Aluminum oxide, Benzocaine, Magnesium oxide

Pharmacological properties

Almagel a is a balanced combination of aluminum hydroxide and magnesium hydroxide in combination with sorbitol. drug Almagel A has a moderate antacid effect when applying the recommended single and daily doses for 40-60 minutes after eating.

Aluminum hydroxide neutralizes the increased secretion of hydrochloric acid and reduces the activity of pepsin in the stomach, forming aluminum chloride. Under the influence of the alkaline environment of the intestine, the latter turns into alkaline aluminum salts, which are almost not absorbed and slightly alter the concentration of aluminum salts in the blood with prolonged use of Almagel A. On the other hand, aluminum hydroxide tends to change the concentration of phosphates, binding phosphate ions in the intestine and thus limiting their absorption.

Antacids containing aluminum, including Almagel A, also have a known cytoprotective effect on the gastric mucosa associated with activation of prostaglandin synthesis. Thus, the stability of the mucous membrane increases, which protects it from inflammatory-necrotic and erosive-hemorrhagic changes caused by irritating and ulcerogenic agents, such as acetylsalicylic acid, NSAIDs, ethyl alcohol.

Magnesium hydroxide also neutralizes hydrochloric acid in the stomach, turning into magnesium chloride, which has a slight laxative effect.

Benzocaine has a local anesthetic effect in the presence of severe pain.

Sorbitol has a weak carminative and moderate choleretic and laxative effect. Such effects compensate in most patients a tendency to constipation under the influence of aluminum hydroxide.

The drug does not lead to the development of alkalosis and the formation of carbon dioxide (CO₂) in the stomach.

Pharmacokinetics Aluminum salts are slightly absorbed in the intestines. 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 emptying of the stomach. When applied on an empty stomach, the effect lasts 20-60 minutes.

Benzocaine is absorbed in minimal quantities and practically does not have a systemic effect on the body. Its local analgesic effect occurs 1–2 minutes after application of the suspension.

Indications

Short symptomatic treatment of inflammatory and erosive lesions, accompanied by heartburn, discomfort, pain, nausea, vomiting; in acute or chronic inflammatory processes or other disorders of the mucous membranes of the esophagus, stomach or duodenum.

Application

Almagel A should be used to treat adults.

Before use, the suspension must be thoroughly homogenized by shaking the bottle or kneading the bag. The drug should not be diluted or washed down. Measuring the required amount of the drug from the vial occurs by using the dosage spoon contained in the kit. When using the drug in bags, it is necessary to adhere to the following recommendations: 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 oral cavity.

Doses Apply 5-10 ml (1-2 dosage spoons) 3-4 times a day or 1 sachet 3-4 times a day 10-15 minutes before meals.

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

The duration of treatment with Almagel A should not exceed 7 days, then, according to the doctors prescription, you can continue treatment with Almagel.

Children.The drug should not be prescribed to children, given the risk of methemoglobinemia.

Contraindications

The drug should not be prescribed to children regardless of age, as well as pregnant and breastfeeding due to the content of benzocaine.

Almagel A is contraindicated in case of hypersensitivity to any active and / or auxiliary substances that make up the drug; hypersensitivity to anesthetics; chronic constipation; chronic diarrhea; severe abdominal pain of unspecified genesis, suspected acute appendicitis; Alzheimers disease; severe forms of renal failure (due to the risk of hypermagnesemia and aluminum intoxication); hypophosphatemia.

Side effects

When using the drug in recommended doses, side effects rarely occur.

From the digestive system: constipation (disappears after a dose reduction), nausea, vomiting, stomach spasm, change in taste.

On the part of the immune system: hypersensitivity reactions, including skin rashes, itching, urticaria, angioedema and anaphylactic reactions.

Metabolic and nutritional disorders: hypermagnesemia, hyperaluminemia, hypophosphatemia.

In patients with renal failure and patients undergoing dialysis, prolonged use of aluminum and magnesium salts in high doses can lead to the development of encephalopathy, dementia, microcytic anemia or worsen the course of osteomalacia induced by dialysis, and, due to the development of hypophosphatemia, lead to an increase in bone resorption processes tissue and the occurrence of hypercalciuria with an increased risk of osteomalacia.

special instructions

It is not recommended to use the drug in patients with metabolic alkalosis, liver cirrhosis, severe heart failure, ulcerative colitis, diverticulosis, colostomy and ileostomy (increased risk of water-electrolyte imbalance), acute hemorrhoids, renal failure.

Patients should be advised to consult a doctor in the following cases: weight loss; difficulty swallowing or a constant feeling of discomfort in the abdomen; digestive disorders that appeared for the first time, or a change in the course of existing digestive disorders; renal failure.

Aluminum hydroxide can cause constipation, and an overdose of magnesium salts can lead to intestinal hypokinesia; the use of high doses of the drug can cause or exacerbate mechanical and dynamic intestinal obstruction in patients at high risk, such as patients with renal failure or the elderly.

When treating patients with renal failure or those undergoing permanent hemodialysis, the presence of aluminum and magnesium in the preparation should be considered (there is a risk of encephalopathy, dementia, microcytic anemia or may worsen osteomalacia caused by dialysis).

Aluminum hydroxide can be dangerous when used in patients with porphyria undergoing hemodialysis. Long-term use of the drug (more than 7 days) is not recommended due to the content of benzocaine (see APPLICATION).

Long-term use in elderly patients can worsen the condition of existing diseases of bones and joints.

During treatment with Almagel A, alcohol and acids (such as lemon juice, vinegar), which can weaken the local analgesic effect of benzocaine, must be avoided.

With manifestations of an allergy to the drug - rash, itching, swelling of the face, difficulty breathing - the use of the drug must be stopped and consult a doctor.

When using the suspension, numbness and anesthesia of the mucous membrane of the oral cavity and tongue occur. This phenomenon goes away and it should not bother the patient.

The drug does not contain sugar, so it can be used for patients with diabetes.

The drug contains sorbitol, which is contraindicated in congenital fructose intolerance.

Almagel A contains parabens (excipients propyl parahydroxybenzoate and ethyl parahydroxybenzoate), which can cause allergic reactions. Usually these are delayed reactions. Very rarely, the development of allergic reactions of an immediate type, including bronchospasm, is possible.

The drug contains ethyl alcohol. Therefore, the use of the drug can adversely affect patients with alcoholism, liver and central nervous system diseases, and epilepsy.

In cases where treatment with other drugs that are administered orally is carried out, the drug should be taken 2 hours before or 2 hours after the use of the drugs indicated in the INTERACTIONS section.

Effect on laboratory tests. Almagel A 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 of visualization of diverticula and bone scintigraphy using technetium (⁹⁹Tc); moderately and for a short time increases the plasma level of gastrin, phosphorus, blood plasma and urine pH.

Use during pregnancy or lactation. The drug should not be prescribed during pregnancy and lactation due to the content of benzocaine.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. A small amount of ethyl alcohol in the dosage form, subject to the recommended doses, does not affect the ability to drive vehicles or work with mechanisms that require increased attention.

Interactions

A decrease in the gastrointestinal absorption of drugs used simultaneously with antacids is noted. this may be due to the fact that the drug changes the acidity of the gastric juice, which affects the absorption, max, bioavailability, as well as the removal of a large number of drugs with their simultaneous use. as a preventive measure, a break of at least 2 hours between taking antacids and other drugs should be maintained.

If possible, the time period should be more than 2 hours between the use of Almagel A and the following drugs: acetylsalicylic acid, H blockers₂-histamine receptors (cimetidine, ranitidine), anti-tuberculosis drugs (ethambutol, isoniazid for oral use), mexiletine, lithium preparations, atenolol, metoprolol, propanolol, chloroquine, cyclins, diflunisal, digoxin, quinidine, bisphosphonates, ferox, iron e.g. ciprofloxacin), sodium fluoride, GCS, excluding cortisol during replacement therapy (described for prednisone and dexamethasone), indomethacin, ketoconazole (decreased gastrointestinal absorption of ketoconazole due to increased levels of gastric pH), lansoprazole, lincosamines, phenothiazine antipsychotics, tetracycline antibiotics, sulpiride, penicillamine, phosphorus (additives), thyroxin, sodium sulfate cation exchange resin (a decrease in the ability of the resin to bind to potassium, which can lead to a risk of metabolic alkalosis in patients with renal )

Caution should be exercised when using the drug simultaneously with polystyrenesulfonate due to the potential risk of a decrease in the efficiency of potassium binding by ion-exchange resin, the occurrence of metabolic alkalosis in patients with renal failure (noted with aluminum hydroxide and magnesium hydroxide) and mechanical intestinal obstruction (detected with aluminum hydroxide) .

With the simultaneous use of enteric-soluble tablets, an increase in the alkalinity of the gastric juice can lead to an accelerated dissolution of its membrane and, as a result, cause irritation of the stomach and duodenum.

Combinations to consider. Increased renal excretion of salicylates due to alkalization of urine when combined with salicylates. In patients with renal failure, combined administration with citrates can lead to an increase in aluminum levels in the blood.

Almagel A should not be used simultaneously with sulfonamides, as it contains benzocaine. Being a derivative of para-aminobenzoic acid, benzocaine acts as an antagonist of the antibacterial activity of sulfonamides, as a result of which the therapeutic effect of the latter is reduced.

Effect on laboratory tests - see SPECIAL INSTRUCTIONS.

Overdose

With a single use of high doses of the drug, no other manifestations of an overdose were noted, except for constipation, flatulence, metallic taste in the mouth.

Long-term use of Almagel A in doses exceeding the usual, can cause the formation of calculi in the kidneys (nephrocalcinosis), severe constipation, drowsiness, hypermagnesemia, despite the fact that the drug is almost not absorbed in the digestive tract. Manifestations of metabolic alkalosis can also be noted: changes in mood and mental activity, numbness and muscle pain, nervousness and fatigue, difficulty breathing, unpleasant taste sensations. Other signs of intoxication can be a decrease in blood pressure, nausea, vomiting, decreased reflexes, muscle fatigue, neuromuscular paralysis, bradycardia, abnormal ECG values, hypoventilation, in the most severe cases, respiratory paralysis, coma, renal failure and cardiac arrest, anuria

Treatment. Measures should be applied for the speedy removal of the drug from the body by washing the stomach (stimulating vomiting, taking activated charcoal).

Treatment of magnesium overdose: the effects of hypermagnesemia can be eliminated with the help of calcium gluconate, rehydration and forced diuresis. Patients with renal failure require hemodialysis or peritoneal dialysis.

Storage conditions

In the dark place at a temperature of no higher than 25 ° c. prevent freezing. after the first opening of the vial, the suspension can be used for 3 months when stored under the indicated conditions.

Medicinal product information for healthcare professionals.