Infusan Magnesium Sulfate Heptahydrate

Infusan Magnesium Sulfate Heptahydrate

magnesium sulfate

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Contents
Mg sulfate heptahydrate.
Description
Infusan Magnesium Sulfate Heptahydrate 20%: Each mL contains: Magnesium Sulfate Heptahydrate 200 mg.
Osmolarity 1.6 mOsm/mL
Infusan Magnesium Sulfate Heptahydrate 40%: Each mL contains: Magnesium Sulfate Heptahydrate 400 mg.
Osmolarity 3.2 mOsm/mL
Action
Pharmacology: By in vitro and in vivo, Magnesium increase endothelium vasodilator as prostacyclin. Endothelium disfunction caused by injury effect of free radical. Magnesium protect endothelium cell from injury, so Magnesium can protect ischemic damage by Calcium changing, and as inhibition for Calcium influx into ischemic cell.
Magnesium is co-factor for several enzymes too, included energy metabolism need Magnesium as anti-convulsan which runs as competitive antagonize from Glutamat N-Metil-D-Aspartate Receptor that had epileptogenic character. As strong vasodilator, administration Magnesium for mother pre-eclampsia can increase blood flowing of brain.
Indications/Uses
To control and avoid convulsions for patients with pre-eclampsia and eclampsia.
Dosage/Direction for Use
If administered intramuscularly, abscess happened on 0.5% in case and followed by pain, based on that reason it is more preferred administered intravenously. For the intravenous route use INFUSAN MgSO4 20% while for intramuscular route use INFUSAN MgSO4 40%.
A. Severe Pre-eclampsia with more than 37 weeks pregnancy: Inject Magnesium Sulfate 8 g i.m (4 g for the left buttock and 4 g for the right buttock) followed by injection of 4 g Magnesium Sulfate each 4 hours.
Preferably continue giving Magnesium Sulfate until 24 hours post partum if not contraindicated. Could be stopped earlier whenever the blood pressure is becoming normal (normotensive) after 8 hours severe control.
B. Severe Pre-eclampsia with less than 37 weeks pregnancy: In case the fetus indicates lung maturity (Lecithin sphingomyelin ratio, shake test), treat according to A.
In case the fetus does not yet indicate lung maturity, inject Magnesium Sulfate during 24 hours (32 g), if it is not contraindicated. Catapres or diuretic could be given whenever indicated (Ref. A).
1. If no progress appears, terminate the pregnancy.
2. If progress appears: When mild pre-eclampsia is not yet reached, continue giving Magnesium Sulfate for 2 x 24 hours, whenever it is not contraindicated. Injection could begin with giving at once Magnesium Sulfate 4 g 20% intravenous solution slowly (5 -10 minutes), followed by Magnesium Sulfate 4 g intramuscularly every 4 hours. Further on if mild pre-eclampsia not yet appears, but clear progress observed, treat further and give Magnesium Sulfate 1 x 8 hours or 1 x 12 hours to avoid convulsion. Partus induction for 37 weeks pregnancy (viable for life) or the fetus indicated lung maturity.
Whenever mild pre-eclampsia is reached: stop giving Magnesium Sulfate, further treatment refer to the mild pre-eclampsia treatment but take care further. Monitoring and evaluation of the condition of the mother and fetus should be done further accurately.
Eclampsia: Begin by giving intravenously 20 mL of INFUSAN MgSO4 20% for 3 - 4 minutes, follow immediately 10 g i.m. (25 mL of INFUSAN MgSO4 40%), so the total loading dose is 14 g. If within 20 minutes still convulsions happen, add another 2 - 4 g intravenously. Rarely appears convulsions, slowly give amobarbital (until 250 mg) intravenously, further on give 5 g Magnesium Sulfate each 4 hours until 24 hours post partum.
In Brief: Treatment with Magnesium Sulfate intramuscularly is as follows: 4 g i.v. + 10 g i.m. as the loading dose (totally 14 g) can be added 2 - 4 g i.v.
Can be added 250 mg Sodium Amobarbital, followed by 5 g Magnesium Sulfate every 4 hours until 24 hours post partum.
Treatment with Magnesium Sulfate Intravenously is as follows: 4 - 6 g i.v. as the loading dose, followed by 1 g i.v. until 24 hours post partum.
By every time giving Magnesium Sulfate, every hour shall be checked whether the requirements are still conformed.
Overdosage
Hypermagnesemia may occur when large dosage of Magnesium are given, especially in patients with renal failure.
Signs of hypermagnesemia include: nausea, vomiting, flushing, hypotension, muscle weakness, muscle paralysis, blurred or double vision, CNS depression and loss of reflexes. More severe hypermagnesemia may result in respiratory depression, respiratory paralysis, renal failure, coma, cardiac arrhythmias and cardiac arrest.
Treatment: The following measures may be required, blood pressure and respiratory support, i.v administration of 2.5 - 10 mmol calcium salt (i.e. Ca Gluconate) reverses the effects of magnesium toxicity, dialysis may be required, particularly if renal function is impaired. If renal function is normal, adequate fluid should be given so that urine output is at least 60 mL/hr to assist removal of magnesium from the body.
Antidotum of Magnesium Sulfate: 1 g Calcium Gluconate in 10 % injection i.v.
Niostigmine.
Penthylenetetrazol (Metrazol).
Contraindications
Patients not conforming the: Positive patella reflex.
Diuresis more than 100 mL/4 hours.
No sign of respiratory depression.
Respiration more than 16 times/minute.
Magnesium is contraindicated in patients with heart block, since Magnesium may exacerbate this condition.
Patients with renal failure (creatinine clearance < 20 mL/minute), since there is an increased risk of hypermagnesemia in these patients.
Magnesium Sulfate should not be administered to pregnant women in the two hours prior to delivery, unless it is the only therapy available to pregnant aclamtic seizures.
Special Precautions
Requirements for Magnesium Sulfate treatment: Positive patella reflex.
Diuresis more than 100 mL/4 hours.
No sign of respiratory depression.
Respiration more than 16 times/minute.
Magnesium Sulfate may precipitate an acute myasthenic crisis.
Impaired renal function: Magnesium should be administered with caution in patients with impaired renal function, since the risk of hypermagnesemia is increased in these patients.
Use in Pregnancy: Magnesium Sulfate is administered to pregnant women to treat seizures associated with severe pre-eclampsia and eclampsia. Magnesium Sulfate readily crosses the placenta. Fetal serum concentrations approximate those of the mother. If Magnesium Sulfate is administered in the two hours preceding delivery, the neonate may be born with signs of hypermagnesemia, including respiratory depression, and therefore Magnesium Sulfate Injection should not be given in the two hours preceding delivery unless it is the only therapy available to prevent or treat eclamptic seizures. Bony abnormalities and congenital rickets have been reported in neonates born mother treated with parenteral Magnesium Sulfate for prolonged periods of time (4 - 13 weeks duration).
Use in Lactation: After intravenous administration, Magnesium is distributed into breast milk, and the concentration of Magnesium in the breast milk is approximately twice that in the maternal serum. Magnesium salts should therefore be used with caution in lactating patients. However, Magnesium is cleared from the breast milk within 24 hour of the cessation of the infusion.
Use In Pregnancy & Lactation
Use in Pregnancy: Magnesium Sulfate is administered to pregnant women to treat seizures associated with severe pre-eclampsia and eclampsia. Magnesium Sulfate readily crosses the placenta. Fetal serum concentrations approximate those of the mother. If Magnesium Sulfate is administered in the two hours preceding delivery, the neonate may be born with signs of hypermagnesemia, including respiratory depression, and therefore Magnesium Sulfate Injection should not be given in the two hours preceding delivery unless it is the only therapy available to prevent or treat eclamptic seizures. Bony abnormalities and congenital rickets have been reported in neonates born mother treated with parenteral Magnesium Sulfate for prolonged periods of time (4 - 13 weeks duration).
Use in Lactation: After intravenous administration, Magnesium is distributed into breast milk, and the concentration of Magnesium in the breast milk is approximately twice that in the maternal serum. Magnesium salts should therefore be used with caution in lactating patients. However, Magnesium is cleared from the breast milk within 24 hour of the cessation of the infusion.
Adverse Reactions
Painful intramuscular injection.
Excessive administration of magnesium sulfate may result in hypermagnesemia. The signs of hypermagnesemia may include: nausea, vomiting, flushing, hypotension, muscle weakness, muscle paralysis, blurred or double vision, CNS depression and loss of reflexes.
More severe hypermagnesemia may result in respiratory depression, respiratory paralysis, renal failure, coma, cardiac arrhythmias and cardiac arrest.
Hypocalemia with tetany, secondary to hypermagnesemia, has been reported.
Drug Interactions
This product should be administered with care when coadministered with Ritodrine hydrochloride.
Magnesium salt should be administered with caution in patients treated with cardiac glycosides, since heart block may occur if calcium salt are required to treat magnesium toxicity.
Concurrent use of Magnesium Salt and CNS depressant drugs may result in an enhanced CNS depressant effect.
Concurrent use of Magnesium Salt with neuromuscular blocking agents may result in an excessive neuromuscular blockade.
Concurrent use of Magnesium Sulfate and nifedipine may result in an exaggerated hypotensive response.
Clinical symptom: Creatine phosphokinase (CPK) levels may increase.
Mechanism and risk factors: The mechanism for the increase in CPK with threatened premature delivery.
Incompatibilities: Magnesium Sulfate is incompatible with Calcium Salts. Calcium Sulfate may precipitate when Calcium Salt are mixed with Magnesium Sulfate in the same i.v. solution.
Magnesium salt have also been reported to be incompatible with alkaly carbonates and bicarbonates and soluble phosphates.
Storage
Store below 30°C.
Do not use if the solution is cloudy, changes colour, containing visible solid particles, also if the container is damaged and leaking.
MIMS Class
ATC Classification
B05XA05 - magnesium sulfate ; Belongs to the class of electrolyte solutions used in I.V. solutions.
Presentation/Packing
Inj conc (amp) 200 mg/mL x 20 mL x 5's. 400 mg/mL x 20 mL x 5's.
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