Mannitol Injection
Name: Mannitol Injection
Main ingredients: D-Mannitol
Structural formula : C6H14O6
Mol wt: 182.17
Description The product is clear colorless liquid.
Pharmacology and toxicity
Mannitol is one of glycose. It could not be metabolized in the body, and only little could be re-absorbed in the renal tububle after filtration by the glomerulum and have the effect of osmosis diuresis.
(1)Tissue Dehydration. Mannitol could increase the plasma osmosis pressure, lead to that the water in the tissues (including the eyes, cerebral, cerebrospinal fluid and etc. )come into the vein, and get the effect of decreasing the tissue hydrops, lowering the volume and pressure of intracular pressure, intracranial pressure and cerebrospinal fluid. Mannitol 1g could produce the osmosis concentration 5.5mOsm,and administration intravenously of Mannitol 100g could make 2000ml liquid transfer from the inner cell to outer cell and excrete the sodium 50g.
Osmosis concentration of different concentration Mannitol solution is just as follows:
| Concentration(%) |
Osmosis concentration(mOsm/L) |
concentration(%) |
Osmosis concentration(mOsm/L) |
| 5 |
275 |
20 |
1100 |
| 10 |
550 |
25 |
1375 |
| 15 |
825 |
|
|
(2)diuresis. The effect of Mannitol are mainly the following two factors::
Mannitol could increase the blood volume, promote the excretion of pg I2,then expand the renal vein, increase renal and spinal cord blood flow amount.
Very little Mannitol (<10%)could be re-absorbed by renal tububle after filtrating by renal glomerule, so Mannitol could heighten the osmosis concentration of liquid in the renal tububle, and decrease the re-absorbance of water, Na+,Cl-,K+,Ca2+,Mg2+and other solute.
After using Mannitol the fluid flow amount in the renal tububle increases. When drug or toxic substance intoxication happen, the concentration may decrease in the renal tububle, thus the toxicity of those substances decrease for the renal, and excretion speed will be quickened through the renal.
Pharmacokinetics
The absorbance rate is very little if Mannitol is taken orally. Taken intravenously Mannitol quickly enter into the extracellular fluid and not enter into the cell. But when Mannitol - plasma concentration is very high or acidosis happen, Mannitol could penetrate the blood brain barrier and may lead to intracranial pressure spring. Diuresis appears after administering intravenously one hour and could keep 3 hours. Decreasing the intra-ocular pressure and intracranial pressure appear after administering intravenously 15 minutes, reach the peak after30~60minutes,keep 3~8hours. Mannitol can produce glucogen through liver, but usually the amount is excreted through kidney is very little because Mannitol is excreted quickly through kidney after administering intravenously. T1/2 of this product is 100minutes,but when acute renal function happens T1/2 could be extended to 6 hours; and when the renal function is normal, administering intravenously mannitol 100g, 80% of Mannitol is excreted in 3 hours by kidney.
The product can promotes diuresis, lower the intracranial pressure and intracular pressure. It is mainly used for the preventive and treatment of renal failure, collapse and shock.
Action and usage:
(1)Dehydration drug. It can be used for the treatment of cerebral edema, decreasing the intracranial pressure, and the prevention of cerebral hernia.
(2)Decrease the intra-ocular pressure. The product can be used when there is any effect with other medicine or used for the preparation of eye surgery.
(3) Osmotic diuretic. Used to identify oliguresis caused by all kinds of factors, also used for the prevention of acute renal tububle necroses.
(4) Used to treat the renal disease syndrome, ascites due to cirrhosis as the auxiliary hydragog.
(5) For the overdose or toxicosis of some medicine, such as , lithium, salicylate and bromide, the product can promote the excretion of the aforementioned and prevent the renal toxicity.
(6) Used as irrigation when the patient is made prostate excision surgery through the urethra.
(7) Before the surgery make the intestinal canal preparation.
Administration and dosage
1.gentle dose for the adult:
(1)diuresis.Calculate the dose according to the weight 1~2g/kg,administer 250ml solution with the concentration 20% intravenously. Adjust the dose to make the urine amount maintain 30~50m1/hour.
(2)For the treatment of cerebral edema, intracranial hypertension and glaucoma. Calculate the dose according to the weight 0.25~2g/kg administer 15%~20% solution within 30~60minutes intravenously. If the patient is weak the dose can be decreased to 0.5g/kg.
(3)Used for the identification of oliguresis cause. Administer intravenously with the concentration 20% and finish the course within 3~5 minutes, calculating the dose according to the weight 0.2g/kg. if the urine amount is still lower than 30~50ml after 2~3 hours,administer again, if there is not yet any reaction the product should be stopped using. For the patients with the heart function decrease or heart function failure administer carefully or forbidden to use.
(4)Prevent the renal tububle from necrosis. Administer intravenously 12.5~25g at first,finish the course within 10minutes; If there is not any special case, administer 50g again,finish the course within 1hour. If the urine can maintain more than 50ml/hour, continue using 5% solution; otherwise stop using the product.
(5)Used for the treatment of poisoning. 20% solution 50g is taken by phleboclysis,adjust the dose to make the amount of urine keep 100~500ml/hour.
(6)make the intestinal tract preparation. 4~8 hours before the surgery,10% solution1000ml is taken orally within 30 minutes.
2. gentle dose for the children:
(1)diuresis.Calculate the dose according to the weight 0.25~2g/kg or according to the body surface area 60g/m2,administer 15%~20% solution within 2~6hours intravenously.
(2)For the treatment of cerebral edema, intracranial hypertension and glaucoma. Calculate the dose according to the weight 1~2g/kg or according to the body surface area 30~60g/m2,administer 15%~20% solution within 30~60minutes intravenously. If the patient is weak the dose can be decreased to 0.5g/kg.
(3)Used for the identification of oliguresis cause. Administer intravenously with the concentration 15%~25% and finish the course within 3~5 minutes, calculating the dose according to the weight 0.2g/kg or the body surface area6g/m2. if the urine amount does not increase obviously after 2~3 hours,administer again, if there is not yet any reaction the product should be stopped using.
(4)Used for the treatment of drug and toxic substance intoxication, administer intravenously with the concentration 5%~10% and calculate the dose according to the weight 2g/kg or the body surface area 60gk/m2.
Side-effect
(1)Water and electrolyte disturbance
1,Administering intravenously fast and with high dose may lead to the deposit of Mannitol in the body, and increase of blood volume(especially acute and chronicity renal failure),even lead to cardiac failure(especially with the heart function damage),diluted hyponatremia, occasionally lead to hyperkalemia;
2,Excessive diuresis may lead to the decrease of blood volume and increase of little urine.
3,That a lot of intracellular fluid transfer to outer cell may lead to tissue dehydration, also may lead to central nerve system symptom.
(2)chill and pyrexia
(3)dysuria
(4)thrombophlebitis
(5)exosmotic Mannitol may lead to tissue hydrops and skin necroses.
(6)allergic reaction may induce tetter, hives, dyspnoea, and allergic shock.
(7)swirl, blurred vision
(8)high infiltration may induce thirst.
(9)infiltrative renal disease (or call "Mannitol renal disease") mainly occur when Mannitol injection is administered with high dose and fast by phleboclysis. The cause is not definite. Pathology show that the renal tububle epith epithelial cell is tumid, and there is physalis. In the clinic work urine amount decrease may happen, even the acute renal function failure. Osmosis renal disease probably happen for the patients with the decreased renal blood amount and hyponatremia, dehydration.
Contraindication
1the patients who have been confirmed with renal tubules necrosis, included the patients without any reaction to Mannitol test.
2the patients with serious dehydration
3the patients with encephalic active bleeding, but excluded the patients with encephalic surgery.
4the patients with acute pulmonary edema or serious pulmonary sludge.
Attention
(1)Except used for the intestinal tract preparation, the product is usually be administered intravenously.
(2)Examination should be made carefully before the use because Mannitol is easy to crystallize in the cool place. If crystal happens, please place the injection into the hot water or shake forcibly and use only after the crystal has been dissolved. When the concentration is higher than 15%, we should use the transfusion system with filter.
(3)Select the moderate concentration according to the disease for fear that the high concentration and high dose was used unnecessarily.
(4)Using low concentration and NaCl-included Mannitol could decrease the opportunity of excessive dehydration and electrolyte diffusion.
(5)When the product is used to treat salicylate or poisoning, it should be administered combined with sodium bicarbonate to alkalize the urine.
(6)Administer cautiously for the following cases:
1,For the patients with obvious cardio-pulmo damage. Because the product may lead to the sudden increase of blood volume and accordingly lead to congestive cardiac failure;
2,Hyperkalemia or hyponatremia;
3,If hypovolemia happens, diuresis effect of Mannitol may lead to worsened disease, or the hypovolemia was covered up temporarily.
4,The product may deposit in the body because of the decreased excretion led by the serious renal function failure, accordingly lead to the blood volume increase, increase the heart loading, and induce the heart disease or cardiac failure.
5,The person who dose not tolerate Mannitol.
(7)If the diuresis does not happen after giving high dose Mannitol, plasma osmosis concentration may be heightened obviously. So please look out the occurrence of blood infiltration.
(8)The following points should be tested after the administration:
1,blood pressure;
2,renal function;
3,electrolyte concentration, especially Na+ and K+;
4,urine volume
Indication for women in pregnant and suckle
(1)Mannitol may pass through placental barrier.
(2)Whether the product can be excreted through the latex is not definite.
Indications for the elder patients
The old patients are prone to renal damage when administered so the dose should be controlled.
Substance interactions
- The product can increase the toxicity of digitalis when used with it and related to hypokalemia disease.
- The dose should be adjusted when used with hydragog and carbonic anhydrase inhibitor since the product may increase the effect of diuresis and decreasing the intraocular pressure of theirs.
Overdose: If the overdose happen, gastrolavage should be used as early as possible, and make the treatment against the disease, pay attention to the blood pressure, electrolyte, and renal function.
Specification: 250ml:50g
Storage: Protect from the light and preserve in the tight container.
Package: 30 bottles/carton
Validity: Two years
Approval Coding: GUOYAOZHUNZI H13023037
Manufacturer
Name:Shijiazhuang No.4 Pharmaceutical Co., Ltd.
Address:No.35 Huitong Road, Shijiazhuang. P.R. China
Post code:050021
Shijiazhuang No. 4 Pharmaceutical Co., Ltd., as one of the leading manufacturers in Chinese pharmaceutical industry and a well-known brand, has a business history of seventy years. The company principally specializes in R & D, manufacture and sales of wide types of drugs mainly including intravenous infusion.
The production lines have achieved full automation control and information control in the production process and logistics process and reached international advanced level by integrating the world's leading equipment and technology.
With product quality as its life, the Company always organizes production in strict accordance with GMP requirements, establishes and implements superior service concepts and measures and provides guarantee for the health of the majority of patients at home and abroad with excellent quality products and services.
The Company has a powerful R&D team and made a number of achievements in scientific research and undertaken many major scientific and technological innovation projects and industrialization projects by firmly grasping the pulse of pharmaceutical development, increasing new product development investment and accelerating the pace of technological innovation.
Large volume injection is the key products, tablets, capsules, small volume injection and other forms are manufactured also. Recently API has been put into production and sales. There are more than ten international advanced production lines for the large volume injection, its production scale, technology level, brand influence and economic benefit are on the forefront of domestic counterparts, and it has become one of China's top 100 pharmaceutical industry enterprises and China's top 10 chemical and pharmaceutical industry preparation export-oriented excellent enterprise brands for many consecutive years.
The products are radiated to all provinces, autonomous regions and municipalities in China and also exported to many overseas markets, including more than 80 countries in Asia, Americas, Europe, Oceania, Africa and other continents, and it has become one of the main export enterprises of infusion products.
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