Magnelek powder for solution for oral administration in bags 3g №30

Name:
Magnelek por.d/prig.r-ra d/pr.vn.in pak.3g in unitary enterprise No. 30
Description:
White or almost white powder with a yellowish or gray tint, odorless. Soft lumps are allowed. Main active ingredient Magnesium citrate + pyridoxine hydrochloride Release form Powder for solution for oral administration. Dosage 3 g Pharmacodynamics Magnesium is predominantly an intracellular cation, reduces the excitability of neurons and neuromuscular transmission of excitation, takes part in many enzymatic processes. Magnesium is an essential element of organs and tissues; half of the total amount of magnesium in the body accumulates in bone tissue. Serum magnesium levels: between 12 and 17 mg/l (1 – 1.4 mEq/l or 0.5 – 0.7 mmol/l): indicate a mild magnesium deficiency below 12 mg/l (1 mEq/l or 0.5 mmol/L): indicate severe magnesium deficiency. Deficiency can be: primary, due to a congenital anomaly of metabolism (chronic congenital hypomagnesemia), secondary, due to: inadequate intake (severe malnutrition, alcoholism, exclusively parenteral nutrition); disorders of gastrointestinal absorption (chronic diarrhea, gastrointestinal fistula, hypoparathyroidism); excessive excretion of magnesium by the kidneys (severe polyuria, diuretic abuse, chronic pyelonephritis, primary hyperaldosteronism, treatment with cisplatin). Pyridoxine (vitamin B6) is involved in many metabolic processes, improves the absorption of magnesium from the gastrointestinal tract and its penetration into cells. Pharmacokinetics Gastrointestinal absorption of magnesium salts occurs in part by a passive mechanism in which salt solubility plays a decisive role. The degree of this absorption does not exceed 50%. In the body, magnesium is distributed mainly in the intracellular space (about 99%), of which approximately 2/3 is distributed in bone tissue, and a third is in smooth and striated muscle tissue. Excretion of magnesium occurs in the urine, at least 1/3 of the received dose of magnesium. Pyridoxine is absorbed in the small intestine. Metabolized in the liver with the formation of pharmacologically active metabolites (pyridoxal phosphate and pyridoxamino phosphate). Distribution is predominantly in the muscles, liver and central nervous system. Penetrates through the placenta and into mother’s milk. Excreted by the kidneys. Indications for use Treatment of confirmed magnesium deficiency in the body – both isolated and associated with other deficiency conditions. A combination of a number of the following symptoms may indicate a magnesium deficiency: nervousness, irritability, mild anxiety, transient fatigue, slight sleep disturbances; signs of anxiety such as gastrointestinal cramps or heart palpitations (with a healthy heart); muscle cramps, tingling sensation. magnesium can help relieve these symptoms. Method of administration and doses The use of this medicinal product is possible only after consulting a doctor! For oral administration. The contents of the package should be completely dissolved in a glass of water at room temperature and drunk immediately after preparation. Adults: 3-4 packets per day, divided into 2-3 doses, with meals. Children over the age of 6 years (weighing more than 20 kg): at the rate of 10-30 mg / kg / day (0.4-1.2 mmol / kg / day), i.e. 2-4 packets per day, divided into 2-3 doses, with meals. Children over 1 year old (body weight over 10 kg): at the rate of 10-30 mg / kg / day (0.4-1.2 mmol / kg / day), i.e. 1-4 packets per day, divided into 2-3 doses, with meals. The duration of treatment is usually one month. Treatment should be stopped immediately after the normalization of the level of magnesium in the blood. If you forget to take a medicine, do not take a double dose to make up for the missed one! If you have any doubts or questions, please contact your doctor. Use during pregnancy and lactation If you are pregnant or breastfeeding, if you suspect that you are pregnant or do not exclude the possibility of pregnancy, inform your doctor. Pregnancy. Limited data from clinical studies in animals have not revealed a fetotoxic or embryotoxic effect of the drug. Thus, the use of magnesium during pregnancy is possible only if necessary after consultation with a doctor. breastfeeding period. Each of the active ingredients of the drug is relatively (both magnesium and vitamin B6) is not contraindicated in this period. Given the limited evidence on the use of the maximum daily dose of vitamin B6 during lactation, it is recommended to prescribe no more than 20 mg / day of vitamin B6. Children The drug is not intended for use in children under 1 year of age. Influence on the ability to drive a car and control mechanisms There is no data on the effect of the drug on the ability to drive a car and control mechanisms. Precautions In patients with severe magnesium deficiency, the use of the drug should begin with its administration by intravenous route. It is also indicated in patients with malabsorption. The drug should be used with caution in moderate renal insufficiency, as there is a risk of developing hypermagnesemia. With concomitant calcium deficiency, magnesium deficiency in the body should be eliminated before taking calcium supplements. Since this drug contains sucrose, it is contraindicated in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency. Use with caution in gastric ulcer and duodenal ulcer, coronary heart disease. In severe liver damage, pyridoxine in high doses can cause a deterioration in its function. When using pyridoxine at high doses (> 300 mg / day) for a long time (several months or in some cases – years), sensory neuropathy may develop, accompanied by the following symptoms: numbness and vestibular disturbances, tremor of the distal extremities and gradually developing sensory ataxia (impaired coordination of movements). These disorders are usually reversible and disappear after high doses of vitamin B are discontinued. Interactions with other drugs If you are currently or have recently taken other drugs, tell your doctor. Salts of phosphorus or calcium These drugs inhibit the absorption of magnesium from the intestines. Orally administered tetracyclines Between ingestion of tetracyclines and magnesium preparations, an interval of at least 2 hours should be observed due to a decrease in the absorption of tetracyclines in the gastrointestinal tract. Oral thrombolytic agents When combined, magnesium weakens the effect of these drugs Levodopa The activity of levodopa (if this drug is not combined with the use of peripheral dopa decarboxylase inhibitors) is inhibited by pyridoxine. Any use of pyridoxine should be avoided unless peripheral dopa decarboxylase inhibitors are prescribed concomitantly with levodopa. Hormonal contraceptives With simultaneous use, an increase in the concentration of pyridoxine in the blood is possible. Diuretics With the simultaneous use of pyridoxine potentiates the action of diuretics. Isonicoting hydrazide, penicillamine, cycloserine It is possible to reduce the effectiveness of pyridoxine when used simultaneously with these drugs. Phenytoin, phenobarbital With simultaneous use, a decrease in plasma concentrations of phenytoin and phenobarbital is possible. Contraindications Hypersensitivity to the components of the drug. Severe renal failure with creatinine clearance less than 30 ml / minute. Combined use with levodopa. pyridoxine hydrochloride – 10.0 mg Excipients: anhydrous citric acid, sugar. Overdose Oral overdose of magnesium usually does not lead to toxic reactions if the kidneys are functioning normally. However, magnesium poisoning can develop in case of kidney failure. Toxic effects depend on the level of magnesium in the blood. Symptoms: drop in blood pressure, nausea, vomiting, CNS depression, impaired reflexes, ECG changes, respiratory depression, coma, cardiac arrest and respiratory paralysis, anuric syndrome. Treatment: rehydration, forced diuresis. Renal failure requires hemodialysis or peritoneal dialysis. Side effects The drug is well tolerated. From the digestive system: rarely – abdominal pain, diarrhea. Other: skin reactions, allergic reactions. If side effects occur, tell your doctor about it. This applies to all possible side effects, including those not described in this package insert. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Magnelek powder for oral solution in 3g bags №30 №30 Instructions for use for Magnelek powder for solution for oral administration in 3g bags №30