甘露醇注射液说明书英文版
The specifications of Mannitol Injection
【chemical composition】:D-mannitol
【Molecular formula】：C6H14O6
【molecular weight】：182.17
【Auxiliary materials】：Hydrochloric acid and sodium hydroxide
【Character】:The quality of this product is colorless clear liquid.
【Indications】: 1.tissue dehydrating medicine. It is used to treat brain edema caused by various reasons, reduce intracranial pressure and prevent cerebral hernia.
2.reduce intraocular pressure. It can effectively reduce intraocular pressure, which can be applied to other intraocular pressure lowering drugs or before intraocular surgery.
3.osmotic diuretic. It is used to identify oliguria caused by pre renal factors or acute renal failure. It can also be applied to prevent acute tubular necrosis caused by various causes.
4.as a supplementary diuretic measure to treat nephrotic syndrome and ascites due to cirrhosis, especially when hypoproteinemia occurs.
5.for some drug overdose or poison poisoning (such as barbiturate, lithium, salicylate and bromide), this drug can promote the excretion of the above substances and prevent renal toxicity.
https://www.360docs.net/doc/cb18585815.html,ed as a washing agent for transurethral resection of prostate.
7.preoperative bowel preparation.
【specification】：250ml:50g
【Usage and dosage】: 1. adult: (1).Diuresis. The usual dosage is 1 to 2g/kg by weight, and 20% drops of 250ml are injected intravenously, and the dosage is adjusted to maintain 30 to 50ml urine per hour. (2)Treatment of cerebral edema, intracranial hypertension and glaucoma. According to body weight 0.25 to 2g/kg, the concentration was 15% to 25% in 30~60 minutes. When the patient is weak, the dose should be reduced to 0.5g/kg. The renal function was followed up closely. (3) Identification of pre renal oliguria and renal oliguria. According to the weight 0.2g/kg, 20% concentration in 3~5 minutes intravenous drip, such as after 2~3 hours after the medication, the urine volume is still less than 30~ 50ml, the maximum trial, if still no reaction should stop the drug. Patients with heart failure or heart failure are advised to use caution or not. (4) Prevention of acute renal tubular necrosis. First give 12.5 to 25g, 10 minutes intravenous drip, if no special situation, then 50g, 1 hours intravenous drip, if the urine can be maintained at more than 50ml per hour, then can continue to use 5% solution static drops; if ineffective, stop the drug immediately. (5)Treatment of drugs, poison poisoning.50g adjusted the dose by 20% drops of intravenous drip to maintain urine volume at 100 to 500ml per hour.
2.children.Diuresis. (1) According to body weight 0.25 to 2g/kg or by body surface area 60g/m2, intravenous infusion of 15% to 20% solution within 2~6 hours.
(2)Treatment of cerebral edema, intracranial hypertension and glaucoma. According to body weight 1 to 2g/kg or by body surface area 30 to 60g/m2, intravenous infusion of 15% to 20% concentration solution in 30~60 minutes. When the patient is weak, the dose is reduced to 0.5g/kg.
(3)Identification of pre renal oliguria and renal oliguria. According to the body weight 0.2g/kg or the body surface area 6g/m2, 15% ~ 25% concentration of intravenous drip for
3~5 minutes, if the urine volume of 2~3 hours after medication no significant increase, can be reused 1 times, if still no reaction is no longer used.
(4)Treatment of drugs, poison poisoning. According to body weight 2g/kg or 60g/m2 according to body surface area, 5% to 10% solution was dripped intravenously. 【Adverse reactions】: 1. water and electrolyte disorders are most common. (1) a rapid and large amount of mannitol can cause the accumulation of mannitol in the body, and a rapid increase in blood volume (especially in acute and chronic renal failure), which leads to heart failure (especially when cardiac dysfunction),dilute hyponatremia,and even hyperkalemia. (2) inappropriate excessive diuresis leads to decreased blood volume and aggravated oliguria. (3) a large number of intracellular fluid transfer to extracellular tissue can cause tissue dehydration and can cause symptoms of central nervous system.
2. chills, fever.
3. dysuria is difficult.
4. thrombotic phlebitis.
5. mannitol exudation can cause tissue edema and skin necrosis.
6. allergies cause rash, urticaria, dyspnea, and anaphylactic shock.
7. dizziness and blurred vision.
8. hyperosmotic causes thirst.
9. osmotic nephropathy (or mannitol nephropathy) is mainly seen in high dose rapid intravenous infusion. The mechanism has not yet been fully elucidated. It may be caused by excessive elevation of osmotic pressure in renal tubular fluid induced by mannitol, which may lead to injury of renal tubular epithelial cells. Pathological findings showed that the renal tubular epithelial cells were swollen and vacuolated. Clinically, there is a decrease in urine volume and even acute renal failure. Osmotic nephropathy is commonly seen in elderly patients with reduced renal blood flow and hyponatremia and dehydration. 【Taboos】: 1. the patients who have been diagnosed with acute renal tubular necrosis, including those who have no response to mannitol, increase the volume of blood and increase the burden of the heart because of the accumulation of mannitol.
2. the serious water lost.
3. patients with intracranial active bleeding aggravate bleeding due to dilatation, except for intracranial surgery.
4. acute pulmonary edema, or severe pulmonary ecchymosis.
【Cautions】: 1.except for intestinal preparation, intravenous administration should be given.
2.mannitol is easy to crystallize when it is cold, so it should be carefully checked before application. If there is crystallization, it can be placed in hot water or oscillate vigorously until it is completely dissolved before it is used. When the concentration of mannitol is above 15%, the infusion set with filter should be used.
3.choose the appropriate concentration according to the condition and avoid unnecessary use of high concentration and large dose.
4.the use of low concentration and mannitol containing Sodium Chloride Solution can reduce the chance of over dehydration and electrolyte disturbance.
5. when treating salicylate or barbiturates poisoning, sodium bicarbonate should be used to alkylate urine.
6. caution should be applied to the following situations: (1) patients with obvious heart and lung dysfunction may cause congestive heart failure due to the sudden increase of blood volume caused by this medicine. (2) hyperkalemia or hyponatremia. (3) low blood volume. After application, it can aggravate the condition due to the urine and make the original low blood volume temporarily dilated. (4) reduced excretion of severe renal failure causes the drug to accumulate in the body, resulting in a marked increase in blood volume, aggravating cardiac load, inducing or aggravating heart failure. (.) an intolerant of mannitol.
7.high dose mannitol does not appear diuretic reaction, which can significantly increase plasma osmotic concentration. Therefore, we should be vigilant against hypertonic infiltration.
8.follow up examination: (1) blood pressure. (2) renal function. (3) the concentration of blood electrolyte, especially Na+ and K+. (4) urine volume.
【Pregnant women and lactating women use】1. mannitol through the placental barrier.
2. it is not clear whether it can be secreted by milk.
【children use】The use of drugs for children is not clear and is not recommended. 【The elderly use】The elderly are more likely to suffer kidney damage by using the drug, and the chance of kidney damage increases with age. Control the amount properly. 【Drug interaction】1.increases the toxic effect of digitalis and is associated with hypokalemia.
2.increase the diuretic and intraocular pressure effects of diuretics and carbonic anhydrase inhibitors. When combined with these drugs, dosage should be adjusted. 【The pharmacology and toxicological】literature reports that mannitol is monosaccharide and is not metabolized in the body. After glomerular filtration, the mannitol is rarely reabsorbed in the renal tubules and plays the role of permeation diuresis.
1. the dehydration of the tissues. Increase the osmotic pressure of plasma and lead to the intravascular water in the tissue, including the eye, brain and cerebrospinal fluid, so as to reduce the edema of the tissue and reduce the pressure of intraocular pressure, intracranial pressure and cerebrospinal fluid capacity and pressure. 1g mannitol can produce osmotic concentration of 5.5mOsm, injection of 100g mannitol can make 2000ml cells in water transfer to extracellular, urinary sodium excretion 50g.
2. diuretic effect. The diuretic mechanism of mannitol is divided into two aspects: (1) mannitol increases blood volume and promotes the secretion of prostaglandin I2, thus expanding the renal vessels and increasing renal blood flow, including renal medullary blood flow. Glomerular arterioles dilated, glomerular capillary pressure increased, and cortical glomerular filtration rate increased. (2) it is rare since the glomerulonephritis 【Pharmacokinetics】studies reported that mannitol rapidly entered the extracellular fluid after intravenous injection without entering the cell. However, when blood mannitol concentration is high or acidosis occurs, mannitol can pass through blood brain barrier and cause intracranial pressure rebound. Diuresis occurred 1 hours after intravenous injection and lasted for 3 hours. The decrease of intraocular pressure and intracranial pressure occurred within 15 minutes after intravenous injection. The peak time was 30-60 minutes, and maintained for 3-8 hours. This drug can be produced from the liver glycogen,
but because of rapid renal excretion after intravenous injection, it is generally rare to metabolize the liver through the liver. The half-life (t1/2) of the drug is 100 minutes and can be extended to 6 hours when acute renal failure occurs. When renal function was normal, mannitol 100g was injected intravenously, and 80% of them were excreted by kidney in 3 hours.
【Storage】Storage and shading, closed and preserved.
【The period of validity】24 months
【executive standard】《Chinese pharmacopoeia》2015（II）
【approval number】H37021265