Asynta™ Max Tablet: Each chewable tablet contains Sodium Alginate USP 250 mg, Sodium Bicarbonate BP 106.5 mg & Calcium Carbonate BP 187.5 mg.
ASYNTA™ MAX Suspension: Each 10 ml suspension contains Sodium Alginate USP 500 mg, Sodium Bicarbonate BP 213 mg and Calcium Carbonate BP 325 mg.
The mode of action of the product is physical and does not depend on absorption into the systemic circulation. The product is a combination of two antacids (Calcium Carbonate and Sodium Bicarbonate) and an Alginate. On ingestion, the medicinal product reacts rapidly with gastric acid to form a raft of Alginic Acid gel having a near neutral pH and studies have shown that the raft interacts with and caps the acid pocket in the stomach, reducing esophageal acid exposure. The raft floats on the stomach contents effectively impeding gastro-esophageal reflux, for up to 4 hours, and protecting the esophagus from Acid, Pepsin and Bile. In severe cases, the raft itself may be refluxed into the esophagus, in preference to the stomach contents, and exert a demulcent effect. In addition, in vitro evidence has shown that the raft has a secondary action and is able to entrap bile and pepsin within it structure, further protecting the esophagus from these gastric components. Calcium Carbonate neutralizes gastric acid to provide fast relief from indigestion and heartburn. This effect is increased by the addition of Sodium Bicarbonate which also has a neutralizing action.
Acid regurgitation, heartburn, indigestion and hyperacidity. It can also be used to treat the symptoms of gastroesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
Adults and children 12 years and over: 2-4 tablets or 10-20 ml suspension after meals and at bedtime, up to four times per day. Children under 12 years: Should be given only on medical advice.
USE IN SPECIAL POPULATION:
Pregnancy: Clinical studies in 281 pregnant women did not demonstrate any significant adverse effects on the course of pregnancy or on the health of the foetus/new-born child. This product may be used during pregnancy, if clinically needed.
Breastfeeding: No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This product can be used during breast-feeding if clinically needed.
Elderly: No dose modification necessary.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary.
A time-interval of 2 hours should be considered between intake of this product and the administration of other medicinal products, especially Anti-histamines, Tetracyclines, Digoxine, Fluoroquinolones, Iron salts, Thyroid hormones, Ketoconazole, Neuroleptics, Thyroxine, Penicillamine, Beta-blockers, Glucocorticoid, Chloroquine, Diphosphonates, Estramustine etc.
Suspension contains 127.88 mg Sodium per 10 ml dose, equivalent to 6.4% of the WHO recommended maximum daily intake for Sodium and tablet contains 223.56 mg Sodium per 4 tablets dose, equivalent to 11.18 % of the WHO recommended maximum daily intake for sodium. The maximum daily dose of suspension is equivalent to 51.15% of the WHO recommended maximum daily intake for Sodium and the maximum daily dose of tablet is equivalent to 44.71% of the WHO recommended maximum daily intake for sodium. This product is considered high in Sodium. This should be particularly taken into account for those on a low salt diet (e.g. in some cases of congestive heart failure and renal impairment). Each 20 ml contains 260 mg (6.5 mmol) of Calcium and each 4 tablets contain 300 mg (7.5 mmol) of Calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent Calcium containing renal calculi.
Store below 30°C in dry place. Keep away from light. Keep out of reach of children. Do not refrigerate.