Antareit tab chewable 800+40 mg without sugar N 24


Antareit tablet chew 800 mg+40 mg x24

Instructions

on medical use of a medicinal product

ANTAREIT

,

Trade name of the drug: Antareit

International nonproprietary or generic name: magaldrate + simethicone

Dosage form: chewable tablets

Compound:

1 chewable tablet with a dosage of 400 mg + 20 mg contains:

Active ingredients: magaldrate - 400.00 mg, simethicone (in terms of dimethylpolysiloxane) - 30.77 (20.00) mg.

Excipients: ethylcellulose - 18.00 mg, macragol-4000 - 70.00 mg, sorbitol - 256.59 mg, sucralose - 2.16 mg, aspartame - 2.50 mg, caramel flavor - 6.48 mg, silicon colloidal dioxide - 4.50 mg, glyceryl dibehenate - 9.00 mg.

Tablet weight: 800.00 mg.

1 chewable tablet with a dosage of 800 mg + 40 mg contains:

Active ingredients: magaldrate - 800.00 mg, simethicone (in terms of dimethylpolysiloxane) - 61.54 (40.00) mg.

Excipients: ethylcellulose - 36.00 mg, macragol-4000 - 140.00 mg, sorbitol - 513.18 mg, sucralose - 4.32 mg, aspartame - 5.00 mg, caramel flavor - 12.96 mg, silicon dioxide colloidal - 9.00 mg, glyceryl dibehenate - 18.00 mg.

Tablet weight: 1600.00 mg.

,

Description

Biconvex tablets are white or off-white, octagonal in shape, with beveled edges, engraved with an apple shape and the letter “r” on one side. Dark inclusions are allowed.

Pharmacotherapeutic group: Antacid + carminative

ATX code: A02AF02.

,

Pharmacological properties

Pharmacodynamics

A combined drug whose effect is determined by the properties of its constituent components. It has an antacid, adsorbent, enveloping, carminative effect.

Magaldrat

Magaldrate (aluminum magnesium hydroxide sulfate) neutralizes free hydrochloric acid in the stomach without causing secondary hypersecretion of gastric juice. Due to the increase in pH when taken, the peptic activity of gastric juice decreases. It has an adsorbing and enveloping effect, due to which the impact of damaging factors on the gastric mucosa is reduced, and binds bile acids.

Simethicone

Simethicone changes the surface tension of gas bubbles formed in the contents of the stomach and intestinal mucus and causes their destruction. The gases released during this process can be absorbed by the cells of the intestinal walls, or excreted through peristalsis. Simethicone removes foam purely physically, does not enter into chemical reactions, and is pharmacologically inert.

Pharmacokinetics

Magaldrat

Absorption of aluminum and magnesium ions in the blood is low. With normal kidney function, the concentration of aluminum and magnesium in the blood does not change. In patients with chronic renal failure, the content of aluminum and magnesium in the blood may increase to toxic levels as a result of impaired excretion.

Simethicone

Due to pharmacological and chemical inertness, simethicone is not absorbed into organs and tissues after oral administration. After passing through the gastrointestinal tract (GIT), it is excreted unchanged by the intestines.

,

Indications for use

Symptoms associated with increased acidity of gastric juice and reflux esophagitis: heartburn, belching with a “sour taste”, pain in the stomach (appear irregularly), a feeling of fullness or heaviness in the epigastric region, flatulence, dyspepsia (including those caused by errors in diet , taking medications, abuse of alcohol, coffee, nicotine).

,

Contraindications

Hypersensitivity to the components of the drug, severe renal failure, hypophosphatemia, fructose intolerance (due to the presence of sorbitol in the drug), children under 12 years of age.

With caution: with renal failure (with long-term use, an increase in the content of magnesium and aluminum in the blood plasma is possible), with Alzheimer's disease, with a low phosphate content in food (risk of developing phosphate deficiency).

,

Use during pregnancy and breastfeeding

There have been no controlled clinical studies examining the use of Antareit in pregnant women, but no teratogenic effect or effect was identified in preclinical studies. Due to the lack of clinical experience, the use of the drug during pregnancy is possible only if the benefit from its use for the mother outweighs the potential risk to the fetus.

Prescribing the drug during pregnancy in large doses and for a long time should be avoided.

While taking Antareit, breastfeeding is not required.

,

Directions for use and doses

Inside. The tablets should be chewed thoroughly or kept in the mouth until completely dissolved.

Adults and adolescents over 12 years of age: Unless otherwise recommended by a doctor, take 1-2 tablets shortly after meals. If necessary, you can repeat the drug after 2 hours.

The maximum daily dose for tablets 400 mg + 20 mg is 16 tablets, for tablets 800 mg + 40 mg - 8 tablets.

,

Side effect

Allergic reactions, nausea, vomiting, taste disturbances, constipation, diarrhea.

With long-term use in high doses - hypophosphatemia, hypocalcemia, hypercalciuria, osteomalacia, osteoporosis, hypermagnesemia, hyperaluminemia, encephalopathy, nephrocalcinosis, impaired renal function. In patients with concomitant renal failure - a feeling of thirst, decreased blood pressure, hyporeflexia.

,

Overdose

Symptoms: with prolonged use of high doses, formation of kidney stones, constipation, drowsiness, hypermagnesemia is possible. Signs of metabolic alkalosis may also be observed: mood lability, numbness or muscle pain, nervousness and fatigue, and unpleasant taste sensations.

Treatment: it is necessary to take measures to quickly eliminate the drug: rinse the stomach, induce vomiting, take activated charcoal.

,

Interaction with other drugs

Antareit reduces and slows down the absorption of digoxin, indomethacin, salicylates, chlorpromazine, phenytoin, H2-histamine blockers, beta-blockers, diflunisal, isoniazid, tetracycline antibiotics, quinolones (ciprofloxacin, norfloxacin, ofloxacin, enoxacin, grepofloxacin, etc. .), azithromycin, cefpodoxime , pivampicillin, rifampicin, indirect anticoagulants, barbiturates, fexofenadine, dipyridamole, zalcitabine, bile acids - chenodeoxycholic and ursodeoxycholic, penicillamine, iron and lithium preparations, quinidine, lansoprazole, mexiletine, ketoconazole. M-anticholinergics, by slowing down gastric emptying, enhance and prolong the effect of the drug.

,

special instructions

When using Antareit and other medications simultaneously, an interval of at least 1-2 hours should be maintained. With long-term use, sufficient intake of phosphorus from food should be ensured. In case of mild to moderate renal dysfunction, it is necessary to regularly monitor the content of aluminum, calcium, and phosphates in the blood plasma. The drug contains sorbitol, which is contraindicated in cases of congenital fructose intolerance.

,

Features of the effect of the drug on the ability to drive vehicles or when working with potentially dangerous mechanisms

Does not have a negative impact on the ability to drive vehicles and operate mechanisms that require increased concentration and speed of psychomotor reactions.

,

Release form

Chewable tablets 400 mg+20 mg and 800 mg+40 mg. 6 tablets per blister made of PVC/A1 foil.

2 or 4 blisters along with instructions for use in a cardboard box.

,

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25°C.

Keep out of the reach of children.

,

Best before date

3 years.

Do not use after the expiration date stated on the packaging.

,

Vacation conditions

Available without a prescription.

,

Antareit tab chewable 800+40 mg without sugar N 24

Dosage form: chewable tablets

Compound

1 chewable tablet with a dosage of 400 mg + 20 mg contains:

Active ingredients: magaldrate - 400.00 mg, simethicone (in terms of dimethylpolysiloxane) - 30.77 (20.00) mg.

Excipients: ethylcellulose - 18.00 mg, macrogol-4000 - 70.00 mg, sorbitol - 256.59 mg, sucralose - 2.16 mg, aspartame - 2.50 mg, caramel flavor - 6.48 mg, silicon dioxide colloidal – 4.50 mg, glyceryl dibehenate – 9.00 mg.

Tablet weight – 800.00 mg.

1 chewable tablet with a dosage of 800 mg + 40 mg contains:

Active ingredients: magaldrate - 800.00 mg, simethicone (in terms of dimethylpolysiloxane) - 61.54 (40.00) mg.

Excipients: ethylcellulose – 36.00 mg, macrogol-4000 – 140.00 mg, sorbitol – 513.18 mg, sucralose – 4.32 mg, aspartame – 5.00 mg, caramel flavor – 12.96 mg, silicon dioxide colloidal – 9.00 mg, glyceryl dibehenate – 18.00 mg.

Tablet weight – 1600.00 mg.

Description

Biconvex tablets are white or off-white, octagonal in shape, with beveled edges, engraved with an apple shape and the letter “r” on one side. Dark inclusions are allowed.

Pharmacotherapeutic group: Antacid + carminative

ATX code: A02AF02.

Pharmacological properties

Pharmacodynamics

A combined drug whose effect is determined by the properties of its constituent components. It has an antacid, adsorbent, enveloping, carminative effect.

Magaldrat

Magaldrate (aluminum magnesium hydroxide sulfate) neutralizes free hydrochloric acid in the stomach without causing secondary hypersecretion of gastric juice. Due to the increase in pH when taken, the peptic activity of gastric juice decreases. It has an adsorbing and enveloping effect, due to which the impact of damaging factors on the gastric mucosa is reduced, and binds bile acids.

Simethicone

Simethicone changes the surface tension of gas bubbles formed in the contents of the stomach and intestinal mucus and causes their destruction. The gases released during this process can be absorbed by the cells of the intestinal walls, or excreted through peristalsis. Simethicone removes foam purely physically, does not enter into chemical reactions, and is pharmacologically inert.

Pharmacokinetics

Magaldrat

Absorption of aluminum and magnesium ions in the blood is low. With normal kidney function, the concentration of aluminum and magnesium in the blood does not change. In patients with chronic renal failure, the content of aluminum and magnesium in the blood may increase to toxic levels as a result of impaired excretion.

Simethicone

Due to pharmacological and chemical inertness, simethicone is not absorbed into organs and tissues after oral administration. After passing through the gastrointestinal tract (GIT), it is excreted unchanged by the intestines.

Indications for use

Symptoms associated with increased acidity of gastric juice and reflux esophagitis: heartburn, belching with a “sour taste”, pain in the stomach (appear irregularly), a feeling of fullness or heaviness in the epigastric region, flatulence, dyspepsia (including those caused by errors in diet , taking medications, abuse of alcohol, coffee, nicotine).

Contraindications

Hypersensitivity to the components of the drug; severe renal failure; hypophosphatemia; fructose intolerance (due to the presence of sorbitol in the drug); children up to 12 years of age.

With caution: in case of renal failure (with long-term use, an increase in the content of magnesium and aluminum in the blood plasma is possible); for Alzheimer's disease; with low phosphate content in food (risk of developing phosphate deficiency).

Use during pregnancy and breastfeeding

There have been no controlled clinical studies examining the use of Antareit in pregnant women, but no teratogenic effect or effect was identified in preclinical studies. Due to the lack of clinical experience, the use of the drug during pregnancy is possible only if the benefit from its use for the mother outweighs the potential risk to the fetus.

Prescribing the drug during pregnancy in large doses and for a long time should be avoided.

While taking Antareit, breastfeeding is not required.

Directions for use and doses

Inside. The tablets should be chewed thoroughly or kept in the mouth until completely dissolved.

Adults and adolescents over 12 years of age: Unless otherwise recommended by a doctor, take 1-2 tablets shortly after meals. If necessary, you can repeat the drug after 2 hours.

The maximum daily dose for tablets 400 mg + 20 mg is 16 tablets; for tablets

800 mg+40 mg – 8 tablets.

Side effect

Allergic reactions, nausea, vomiting, taste disturbances, constipation, diarrhea. With long-term use in high doses - hypophosphatemia, hypocalcemia, hypercalciuria, osteomalacia, osteoporosis, hypermagnesemia, hyperaluminemia, encephalopathy, nephrocalcinosis, impaired renal function. In patients with concomitant renal failure - a feeling of thirst, decreased blood pressure, hyporeflexia.

Overdose

Symptoms: with prolonged use of high doses, the formation of kidney stones, constipation, drowsiness, and hypermagnesemia are possible. Signs of metabolic alkalosis may also be observed: mood lability, numbness or muscle pain, nervousness and fatigue, and unpleasant taste sensations. Treatment: it is necessary to take measures to quickly eliminate the drug: rinse the stomach, induce vomiting, take activated charcoal.

Interaction with other drugs

Antareit reduces and slows down the absorption of digoxin, indomethacin, salicylates, chlorpromazine, phenytoin, H2-histamine blockers, beta-blockers, diflunisal, isoniazid, tetracycline antibiotics, quinolones (ciprofloxacin, norfloxacin, ofloxacin, enoxacin, grepofloxacin, etc. .), azithromycin, cefpodoxime , pivampicillin, rifampicin, indirect anticoagulants, barbiturates, fexofenadine, dipyridamole, zalcitabine, bile acids - chenodeoxycholic and ursodeoxycholic, penicillamine, iron and lithium preparations, quinidine, lansoprazole, mexiletine, ketoconazole. M-anticholinergics, by slowing down gastric emptying, enhance and prolong the effect of the drug.

special instructions

When using Antareit and other medications simultaneously, an interval of at least 1-2 hours should be maintained. With long-term use, sufficient intake of phosphorus from food should be ensured. In case of mild to moderate renal dysfunction, it is necessary to regularly monitor the content of aluminum, calcium, and phosphates in the blood plasma. The drug contains sorbitol, which is contraindicated in cases of congenital fructose intolerance.

Features of the effect of the drug on the ability to drive vehicles or when working with potentially dangerous mechanisms

Does not have a negative impact on the ability to drive vehicles and operate mechanisms that require increased concentration and speed of psychomotor reactions.

Release form

Chewable tablets 400 mg+20 mg and 800 mg+40 mg. 6 tablets per blister made of PVC/Al foil.

2 or 4 blisters along with instructions for use in a cardboard box.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Best before date

3 years.

Do not use after the expiration date stated on the packaging.

Vacation conditions

Available without a prescription.

Antareit

Antareit

(Antareyt) is a complex drug whose active ingredients are the non-absorbable antacid magaldrate and the defoamer simethicone, which reduces the amount of gases in the gastrointestinal tract. Magaldrate is aluminum magnesium hydroxide sulfate, its chemical formula is Al5Mg10(OH)31(SO4)2·nH2O.

Pharmacological properties of Antareit

Antareit works on the principle of pharmacological synergy.
Features of the composition and structure of magaldrate determine the mechanism of its action. Unlike a mixture of substances amorphous in structure, which are antacids based on aluminum hydroxide and magnesium hydroxide, magaldrate is a crystalline substance. Particles of magaldrate and amorphous mixtures of aluminum and magnesium hydroxides behave differently when dissolved in hydrochloric acid. Crystalline magaldrate particles placed in a solution of hydrochloric acid have the same size and consist of a dense core of aluminum hydroxide and a thin shell of magnesium hydroxide. First, they decrease in size depending on the concentration of hydrochloric acid, then the particle size in the solution increases to 2 microns and remains stable. When mixtures based on aluminum and magnesium hydroxides are dissolved in hydrochloric acid, unstable particles of different sizes are formed, consisting of a loose core of magnesium hydroxide surrounded by a shell of aluminum hydroxide. The layered network crystal structure of magaldrate serves as the basis for maintaining optimal acidity values. The surface layers of magaldrate sequentially interact with hydrochloric acid. Within one to two minutes, the pH value in the stomach reaches 3-5. As soon as the pH value rises above 5, the reaction stops. The remaining layers of the lattice are maintained until acid secretion increases again, after which the reaction begins with the next layer of magaldrate. When using magaldrate, there is a stable retention of values ​​in the range of 3-5 for three hours. The effectiveness of magaldrate for the healing of duodenal ulcers is comparable to that of the H2 blocker cimetidine. Magaldrate adsorbs bile acids much better than other antacids, and also adsorbs lysolecithin well (Trukhmanov A.S., Gromova O.A.). Simethicone removes gases from the gastrointestinal tract without entering into chemical reactions, changing the surface tension of gas bubbles formed in the stomach and intestines and, thus, destroying them.

Dosage forms and composition of Antareit

In Russia, two dosage forms of Antareit are approved for use:

  • chewable tablets 400/20 and
  • chewable tablets 800/40.

The numbers 400/20 and 800/40 show the content of active ingredients in one tablet: 400 (or 800) mg of magaldrate and 30.77 (or 61.54) mg of simethicone, which in terms of dimethylpolysiloxane is equal to 20 (or 40) mg.
In addition, one chewable tablet 400/20 contains excipients: macrogol-4000 - 70.0 mg, sorbitol - 256.59 mg, aspartame - 2.50 mg, ethylcellulose - 18.0 mg, sucralose - 2.16 mg, caramel flavoring - 6.48 mg, glyceryl dibehenate - 9.0 mg, colloidal silicon dioxide - 4.5 mg. Tablet 800/400 contains the same excipients, but in double quantities.

Indications for use of Antareit

Antareit is indicated to reduce and relieve the following symptoms caused by reflux esophagitis and increased acidity of gastric juice:

  • heartburn
  • belching sour
  • irregular pain in the stomach area
  • flatulence
  • dyspepsia
  • feeling of fullness or heaviness in the epigastric region
Contraindications and restrictions for the use of Antareit

Antareit is contraindicated for:

  • hypophosphatemia
  • severe renal failure
  • fructose intolerance
  • hypersensitivity to substances contained in Antareit
  • children up to 12 years old
Procedure for using Antareit and dose

1-2 tablets of Antareit are taken orally immediately after meals, chewing or dissolving thoroughly.
If necessary, repeat the dose after 2 hours. The doctor may recommend a different dosage regimen.

It is recommended to take Antareit separately from other drugs, with an interval of at least 1-2 hours. Since magaldrate adsorbs phosphorus from food transit, when taking the drug Antareit for a long time, sufficient intake of phosphorus from food should be ensured. In case of impaired renal function, it is necessary to periodically monitor the content of aluminum, calcium, and phosphates in the blood plasma (Gromova O.A. et al.).

Maximum daily dose, no more than:

  • 16 tablets 400/20
  • 8 tablets 800/40
Side effects of Antareit

Anteritis can cause the following symptoms and conditions:

  • nausea, vomiting, taste disturbance
  • constipation, diarrhea
  • allergic reactions

With long-term use in large doses:

  • hypermagnesemia
  • hypophosphatemia
  • hyperaluminemia
  • hypocalcemia, hypercalciuria
  • osteomalacia
  • osteoporosis
  • encephalopathy
  • nephrocalcinosis
  • renal dysfunction
Interaction of Antareit with other drugs

Antareit reduces and slows down the absorption of lansoprazole, H2-blockers, chenodeoxycholic and ursodoxycholic bile acids, azithromycin, fluoroquinolones (ciprofloxacin, norfloxacin, ofloxacin and others), tetracycline and its derivatives, digoxip, indomsgacin, salicylates, chlorpromazine, phenytoin, beta - adrenergic blockers, diflunisal , isoniazid, cefpodoxime, pivampicillin, rifampicin, indirect anticoagulants, barbiturates, fexofenadine, dipyridamole, zalcitabine, penicillamine, iron and lithium preparations, quinidine, mexilegine, ketoconazole. M-anticholinergics, by slowing down gastric emptying, enhance and prolong the effect of the drug.

general information

According to ATC, Antareit belongs to the section “A02A Antacids”, group “A02AF Antacids in combination with carminatives” and has the code “A02AF02 Simple combinations of salts and carminatives”.
The instructions for Antareit, approved by the Russian Ministry of Health (see, pdf), indicate that the manufacturer of Antareit is Sequel Pharmaceutical Pvt. Ltd.", India, and the owner of the registration certificate is LLC "Remedia", Russia.

Antareit is an over-the-counter drug.

Antarate does not have a negative impact on the ability to drive vehicles.

Materials for healthcare professionals regarding the use of Antareit

Articles
  • Gromova O.A., Torshin I.Yu., Maksimov V.A. Magaldrate as an antacid with multitarget effects: clinical and pharmacological essay // Attending physician. – 2021. No. 2, p. .
  • Trukhmanov A.S., Gromova O.A. Magaldrate is a unique new generation antacid. Rationale for the feasibility of using antacids in clinical practice: gastroenterologist and pharmacologist // Effective pharmacotherapy. 2021. No. 16. pp. 52–54.

On the website GastroScan.ru in the “Literature” section there is a subsection “Antacids”, containing articles devoted to the treatment of diseases of the gastrointestinal tract with antacids.

Video

Still from video by E.S. Vyuchnova Tactics for managing patients with duodenogastric/biliary reflux

On the website GastroScan.ru in the “Video” section there is a subsection “For doctors”, containing video recordings of reports, lectures, webinars in various areas of gastroenterology for healthcare professionals, as well as a subsection “For students of medical universities”.

Antareit has contraindications, side effects and application features; consultation with a specialist is necessary. Back to section

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