It is reported that the normal potassium ion content of human milk is found to be about 13 mEq/L. It is unknown if Potassium Citrate has any effect on this content. Potassium Citrate should be stricter for those on anticholinergic medication, given to a woman who is breastfeeding only if clearly needed.

Pediatric Use

Safety and efficacy in children have not been established.

Geriatric Use

There is no specific information available comparing the use of Potassium Citrate Potassium in the elderly with use in other age groups.

Physicians should be knowledgeable and vigilant about the treatment pertaining to the treatment and identification of overdosage of Potassium Citrate.

Treatment of Over dosage: The administration of potassium salts to persons having predisposing conditions of hyperkalemia rarely causes serious hyperkalemia at the recommended dosages. Hence, it is important to recognize that hyperkalemia is usually an asymptomatic and might be manifested only by an increased serum potassium concentration as well as characteristic electrocardiographic changes such as peaking of the T-wave, loss of P-wave, depression of S-T segment, and prolongation of the Q.T. interval. The late manifestations include muscle paralysis as well as cardiovascular collapse from cardiac arrest.

Treatment measures for hyperkalemia include the following:

1. Patients should be closely monitored for the episodes of arrhythmias and electrolyte changes.

2. Elimination of medications containing potassium and agents such as potassium-sparing diuretics, NSAIDs, ARBs, ACE inhibitors,certain nutritional supplements, and many others.

3. Elimination of foods containing high levels of potassium such as bananas, beans, almonds, apricots, (lima, pinto, white),halibut, milk, oat bran, potato (with skin), salmon, cantaloupe, carrot juice (canned), figs, grapefruit juice, spinach, tuna, and many others.

4. Intravenous administration of calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.

5. Intravenous administration of about 300-500 mL/hr of 10% dextrose solution which contains 10-20 units of crystalline insulin per 1,000 mL.

6. Correction of the acidosis, if present, with an intravenous sodium bicarbonate.

7. Hemodialysis or a peritoneal dialysis.

8. Exchange resins might be used. However, this measure itself is not sufficient for the acute treatment of hyperkalemia. Hence ,lowering potassium levels too rapidly in patients taking digitalis can produce digitalis toxicity.

Pharmacodynamics

Potassium citrate is said to induce changes in the urine which renders the urine less susceptible to the formation of the crystals and stones from salts, such as calcium oxalate, calcium phosphate, as well as uric acid. The increased citrate levels in the urine will make complexations with the calcium which decrease the calcium ion activity as well as decreases the chance of formation of calcium phosphate crystals. The citrate also inhibits the spontaneous nucleation of calcium oxalate and calcium phosphate.

Pharmacokinetics

• Metabolism

Potassium Citrate is said to be absorbed, and the citrate is metabolized to bicarbonate.

• Elimination

Oxidation of potassium citrate is virtually complete, so <5% is excreted in the urine unchanged.

1. https://go.drugbank.com/drugs/DB09125
2. https://www.drugs.com/pro/potassium-citrate.html
3. https://www.thekidneydietitian.org/potassium-citrate-in-food-drinks/
4. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019071s012lbl.pdf
5. https://reference.medscape.com/drug/cytra-k-potassium-citrate-citric-acid-999836#10ps://pubchem.ncbi.nlm.nih.gov/compound/Potassium-citrate