What is a Generic Drug?
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.
Pheburane (Sodium Phenylbutyrate)
Prescription Required
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Product Details
Description
Pheburane (sodium phenylbutyrate) is a prescription medication used with diet to manage adult and pediatric patients with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).
Pheburane is available in oral pellets containing 84 grams of sodium phenylbutyrate per bottle.
Fact Table
Formula
C10H11NaO2
License
EMA
Bioavailability
~100% (oral)
Legal status
Prescription only
Chemical Name
Sodium 4-phenylbutanoate
Elimination half-life
0.8 to 1 hour
Dosage (Strength)
483 mg/g oral granules
Pregnancy
Consult a doctor
Brands
Pheburane, Buphenyl
Protein binding
80% to 100%
PubChem CID
23663863
MedlinePlus
a694020
ChEBI
CHEBI:75043
ATC code
A16AX03
DrugBank
DB00360
KEGG
D01235
Routes of administration
Oral
Directions
Pheburane should be used as prescribed. The doctor will determine an appropriate dosage based on weight and any existing liver issues. The dose should be measured with the calibrated spoon provided with the prescription.
Store Pheburane between 20°C and 25°C (68°F and 77°F) and away from children’s reach.
You may refer to the medication leaflet that comes with the Pheburane prescription for further instructions for use.
Speak with your doctor or pharmacist about any questions or concerns you have.
Ingredients
The active ingredient in Pheburane is sodium phenylbutyrate.
Inactive ingredients include ethylcellulose, hypromellose, polyethylene glycol 1500, povidone K25, and sugar spheres.
Contraindications
There are no contraindications per the most recent Prescribing Information.
Cautions
- Before you begin treatment with Pheburane, tell your doctor about:
- All the prescription and over-the-counter medications you take
- Your allergies
- Your current health problems and past medical history
- Your pregnancy or breastfeeding status
- Pheburane contains the following warnings and precautions:
- Neurotoxicity with increased exposure to phenylacetate, which is the major metabolite of Pheburane
- Low potassium levels in the blood
- Edema (swelling)
- Pheburane should be avoided by patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.
Side Effects
Menstrual problems, decreased appetite, body odor, and bad taste or taste changes are common Pheburane side effects; however, other side effects may also occur.
Immediately notify your doctor if you have side effects that bother you or persist.
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Reference
Pheburane. Princeton, NJ: Medunik USA, Inc.; 2023.
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 : 14618
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