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COMPOSITION 

10%w/v Mannitol infusion B.P.

Mannitol B.P.                                          10g                                      

Water for Injection B.P.                          q.s.  

  

20%w/v Mannitol infusion B.P.

Mannitol B.P.                                          20g                                      

Water for Injection B.P.                          q.s.  

 

PHARMACOLOGICAL PROPERTIES

Mannitol, a carbohydrate, is confined to the extracellular compartment. It is an osmotic effect which causes fluid to pass from the intracellular to the extracellular compartment.

Mannitol is freely filterable at the kidney glomerulus and less than 10% is reabsorbed back from the kidney tubule. Confined to the kidney tubules, mannitol exerts an osmotic effect which prevents fluid reabsorption from the glomerular filtrate and produces diuresis. It thereby promotes urine flow in oliguria/anuria or in situations where the patient is at risk of onset of acute renal failure. Mannitol also increases electrolyte excretion, especially sodium, potassium and chloride. Excretion of renally excreted toxic substances such as aspirin and barbiturates is also increased.

Mannitol does not penetrate the blood-brain barrier under usual circumstances. Confined to the plasma, mannitol exerts an osmotic pressure, causing fluid to leave the brain tissue, and brain volume and intracranial pressure to be reduced.

Mannitol does not penetrate the eye. Mannitol promotes excretion of aqueous humour and thereby reduces intraocular pressure.

 

INDICATIONS

Mannitol infusion is indicated for use as an osmotic diuretic in the following situations:

1. Promotion of diuresis in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established.
2. Reduction of intracranial pressure and cerebral oedema, when blood-barrier is intact.
3. Reduction of elevated intraocular pressure when it cannot be lowered by other means.
4. Promotion of elimination of renally excreted toxic substances in poisoning.

 

METHOD OF ADMINISTRATION / DOSAGE

Dosage:

The dosage depends on the age, weight, clinical and biological condition of the patient and concomitant therapy.

Adults and adolescents:

 

The general dose range is 500 ml to 2000 ml/day (50 to 200 g mannitol in a 24 hour period), with a dosage limit of 500ml (50 g mannitol) on any one occasion. In most instances adequate response will be achieved at a dosage of 500 ml to 1000 ml/day (50 to 100 g mannitol/day).

 

The normal infusion rate is 30 to 50 ml/hour. Only in emergency situations, the maximum infusion rate can be as high as 140 ml/hour for 5 minutes (see also test dose). After 5 minutes, the infusion rate should be readjusted to normal range of 30 to 50 ml/hour.

 

Patients with marked oliguria or suspected inadequate renal function should first receive a test dose of approximately 2ml/kg bw (200 mg mannitol) over a period of 3 to 5 minutes. The response to the test dose is considered adequate if at least 30 – 50 ml/hour of urine is excreted for 2-3 hours. If an adequate response is not attained, a further test dose may be given.

If an adequate response to the second test dose is not attained, treatment with mannitol should be discontinued and the patient reassessed as established renal failure may be present.

 

Reduction of intracranial pressure, cerebral volume and intraocular pressure

The usual dose is 15 to 20 ml/kg bw, infused over 30 to 60 minutes. When used preoperatively, the dose should be administered 1 to 1.5 hours before surgery to obtain the maximum effect.

Children: In renal insufficiency, the test dose should be 2 ml/kg bw (200 mg mannitol) over 3-5 minutes. The treatment dose ranges from 5 ml/kg bw to 15 ml/kg bw. This dose may be repeated once or twice, after an interval of 4 to 8 hours, if necessary.

For cerebral and ocular oedema, this dose may be given over 30 to 60 minutes as for adults.

 

Elderly: As for adults, the dosage depends on the weight, clinical and biological condition of the patient and concomitant therapy. The general dose range is the same as for adults, 500 ml to 2000 ml/day (50 to 200 g in a 24 hour period), with a dosage limit of 500 ml (50 g mannitol) on any one occasion. Since incipient renal insufficiency may be present, caution should be used when reviewing patient’s status prior to dose selection.

 

CONTRAINDICATIONS

• Mannitol 10% Solution for Infusion is contra-indicated in patients presenting with:
  • Pre-existing plasma hyper-osmolarity
  • Severe dehydration
  • Well established anuria
  • Severe heart failure
  • Severe pulmonary congestion or pulmonary oedema
  • Active intracranial bleeding, except during craniotomy
  • Disturbance of the blood-brain barrier
  • Hypersensitivity to mannitol

 

WARNINGS & PRECAUTIONS 

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.

SIDE 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.

 

OVERDOSE

Too rapid infusion of large amounts of mannitol (mannitol (mannitol injection) injection) will cause a shift of intracellular water into the extracellular compartment resulting in cellular dehydration and overexpansion of the intravascular space with hyponatremia, congestive heart failure and pulmonary edema. Repeated doses should not be given to patients with persistent oliguria as this can produce a hyperosmolar state and precipitate congestive heart failure and pulmonary edema due to volume overload. Dosage must be carefully monitored and adjusted in accordance with the clinical situation to avoid the consequences of overdosage.

 

DRUG INTERACTION

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

PREGNANCY AND LACTATION 

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

STORAGE

Store below 30°C in a cool, dry place.

 

PRESENTATION

500ml sterile solution in a PE