Almagel A, 10 ml suspension 10 pcs

Pharmacotherapeutic group

Antacid + local anesthetic

ATX code: A02AB10

Pharmacological properties

.Pharmacodynamics

Almagel^® A is a drug that is a balanced combination of algeldrate (aluminum hydroxide), magnesium hydroxide and benzocaine. Almagel^® A neutralizes free hydrochloric acid in the stomach, reduces the activity of pepsin, which leads to a decrease in the digestive activity of gastric juice. It has a coating and adsorptive effect. It protects the mucous membrane of the stomach by stimulating the synthesis of prostaglandins (cytoprotective effect). This protects the mucous membrane from inflammatory and erosive-hemorrhagic lesions due to irritating and ulcerogenic agents such as ethyl alcohol and nonsteroidal anti-inflammatory drugs (e.g., indomethacin, diclofenac, aspirin, acetylsalicylic acid, corticosteroid drugs). The therapeutic effect after taking the drug comes in 3-5 minutes. The duration of action depends on the rate of gastric emptying. When taken on an empty stomach, the action lasts up to 60 minutes. When taken one hour after a meal, the antacid action may last up to 3 hours.

Does not cause secondary hypersecretion of gastric juice.

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

Pharmacokinetics

Algeldrate

absorption –small amounts of the drug are resorbed with little or no change in the concentration of aluminum salts in the blood.

Distribution – no.

Metabolism – no.

Evolution – excreted through the intestine.

Magnesium hydroxide

absorption – magnesium ions are resorbed in about 10% of the dose taken and do not change the concentration of magnesium ions in the blood.

Distribution – is usually local.

Metabolism – no.

Evolution – is excreted through the intestine.

Benzocaine

Benzocaine is absorbed in minimal amounts and has virtually no systemic effects on the body. Its local analgesic effect occurs 1-2 minutes after taking the suspension.

Indications

Active ingredient

Composition

5 ml (1 scoop) of suspension contain: acting ingredients: aluminum hydroxide gel 2.18 g (in terms of Al2O3 218 mg), magnesium hydroxide paste 350 mg (in terms of MgO 75 mg), benzocaine 109 mg; excipients: Hydrogen peroxide solution 30% 0.41 mg, sorbitol 801.15 mg, guetellose 15.26 mg, methyl parahydroxybenzoate 10.90 mg, propyl parahydroxybenzoate 1.363 mg, butyl parahydroxybenzoate 1,363 mg, sodium saccharinate dihydrate 0.818 mg, propylene glycol 327.00 mg, macrogol 4000 218.00 mg, lemon oil 1.635 mg, ethanol 96% 98.10 mg, purified water to 5 ml.

10 ml (1 sachet) of suspension contain: acting ingredients: aluminum hydroxide gel 4.36 g (in terms of Al2O3 436 mg), magnesium hydroxide paste 700 mg (in terms of MgO 150 mg), benzocaine 218 mg; excipients: Hydrogen peroxide solution 30% 0.82 mg, sorbitol 1602.30 mg, guetellose 30.52 mg, methyl parahydroxybenzoate 21.80 mg, propyl parahydroxybenzoate 2.726 mg, butyl parahydroxybenzoate 2,726 mg, sodium saccharinate dihydrate 1.636 mg, propylene glycol 654.00 mg, macrogol 4000 436.00 mg, lemon oil 3.27 mg, ethanol 96% 196.20 mg, purified water to 10 ml.

How to take, the dosage

For oral administration.

Adults

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

The maximum duration of treatment is 7 days, then the drug Almagel ® is changed.

It is not recommended to take liquids for 15 minutes after taking the drug.

The suspension should be thoroughly homogenized before use by shaking the bottle or by kneading and shaking the bag.

Interaction

Almagel® A changes the acidity of the stomach contents, which affects absorption, maximum plasma concentration and bioavailability, as well as excretion of a large number of drugs used simultaneously with it.

The antacids containing aluminum decrease the absorption of H2 blockers-histamine receptors, atenolol, digoxin, cefdinir, cefpodoxime, chloroquine, tetracyclines, diflunisal, biphosphonates, ethambutol, fluoroquinolones, sodium fluoride, glucocorticoids, indomethacin, isoniazid, polystyrene sulfonate, ketoconazole, lincosamides, metoprolol, neuroleptics, phenothiazines, penicillamines, propranolol, iron salts, vitamins. Reduced absorption of these drugs is associated with the formation of insoluble complexes and/or alkalinization of the stomach contents. To avoid undesirable drug interactions, it is necessary to keep a 2-hour interval between the intake of these drugs (4 hours for fluoroquinolones) and Almagel ® A.

If taken concomitantly with enteric-soluble tablets, increased alkalinity of gastric juices may cause their shells to dissolve more quickly and cause gastric and duodenal irritation.

Simultaneous use with quinidine may increase the plasma concentration of quinidine and lead to quinidine overdose.

Caution should be exercised when concomitant use of Almagel ® A with polystyrene sulfonate because the potassium binding efficiency to the resin may decrease; because of the risk of metabolic alkalosis in patients with renal insufficiency (associated with the use of aluminum hydroxide and magnesium hydroxide) and the risk of intestinal obstruction (associated with the use of aluminum hydroxide).

The concomitant use of aluminum hydroxide with citrates may lead to higher aluminum concentrations, especially in patients with impaired renal function.

The alkalinization of the urine due to the use of magnesium hydroxide may alter the excretion of some drugs, and increased excretion of salicylates has been observed in this regard.

Almagel® A should not be taken simultaneously with sulfonamides due to the presence of benzocaine in its composition. As a derivative of para-aminobenzoic acid, benzocaine acts as an antagonist to the antibacterial activity of sulfonamides.

Almagel® A may affect the results of some laboratory and functional tests and examinations: it decreases gastric secretion in determining its acidity; it interferes with the test of diverticulosis imaging and technetium bone scintigraphy (Tc99); it moderately and briefly increases serum gastrin levels and increases serum phosphorus, serum pH and urine levels.

Special Instructions

Aluminum hydroxide may cause constipation; an overdose of magnesium salts may result in decreased intestinal motility. In high-risk patients (patients with renal impairment or the elderly) high doses of this drug may cause or worsen intestinal obstruction and bowel obstruction.

Aluminum hydroxide is only slightly absorbed in the gastrointestinal tract, so systemic effects are rarely seen in patients with normal renal function. However, prolonged use, administration of very high doses or use of conventional doses in patients following a diet low in phosphates in the diet may lead to phosphate deficiency (due to aluminum binding to phosphates), which is accompanied by increased bone resorption, hypercalciuria and risk of osteomalacia. Prolonged use or treatment of patients at risk of phosphate deficiency should be under medical supervision.

In patients with renal insufficiency, increased plasma aluminum and magnesium concentrations are possible. In these patients, long-term use of high doses of aluminum and magnesium salts may cause encephalopathy, dementia, microcytic anemia or worsen dialysis-induced osteomalacia.

The use of aluminum hydroxide in patients with porphyria undergoing hemodialysis may be dangerous because it has been shown that aluminum can lead to porphyrin metabolism disorders.

In elderly patients, bone and joint disease may worsen and Alzheimer’s disease may progress.

Long-term use of antacids may mask symptoms of more serious conditions, such as ulcers or gastrointestinal cancer.

A During treatment with Almagel ® A, alcohol and acids (lemon juice, vinegar, etc.) should be avoided because of the possibility of weakening the local anesthetic effect of benzocaine.

The drug causes numbness and anesthesia of the oral mucosa and tongue. This is transient and does not require therapeutic measures.

The drug is sugar-free, so it can be taken by people with diabetes.

The drug contains sorbitol, which is contraindicated if you have an inborn intolerance to fructose.

Influence on driving and operating machinery

Almagel ® A has no effect on the ability to drive vehicles and operate machinery. When taken in recommended daily dose, the ethanol contained in the drug does not affect the ability to drive vehicles and operate machinery.

Synopsis

Contraindications

Side effects

Unwanted reactions are listed according to the system-organ class of the Medical Dictionary of Regulatory Affairs (MedDRA). Unwanted reactions are categorized according to the World Health Organization (WHO) classification: very common (≥1/10); common (≥1/100, < 1/10); infrequent (≥1/1000, < 1/100); rare (≥1/10000, < 1/1000); very rare (< 1/10000); frequency unknown (cannot be determined based on available data).

Immune system disorders:frequency unknown-allergic reactions such as bronchospasm, pruritus, urticaria, angioedema, and anaphylactic reactions of the rapid type.

Disorders of metabolism and nutrition: very rare – hypermagnesemia1; frequency unknown – hyperaluminemia, hypophosphatemia2, which may lead to increased bone resorption, hypercalciuria, osteomalacia (see See section “Special Indications”).

Gastrointestinal tract disorders: infrequent – diarrhea or constipation; frequency unknown – abdominal pain.

1Anomalies have been observed with prolonged use of magnesium hydroxide in patients with renal insufficiency.

2Was observed with prolonged use of high doses, and with usual doses in patients with limited phosphate intake.

Overdose

Pregnancy use