Indications:
Treatment of severe hypomagnesemia, isolated or associated.
Treatment of functional manifestations of acute anxiety crisis with hyperventilation (spasmophilia) in the absence of specific treatment.
Administration, dosage:
Administration: MAGISIX should be taken with plenty of water.
Dosage:
Adults:
Severe magnesium deficiency: 6 tablets daily.
Spasmophilia: 4 tablets daily.
Children over 6 years old: 2 – 4 tablets daily.
Daily dosage should be divided into 2 or 3 doses, taken at breakfast, noon and afternoon.
Some attention on handling of the medicine before and after use:
There are no special requirements for handling this medicine after use.
Warnings and precautions for use:
MAGISIX should not be taken with any other medicines containing magnesium or vitamin B6.
When calcium deficiency is associated, magnesium deficiency must be supplied before calcium in most cases.
MAGISIX should be used cautiously in case of moderate kidney failure to avoid the risk of hypermagnesemia. Drug use should be monitored by the doctor.
MAGISIX should only be administered to subjects more than 6 years old.
MAGISIX overdose can cause aperient.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medication.
Pregnancy and lactation:
Pregnancy:
MAGISIX should be used during pregnancy only if clearly needed.
Lactation:
MAGISIX should not be used during lactation because magnesium is excreted in breast milk.
Effects on ability to drive and use machines:
There is inadequate information on the effects of drugs on ability to drive and use machines.
Interactions, incompatibilities of medicine:
Interaction:
MAGISIX should not be used in combination with preparations containing phosphate and calcium salts which are inhibitors of magnesium absorption in the small intestine.
If oral tetracycline is coadministered, these two medicines must be taken with an interval of 3 hours.
MAGISIX should not be used concomitantly with levodopa because pyridoxine (vitamin B6) has been found to inhibit the effects of levodopa.
Quinidine: Concomitant use of MAGISIX with quinidine increases the amount of plasma quinidine and the risk of overdose.
In some patients, dose of 200 mg pyridoxine daily may decrease blood levels of phenytoin and phenobarbital by 40 – 50%.
To avoid interactions between drugs, inform your doctor or pharmacist about all the medicines you are taking.
Incompatibilities:
Because there are no studies about the incompatibility of the medicine, it should not be mixed with other medicines.
Undesirable effects:
Vitamin B6:
Severe allergic reactions: Rash, urticaria; itching, difficulty breathing, chest tightness, swelling of the mouth, face, lips, or tongue; decreased sensation of touch, temperature or vibration; ataxia; numbness of the feet or around the mouth; numbness or tingling of the skin.
Long term use at high doses may increase severe peripheral neuropathy.
Magnesium:
If there are symptoms of allergic reactions such as rash, difficulty breathing, swelling of the face, tongue, lips or throat, patient should be moved to the nearest health center for timely medical care.
Common: Diarrhea, flatulence, bloating or gastrointestinal disorders.
Inform your doctor about adverse effects encountered while using the medicine.
Overdose and management:
Overdose:
Generally, when oral overdose, toxic reactions caused by magnesium may not occur in case of normal renal function. However, magnesium poisoning may occur in patients with renal impairment.
The harmful effects depends on the concentration of magnesium in the blood and the signs are hypotension, nausea, vomiting, depression of the central nervous system, hyporeflexia, abnormal ECG, respiratory distress, coma, cardiac and respiratory arrest.
Management:
If overdose symptoms occur, MAGISIX should be discontinued.
Treatment: Rehydration, diuresis. In case of kidney failure, hemodialysis or peritoneal dialysis is required.
Pharmacodynamics:
Pharmacotherapeutic group: Mineral and vitamin.
ATC code: A12CC06; A11HA02.
Magnesium:
Magnesium is a cation found in intracellular fluid, reduces the excitability of nerve cells, electrical conduction in nerves and muscles and takes part in numerous enzymatic reactions. As an element of the body, half of the body’s magnesium is found in the bones.
Oral magnesium lactate is a source of Mg2+ supplement in the treatment of magnesium deficiency.
Clinically, plasma magnesium levels:
From 12 to 17 mg/l: Moderate magnesium deficiency.
Less than 12 mg/l: Severe magnesium deficiency.
Magnesium deficiency can be primary due to congenital abnormalities in the metabolism of magnesium or secondary due to decreased supply (severe malnutrition, alcoholism, parenteral feeding only), due to gastrointestinal malabsorption (chronic diarrhea, the gastrointestinal fistula, hypoparathyroidism), due to magnesium depletion by the kidneys (renal tubular disease, polyuria, abuse of diuretics, chronic pyelonephritis, primary increased aldosteronism, treatment with cisplatin).
Due to lack of magnesium some clinical manifestations that are not specific may occur such as: Tremor, muscle weakness, muscle spasms, ataxia, hyperreflexia, mental disorders (excitability, insomnia etc.), arrhythmias (extra systole, tachycardia), gastrointestinal disorders (diarrhea).
Pyridoxine (Vitamin B6):
Pyridoxine is a coenzyme, involves in many metabolic processes and helps magnesium easily penetrate into cells. Vitamin B6 exists in 3 forms of pyridoxal, pyridoxine and pyridoxamine. In the body, they are converted to pyridoxal phosphate and partially to pyridoxamine phosphate. Both compounds act as coenzyme in the metabolism of protein, glucide and lipid. Pyridoxine participates in the synthesis of gamma aminobutyric acid (GABA) in the central nervous system and the synthesis of hemoglobin.
Pharmacokinetics:
Magnesium:
Magnesium is an element of the body, the average concentration is 17 mmol/kg body, of which 99% is located in cells, it is absorbed selectively from the small intestinal mucosa, where 40 to 50% of magnesium intake is absorbed.
About two-thirds of intracellular magnesium is distributed into the bones tissues and the remaining one-third is distributed in smooth muscle or skeletal muscle and in erythrocytes.
Magnesium is metabolized to form magnesium chloride. Approximately 15 – 30% of the formed magnesium chloride amount is absorbed and then excreted in the urine in patients with normal renal function.
Magnesium is excreted in the urine. In the kidney, 70% of plasma magnesium is filtered by the glomeruli, 95 – 97% of filtered Mg2+ is reabsorbed in the renal tubules. The amount of magnesium excreted in urine, accounts for about 1/3 of the amount ingested. Magnesium crosses the placenta and a small amount of magnesium is found in breast milk.
Pyridoxine (Vitamin B6):
Pyridoxine is rapidly absorbed from the gastrointestinal tract, except in case of malabsorption syndrome. After oral administration, pyridoxine is stored mostly in the liver and partially in the muscles and brain.
Pyridoxine is primarily excreted through the kidneys as metabolites. If the intake amount exceeds the daily requirement, it will be excreted mostly as unchanged form.
Storage conditions, shelf – life, quality specification of the medicine:
Storage conditions: Protect from humidity and light, below 300C.
Shelf – life: 24 months from the manufacture date.
Quality specification: In house.
