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Prosol

  • Generic Name: amino acids injection, for intravenous use
  • Brand Name: Prosol

Prosol (Amino Acids Injection, for Intravenous Use) side effects drug center

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  • Prosol Side Effects Center

    What Is Prosol?

    Prosol (amino acids) is indicated as a source of amino acids for patients requiring parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. Prosol may be used to treat negative nitrogen balance in patents.

    What Are Side Effects of Prosol?

    Side effects of Prosol include:

    Dosage for Prosol

    The dosage of Prosol is individualized based on the patient's clinical condition (ability to adequately metabolize amino acids), body weight and nutritional/fluid requirements, as well as additional energy given orally/enterally to the patient.

    Prosol In Children

    Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.

    Plasma electrolyte concentrations should be closely monitored in the pediatric patients who may have impaired ability to regulate fluids and electrolytes.

    Hyperammonemia is of special significance in infants (birth to two years). This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants.

    Because of immature renal function, preterm infants receiving prolonged PN treatment with Prosol may be at risk of aluminum toxicity.

    Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD).

    What Drugs, Substances, or Supplements Interact with Prosol?

    Prosol may interact with other medicines.

    Tell your doctor all medications and supplements you use.

    Prosol During Pregnancy and Breastfeeding

    Tell your doctor if you are pregnant or plan to become pregnant before using Prosol; it is unknown how it could affect a fetus. However, malnutrition in pregnant women is associated with adverse maternal and fetal outcomes. It is unknown if injectable amino acids, including Prosol, pass into breast milk. Consult your doctor before breastfeeding.

    Additional Information

    Our Prosol (amino acids) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Prosol Professional Information

    SIDE EFFECTS

    The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information.

    • Pulmonary embolism due to pulmonary vascular precipitates [see WARNINGS AND PRECAUTIONS]
    • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
    • Risk of infections [see WARNINGS AND PRECAUTIONS]
    • Refeeding syndrome [see WARNINGS AND PRECAUTIONS]
    • Hyperglycemia or hyperosmolar hyperglycemic state [see WARNINGS AND PRECAUTIONS]
    • Vein damage and thrombosis [see WARNINGS AND PRECAUTIONS]
    • Hepatobiliary disorders [see WARNINGS AND PRECAUTIONS]
    • Aluminum toxicity [see WARNINGS AND PRECAUTIONS]
    • Parenteral Nutrition Associated Liver Disease [see WARNINGS AND PRECAUTIONS]
    • Electrolyte imbalance and fluid overload [see WARNINGS AND PRECAUTIONS]

    The following adverse reactions from voluntary reports or clinical studies have been reported with parenteral amino acid products. Because many 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.

    • Metabolic acidosis
    • Alkalosis
    • Osmotic diuresis and dehydration
    • Rebound hypoglycemia
    • Hypo and hypervitaminosis

    Read the entire FDA prescribing information for Prosol (Amino Acids Injection, for Intravenous Use)

    © Prosol Patient Information is supplied by Cerner Multum, Inc. and Prosol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.