GELUSIL PLUS TABLET (REVISED FORMULA)

Aluminium Hydroxide
Magnesium Hydroxide
Methylpolysiloxane

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

Aluminium hydroxide | Aluminium hydroxide gel, dried | Aluminium hydroxide, dried | Aluminum hydroxide gel, dried | Aluminum hydroxide, dried | Dried aluminium hydroxide | Dried aluminum hydroxide gel | Aluminum hydroxide |

Description

Aluminum hydroxide is an inorganic salt used as an antacid. It is a basic compound that acts by neutralizing hydrochloric acid in gastric secretions. Subsequent increases in pH may inhibit the action of pepsin. An increase in bicarbonate ions and prostaglandins may also confer cytoprotective effects.

Indication

For relief of heartburn and acid indigestion.

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. Cytoprotective effects may occur through increases in bicarbonate ion (HCO3-) and prostaglandins.

Pharmacodynamics

Gastric-peptic disease occurs as a result of an imbalance between protective factors, such as mucus, bicarbonate, and prostaglandin secretion, and aggressive factors, such as hydrochloric acid, pepsin, and Helicobacter pylori (H. pylori). Antacids work by restoring acid-base balance, attenuating the pepsin activity and increasing bicarbonate and prostaglandin secretion.

Pharmacokinetics

Absorption:

Approximately 17-30% of the aluminum chloride formed is absorbed.

Distribution:

Not Available

Metabolism:

Not metabolized.

Elimination:

Absorbed aluminum chloride is rapidly eliminated by the kidneys in patients with normal renal function.

Half-life

Not Available

Clearance

Not Available

Toxicity

Not Available

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

Magnesium dihydroxide | Milk of magnesia | Magnesium hydroxide |

Description

Magnesium hydroxide is an inorganic compound with the chemical formula Mg(OH)2. It is naturally found as the mineral brucite. Magnesium hydroxide can be used an antacid or a laxative in either an oral liquid suspension or chewable tablet form. Additionally, magnesium hydroxide has smoke supressing and flame retardant properties and is thus used commercially as a fire retardant. It can also be used topically as an antiperspirant underarm deodorant or for relief of canker sores (aphthous ulcers).

Indication

Magnesium hydroxide can be used as an antacid or a laxative depending on the administered dose. As an antacid, it is used for the temporary relief of heartburn, upset stomach, sour stomach or acid indigestion. As a laxative, it is used for the relief of occasional constipation by promoting bowel movements for 30 minutes and up to 6 hours.

Mechanism of Action

The suspension of magnesium hydroxide is ingested and enters the stomach. According to the amount ingested, the magnesium hydroxide will either act as an antacid or a laxative. Through the ingestion of 0.5-1.5 grams (in adults) the magnesium hydroxide will act by simple acid neutralization 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. Through the ingestion of 2-5 grams (in adults) the magnesium hydroxide acts as a laxative in the colon. The majority of the suspension is not absorbed in the intestinal tract and will create an osmotic effect to draw water into the gut from surrounding tissues. With this increase of water in the intestines, the feces will soften and the intraluminal volume of the feces will increase. These effects still stimulate intestinal motility and induce the urge to defecate. Magnesium hydroxide will also release cholecystokinin (CKK) in the intestines which will accumulate water and electrolytes in the lumen and furthermore increase intestinal motility.

Pharmacodynamics

As an antacid, magnesium hydroxide suspension neutralizes gastric acid by reacting with hydrochloric acid in the stomach to form magnesium chloride and water. It is practically insoluble in water and does not have any effect until it reacts with the hydrochloric acid in the stomach. There, it decreases the direct acid irritant effect and increases the pH in the stomach leading to inactivation of pepsin. Magnesium hydroxide enhances the integrity of the mucosal barrier of the stomach as well as improving the tone of both the gastric and esophageal sphincters. As a laxative, the magnesium hydroxide works by increasing the osmotic effect in the intestinal tract and drawing water in. This creates distension of the colon which results in an increase in peristaltic movement and bowel evacuation.

Pharmacokinetics

Absorption:

About 15%-50% of magnesium hydroxide is absorbed very slowly through the small intestine.

Distribution:

The peak action and distribution of magnesium hydroxide are variable.

Metabolism:

Unless a patient is deficient in magnesium, very little is absorbed by the intestine. Overall, about 15%-50% of the magnesium hydroxide suspension is absorbed systemically. However, it does not undergo any metabolism as it is rapidly excreted in the urine.

Elimination:

After oral administration, up to 50% of the magnesium hydroxide suspension may be absorbed as magnesium ions through the small intestines and then rapidly excreted in the urine through the kidneys. The unabsorbed drug is mainly excreted in the feces and saliva.

Half-life

N/A

Clearance

Magnesium hydroxide is mainly excreted in the urine by the kidneys. Since the kidneys play a major role in its clearance, individuals with renal failure are at risk of hypermagnesemia with long term consumption as the appropriate amounts of magnesium may not be excreted.

Toxicity

LD50=8500 mg/kg (rat, oral) Common side effects include drowsiness or flushing (warmth, redness or tingly feeling). Daily use of magnesium hydroxide can result in fluid and electrolyte disturbances. Excessive use of the laxative effects of magnesium hydroxide may result in abdominal cramping, nausea and/or diarrhea. In overdose, symptoms of gastrointestinal irritation and/or watery diarrhea may occur. Magnesium hydroxide poisoning can result in hypermagnesemia which includes symptoms of: nausea, vomiting, flushing, thirst, hypotension, drowsiness, confusion, loss of tendon reflexes, muscle weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest. Not to be used in individuals with any form of kidney disease or renal failure, a magnesium restricted diet or with any sudden changes in bowel movement lasting over two weeks. Also not to be used in those individuals with abdominal pain, nausea, vomiting, symptoms of appendicitis or myocardial damage, heart block, fecal impaction, rectal fissures, intestinal obstruction or perforation or renal disease. Not to be used in women who are about to deliver as magnesium crosses the placenta and is excreted in small amounts in breast milk. Using magnesium hydroxide with aluminum hydroxide can decrease the absorption rate of these drugs. Magnesium hydroxide can react with digoxin, dicoumerol and cimetidine. Use of ibuprofen with magnesium hydroxide can increase the absorption of the ibuprofen. Use of magnesium hydroxide with penicallamine, bisphosphates, ketoconazole, quinolones or tetracycline can decrease the absorption of these drugs. Enteric-coated tablets can be prematurely released when taken with magnesium hydroxide. It is important to routinely monitor levels of serum magnesium and potassium in patients using magnesium hydroxide. Serum magnesium levels are necessary to determine how much magnesium is being absorbed and how much is being excreted by the kidneys. Excessive diarrhea can occur from use of magnesium hydroxide and thus it is important to also monitor serum potassium levels to ensure hypokalemia does not occur.

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

Not Available

Description

Not Available

Indication

Not Available

Mechanism of Action

Not Available

Pharmacodynamics

Not Available

Pharmacokinetics

Absorption:

Not Available

Distribution:

Not Available

Metabolism:

Not Available

Elimination:

Not Available

Half-life

Not Available

Clearance

Not Available

Toxicity

Not Available

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

GELUSIL PLUS TABLET (REVISED FORMULA) was registered with Health Science Authority of Singapore by JOHNSON & JOHNSON PTE LTD. It is marketed with the registration number of SIN11367P with effective from 2000-10-08.

This product contains 200mg of Aluminium Hydroxide, 200mg of Magnesium Hydroxide, and 20mg of Methylpolysiloxane in the form of TABLET.

The medicine was manufactured by PT BAYER INDONESIA in INDONESIA

It is a an Over-the-counter Medicine which can be freely obtained from any retailer

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: A02AF02

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