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 The most frequently reported adverse reactions (incidence ≥ 6%) are vomiting, hyperglycemia, hypokalemia, convulsions, and mental impairment.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals USA Inc.
Pennington, NJ 08534 at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data were obtained from 316 patients who received Sodium Phenylacetate and Sodium Benzoate Injection as emergency (rescue) or prospective treatment for hyperammonemia as part of an uncontrolled, open-label study.
The study population included patients between the ages of 0 to 53 years with a mean (SD) of 6.2 (8.54) years;
51% were male and 49% were female who had the following diagnoses: OTC (46%), ASS (22%), CPS (12%), ASL (2%), ARG (<1%), THN (<1%), and other (18%).
Adverse reactions were reported with similar frequency in patients with OTC, ASS, CPS, and diagnoses categorized as "other." Nervous system disorders were more frequent in patients with OTC and CPS, compared with patients with ASS and patients with "other" diagnoses.
Convulsions and mental impairment were reported in patients with OTC and CPS.
These observations are consistent with literature reports that patients with enzyme deficiencies occurring earlier in the urea cycle (i.e., OTC and CPS) tend to be more severely affected.
5 WARNINGS AND PRECAUTIONS Decreased Potassium Levels: Plasma potassium levels should be carefully monitored and appropriate treatment given when necessary.
( 5.1 ) Conditions Associated with Fluid Overload: Sodium Phenylacetate and Sodium Benzoate Injection contains 30.5 mg of sodium per mL of undiluted product.
Caution should be used if Sodium Phenylacetate and Sodium Benzoate Injection is administered to patients with congestive heart failure, severe renal insufficiency, or with conditions in which there is sodium retention with edema.
( 5.2 ) Extravasation: Extravasation of Sodium Phenylacetate and Sodium Benzoate Injection into the perivenous tissues during high flow bolus infusion may lead to skin necrosis, especially in infants.
The infusion site must be monitored closely for possible tissue infiltration during drug administration.
Like all medications, Sodium Phenylacetate And Sodium Benzoate 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: