Name:
Almox suspension.d/in.prim.in vial 150g with dosing glass in pack №1
Description:
Suspension of white or almost white color with lemon smell. Stratification of the suspension is allowed, which is eliminated by shaking. The main active ingredient Algeldrate + magnesium hydroxide + benzocaine Release formSuspension Dosage 150g Pharmacological properties Almox A is a balanced combination of aluminum hydroxide, magnesium hydroxide and benzocaine. Magnesium hydroxide and aluminum hydroxide neutralize free hydrochloric acid, which leads to a decrease in the peptic activity of gastric juice. Benzocaine has a local anesthetic effect in the presence of severe pain; this action manifests itself 1-2 minutes after taking the drug Almox A inside. Aluminum hydroxide, helping to slow down intestinal motility, balances the laxative effect of magnesium hydroxide. The drug Almox A does not cause alkalosis and the formation of CO2 in the stomach. Magnesium and aluminum hydroxides are considered local antacids that do not have systemic effects on the body, provided that all recommendations for use are observed. Ingested aluminum hydroxide and magnesium hydroxide react with the hydrochloric acid of gastric juice to form salts that are only partially absorbed. Removal of absorbed salts is carried out mainly with urine. Benzocaine is absorbed in minimal amounts and has virtually no systemic effects on the body. Indications for use Antacid therapy for heartburn and gastroesophageal reflux, accompanied by severe pain, in patients over 18 years of age. Route of administration and doses Route of administration The drug Almox A is intended only for adults (that is, for persons over 18 years of age). Shake the vial before use to obtain a homogeneous suspension. It is not recommended to take liquids for at least 15 minutes after taking the drug. Long-term use of the drug is not recommended. The maximum duration of use without consulting a doctor is 7 days. The need for further treatment and what drug it can be carried out is determined by the doctor. Doses It is recommended to take 5-10 ml of suspension 3-4 times a day 10-15 minutes before meals. Do not exceed the maximum daily dose of the drug. Patients with mild to moderate renal insufficiency are advised to take the drug under the direct supervision of a physician. In this category of patients, it may be necessary to reduce the daily dose and / or lengthen the intervals between doses, depending on the severity of renal dysfunction. Long-term use of the drug should also be avoided in patients with mild to moderate renal insufficiency. Almox A is contraindicated in patients with severe renal insufficiency (see sections “Special instructions and precautions”, “Contraindications”). If you have accidentally taken an excessive dose of the drug, you should immediately seek advice from your doctor or the nearest medical facility (see also sections “Overdose”, “Side effects”, “Special instructions and precautions”). If you miss taking the next dose of the drug, you need to take the next dose according to the established schedule. It is not allowed to take a double dose in order to compensate for the missed one! Use during pregnancy and lactation Almox A is not prescribed during periods of pregnancy and lactation, since the drug contains benzocaine. Contraindications The appointment and use of Almox A is contraindicated if the patient has the following conditions: known individual hypersensitivity to any of the active substances and / or to any of the excipients of the drug; congenital or acquired methemoglobinemia (including personal and family history) (see section “Special Instructions and Precautions”); porphyria; severe renal failure (since the drug contains magnesium); cachexia; severe abdominal pain of unknown origin; suspected intestinal obstruction or diagnosed intestinal obstruction; age up to 18 years; pregnancy; lactation. Active ingredients: each 5 ml of suspension contains as active substances aluminum oxide (in the form of aluminum hydroxide gel or aluminum hydroxide gel paste) 218 mg, magnesium oxide (in the form of magnesium hydroxide paste) 75 mg and benzocaine 109 mg; excipients: sorbitol non-crystallizing solution (E 420), ethyl alcohol 96%, hydroxyethyl cellulose, methyl parahydroxybenzoate (E 218), lemon oil, propyl parahydroxybenzoate (E 216), butyl parahydroxybenzoate, sodium saccharin (E 954), purified water. OverdoseSymptoms Data on intentional overdose is limited. An overdose of magnesium usually does not lead to the development of toxic reactions in patients with normal kidney function. The likelihood of developing such reactions is increased in patients with renal insufficiency (see section “Special instructions and precautions”). An overdose of aluminum salts also develops more easily in patients with severe renal insufficiency and leads to the development of symptoms such as encephalopathy, seizures, dementia, hypermagnesemia. Manifestations of toxic action depend on the concentration of magnesium in the blood serum. Possible manifestations of toxic effects include lowering blood pressure, nausea, vomiting, drowsiness, decreased reflexes, muscle weakness, neuromuscular paralysis, bradycardia, ECG abnormalities, hypoventilation, anuria, in the most severe cases, respiratory paralysis, coma, impaired renal function and /or hearts. In acute overdose of the aluminum hydroxide + magnesium hydroxide combination, diarrhea, abdominal pain, and vomiting may occur. High doses of the drug may cause or worsen intestinal obstruction in patients with risk factors for such a condition (see section “Special instructions and precautions”). Since Almox A contains benzocaine, overdose of the drug may cause loss of sensitivity when swallowing. Treatment Absorbed aluminum and magnesium are excreted in the urine. The complex of measures for acute overdose should include rehydration, the provision of forced diuresis. In case of renal failure, hemodialysis or peritoneal dialysis is required. Symptomatic and supportive treatment is also indicated. Interaction with other medicinal products and other forms of interaction Antacids may interact with some other oral medicinal products. Since aluminum and magnesium salts reduce the absorption of tetracyclines from the gastrointestinal tract, it is recommended to avoid the use of Almox A during oral tetracycline therapy. With simultaneous use with quinidine, it is possible to increase the concentration of quinidine in the blood serum and, as a result, the manifestation of symptoms characteristic of an overdose of quinidine. With prolonged use of the drug Almox A in high doses and the concomitant use of salicylates, the excretion of salicylates in the urine may increase due to the creation of an alkaline urine reaction. With the simultaneous use of aluminum hydroxide and citrates, an increase in the concentration of aluminum in the blood plasma is possible, especially in patients with renal insufficiency. With simultaneous use with ulipristal, there may be a decrease in the effectiveness of ulipristal due to a decrease in its absorption. In the case of simultaneous oral administration, Almox A may reduce the absorption of a number of other drugs. Therefore, the following medicines are recommended to be taken at least 2 hours before or 2 hours after taking Almox A: acetysalicylic acid, H2-antihistamines, ethambutol, isoniazid, atenolol, metoprolol, propranolol, cefdinir, cefpodoxime, chloroquine, cyclins, tetracyclines , diflunisal, digoxin, bisphosphonates, fexofenadine, iron salts, sodium fluoride, glucocorticosteroids, with the exception of hydrocortisone, used for replacement therapy (described for prednisolone and dexamethasone), indomethacin, ketoconazole (reduced absorption of ketoconazole from the gastrointestinal tract due to increased pH gastric juice), lansoprazole, lincosamides, phenothiazine antipsychotics, penicillamine, phosphorus (additives), thyroid hormones, rosuvastatin, sulpiride, elvitegravir (almost half the concentration of elvitegravir in case of simultaneous use), ulipristal (risk of reducing the effectiveness of ulipristal due to reduced absorption) , citrates ( an increase in the concentration of aluminum in the blood plasma is possible, especially in patients with renal insufficiency). Fluoroquinolones are recommended to be taken at least 4 hours before or 4 hours after taking the drug Almox A. Compliance with the indicated intervals in most cases allows you to avoid a decrease in the absorption of these drugs. Precautions should be observed when used simultaneously with polystyrene sulfonate (kayexalate), as there is a possibility of reducing the effectiveness of the resin in binding potassium with the risk of metabolic alkalosis in patients with renal insufficiency (for aluminum hydroxide and magnesium hydroxide) and the risk of intestinal obstruction (for aluminum hydroxide ). Therefore, when used with kayexalate, a 2-hour interval should also be maintained. Since the drug contains benzocaine, Almox A should not be taken simultaneously with sulfonamides (being a derivative of para-aminobenzoic acid, benzocaine prevents the antibacterial action of sulfonamides). Almox A 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 tests using technetium (Tc99) (for example, bone scans and some tests for examining the esophagus); increases serum phosphorus levels, serum and urine pH values. It is necessary to inform the doctor about all the drugs that will be taken or already taken together with Almox A. consult a doctor immediately. The patient should consult a doctor in case of: weight loss; difficulty in swallowing and a constant feeling of discomfort in the abdomen; digestive disorders that arose for the first time; changes in existing digestive disorders; kidney failure. Benzocaine, which is part of the drug, can lead to the development of methemoglobinemia, a condition in which the level of methemoglobin in the blood is elevated and the tissues do not receive enough oxygen. Methemoglobinemia can be fatal. Symptoms of methemoglobinemia: pale, with a gray or blue tint, skin, lips, nail beds; headache; pre-fainting state; anxiety; confusion; general weakness; tachycardia; dyspnea. These symptoms may appear within a few minutes or within 1-2 hours after the use of benzocaine. Methemoglobinemia can develop both after the first use of benzocaine, and with its repeated use. The risk of developing methemoglobinemia may be higher in elderly patients, in patients with certain congenital disorders, such as glucose-6-phosphodiesterase deficiency, hereditary methemoglobinemia, NADH-methemoglobin reductase (diaphorase 1) deficiency, pyruvate kinase deficiency. In patients with pathology of the respiratory system (for example, asthma, bronchitis, emphysema), in patients with heart disease, in elderly patients, in smoking patients, the risk of complications associated with methemoglobinemia is higher. When using the drug Almox A, the patient must take into account the risk of developing methemoglobinemia. If any of the symptoms listed above occur, you should immediately stop using the drug Almox A and immediately consult a doctor. To minimize the risk of developing methemoglobinemia, the recommendations in this leaflet must be strictly followed. With already existing methemoglobinemia or when indicating the development of this condition in the past (regardless of cause) in a patient or his relatives, the use of the drug Almox A is contraindicated (see sections “Contraindications”, “Side effects”). Long-term use of the drug is not recommended. The maximum duration of use without consulting a doctor is 7 days. If symptoms persist after 7 days of using Almox A or the condition worsens, you should consult a doctor to clarify the diagnosis and correct treatment. The need for further treatment and what drug it can be carried out is determined by the doctor. With prolonged use of the drug, periodic monitoring of the level of magnesium in the blood serum is necessary. A 2-hour interval should be observed between the ingestion of the drug Almox A and the ingestion of a number of other drugs; between ingestion of the drug Almox A and ingestion of antibacterial agents from the group of fluoroquinolones, a 4-hour interval should be maintained (see section “Interaction with other drugs and other forms of interaction”). Magnesium salts can cause diarrhea. Aluminum hydroxide may cause constipation; an overdose of magnesium salts can cause intestinal hypokinesia. Therefore, taking the drug in high doses can lead to the development of intestinal obstruction in patients with risk factors (for example, older age, renal failure, history of constipation) or worsen intestinal obstruction. Aluminum hydroxide is poorly absorbed from the gastrointestinal tract; therefore, systemic effects rarely occur in patients with normal renal function. In the following cases, phosphate deficiency may develop due to the ability of aluminum to bind phosphate ions (phosphate deficiency is accompanied by increased bone resorption, hypercalciuria and an increased risk of osteomalacia): taking the drug in high doses; long-term use; the use of recommended doses by patients on a diet low in phosphorus. In this regard, it is recommended to seek medical advice with prolonged use of the drug and / or if there are other risk factors for the development of phosphate deficiency. In elderly patients, osteoarticular diseases and Alzheimer’s disease may worsen. The presence of aluminum and magnesium in the drug should always be taken into account in renal insufficiency, including in renal insufficiency requiring periodic hemodialysis. Plasma magnesium and aluminum levels may be elevated in patients with renal insufficiency. In these patients, with prolonged use of the drug in high doses (including high therapeutic doses), the development of conditions such as encephalopathy, dementia, microcytic anemia, as well as aggravation of osteomalacia caused by dialysis, may develop. Patients with mild or moderate renal insufficiency are advised to take the drug under medical supervision. Long-term use should be avoided in the presence of impaired renal function. In the presence of renal insufficiency, the combined use of the drug Almox A and citrates can lead to an increase in plasma aluminum levels (see section “Interaction with other drugs and other forms of interaction”). The use of aluminum hydroxide may be unsafe for porphyria patients on hemodialysis. During the period of use of the drug Almox A, it is necessary to avoid drinking alcohol, as well as foods and drinks containing acids (for example, lemon juice, vinegar), due to the possibility of weakening the local anesthetic effect of benzocaine. When taking the drug, numbness and loss of sensitivity of the mucous membrane of the oral cavity and tongue may occur, due to the presence of benzocaine in the composition. This phenomenon is transient; it does not require therapeutic measures. The medicinal product contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions). The medicinal product contains sorbitol and is therefore contraindicated in patients with rare hereditary fructose intolerance. If you have intolerance to other sugars, consult your doctor before use. The calorie content of one dose in 5 ml of Almox A suspension contains 2 kcal; 10 ml suspension – 4 kcal. Almox A contains ethyl alcohol (98.1 mg of ethyl alcohol per 5 ml of suspension) or 2.5 vol%, which at a dose of 5 ml of suspension is equivalent to 2.5 ml of beer and 1 ml of wine, at a dose of 10 ml – 5 ml of beer and 2 ml of wine. It is dangerous to apply to patients suffering from alcoholism. Consideration should be given to pregnant and breastfeeding women, as well as to high-risk patients, including those with liver disease and those with epilepsy. Use in children The use of the drug Almox A in children and adolescents under 18 years of age is contraindicated. Influence on the ability to drive vehicles or other moving mechanisms The presence of ethyl alcohol in the composition of the drug should be taken into account, despite the fact that ethyl alcohol is contained in such an amount that cannot affect the ability to drive a car or other moving mechanisms when taking the drug in the recommended daily doses. Side effects Side effects are distributed by type and by frequency of occurrence. The frequency of occurrence of side effects is estimated according to the following scheme: very often (? 1/10); often (?1/100 to <1/10); infrequently (?1/1000 to <1/100); rarely (?1/10000 to <1/1000); very rarely (<1/10000); unknown (frequency cannot be estimated from the available data). If the recommended dosage regimen is observed, the drug may have minor side effects. Blood and lymphatic system disorders: unknown - methemoglobinemia. Immune system disorders: unknown - hypersensitivity reactions (itching, urticaria, Quincke's edema, anaphylactic reactions). Gastrointestinal disorders: infrequently - diarrhea, constipation; unknown - abdominal pain. Metabolic and nutritional disorders: very rarely - hypermagnesemia; (increased levels of magnesium in the blood), including cases observed after prolonged use of magnesium hydroxide in patients with renal insufficiency; unknown - hyperaluminemia (increase in the level of aluminum in the blood), hypophosphatemia (decrease in the level of phosphate in the blood). Hyperaluminemia was mainly observed in patients with renal insufficiency and in elderly patients. The risk of developing hyperaluminemia increases with the simultaneous ingestion of citric acid, sodium citrate or calcium citrate (see section "Interaction with other medicinal products and other forms of interaction"). Hypophosphatemia may develop with prolonged use of the drug and / or when used in high doses, as well as when used at recommended doses in patients whose diet is characterized by a low phosphorus content. Hypophosphatemia can lead to increased bone resorption, hypercalciuria and an increased risk of osteomalacia (see section "Special Instructions and Precautions"). If you experience any of these adverse reactions, as well as reactions not listed in this section of the package insert, you should consult a doctor. Reporting adverse reactions If you experience any adverse reactions, it is recommended that you consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the package insert for the use of the medicinal product. You can also report adverse reactions to the Adverse Drug Reactions Information Database. By reporting adverse reactions, you help to get more information about the safety of the medicine. Storage conditions Store in a place protected from light at a temperature not exceeding 25 ° C. Do not freeze. Keep out of the reach of children. Buy Almox susp.d/in. prim. No. 1 Instructions for use for Almox susp.d/in. prim.
Almox susp.d/in.prim.in vial 150g with dosing glass in pack №1
$18.00
SKU: 72746
Category: Gastrointestinal tract
INN | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE |
---|---|
The code | 72 746 |
Barcode | 4 810 183 008 016 |
Dosage | 150g |
Active substance | Aluminum hydroxide, magnesium hydroxide |
Manufacturer | Pharmtekhnologiya LLC, Belarus |
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