Aluminum hydroxide, Magnesium hydroxide, Simethicone

Pharmacological properties

Neo-Almagel is a balanced gel of aluminum hydroxide and magnesium hydroxide in combination with a carminative component - Simethicone. It has a long antacid effect, exhibits a mild laxative effect, successfully eliminates constipation and reduces flatulence in patients with stomach ulcers.

A dual mechanism of action, combining acid neutralizing ability and cytoprotective activity, provides protection of the gastric mucosa and its healing in case of damage.

The alkaline active components of the drug are finely dispersed, due to which their active surface increases, closer contact with the surface of the mucous membrane of the stomach and duodenum is provided, the evacuation of the contents of the stomach is slowed down, and the neutralizing effect is prolonged.

Cytoprotective activity is associated with activation of the synthesis of prostaglandins, which stimulate the secretion of mucus and bicarbonates from the gastric mucosa.

Given the ability of the drug to bind bile acids and lysolecithin, as well as provide a gastroprotective effect, Almagel Neo can be used to treat duodenogastric reflux.

Simethicone, which is part of the drug Almagel Neo, helps to eliminate flatulence. Simethicone is a stable silicone compound, it is not absorbed in the gastrointestinal tract, causes a natural release of gases and their absorption by the intestinal walls. Simethicone has an effect in the lumen of the small intestine and is excreted unchanged from the body.

The components of the drug are not absorbed in the digestive tract and, therefore, do not lead to clinically significant plasma concentrations when used in the recommended doses and at the recommended duration of treatment.

Aluminum hydroxide neutralizes the increased secretion of hydrochloric acid 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 little absorbed and excreted in the feces. With normal renal function, the plasma level of aluminum remains virtually unchanged.

Magnesium hydroxide also neutralizes hydrochloric acid in the stomach and turns into magnesium chloride. In the intestine, it turns into magnesium carbonate, which is poorly absorbed, so the concentration of magnesium ions in the blood practically does not change.

In patients with chronic renal failure, the level of aluminum and magnesium ions may increase to toxic values ​​due to violation of their excretion.

Indications

Symptomatic treatment of diseases of the digestive tract, accompanied by increased or normal acidity of the gastric juice and increased gas formation.

The drug should be used alone or in combination with other drugs with:

• gastritis and duodenitis;
• gastric and duodenal ulcer;
• erosion of the stomach and duodenum;
• gastroesophageal reflux disease;
• duodenogastric reflux;
• functional dyspepsia;
• flatulence, discomfort due to increased gas formation.

Application

Adults and children over the age of 14: with gastroesophageal reflux disease, the recommended dose is 10-15 ml (2-3 scoops) or 1 sachet 4 times a day 1 hour after eating and at bedtime. after achieving the desired effect, the recommended dose is 10 ml (2 scoops) or 1 sachet 4 times a day.

For gastritis, duodenitis, erosion of the stomach and duodenum, gastric and duodenal ulcers, duodenogastric reflux, functional dyspepsia, flatulence, the recommended dose is 10 ml (2 scoops) or 1 sachet 4 times a day 1 hour after meals and before .

The duration of treatment is determined by the doctor.

The maximum daily dose is 60 ml (12 scoops or 6 sachets), the maximum duration of treatment is 4 weeks.

If symptoms persist, consult a doctor.

The drug must be taken undiluted. It is not recommended to drink fluid within 30 minutes after administration. Before use, the suspension must be thoroughly homogenized by shaking the bottle.

Patients with impaired renal function. The drug should be taken after consulting a doctor. With prolonged use, it is necessary to take into account the state of renal function.

Contraindications

Hypersensitivity to any of the active and / or auxiliary substances that make up the drug. severe renal impairment, including in patients on hemodialysis, who are at risk of increasing the concentration of aluminum and magnesium ions in blood plasma to toxic levels as a result of a decrease in kidney excretion. hypophosphatemia, severe osteoporosis, Alzheimers disease, habitual constipation, chronic diarrhea, intestinal obstruction, suspected appendicitis, bleeding from the gastrointestinal tract of unknown origin, severe abdominal pain of unspecified origin, ulcerative colitis, conditions causing a violation of water-electrolyte balance.

Side effects

Prolonged use of neo-Almagel or its administration in high doses can cause phosphorus deficiency syndrome (loss of appetite, muscle weakness, weight loss).

It should be borne in mind that even when using the drug in normal doses in patients whose diet is low in phosphorus, it is possible to decrease the phosphorus content in the body, increase bone resorption, hypercalciuria, osteomalacia, osteoporosis, since this medicine contains aluminum (see . SPECIAL INSTRUCTIONS).

In patients with renal failure, increased plasma concentrations of both aluminum and magnesium are noted, therefore, 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. Patients with renal failure should take a reduced dose of the drug or increase the interval between doses of the drug, based on the severity of renal failure. In patients of this group, plasma plasma concentrations of aluminum and magnesium should be monitored.

Aluminum hydroxide can be dangerous for hemodialysis patients with porphyria.

Adverse Reactions:

• from the digestive system: taste disturbance (chalky taste), diarrhea, constipation, nausea, vomiting, discoloration of feces;
• from the immune system: hypersensitivity reactions, including bronchospasm, pruritus, urticaria, angioedema and anaphylactic reactions;
• from the nervous system: intoxication with aluminum and / or magnesium, most often in patients with renal failure, dementia, deterioration in Alzheimers disease.

In case of revealing any undesirable effects or unusual reactions, you should consult your doctor regarding the further use of the drug!

special instructions

Before starting the use of the drug, the presence of a malignant process should be excluded.

Aluminum hydroxide can cause constipation, and magnesium hydroxide can cause intestinal hypokinesia. The use of this drug in high doses can cause or complicate intestinal obstruction and intestinal obstruction, especially in patients with an increased risk of such complications, for example in patients with renal failure or in the elderly.

Patients should consult a doctor if:

• weight loss;
• difficulty in swallowing or a constant feeling of discomfort in the abdomen;
• digestive disorders, which appeared for the first time, or changes in the course of existing digestive disorders;
• renal failure.

In patients with impaired renal function, an increase in plasma levels of aluminum and / or magnesium is possible, therefore, it should be borne in mind that prolonged use of the drug in high doses can lead to the development of dementia and microcytic anemia.

Long-term use of the drug in the presence of Alzheimers disease is not recommended, since there is an opinion that aluminum is concentrated in neurofibrils of brain tissue and can lead to complications.

With prolonged use of the drug, it is necessary to ensure the intake of a sufficient amount of phosphorus, since aluminum hydroxide binds to phosphates and reduces their absorption in the digestive tract. In addition, increased excretion of calcium in the urine, which can lead to impaired calcium-phosphate balance and create conditions for the development of osteomalacia (symptoms - complaints of weakness and bone pain). This drug is not suitable for patients with hypophosphatemia, since with prolonged use it can cause hypophosphatemia.

This drug should be used with caution in patients with renal failure. During treatment of patients with renal failure, it is necessary to monitor the dynamics of the state of the kidneys, the size of the ulcer, the appearance of diarrhea, the plasma level of aluminum and magnesium.

Each dose (10 ml) of Almagel Neo contains:

• 0.226 g of ethanol, the presence of which can negatively affect the condition of patients with diseases of the liver and brain, people with alcohol dependence, epilepsy, pregnant women and children under the age of 14;
• 0.95 g of sorbitol, which is contraindicated in patients with rare hereditary diseases, such as fructose intolerance, and can cause stomach irritation and diarrhea.

Parabens, which are part of the drug as excipients, can cause allergic reactions, including urticaria, bronchospasm.

Use during pregnancy and lactation. Due to the lack of clinical experience, it is advisable to avoid the use of the drug during pregnancy and lactation. Due to the lack of adequate clinical research data for women during pregnancy, Almagel Neo can be used only as directed by a doctor if the expected benefit to the mother outweighs the possible risk to the fetus / baby.

The content of aluminum and magnesium ions that can affect the transit to the digestive tract should be taken into account, namely:

• magnesium hydroxide salts can cause diarrhea;
• aluminum salts can cause constipation and worsen the course of constipation, which is often observed during pregnancy, so prolonged use and excessive doses of this drug should be avoided.

When used in pregnant women, the drug may cause damage due to the content of ethyl alcohol (0.226 g in a single dose).

During treatment with the drug should stop breast-feeding.

Children. The drug can be used in children over the age of 14 years. Safety and efficacy of the drug in children under the age of 14 years have not been established.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. There is no data on the negative impact on the ability to drive vehicles or work with complex mechanisms.

Interactions

Almagel neo interacts with some other drugs used orally. note a decrease in the amount of absorption of drugs taken simultaneously in the digestive tract. as a precaution, a break of at least 2 hours should be taken between antacids and other medicines.

It is recommended to take 2 hours before or 2 hours after the use of Almagel Neo: antibiotics of the tetracycline group (tetracycline, doxycycline), fluoroquinolones (ciprofloxacin, norfloxacin, ofloxacin), H₂antihistamines, anti-TB drugs: ethambutol, isoniazid (oral), atenolol, metoprolol, propranolol, chloroquine, cyclins, diflunisal, digoxin, diphosphonates, fexofenadine, iron (salts), sodium fluoride, GCS (described interaction with predamethasone and indomethacin, sodium polystyrenesulfonate, ketoconazole, lansoprazole, lincosamides, phenothiazine antipsychotics, penicillamine, phosphorus (additives), thyroxine.

Combinations to be considered: with simultaneous use with salicylates, the release of salicylates by the kidneys is increased due to alkalization of urine.

The drug should not be used simultaneously with quinolines.

Withdrawal of quinidine with manifestations of quinidine toxicity may be impaired, especially in patients with renal failure.

The simultaneous use of cholinergic agents reduces their effectiveness.

The simultaneous use of aluminum hydroxide and citrates can lead to an increase in aluminum levels, especially in patients with renal failure.

The use of the drug simultaneously with drugs having an enteric-soluble membrane can lead to faster dissolution of the membrane and irritation of the stomach and duodenum.

The simultaneous use with the drug Almagel Neo can lead to a decrease in the absorption of the following drugs:

• tetracycline antibiotics (tetracycline, doxycycline);
• quinolones (ciprofloxacin, norfloxacin, ofloxacin);
• derivatives of bisphosphonates (clodronate, alendronate, risedronate);
• protease inhibitors (atazanavir, tipranavir, fosamprenavir);
• ketoconazole, itraconazole;
• rosuvastatin;
• allopurinol, diflunisal, gabapentin, iron, mycophenolate mofetil;
• levothyroxine;
• dasatinib;
• ranelate strontium.

The drug may decrease the absorption of folic acid.

When combined with levothyroxine, a decrease in the severity of its hormonal action is possible. Pirenzepine enhances and prolongs the action of the drug Almagel Neo.

Plasma concentrations of penicillamine, sotalol, propranolol, phenytoin, cefpodoxime, fexofenadine may decrease with simultaneous use with antacid drugs.

The effect of calcium polystyrenesulfonate can be weakened while the use of antacids.

The likelihood of drug interactions is less when using antacids in low doses.

Overdose

Long-term use of Almagel neo can cause hypermagnesemia, despite the fact that the drug is almost not absorbed in the digestive tract. overdose symptoms are manifested by rapid fatigue, facial flushing, exhaustion, muscle weakness and inappropriate behavior.

Signs of metabolic alkalosis may also be noted: a change in mood or mental activity, numbness or muscle pain, nervousness and fatigue, respiratory depression, unpleasant taste sensations.

If you suspect an overdose of the drug or the appearance of clinical signs, it is necessary to cancel the drug and take measures to quickly remove the drug from the digestive tract (inject activated charcoal, perform gastric lavage and other procedures to reduce the absorption of aluminum and magnesium ions).

Treatment for overdose of magnesium: rehydration, forced diuresis. You can prescribe calcium gluconate iv. In case of renal failure, hemodialysis or peritoneal dialysis is necessary.

Storage conditions

In the original packaging at a temperature not exceeding 25 ° c. do not freeze! after the first opening of the primary packaging, the suspension can be stored for 30 days under the indicated conditions.