Description
Release form
Suspension for oral administration of 10 ml per sachet – 10 sachets in a carton pack
Pharmacological action
Pharmacotherapeutic group
Antacid
ATX code: A02AX
Pharmacological action of
Pharmacodynamics
Almagel ® is a drug 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 digesting activity of gastric juice. It 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 (e.g. indomethacin, diclofenac, aspirin, acetylsalicylic acid, corticosteroid drugs). The therapeutic effect after taking the drug occurs 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 an 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 absorbed, 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 and do not change the concentration of magnesium ions in the blood.
Distribution – usually locally.
Metabolism – no. Excretion – excreted through the intestines.
Indications
Treatment of
Acute gastritis, chronic gastritis with increased and normal secretory function of the stomach (in the acute phase), acute duodenitis, enteritis, colitis
gastric ulcer and duodenal ulcer (in the exacerbation phase) gastric reflux, gastric esophagitis, duodenogastric reflux
symptomatic gastrointestinal ulcers of various origins of erosion of the mucous membrane of the upper gastrointestinal tract
acute pancreatitis, exacerbation of chronic pancreatitis
heartburn and epigastric pain after nutrition errors, excessive consumption of ethanol, nicotine, coffee, taking medications that irritate the gastric mucosa.
Prevention of gastric and duodenal disorders
reduction of irritating and ulcerogenic effects associated with taking medications that irritate the gastric mucosa.
Contraindications
Hypersensitivity to the active or to any auxiliary substance that is part of the drug.
Severe renal failure (due to the danger of developing hypermagnesemia and aluminum intoxication).
Pregnancy.
Alzheimer’s disease.
Hypophosphatemia.
Children under 10 years old.
Congenital intolerance to fructose (contains sorbitol)
Pregnancy and lactation
Animal studies have shown that there is no evidence of teratogenic potential or other adverse effects on the embryo and / or fetus.
There is no clinical data on the use of Almagel in pregnant women. The drug is not recommended during pregnancy, but if the intended benefit of its use exceeds the potential risk to the fetus, the drug should be taken under medical supervision for no more than 5-6 days.
There is no data on the release of the active substances of the drug with breast milk. Almagel can be used during breastfeeding only after a careful assessment of the ratio of benefits for the mother and the potential risk for the newborn.
During breastfeeding, it is recommended to use no more than 5-6 days under the supervision of a doctor.
Special instructions
It is not recommended to use the drug in patients with severe constipation with pain in the stomach of unknown origin and with suspected acute appendicitis in the presence of ulcerative colitis, diverticulosis, colostomy or ileostomy in case of chronic diarrhea, acute hemorrhoids with changes in acid-base balance, acid-base balance as well as in the presence of metabolic alkalosis in cirrhosis of the liver of severe heart failure in case of toxicosis of pregnant women with impaired renal function (creatinine clearance <30 ml / min, because of the danger spine of gipermagniemii and aluminum toxicity). With prolonged use of the drug (more than 20 days), regular medical attention is required, monitoring of serum magnesium levels in the treatment of patients with renal failure. The product does not contain sugar, which allows you to take it to patients with diabetes. The drug contains sorbitol, which is contraindicated in congenital fructose intolerance. Effect of the drug on the ability to drive vehicles and other 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. Composition 10 ml (1 sachet) suspension contains: Active ingredients: Aluminum hydroxide gel – 4.36 g in terms of Al2O3 – 436 mg Magnesium hydroxide – 700 mg in 150 mg srdlOp in terms of mgrd Excipients: Hydrogen peroxide solution 30% – 0.82 mg, sorbitol – 1602,300 mg, hyetellose – 21.80 mg, methyl parahydroxybenzoate – 21.80 mg, propyl parahydroxybenzoate – 2.726 mg, butyl parahydroxybenzoate – 2.726 mg sodium mg, propylene glycol – 654.00 mg, macrogol 4000 – 436.00 mg, lemon oil – 3.27 mg, ethanol 96% – 196.20 mg, och water searched up to 10 ml. Dosage and administration of Treatment of Adults and children over 15 years of age 510 ml (1-2 scoops) or 1 sachet 3-4 times a day. If necessary, a single dose can be increased to 15 ml (3 scoops). For children from 10 to 15 years old is used in a dose equal to half the dose for adults – 1 scoop 2-4 times a day or 2 scoops 1-2 times a day or 1 sachet 1-2 times a day. The drug is taken 45-60 minutes after eating and in the evening before bedtime. After achieving the therapeutic effect, the daily dose is reduced to 5 ml (1 scoop) 3-4 times a day or 1 sachet 1-2 times a day for 15-20 days. It is not recommended to take fluids within 15 minutes after taking the drug Almagel. Before use, the suspension must be thoroughly homogenized by shaking the bottle or kneading and shaking the bag. For the prevention of 5-15 ml (1-3 scoops) or 1 sachet 15 minutes before taking drugs with an irritating effect. Side effects Almagel can cause constipation, which disappears after a dose reduction. In rare cases, nausea, vomiting, stomach spasm, changes in taste, allergic reactions and hypermagnesemia (increased levels of magnesium in the blood) are observed. With prolonged use of the drug in patients with renal failure and dialysis, changes in mood and mental activity are possible. With prolonged use of high doses of the drug, along with a deficiency of phosphorus in food, osteomalacia may occur. Overdose With a single dose exceeding, no other signs of overdose are observed except for constipation, flatulence, a metallic taste in the mouth. With prolonged use of high doses, kidney stones, severe constipation, mild drowsiness, hypermagnesemia are possible. There may also be signs of metabolic alkalosis: mood changes or mental activity, numbness or muscle pain, irritability and fatigue, slow breathing, unpleasant taste sensations. In these cases, you must immediately take measures to quickly remove the drug from the body – washing the stomach, stimulating vomiting, taking activated charcoal. Storage Conditions The product should be stored out of reach of children, protected from light at a temperature not exceeding 25 ° C. Do not freeze. Expiration 2 years. Conditions of release from drugstores Without a prescription lekarstvennaja form suspensions for pryema inside Prescription Nursing mothers, prescribed by a doctor, For pregnant women, Children over 10 years old, For adults
