Aluminum oxide, Magnesium oxide

Pharmacological properties

Almagel is a balanced combination of aluminum hydroxide and magnesium hydroxide. the drug has an antacid effect when applying the recommended single dose (40-60 minutes after eating) or a daily dose during the day. aluminum hydroxide neutralizes the increased secretion of hydrochloric acid and reduces the activity of pepsin in the stomach, forming aluminum chloride, which, under the influence of the alkaline contents of the intestine, turns into alkaline aluminum salts. they are slightly absorbed and practically do not change the concentration of aluminum salts in the blood with a short application of almagel (15–20 days). aluminum hydroxide reduces the concentration of phosphates, binding phosphate ions in the intestine and thereby limiting their absorption. the use of the drug does not cause alkalosis and does not contribute to the formation of co2 in the stomach. Magnesium hydroxide also neutralizes hydrochloric acid in the stomach, turning into magnesium chloride, which has a slight laxative effect.

Almagel, like other antacids containing aluminum, exhibits a cytoprotective effect on the gastric mucosa due to the stimulation of prostaglandin synthesis. This increases its stability and protects against necrotic inflammatory and erosive hemorrhagic lesions due to the use of irritating and ulcerogenic agents, such as acetylsalicylic acid, NSAIDs, ethanol. On the other hand, aluminum hydroxide has a pronounced astringent and anti-inflammatory effect on the inflamed mucous membrane of the stomach and duodenum when using the drug 10-15 minutes before eating.

Sorbitol has a mild carminative and moderate choleretic effect, as well as a mild laxative effect that compensates for the tendency of constipation in most patients to the action of aluminum hydroxide.

Pharmacokinetics Aluminum salts are slightly absorbed in the intestines and excreted in the feces. With normal kidney function, the plasma level of aluminum remains virtually unchanged. Magnesium ions are absorbed only by 10%, and their concentration in the blood almost does not change. The duration of action depends on the rate of emptying of the stomach. When applied on an empty stomach, it varies from 20 to 60 minutes. When used 1 hour after a meal, the antacid effect can last up to 3 hours.

Indications

Symptomatic treatment of diseases of the digestive tract accompanied by increased acidity of the gastric juice, such as esophagitis, hiatal hernia, gastroesophageal reflux disease, acute and chronic gastritis, gastroduodenitis, gastric ulcer and duodenal ulcer, gastrointestinal reflux disease and gastrointestinal tract gastritis .

Prophylactically to reduce the irritating and ulcerogenic effects of certain drugs on the mucous membrane of the esophagus, stomach and duodenum (e.g. corticosteroids, NSAIDs).

Application

Symptomatic treatment of diseases of the digestive tract, accompanied by increased acidity of the gastric juice. adults and children over the age of 14 years - 5-10 ml (1-2 scoops) 3 times a day or 1 sachet 3 times a day. if necessary, a single dose can be increased to 15 ml - 3 measured (dosage) spoons. after reaching the therapeutic effect, reduce the dose to 5 ml 3-4 times a day for 2-3 months. Do not drink water for 15 minutes after using the drug.

In order to achieve a symptomatic antacid effect, Almagel is usually used 45-60 minutes after eating and in the evening before bedtime.

For prevention. Adults and children over the age of 14 years - 5-15 ml (1-3 measured spoons) or 1 sachet 15 minutes before taking medications that irritate the mucous membrane of the esophagus, stomach or duodenum.For children aged 10-14 years, prescribe half the dose recommended by adults. Recommended treatment duration is 12 days.

In the case of prescribing the drug in a single dose of 5 or 15 ml, it is recommended to use Almagel in bottles, since this type of package provides a dosage spoon, which makes it possible to accurately measure the required volume of the drug.

Before use, the suspension must be thoroughly homogenized by shaking the bottle or kneading the bag. Measuring the required amount of the drug from the vial occurs using a dosage spoon, which is contained in the kit. When using the drug in sachets, the following recommendations must be observed: keep the bag upright, cut or tear off one of the corners in the designated place. Pour the contents of the sachet through the opening of the sachet into a spoon or directly into the oral cavity.

Patients with renal failure. In the treatment of patients with impaired renal function, it is necessary to reduce the dose or increase the interval between doses.

Children. Do not use in children under the age of 10 years due to the impossibility of accurate dosing.

Contraindications

The drug is not recommended for use with hypersensitivity to its components, habitual constipation, Alzheimers disease, intense abdominal pain of unspecified genesis, suspected acute appendicitis, ulcerative colitis, colostomy or ileostomy, chronic diarrhea, hemorrhoids, severe renal failure, hypophosphatemia lactation period.

Side effects

From the digestive tract: possible manifestations of constipation, which disappear with a decrease in dose, diarrhea; discoloration of feces, nausea, vomiting, stomach cramps;

laboratory indicators: most often in patients with renal failure and in the case of prolonged use or taking the drug in high doses due to hypermagnesemia, hyperaluminemia, intoxication with magnesium and aluminum develops; hypophosphatemia (manifestations of which may be a decrease in appetite, muscle weakness, weight loss); possible hypocalcemia, hypercalciuria;

from the kidneys and urinary tract: nephrocalcinosis, impaired renal function;

hypersensitivity reactions: allergic reactions of local and general type, including pruritus, urticaria, angioneurotic and anaphylactic reactions, bronchospasm;

from the side of the central nervous system: with prolonged use of the drug in patients with renal failure and patients on dialysis, manifestations of encephalopathy, neurotoxicity (changes in mood and mental activity) are possible; dementia, Alzheimers disease;

from the musculoskeletal system: osteoporosis; with prolonged use of the drug in high doses against a background of phosphorus deficiency in food, osteomalacia may occur;

others: a change in taste.

With prolonged use of the drug in patients with renal failure and in patients undergoing dialysis, thirst, decreased blood pressure, hyporeflexia, and the development of microcytic anemia are possible.

special instructions

The drug is not recommended for patients with diverticulosis, acid-base imbalance in the body in the presence of metabolic alkalosis, cirrhosis of the liver, severe heart failure, toxicosis of pregnant women, and renal impairment (due to the risk of hypermagnesemia and aluminum intoxication).

Patients need to see a doctor in case of weight loss, difficulty swallowing or a constant feeling of discomfort in the abdomen, the first occurrence of digestive disorders or when the course of existing digestive disorders changes.

Aluminum hydroxide can cause constipation, and magnesium hydroxide can lead to intestinal hypokinesia.The use of this drug in high doses can cause or aggravate bowel obstruction and intestinal obstruction, especially in patients with an increased risk of such complications, for example, patients with renal failure or elderly patients.

The use of antacids containing aluminum in elderly patients should be limited. With prolonged use in elderly patients, the state of existing diseases of bones and joints may worsen.

With prolonged use of the drug, it is necessary to ensure that a sufficient amount of phosphorus is ingested, since aluminum hydroxide binds to phosphates and reduces their absorption from the digestive tract. Excretion of calcium in the urine increases, which can lead to impaired calcium-phosphate balance and create conditions for the development of osteomalacia (symptoms - complaints of weakness and bone pain). Aluminum hydroxide can be dangerous when used in patients with porphyria undergoing hemodialysis.

With prolonged use (14 days), regular monitoring by a doctor and monitoring of the plasma levels of magnesium and aluminum in the treatment of patients with renal failure are necessary. In this category of patients, it is also necessary to control the dynamics of the state of the kidneys, the size of the ulcer, the appearance of diarrhea.

During treatment, it is not recommended to drink alcohol and caffeine due to a decrease in the effect of the drug.

Excipients. The drug contains sorbitol, which allows it to be taken by patients with diabetes mellitus, but should not be used in patients with congenital fructose intolerance, as this can cause stomach irritation and diarrhea.

The drug contains parabens that can provoke urticaria and very rarely allergic reactions of an immediate type - bronchospasm.

The drug contains ethyl alcohol, as a result of which complications may occur in patients with diseases of the liver and brain, in patients with epilepsy and alcoholism, in pregnant women and children under the age of 10 years.

Use during pregnancy and lactation. There are no data from clinical studies on the use of Almagel in pregnant women, so the drug is not recommended for use during pregnancy. If necessary, Almagel can be used during pregnancy only as prescribed by the doctor, if the expected benefit to the mother outweighs the possible risk to the fetus / child. In this case, the drug is recommended to be used no more than 5-6 days and only under the supervision of a doctor.

The content of aluminum and magnesium ions that can affect the transit of gastrointestinal contents should be taken into account, namely:

• magnesium hydroxide salts can cause diarrhea;
• aluminum salts can cause constipation, which can worsen the course of constipation, which quite often occurs during pregnancy, so prolonged use and excessive doses of the drug should be avoided.

The drug is not recommended for pregnant women with toxicosis.

Lactation. There is no data on the ability of the active substances of the drug to pass into breast milk, therefore, if treatment is necessary for them, breast-feeding should be discontinued.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Ethanol contained in the preparation in the indicated amount cannot affect the ability to drive vehicles or work with mechanisms when taking it in the recommended daily doses.

Interactions

The interval between the use of almagel and other drugs should be ≥1–2 hours.

Almagel changes the acidity of the contents of the stomach, which affects the absorption, bioavailability, maximum plasma concentrations, as well as the excretion of most drugs with simultaneous use.

Almagel reduces the absorption of digoxin, indomethacin, salicylates, chlorpromazine, phenytoin, reserpine, N blockers₂receptor antagonists (cimetidine, ranitidine, famotidine), lansoprazole, β-adrenoceptor blockers (eg atenolol, metoprolol, propranolol), chloroquine, cyclin, diflunisal, diphosphonates, quinolones (ciprofloxacin, norfloxacin, ofloxacin, enoxacin, grepafloksatsin) azithromycin, cefpodoxime, pivampicillin, rifampicin, indirect anticoagulants, barbiturates, fexofenadine, sodium fluoride, dipyridamole, zalcitabine, bile acids (chenodeoxycholic and ursodeoxycholic acids), penicillamine, digitalis glycosides, iron salts, prep lithium, quinidine, mexiletine, phenothiazine drugs, tetracycline antibiotics, lincosamides, phosphorus (additives), anti-tuberculosis drugs (ethambutol, isoniazid for oral administration), chloroquine, glucocorticoid drugs (known to interact with prednisolone and dexamethasone). Therefore, if possible, the time interval between taking Almagel and these drugs should be 2 hours.

Lower absorption of these drugs is associated with the formation of insoluble complexes and / or alkalization of the contents of the stomach.

With the simultaneous use of enteric-soluble drugs, the increased alkalinity of gastric juice can lead to accelerated destruction of their membrane and cause irritation of the stomach and duodenum.

M-cholinergic blockers slow down gastric emptying and enhance, prolong the action of Almagel.

Withdrawal of quinidine with manifestations of quinidine toxicity may be impaired, especially in patients with renal failure. The simultaneous use of aluminum hydroxide and citrates can lead to an increase in aluminum levels, especially in patients with renal failure. The drug may decrease the absorption of folic acid.

When combined with levothyroxine, a decrease in its hormonal effect is possible.

Pirenzepine enhances and prolongs the action of Almagel.

Influence on laboratory research. Almagel can affect the results of certain laboratory and functional studies and tests: it reduces the level of gastric secretion in determining its acidity; violates the test for visualization of diverticulum and bone scintigraphy using technetium (⁹⁹Tc); moderately and for a short time increases the plasma level of gastrin, increases the plasma level of phosphorus, pH of blood plasma and urine.

Overdose

With a single random dose of the drug in high doses, there are no signs of an overdose other than constipation, flatulence, a metallic taste in the mouth.

With prolonged use of the drug in high doses, the formation of kidney stones, the appearance of severe constipation, abdominal pain, drowsiness, hypermagnesemia are possible. There may also be signs of metabolic alkalosis - a change in mood or mental activity, numbness or muscle pain, nervousness or fatigue, respiratory depression, unpleasant taste sensations.

Treatment: immediate steps must be taken to quickly remove the drug - rinse the stomach, induce vomiting, take enterosorbents. In case of an overdose of magnesium, rehydration, forced diuresis is recommended. You can apply calcium gluconate iv. In case of renal failure, hemodialysis or peritoneal dialysis is necessary.

Storage conditions

Store at a temperature of ≤25 ° C in the original packaging. do not freeze.

Medicinal product information for healthcare professionals.