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.

Zyflo CR (Ziluton)

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Brand

Zyflo CR (Ziluton)

Prescription Required

Strength
Qty
600mg

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  • Product Details

    Description

    Zyflo CR (zileuton) is a medication used to prevent and treat asthma in adults and children who are at least 12 years old.

    Zyflo CR should not be used to treat a sudden asthma attack.

    Zyflo CR belongs to a class of medications known as leukotriene synthesis inhibitors.


    Fact Table

    Formula

    C11H12N2O2S

    License

    US FDA, US DailyMed

    Bioavailability

    Not yet established

    Legal status

    Rx-Only

    Chemical Name

    Zileuton

    Elimination half-life

    2.5 hours

    Dosage (Strength)

    600mg

    Pregnancy

    Consult doctor

    Brands

    Zyflo

    Protein binding

    93%

    PubChem CID

    60490

    MedlinePlus

    a697013

    ChEBI

    10112

    ATC code

    none

    DrugBank

    DB00744

    KEGG

    D00414

    Routes of administration

    Oral

    Directions

    Follow the instructions that come with your Zyflo CR prescription. If you have any questions or concerns regarding your Zyflo CR prescription, talk to your doctor or pharmacist.

    Zyflo CR is available as an extended-release 600 mg tablet. 

    Patients are recommended to take two tablets by mouth twice daily. The tablets should be taken within one hour after breakfast and dinner. 

    Ingredients

    Each Zyflo CR tablet contains the active ingredient, zileuton. Inactive ingredients include crospovidone, ferric oxide, glyceryl behenate, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, and talc.

    Contraindications

    Patients who have liver disease or liver function enzymes that are consistently 3 times or more than the upper normal limit should not take Zyflo CR.

    Patients who are allergic to zileuton or any of the other ingredients should not take Zyflo CR.

    Cautions

    • Before starting Zyflo CR, patients should discuss their allergies and health problems with their doctor. Patients should also inform their doctor of all the medications they take, including prescription, over-the-counter, vitamins, and herbal supplements. In addition, patients should inform their doctor if they are pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed. 
    • Zyflo CR can cause elevations in liver function enzymes and bilirubin. Caution should be used in patients who drink alcohol and/or have or have had liver disease.
    • Zyflo CR can cause problems with sleep and changes in behavior. Patients should monitor for these effects.

    Side Effects

    The most common side effects of Zyflo CR include sinusitis, nausea, and pharyngolaryngeal pain. However, these are not all the side effects that can be caused by taking Zyflo CR. Patients should immediately inform their doctor of any bothersome or persistent side effects that may occur.

    Reference:

    Zyflo CR (zileuton) extended-release tablets. Cary, NC: Chiesi USA, Inc.; 2018.



    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 : 11393

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