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Eviline

 

Composition

Each tablet contains

Magnesium Hydroxide B.P. ..... 200mg

Aluminium Hydroxide B.P. ....... 200mg

Simethicone ............................. 20mg

 

Contains Methylparaben 0.1 % w/w as preservative.

Presentation
Flat, white, round tablet, 12.9mm in diameter, marked KOTRA logo on one side.

Indications
Axcel Eviline is an antacid/deflatulent for symptomatic treatment of peptic ulcer, dyspepsia of functional or organic origin, heartburn in hiatus hernia or pregnancy, flatulence and abdominal distension, gastritis oesophagitis and other conditions where hyperacidity or flatulence may be present.

Mechanisms of actions
Axcel Eviline is an antacid used to prevent and relief pain in the symptomatic management of gastric and duodenal ulcers and gastrointestinal reflux by neutralising hydrochloric acid in the gastric secretions. It does not reduce the volume of HCL secreted and may increase it but by increasing the gastric pH which will diminished the activity of pepsin in the gastric secretions. However if the increase of gastric pH is slight, there may be an increase in pepsin activity. Therefore, Axcel Eviline indirectly suppress peptic activity when given in sufficient quantity to elevate the pH of human gastric contents above 5. Between pH 7 and 8, pepsin is irreversibly inactivated. The presence of antacid increases the volume of gastric juice secreted and the output of HCL. Both aluminium and magnesium hydroxide are classified as non-systemic antacids which neutralise the gastric contents but do not cause systemic alkalosis, because the cationic moiety in the intestine form insoluble basic compounds that are not subsequently absorbed. Both aluminium and magnesium hydroxides react with hydrochloric acid in the stomach to form aluminium chloride and magnesium chloride respectively.
 

The insolubility of both the hydroxide compounds is a desirable property in that fractions of sedimented unreacted excess remain in the stomach to yield a sustained effect. Therefore, the product has a prolonged duration of action. The cathartic effect of magnesium hydroxide is minimized by the aluminium hydroxide, which have constipating effects. Aluminium hydroxide is an effective absorbent and interacts with many drugs in the gastrointestinal tract. Polymethylsiloxane, or simethicone, is an antifoaming agent with water-repellent properties. It is an adjunct in the treatment of conditions in which gas is a problem, such as flatulence, functional gastric bloating and postoperative gaseous distension.

Pharmacology
Aluminium hydroxide has a very low equivalent weight and hence a high theoretical neutralising capacity. Proteins, peptides, amino acids and certain dietary organic acids greatly impair the neutralising capacity of Aluminium hydroxide. Although both the hydroxide compounds are classified as non-systemic, some absorption from the gastrointestinal tract does not take place, 5 - 10% of the magnesium can be absorbed. 17 - 31% of dietary aluminium is excreted in the urine and a considerable amount is distributed to bone and lung. In renal failure, the administration of aluminium hydroxide can elevate the plasma aluminium concentration. Among the compounds formed in the intestine from aluminium hydroxide are insoluble aluminium phosphates which pass through the intestinal tract unabsorbed, and excreted in the faeces. Ordinarily the absorbed magnesium ion is rapidly excreted by the kidney. The urine may be alkalinized, which can decreased the excretion of various weakly basic drugs e.g. quinidine.

Dosage
1 - 2 tablets to be chewed or sucked 3 times daily or as required, preferably after meals.

Ccontraindication
No known contraindications.

Side effects
In renal failure, the administration of aluminium hydroxide can elevate the plasma aluminium concentration as high as 53mg/ml. Among compounds form in the intestine from aluminium hydroxide are insoluble aluminium phosphates which pass through the intestinal tract unabsorbed. This can resulting in hypophosphatemia, hypophosphaturia and hypopyrophosphaturia. Phosphate depletion syndrome occasionally observed after chronic aluminium hydroxide ingestion. Patients on therapeutic regimen for peptic ulcer, usually have high phosphate intake. Therefore ingestion of aluminium hydroxide for this patient results in decrease phosphate absorption and accompanied by increase in calcium absorption which along with resorption of bone salts causes hypercalciuria. Hypomagnesaemia and hypomagnaesiuria occur. Aluminium hydroxide is astringent and may cause nausea, vomiting and constipation. Large doses can cause intestinal obstruction and concretion of fatty acid salts of aluminium in stool.

 

Several cases of intestinal obstruction by a large mass composed of clotted blood has been reported. It also reduces absorption of other drugs including tetracycline and vitamins and could delay the absorption of quinidine. Magnesium hydroxide in some patients has its cathartic effect. Although magnesium hydroxide is classified as a non-systemic antacid, 5 - 10% of magnesium can be absorbed. Retention of any absorbed magnesium can cause neurological, neuromuscular and cardiovascular impairment and even death in persons with renal insufficiency. Ordinarily the absorbed magnesium ion is rapidly excreted by the kidney but urine may become alkaline.

 

Alkalinization of the urine decrease the excretion of various weakly basic drugs e.g. quinidine. Magnesium hydroxide increases the absorption of warfarin.

Precautions
Care should be taken in patients suffering from hypophosphataemia and impaired renal function. It is probably wise to avoid administration during the first trimester of pregnancy unless there are compelling reasons for its use. Undesirable drug interactions may results, including reduced absorption of tetracycline and vitamins when given concomitantly.

Overdosage
Hypophosphataemia may be avoided by concurrent high phosphate intake. The effects of hypermagnesaemia may be corrected by the intravenous injection of 10 to 20m1 of 10% Calcium Gluconate Injection.

Storage
Keep container well closed. Store below 30C. Protect from light.

 

Package quantities

Available in loose pack of 1000's and blister pack of 100 x 10's and 10 x 10's.

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