Molaxole

Uses

Each 25 ml concentrated oral solution contains Macrogol (3350) 13.125 gm, Sodium Bicarbonate 178.500 mg, Sodium Chloride 350.700 mg, Potassium Chloride 46.600 mg.

For use in adults and children over 12 years of age for effective relief from constipation and treatment of chronic constipation. Also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and colon.

Molaxole is also used to associated treatment for these conditions: Dehydration, Dry Mouth, Hypokalemia, Hypotonic Dehydration, Hypovolaemia, Isotonic Dehydration, Markedly Reduced Food Intake, Metabolic Acidosis, Hypodermoclysis, Mild Metabolic acidosis, Mild, moderate Metabolic Acidosis, Ocular edema, Acid-Base Balance, Bowel preparation therapy, Electrolyte replacement, Fluid replacement therapy, Hemodialysis Treatment, Hemofiltration, Parenteral Nutrition, Parenteral rehydration therapy, Plasma Volume Replacement, Urine alkalinization therapy, Fluid and electrolyte maintenance therapyAcid 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 therapyAllergic Rhinitis (AR), Corneal Edema, Dehydration, Dehydration Hypertonic, Fluid Loss, Hemodilution, Hypertension Intracranial, Hypokalemia, Hyponatremia, Hypotonic Dehydration, Hypovolaemia, Increased Intra Ocular Pressure (IOP), Inflammation of the Nasal Mucosa, Isotonic Dehydration, Metabolic Acidosis, Nasal Congestion, Nasal irritation, Oliguria caused by Acute Renal Failure (ARF), Potassium deficiency, Sinusitis, Skin Irritation, Sodium Depletion, Dryness of the nose, Hypochloremic state, Mild Metabolic acidosis, Mild, moderate Metabolic Acidosis, Electrolyte replacement, Fluid replacement therapy, Heart-Lung-Machine, Oral rehydration therapy, Parenteral Nutrition, Parenteral rehydration therapy, Peritoneal dialysis therapy, Plasma Volume Replacement, Regional Citrate Anticoagulation (RCA), Renal Replacement Therapies, Urine alkalinization therapy, Wound irrigation therapy, Ear wax removal, Fluid and electrolyte maintenance therapy, Increased renal excretion of toxic substances, Maintenance source of fluid and electrolytes, Parenteral drug administration, Reducing brain mass

How Molaxole works

Supplemental potassium in the form of high potassium food or potassium chloride may be able to restore normal potassium levels.

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]

Sodium and chloride — major electrolytes of the fluid compartment outside of cells (i.e., extracellular) — work together to control extracellular volume and blood pressure. Disturbances in sodium concentrations in the extracellular fluid are associated with disorders of water balance.

Dosage

Molaxole dosage

Measure 25 mL of this oral solution with measuring cup provided, then add this to 100 mL of water. Any unused diluted solution should be discarded within 24 hours.

Constipation: 25 mL of this oral solution added to 100 mL of water once daily (to make a totalvolume of 125 mL). This may be increased to 2 - 3 doses of 25 mL daily (each 25 mL dose added to 100 mL of water), if required according to individual response.

Fecal Impaction: 8 doses of 25 mL daily (each 25 mL dose added to 100 mL of water). A course of treatment for faecal impaction does not normally exceed 3 days. Children (12 -18 years): 25 mL of this oral solution added to 100 mL of water once daily.

Side Effects

In the treatment of chronic constipation, diarrhoea or loose stools normally respond to a reduction in dose. Diarrhoea, abdominal distension, anorectal discomfort and mild vomiting are more often observed during the treatment for fecal impaction. Vomiting may be resolved if the dose is reduced or delayed.

Toxicity

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, of if potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result. It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, 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 (9-12 mEq/L).

The rare inadvertent intravascular administration or rapid intravascular absorption of hypertonic sodium chloride can cause a shift of tissue fluids into the vascular bed, resulting in hypervolemia, electrolyte disturbances, circulatory failure, pulmonary embolism, or augmented hypertension.

Precaution

This medicinal product contains 8.125 mmol of sodium in each dose of 125 ml. The sodium content of this oral solution should be taken into consideration when administering the product to patients on a controlled sodium diet.

Interaction

There is a possibility that the absorption of other medicinal products could be transiently reduced during use with this oral solution. There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.

Volume of Distribution

The volume of distribution is 0.64 L/kg.

Elimination Route

Potassium is a normal dietary constituent and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine.

Absorption of sodium in the small intestine plays an important role in the absorption of chloride, amino acids, glucose, and water. Chloride, in the form of hydrochloric acid (HCl), is also an important component of gastric juice, which aids the digestion and absorption of many nutrients.

Half Life

17 minutes

Elimination Route

Potassium is a normal dietary constituent and, under steady-state conditions, the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake.

Substantially excreted by the kidneys.

Pregnancy & Breastfeeding use

Clinically, no effects during pregnancy are anticipated, since systemic exposure to Macrogol (3350) is negligible. GOL™ oral solution can be used during pregnancy.

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Macrogol (3350) is negligible. GOL™ oral solution can be used during breast-feeding.

Contraindication

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis and toxic megacolon. Hypersensitivity to the active substances.

Acute Overdose

Extensive fluid loss by diarrhea or vomiting may require correction of electrolyte disturbances.

Storage Condition

Store below 30° C and in a place protected from light. Do not refrigerate.

Innovators Monograph

You find simplified version here Molaxole