**Important Disclaimer:** This summary is for educational and informational purposes only and should not, under any circumstances, replace direct consultation with a qualified physician or pharmacist. Always refer to the product's internal leaflet or consult a healthcare professional before use.
**Drug Name:** Accolate Tablet
**Manufacturer:**
Accolate (zafirlukast) was originally developed by AstraZeneca. Generic versions of zafirlukast are now manufactured by various pharmaceutical companies, including Strides Pharma, Annora Pharma, Aurobindo Pharma, Dr. Reddy's Labs Ltd., Rising Pharms, and Camber Pharmaceuticals.
**Main Commentary Body:**
Accolate (zafirlukast) is a prescription medicine classified as a leukotriene receptor antagonist (LTRA). It is used for the prophylaxis and chronic treatment of asthma in adults and children aged 5 years and older. It works by reducing inflammation in the airways, making it easier to breathe. Accolate is not a fast-acting rescue medicine and should not be used to treat sudden asthma attacks.
* **Indications and Usage:**
Accolate is indicated for the chronic treatment and prophylaxis of asthma in adults and children 5 years of age and older. It helps to prevent asthma attacks and control symptoms such as tightness in the chest, wheezing, breathlessness, and coughing. It may also be effective in preventing exercise-induced asthma and relieving symptoms of allergic rhinitis.
* **Characteristics:**
Zafirlukast, the active ingredient in Accolate, is a selective and competitive receptor antagonist of leukotriene D4 and E4 (LTD4 and LTE4). Leukotrienes are natural substances in the lungs that contribute to the pathophysiology of asthma, including airway edema, smooth muscle constriction, and altered cellular activity associated with inflammation. By blocking the binding of these leukotrienes, zafirlukast helps to inhibit bronchoconstriction and reduce inflammation in the airways. Accolate is supplied as 10 mg and 20 mg film-coated tablets for oral administration.
* **Dosage and Administration:**
Accolate tablets are for oral administration and should be swallowed whole with water. It is crucial to take Accolate on an empty stomach, at least 1 hour before or 2 hours after meals, as food can reduce its bioavailability.
* **Adults and children 12 years and older:** The recommended dose is 20 mg twice daily.
* **Children 5 through 11 years of age:** The recommended dose is 10 mg twice daily.
* Accolate should be taken regularly as prescribed, even during symptom-free periods. It is not for acute asthma attacks.
* **Contraindications:**
Accolate is contraindicated in patients who are hypersensitive to zafirlukast or any of its inactive ingredients. It is also contraindicated in patients with hepatic impairment, including hepatic cirrhosis, and in patients where Accolate was discontinued due to hepatotoxicity with no other attributable cause. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine due to its lactose content.
* **Warnings and Precautions:**
* **Hepatotoxicity:** Cases of life-threatening hepatic failure, liver transplantation, and death have been reported. Patients should be advised to contact their physician immediately if they experience symptoms of liver dysfunction (e.g., right upper quadrant abdominal pain, nausea, fatigue, lethargy, pruritus, jaundice, flu-like symptoms, anorexia).
* **Neuropsychiatric Events:** New or worsening mental problems, including agitation, aggression, depression, suicidal thoughts or actions, hallucinations, and sleep disturbances, have been reported. Patients and their families should monitor for these changes and contact their physician immediately if they occur.
* **Not for Acute Attacks:** Accolate is not a bronchodilator and should not be used to treat acute episodes of asthma. Patients should always have a short-acting beta2-agonist (rescue inhaler) available for sudden asthma attacks.
* **Eosinophilic Conditions:** In rare cases, patients on Accolate therapy may present with systemic eosinophilia, eosinophilic pneumonia, or clinical features of vasculitis consistent with Churg-Strauss syndrome.
* **Warfarin Interaction:** Co-administration with warfarin can significantly increase prothrombin time (PT), increasing the risk of bleeding. Close monitoring of PT and anticoagulant dose adjustment are necessary.
* **Pregnancy and Breastfeeding:** Accolate should be used during pregnancy only if clearly needed and prescribed by a doctor. It passes into breast milk, and breastfeeding is not recommended while taking this medication.
* **Elderly Patients:** Clearance of zafirlukast is reduced in elderly patients (65 years and older), leading to higher plasma concentrations. While clinical trials did not show an increased incidence of adverse events, caution is advised.
* **Renal Impairment:** Experience is limited; use with caution.
* **Nutrient Absorption and Metabolism (Pharmacokinetics):**
Zafirlukast is rapidly absorbed following oral administration, with peak plasma concentrations generally achieved within 3 hours. Its absolute bioavailability is unknown, but it is reduced by approximately 40% when taken with food. Zafirlukast is extensively metabolized in the liver, primarily by the cytochrome P450 2C9 (CYP2C9) pathway, and to a lesser extent by CYP3A4. The metabolites are primarily excreted in the feces, with about 10% recovered in the urine. The mean terminal half-life of zafirlukast is approximately 8 to 16 hours.
* **Side Effects:**
Like all medicines, Accolate can cause side effects, although not everybody gets them.
* **Common (may affect more than 1 in 100 people):** Headache, sore throat, cold symptoms, nausea, stomach pain, diarrhea, weakness, dizziness, muscle pain, fatigue, malaise.
* **Less Common/Rare (may affect up to 1 in 100 people or less, some serious):**
* **Liver injury:** Right upper belly pain, loss of appetite, nausea, dark urine, yellowing skin or eyes (jaundice), unusual weakness or fatigue.
* **Neuropsychiatric changes:** Agitation, aggression, depression, suicidal thoughts/actions, hallucinations, sleep problems, vivid dreams, irritability, anxiety.
* Allergic reactions: Skin rash, itching, hives, swelling of the face, lips, tongue, or throat.
* Eosinophilic conditions (e.g., Churg-Strauss syndrome): Unusual weakness or fatigue, fever, headache, skin rash, muscle or joint pain, loss of appetite, pain, tingling, or numbness in the hands or feet.
* Bleeding problems (especially with warfarin): Unusual nosebleeds, bruising, blood in urine, coughing blood.
* Sinus pain or pressure.
* **Drug Interactions:**
* **Warfarin:** Co-administration significantly increases prothrombin time (PT) and bleeding risk. Close monitoring and dose adjustment of warfarin are required.
* **Aspirin:** May increase zafirlukast plasma levels.
* **Erythromycin:** Can decrease zafirlukast plasma levels.
* **Theophylline:** Zafirlukast can increase theophylline levels, potentially leading to toxicity.
* **Phenytoin, Carbamazepine, Tolbutamide:** Zafirlukast may increase the levels of these drugs by inhibiting CYP2C9 metabolism.
* **CYP3A4 Inhibitors/Substrates:** Zafirlukast inhibits CYP3A4 in vitro, so caution is advised when co-administering with drugs metabolized by this enzyme (e.g., some calcium-channel blockers, cyclosporine, cisapride, simvastatin, some antifungals like itraconazole).
* **Oral Contraceptives:** No significant effect on ethinyl estradiol plasma concentrations or contraceptive efficacy has been observed.
* **Patient Counseling:**
* Take Accolate exactly as prescribed by your doctor, even during symptom-free periods.
* Do not use Accolate for sudden asthma attacks; always have your rescue inhaler available.
* Take Accolate on an empty stomach, at least 1 hour before or 2 hours after meals.
* Do not decrease the dose or stop taking any other asthma medications unless instructed by your physician.
* Report any signs of liver problems (e.g., right upper abdominal pain, nausea, yellowing skin/eyes, dark urine) to your doctor immediately.
* Report any unusual changes in mood or behavior (e.g., agitation, depression, suicidal thoughts) to your doctor immediately.
* If you are taking warfarin, your doctor will need to monitor your blood clotting time closely.
* Do not breastfeed while taking Accolate.
* Keep Accolate tablets dry and protected from light and moisture. Store at controlled room temperature.
* Keep out of reach of children.
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