Composition, form of production and packaging
? Solution for ingestion in the form of a transparent liquid of brown color with the smell of caramel.
1 amp.
magnesium lactate dihydrate 186 mg
magnesium pidolate 936 mg,
which is equivalent to the total content of Mg 2+ of 100 mg
pyridoxine hydrochloride 10 mg
Excipients: sodium disulfite - 15 mg, sodium saccharinate - 15 mg, flavoring cherry-caramel - 0.3 ml, purified water - up to 10 ml.
10 ml - double-pointed ampoules of dark glass (10) - inserts made of cardboard (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
The preparation of magnesium. Magnesium is a vital element that is found in all tissues of the body and is necessary for the normal functioning of cells, is involved in most metabolic reactions. In particular, it is involved in the regulation of the transmission of nerve impulses and in muscle contraction.
The body gets magnesium along with the food. The lack of magnesium in the body can be observed with a violation of diet (diet) or with increasing demand for magnesium (with increased physical and mental stress, stress, pregnancy, the use of diuretics).
Pyridoxine (vitamin B 6 ) is involved in many metabolic processes, in the regulation of the metabolism of the nervous system. Improves the absorption of magnesium from the digestive tract and its penetration into the cells.
Magnesium content in the serum from 12 to 17 mg / l (0.5-0.7 mmol / l) indicates a moderate magnesium deficiency; below 12 mg / L (0.5 mmol / L) indicates a severe magnesium deficiency.
PHARMACOKINETICS
Suction and distribution
Absorption of magnesium from the gastrointestinal tract is no more than 50% of the dose taken internally. In the body, magnesium is distributed mainly in the intracellular space - about 99%, of which about 2/3 is distributed in the bone tissue, and 1/3 is in the smooth and striated muscle tissue.
Excretion
Magnesium is excreted mainly by urine. With urine, at least 1/3 of the dose of magnesium taken is excreted.
INDICATIONS
- established magnesium deficiency, isolated or associated with other deficient conditions, accompanied by symptoms such as increased irritability, minor sleep disorders, gastrointestinal spasms or heart palpitations, fatigue, pain and muscle spasms, tingling sensations.
DOSING MODE
Solution for oral administration: adults are recommended to prescribe 3-4 ampoules / day; children over 1 year old (body weight more than 10 kg ) - daily dose is 10-30 mg magnesium / kg body weight (0.4-1.2 mmol magnesium / kg / day) or 1-4 ampoules / day.
The daily dose should be divided into 2-3 divided doses, taken with meals.
Treatment should be discontinued after the normalization of the magnesium concentration in the blood.
The solution from the ampoules before taking is dissolved in 1/2 cup of water.
Self-tearing ampoules with Magne B6 В® do not require the use of a nail file. To open the ampoule, you should take it by the tip, first covering it with a piece of tissue and breaking it off sharply first from one pointed end and then from the other, first directing the open first end of the ampoule at an angle into a glass of water so that the second tip of the ampoule breaks off was not over the glass. After breaking off the second tip of the ampoule, its contents freely poured into the glass.
SIDE EFFECT
From the immune system: very rarely (<0.01%) - allergic reactions, including skin reactions.
On the part of the digestive system: the frequency is unknown (according to available data it is not possible to estimate the incidence) - diarrhea, abdominal pain, nausea, vomiting, flatulence.
CONTRAINDICATIONS
- severe renal failure (CK <30 ml / min);
- phenylketonuria;
- Children's age up to 1 year;
- a syndrome of glucose-galactose malabsorption;
- simultaneous intake of levodopa;
- Hypersensitivity to the components of the drug.
With caution: with a moderate degree of renal failure, t. there is a risk of hypermagnesemia.
PREGNANCY AND LACTATION
The clinical experience of using the drug in a sufficient number of pregnant women has not revealed any adverse effect on the onset of fetal developmental or fetotoxic effects.
Magne B6 В® can be used during pregnancy only if necessary, on the recommendation of a doctor.
Magnesium penetrates into breast milk. Avoid the use of the drug during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution appoint a drug for renal failure of moderate degree, t. there is a risk of hypermagnesemia. The drug is contraindicated in patients with severe renal insufficiency (CC less than 30 ml / min).
APPLICATION FOR CHILDREN
Contraindication: children under 6 years (for tablets); children under 1 year (for solution).
SPECIAL INSTRUCTIONS
In the case of a severe degree of magnesium deficiency or malabsorption syndrome, treatment is started with iv administration of magnesium preparations.
With concomitant calcium deficiency, it is recommended to eliminate magnesium deficiency before taking calcium supplements or calcium supplements.
With frequent use of laxatives, alcohol, intense physical and mental stress, the need for magnesium increases, which can lead to the development of magnesium deficiency in the body.
The oral solution contains sulfite, which can cause or intensify manifestations of allergic reactions, including anaphylactic reactions, especially in patients at risk.
When using pyridoxine at high doses (more than 200 mg / day) for a long time (for several months or in some cases - years) sensory axonal neuropathy can develop, which is accompanied by symptoms such as numbness, disturbances of proprioceptive sensitivity, tremor of distal calves limbs and gradually developing sensory ataxia (impaired coordination of movements). These disorders are usually reversible and pass after stopping the intake of vitamin B 6 .
Impact on the ability to drive vehicles and manage mechanisms
Does not affect. There are no specific recommendations.
OVERDOSE
With normal kidney function, an overdose of magnesium with its intake usually does not lead to the occurrence of toxic reactions. However, in the case of kidney failure, the development of magnesium poisoning is possible. The severity of symptoms depends on the concentration of magnesium in the blood.
Symptoms: decreased blood pressure, nausea, vomiting, CNS depression, decreased reflexes, ECG changes, respiratory depression, coma, cardiac arrest and respiratory paralysis, anuric syndrome.
Treatment: rehydration, forced diuresis. With renal failure, hemodialysis or peritoneal dialysis is necessary.
DRUG INTERACTION
Contraindicated combinations
With levodopa: the activity of levodopa (if the drug is not combined with the reception of inhibitors of peripheral decarboxylase aromatic L-amino acids). Any amount of pyridoxine should be avoided if levodopa is not taken in conjunction with inhibitors of the peripheral decarboxylase of aromatic L-amino acids.
Unrecommended combinations
Simultaneous use of drugs containing phosphates or calcium salts can impair magnesium absorption in the intestine.
Combinations that should be taken into account
In the treatment with antibiotics of the tetracycline group, an interval of at least 3 hours should be observed between ingestion of tetracycline and Magne B6 В® ,Magnesium preparations reduce the absorption of tetracyclines.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children, protected from light, at a temperature of no higher than 25 В° C. Shelf life - 3 years.
