Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS No zinc-related adverse reactions have been reported in clinical studies or post-marketing reports in patients receiving intravenously administered parenteral nutrition solutions containing zinc sulfate within the recommended dosage range.
The following were identified in clinical studies or post-marketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Adverse reactions with other components of parenteral nutrition solutions: Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )] Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )] Aluminum toxicity [see Warnings and Precautions ( 5.3 )] Adverse reactions with the use of zinc-containing products administered by other routes of administration: Copper deficiency [see Warnings and Precautions ( 5.5 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.6 )] No zinc-related adverse reactions in patients receiving intravenously administered parenteral nutrition solutions containing zinc within the recommended dosage range.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc.
at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
5 WARNINGS AND PRECAUTIONS Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
( 5.1 ) Vein Damage and Thrombosis: Solutions with osmolarity of 900 mOsmol/L or more must be infused through a central catheter.
( 2.1 , 5.2 ) Aluminum Toxicity: Increase risk in patients with renal impairment, including preterm infants ( 5.3 , 8.4 ) Monitoring and Laboratory Tests: Monitor fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters throughout treatment.
( 5.4 , 2.4 ) Copper Deficiency: If signs and symptoms develop, interrupt treatment with Zinc Sulfate Injection and check zinc, copper, and ceruloplasmin levels.
( 5.5 ) Hypersensitivity Reactions: If reactions occur, discontinue Zinc Sulfate Injection and initiate appropriate medical treatment.
Like all medications, Zinc Sulfate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: