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sodium benzoate/sodium phenylacetate (Rx)Brand and Other Names:Ammonul

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

sodium benzoate/sodium phenylacetate

injectable solution

  • 10% / 10%
more...

Urea Cycle Enzyme Deficiency

Indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle

Loading dose (>20 kg): 5.5 g-5.5 g/m² IV infusion over 90-120 minutes 

Maintenance: 5.5 g-5.5 g/m² IV infusion over 24 hours

Encephalopathy (Orphan)

Treatment of grade III & IV hepatic encephalopathy

Orphan indication sponsor

  • Ucyclyd Pharma, Inc; 7720 N. Dobson Rd; Scottsdale, AZ 85256

Monitor

Serum ammonia, neurological tests, clinical response, electrolytes

Dosage Forms & Strengths

sodium benzoate/sodium phenylacetate

injectable solution

  • 10% / 10%
more...

Urea Cycle Enzyme Deficiency

Indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle

Loading dose (<20 kg): 250 mg-250 mg/kg (2.5 mL/kg) IV infusion over 90-120 minutes

Maintenance: 250 mg-250 mg/kg (2.5 mL/kg) IV infusion over 24 hr 

Monitor

Serum ammonia, neurological tests, clinical response, electrolytes

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Interactions

Interaction Checker

sodium benzoate/sodium phenylacetate and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Vomiting (12%)

            1-10%

            Acidosis (3%)

            Agitation (3%)

            Anemia (4%)

            Brain edema (5%)

            Coma (3%)

            Convulsions (6%)

            Diarrhea (3%)

            DIC (3%)

            Hyperammonemia (5%)

            Hyperglycemia (7%)

            Hypocalcemia (3%)

            Hypotension (4%)

            Inj-site reaction (3%)

            Mental impairment (6%)

            Nausea (3%)

            Pyrexia (5%)

            Respiratory distress (3%)

            Skin disorder (6%)

            UTI (3%)

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Discontinue oral antihyperammonemic drugs prior to administration

            Caution in hepatic/renal impairment, heart failure, sodium retention associated with edema

            Avoid repeat loading doses

            Nausea/vomiting may occur

            Contains 30.5 mg/mL of sodium in undiluted product

            Phenylacetate has been associated with neurotoxicity risk

            Administration through peripheral line may cause burns

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Not known whether distributed in breast milk, use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Each component of the product provide an alternative pathway for removal of ammonia through the formation of their metabolites

            Pharmacokinetics

            Metabolism: Liver, kidney

            Excretion: Urine

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            Administration

            IV Preparation

            Dilute with D10W

            IV Administration

            Administer through central line

            Discontinue analogous oral drugs prior to administration

            Load infusion over 90-120 min; maint over 24 hr

            Extravasation Mgmt

            If extravasation suspected, discontinue infusion & resume at different site, if necessary

            Standard tx include aspiration of drug from catheter, limb elevation, intermittent cold packs

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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