Almagel A oral suspension 10ml x 20 sachets — Made in Bulgaria — Free Delivery

Pharmacological properties

Pharmacodynamics. Almagel a is a balanced combination of aluminum hydroxide and magnesium hydroxide in combination with sorbitol. Preparation Almagel a has a moderate antacid effect when using the recommended single and daily dose within 40-60 minutes after meals.

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 change 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 the activation of prostaglandin synthesis. Thus, the resistance 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, converting to magnesium chloride, which has a mild laxative effect.

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

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

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

Pharmacokinetics. Aluminum salts are absorbed to a small extent in the intestine. Magnesium ions are absorbed by only 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, the action lasts 20-60 minutes.

Benzocaine is absorbed in minimal amounts and has practically no systemic effect on the body. Its local anesthetic effect occurs within 1–2 minutes after application of the suspension.

Indications

Short-term 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 sachet. The preparation should not be diluted or washed down. Measurement of the required amount of the preparation from the vial occurs by using the dosage spoon contained in the kit. When using the preparation in sachets, you must 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 mouth.

Doses. Apply 5-10 ml (1-2 dosing 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 preparation in a single dose of 5 ml, it is recommended to use Almagel A in vials, since this type of packaging provides a dosage spoon, which makes it possible to accurately measure the required volume of the preparation.

The duration of treatment with Almagel A should not exceed 7 days, then, as prescribed by a doctor, you can continue treatment with Almagel.

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

Contraindications

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

Almagel A is contraindicated for use in case of hypersensitivity to any active and / or auxiliary substances that are part of the preparation; hypersensitivity to anesthetics; chronic constipation; chronic diarrhea; severe abdominal pain of unspecified genesis, suspected acute appendicitis; Alzheimer's disease; severe forms of renal failure (due to the risk of hypermagnesemia and aluminum intoxication); hypophosphatemia.

Side effects

When using the preparation in recommended doses, side effects are rare.

On the part of the digestive system: constipation (disappears after lowering the dose), nausea, vomiting, stomach cramps, changes in taste.

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

Metabolic and nutritional disorders: hypermagnesemia, hyperaluminaemia, hypophosphatemia.

In patients with renal failure and patients on dialysis, long-term use of aluminum and magnesium salts in high doses can lead to the development of encephalopathy, dementia, microcytic anemia or worsen the course of dialysis-induced osteomalacia, 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 preparation in patients with metabolic alkalosis, liver cirrhosis, severe heart failure, ulcerative colitis, diverticulosis, colostomy and ileostomy (increased risk of imbalance in water and electrolyte balance), acute hemorrhoids, renal failure.

Patients should be advised to consult a doctor in the following cases: weight loss; Difficulty swallowing or persistent abdominal discomfort 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 preparation can cause or exacerbate mechanical and dynamic intestinal obstruction in high-risk patients, such as patients with renal insufficiency or the elderly.

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

Aluminum hydroxide can be hazardous when used in patients with porphyria on hemodialysis. Long-term use of the preparation (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 the bones and joints.

During treatment with Almagel A, it is necessary to avoid taking alcohol and acids (for example, lemon juice, vinegar), which can weaken the local anesthetic effect of benzocaine.

In case of manifestations of allergy to the preparation - rash, itching, swelling of the face, difficulty breathing - the use of the preparation should be discontinued and consult a doctor.

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

The preparation does not contain sugar, so it can be used by patients with diabetes.

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

Almagel A contains parabens (excipients propyl parahydroxybenzoate and ethyl parahydroxybenzoate), which can cause allergic reactions. These are usually delayed-type reactions. The development of immediate allergic reactions, including bronchospasm, is very rare.

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

In cases when treatment with other preparations that are used orally is carried out, the preparation should be taken 2 hours before or 2 hours after using the preparations specified in the INTERACTIONS section.

Impact on laboratory tests. Almagel A can affect the results of some laboratory and functional studies and tests: reduces the level of gastric secretion when determining its acidity; interferes with 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, pH of blood plasma and urine.

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

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

Interactions

There is a decrease in gastrointestinal absorption of preparations used simultaneously with antacids. this may be due to the fact that the preparation changes the acidity of the gastric juice, which affects the absorption, сmax, bioavailability, as well as the excretion of a large number of preparations with their simultaneous use. as a preventive measure, you should maintain a break of at least 2 hours between taking antacids and other preparations.

If possible, the time interval should be more than 2 hours between the use of Almagel A and the following preparations: acetylsalicylic acid, H2-histamine receptor blockers (cimetidine, ranitidine), anti-tuberculosis preparations (ethambutol, isoniazid for oral administration), mexiletine, lithium preparations, atenolol, metoprolol, propanolol, chloroquine, cyclins, diflunisal, digoxin, quinidine, bisphosphonates, fexofenadine, iron salts, fluoroquinolones (for example ciprofloxacin), sodium fluoride, GCS, excluding cortisol during replacement therapy (described for prednisolone and dexamethazolone, ketazone), gastrointestinal absorption of ketoconazole due to an increase in the pH of the stomach), lansoprazole, lincosamines, antipsychotics of the phenothiazine series, tetracycline antibiotics, sulpiride, penicillamine, phosphorus (additives), thyroxine, sodium sulfate cationite (a decrease in the ability of the resin that can combine with lead to the risk of metabolic alkalosis in p patients with renal failure).

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

With the simultaneous use of enteric-soluble tablets, an increase in the alkalinity of gastric juice can lead to an accelerated dissolution of its shell and, as a result, irritate 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 insufficiency, combined administration with citrates can lead to an increase in the level of aluminum 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.

Impact on laboratory tests - see SPECIAL INSTRUCTIONS.

Overdose

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

Long-term use of Almagel A in doses exceeding usual can cause the formation of calculi in the kidneys (nephrocalcinosis), severe constipation, drowsiness, hypermagnesemia, despite the fact that the preparation is almost not absorbed in the gastrointestinal tract. Manifestations of metabolic alkalosis may also be noted: changes in mood and mental activity, numbness and pain in muscles, 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 readings, hypoventilation, in the most severe cases, respiratory paralysis, coma, renal failure and cardiac arrest may occur. anuria.

Treatment. Measures should be taken to remove the preparation from the body as soon as possible by gastric lavage (stimulation of vomiting, intake of activated carbon).

Treatment of magnesium overdose: to eliminate the effects of hypermagnesemia, you can use the introduction of calcium gluconate, rehydration and forced diuresis. Patients with renal failure require hemodialysis or peritoneal dialysis.

Storage conditions

In a dark place at a temperature not exceeding 25 ° c. prevent freezing. after the first opening of the vial, the suspension can be used within 3 months when stored under the specified conditions.