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.
Accolate (Zafirlukast)
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Product Details
Description
Accolate (Zafirlukast) is a medication used to help treat and control the symptoms of asthma in people aged 5 years and older. Zafirlukast is part of a class of drugs called leukotriene receptor antagonists (LTRAs), which work by blocking the action of leukotrienes, substances in the body that cause inflammation in the airways. This medication is taken orally in tablet form and is not recommended for relieving asthma attacks that have already started.
Fact Table
Formula
C31H33N3O6S
License
US DailyMed
Bioavailability
Unknown
Legal status
Rx-only
Chemical Name
Zafirlukast
Elimination half-life
10 hours
Dosage (Strength)
10mg, 20mg
Pregnancy
FDA Pregnancy Category B - No proven risk in humans
Brands
Accolate
Protein binding
99%
PubChem CID
5717
MedlinePlus
a697007
ChEBI
10100
ATC code
R03DC01
DrugBank
DB00549
KEGG
D00411
Routes of administration
Oral
Directions
The standard dosage of Accolate medication is 20 mg twice daily in adults and children 12 years and older. In children aged 5 to 11, the usual dosage is 10 mg twice daily. It is recommended to take Accolate at least 1 hour before or 2 hours after meals. The dosage may need to be reduced in older adults over 65 to reduce the risk of side effects. This medication is not intended for relief during an ongoing asthma attack; instead, you should use a rescue inhaler in such situations. Follow the recommended dosage and timing instructions indicated by your healthcare provider.
Ingredients
The main active ingredient in Accolate is Zafirlukast, which is a selective and competitive receptor antagonist of leukotriene D4 and E4 (LTD4 and LTE4). Apart from Zafirlukast, Accolate tablets may also contain various inactive ingredients to support its delivery and effectiveness.
These inactive ingredients may include croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone, hypromellose, and titanium dioxide. Each of these may support the medication's stability, appearance, and ease of administration.
Contraindications
Avoid taking or using Accolate if any of the following apply:
- You have experienced allergic reactions to Zafirlukast or any of the medication’s ingredients in the past.
- You have liver problems, including cirrhosis, as Zafirlukast may worsen your condition or lead to further complications.
Cautions
- Before taking Zafirlukast, inform your healthcare provider of the following:
- Any existing medical conditions, especially liver disease. Zafirlukast should not be used in people with liver disease, including cirrhosis.
- Any medications you take
- If you are pregnant or breastfeeding
- A rare side effect of Accolate may include liver problems. Contact your doctor if you notice symptoms like upper right abdominal pain, fatigue, or jaundice (yellowing of the skin or eyes).
- Accolate is for long-term treatment; do not use it for sudden episodes. Continue other medications unless directed otherwise.
- Breastfeeding women are advised against taking Accolate. Discuss alternative treatments with your healthcare provider.
- Take Accolate 1 hour before or 2 hours after meals to optimize absorption.
- Patients on medications like Accolate might cause symptoms resembling Churg-Strauss syndrome. Watch for signs like rashes, deteriorating lung symptoms, or heart complications.
- Neuropsychiatric events, like insomnia and depression, have been linked to similar medications. Notify your healthcare provider if these symptoms develop.
Side Effects
Accolate may cause various side effects. The most common Accolate side effects may include headache, nausea, diarrhea, and stomach pain. Additionally, some people may experience dizziness, muscle pain, back pain, indigestion, and cold symptoms, such as stuffy nose, sneezing, and sore throat. These common side effects may not pose a significant health risk; however, it is vital to monitor any changes in severity or frequency.
In some cases, Accolate may lead to more serious side effects that require immediate medical attention. These may include liver problems, such as nausea, loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, and jaundice. If you experience any of these severe side effects, seek prompt medical advice.
References:
- Accolate (Zafirlukast) Product Monograph. Wilmington, DE: AstraZeneca Pharmaceuticals; 2013.
- Accolate (Zafirlukast) Drug Label Information. Chestnut Ridge, NY: Par Pharmaceutical, Inc.; 2015.
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 : 1307
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