For the use of Registered Medical Practitioner or Hospital or Laboratory only (June-2025)

MINTGARD* MPS

(Antacid Suspension with Oxetacaine & Simethicone)

 MINTGARD* MPS

COMPOSITION:

 Each 5 ml contains:

 Dried Aluminium Hydroxide Gel USP 300 mg

 Magnesium Hydroxide IP                     150 mg

 Simethicone Emulsion USP                  125 mg

 Oxetacaine BP                                     10 mg              

CLINICAL PHARMACOLOGY:

Mechanism of Action:  

Aluminum hydroxide is a basic inorganic salt that acts by neutralizing hydrochloric acid in gastric secretions. Aluminum hydroxide is slowly solubilized in the stomach and reacts with hydrochloric acid to form aluminum chloride and water. It also inhibits the action of pepsin by increasing the pH and via adsorption.

Magnesium hydroxide acts by simply neutralizing acid in the stomach. The hydroxide ions from the magnesium hydroxide suspension will combine with the acidic H+ ions of the hydrochloric acid made by the stomachs parietal cells. This neutralization reaction will result in the formation of magnesium chloride and water.

Simethicone decreases the surface tension of gas bubbles in the gastrointestinal tract, facilitating their expulsion. It has a short duration of action as it is generally given as needed, and a wide therapeutic index as it is not systemically absorbed. Oxetacaine has anesthetic action produces the loss of sensation, has inhibitory activity against the nerve impulses and decrease in permeability of the cell membrane. It also inhibits gastric acid secretion by suppressing gastrin secretion.

 PHARMACOKINETICS:

Absorption: A peak plasma concentration of   oxetacaine approximately 20 ng/ml is attained about one hour after oral administration. Less than 1/3 of the administered dose is absorbed as it undergoes extensive metabolism. Simethicone, Aluminum hydroxide and Magnesium hydroxide are not systemically absorbed.  

Distribution: This pharmacokinetic property has not been studied. Due to the low half-life, it is thought that oxetacaine, when absorbed, presents a very low protein plasma binding

Metabolism and Excretion: Oxetacaine is rapidly and extensively metabolized hepatically. After metabolism, there is a formation of primary metabolites such as beta-hydroxy-mephentermine and beta-hydroxy-phentermine. The major metabolites are found in the plasma in insignificant amount.

INDICATIONS AND USAGE:

Mintgard MPS is indicated in adults and children aged 12 years and older.

Antacids are used to relieve symptoms of gastric and duodenal ulcers, gastritis, heartburn, and indigestion. They also help manage acid-related discomfort in reflux conditions like hiatus hernia and esophagitis.

DOSAGE AND ADMINISTRATION:

10-20 ml three times daily 20 minutes to one hour after meals, and at bedtime, or as required for adults, elderly and children aged 12 years and older.

Mintgard MPS should not be used in children less than 12 years of age.

Unopened: 2 years. After opening use within 28 days

CONTRAINDICATIONS:

Hypersensitivity to the active substances or to any of the excipients listed. Should not be used in patients who are severely debilitated or suffering from kidney failure.

 DRUG INTERACTIONS:

Antacids inhibit the absorption of tetracyclines and vitamins and should not be taken concomitantly.

Urine alkalinisation secondary to administration of magnesium hydroxide may modify excretion of some drugs; thus, increased excretion of salicylates has been seen.

Mintgard MPS with aspirin may decrease the effects of aspirin. Contact your doctor if your condition changes.

Mintgard MPS with Vitamin D3 (cholecalciferol) can lead to elevated magnesium blood levels, particularly in individuals with reduced kidney function. Symptoms of high magnesium levels may include nausea, vomiting, flushing, drowsiness, dizziness, confusion, muscle weakness, reduced reflexes, low blood pressure, slow heart rate, and impaired breathing.

 WARNINGS AND PRECAUTIONS:

In young children the use of magnesium hydroxide can produce a hypermagnesemia, especially if they present with renal impairment or dehydration.

ADVERSE REACTIONS:

Gastrointestinal side effects are uncommon, as this formulation reduces the risk of both diarrhea and constipation. However, prolonged use of magnesium hydroxide in patients with renal impairment may lead to hypermagnesemia.

 USE IN SPECIFIC POPULATIONS:

Animal studies have shown no direct or indirect harmful effects on pregnancy, fetal development, parturition, or postnatal development. However, caution is advised when prescribing to pregnant women.

OVERDOSAGE:

Serious symptoms are unlikely to follow overdosage.

STORAGE: Store in a cool & dry place, protected from light & moisture below 30°C.

PRESENTATION:200 ml of amber pet bottle with ROPP caps.