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Drug Catalog - Product Detail

MANNITOL IV SOL 25% 50ML X 25

NDC Mfr Size Str Form
00409-4031-01 HOSPIRA 50 25% SOLUTION
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Generic Name
MANNITOL
Substance Name
MANNITOL
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Application Number
NDA016269
Description
11 DESCRIPTION Mannitol Injection, USP is a sterile, nonpyrogenic solution of mannitol in water for injection available in a fliptop vial for intravenous administration as an osmotic diuretic. The content and characteristics are as follows: Conc. (%) g/100 mL mOsmol/liter (calc.) pH May contain sodium bicarbonate and/or hydrochloric acid for pH adjustment. 25 25 1372 5.9 (4.5 to 7.0) The solution contains no bacteriostat, antimicrobial agent, or added buffer (except for pH adjustment) and is intended only as a single-dose injection. Mannitol, USP is chemically designated D-mannitol (C 6 H 14 O 6 ), a white crystalline powder or free-flowing granules freely soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 O. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Mannitol Injection 25%, USP is available as 12.5 g/50 mL (0.25 g/mL) of mannitol in a single-dose vial. Supplied as a tray of 25 vials (NDC 0409-4031-01). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.
Indications & Usage
1 INDICATIONS AND USAGE Mannitol Injection is indicated for the reduction of: • intracranial pressure and treatment of cerebral edema. • elevated intraocular pressure. Mannitol Injection is an osmotic diuretic, indicated for the reduction of: • intracranial pressure and treatment of cerebral edema. ( 1 ) • elevated intraocular pressure. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Administration Instructions ( 2.1 ) : • For intravenous infusion, preferably through a central venous catheter. • Prior to administration, evaluate renal, cardiac and pulmonary status and correct fluid and electrolyte imbalances. Recommended Dosage ( 2.2 ) : • The dosage, concentration and rate of administration depend on the age, weight and condition of the patient, including fluid requirement, urinary output and concomitant therapy. • Reduction of Intracranial Pressure and Treatment of Cerebral Edema : 0.25 g/kg administered every 6 to 8 hours as an intravenous infusion over at least 30 minutes. • Reduction of Intraocular Pressure: 1.5 to 2 g/kg administered as a single dose intravenously over at least 30 minutes. Administer 60 to 90 minutes before surgery to achieve maximal effect. 2.1 Important Preparation and Administration Instructions • Mannitol Injection is for intravenous infusion preferably through a central venous catheter [see Warnings and Precautions (5.6) , Description (11) ] . • Prior to the administration of Mannitol Injection, evaluate renal, cardiac, and pulmonary status of the patient and correct fluid and electrolyte imbalances [see Dosage and Administration (2.2) ]. • Do not administer Mannitol Injection simultaneously with blood products or through the same administration set because of the possibility of pseduoagglutination or hemolysis. If it is essential that blood be given simultaneously, at least 20 mEq of sodium chloride should be added to each liter of mannitol solution to avoid pseudoagglutination. • Do not transfer Mannitol Injection into polyvinylchloride (PVC) bags; a white flocculent precipitate may form from contact with PVC surfaces. • Administer Mannitol Injection using an administration set with a filter to ensure against infusion of mannitol crystals. Preparation 1. Visually inspect the container before preparation and again before administration. Do not administer unless solution is clear, the container undamaged, and the fliptop vial seal intact. 2. Crystals may form in Mannitol Injection, especially if the solution is exposed to low temperatures. If crystallization occurs, warm the vial in water at 80°C and periodically shake vigorously to dissolve the crystals. Mannitol Injection may be autoclaved at 121°C for 20 minutes at 15 psi. Cool to body temperature or less before administering. Re-inspect Mannitol Injection for crystals prior to administration. Discard the solution if all the crystals cannot be dissolved. 3. Remove cover from fliptop vial and cleanse stopper with antiseptic before use. 4. Additives may be incompatible. Consult with pharmacist, if available. 5. For single use only; discard unused portion. 2.2 Recommended Dosage Prior to administration of Mannitol Injection, evaluate renal, cardiac, and pulmonary status of the patient and correct fluid and electrolyte imbalances. The total dosage, concentration, and rate of administration depend on the age, weight, and condition of the patient being treated, including fluid requirement, electrolyte balance, serum osmolality, urinary output, and concomitant therapy. The following outline of administration and dosage is only a general guide to therapy. Reduction of Intracranial Pressure and Treatment of Cerebral Edema Usually a maximum reduction in intracranial pressure can be achieved with a dose of 0.25 g/kg administered as an intravenous infusion over at least 30 minutes, which may be repeated every six to eight hours. During and following infusion of Mannitol Injection, monitor fluid and electrolytes, serum osmolarity, and renal, cardiac, and pulmonary function. Discontinue Mannitol Injection if renal, cardiac, or pulmonary status worsens or CNS toxicity develops [see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.5) ] . Reduction of Intraocular Pressure The recommended dosage is 1.5 to 2 g/kg as a single dose administered as an intravenous infusion over at least 30 minutes. When used preoperatively, administer Mannitol Injection 60 to 90 minutes before surgery to achieve maximal reduction of intraocular pressure before operation.