AMMONUL Solution for injection (2019)
Βιβλιογραφική αναφορά
Συγγραφείς
Bausch Health US LLC
Λέξεις κλειδιά
0187-0010
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1. Indications and Usage
AMMONUL is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. ...
2. Dosage and Administration
2.1 Recommended Dose AMMONUL must be diluted with sterile 10% Dextrose Injection (D10W) before administration. The dilution and dosage of AMMONUL are determined by weight for neonates, infants and young ...
3. Dosage Forms and Strengths
AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10% per 10% is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate.
4. Contraindications
None.
5. Warnings and Precautions
5.1 Management of Acute Hyperammonemia Any episode of acute symptomatic hyperammonemia should be treated as a life-threatening emergency. Uncontrolled hyperammonemia can rapidly result in brain damage ...
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 ...
7. Drug Interactions
Formal drug interaction studies have not been performed with AMMONUL. Some antibiotics such as penicillin may compete with phenylacetylglutamine and hippurate for active secretion by renal tubules, which ...
8. Use in Specific Populations
8.6 Gender Pharmacokinetic parameters of AMMONUL were compared in healthy males and females. Bioavailability of both benzoate and phenylacetate was slightly higher in females than in males. However, conclusions ...
8.1. Pregnancy
Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with AMMONUL. It is not known whether AMMONUL can cause fetal harm when administered to a pregnant woman or ...
8.3. Nursing Mothers
It is not known whether sodium phenylacetate, sodium benzoate, or their conjugation products are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ...
8.4. Pediatric Use
AMMONUL has been used as a treatment for acute hyperammonemia in pediatric patients including patients in the early neonatal period <em>[see Dosage and Administration (2)]</em>.
8.5. Geriatric Use
Clinical studies of AMMONUL did not include any patients aged 65 and over to determine whether they respond differently from younger patients. Urea cycle disorders are presently diseases of the pediatric ...
8.7. Hepatic Impairment
Hepatic Insufficiency Limited information is available on the metabolism and excretion of sodium phenylacetate and sodium benzoate in patients with impaired hepatic function. However, metabolic conjugation ...
8.8. Renal Impairment
The drug metabolites of AMMONUL (phenylacetylglutamine and hippurate) and subsequently ammonia are primarily excreted by the kidney. Therefore, use caution and closely monitor patients with impaired renal ...
10. Overdosage
Overdosage has been reported during AMMONUL treatment in urea cycle-deficient patients. All patients in the uncontrolled open-label study were to be treated with the same dose of AMMONUL. However, some ...
11. Description
AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10% per 10% (a nitrogen binding agent) is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the ...
12.1. Mechanism of Action
Urea cycle disorders can result from decreased activity of any of the following enzymes: <em>N</em>-acetylglutamate synthetase (NAGS), carbamyl phosphate synthetase (CPS), argininosuccinate synthetase ...
12.2. Pharmacodynamics
In patients with hyperammonemia due to deficiencies in enzymes of the urea cycle, AMMONUL has been shown to decrease elevated plasma ammonia levels. These effects are considered to be the result of reduction ...
12.3. Pharmacokinetics
The pharmacokinetics of intravenously administered AMMONUL was characterized in healthy adult volunteers. Both benzoate and phenylacetate exhibited nonlinear kinetics. Following 90 minute intravenous infusion ...
13.1. Carcinogensis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of AMMONUL. Studies to evaluate the possible impairment of fertility or mutagenic potential of AMMONUL have not ...
13.2. Animal Toxicology and/or Pharmacology
In animal studies, subcutaneous administration to rat pups of 190–474 mg/kg of phenylacetate caused decreased proliferation and increased loss of neurons, and reduced central nervous system (CNS) myelin. ...
14. Clinical Studies
The efficacy of AMMONUL in improving patient survival of acute hyperammonemic episodes was demonstrated in an analysis of 316 patients (1,045 episodes of hospitalization) treated between 1981 and 2003. ...
16.1. How Supplied
AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10% per 10% is supplied in a sterile, non-pyrogenic, single use glass vial. NDC 0187-0010-50 single use vial containing 50 mL of sodium phenylacetate ...
16.2. Storage and Handling
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
17. Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Physicians should advise patients and caregivers about the following for safe use of AMMONUL: When plasma ammonia levels have normalized, dietary protein intake can usually ...