Freego Peg

Uses

This is white powder for reconstitution. It is a synthetic polyglycol having an average molecular weight of 3350. Polyethylene Glycol is an osmotic agent that causes water to be retained with the stool. Polyethylene Glycol appears to have no effect on the active absorption or secretion of glucose or electrolytes.

Polyethylene Glycol is used for the treatment of constipation. This should be used for 2 weeks or less or as directed by physician. Polyethylene Glycol 3350 is a prescription only laxative that has been prescribed by physician to treat constipation. This product should only be used by the person for whom it is prescribed.

Potassium is a medication used to treat hypokalemic conditions and to clear the colon prior to colonoscopy.

General uses of potassium

Potassium is indicated to treat a variety of conditions. Firstly, it used to replenish potassium that has been depleted by conditions including but not limited to malabsorption, decreased intake, or excess sodium intake. The causes of potassium deficiency are numerous. The following indications for potassium are not comprehensive, but include the main indications for which this nutrient is used. Various products and preparations contain potassium.

Potassium chloride

Potassium chloride is one of the main preparations of potassium used in a clinical setting. The oral solution is indicated for the prevention and treatment of hypokalemia presenting with or without metabolic alkalosis, in patients who have failed conservative management with potassium-rich foods or diuretic dose titrations. The injection form of potassium chloride is indicated to replenish potassium in patients who are not feasible candidates for oral potassium. Highly concentrated potassium is intended for the treatment of potassium deficiency in fluid restricted individuals who cannot tolerate fluid volumes normally associated with injected potassium solutions that contain lower concentrations. Finally, the extended-release tablet preparation of potassium chloride is used to treat hypokalemia with or without metabolic alkalosis, to treat digitalis intoxication, and to manage patients with hypokalemic familial periodic paralysis. It is also used in the prevention of hypokalemia in those who are at a high risk of negative clinical outcomes if hypokalemia occurs; patients on digitalis or those with cardiac arrhythmias would be at particular risk of negative outcomes.

Potassium chloride with dextrose and sodium chloride

This liquid preparation is is indicated in a clinical setting as a source of water, calories and electrolytes. Potassium acetate solution is meant as an alternative to potassium chloride, replenishing potassium and added to large volume infusion fluids for intravenous injection.

Potassium citrate

The potassium citrate preparation is used for the management of renal tubular acidosis (RTA) with calcium stones (nephrolithiasis); calcium oxalate stones by any cause, and uric acid nephrolithiasis (with or without calcium stones). This regimen also includes adequate water intake (leading to a urine out put of 2 L/day or more) and sodium restriction.

Management of acidosis in cardiac arrest.

Management of metabolic acidosis in:

• Severe renal disease
• Uncontrolled diabetes
• Circulatory insufficiency from shock or dehydration
• Severe primary lactic acidosis

Alkalinization of urine.

Freego Peg is also used to associated treatment for these conditions: Chronic Constipation, Constipation, Dry Eye Syndrome (DES), Dry Eyes, Occasional Constipation, Bowel preparation therapy, Eye lubricationCaloric Intake, Electrolyte and fluid balance conditions, Hydration, Hypokalemia, PotassiumAcid indigestion, Barbiturate intoxication, Breast Cancer, Constipation, Dental Decay, Duodenal Ulcer, Dyspepsia, Gastro-esophageal Reflux Disease (GERD), Gingival Bleeding, Heartburn, Helicobacter Infections, Hyperkalemia, Ischaemia, Metabolic Acidosis, Myocardial Infarction, Plaque, Dental, Pruritis of the skin, Skin Irritation, Upset stomach, Zollinger-Ellison Syndrome, Abdominal bloating, Benign, active Gastric Ulcer, Methyl alcohol poisoning, Prophylaxis of Contrast-induced nephropathy, Salicylate poisoning, Severe Diarrhea, Swelling of the gums, Bowel preparation therapy

How Freego Peg works

Osmotic laxatives contain substances that are poorly absorbable and draw water into the lumen of the bowel. Polyethylene glycol functions is an osmotic laxative that causes increased water retention in the lumen of the colon by binding to water molecules, thereby producing loose stools.

Potassium ion is the primary intracellular cation found in virtually all body tissues. The total amount of body potassium in adults is estimated at 45 millimole (mmol)/kg body weight (about 140 g for an adult weighing 175 pounds; 1 mmol = 1 milliequivalent or 39.1 mg of potassium). Potassium mainly stays in cells, and a small amount can be found in the extracellular fluid. The amount of potassium that stays in the cell (intracellular) is 30 times that of extracellular concentration, creating a transmembrane gradient, regulated by the sodium-potassium (Na+/K+) ATPase transporter. This is an important gradient for nerve conduction, muscle contractions, and renal function. Vomiting, diarrhea, renal disease, medications, and other conditions that alter potassium excretion or shift it inside or outside of cells. In healthy patients individuals with normal renal function, markedly high or low potassium levels are rare.

Effect on blood pressure

Potassium decreases reduces intravascular volume, by reducing sodium reabsorption through an increase in urinary sodium excretion. This short-term effect, however, does not explain the long-term effects of potassium on blood pressure. Increased plasma potassium levels that occur through intake are associated with vasodilation occurring via stimulation of the sodium-potassium adenosine triphosphatase pump (Na+/-K+ATPase) and opening of potassium channels of the sodium-potassium adenosine triphosphatase pump. Other possible mechanisms of action for potassium may include alterations in barroreflex sensitivity and hormone sensitivity in vascular smooth muscle and cells of the sympathetic nervous system.

Effect on electrolyte balance and body systems

The potassium gradient across the membrane of a cell regulates cell membrane potential, maintained predominantly by the sodium-potassium (Na+/-K+ ATPase pump). Transmembrane electro-chemical gradients encourage diffusion of Na+ extracellularly and K+ intracellularly. Potassium supplementation prevents hypokalemia to maintain this balance and is often used in an oral solution or injection form in the clinical setting, preventing harmful effects such as arrhythmias, abnormal muscle function, and neurological disturbances. When activated, the Na+/-K+ ATPase pump exchanges two extracellular K+ ions for three intracellular sodium (Na+) ions, impacting membrane potential via either excitation or inhibition. This is especially important in the homeostasis of the nervous system, kidney, and cardiac muscle tissue. The body and cell distributions of potassium in normal conditions are known as internal and external balance, respectively. Reduced serum potassium (or imbalance) increases the risk of ventricular arrhythmia, heart failure and left ventricular hypertrophy (LVH).

Sodium bicarbonate is a systemic alkalizer, which increases plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH, thereby reversing the clinical manifestations of acidosis. It is also a urinary alkalizer, increasing the excretion of free bicarbonate ions in the urine, thus effectively raising the urinary pH. By maintaining an alkaline urine, the actual dissolution of uric acid stones may be accomplished. Sodium bicarbonate acts as an antacid and reacts chemically to neutralize or buffer existing quantities of stomach acid but has no direct effect on its output. This action results in increased pH value of stomach contents, thus providing relief of hyperacidity symptoms. [PharmGKB]

Dosage

Freego Peg dosage

The usual dose of Polyethylene Glycol is 17 gm of powder per day (or as directed by physician) in a glass of water, juice, coke, coffee or tea. Each bottle of Polyethylene Glycol is supplied with a cup that is used to measure 17 gm or 8.5 gm of laxative powder when filled upto the marked line.

Oral: The usual dose is 300 mg to 2 grams, 1 to 4 times daily.

Intravenous (Severe metabolic acidosis):

• Adult: By slow inj of a hypertonic solution of up to 8.4% (1000 mmol/L), or by continuous infusion of a weaker solution, usually 1.26% (150 mmol/L). For correction of acidosis during advanced cardiac life support procedures, 50 ml of an 8.4% solution may be given.
• Elderly: Dosage adjustments may be required.

It should always be taken by mouth. Measure the dose using the supplied cup, stir and dissolve in a glass of water, juice, coke, coffee or tea. Taking more than the prescribed dose may cause loss of fluid due to severe diarrhea.

Duration of Treatment

Polyethylene Glycol achieves its best results when used between one and two weeks. It may be discontinued after several satisfactory bowel movements. Should unusual cramps, bloating, or diarrhea occur, consultation with physician is needed. Polyethylene Glycol is intended for up to a two-week course of therapy. It should not be used for a longer time unless directed by a physician. After successfully completing the Polyethylene Glycol therapy (usually between one and two weeks) discussion with a physician is needed to change lifestyle that may produce more regular bowel habits (adequate dietary and fluid intake, regular exercise).

Side Effects

Nausea, abdominal bloating, cramping and flatulence may occur. High doses may produce diarrhea and excessive stool frequency, particularly in elderly nursing home patients. Patients taking other medications containing polyethylene glycol have occasionally developed urticaria suggestive of an allergic reaction.

This medication is generally well tolerated. However, high doses may cause headache, nausea or irritability. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you develop: muscle weakness, slow reflexes, confusion, swelling of the feet or ankles, black tar-like stools, coffee-ground vomit. If you notice other effects not listed above, contact your doctor or pharmacist.

Toxicity

The oral LD₅₀ of PEG 3350 in rats is 22000 mg/kg.

There is limited clinical information on the overdose of polyethylene glycols. Based on the pharmacological action of the compound, severe diarrhea may be suspected. Overdose of polyethylene glycols should be responded with symptomatic and supportive care.

The oral LD50 of potassium chloride in rats is 2600 mg/kg.

Overdose information

An overdose of potassium may result in hyperkalemia, and in some cases, death due to various causes. Signs and symptoms of an overdose of potassium are mainly cardiovascular, neurological and musculoskeletal in nature. Arrhythmia, changes in cardiac conduction, including astystole, bradycardia, heart block, ventral fibrillation, and ventricular tachycardia may occur. In addition, hypotension may also occur along with cardiac ECG changes. Muscular weakness and respiratory muscle paralysis may occur, in addition to paresthesia. In case of an overdose, discontinue potassium administration, reduce the dose, and monitor fluid levels and electrolyte concentrations in addition to acid-base balance. Corrective therapy, such as insulin administration or potassium binding drugs, may be required. Offer supportive care and resuscitation as deemed necessary.

Important note regarding hyperkalemia

Normally, hyperkalemia is asymptomatic and only detected by laboratory testing (at values of 6.5-8.0 mEq/L) and ECG changes (peaked T- waves, lost P-waves, ST depression, and a prolonged QT interval). Muscle paralysis and cardiac arrest may occur in the advanced stages of hyperkalemia, at potassium concentrations of 9-12 mEq/L.

Precaution

Patients with symptoms suggestive of bowel obstruction (nausea, vomiting, abdominal pain or distention) should be evaluated to rule out this condition before initiating Polyethylene Glycol therapy. Polyethylene Glycol should be administered after being dissolved in water, juice, coke, coffee or tea.

Pre-existing heart disease, kidney disease, liver disease, high blood pressure, any allergies.

Interaction

No specific drug interactions have been demonstrated.

This medication has the potential to interact with many medications. Should not take any other medication within 1 to 2 hours of taking an antacid. Potentially hazardous interactions with Corticosteroids and Corticotropin, Alkalis, Calcium, Diuretics and Potassium.

Volume of Distribution

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean volume of distribution was 48,481 L.

Potassium is present in almost all body tissues. Approximately 98% of potassium is maintained intracellularly in muscular tissue, the liver, and red blood cells. The remainder is distributed extracellularly.

Elimination Route

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean Cmax was 2.7 mcg/mL and the mean Tmax was 3 hours. Typically, polyethylene glycols with a high molecular weight are poorly absorbed from the gastrointestinal tract following oral administration.

When taken orally from a dietary source, potassium is mainly absorbed via passive diffusion in the small intestine. Approximately 90% of potassium is absorbed, and maintains concentrations both inside and outside cells. The kidneys can adapt to variable potassium intake in healthy individuals, but a minimum of 5 mmol (about 195 mg) dietary potassium is measured to be excreted in the urine.

Some studies have measured the absorption various forms of potassium from dietary supplements. Results from a clinical trial in 2016 showed that potassium gluconate supplements are 94% absorbed, which is similar to the absorption rate from potatoes. An older study advised that liquid forms of potassium are absorbed a few hours post-administration. Enteric coated tablets of potassium chloride are not absorbed as rapidly as liquid forms, due to their delayed release design.

Half Life

Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean half life was 4.1 hours.

In one clinical study, the apparent half-life of oral potassium was between 1.6 and 14 hours. A radio tracer study determined that the biological half-life of radiolabeled potassium ranges from 10 to 28 days.

Clearance

There is limited information on the clearance rate of polyethylene glycols.

Potassium is freely filtered in the kidney with most of an ingested amount being reabsorbed into the circulation (70%–80%) by the proximal tubule and loop of Henle. Secretion of potassium by the distal nephron in the kidney varies and dependent on the intracellular potassium concentration, luminal potassium concentration concentration, in addition to cellular permeability.

Elimination Route

Following administration of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, up to 85% to 99% of the compound was excreted in the feces.

Potassium is excreted primarily in the urine, excreted in small amounts in the stool, and negligibly in perspiration (sweat). The renal system regulates potassium excretion according to dietary intake. Potassium excretion rises quickly in healthy patients after ingestion unless body stores have been depleted. Potassium undergoes glomerular filtration, tubular reabsorption, and distal tubular secretion. Renal clearance of potassium shifts between net tubular secretion and reabsorption, depending on the clinical circumstances.

Pregnancy & Breastfeeding use

Pregnancy: It is not known whether Polyethylene glycol can cause fetal harm when administered to a pregnant woman, or can effect reproductive capacity. Polyethylene glycol should only be administered to a pregnant woman if clearly needed.

Lactation: There is no information on the use of Polyethylene glycol while nursing. Consultation with a physician is necessary in case of breastfeeding.

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Contraindication

Polyethylene glycol is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.

This drug is contraindicated in hypoventilatory states, chloride depletion owing to continuous gastric fluid loss, metabolic and/or respiratory alkalosis, hypocalcemia and diuretics known to produce hypochloremic alkalosis.

Acute Overdose

There have been no reports of accidental overdosage. In the event of overdosage diarrhea would be the expected major event. If an overdose of drug occurred without concomitant ingestion of fluid, dehydration due to diarrhea may result. Medication should be terminated and free water administered.

If alkalosis results, the bicarbonate should be stopped and the patient managed according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indication in severe alkalosis.

Storage Condition

Store in a cool & dry place protected from light. Keep out of reach of children.

Innovators Monograph

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