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MANNITOL INFUSION 250ML50G 100ML20G

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Other Preparations

CAS NO:

---

Standard:

ChP,USP,

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Central/South America,Eastern Europe,Asia,Middle East,Africa

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Hebei Tiancheng Pharmaceutical Co., Ltd.

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Product Description

Specification:

It is clear, colorless or almost colorless liquid.

Indication:

Mannitol Injection, USP, is indicated for the following purposes in adults and pediatric patients.Therapeutic Use

1. Promotion of diuresis in the prevention or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established.

2. Reduction of intracranial pressure and brain mass.

3. Reduction of high intraocular pressure when the pressure cannot be lowered by other means.

4. Promotion of urinary excretion of toxic materials.

Diagnostic Use:

Measurement of glomerular filtration rate.

Recommended posology:

Mannitol I.V. (Mannitol Injection, USP) should be administered only by intravenous infusion. The total dosage, concentration and rate of administration should be governed by the nature and severity of the condition being treated, fluid requirement and urinary output. The usual adult dosage ranges from 50 to 200 g in a 24-hour period, but in most instances an adequate response will be achieved at a dosage of approximately 100 g/24 hours. The rate of administration is usually adjusted to maintain a urine flow of at least 30 to 50 mL/hr. The total dose should be adjusted according to the clinical response and adverse events (See WARNINGS).

Test Dose: A test dose of Mannitol should be given prior to instituting Mannitol I.V. therapy for patients with marked oliguria or those believed to have inadequate renal function. In adults the dose is 0.2 g/kg body weight. In pediatric patients the dose is 0.2 g/kg body weight or 6 g/m2 body surface area. The infusion is given as a 15% to 25% solution over a period of 3 to 5 minutes to produce a urine flow of at least 30 to 50 mL/hour. If urine flow does not increase, a second dose may be given; but if there is inadequate response, the patient should be re-evaluated.

Prevention of Acute Renal Failure (Oliguria): When used during cardiovascular or other types of surgery, 50 to 100 g of mannitol as a 5%, 10%, or 15% solution may be given. The concentration will depend on the fluid requirements of the patient.

Treatment of Oliguria: The usual dose to promote diuresis in oliguric patients: Adults, 300 to 400 mg/kg of body weight (21 to 28 g for a 70 kg patient) or up to 100 g of solution, given as a single dose (often in conjunction with furosemide); pediatric patients, 0.25 to 2 g/kg body weight or 60 g/m2 body surface area as a 15% to 20% solution over a period of 2 to 6 hours. Doses should not be repeated in patients with persistent oliguria.

Reduction of Intracranial Pressure and Brain Mass: In adults a dose of 0.25 to 2 g/kg body weight as a 15% to 25% solution administered over a period of 30 to 60 minutes; pediatric patients 1 to 2 g/kg body weight or 30 to 60 g/m2 body surface area over a period of 30 to 60 minutes. In small or debilitated patients, a dose of 500 mg/kg may be sufficient. Careful evaluation must be made of the circulatory and renal reserve prior to and during administration of Mannitol at the higher doses and rapid infusion rates. Careful attention must be paid to fluid and electrolyte balance, body weight, and total input and output before and after infusion of mannitol. Evidence of reduced cerebral spinal fluid pressure must be observed within 15 minutes after starting infusion.

Reduction of Intraocular Pressure: In adults a dose of 0.25 to 2 g/kg body weight as a 15% to 25% solution administered over a period of 30 to 60 minutes; pediatric patients 1 to 2 g/kg body weight or 30 to 60 g/m2 body surface area over a period of 30 to 60 minutes. In small or debilitated patients, a dose of 500 mg/kg may be sufficient. When used preoperatively, the dose should be given one to one and one-half hours before surgery to achieve maximal reduction of intraocular pressure before operation.

Adjunctive Therapy for Intoxications: As an agent to promote urinary excretion of toxic substances: Adults may receive a 5% to 25% solution for as long as indicated if urinary output remains high; pediatric patients may receive 2 g/kg of body weight of a 5% or 10% solution. The concentration will depend upon the fluid requirement and urinary output of the patient. If benefits are not observed after 200 g of Mannitol are administered, discontinue the Mannitol therapy. Intravenous water and electrolytes must be given to match the loss of these substances in the urine, sweat and expired air.

Measurement of Glomerular Filtration Rate (GFR): 100 mL of a 20% solution (20 g) should be diluted with 180 mL of sodium chloride injection (normal saline) or 200 mL of a 10% solution (20 g) should be diluted with 80 mL of sodium chloride injection (normal saline). The resulting 280 mL of 7.2% solution is infused at a rate of 20 mL per minute. The urine is collected by catheter for a specific period of time and analyzed for Mannitol excreted in mg per minute. A blood sample is drawn at the start and at the end of the time period and the concentration of Mannitol determined in mg/mL of plasma. GFR is the number of mL of plasma that must have been filtered to account for the amount excreted per minute in the urine. Normal clearance rates are approximately 125 mL/minute for men; 116 mL/minute for women.

Recommended route of administration:

Mannitol Injection should be administered only by intravenous infusion

Store at 20° to 25°C Dispense in a tight, light resistant container with a child resistant closure