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Ravicti

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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

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  • Product Details

    Description

    Ravicti (glycerol phenylbutyrate) is an oral nitrogen-binding agent indicated for the chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. UCDs are rare genetic conditions that result in an accumulation of ammonia in the blood due to the body's inability to eliminate nitrogen waste. Ravicti helps reduce systemic ammonia levels by facilitating the excretion of nitrogen through an alternative pathway, thereby preventing hyperammonemia. It is approved for use in patients aged two months and older, excluding those with acute hyperammonemia.

    Fact Table

    Formula

    C27H45NO6

    License

    US FDA (2013), EMA

    Bioavailability

    High (prodrug of phenylbutyrate)

    Legal status

    Rx-only

    Chemical Name

    Glycerol phenylbutyrate

    Elimination half-life

    ~1.2 hours (phenylbutyrate); ~0.8 hours (metabolite)

    Dosage (Strength)

    1.1 g/mL oral liquid; dosing individualized by BSA

    Pregnancy

    Use only if clearly needed; no adequate data

    Brands

    Ravicti

    Protein binding

    Phenylbutyrate: ~82%

    PubChem CID

    16041314

    MedlinePlus

    a613023

    ChEBI

    142201

    ATC code

    A16AX09

    DrugBank

    DB08909

    KEGG

    D09973

    Routes of administration

    Oral (liquid)

    Directions

    Ravicti is administered orally and dosed based on body surface area (BSA), dietary protein intake, and plasma ammonia levels. It should be taken with food and may be mixed with certain soft foods or liquids for pediatric use. Doses are typically divided into three to six doses per day, and precise administration requires a calibrated oral syringe. Treatment should be supervised by a clinician experienced in managing metabolic disorders. Regular monitoring of plasma ammonia and amino acid levels is necessary to adjust dosing.

    Ingredients

    Active Ingredient: Glycerol phenylbutyrate

    Inactive Ingredients: None (Ravicti is a pure active compound in liquid form without added excipients)

    Contraindications

    Ravicti is contraindicated in:

    Patients with known hypersensitivity to glycerol phenylbutyrate or any of its metabolites

    Neonates and infants less than two months of age due to immature pancreatic function and limited capacity to hydrolyze glycerol phenylbutyrate

    Cautions

    Use with caution in patients with hepatic impairment or gastrointestinal conditions that may impair absorption or metabolism. Ravicti is not effective for the acute treatment of hyperammonemia and should not replace emergency care. Monitoring is essential to avoid under- or overdosing, especially in growing children. Careful dietary management must accompany pharmacologic therapy. Concomitant use of probenecid or valproate may increase the risk of hyperammonemia.

    Side Effects

    Common side effects may include:

    Diarrhea

    Abdominal pain

    Decreased appetite

    Vomiting

    Nausea

    Headache

    Fatigue

    Serious adverse effects may include:

    Neurotoxicity (associated with phenylacetate accumulation)

    Hyperammonemia due to underdosing or poor compliance

    Pancreatic insufficiency in young children

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 14195

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