Osmosol

Mannitol BP 20% w/v
Intravenous Infusion BP

1. What Osmosol® 20 is and what it is used for?
Osmosol® 20 is a clear, almost colorless and sterile solution of Mannitol. Each 100ml of Osmosol® 20 contains Mannitol BP 20g. Administered parenterally, Osmosol® 20 raises the osmotic pressure of the plasma, thus drawing water out of body tissues and produces an osmotic diuresis. Osmosol® 20 is principally used by IV infusion as an osmotic diuretic to preserve renal function in acute renal failure and to reduce raised intracranial and intraocular pressure. Osmosol® 20 is also used as an irrigating solution to prevent hemolysis and hemoglobin buildup during transurethral prostatic resection. It is useful in the management of acute drug poisoning where a route of elimination is through kidney. Besides these, it is also used in symptomatic relief of edema, reperfusion injury, termination of pregnancy, and bowel preparation.

2. Before you take Osmosol® 20
Do not take this medicine and tell your doctor if:

Mannitol intravenous infusion is contraindicated in patients with pulmonary edema or congestive heart failure. It is also contraindicated during inadequate urine flow, dehydration or acidosis, intracranial bleeding and in patients with renal failure unless a test dose has produced a diuretic response.

Take special care with Osmosol® 20
Check with your doctor before taking this medicine if:

Careful monitoring of rate of administration of Osmosol® 20 is necessary to avoid fluid and electrolyte imbalance and circulatory overloading. The infusion should be discontinued if the patient develops signs of progressive renal dysfunction, heart failure or pulmonary congestion. Mannitol should not be administered with whole blood.

Pregnancy and breast-feeding
Safety of Mannitol intravenous infusion in pregnancy has not been established yet. No information is available on the excretion of mannitol in breast milk and should be administered after careful consideration of risk-benefit ratio.

3. How to take Osmosol® 20?
Taking this medicine. Always use Osmosol® 20 exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take
The adult dose of Mannitol ranges from 50 to 100g by IV infusion. The rate of administration is usually adjusted to maintain a urine flow of at least 30 to 50ml/hr. Total dosage, concentration and the rate of administration depends on fluid requirement, urinary output and the severity of the condition being treated.
Indications
Renal insufficiency
Cerebral edema, elevated intracranial pressure, elevated intraocular pressure, Glaucoma
Adjunctive therapy for removal of toxic substances
Adults
50 to 100 g of Osmosol 20-20 administered at a rate adjusted to maintain a urine flow of at least 30 to 50 ml/hr.
1.5 to 2 g/kg of body wt. administered over a period of 30 to 60 minutes.
50 to 200 g of Osmosol 20-20 administered at a rate adjust to maintain a urine flow of at least 100 to 500 ml/hr.
Children
2 g/kg body wt. or 60 g/sq. meter of body surface area administered over a period of 2 to 6 hrs.
1 to 2 g/kg body wt. or 30 to 60 g/sq. meter of body surface area administered over a period of 30 to 60 mins.
2 g/kg body wt. or 60 g/sq. meter of body surface area

4. Possible side effects
The most common side effects associated with Mannitol intravenous infusion is fluid and electrolytes imbalance including circulatory overload and acidosis at high doses. Other side effects include nausea, vomiting, thirst, headache, dizziness, fever, tachycardia, chest pain, hyponatraemia, dehydration, blurred vision, urticaria, and hypertension or hypotension.

Tell your doctor if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet

5. How to store Osmosol® 20?
Osmosol 20 20 should be stored at a temperature of 200 to 300c. Exposure to lower temperatures may cause deposition of crystals, which should be dissolved by warming the bottle in hot water for about 30 minutes. Cool to body temperature before using. If all crystals can not be dissolved, the solution should not be used. The content of open containers should be used promptly. Unused contents should be discarded.


Osmosol Prescribing Information

Located in: Intravenous Fluids