Almagel oral suspension 10ml x 20 sachets — Made in Bulgaria — Free Delivery
(Almagel )
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Description Almagel oral suspension 10ml x 20 sachets — Made in Bulgaria — Free Delivery
Pharmacological properties
Pharmacodynamics. Almagel is a balanced combination of aluminum hydroxide and magnesium hydroxide. The preparation has an antacid effect when using the recommended one-time (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 poorly absorbed and practically do not change the concentration of aluminum salts in the blood with a short use of Almagel (15–20 days). Aluminum hydroxide reduces the concentration of phosphates by binding phosphate ions in the intestine and thus limiting their absorption. the use of the preparation 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, converting to magnesium chloride, which has a mild 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 resistance 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 exhibits a pronounced astringent and anti-inflammatory effect on the inflamed mucous membrane of the stomach and duodenum when the preparation is used 10-15 minutes before meals.
Sorbitol has a mild carminative and moderate choleretic effect, as well as a moderate laxative effect, which compensates for the tendency to constipation in most patients under the influence of aluminum hydroxide.
Pharmacokinetics. Aluminum salts are absorbed slightly in the intestines and excreted in the feces. With normal renal function, the plasma level of aluminum remains practically unchanged. Magnesium ions are absorbed only by 10%, and their concentration in the blood remains almost unchanged. The duration of action depends on the rate of gastric emptying. When applied on an empty stomach, it varies from 20 to 60 minutes. When applied 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 gastric juice, such as esophagitis, hiatal hernia, gastroesophageal reflux disease, acute and chronic gastritis, gastroduodenitis, gastric ulcer and duodenal ulcer, gastroesophageal gastrointestinal tractitis and reflux disease) ...
Prophylactically to reduce the irritating and ulcerogenic effect of certain preparations on the mucous membrane of the esophagus, stomach and duodenum (for example, corticosteroids, NSAIDs).
Application
Symptomatic treatment of diseases of the digestive tract, accompanied by increased acidity of 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 measuring (dosage) spoons. after reaching the therapeutic effect, the dose should be reduced to 5 ml 3-4 times a day for 2-3 months. within 15 minutes after using the preparation, you should not drink water.
In order to achieve a symptomatic antacid effect, Almagel is usually used 45-60 minutes after meals and in the evening before bedtime.
For prevention. Adults and children over the age of 14 years - 5-15 ml (1-3 scoops) 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, give half the dose recommended for adults. The recommended duration of treatment is 12 days.
In the case of prescribing the preparation in a single dose of 5 or 15 ml, it is recommended to use Almagel in vials, since this type of packaging provides a dosage spoon, which makes it possible to accurately measure the required volume of the preparation.
Before use, the suspension must be thoroughly homogenized by shaking the bottle or kneading the sachet. Measurement of the required amount of the preparation from the vial occurs using the dosage spoon, which is contained in the kit. When using the preparation in sachets, the following recommendations must be observed: keep the package 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 mouth.
Patients with renal impairment. When treating 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 10 years of age due to the impossibility of accurate dosing.
Contraindications
The preparation is not recommended for use in case of hypersensitivity to its components, habitual constipation, Alzheimer's disease, intense abdominal pain of unspecified origin, suspected acute appendicitis, the presence of ulcerative colitis, colostomy or ileostomy, with chronic diarrhea, hemorrhoids, severe renal failure, hypophosphatemia, in lactation period.
Side effects
From the gastrointestinal tract: manifestations of constipation are possible, which disappear when the dose is reduced, 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 preparation in high doses due to hypermagnesemia, hyperaluminaemia, intoxication with magnesium and aluminum develops; hypophosphatemia (manifestations of which may be decreased appetite, muscle weakness, weight loss); possible hypocalcemia, hypercalciuria;
from the kidneys and urinary tract: nephrocalcinosis, impaired renal function;
hypersensitivity reactions: local and general allergic reactions, including pruritus, urticaria, angioedema and anaphylactic reactions, bronchospasm;
from the side of the central nervous system: with prolonged use of the preparation in patients with renal failure and patients on dialysis, manifestations of encephalopathy, neurotoxicity (changes in mood and mental activity) are possible; dementia, disorders of the condition in Alzheimer's disease;
on the part of the musculoskeletal system: osteoporosis; with prolonged use of the preparation in high doses against a background of phosphorus deficiency in food, osteomalacia may occur;
others: change in taste.
With prolonged use of the preparation in patients with renal failure and in patients on dialysis, manifestations of thirst, a decrease in blood pressure, hyporeflexia, and the development of microcytic anemia are possible.
Special instructions
It is not recommended to use the preparation in patients with diverticulosis, violations of acid-base balance in the body in the presence of metabolic alkalosis, with cirrhosis of the liver, severe heart failure, toxicosis of pregnant women, renal disorders (due to the risk of developing hypermagnesemia and aluminum intoxication).
Patients should consult a doctor in case of weight loss, difficulty swallowing or persistent abdominal discomfort, new-onset digestive disorders, or if the course of existing digestive disorders changes.
Aluminum hydroxide can lead to constipation, and magnesium hydroxide can lead to intestinal hypokinesia. The use of this preparation in high doses can cause or worsen bowel obstruction and intestinal obstruction, especially in patients at increased risk of such complications, such as those with renal insufficiency or elderly patients.
The use of antacids containing aluminum in elderly patients should be limited. With prolonged use in elderly patients, the condition of existing diseases of the bones and joints may worsen.
With prolonged use of the preparation, it is necessary to ensure that a sufficient amount of phosphorus is supplied to the body, since aluminum hydroxide binds to phosphates and reduces their absorption from the digestive tract. The excretion of calcium in the urine increases, which can lead to disturbances in calcium-phosphate balance and create conditions for the development of osteomalacia (symptoms are complaints of weakness and pain in the bones). Aluminum hydroxide can be hazardous when used in patients with porphyria on hemodialysis.
With prolonged use (14 days), regular monitoring by a physician and monitoring of the plasma levels of magnesium and aluminum is necessary in the treatment of patients with renal insufficiency. In this category of patients, it is also necessary to monitor the dynamics of the indicators of the state of the kidneys, the size of the ulcer, the appearance of diarrhea.
During treatment, it is not recommended to consume alcohol and caffeine due to a decrease in the effect of the preparation.
Excipients. The preparation contains sorbitol, which allows diabetic patients to take it, but should not be used in patients with congenital fructose intolerance, as this can cause stomach irritation and diarrhea.
The preparation contains parabens, which can provoke urticaria and very rarely - allergic reactions of an immediate type - bronchospasm.
The preparation contains ethyl alcohol, as a result of which complications may occur in patients with liver and brain diseases, in patients with epilepsy and alcoholism, in pregnant women and children under 10 years of age.
Use during pregnancy and lactation. There are no data from clinical studies on the use of Almagel in pregnant women, therefore, the preparation is not recommended for use during pregnancy. If necessary, Almagel can be used during pregnancy only as directed by a doctor, if the expected benefit to the mother outweighs the possible risk to the fetus / child. In this case, the preparation is recommended to be used for no more than 5-6 days and only under medical supervision.
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 often occurs during pregnancy, therefore, prolonged use and excess doses of the preparation should be avoided.
The preparation is not recommended to be prescribed for toxicosis of pregnant women.
Lactation. There is no data on the ability of the active substances of the preparation to penetrate into breast milk, therefore, if treatment is necessary, breastfeeding should be discontinued.
The ability to influence the reaction rate when driving or working with other mechanisms. Ethanol contained in the preparation in the indicated amount cannot affect the ability to drive vehicles or operate machinery when taken in recommended daily doses.
Interactions
The interval between the use of Almagel and other medicines should be ≥1–2 hours.
Almagel changes the acidity of the contents of the stomach, which affects absorption, bioavailability, maximum plasma concentrations, as well as the elimination of most preparations when used simultaneously.
Almagel reduces the absorption of digoxin, indomethacin, salicylates, chlorpromazine, phenytoin, reserpine, H2-receptor blockers (cimetidine, ranitidine, famotidine), lansoprazole, β-adrenergic receptor blockers (for example, atenolol, metoprolatov, chlorofluorone) quinolones (ciprofloxacin, norfloxacin, ofloxacin, enoxacin, grepafloxacin), azithromycin, cefpodoxime, pivampicillin, rifampicin, indirect anticoagulants, barbiturates, fexofenadine, sodium fluoride, dipyridoxidamole, bile acid iron, lithium preparations, quinidine, mexiletine, phenothiazine preparations, tetracycline antibiotics, lincosamides, phosphorus (additives), anti-tuberculosis preparations (ethambutol, oral isoniazid), chloroquine, glucocorticoid preparations (known to interact with prednisolone) and ceksayetazelate ola. Therefore, if possible, the time interval between taking Almagel and these preparations should be 2 hours.
The lower absorption of these preparations is associated with the formation of insoluble complexes and / or alkalization of the stomach contents.
With the simultaneous use of enteric-soluble preparations, the increased alkalinity of gastric juice can lead to accelerated destruction of their membrane and cause irritation of the stomach and duodenum.
Blockers of M-cholinergic receptors slow down gastric emptying and enhance, prolong the action of Almagel.
Excretion of quinidine with manifestations of quinidine toxicity may be impaired, especially in patients with renal insufficiency. The simultaneous use of aluminum hydroxide and citrates can lead to an increase in the level of aluminum, especially in patients with renal insufficiency. The preparation can reduce the absorption of folic acid.
When combined with levothyroxine, its hormonal effect may be reduced.
Pirenzepine enhances and prolongs the action of Almagel.
Impact on laboratory research. Almagel can affect the results of some laboratory and functional studies and tests: it reduces the level of gastric secretion when determining its acidity; violates the test of visualization of diverticula and bone scintigraphy using technetium (99Tc); moderately and for a short time increases the plasma level of gastrin, increases the plasma level of phosphorus, the pH of blood plasma and urine.
Overdose
With a single accidental intake of the preparation in a high dose, there are no other signs of an overdose other than constipation, flatulence, a feeling of a metallic taste in the mouth.
With prolonged use of the preparation in high doses, the formation of kidney stones, the appearance of severe constipation, abdominal pain, drowsiness, and hypermagnesemia are possible. Signs of metabolic alkalosis may also occur - changes in mood or mental activity, numbness or muscle pain, nervousness or fatigue, slow breathing, unpleasant taste sensations.
Treatment: it is necessary to immediately take measures for the rapid elimination of the preparation - rinse the stomach, induce vomiting, take enterosorbents. In case of an overdose of magnesium, rehydration and forced diuresis are recommended. You can use calcium gluconate IV. In case of renal failure, hemodialysis or peritoneal dialysis is necessary.
Storage conditions
Store at ≤25 ° c in original packaging. do not freeze.
Tags: Almagel
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