Mannitol injectio








Indication


1. The promotion of diuresis in the prevention of and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established.


2. The reduction of intracranial pressure and the treatment of cerebral oedema.


3. The reduction of elevated intraocular pressure when the pressure cannot be lowered by other means.


4. Promoting the urinary excretion of toxic substances such as aspirin and barbiturates.


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Posology and method of administration


The dose range for adults is 50 to 200gm in a 24 hr period with a dosage limit of 50gm on any one occasion. In most instances an adequate response will be achieved at a dosage of approximately 100gm per 24hr period. The rate of administration is usually adjusted to maintain a urine flow of at least 30-50ml per hour.


The dosage requirements for patients 12 years of age and under have not been established.


Treatment of oliguria: the usual dose is 100gm of Mannitol administered as a 15% w/v or 20% w/v solution.


Reduction of intraocular pressure: a dose of 1.5 to 2.0gm per kg of body weight may be given, as a 15% w/v or 20% w/v solution, over a period as short as 30 minutes in order to obtain a prompt and maximal effect. When used preoperatively, the dose should be given 1-1.5 hours before surgery to obtain the maximum effect.


An infusion of 50 to 100gm of Mannitol may be given during cardiovascular and other types of surgery as an aid in preventing acute renal failure. The concentration and volume to be administered will depend upon the fluid requirement of the patient.


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Contraindications


1. Well-established anuria due to severe renal disease.


2. Severe pulmonary congestion or pulmonary oedema.


3. Active intracranial bleeding except during craniotomy.


4. Severe dehydration.


5. Progressive renal damage or dysfunction after institution of mannitol therapy, including increasing oliguria and azotaemia.


6. Progressive heart failure or pulmonary congestion after institution of mannitol therapy.


7. No response to the test dose.


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Special warnings and precautions for use


1. Mannitol should be administered with caution to patients with severe impairment of renal function.


2. The obligatory diuretic response following rapid infusion of 15% w/v or 20% w/v Mannitol Intravenous Infusion EP may further aggrevate pre-existing haemoconcentration.


3. Accumulation of Mannitol may result if urine output continues to decline during administration and this may intensify existing or latent congestive heart failure.


4. The cardiovascular status of the patient should be carefully evaluated before rapidly administering Mannitol Intravenous Infusion EP since sudden expansion of the extracellular fluid may lead to sudden congestive heart failure.


5. During Mannitol Infusion the renal function must be closely monitored.


6. By sustaining diuresis, Mannitol administration may obscure and intensify inadequate hydration or hypovolaemia.


7. Shift of sodium-free intracellular fluid into the extra cellular compartment following mannitol infusion may lower serum sodium concentration and aggrevate pre-existing hyponatraemia.


8. Rapid infusion may be harmful. This hypertonic solution may cause vein damage.


4.5 Interaction with other medicinal products and other forms of interaction


Mannitol Intravenous Infusion EP should not be administered simultaneously with, before or after an administration of blood through the same infusion equipment.


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Pregnancy and lactation


The safe use of Mannitol has not been established with respect to adverse effects upon foetal development.


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Effects on ability to drive and use machines


Not stated


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Undesirable effects


Isolated cases of pulmonary congestion, fluid and electrolyte imbalance, acidosis, dryness of mouth, thirst, marked diuresis, urinary retention, oedema, headache, blurred vision, convulsions, nausea, vomiting, rhinitis, arm pain, skin necrosis, chills, dizziness, urticaria, dehydration, hypotension, tachycardia, fever and angina-like chest pains have been reported during or following Mannitol infusion.





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