Almagel, suspension 170 ml

Pharmacotherapeutic group

Antacidal agent

ATX code: A02AX

Pharmacological action

Pharmacodynamics

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

It has an enveloping, adsorptive effect. It protects the mucous membrane of the stomach by stimulating the synthesis of prostaglandins (cytoprotective effect). This protects the mucous membrane from inflammatory and erosive-hemorrhagic lesions due to irritating and ulcerogenic agents such as ethyl alcohol and nonsteroidal anti-inflammatory drugs (e.g., indomethacin, diclofenac, aspirin, acetylsalicylic acid, corticosteroid drugs). The therapeutic effect after taking the drug comes in 3-5 minutes.

The duration of action depends on the rate of gastric emptying. When taken on an empty stomach, the action lasts up to 60 minutes. When taken one hour after a meal the antacid action may last up to 3 hours. Does not cause secondary hypersecretion of gastric juice.

Pharmacokinetics

Algeldrate

Intake – small amounts of the drug are resorbed, which almost does not change the concentration of aluminum salts in the blood.

Distribution – no.

Metabolism – no.

Exhaustion – excreted through the intestine.

Magnesium hydroxide

Intake – Magnesium ions are resorbed in about 10% of the dose taken and do not change the concentration of magnesium ions in the blood.

Distribution – usually locally.

Metabolism – none. Excretion – excreted through the intestine.

Indications

Treatment
Acute gastritis; chronic gastritis with increased and normal secretory function of the stomach (in the acute phase); acute duodenitis, enteritis, colitis;
peptic ulcer of the stomach and duodenum (in the acute phase);
hiatal hernia, gastroesophageal reflux, reflux esophagitis, duodenogastric reflux;
symptomatic gastrointestinal ulcers of various origins; erosion of the mucous membrane of the upper gastrointestinal tract;
acute pancreatitis, exacerbation of chronic pancreatitis;
heartburn and epigastric pain after errors in diet, excessive consumption of ethanol, nicotine, coffee, taking medications that irritate the gastric mucosa.
Prevention of gastric and duodenal disorders
reducing the irritant and ulcerogenic effects associated with taking medications that irritate the gastric mucosa.

Pharmacological effect

Pharmacotherapeutic group

Antacid

ATX code: A02AX

Pharmacological action

Pharmacodynamics

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

Has an enveloping, adsorbing effect. Protects the gastric mucosa by stimulating the synthesis of prostaglandins (cytoprotective effect). This protects the mucous membrane from inflammatory and erosive-hemorrhagic lesions as a result of the use of irritating and ulcerogenic agents such as ethyl alcohol and non-steroidal anti-inflammatory drugs (for example, indomethacin, diclofenac, aspirin, acetylsalicylic acid, corticosteroid drugs). 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. Does not cause secondary hypersecretion of gastric juice.

Pharmacokinetics

Algeldrat

Absorption – small amounts of the drug are resorbed, which practically do not change the concentration of aluminum salts in the blood.

Distribution – no.

Metabolism – no.

Excretion – excreted through the intestines.

Magnesium hydroxide

Absorption – magnesium ions are resorbed in about 10% of the dose taken and do not change the concentration of magnesium ions in the blood.

Distribution is usually local.

Metabolism – no. Excretion – excreted through the intestines.

Special instructions

The use of the drug in patients with severe constipation is not recommended; for stomach pain of unknown origin and suspected acute appendicitis; in the presence of ulcerative colitis, diverticulosis, colostomy or ileostomy; for chronic diarrhea; acute hemorrhoids; when the acid-base balance in the body changes, as well as in the presence of metabolic alkalosis; with cirrhosis of the liver; severe heart failure; with toxicosis of pregnant women; with impaired renal function (creatinine clearance

With prolonged use of the drug (more than 20 days), regular medical monitoring of serum magnesium levels is necessary when treating patients with renal failure. The drug does not contain sugar, which allows it to be taken by patients with diabetes. The drug contains sorbitol, which is contraindicated in cases of congenital fructose intolerance.

The effect of the drug on the ability to drive vehicles and other mechanisms:

Almagel does not affect the ability to drive a car or operate machinery. When taken in the recommended daily dose, the ethyl alcohol contained in the drug does not affect the ability to drive a car or operate machinery.

Active ingredient

Algeldrat, Magnesium hydroxide

Composition

5 ml (one scoop) of suspension contains:

Active ingredients:

Aluminum hydroxide gel -2.18 g

in terms of Al2O3 -218 mg

Magnesium hydroxide infusion – 350 mg

in terms of MgO – 75 mg

Excipients:

Hydrogen peroxide solution 30% – 0.41 mg,

sorbitol – 801.15 mg,

hyaetellose – 10.90 mg,

methyl parahydroxybenzoate – 10.90 mg,

propyl parahydroxybnzoate – 1.363 mg,

butyl parahydroxybenzoate – 1.363 mg,

sodium saccharinate dihydrate – 0.818 mg,

propylene glycol – 327.00 mg,

macrogol 4000 – 218.00 mg,

lemon oil – 1.635 mg,

ethanol 96% – 98.10 mg,

purified water up to 5 ml

Pregnancy

Animal studies have not demonstrated teratogenic potential or other adverse effects on the embryo and/or fetus.

There are no clinical data on the use of Almagel® by pregnant women. The drug Almagel® is not recommended to be taken during pregnancy, but if the benefits of its use outweigh the potential risk to the fetus, then the duration of use should not exceed 5 – 6 days under medical supervision.

There is no data on the excretion of the active ingredients of the drug Almagel® in breast milk. The drug Almagel® can be used during breastfeeding only after a careful assessment of the balance of benefit for the mother and potential risk for the newborn.

During breastfeeding, the duration of use should not exceed 5 – 6 days under medical supervision.

Contraindications

Hypersensitivity to the active substance or to any excipient included in the drug.
Severe form of renal failure (due to the risk of developing hypermagnesemia and aluminum intoxication).
Pregnancy.
Alzheimer’s disease.
Hypophosphatemia.
Children’s age up to 10 years.
Congenital fructose intolerance (contains sorbitol)

Side Effects

Adverse reactions are systematized in accordance with the World Health Organization (WHO) Classification: very common (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (< 1/10000); frequency unknown (cannot be determined from available data).

Immune system disorders: rarely – allergic reactions.

Metabolic and nutritional disorders: very rarely – hypermagnesemia1 (with concomitant arterial hypotension); frequency unknown – hypophosphatemia, hypercalciuria.

Musculoskeletal and connective tissue disorders: frequency unknown – osteomalacia.

Gastrointestinal disorders: rarely – nausea, vomiting, stomach spasms, changes in taste; frequency unknown – abdominal pain1; constipation (goes away after reducing the dose).

With long-term use of the drug by patients with renal failure and patients on hemodialysis, changes in mood and mental activity are possible.

With long-term use of high doses of the drug and phosphorus deficiency in food, osteomalacia may occur.

1 Observed with long-term use of magnesium hydroxide in patients with renal failure.

Interaction

It may absorb some medications, thereby reducing their absorption, therefore, when taking other medications simultaneously, they must be taken 1-2 hours before or after taking Almagel.

Almagel reduces the acidity of gastric juice, and this can affect the effect of a large number of medications when taken 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 taking enteric drugs simultaneously, the increased pH of gastric juice can lead to accelerated breakdown of the gastric membrane and cause irritation of the stomach and duodenum. Almagel may affect the results of some laboratory and functional studies and tests: it reduces the level of gastric secretion when determining its acidity; alters the results of technetium (TC??) tests, such as bone scintigraphy and some esophageal tests, increases serum phosphorus levels, serum and urine pH values.

Overdose

Symptoms: with a single dose exceeding the recommended dose, there are usually no other signs of overdose other than constipation, flatulence, and a metallic taste in the mouth.

With prolonged use of high doses, the formation of kidney stones, severe constipation, mild drowsiness, and hypermagnesemia are possible. Signs of metabolic alkalosis may also be observed: changes in mood or mental activity, numbness or muscle pain, irritability and fatigue, slow breathing, unpleasant taste sensations.

Urgent measures: in these cases, it is necessary to immediately take measures to quickly remove the drug from the body – gastric lavage, stimulation of vomiting, taking activated charcoal.

In case of overdose, symptomatic therapy is required.

Storage conditions

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

Avoid freezing.

Shelf life

2 years

Manufacturer

Balkanpharma-Troyan AD, Bulgaria