Osmitrol 10% in Water (mannitol): FDA label

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Indications

OSMITROL is indicated for:

The reduction of intracranial pressure and treatment of cerebral edema;
The reduction of elevated intraocular pressure. OSMITROL is an osmotic diuretic, indicated for the reduction of:
intracranial pressure and treatment of cerebral edema. ( 1 )
elevated intraocular pressure. ( 1 )

Contraindications

OSMITROL is contraindicated in patients with:

Known hypersensitivity to mannitol [see Warnings and Precautions (5.1) ]
Anuria [see Warnings and Precautions (5.2) ]
Severe hypovolemia [see Warnings and Precautions (5.4) ]
Pre-existing severe pulmonary vascular congestion or pulmonary edema [see Warnings and Precautions (5.5) ]
Active intracranial bleeding except during craniotomy
Known hypersensitivity to mannitol. ( 4 , 5.1 )
Anuria. ( 4 , 5.2 )
Severe hypovolemia. ( 4 , 5.4 )
Pre-existing severe pulmonary vascular congestion or pulmonary edema. ( 4 , 5.5 )
Active intracranial bleeding except during craniotomy. ( 4 )

Warnings and precautions

Hypersensitivity Reactions, including anaphylaxis : Stop infusion immediately if hypersensitivity reactions develop. ( 5.1 )
Renal Complications Including Renal Failure : Risk factors include pre-existing renal failure, concomitant use of nephrotoxic drugs or other diuretics. Avoid use of nephrotoxic drugs. Discontinue OSMITROL if renal function worsens. ( 5.2 , 8.6 )
Central Nervous System (CNS) Toxicity : Confusion, lethargy and coma may occur during or after infusion. Concomitant neurotoxic drugs may potentiate toxicity. Avoid use of neurotoxic drugs. Discontinue OSMITROL if CNS toxicity develops. ( 5.3 )
Fluid and Electrolyte Imbalances, Hyperosmolarity : Hypervolemia may exacerbate congestive heart failure, hyponatremia can lead to encephalopathy; hypo/hyperkalemia can result in cardiac adverse reactions in sensitive patients. Discontinue OSMITROL if fluid and/or electrolyte imbalances occur. ( 5.4 )

Interactions

Nephrotoxic Drugs and Diuretics : May increase the risk of renal failure; avoid concomitant use. ( 7.1 , 7.2 )
Neurotoxic Drugs : May potentiate CNS toxicity of mannitol; avoid concomitant use. ( 7.3 )
Drugs Affected by Electrolyte Imbalances : May result in cardiac adverse reactions; monitor serum electrolytes and discontinue OSMITROL if cardiac status worsens. ( 7.4 )
Renally Eliminated Agents : Concomitant use may decrease the effectiveness of agents that undergo significant renal elimination. However, concomitant use of mannitol and lithium may increase risk of lithium toxicity. If concomitant use is necessary, frequently monitor lithium concentrations and for signs of toxicity. ( 7.5 )

7.1Nephrotoxic Drugs

Concomitant administration of nephrotoxic drugs (e.g., cyclosporine, aminoglycosides) increases the risk of renal failure following administration of mannitol. Avoid use of nephrotoxic drugs with OSMITROL, if possible [see Warnings and Precautions (5.2) ].

7.2Diuretics

Concomitant administration of other diuretics may potentiate the renal toxicity of mannitol. Avoid use of other diuretics with OSMITROL, if possible [see Warnings and Precautions (5.2) ].

7.3Neurotoxic Drugs

Concomitant administration of systemic neurotoxic drugs (e.g., aminoglycosides) with OSMITROL may potentiate the CNS toxicity of mannitol. Avoid use of systemic neurotoxic drugs with OSMITROL, if possible [see Warnings and Precautions (5.3) ].

7.4Drugs Affected by Electrolyte Imbalances

The development of electrolyte imbalances (e.g., hyperkalemia, hypokalemia) associated with mannitol administration may result in cardiac adverse reactions in patients receiving drugs that are sensitive to such imbalances (e.g., digoxin, drugs that prolong the QT interval, neuromuscular blocking agents) [see Warnings and Precautions (5.4) ]. During and following OSMITROL infusion, monitor serum electrolytes and discontinue OSMITROL if cardiac status worsens [see Warnings and Precautions (5.5) ].

7.5Renally Eliminated Drugs

Mannitol therapy may increase the elimination, and decrease the effectiveness of treatment with, drugs that undergo significant renal elimination. Concomitant administration of mannitol with lithium may initially increase the elimination of lithium but may also increase the risk of lithium toxicity if patients develop hypovolemia or renal impairment. In patients receiving lithium, consider holding lithium doses during treatment with OSMITROL.

In patients requiring concomitant administration of lithium and OSMITROL, frequently monitor serum lithium concentrations and for signs of lithium toxicity.

7.6Interference with Laboratory Tests

High concentrations of mannitol can cause false low results for inorganic phosphorus blood concentrations when an assay based on the conversion of phosphate (orthophosphate) to the phosphomolybdate complex is used. Mannitol may produce false positive results in tests for blood ethylene glycol concentrations in which mannitol is initially oxidized to an aldehyde.

Osmitrol 10% in Water

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Hypersensitivity Reactions

5.2Renal Complications Including Renal Failure

5.3Central Nervous System (CNS) Toxicity

5.4Fluid and Electrolyte Imbalances, Hyperosmolarity Depending

5.6Infusion Site Reactions

Interactions

7.1Nephrotoxic Drugs

7.2Diuretics

7.3Neurotoxic Drugs

7.4Drugs Affected by Electrolyte Imbalances

7.5Renally Eliminated Drugs

7.6Interference with Laboratory Tests

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Official product information

At a glance

Guidelines