Accolate

DRUG DESCRIPTION

Zafirlukast is a synthetic, selective peptide leukotriene receptor antagonist (LTRA), with the chemical name 4(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide. The molecular weight of zafirlukast is 575.7 and the structural formula is:

ACCOLATE® (zafirlukast) Structural Formula Illustration

The empirical formula is: C31H33N3O6S

Zafirlukast, a fine white to pale yellow amorphous powder, is practically insoluble in water. It is slightly soluble in methanol and freely soluble in tetrahydrofuran, dimethylsulfoxide, and acetone.

ACCOLATE is supplied as 10 and 20 mg tablets for oral administration.

Inactive Ingredients: Film-coated tablets containing croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone, hypromellose, and titanium dioxide.

What are the possible side effects of zafirlukast (Accolate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • worsening asthma symptoms;
  • mood or behavior changes, anxiety, depression, or thoughts about suicide or hurting yourself;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or
  • nausea, stomach pain, loss of appetite, itching, dark urine,...

Read All Potential Side Effects and See Pictures of Accolate »

What are the precautions when taking zafirlukast (Accolate)?

Before taking zafirlukast, tell your doctor or pharmacist if you are allergic to it; or to other leukotriene blockers (e.g., montelukast); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially headache, diarrhea and nausea.

This medication should be used during pregnancy only if clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk....

Read All Potential Precautions of Accolate »


Accolate Consumer (continued)

SIDE EFFECTS: Headache, sore throat, trouble sleeping, malaise, and nausea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This drug may rarely cause serious (possibly fatal) liver disease. Seek immediate medical attention if you notice any of the following unlikely but very serious side effects: severe stomach/abdominal pain, persistent nausea/vomiting, unusual tiredness, yellowing of the eyes/skin, dark urine.

If your doctor determines that you have experienced liver problems from this medication, do not take it again.

Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes (e.g., agitation, aggression, hallucinations, abnormal dreams, depression, suicidal thoughts/suicide), worsening shortness of breath, tingling of the hands/feet, muscle/joint aches, coughing up blood, swelling of the hands/feet, chest pain, easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking zafirlukast, tell your doctor or pharmacist if you are allergic to it; or to other leukotriene blockers (e.g., montelukast); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially headache, diarrhea and nausea.

This medication should be used during pregnancy only if clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.


Accolate Patient Information Including Side Effects

Brand Names: Accolate

Generic Name: zafirlukast (Pronunciation: za FIR loo cast)

  • What is zafirlukast (Accolate)?
  • What are the possible side effects of zafirlukast (Accolate)?
  • What is the most important information I should know about zafirlukast (Accolate)?
  • What should I discuss with my healthcare provider before taking zafirlukast (Accolate)?
  • How should I take zafirlukast (Accolate)?
  • What happens if I miss a dose (Accolate)?
  • What happens if I overdose (Accolate)?
  • What should I avoid while taking zafirlukast (Accolate)?
  • What other drugs will affect zafirlukast (Accolate)?
  • Where can I get more information?

What is zafirlukast (Accolate)?

Zafirlukast is a leukotriene (loo-koe-TRY-een) inhibitor. Leukotrienes are chemicals your body releases when you breathe in an allergen (such as pollen). These chemicals cause swelling in your lungs and tightening of the muscles around your airways, which can result in asthma symptoms.

Zafirlukast is used to treat and prevent asthma attacks in adults and children as young as 5 years old.

Do not give this medication to a child without a doctor's advice.

Zafirlukast may also be used for other purposes not listed in this medication guide.

What are the possible side effects of zafirlukast (Accolate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • worsening asthma symptoms;
  • mood or behavior changes, anxiety, depression, or thoughts about suicide or hurting yourself;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache;
  • nausea, vomiting, diarrhea, stomach pain;
  • weakness;
  • dizziness;
  • muscle pain; or
  • fever, sore throat, cold symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about zafirlukast (Accolate)?

Do not use zafirlukast to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medication to treat an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

It may take up to several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after several weeks of treatment.

Call your doctor right away if you feel that this medicine is not working as well as usual, or if it makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

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