Magaldrate

Pharmacological properties

riopan is an antacid with a layered lattice structure. the active substance of the drug riopan is Magaldrate. It contains aluminum and magnesium hydroxide in one molecule.

The drug Riopan reduces the amount of acid in the stomach and, depending on the dose and pH level, binds pepsin, bile acids and lysolecithin. This eliminates the aggressive effects of gastric juice and forms a layer that protects its mucous membrane.

Acid binding is explained by proton binding by sulfate and hydroxide ions of the middle layer of the lattice. During neutralization, the lattice structure is destroyed.

800 mg of anhydrous Magaldrate neutralizes approximately 18–25 mEq of hydrochloric acid.

A Riopan 800 mg tablet corresponds in vitro to approximately 19 mEq of acid-neutralizing activity.

10 ml of the drug Riopan, oral suspension, 800 mg corresponds in vitro to approximately 20 mEq of acid-neutralizing activity.

10 ml of the drug Riopan, oral suspension, 1600 mg corresponds in vitro to approximately 45.2 mEq of acid-neutralizing activity.

Since the pH level for 20–40 min is in the range from 3 to 5, which is therapeutically optimal, the use of the drug does not cause acid ricochet.

Magaldrate does not affect gastric motility.

Pharmacokinetics Magaldrate is not absorbed in the digestive tract. In the process of neutralization, a small amount of aluminum and magnesium ions is released, which, when passing through the intestine, turn into insoluble phosphates and then are excreted in the feces. A certain amount of cations is absorbed. A slight increase in aluminum levels was noted even in patients with normal renal function. Long-term use of antacids containing aluminum can lead to a decrease in phosphate absorption.

Indications

Heartburn, sour belching, a feeling of heaviness and overflow in the stomach.

Application

Riopan, chewable tablets. adults: the recommended dose is 1 tablet of riopan.

For minor complaints, the drug should be used 0.5-1 hours after a meal or immediately when significant complaints appear.

Chewable tablets must be dissolved or chewed thoroughly.

Do not exceed the maximum daily dose of 8 chewable tablets (6.4 g of Magaldrate).

Riopan, oral suspension. Adults: The recommended dose is 1 sachet of Riopan.

For minor complaints, the drug should be used 0.5-1 hours after a meal or immediately when significant complaints appear.

The drug Riopan in sachets must be shaken before use, open along the specified line. Squeeze the contents of the sachet directly into the oral cavity and swallow.

Do not exceed the maximum daily dose - 8 sachets of 800 mg or 4 sachets of 1600 mg (6.4 g of Magaldrate).

If the symptoms do not disappear after 2 weeks of treatment, you should consult a doctor for an examination.

Elderly patients do not need dose adjustment.

Contraindications

• Hypersensitivity to the active substance or other components of the drug. hypophosphatemia. habitual constipation. chronic diarrhea. severe abdominal pain of unspecified genesis. Alzheimers disease. fructose and sorbitol intolerance (riopan, chewable tablets).

The drug can be used in patients with impaired renal function (creatinine clearance of 30 ml / min) only with regular monitoring of plasma levels of magnesium and aluminum. The level of aluminum in blood plasma should not exceed 40 ng / ml.

Side effects

Side effects by frequency of occurrence are classified into the following categories: very often (≥10%), often (≥1% –10%), infrequently (≥0.1% –1%), rarely (≥0.01% –0, 1%), very rarely (1/10 000, including isolated cases).

From the digestive tract: often - stools of soft consistency (especially when using the drug in a high dose); very rarely - diarrhea, constipation.

In patients with renal failure or prolonged use of the drug in high doses, an increase in the level of aluminum and magnesium in the blood is possible, which can lead to the accumulation of aluminum, mainly in the nervous and bone tissues, and to a deficiency of phosphates.

Impaired taste (chalky taste), nausea, vomiting, intoxication with aluminum and / or magnesium, most often in patients with renal failure.

Dementia, Alzheimers disease worsening.

Osteomalacia, osteoporosis.

Hypersensitivity reactions, including pruritus, urticaria, angioedema and anaphylactic reactions, bronchospasm.

A decrease in the phosphorus content in the body is also possible with the use of the drug in normal doses in patients whose diet is characterized by a low phosphorus content.

Strengthening the processes of resorption in bone tissue, hypercalciuria.

In patients with renal failure, prolonged use of aluminum and magnesium salts in high doses can lead to the development of encephalopathy, microcytic anemia or worsen the course of osteomalacia induced by dialysis. Prolonged use or administration of the drug in high doses can cause phosphorus deficiency syndrome (loss of appetite, muscle weakness, weight loss).

Aluminum hydroxide can be dangerous for patients with porphyria on hemodialysis.

special instructions

The drug riopan can not be used for more than 2 weeks without consulting a doctor. if complaints persist for a long time and / or are often repeated, an examination is necessary to rule out the presence of a serious illness, such as a peptic ulcer or a malignant tumor. to establish a diagnosis should consult a doctor.

In rare cases, after using the drug in high doses for several years, there was a decrease in the absorption of calcium and phosphates, followed by osteomalacia.

The drug can be used in patients with impaired renal function (creatinine clearance of 30 ml / min), especially those who are on dialysis, only with regular monitoring of plasma levels of magnesium and aluminum. The level of aluminum in blood plasma should not exceed 40 ng / ml. The drug is contraindicated for patients with Alzheimers disease and should be used with caution in patients with metabolic disorders in bone tissue, patients on a low-phosphate diet to reduce the risk of aluminum intoxication, hypermagnesemia and hypophosphatemia. When using the drug for a long time and in high doses, it is necessary to regularly monitor the level of magnesium and aluminum in the blood serum.

In case of impaired renal function and prolonged use of the drug due to the content of aluminum salts, high levels of aluminum in the blood plasma and / or tissues (deposits of aluminum, primarily in the nervous and bone tissues), as well as signs of an overdose, can be noted. However, the results of studies indicate that the absorption of aluminum in patients with impaired renal function when using Magaldrate is lower than when using aluminum salts. In addition, after a short-term use of Magaldrate in patients with normal renal function, aluminum deposits in the brain and bone tissue are not observed, in contrast to the use of aluminum salts without the use of antacids.

Increasing the pH of gastric juice increases the risk of the multiplication of pathogenic microorganisms; during artificial respiration, it can increase the incidence of nosocomial pneumonia in patients.

Since Riopan does not contain sugar and contains a small amount of sodium, it can be used to treat patients with diabetes and hypertension.

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

Patients need to see a doctor in case of weight loss, difficulty swallowing and a constant feeling of discomfort in the abdomen, with digestive disorders, the first appearance or change in the course of existing digestive disorders; with renal failure.

With prolonged use of the drug, it is necessary to ensure that a sufficient amount of phosphorus is ingested, since aluminum hydroxide binds to phosphates and reduces their absorption from the digestive tract. Excretion of calcium in the urine increases, which can lead to impaired calcium-phosphate balance and create conditions for the development of osteomalacia (symptoms - complaints of weakness and bone pain).

During the 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 level of aluminum and magnesium in the blood serum.

Use during pregnancy and lactation

Controlled studies of the effects of Magaldrate in animals, as well as in humans during pregnancy, have not been carried out. Animal experiments have shown that the use of aluminum salts has an adverse effect on the fetus. To prevent intoxication with aluminum, the drug is taken for a short time and at the lowest possible dose.

Aluminum compounds also pass into breast milk. Studies have shown that the level of aluminum after taking aluminum salts increases markedly, whereas after taking Magaldrate due to the layered structure of the lattice, the level of aluminum in blood plasma does not differ from the level without the use of antacids.

The content of aluminum and magnesium ions that can affect the transit in the gastrointestinal 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.

Avoid prolonged use and excess doses of the drug during pregnancy.

During treatment, breast-feeding should be discontinued.

Children. Currently, there are no data from systematic studies on the use and safety of the drug in children.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Does not affect.

Interactions

When taking riopan and other drugs, an interval of at least 2 hours should be observed, since antacids can affect the absorption of other drugs.

There was a significant decrease in the absorption of antibiotics, including tetracycline, quinolone derivatives (ciprofloxacin, ofloxacin, norfloxacin), so it is not recommended to take antacids during treatment with these antibiotics. There was also a slight decrease in the absorption of digoxin, isoniazid, iron preparations, chlorpromazine, benzodiazepines, hypo- and ursodeoxycholic acid, indomethacin and cimetidine when using these drugs simultaneously with the drug Riopan.

Potential enhancement of the action of coumarin anticoagulants was noted.

Antacids containing aluminum should not be used in combination with acidic drinks (fruit juices, wines), effervescent tablets, citric and tartaric acid, since the absorption of aluminum salts in the intestine is enhanced.

With simultaneous use with salicylates, the excretion of salicylates by the kidneys is increased due to alkalization of urine.

Overdose

There are no cases of overdose of the drug riopan.

Symptoms of an overdose of aluminum hydroxide and magnesium hydroxide are manifested by rapid fatigue, facial flushing, exhaustion, muscle weakness and inappropriate behavior.

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

Treatment for overdose of magnesium: rehydration, forced diuresis. Intravenous administration of calcium gluconate can be prescribed. In case of renal failure, hemodialysis or peritoneal dialysis is necessary.

Storage conditions

At a temperature not exceeding 25 ° C. do not freeze riopan in the form of an oral suspension.

UA / (PPIF) / 1018/0045.