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Accolate (zafirkulast)

Brand Name Drug: Accolate (other brand names Accoleit, and Vanticon)
Active Ingredient Drug: zafirkulast
Company Name: AstraZeneca International

Accolate is a nonsteroidal tablet for the prevention and continuous treatment of asthma in adults and children 5 years of age and older, available only by prescription. Accolate is not for use in the reversal of acute asthma attacks.

Accolate bottle Much like a rocket has two stages, to reach its destination, Accolate® (zafirkulast) has twice-daily dosing, providing 24-hour leukotriene receptor antagonist (LTRA) coverage to help prevent asthma breakthrough. Leukotrienes are natural substances in everyone’s body, but in people with asthma, these substances can cause many of the symptoms of asthma.

With its twice-daily dosing, Accolate has been proven to significantly reduce both daytime symptoms and nighttime awakenings due to asthma*.

And, in large-scale clinical trials of nearly 1400 adolescent and adult patients, Accolate significantly reduced rescue-inhaler use (B2-agonist, puffs/day)*. Frequent rescue-inhaler use is an indicator of asthma breakthrough.

Finally, Accolate has been shown to improve airway function, as demonstrated by improvements in traditional measures such as FEV1 and PEFR (peak expiratory flow rate).

*Adolescent and adult patients with mild-to-moderate asthma previously using PRN B2-agonist alone.

Accolate is generally well tolerated. Common side effects for Accolate included headache (12.9%), infection (3.5%),** and nausea (3.1%) in adults and headache (4.5%) and abdominal pain (2.8%) in children. These were not significantly different from placebo.

**In clinical trials, an increased proportion of patients taking Accolate over the age of 55 years reported infections as compared to placebo-treated patients. Infections were generally mild to moderate and predominantly of the respiratory tract.

Accolate_(zafirkulast)

How Accolate Works

Accolate is a tablet you take daily in the morning and evening to help control asthma symptoms.

Accolate works by directly blocking production of substances (leukotrienes) that can cause asthma symptoms.

Leukotrienes are natural substances in everyone’s body, but in people with asthma, these substances can cause many of the symptoms of asthma.

In people with asthma, leukotrienes cause the muscles in the airways to tighten and mucus to be produced. This mucus can block the smaller airways, which can result in coughing, wheezing, and breathing problems.

Even if symptoms are not present, you should keep taking Accolate so it can continue to block the leukotrienes and help keep your asthma under control.

How it helps provide control

When taken on a regular basis, Accolate can help control asthma symptoms. This can mean fewer symptoms during the day, and fewer nighttime awakenings.

Although improvement will vary between people, you’ll find that you may be able to breathe easier! And remember: even if you are not having asthma symptoms, continue to take Accolate as your doctor or health care provider directs. Take Accolate 1 hour before meals or 2 hours after meals.

You are probably using your rescue inhaler for what is called an acute or sudden asthma attack or to relieve symptoms. When you take Accolate on a regular basis, you might not have to use your rescue inhaler as often because you may be having fewer asthma symptoms. However, Accolate is not a substitute for your rescue inhaler, and you may still need it, so always keep it nearby.

Accolate is generally well tolerated. Common side effects for Accolate included headache (12.9%), infection (3.5%), and nausea (3.1%) in adults and headache (4.5%) and abdominal pain (2.8%) in children. These were not significantly different from placebo.

Dosing Accolate

Recommended Dosing for Adults and Pediatric Patients (5 through 11 years of age)
Age Recommend Dose Frequency
Adults and Children 12 years of age and older 20 mg tablet Twice daily
Pediatric Patients 5 through 11 years of age 10 mg tablet Twice daily

Accolate is a nonsteroidal tablet for the prevention and continuous treatment of asthma in adults and children 5 years of age and older.***

*** The effectiveness of Accolate in pediatric patients 5 to 11 years of age is based on the extrapolation of demonstrated efficacy in adults.

Accolate is not for the reversal of acute asthma attacks.

Accolate should be taken twice a day, 1 hour before or 2 hours following meals, even during symptom-free periods.

Patients should not decrease the dose, or stop taking any of their asthma medications unless instructed by a physician.

Accolate should be used during pregnancy only if clearly needed. Accolate should not be administered to mothers who are breast-feeding.

Patients on oral warfarin and Accolate should have their prothrombin times monitored and warfarin dose adjusted accordingly.

Your doctor will need to know if you are taking Theophylline. In rare cases, an increase in theophylline blood levels can occur in patients taking Accolate.

Side effect profile

It’s important to know that Accolate is not a steroid or a theophylline.

When Accolate was studied in clinical trials, it was found to be generally well tolerated. Common side effects for Accolate included headache (12.9%), infection (3.5%), and nausea (3.1%) in adults and headache (4.5%) and abdominal pain (2.8%) in children.

A rare side effect of Accolate is an increase in liver enzymes, which is measured by a blood test. If you develop right-side abdominal pain, nausea, tiredness, itching, yellow coloring of the skin, flu-like symptoms or loss of appetite, contact your physician immediately.

Is Accolate right for you?

Not every medication is right for every individual.

For example:

  • Women who are nursing should not take Accolate
  • Patients taking blood thinner medication, such as warfarin, should have their blood clotting times closely monitored and the medication adjusted accordingly if they are taking Accolate
  • Women who are pregnant should talk to their doctor or health care provider before taking Accolate

If your doctor or health care provider prescribes Accolate alone or with other asthma medications, be sure to take each medication exactly as prescribed. And remember to always talk with your doctor or health care provider before changing your current asthma treatments or if your medical condition worsens.

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