This information is intended for use by health professionals

1. Name of the medicinal product

Mannitol Intravenous Infusion EP 20% w/v

2. Qualitative and quantitative composition
Mannitol EP 200.00gm

3. Pharmaceutical form

A sterile non-pyrogenic Intravenous Infusion for administration to human beings.

4. Clinical particulars
4.1 Therapeutic indications

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.

4.2 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.

4.3 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.

4.4 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 aggravate 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 aggravate 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.

4.6 Pregnancy and lactation

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

4.7 Effects on ability to drive and use machines

Not stated

4.8 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.

4.9 Overdose

Not stated

5. Pharmacological properties
5.1 Pharmacodynamic properties

Not applicable.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6. Pharmaceutical particulars
6.1 List of excipients

Sodium hydroxide EP QS

Water for Injection EP to 1 litre

6.2 Incompatibilities

Check additive compatibility before use.

6.3 Shelf life

24 months for pack sizes 200ml, 250ml, 500ml and 1000ml from the date of manufacture providing the unit has not been opened.

6.4 Special precautions for storage

Storage between 20 - 30°C.

6.5 Nature and contents of container

Viaflex plastic container. It contains either 200ml, 250ml, 500ml, or 1000ml of sterile solution. The container is sealed into a plastic overpouch.

6.6 Special precautions for disposal and other handling

Do not use unless solution is clear and the container is undamaged. Any contents of the product remaining after use should be discarded.

7. Marketing authorisation holder

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

8. Marketing authorisation number(s)

PL 0116/5056R

9. Date of first authorisation/renewal of the authorisation

18th December 1984

10. Date of revision of the text

21st January 1996