Instructions for Magne-B6 solution for oral administration, ampoule 10 ml No. 10
Composition
active ingredients: 1 ampoule of 10 ml contains magnesium lactate dihydrate 186 mg and magnesium podolate 936 mg (corresponding to 100 mg Mg++, or 4.12 mmol), pyridoxine hydrochloride (vitamin B6) 10 mg;
Excipients: sodium metabisulfite (E 223), sodium saccharin, caramel with cherry flavoring, purified water.
Dosage form
Solution for oral use.
Main physicochemical properties: transparent brown liquid with a caramel odor.
Pharmacotherapeutic group
B vitamin complex with minerals.
ATX code A11E S.
Pharmacological properties
Pharmacodynamics
Magnesium is an intracellular cation that reduces neuronal excitability and inhibits neuromuscular transmission, and is also involved in many enzymatic reactions. Magnesium is an important component of body tissues: skeletal bones contain half of the total amount of magnesium in the body.
A serum magnesium concentration of 12 to 17 mg/L (1–1.4 mEq/L, or 0.5–0.7 mmol/L) indicates moderate magnesium deficiency; below 12 mg/L (1 mEq/L, or 0.5 mmol/L) indicates severe magnesium deficiency.
Magnesium deficiency can be:
– primary, due to metabolic pathology (chronic congenital hypomagnesemia);
– secondary, due to:
– insufficient intake of magnesium with food (unhealthy diet, chronic alcohol abuse, exclusively parenteral nutrition);
– impaired absorption of magnesium in the gastrointestinal tract (chronic diarrhea, gastrointestinal fistulas, hypoparathyroidism);
– excessive loss of magnesium due to renal excretion (tubular disorders, severe polyuria, diuretic abuse, chronic pyelonephritis, primary hyperaldosteronism, cisplatin treatment).
Pharmacokinetics
The absorption of magnesium salts in the gastrointestinal tract involves, among other mechanisms, a passive mechanism for which the solubility of the salt is a determining factor.
Absorption of magnesium salts in the gastrointestinal tract does not exceed 50%. Magnesium is excreted mainly in the urine.
Indication
Treatment of confirmed magnesium deficiency in the body, both isolated and associated with other deficiency conditions.
Contraindication
Hypersensitivity to any component of the drug. Severe renal failure with creatinine clearance less than 30 ml/min. Phenylketonuria. Hypermagnesemia, vitamin B6 hypervitaminosis, myasthenia gravis. Atrioventricular block, severe arterial hypotension. Simultaneous use with levodopa (see section "Interaction with other medicinal products and other types of interactions"). Diarrhea.
Interaction with other medicinal products and other types of interactions
Contraindicated combinations.
Concomitant use with levodopa should be avoided, as the effect of levodopa is inhibited when its use is not accompanied by peripheral dopa decarboxylase inhibitors. The use of pyridoxine in any quantities is not indicated if levodopa is not accompanied by dopa decarboxylase inhibitors.
Not recommended combinations.
Do not use with drugs containing phosphate or calcium salts, as they inhibit the absorption of magnesium from the intestines.
Combinations requiring caution when used.
Use with caution with oral tetracyclines, as magnesium reduces the absorption of tetracyclines from the stomach and intestines. When used simultaneously with oral tetracyclines, the administration of Magne-B6Ò should be delayed by at least 3 hours.
Magnesium preparations weaken the effect of oral anticoagulants and reduce iron absorption.
Diuretics increase the excretion of magnesium in the urine.
The use of hydralazine, isoniazid, penicillamine, and oral contraceptives increases the need for vitamin B6.
Application features
Patients with severe magnesium deficiency should be started on intravenous magnesium injections. This is also indicated for patients with malabsorption.
In patients with concomitant calcium deficiency, it is recommended in most cases to first correct the magnesium deficiency before prescribing calcium.
This medicine contains sodium metabisulfite and may cause severe allergic reactions and bronchospasm.
Pyridoxine abuse can lead to sensory neuropathy when taken in high doses (>200 mg/day) over a long period of time (i.e., several months or years). Symptoms include numbness, sensory disturbances, tremors, and gradually progressive sensory ataxia (problems with coordination). This effect is usually reversible and disappears after discontinuation of the drug.
Precautions for use
Patients with moderate renal insufficiency should take precautions to prevent any risks associated with hypermagnesemia.
Use during pregnancy or breastfeeding
Pregnancy: Limited data from clinical studies in animals have not revealed fetotoxic or embryotoxic effects of the drug. Therefore, the use of magnesium during pregnancy is possible only if necessary and after consultation with a doctor.
Breastfeeding. Each of the active ingredients of the drug separately (both magnesium and vitamin B6) is not contraindicated during this period. Given the limited evidence on the use of the maximum recommended daily dose of vitamin B6 during breastfeeding, it is recommended to prescribe no more than 20 mg/day of vitamin B6.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug Magne-B6®, solution for oral administration, has no or negligible effect on the reaction rate when driving vehicles or using other mechanisms.
Method of administration and doses
Dissolve the contents of the ampoules in half a glass of water.
Adults: 3–4 ampoules per day, dividing the total dose into 2 or 3 doses during meals.
Children and infants weighing more than 10 kg (about 1 year of age): 10–30 mg/kg body weight per day (i.e. 0.4–1.2 mmol/kg body weight per day), which corresponds to 1–4 ampoules per day, with the total dose divided into 2 or 3 doses during meals.
The use of the drug should be discontinued as soon as the magnesium level in the blood returns to normal.
Children
The drug should be used in children weighing more than 10 kg (about 1 year of age).
Overdose
Magnesium-related
Overdose of oral magnesium usually does not lead to toxic reactions in patients with normal renal function. However, magnesium intoxication may develop in patients with renal insufficiency.
Toxic effects depend on magnesium levels in the blood and are manifested by the following signs:
a sharp decrease in blood pressure;
nausea, vomiting;
central nervous system depression, impaired reflex functions;
pathological changes on the ECG;
development of respiratory depression, coma, cardiac arrest and respiratory paralysis;
anury.
Treatment of overdose: rehydration, forced diuresis. Patients with renal failure require hemodialysis or peritoneal dialysis.
Related to pyridoxine
Sensory axonal neuropathy is a major effect that can occur with prolonged and/or long-term use of high doses of pyridoxine (several months or years).
Signs and symptoms
In particular, paraesthesia, dysesthesia, hypoesthesia, sensory deficits, pain in the extremities, involuntary muscle contractions, burning, balance disorders, gait disturbances, tremor of the hands and feet and progressive sensory ataxia (difficulty in coordinating movements) have been reported.
Treatment
Neurological symptoms gradually disappear after discontinuation of treatment.
Adverse reactions
Adverse reactions that may occur with the use of Magne-B6® are listed below according to the system organ class and frequency of occurrence: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1000); very rare (< 1/10,000); frequency unknown (cannot be estimated from the available data).
Immune system disorders.
Frequency unknown: allergic reactions, hypersensitivity, angioedema.
Gastrointestinal disorders.
Frequency unknown: diarrhea*, nausea, vomiting, abdominal pain*.
Skin and subcutaneous tissue disorders.
Frequency unknown: skin reactions, including urticaria, pruritus, eczema, erythema.
* Adverse reactions related to magnesium.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after the registration of a medicinal product is an important procedure. This allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report all adverse reactions through the national pharmacovigilance system.
Expiration date
3 years.
Storage conditions
Keep out of reach of children.
Store in the original packaging at a temperature below 25 °C.
Packaging
No. 10: 10 ml in an ampoule, 10 ampoules with two break lines in a cardboard pallet in a cardboard box.
Vacation category
Without a prescription.
Producer
COOPERATION PHARMACY FRANCEZ.
Location of the manufacturer and its business address
Place Lucien Auvert, 77020 MELUN, France.
Applicant
Opela Healthcare Ukraine LLC, Ukraine.
Location of the applicant and/or applicant's representative
Ukraine, 01033, Kyiv, Zhylyanska St., 48-50A.
