INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo INTRAMED MANNITOL 25% m/v INJECTION

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

INTRAMED MANNITOL 25% m/v INJECTION

COMPOSITION:
Each 50 mL contains 12,5 g of
Mannitol.

PHARMACOLOGICAL CLASSIFICATION:
A 18.1 Diuretics

PHARMACOLOGICAL ACTION:
Mannitol is an osmotic diuretic. It is freely filterable at the glomerulus, undergoes limited re-absorption by the renal tubule and is pharmacologically inert by conventional criteria. These three characteristics permit the administration of this agent in sufficiently large quantities to contribute significantly to the osmolality of the plasma, the glomerular filtrate and the tubular fluid. Mannitol is resistant to metabolic alteration.
When renal circulation is acutely compromised, mannitol is still filtered at the glomerulus. The tubular impermeability to mannitol is not altered by acute renal ischemia of short duration.
An additional action of the osmotic diuretics is to increase the rate of electrolyte excretion, particularly sodium, chloride and potassium.
Mannitol undergoes very little reabsorption. Mannitol must be administered parenterally in order to achieve effective plasma concentrations.

INDICATIONS:
Renal failure –Prophylaxis against acute renal failure in conditions such as cardiovascular operations, severe traumatic injury, operations in the presence of severe jaundice, and management of haemolytic transfusion reactions.
Differential diagnosis of acute oliguria. If either glomerular or tubular function is too severely compromised, mannitol will not increase urine flow.
Reduction of cerebrospinal and intra-ocular fluid pressures.

CONTRA-INDICATIONS:
Renal disease of sufficient severity to produce anuria and marked pulmonary congestion, patients with renal failure unless a test dose has produced a diuretic response. Mannitol should not be given to patients with pulmonary congestion or oedema, intracranial bleeding, congestive heart failure, or to dehydrated patients.

WARNINGS:
This is a hyperosmolar solution. This solution may not be mixed with other parenteral medicines. It may however, be diluted with Water for Injections or Sodium Chloride 0,45 % solution if necessary. Hyperosmotic solutions of mannitol should be administered slowly be intravenous injection and should not be mixed with blood in the transfusion apparatus. Patients should be closely observed for signs of electrolyte and fluid imbalance, especially in patients with diminished cardiac reserve.

DOSAGE AND DIRECTIONS FOR USE:
Warm before use to dissolve crystals. Do not use unless solution is clear. Use filter type administration set for large volumes. The adult dose for promotion of diuresis ranges from 50 to 200 g over a 24 hour period of infusion or slow injection; the rate is generally adjusted to maintain a urinary output of at least 30 to 50 mL per hour. It should be preceded by a test dose in patients with marked oliguria or questionable adequacy of renal function. The recommended test dose is 200 mg/kg (approximately 65 mL of a 20% or 50 mL of a 25% solution for an adult patient), slowly injected over 3 to 5 minutes; if the first or a second test dose fails to promote a urinary flow greater than 30 mL per hour for 2 to 3 hours, the patients' status should be re-evaluated prior to continuation of therapy.
For the prevention of acute renal failure during various types of surgery or for the treatment of oliguria, the total dose is 50 to 100 g of mannitol for an adult patient.
For the reduction of intracranial pressure and brain mass prior to neurosurgery, or for the reduction of intraoccular tension during an acute attack of congestive glaucoma or for ophthalmic surgery, is 1,5 to 2 g/kg given as a 15%, 20% or 25% solution over a period of 30 to 60 minutes.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The infusion or injection of mannitol should be terminated if the patient develops signs of progressive renal dysfunction, heart failure, or pulmonary congestion. Acute water toxicity may follow the intravenous administration of mannitol if renal flow is inadequate.
Infusion of mannitol has been associated with urinary retention, dehydration, hyponatraemia, pulmonary oedema, hypertension or hypotension, convulsions, tachycardia, chest pain, nausea, vomiting, thirst, headache, dizziness, chills, fever, blurred vision.
Extravasation of the solution may cause oedema and skin necrosis; thrombophlebitis may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See under "Side-effects and special precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
Sterile, non-pyrogenic solution of Mannitol in Water for Injections in clear 50 mL ampoules.

PRESENTATION:
50 mL ampoules.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATIONS NUMBERS:
W/18.1/190

NAME AND BUSINESS ADDRESS OF APPLICANT:
Intramed (Pty) Ltd
6 Gibaud Road
Port Elizabeth
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
April 1989 12-213/1-95
  Tradepak PE

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