Composition
1 tablet contains: active ingredients: aluminum hydroxide-magnesium carbonate gel 450,0 mg, magnesium hydroxide 300,0 mg; excipients: lactose monohydrate 111,5/112,0/112,0 mg, Manni-tol 110,0/112,0/112,0 mg, starch pregelatinization 32,0/32,0/32,0 mg, silicon dioxide colloid 2,0/2,0/2,0 mg, croscarmellose sodium (type A) 50,0/50,0/50,0 mg aspartame 2,5/2,0/2,0 mg, magnesium stearate 6,0/6,0/6,0 mg, mint flavor 11890-71 (tablets mint) 6.0 mg or cherry flavoring E 9407963 (tablets cherry) 4.0 mg or orange flavor 1013042 (tablets orange) 4,0 mg.
Pharmacological properties
pharmacotherapeutic group: anti-acid Crestwood ATKH: 02 Farmakologicheskie And soilformation. Gastal® is a combined antacid that reduces the increased acidity of gastric juice and does not have a stimulating effect on the secretion of gastric juice. Aluminum hydroxide-magnesium carbonate gel and magnesium hydroxide provide immediate (immediately after ingestion) and prolonged (about 2 hours) neutralization of hydrochloric acid of gastric juice, while maintaining the acidity in the stomach at a physiological level (pH 3-5). One tablet of Gastal® neutralizes 21.5 mmol of hydrochloric acid. The drug Gastal® suppresses the action of pepsin, lysolecithin and bile acids, eliminates dyspeptic phenomena. Enhances protective and regenerative processes in the gastric mucosa. Aluminum ions have a cytoprotective effect by increasing the secretion of mucin and sodium bicarbonate, activating prostaglandin E2 and NO, accumulating epidermal growth factor at the site of mucosal damage, and increasing the concentration of phospholipids in the stomach walls. Pharmacokinetics. Gastal® does not have a systemic effect in patients with normal renal function. After reacting with the hydrochloric acid of gastric juice, aluminum hydroxide reacts with phosphates and carbonates in the alkaline environment of the intestine and is excreted in the feces as insoluble salts. Magnesium hydroxide reacts with hydrochloric acid in gastric juice to form magnesium chloride, which has osmotic properties and a mild laxative effect that neutralizes the fixing effect of aluminum hydroxide in the small intestine. Magnesium ions are excreted in the feces as insoluble carbonate.
Indications
heartburn (including after use of drugs, alcohol, coffee, errors in the diet, the abuse of nicotine);
— state, accompanied by increased acid production in the stomach: gastritis, peptic ulcer and duodenal ulcer;
symptomatic ulcers of various origin;
— erosion of the gastric mucosa of the upper gastrointestinal tract;
— reflux esophagitis;
— hernia hiatal;
acute pancreatitis, exacerbation of chronic pancreatitis (as part of combination therapy);
— fermentative or putrefactive dyspepsia (in combination therapy).
Contraindications
Hypersensitivity to aluminum, magnesium or other components of the drug; severe renal failure; Alzheimer’s disease; hypophosphatemia; lactose intolerance, lactase deficiency or glucose-galactose malabsorption; children under 6 years of age. Use caution in chronic renal failure (CRF), pregnancy and lactation, adults and children over 12 years of age with a body weight of less than 50 kg, children aged 6-12 years, the elderly.
Side effects
When using the drug in the recommended doses, adverse reactions are rare (not less than 0.01%, but less than 0.1%): nausea, constipation, diarrhea, changes in taste sensations. In exceptional cases, allergic reactions are possible.
Interaction
The drug Gastal® when used simultaneously increases the activity of levodopa and nalidixic acid, reduces and slows down the absorption of quinolones, isoniazid, naproxen, iron preparations, Indometacin, aminazine, beta-blockers, diflunisal, H2-histamine receptor blockers, fat-soluble vitamins, indirect anticoagulants, barbiturates.
When interacting with metal ions that make up antacids, tetracyclines form insoluble chelate complexes; as a result of this interaction, the absorption of tetracyclines decreases by more than 90%. Simultaneous use of these drugs is not possible. If combined use is necessary, tetracycline should be taken at least 2 hours before taking the antacid.
In the presence of aluminum and magnesium hydroxides contained in the antacid, the absorption of ciprofloxacin and ofloxacin decreases by 50-90%.
In the presence of antacids, the bioavailability of captopril is significantly reduced, and the combined use of antacids and metoprolol leads to a decrease in the concentration of metoprolol in blood plasma.
Concomitant use of high doses of antacids may reduce the absorption of ranitidine by 10-33%.
The use of antacids does not affect the bioavailability of amoxicillin, cephalexin and the combination of amoxicillin and clavulanic acid, but it can significantly reduce the absorption of doxycycline from the gastrointestinal tract.
An increase in the pH of urine during antacid therapy can increase the tubular reabsorption of basic (alkaline) drugs and reduce the reabsorption of acidic compounds. Antacids can reduce and slow down the absorption of salicylates, including acetylsalicylic acid, and also, by increasing the pH of urine, promote faster excretion of salicylates in the urine from the body, with a concomitant decrease in their concentration in the blood serum by 30-70%.
The absorption of cardiac glycosides, including digoxin and digitoxin, does not significantly decrease when used concomitantly with antacids.
M-holinoblockers, slowing down the motility of the stomach, increase the duration of action of the drug Gastal®.
In order to prevent possible interaction of Gastal® with other medications, it is recommended to take it 1 hour before or 1 hour after their use.
How to take, course of use and dosage
Inside, gradually dissolving in the mouth.
Adults and children over 12 years of age with a body weight of at least 50 kg
1-2 tablets 4-6 times a day approximately 1 hour after meals and before bedtime, but no more than 8 tablets per day. The duration of admission is not more than 2 weeks.
Similar doses are recommended for treating heartburn regardless of food intake.
Adults and children over 12 years of age with a body weight of less than 50 kg, children aged 6-12 years
The dose is half of the recommended dose for adults and children over 12 years of age with a body weight of at least 50 kg. The duration of admission is not more than 2 weeks.
Patients with CRF
No dose adjustment is required. The duration of admission is not more than 2 weeks.
Overdose
Symptoms of acute overdose are not described. With prolonged use of high doses of drugs containing aluminum and magnesium, hypophosphatemia, hypocalcemia, hypercalciuria, osteomalacia, osteoporosis, hypermagnesemia, hyperaluminemia, encephalopathy, nephrocalcinosis and impaired renal function may develop. It is possible to develop more pronounced adverse reactions from the gastrointestinal tract (GIT) (constipation, diarrhea), in patients with renal insufficiency – thirst, low blood pressure, hyporeflexia. Treatment: symptomatic therapy.
Special instructions
In patients with low body weight and in children over the age of 6 years, Gastal® should be used in smaller doses and for a shorter period of time.
In patients with impaired renal function, it is not recommended to use Gastal® in doses higher than recommended, and for a longer time.
Continuous admission for more than 2 weeks is possible only with a doctor’s appointment.
Form of production
Tablets for resorption
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of the reach of children.
Shelf life
3 years
Active ingredient
Hydrothalcite, Magnesium Hydroxide
Dosage form
tablets for resorption
Description
Children over 6 years of age, Pregnant women as prescribed by a doctor, Nursing mothers as prescribed by a doctor, For adults
Indications
Heartburn, Gastritis, Reflux Esophagitis, Chronic pancreatitis, Gastric Ulcer and Duodenal ulcer
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Side effects of Gastal, mint lozenges 12pcs.
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