Instructions Almagel oral suspension sachet 10 ml No. 20
Composition
active ingredients: aluminum hydroxide, magnesium hydroxide;
5 ml of suspension (1 measuring spoon) contains:
aluminum hydroxide gel 2.18 g in terms of aluminum oxide 218 mg;
magnesium hydroxide paste 350 mg converted to magnesium oxide 75 mg;
benzocaine 109 mg;
10 ml (1 sachet) of suspension contains:
aluminum hydroxide gel 4.36 g in terms of aluminum oxide 436 mg;
magnesium hydroxide paste 700 mg in terms of magnesium oxide 150 mg;
benzocaine 218 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 the storage period, a layer of clear liquid may form on the surface of the suspension. When the contents of the vial are shaken vigorously, the homogeneity of the suspension is restored.
Pharmacotherapeutic group
Drugs for the treatment of acid-dependent diseases. Antacids. Aluminum compounds. Combinations.
ATX code A02A B10.
Pharmacological properties
Pharmacodynamics
Almagel® A is a balanced combination of aluminum hydroxide and magnesium hydroxide in combination with sorbitol. The drug has a moderate antacid effect when used in the recommended single and daily doses within 40-60 minutes after a meal.
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 is converted into alkaline aluminum salts, which are almost not absorbed and slightly change the concentration of aluminum salts in the blood with prolonged use of the drug Almagel® A. On the other hand, aluminum hydroxide has the property of changing the concentration of phosphates, binding phosphate ions in the intestine and thus limiting their absorption.
Antacids containing aluminum, including Almagel® A, also have a cytoprotective effect on the gastric mucosa, associated with the activation of prostaglandin synthesis. Thus, the resistance of the mucosa increases, protecting it from inflammatory-necrotic and erosive-hemorrhagic changes caused by irritating and ulcerogenic agents, such as acetylsalicylic acid, nonsteroidal anti-inflammatory drugs, ethanol.
Magnesium hydroxide also neutralizes hydrochloric acid in the stomach, converting to magnesium chloride, which has a slight laxative effect.
Benzocaine has a local analgesic effect in the presence of severe pain.
Sorbitol has a weak carminative and moderate choleretic and laxative effect. Such effects compensate for the tendency to constipation under the influence of aluminum hydroxide in most patients.
The drug 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 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, the action lasts 20-60 minutes, when used 1 hour after a meal, the antacid effect can last up to 3 hours.
Benzocaine is absorbed in minimal amounts and has virtually no systemic effect on the body. Its local anesthetic effect occurs 1-2 minutes after application of the suspension.
Indication
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.
Contraindication
The medicine should not be prescribed to children (due to the risk of developing methemoglobinemia), as well as to pregnant and breastfeeding women, given the benzocaine content.
Almagel® A is contraindicated for use in:
hypersensitivity to any active and/or excipients included in the medicinal product;
hypersensitivity to anesthetics;
chronic constipation;
chronic diarrhea;
severe abdominal pain of unspecified origin, suspected acute appendicitis;
Alzheimer's disease;
severe forms of renal failure (due to the risk of hypermagnesemia and aluminum intoxication);
hypophosphatemia;
the patient's severe exhaustion.
Interaction with other medicinal products and other types of interactions
There is a decrease in gastrointestinal absorption of drugs used concomitantly with antacids. This may be due to the fact that the drug changes the acidity of gastric juice, which affects the absorption, maximum plasma concentrations, bioavailability, and excretion of large amounts of drugs when used simultaneously.
Almagel® A reduces the absorption of the following drugs: acetylsalicylic acid, H2-blockers of histamine receptors (cimetidine, ranitidine), anti-tuberculosis drugs [ethambutol, isoniazid (for oral use)], mexiletine, lithium preparations, atenolol, metoprolol, propranolol, chloroquine, cyclines, diflunisal, digoxin, cefdinir, cefpodoxime, quinidine, bisphosphonates, fexofenadine, iron salts, vitamins, fluoroquinolones (e.g. ciprofloxacin), folic acid, sodium fluoride, glucocorticoids, excluding cortisol in replacement therapy (described for prednisolone and dexamethasone), indomethacin, ketoconazole (reduction of gastrointestinal absorption of ketoconazole due to increased gastric pH), lansoprazole, lincosamides, phenothiazine neuroleptics series, tetracycline antibiotics, sulpiride, penicillamine, phosphorus (supplements), thyroxine, sodium sulfate cationite (reduced ability of the resin to combine with potassium, which can lead to metabolic alkalosis in patients with renal failure).
If possible, the time interval between the use of Almagel® A and the above-mentioned drugs should be more than 2 hours. The decrease in binding of these drugs is associated with the formation of insoluble complexes and/or alkalization of the gastric contents.
Caution should be exercised when using the drug simultaneously with polystyrene sulfonate (kayexalate) 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 mechanical intestinal obstruction (observed with the use of aluminum hydroxide).
With the simultaneous use of enteric-coated tablets, an increase in the alkalinity of the gastric juice can lead to accelerated dissolution of its membrane and, as a result, cause irritation of the stomach and duodenum.
When used simultaneously with quinidine, the plasma concentration of quinidine may increase and lead to an overdose of the latter.
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.
In patients with renal insufficiency, combined administration with citrates may lead to increased blood aluminum levels, particularly in patients with impaired renal function.
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.
Effects on laboratory tests - see section "Special instructions for use".
Application features
The drug is not recommended for use in patients with metabolic alkalosis, liver cirrhosis, severe heart failure, ulcerative colitis, diverticulosis, colostomy and ileostomy (increased risk of water and electrolyte imbalance), acute hemorrhoids, and renal failure.
Long-term use of antacids can mask symptoms of more serious conditions, such as gastrointestinal ulcers or cancer.
Patients should be advised to consult a doctor in the following cases:
- weight loss;
- difficulty swallowing or a constant feeling of discomfort in the stomach;
- digestive disorders that appeared for the first time or a change in the course of existing digestive disorders;
- renal failure.
Aluminum hydroxide may cause constipation, and overdose of magnesium salts may lead to intestinal hypokinesia; use of the drug in high doses may cause or exacerbate mechanical and dynamic intestinal obstruction in high-risk patients, such as those with renal failure 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. When treating patients with renal failure or those on continuous hemodialysis, the presence of aluminum and magnesium in the drug should be taken into account (there is a risk of encephalopathy, dementia, microcytic anemia or exacerbation of dialysis-induced osteomalacia).
Aluminum hydroxide may be dangerous for porphyria patients on hemodialysis, as it has been proven that aluminum can lead to disturbances in porphyrin metabolism. Long-term use of the drug (more than 7 days) is not recommended due to the benzocaine content (see section "Method of administration and dosage").
During treatment with Almagel® A, it is necessary to avoid the use of alcohol and acids (e.g. lemon juice, vinegar), which may reduce the local analgesic effect of benzocaine.
If you experience any signs of allergy to the drug (rash, itching, facial swelling, difficulty breathing), you should stop using the drug and immediately consult a doctor.
When using the suspension, numbness and anesthesia of the oral mucosa and tongue occur. This phenomenon passes, does not require therapeutic measures and should not bother the patient.
The drug contains sorbitol, which is contraindicated in congenital fructose intolerance.
Almagel® A contains parabens [excipients propyl parahydroxybenzoate (E 216) and methyl parahydroxybenzoate (E 218)], which may cause allergic reactions. Usually these are delayed reactions. Very rarely, immediate allergic reactions, including bronchospasm, may develop.
The drug contains ethanol 2.5% vol. (98.1 mg of ethanol in a dose of 5 ml is equivalent to 2.5 ml of beer or 1 ml of wine, and 196.2 mg of ethanol in a dose of 10 ml is equivalent to 5 ml of beer or 2 ml of wine). Therefore, the use of the drug may have a negative effect on patients suffering from alcoholism, patients with liver and central nervous system diseases, epilepsy, as well as during pregnancy and breastfeeding.
In cases where treatment is carried out with other drugs that are administered orally, Almagel® A should be taken 2 hours (for fluoroquinolones - 4 hours) before or 2 hours after taking the drugs listed in the section "Interaction with other medicinal products and other types of interactions".
Impact on laboratory tests
Almagel® A may affect the results of some laboratory and functional studies and tests: reduces the level of gastric secretion when determining its acidity; disrupts the test for visualization of diverticula and bone scintigraphy using technetium (99mTc); moderately and for a short time increases the plasma level of gastrin, phosphorus, pH of blood plasma and urine.
Use during pregnancy or breastfeeding
Almagel® A should not be prescribed during pregnancy or breastfeeding due to the content of benzocaine.
Ability to influence reaction speed when driving vehicles or other mechanisms
A small amount of ethanol in the dosage form, when taken in recommended doses, does not affect the ability to drive a vehicle or operate other mechanisms that require increased attention.
Method of administration and doses
Almagel® A should be used for the treatment of adults.
Before use, the suspension must be made homogeneous by thoroughly shaking the bottle or gently kneading the sachet. The medicine does not need to be diluted or washed down. 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, it is necessary, holding the sachet vertically, to cut or tear off one of the corners at the marked place, and pour the contents of the sachet through the hole into a spoon or directly into the oral cavity.
Doses
Use 5-10 ml (1-2 measuring spoons) 3-4 times a day or 1 sachet 3-4 times a day 10-15 minutes before meals.
When prescribing the drug in a single dose of 5 ml, it is recommended to use Almagel® A in vials, since this type of packaging includes a dosing spoon, which allows you to accurately measure the required volume of the drug.
The duration of treatment with Almagel® A should not exceed 7 days, then treatment with Almagel® can be continued as prescribed by a doctor.
Renal insufficiency. In case of decreased renal function, the daily dose should be reduced or the intervals between doses should be extended according to the severity of the impairment.
Children
The drug should not be prescribed to children due to the risk of developing methemoglobinemia.
In young children, the use of magnesium hydroxide may cause hypermagnesemia, particularly if they have impaired renal function or dehydration.
Overdose
With a single use of significant doses of the drug, no other manifestations of overdose were observed, except for constipation, flatulence, and a metallic taste in the mouth.
Prolonged use of Almagel® A in doses exceeding the usual ones can cause the formation of kidney stones (nephrocalcinosis), severe constipation, drowsiness, hypermagnesemia, despite the fact that the drug is almost not absorbed in the digestive tract. Also, prolonged use of Almagel® A can cause phosphate deficiency. Manifestations of metabolic alkalosis may also be observed: changes in mood and mental activity, numbness and pain in the muscles, nervousness and rapid fatigue, difficulty breathing, unpleasant taste sensations. Other signs of intoxication may include decreased blood pressure, nausea, vomiting, decreased reflexes, muscle fatigue, neuromuscular paralysis, bradycardia, abnormal ECG readings, hypoventilation, and in the most severe cases, respiratory paralysis, coma, renal failure and cardiac arrest, and anuria may occur.
Treatment of magnesium overdose: The effects of hypermagnesemia can be reversed by intravenous calcium gluconate, rehydration, and forced diuresis. Patients with renal failure require hemodialysis or peritoneal dialysis.
Side effects
When using the drug in recommended doses, side effects rarely occur.
Adverse reactions are grouped by frequency according to the MedDRA classification. The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Gastrointestinal: infrequently - diarrhea, constipation (results in a decrease in the dose); unknown - abdominal pain, nausea, vomiting, stomach spasm, change in taste.
Immune system disorders: Not known: hypersensitivity reactions, including bronchospasm, skin rash, pruritus, urticaria, angioedema and anaphylactic reactions.
Metabolic and nutritional disorders: very rare - hypermagnesemia (with prolonged use of magnesium hydroxide in patients with impaired renal function); unknown - hyperaluminemia, hypophosphatemia (was detected after a long period of use of magnesium hydroxide in patients with impaired renal function). Long-term use of aluminum and magnesium salts in high doses in patients with renal failure and patients on dialysis, as well as the use of usual doses in patients with limited phosphate intake may lead to the development of encephalopathy, dementia, microcytic anemia or worsen the course of dialysis-induced osteomalacia, and as a result of the development of hypophosphatemia - lead to increased resorption processes in bone tissue and the occurrence of hypercalciuria with an increased risk of osteomalacia.
If any adverse reactions occur, discontinue use of the drug and consult a doctor.
Expiration date
2 years.
After first opening the vial, the suspension can be stored for 3 months under the specified conditions.
Storage conditions
Store at a temperature not exceeding 25 °C.
Do not allow freezing!
Keep out of reach of children!
Packaging
170 ml of the drug in a bottle, placed in a cardboard pack together with a dosing spoon.
10 ml of the drug in a sachet. 10 or 20 sachets in a cardboard box.
Vacation category
Without a prescription.
Producer
Balkanpharma-Troyan JSC/ Balkanpharma-Troyan AD.
Address
Bulgaria, 5600 Troyan, Krayrechna St., 1/ 1 Krayrechna Str., 5600 Troyan, Bulgaria.
