Pharmacological properties

Pharmacodynamics. Almagel — the balanced combination of aluminum hydroxide and magnesium hydroxide. medicament has antiacid effect at use recommended single (in 40–60 min. after a meal) or a daily dose during the day. aluminum hydroxide neutralizes hypersecretion of hydrochloric acid and reduces activity of pepsin in a stomach, forming aluminum chloride which under the influence of alkaline contents of intestines turns into alkaline salts of aluminum. they are a little soaked up and practically do not change concentration of salts of aluminum in blood at short use of Almagel (15–20 days). aluminum hydroxide reduces concentration of phosphates, connecting phosphatic ions in intestines and limiting thus their absorption. use of medicament does not cause an alkalosis and does not promote formation of co2 in a stomach. magnesium hydroxide also neutralizes hydrochloric acid in a stomach, turning into the magnesium chloride having insignificant laxative effect.

Almagel, as well as other antacids containing aluminum shows the cytoprotective action on a mucous membrane of a stomach caused by stimulation of synthesis of prostaglandins. It increases its stability and protects from necrotic inflammatory and erosive and hemorrhagic defeats owing to use of the irritating and ulcerogenic agents, such as acetylsalicylic acid, NPVP, ethanol. On the other hand, aluminum hydroxide shows expressed the knitting and anti-inflammatory action on the inflamed mucous membrane of a stomach and a duodenum at use of medicament in 10–15 min. prior to food.

Sorbitol has easy carminative and moderate bile-expelling effect and also the moderate laxative effect compensating at most of patients tendency to constipations under the influence of aluminum hydroxide.

Pharmacokinetics. Salts of aluminum are soaked up slightly in intestines and removed with a stake. At normal function of kidneys the plasma level of aluminum practically does not change. Ions of magnesium are soaked up only for 10%, and their concentration in blood almost does not change. Duration of action depends on gastric emptying speed. At use on an empty stomach it varies from 20 to 60 min. At use in 1 h after a meal the antiacid action can continue up to 3 h

Indication

Symptomatic treatment of the diseases of a digestive tract which are followed by hyperoxemia of gastric juice such as esophagitis, hernia of an esophageal opening of a diaphragm, gastroesophageal reflux disease, acute and chronic gastritis, gastroduodenit, the peptic ulcer of a stomach and duodenum, postresection gastritis and gastroanastomozit in the presence of a gastroesophageal reflux (heartburn).

Preventively for reduction of the irritating and ulcerogenic effect of some medicines by a mucous membrane of a gullet, a stomach and a duodenum (for example corticosteroids, NPVP).

Use

Symptomatic treatment of the diseases of a digestive tract which are followed by hyperoxemia of gastric juice. to adults and children 14 years are aged more senior — on 5–10 ml (1–2 measured spoons) 3 times a day or on 1 bag 3 times a day. if necessary the single dose can be raised to 15 ml — 3 measured (dosing) spoons. after achievement of therapeutic effect to lower a dose to 5 ml 3–4 times a day within 2–3 months for 15 min. after use of medicament it is not necessary to drink water.

for the purpose of achievement of symptomatic antiacid effect Almagel is applied usually in 45–60 min. after a meal and in the evening before going to bed.

For prevention. To adults and children 14 years are aged more senior — on 5–15 ml (1–3 measured spoons) or 1 bag in 15 min. prior to medicament intake which irritate a mucous membrane of a gullet, a stomach or a duodenum. To children at the age of 10–14 years to appoint a half of the dose recommended to adults. The recommended treatment duration — 12 days.

in case of prescribing of medicament in a single dose of 5 or 15 ml it is recommended to p to apply Almagel in bottles as the dosing spoon which gives the chance precisely to measure the necessary volume of medicament is provided in this type of packaging.

Before use suspension needs to be homogenized carefully by stirring of a bottle or puddling of a bag. Measuring off of necessary amount of medicament from a bottle happens to the help of a dosing spoon which contains in a set. At use of medicament in bags it is necessary to observe the following recommendations: to hold a package vertically, to cut off or tear off one of corners in the designated place. To pour out contents of a bag through a bag opening in a spoon or directly in an oral cavity.

Patients with a renal failure. At treatment of patients from impaired renal function it is necessary to lower a dose or to increase an interval between receptions.

Children. Not to apply at children 10 years aged are younger in view of impossibility of exact dosing.

Contraindication

Drug is not recommended to use at hypersensitivity to its components, a usual constipation, Alzheimer's disease, a megalgia in a stomach of not specified genesis, suspicion of an acute appendicitis, presence of ulcer colitis, colostomy or ileostomy, in chronic diarrhea, hemorrhoids, a heavy renal failure, a hypophosphatemia, during feeding by a breast.

Side effects

from a GIT: manifestations of a constipation which disappear at a dose decline, diarrhea are possible; discoloration of stool, nausea, vomiting, stomach spasms;

laboratory indicators: most often at patients with a renal failure and in case of long use or administration of medicament in high doses owing to a gipermagniyemiya, a giperalyuminiyemiya intoxication magnesium and aluminum develops; a hypophosphatemia (which manifestations can be a loss of appetite, muscle weakness, degrowth of a body); possible hypocalcemia, hypercalcuria;

from kidneys and urinary tract: nephrocalcinosis, renal failure;

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

from central nervous system: at long use of medicament for patients with a renal failure and the patients who are on dialysis manifestations of encephalopathy, neurotoxicity (change of mood and intellectual activity) are possible; dementia, disturbances of a state in Alzheimer's disease;

from the musculoskeletal system: osteoporosis; at long administration of medicament in high doses against the background of deficiency of phosphorus in food the emergence of osteomalacy is possible;

others: change of flavoring feelings.

At long use of medicament for patients with a renal failure and at the patients who are on dialysis thirst manifestations, decrease in the ABP, hyporeflexia and also development of microcytic anemia are possible

.

Special instructions to

use of medicament for patients at a divertuculosis, disturbances of acid-base equilibrium in an organism in the presence of a metabolic alkalosis is not recommended to

, in cirrhosis, heavy heart failure, toxicosis pregnant, renal disturbances (because of danger of development of a gipermagniyemiya and intoxication by aluminum).

to Patients needs to see a doctor in case of degrowth of a body, emergence of difficulties when swallowing or constant sensation of discomfort in a stomach, the digestive disturbances which for the first time arose or at change of a course of the existing digestion disturbances.

Aluminum hydroxide can lead

to a constipation, and magnesium hydroxide — to an intestines hypokinesia. Use of this medicament in high doses can cause or aggravate obstruction of intestines and intestinal impassability, especially at patients with the increased risk of such complications, for example at patients with a renal failure or patients of advanced age.

Use of the antacids containing aluminum for patients of advanced age should be limited to

. At long use for patients of advanced age the aggravation of symptoms of the existing diseases of bones and joints is possible.

needs to provide to

At prolonged use of medicament receipt in an organism of enough phosphorus as aluminum hydroxide contacts phosphates and reduces their absorption from a digestive tract. Removal of calcium with urine increases that can lead to disturbances of calcium-phosphatic balance and create conditions for development of osteomalacy (symptoms — complaints to weakness and an ostealgia). Aluminum hydroxide can be dangerous at use for the patients with a porphyria who are on a hemodialysis.

regular control of the doctor and tracking plasma level of magnesium and aluminum at treatment of patients with a renal failure is necessary for

At prolonged use (14 days). At this category of patients it is also necessary to control in dynamics indicators of a condition of kidneys, the ulcer size, appearance of diarrhea.

during treatment do not recommend to take alcohol and caffeine because of reduction of effect of drug.

Excipients. Drug contains sorbitol that allows to accept it sick diabetes, but it is not necessary to apply at patients with congenital intolerance of fructose as it can cause irritation of a stomach and diarrhea.

Drug contains parabens which can provoke a small tortoiseshell and is very rare — allergic reactions of immediate type — a spasm of bronchial tubes.

Drug contains alcohol therefore emergence of complications at patients with diseases of a liver and brain, at patients with epilepsy and alcoholism, at pregnant women and children aged up to 10 years is possible.

Use during pregnancy and feeding by a breast. There are no data of clinical trials on use of Almagel for pregnant women therefore medicament is not recommended to use during pregnancy. In case of need Almagel can be applied during pregnancy only on doctor's orders if the expected advantage for mother exceeds possible risk for the fruit/child. In this case no more than 5-6 days and only under observation of the doctor recommend to use drug.

Should consider the maintenance of the ions of aluminum and magnesium capable to influence transit of gastrointestinal contents, namely:

• salt of magnesium hydroxide can cause diarrhea;
• salt of aluminum can cause a constipation that can worsen a course of a constipation which quite often arises during pregnancy therefore it is necessary to avoid prolonged use and exceeding medicament doses.

Drug is not recommended to appoint in toxicosis of pregnant women.

Feeding by a breast. There are no data on ability of active agents of medicament to get into breast milk therefore in case of need treatments they a breast should stop feeding.

Ability to influence speed of response at control of vehicles or work with other mechanisms. The ethanol which is contained in a preprata in the specified quantity cannot affect ability to run vehicles or to work with mechanisms at its reception in the recommended daily doses.

Interaction

Interval between use of Almagel and other medicines has to make ≥1–2 h

Almagel changes acidity of contents of a stomach that influences absorption, bioavailability, the maximum plasma concentration and also removal of the majority of medicines at simultaneous use.

Almagel reduces absorption of digoxin, indometacin, salicylates, Chlorpromazinum, Phenytoinum, reserpine, blockers of N ₂ - receptors (Cimetidinum, ranitidine, famotidine), a lanzoprazol, blockers of β-adrenoceptors (for example atenolol, metoprolol, propranolol), chloroquine, a tsiklin, a diflunizal, diphosphonates, hinolon (ciprofloxacin, norfloxacin, ofloxacin, enoksatsin, grepafloksatsin), azithromycin, a tsefpodoksim, a pivampitsillin, rifampicin, indirect anticoagulants, barbiturates, a feksofenadin, sodium of fluoride, Dipiridamolum, a zaltsitabin, bile acids (chenodeoxycholic and ursodeoksikholevy acids), Penicillaminum, glycosides of a foxglove, salts of iron, medicaments of lithium, quinidine, a meksiletin, fenotiazinovy drugs, antibiotics of a tetracycline row, linkozamid, phosphorus (additive), antitubercular medicaments (Ethambutolum, an isoniazid for oral administration), chloroquine, glucocorticoid medicaments (interaction with Prednisolonum and dexamethasone is known), the kayekselat and a ketokonazol. Therefore whenever possible the period between intake of Almagel and these medicaments has to make 2 h

connect lower absorbability of these medicines with formation of insoluble complexes and/or alkalization of contents of a stomach.

superalkalinity of gastric juice can lead

At simultaneous use of enterosoluble medicaments to the accelerated destruction of their cover and cause irritation of a stomach and duodenum.

Blockers M-holinoretseptorov slow down gastric emptying and strengthen, prolong effect of Almagel.

by

removal of quinidine with manifestations of hinidinovy toxicity, especially at patients with a renal failure Can be broken. Simultaneous use of aluminum of hydroxide and citrates can lead to increase in level of aluminum, especially at patients with a renal failure. Drug can reduce absorption of folic acid.

At the combined use with left thyroxine the decrease in its hormonal effect is possible

.

Pirenzepin strengthens

and prolongs effect of Almagel.

Influence on laboratory researches. Almagel can affect results of some laboratory and functional researches and tests: it reduces the level of gastric secretion when determining its acidity; violates the test of visualization of diverticulums and stsintigrafiya of bones by means of technetium ( ⁹⁹ CU); moderately and for a short time increases the plasma level of gastrin, increases the plasma level of phosphorus, rn blood plasma and urine.

Overdose

At single accidental administration of medicament in high the doses do not note other signs of overdose except a constipation, a meteorism, feeling of metal smack in a mouth.

At long use of medicament in high doses the formation of stones in kidneys, appearance of heavy constipations, an abdominal pain, drowsiness, a gipermagniyemiya is possible

. There can be also symptoms of a metabolic alkalosis — change of mood or intellectual activity, numbness or muscle pain, nervousness or fast fatigue, breath delay, unpleasant flavoring feelings.

Treatment: it is necessary to take immediately measures for fast removal of medicament — to wash out a stomach, to cause vomiting, to accept enterosorbents. At overdose of magnesium rehydration, an artificial diuresis are recommended. It is possible to apply calcium a gluconate in / century. In case of a renal failure the hemodialysis or peritoneal dialysis is necessary.

Storage conditions

to Store

at a temperature of ≤25 °C in original packing. not to freeze.

Information on medicine for experts of health care.