viewed and mannitol infusion suspended if necessary. 5.2 fluid and electrolyte imbalances the obligatory diuretic response following rapid infusion of 25% mannitol may further aggravate pre-existing hemoconcentration. excessive loss of water and electrolytes may lead to serious imbalances. with continued administration of mannitol, loss of water in excess of electrolytes can cause hypernatremia. electrolyte measurements, including sodium and potassium are therefore of vital importance in monitoring the infusion of mannitol. the shift of sodium-free intracellular fluid into the extracellular compartment following mannitol infusion may lower serum sodium concentration and aggravate pre-existing hyponatremia. by sustaining diuresis, mannitol administration may obscure and intensify inadequate hydration or hypovolemia. accumulation of mannitol may result in overexpansion of the extracellular fluid which may intensify existing or latent congestive heart failure. the cardiovascular status of the patient should be carefully evaluated before rapidly administering mannitol since sudden expansion of the extracellular fluid may lead to fulminating congestive heart failure. 5.3 central nervous system (cns) toxicity mannitol injection may increase cerebral blood flow and the risk of postoperative bleeding in neurosurgical patients. mannitol may increase cerebral blood flow and worsen intracranial hypertension in children who develop generalized cerebral hyperemia during the first 24 to 48 hours post injury. 5.4 monitoring serum sodium and potassium should be carefully monitored during mannitol administration. if an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic counter measures and save the remainder of the fluid for examination if deemed necessary. electrolyte-free mannitol solutions should not be given conjointly with blood. if it is essential that blood be given simultaneously, at least 20 meq of sodium chloride should be added to each liter of mannitol solution to avoid pseudoagglutination. when exposed to low temperatures, solutions of mannitol may crystallize. if crystals are observed, the container should be warmed to redissolve, then cooled to body temperature before administering [see how supplied/storage and handling (16) ]. when infusing 25% mannitol, the administration set should include a filter. do not infuse mannitol solution if crystals are present.

r a period of 30 to 60 minutes. in small or debilitated patients, a dose of 500 mg/kg may be sufficient. careful evaluation must be made of the circulatory and renal reserve prior to and during administration of mannitol at the higher doses and rapid infusion rates. careful attention must be paid to fluid and electrolyte balance, body weight, and total input and output before and after infusion of mannitol. evidence of reduced cerebral spinal fluid pressure must be observed within 15 minutes after starting infusion. reduction of intraocular pressure in adults a dose of 0.25 to 2 g/kg body weight as a 15% to 25% solution administered over a period of 30 to 60 minutes; pediatric patients 1 to 2 g/kg body weight or 30 to 60 g/m2 body surface area over a period of 30 to 60 minutes. in small or debilitated patients, a dose of 500 mg/kg may be sufficient. when used preoperatively, the dose should be given one to one and one-half hours before surgery to achieve maximal reduction of intraocular pressure before operation. measurement of glomerular filtration rate (gfr) 100 ml of a 20% solution (20 g) should be diluted with 180 ml of sodium chloride injection (normal saline) or 200 ml of a 10% solution (20 g) should be diluted with 80 ml of sodium chloride injection (normal saline). the resulting 280 ml of 7.2% solution is infused at a rate of 20 ml per minute. the urine is collected by catheter for a specific period of time and analyzed for mannitol excreted in mg per minute. a blood sample is drawn at the start and at the end of the time period and the concentration of mannitol determined in mg/ml of plasma. gfr is the number of ml of plasma that must have been filtered to account for the amount excreted per minute in the urine. normal clearance rates are approximately 125 ml/minute for men; 116 ml/minute for women.

ground risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. data human data published literature reports the presence of mannitol in amniotic fluid when mannitol is administered to pregnant women during the third trimester of pregnancy. 8.2 lactation risk summary lactation studies have not been conducted with mannitol. it is not known whether this drug is excreted in human milk. mannitol injection should be administered to lactating women only if clearly indicated. studies assessing the effects of mannitol injection in breastfed children have not been performed. studies to assess the effect of mannitol on milk production or excretion have not been performed. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mannitol and any potential adverse effects on the breastfed child from mannitol or from the underlying maternal condition. 8.5 geriatric use mannitol is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in elderly patients with impaired renal function. evaluate the renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances prior to administration of mannitol [see warnings and precautions (5) ]. 8.6 renal impairment patients with pre-existing renal disease, patients with conditions that put them at high risk for renal failure, or those receiving potentially nephrotoxic drugs or other diuretics, are at increased risk of renal failure with administration of mannitol. evaluate the renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances prior to administration of mannitol [see warnings and precautions (5)] .

with normal renal function, the total clearance is 87 to 109 ml/minute. the elimination half-life of mannitol is 0.5 to 2.5 hours metabolism only a relatively small amount of the mannitol dose is metabolized after intravenous administration to healthy subjects. excretion approximately 80% of a 100 g dose appears in the urine in 3 hours. the drug is freely filtered by the glomeruli, with less than 10% tubular reabsorption; it is not secreted by tubular cells. specific populations patients with renal impairment in patients with renal impairment, the elimination half-life of mannitol is prolonged. in a published study, in patients with renal impairment including acute renal failure and end stage renal failure, the elimination half-life of mannitol was estimated at about 36 hours, based on serum osmolarity. in patients with renal impairment on dialysis, the elimination half-life of mannitol was reduced to 6 and 21 hours during hemodialysis and peritoneal dialysis, respectively.

should include a filter. protect from freezing. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] instructlons for use remove cover and cleanse stopper with antiseptic before use.