Instructions Almagel oral suspension bottle 170 ml
Composition
active ingredients:
5 ml of suspension (one measuring spoon) contains:
aluminum hydroxide gel 2.18 g; calculated as aluminum oxide 218 mg; magnesium hydroxide paste 350 mg; calculated as magnesium oxide 75 mg;
excipients: sorbitol (E 420), hydroxyethyl cellulose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), butyl parahydroxybenzoate, sodium saccharin, lemon oil, ethanol 96%, purified water, hydrogen peroxide solution (30%), propylene glycol, macrogol 4000.
Dosage form
Oral suspension.
Main physicochemical properties: white or almost white suspension; during storage, a layer of clear liquid may separate on the surface; when the contents of the vial are shaken vigorously, the homogeneity of the suspension is restored.
Pharmacotherapeutic group
Antacids. Combined preparations and complex compounds of aluminum, calcium and magnesium. ATX code A02A D01.
Pharmacological properties
Pharmacodynamics
Almagel is a balanced combination of aluminum hydroxide and magnesium hydroxide. The drug has an antacid effect when used in the recommended single dose (40-60 minutes after a meal) or daily dose during the day. Aluminum hydroxide neutralizes increased secretion of hydrochloric acid and reduces the activity of pepsin in the stomach, forming aluminum chloride, which, under the influence of alkaline intestinal contents, is converted into alkaline aluminum salts. They are poorly absorbed and practically do not change the concentration of aluminum salts in the blood with short-term use of Almagel (15-20 days). On the other hand, aluminum hydroxide reduces the concentration of phosphates, binding phosphate ions in the intestine and thus limiting their absorption. Almagel does not cause alkalosis and the formation of CO2 in the stomach.
Magnesium hydroxide also neutralizes hydrochloric acid in the stomach, converting to magnesium chloride, which has a slight laxative effect.
Almagel, like other aluminum-containing antacids, has a certain cytoprotective effect on the gastric mucosa due to stimulation of prostaglandin synthesis. This increases its resistance and protects against necrotic-inflammatory and erosive-hemorrhagic lesions caused by the use of irritating and ulcerogenic agents, such as acetylsalicylic acid, nonsteroidal anti-inflammatory drugs (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 drug is used 10-15 minutes before meals.
Sorbitol has a weak carminative and moderate choleretic effect, as well as a moderate laxative effect, which compensates for the tendency to constipation under the influence of aluminum hydroxide in most patients.
Pharmacokinetics
Aluminum salts are absorbed to a small extent in the intestine and excreted in the feces. With normal kidney function, serum aluminum levels are practically unchanged.
Magnesium ions are absorbed only by 10%, and their concentration in the blood does not change much. The duration of action depends on the rate of gastric emptying. When used 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.
Indication
Symptomatic treatment of diseases of the digestive tract accompanied by increased acidity of gastric juice - esophagitis, hiatal hernia, gastroesophageal reflux disease (GERD), acute and chronic gastritis, gastroduodenitis, gastric and duodenal ulcer, post-resection gastritis and gastroanastomosis in the presence of gastroesophageal reflux (heartburn).
Prophylactically to reduce the irritating and ulcerogenic effects of certain drugs on the mucous membrane of the esophagus, stomach and duodenum (e.g. corticosteroids, nonsteroidal anti-inflammatory drugs).
Contraindication
The use of Almagel is not recommended in case of hypersensitivity to the components of the drug, habitual constipation, Alzheimer's disease, severe abdominal pain of unspecified genesis, suspected acute appendicitis, ulcerative colitis, colostomy or ileostomy, chronic diarrhea, hemorrhoids, severe patient exhaustion, severe renal failure (due to the risk of hypermagnesemia and aluminum intoxication), hypophosphatemia, and during breastfeeding.
Interaction with other medicinal products and other types of interactions
The interval between the use of Almagel and other medications should be at least 1-2 hours.
Almagel reduces the absorption of indomethacin, salicylates, phenytoin, reserpine, H2-blockers (cimetidine, ranitidine, famotidine), lansoprazole, β-blockers (e.g. atenolol, metoprolol, propranolol), chloroquine, cyclines, diflunisal, diphosphonates, fluoroquinolones (ciprofloxacin, norfloxacin, ofloxacin, enoxacin, grepafloxacin), azithromycin, cefdinir, cefpodoxime, pivampicillin, rifampicin, indirect anticoagulants, barbiturates, fexofenadine, sodium fluoride, dipyridamole, zalcitabine, bile acids (chenodeoxycholic and ursodeoxycholic acids), penicillamine, digitalis glycosides (digoxin), iron salts, vitamins, lithium preparations, quinidine, mexiletine, neuroleptics, phenothiazine preparations (chlorpromazine), tetracycline antibiotics, lincosamides, phosphorus (supplements), anti-tuberculosis preparations [ethambutol, isoniazid (for oral use)], glucocorticoid preparations (known interaction with prednisolone and dexamethasone), kayeksalate and ketoconazole. Therefore, if possible, the time interval between the use of Almagel and these preparations should be more than 2 hours (for fluoroquinolones - 4 hours).
The reduced absorption of these drugs is associated with the formation of insoluble complexes and/or alkalization of gastric contents.
With the simultaneous use of enteric-coated drugs, the increased alkalinity of gastric juice can lead to accelerated destruction of their membrane and cause irritation of the stomach and duodenum.
M-cholinoblockers slow down gastric emptying and enhance and prolong the effect of Almagel.
When used simultaneously with quinidine, the plasma concentration of quinidine may increase and lead to quinidine overdose.
Caution should be exercised when using Almagel simultaneously with polystyrene sulfonate due to the potential risk of reducing the effectiveness of potassium binding by ion exchange resin, the occurrence of metabolic alkalosis in patients with renal failure (observed with the use of aluminum hydroxide and magnesium hydroxide) and intestinal obstruction (observed with the use of aluminum hydroxide).
Concomitant use of aluminum hydroxide and citrates may lead to increased aluminum levels, especially in patients with renal insufficiency.
Alkalinization of the urine due to the use of magnesium hydroxide may alter the excretion of some drugs. In particular, the renal excretion of salicylates is increased when combined with salicylates.
The drug may reduce the absorption of folic acid.
When used in combination with levothyroxine, its hormonal action may be reduced.
Pirenzipine enhances and prolongs the effect of Almagel.
Impact on laboratory tests.
Almagel may affect the results of some laboratory and functional studies and tests: it reduces the level of gastric secretion when determining its acidity; disrupts the test for visualization of diverticula and bone scintigraphy using technetium (Tc99); moderately and for a short time increases the serum level of gastrin, increases the serum level of phosphorus, the pH value of serum and urine.
Application features
The drug is not recommended for use in patients with diverticulosis, acid-base imbalance in the body in the presence of metabolic alkalosis, liver cirrhosis, severe heart failure, toxicosis of pregnant women, and renal disorders (due to the risk of developing hypermagnesemia and aluminum intoxication).
Aluminum hydroxide may cause constipation, and overdose of magnesium salts may cause intestinal hypokinesia. Use of this product in high doses may cause or aggravate intestinal obstruction and ileus, especially in patients at increased risk of such complications, such as patients with renal insufficiency or the elderly.
Aluminum hydroxide is poorly absorbed from the gastrointestinal tract, and therefore systemic effects are rarely observed in patients with normal renal function. However, with prolonged use in high doses in patients on a low-phosphate diet, phosphate deficiency may develop (due to the binding of aluminum to phosphates), accompanied by increased bone resorption, hypercalciuria and the risk of osteomalacia. Long-term treatment of patients at risk of developing phosphate deficiency should be carried out under medical supervision.
In patients with impaired renal function, plasma concentrations of aluminum and magnesium may increase. In these patients, prolonged use of high doses of aluminum and magnesium salts may cause encephalopathy, dementia, microcytic anemia, or exacerbate dialysis-induced osteomalacia. With prolonged use (more than 14 days), regular medical supervision and monitoring of serum magnesium and aluminum levels are necessary in the treatment of patients with renal failure. In this category of patients, it is also necessary to monitor the dynamics of kidney function, ulcer size, and diarrhea.
Aluminum hydroxide may be dangerous when used in patients with porphyria who are on hemodialysis, as it has been shown that aluminum can lead to disturbances in porphyrin metabolism.
The use of antacids containing aluminum should be limited in elderly patients. In elderly patients, worsening of existing bone and joint diseases, as well as progression of Alzheimer's disease, is possible.
Long-term use of antacids may mask symptoms of more serious conditions, such as gastrointestinal ulcers or cancer. Patients should consult a doctor if they experience weight loss, difficulty swallowing or persistent abdominal discomfort, new indigestion, or a change in the course of existing indigestion.
During treatment, the use of alcohol and caffeine is not recommended due to a decrease in the effect of the drug.
Excipients
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains sorbitol, which allows it to be taken by diabetics, but it should not be used by patients with hereditary fructose intolerance, as it may cause stomach irritation and diarrhoea.
Almagel contains parabens, which can cause allergic reactions, provoke urticaria. Delayed allergic reactions are possible, very rarely - immediate allergic reactions - bronchospasm.
The medicinal product contains 2.5 vol.% ethanol (5 ml of the product contains 98.1 mg of ethanol, which is equivalent to 2.5 ml of beer and 1 ml of wine; 10 ml of the product contains 196.2 mg of ethanol, which is equivalent to 5 ml of beer and 2 ml of wine; 15 ml of the product contains 294.3 mg of ethanol, which is equivalent to 7.5 ml of beer and 3 ml of wine).
Harmful for patients with alcoholism. Caution should be exercised when used in pregnant and breastfeeding women, children, and patients from high-risk groups, such as those with liver disease or epilepsy.
Ability to influence reaction speed when driving vehicles or other mechanisms
Almagel does not affect the ability to drive or operate machinery. The ethanol contained in the preparation in such quantities cannot affect the ability to drive or operate other mechanisms when taking the recommended daily doses.
Use during pregnancy or breastfeeding
There are no clinical studies on the use of Almagel in pregnant women, so the drug is not recommended during pregnancy. If necessary, Almagel can be used during pregnancy only as prescribed by a 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 for no more than 5-6 days and only under the supervision of a doctor.
It is necessary to take into account the content of aluminum and magnesium ions, which can affect the transit of gastrointestinal contents, namely:
Magnesium hydroxide salts can cause diarrhea; aluminum salts can cause constipation, which can worsen constipation, which is quite common during pregnancy, so prolonged use and exceeding doses of the drug should be avoided.
It is not recommended to prescribe for toxicosis of pregnant women.
Breast-feeding
There is no data on whether the active substances of the drug penetrate into breast milk, therefore, if treatment with the drug is necessary, breastfeeding should be discontinued.
Method of administration and doses
Symptomatic treatment of diseases of the digestive tract, which are accompanied by increased acidity of gastric juice. Adults and children over 14 years old - 5-10 ml (1-2 measuring spoons) 3 times a day or 1 sachet 3 times a day. If necessary, a single dose can be increased to 15 ml - 3 measuring (dosing) spoons. After achieving a therapeutic effect, the daily dose is reduced to 5 ml 3-4 times a day for 2-3 months.
Do not drink water for 15 minutes after using the medicine.
In order to achieve a symptomatic antacid effect, Almagel should usually be used 45-60 minutes after meals and in the evening before bedtime.
For prevention. Adults and children over 14 years of age – 5-15 ml (1-3 measuring spoons) or 1 sachet 15 minutes before taking medications that irritate the mucous membrane of the esophagus, stomach, or duodenum.
Children aged 10 to 14 should be given half the recommended adult dose.
The recommended duration of treatment is 12 days.
Before use, the suspension must be thoroughly homogenized by shaking the bottle or by kneading the sachet. The required amount of the drug from the bottle is measured using the dosing spoon included in the kit. When using the drug in sachets, the following recommendations must be followed: hold the sachet vertically, cut or tear off one of the corners at the marked 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 insufficiency. When treating patients with impaired renal function, it is necessary to reduce the daily dose or increase the interval between doses.
Children
Do not use in children under 10 years of age, as precise dosing is not possible. In young children, the use of magnesium hydroxide may cause hypermagnesemia, especially if they have impaired renal function or dehydration.
Overdose
With a single accidental intake of a large dose, no other signs of overdose are observed except constipation, flatulence, and a metallic taste in the mouth.
With prolonged use of high doses, kidney stones may form, severe constipation, abdominal pain, drowsiness, hypermagnesemia may occur. Signs of metabolic alkalosis may also occur - changes in mood or mental activity, numbness or pain in the muscles, nervousness or fatigue, slow breathing, unpleasant taste sensations.
Treatment: it is necessary to immediately take measures for the rapid elimination of the drug - apply gastric lavage, induce vomiting, take enterosorbents. In case of magnesium overdose, rehydration, forced diuresis are recommended. Calcium gluconate can be administered intravenously. In case of renal failure, hemodialysis or peritoneal dialysis is necessary.
Adverse reactions
On the part of the gastrointestinal tract: possible manifestations of constipation, which disappear when the dose is reduced, diarrhea; change in the color of feces; nausea, vomiting; abdominal pain, stomach cramps.
Metabolism and nutrition: most often in patients with renal failure and in the case of prolonged use or taking high doses of the drug due to hypermagnesemia, hyperaluminemia, aluminum and magnesium intoxication develops; hypophosphatemia (in the case of prolonged use or taking high doses, as well as when taking normal doses in patients with limited phosphate intake), which can lead to increased bone resorption, hypercalciuria, osteomalacia; manifestations of hypophosphatemia may be loss of appetite, muscle weakness, weight loss; hypocalcemia is possible.
Renal and urinary disorders: nephrocalcinosis, renal dysfunction.
On the part of the immune system: local and general hypersensitivity reactions, including itching, urticaria, angioedema 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, impaired condition in Alzheimer's disease.
On the part of the musculoskeletal system: osteoporosis; with prolonged use of high doses of the drug together with a deficiency of phosphorus in the diet, osteomalacia may occur.
Others: change in taste.
With prolonged use of the drug in patients with renal failure and patients on dialysis, thirst, decreased blood pressure, hyporeflexia, and the development of microcytic anemia are possible.
Expiration date
2 years.
The shelf life of the medicine after first opening the bottle is 3 months.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Do not freeze! Keep out of reach of children.
Packaging
170 ml of suspension in a bottle, placed in a cardboard box together with a dosing spoon.
Vacation category
Without a prescription.
Producer
Balkanfarma-Troyan JSC.
Location of the manufacturer and its business address
5600, Troyan, 1 Krayrechna St., Bulgaria.
