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HYDROSIL TABLET

Product Information

Registration Status: Active

SIN03484P

HYDROSIL TABLET is approved to be sold in Singapore with effective from 1989-06-24. It is marketed by APEX PHARMA MARKETING PTE LTD, with the registration number of SIN03484P.

This product contains Aluminium Hydroxide 200mg,Magnesium Hydroxide 200mg, and Simethicone 20mg in the form of TABLET. It is approved for ORAL use.

This product is manufactured by XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD in MALAYSIA.

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

Product Reference
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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.

Pharmacokinetics

Absorption
Approximately 17-30% of the aluminum chloride formed is absorbed.
Distribution
Metabolism
Not metabolized.
Elimination

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 |


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.


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.

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

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.

Active Ingredient/Synonyms

Magnesium dihydroxide | Milk of magnesia | Magnesium hydroxide |


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.


Description

Simethicone is an orally administered antifoaming agent. It is mainly used to reduce gas from the gastrointestinal tract (GIT) in patients complaining from recurrent flatulence. Simethicone is a mixture of polydimethylsiloxane and hydrated silica gel. It exerts its action locally in the GIT, it is not absorbed into the blood stream. The main side effects of simethicone are GIT related including: mild diarrhea, nausea and vomiting.

Indication

1. To relieve pain and discomfort caused by excess gas in the intestine and stomach in cases such as flatulence and post operative gaseous distention. 2. It could be used also prior to an endoscopy to eliminate foam, gas and air from the gastrointestinal tract to reduce gas shadow which will result in better visualization.

Mechanism of Action

Decreases the surface tension of gas bubbles thereby disperses and prevents gas pockets in the GI system.

Pharmacokinetics

Absorption
Not absorbed following oral administration.
Distribution
Simethicone is pharmacologically inert and is not absorbed from the gastrointestinal tract.
Metabolism
The drug is not absorbed and it is excreted in the feces unchanged.
Elimination

Clearance

Excreted unchanged in feces.

Toxicity

LD50 (oral, rat): 4070 mg/Kg.

Active Ingredient/Synonyms

Simeticone | Simethicone |


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.

References

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

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