Almagel^® (Tablets, Suspension) Instructions for Use

ATC Code

A02AX (Antacids in combination with other agents)

Active Substances

Algeldrate (Rec.INN registered by WHO)

Magnesium hydroxide (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Antacid drug

Pharmacotherapeutic Group

Acid-related disorder treatment agents; antacids; combination salts and complex compounds of aluminum, calcium, and magnesium

Pharmacological Action

An antacid drug, which is a balanced combination of algeldrate (aluminum hydroxide) and magnesium hydroxide. It neutralizes free hydrochloric acid in the stomach and reduces the activity of pepsin, which leads to a decrease in the digestive activity of gastric juice.

It has an enveloping, adsorbing effect. It protects the gastric mucosa by stimulating the synthesis of prostaglandins (cytoprotective effect). It protects the mucosa from inflammatory and erosive-hemorrhagic lesions resulting from the use of irritating and ulcerogenic agents, such as ethanol, NSAIDs (e.g., indomethacin, diclofenac, acetylsalicylic acid), corticosteroids.

The therapeutic effect after taking the drug occurs within 3-5 minutes. The duration of action depends on the rate of gastric emptying. When taken on an empty stomach, the effect lasts up to 60 minutes. When taken one hour after a meal, the antacid effect can last up to 3 hours. It does not cause secondary hypersecretion of gastric juice.

Pharmacokinetics

Algeldrate

An insignificant amount of the drug is absorbed, which practically does not change the concentration of aluminum salts in the blood. It is excreted through the intestines.

Magnesium hydroxide

Magnesium ions are absorbed in insignificant amounts (about 10% of the taken dose) and do not change the concentration of magnesium in the blood. It is usually distributed locally. Magnesium hydroxide is excreted through the intestines.

Indications

Treatment

• Acute gastritis;
• Chronic gastritis with increased and normal secretory function of the stomach (in the acute phase);
• Acute duodenitis, enteritis, colitis;
• Gastric and duodenal ulcer (in the acute phase);
• Hiatal hernia;
• Gastroesophageal reflux, reflux esophagitis, duodenogastric reflux;
• Symptomatic ulcers of the gastrointestinal tract of various origins;
• Erosions of the mucosa of the upper gastrointestinal tract;
• Acute pancreatitis, exacerbation of chronic pancreatitis;
• Heartburn and epigastric pain after dietary errors, excessive consumption of ethanol, nicotine, coffee, taking medications that irritate the gastric mucosa.

Prevention

• Reduction of the irritating and ulcerogenic effect associated with taking medications that irritate the gastric mucosa.

ICD codes

Dosage Regimen

Tablets

Orally, 5-10 ml (suspension, gel) or 2-3 tablets 1-2 hours after meals and at bedtime; for gastric ulcer – 30 minutes before meals; if necessary, the single dose can be increased to 15 ml or 3-4 tablets. After achieving the therapeutic effect – maintenance therapy with 5 ml or 1 tablet 3 times/day for 2-3 months.

Children from 4 to 12 months – 7.5 ml, children over 1 year – 15 ml 3 times/day.

For prevention, take 5-10 ml or 1-2 tablets before possible irritating effects on the gastrointestinal mucosa.

To increase effectiveness, the tablets should be chewed or held in the mouth until completely dissolved. The suspension or gel must be homogenized before use by shaking the bottle or thoroughly kneading the sachet between the fingers. Squeeze the contents of the sachet into a spoon or into the mouth.

Suspension

The drug is taken orally. Before each use, the suspension must be thoroughly homogenized by shaking the bottle.

Treatment

The drug is taken 45-60 minutes after meals and in the evening before bedtime.

Adults and children over 15 years are prescribed 5-10 ml (1-2 measuring spoons) 3-4 times/day. If necessary, the single dose can be increased to 15 ml (3 measuring spoons). Children aged 10 to 15 years are prescribed a dose equal to half the adult dose.

After achieving the therapeutic effect, the daily dose is reduced to 5 ml (1 measuring spoon) 3-4 times/day for 15-20 days.

It is not recommended to take fluids within 15 minutes after taking Almagel^®.

Prevention

5-15 ml 15 minutes before taking medications with an irritating effect.

Adverse Reactions

From the digestive system – constipation is possible, which resolves after reducing the dose; in rare cases – nausea, vomiting, stomach cramps, changes in taste sensations.

From the nervous system – with prolonged use of the drug in patients with renal failure and patients on dialysis, changes in mood and mental activity are possible.

Other – in rare cases – allergic reactions and hypermagnesemia; with long-term use in high doses (in combination with phosphorus deficiency in the diet), the development of osteomalacia is possible.

Contraindications

• Severe renal failure (due to the risk of hypermagnesemia and aluminum intoxication);
• Alzheimer’s disease;
• Hypophosphatemia;
• Pregnancy;
• Children under 10 years of age;
• Congenital fructose intolerance (the drug contains sorbitol);
• Hypersensitivity to the active substances and auxiliary components of the drug.

Use in Pregnancy and Lactation

Experimental studies in animals have shown no teratogenic potential or other adverse effects on the embryo and/or fetus.

There are no clinical data on the use of Almagel^® in pregnant women. The drug is not recommended for use during pregnancy, but if the intended benefit to the mother outweighs the potential risk to the fetus, Almagel^® should be taken under medical supervision for no more than 5-6 days.

There are no data on the excretion of the drug’s active substances in breast milk. Almagel^® can be used during breastfeeding only after a thorough assessment of the ratio of the intended benefit to the mother and the potential risk to the child. During lactation, the drug is recommended to be used for no more than 5-6 days under medical supervision.

Use in Hepatic Impairment

The use of the drug is not recommended for liver cirrhosis.

Use in Renal Impairment

Contraindicated in severe renal failure (due to the risk of hypermagnesemia and aluminum intoxication).

In patients with renal failure with prolonged use of the drug (more than 20 days), regular monitoring of serum magnesium concentration is necessary.

Pediatric Use

The drug is contraindicated for use in children under 10 years of age.

Special Precautions

The use of the drug is not recommended for patients with severe constipation, with stomach pain of unknown origin and suspected acute appendicitis, presence of ulcerative colitis, diverticulosis, colostomy or ileostomy, chronic diarrhea, acute hemorrhoids, changes in the acid-base balance in the body, as well as the presence of metabolic alkalosis, liver cirrhosis, severe heart failure, toxemia of pregnancy, impaired renal function ((CrCl <30 ml/min) due to the risk of hypermagnesemia and aluminum intoxication).

In patients with renal failure with prolonged use of the drug (more than 20 days), regular monitoring of serum magnesium concentration is necessary.

The drug does not contain sugar, which allows it to be taken by patients with diabetes mellitus.

The drug contains sorbitol, therefore it is contraindicated in congenital fructose intolerance.

Effect on ability to drive vehicles and mechanisms

Almagel^® does not affect the ability to drive a car and work with mechanisms. When taken in the recommended daily dose, the ethanol contained in the preparation does not affect the ability to drive a car and work with mechanisms.

Overdose

Symptoms with a single dose exceeding – constipation, flatulence, metallic taste in the mouth. With prolonged use in high doses, the formation of kidney stones, development of severe constipation, slight drowsiness, hypermagnesemia are possible. Signs of metabolic alkalosis may also be observed: changes in mood or mental activity, numbness or muscle pain, irritability and rapid fatigue, slow breathing, unpleasant taste sensations.

Treatment – it is necessary to immediately take measures to quickly remove the drug from the body – gastric lavage, induction of vomiting, intake of activated charcoal.

Drug Interactions

It can adsorb some drugs, thus reducing their absorption. Therefore, when using other drugs simultaneously, it is necessary to observe an interval of 1-2 hours between taking Almagel^® and other agents.

Almagel^® changes the pH of gastric juice to the alkaline side, which may affect the action of a significant number of drugs when used simultaneously.

Almagel^® reduces the effect of histamine H₂-receptor blockers (cimetidine, ranitidine, famotidine), cardiac glycosides, iron salts, lithium preparations, quinidine, mexiletine, phenothiazine drugs, tetracycline antibiotics, ciprofloxacin, isoniazid and ketoconazole.

When prescribing enteric-coated forms of drugs simultaneously, it should be remembered that the increase in gastric juice pH caused by taking Almagel^® may lead to accelerated destruction of the enteric coating and thereby cause irritation of the gastric and duodenal mucosa.

Almagel^® may affect the results of some laboratory and functional studies and tests: reduces the level of gastric secretion when determining the acidity of gastric juice; changes the results of tests using technetium (^99mTc), for example, bone scintigraphy and some tests for examining the esophagus; increases the concentration of phosphorus in the blood serum, changes the pH values of blood serum and urine.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F); do not freeze.

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.