- Accolate tablet
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What Is Zafirlukast?
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 for chronic treatment of asthma, and to prevent asthma attacks in adults and children as young as 5 years old.
Do not give this medicine to a child younger than 5 years without a doctor's advice.
Zafirlukast may also be used for purposes not listed in this medication guide.
You should not use this medicine if you have liver disease (including cirrhosis).
Zafirlukast will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack. Tell your doctor if it seems like your asthma medications don't work as well.
Do not give this medicine to a child younger than 5 years without a doctor's advice.
You should not use this medicine if you are allergic to zafirlukast, or if you have liver disease (including cirrhosis).
To make sure zafirlukast is safe for you, tell your doctor if you have:
- a history of liver disease;
- if you also take erythromycin or theophylline; or
- if you also take a blood thinner (warfarin, Coumadin, Jantoven).
The chewable tablet form of this medication may contain up to 0.842 milligrams of phenylalanine. Talk to your doctor before using this form of zafirlukast if you have phenylketonuria (PKU).
FDA pregnancy category B. Zafirlukast is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Zafirlukast can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
How should I take Accolate (zafirlukast)?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Zafirlukast will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack. Tell your doctor if it seems like your asthma medications don't work as well.
Take zafirlukast on an empty stomach, at least 1 hour before or 2 hours after a meal.
Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.
Keep using this medicine as directed, even if you have no asthma symptoms.
Asthma is sometimes treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Every person with asthma should remain under the care of a doctor.
If you also use a steroid medication, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about tapering your steroid dose before stopping completely.
Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.
What other drugs will affect Accolate (zafirlukast)?
Other drugs may interact with zafirlukast, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Accolate Dosage and Administration
Administer twice daily on an empty stomach (i.e., at least 1 hour before or two hours after meals).1 14 15 16 17 21 22 23 24 25 45
Pediatric PatientsAsthma Oral
Children 5–11 years of age: 10 mg twice daily.1
Children ≥12 years of age: 20 mg twice daily.1 14 15 16 17 21 22 23 24 25 45 52
20 mg twice daily. 1 14 15 16 17 21 22 23 24 25 45 52
Clearance may be decreased.1 Dosage reduction may be necessary;53 however, the manufacturer currently makes no specific recommendations for dosage adjustment.1 45 Not evaluated in patients with hepatitis or in long-term studies in patients with cirrhosis.1 45 (See Special Populations under Absorption and under Elimination in Pharmacokinetics and see Hepatic Impairment.)
Dosage adjustment not required.1 45 52
Dosage adjustment not required.1 45 (See Special Populations under Absorption and under Elimination in Pharmacokinetics.)
Cautions for Accolate
Known hypersensitivity to zafirlukast or any ingredient in the formulation.1
Hepatic dysfunction, including increases in liver enzyme concentrations, hepatitis, and/or hyperbilirubinemia, reported.1 52 Zafirlukast-induced hepatotoxicity usually is reversible following discontinuance of the drug.1 52
Serious and potentially fatal hepatotoxicity, including fulminant hepatitis and liver failure, reported rarely.1 52
Monitor closely for signs and symptoms of hepatic impairment; consider performing liver function tests (e.g., serum AST and ALT) periodically.1 Advise patients to immediately contact their clinician if they notice signs and symptoms of liver dysfunction.1
Discontinue therapy if signs and/or symptoms suggestive of liver dysfunction occur; immediately perform liver function tests (i.e., serum ALT) and manage patient accordingly.52
Do not reinitiate therapy if results of liver function tests are consistent with hepatic dysfunction or if zafirlukast was discontinued because of hepatic dysfunction when no other attributable cause could be identified.1Acute Asthma
Do not use for relief of acute bronchospasm (including status asthmaticus); zafirlukast can be continued during acute exacerbations of asthma, but it will not provide immediate symptomatic relief.1 45 52 Patients who experience exacerbations of asthma should continue their usual regimen of inhaled β2–adrenergic agonists for prophylaxis and have a short-acting orally inhaled β2-adrenergic agonist available for rescue.1 11 45 52Interactions
Concomitant use with warfarin results in a clinically important increase in PT.1 45 (See Specific Drugs under Interactions.)
Sensitivity ReactionsEosinophilia and Churg-Strauss Syndrome
Systemic eosinophilia, eosinophilic pneumonia, or clinical features of vasculitis consistent with Churg-Strauss syndrome reported rarely in patients receiving leukotriene modifiers; these events usually associated with reduction (tapered dosage) or withdrawal of oral or high-dose inhaled corticosteroid therapy.1 57 58 59 60 61 62 63 64
Be alert to the development of eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy; causal relationship not established.1 57 58 59 60 61 62 63 64
General PrecautionsConcomitant Corticosteroid Therapy
Do not abruptly substitute zafirlukast for oral or inhaled corticosteroids. Orally inhaled corticosteroid requirements may be reduced during zafirlukast therapy; undertake only gradual (e.g., at 2-week intervals) reduction of corticosteroid dosage.1 45 52 53Neuropsychiatric Effects
Neuropsychiatric events reported with zafirlukast during postmarketing experience.75 80 81 Data from placebo-controlled trials with leukotriene modifiers indicate that suicidal ideation occurred in 0.01% of 9929 patients treated with montelukast and in none of those receiving other leukotriene modifiers; no completed suicide occurred during therapy with any leukotriene modifier.80 FDA concluded that some neuropsychiatric events reported with zafirlukast (e.g., depression, insomnia) appear consistent with a drug-induced effect.1 81
Be alert to the potential for neuropsychiatric events in patients receiving the drug.1 81 Instruct patients to contact their clinician if behavior or mood changes occur.1 81 Carefully evaluate the risks and benefits of continuing zafirlukast therapy in patients who develop neuropsychiatric symptoms.1 81
ACOG generally recommends use of leukotriene receptor antagonists (i.e., zafirlukast, montelukast) as alternatives to a long-acting β2-agonist in pregnant women with moderate persistent asthma who are inadequately controlled with low to medium dosages of an inhaled corticosteroid.66 (See Asthma under Uses.)Lactation
Distributed into milk.1 45 52 Discontinue nursing or the drug.1 45Pediatric Use
Safety demonstrated in children 5–11 years of age; efficacy extrapolated from demonstrated efficacy in adults with asthma and the likelihood that the disease course, pathophysiology, and drug’s effect are similar between the two populations.1
Safety and efficacy not established in children <5 years of age.1
Increased systemic exposure and AUC, reflecting decreased clearance in children relative to adults.1
Effect on growth in pediatric patients not evaluated in clinical studies to date.1Geriatric Use
Possible increased incidence of infection (e.g., pharyngitis, rhinitis) compared with younger adults.1 12 16 22 23 45Hepatic Impairment
Decreased clearance; dosage reduction may be necessary.1 45 53 (See Special Populations under Absorption and under Elimination in Pharmacokinetics.)
Common Adverse Effects
Headache, infection, nausea, diarrhea.1 45
Precautions While Using Accolate
It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
You or your child may be taking other medicines for asthma along with zafirlukast. Do not stop taking or reduce the dose of the other medicines, even if your asthma seems better, unless you are told to do so by your doctor.
Check with your doctor if your or your child's symptoms do not improve or if your asthma gets worse.
Stop using this medicine and check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause a rare blood condition called Churg-Strauss syndrome. This usually occurs in patients who have asthma or are taking oral steroid medicines that is being stopped or the dose is being reduced or lowered. Tell your doctor right away if you or your child have the following symptoms: a feeling of pins and needles, flu-like symptoms, numbness of the arms or legs, rash, or pain and swelling of the sinuses.
This medicine may cause some people to be agitated, disoriented, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed and have problems with sleep. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Uses of Accolate
- It is used to treat or prevent asthma.
- Do not use Accolate (zafirlukast) to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.
Accolate is contraindicated in patients who are hypersensitive to zafirlukast or any of its inactive ingredients.
Accolate is contraindicated in patients with hepatic impairment including hepatic cirrhosis.
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Information for Patients
Patients should be told that a rare side effect of Accolate is hepatic dysfunction, and to contact their physician immediately if they experience symptoms of hepatic dysfunction (eg. right upper quadrant abdominal pain, nausea, fatigue, lethargy, pruritus, jaundice, flu-like symptoms, and anorexia). Liver failure resulting in liver transplantation and death has occurred in patients taking zafirlukast (see WARNINGS, Hepatotoxicity and ADVERSE REACTIONS).
Accolate is indicated for the chronic treatment of asthma and should be taken regularly as prescribed, even during symptom-free periods. Accolate is not a bronchodilator and should not be used to treat acute episodes of asthma. Patients receiving Accolate should be instructed not to decrease the dose or stop taking any other antiasthma medications unless instructed by a physician. Patients should be instructed to notify their physician if neuropsychiatric events occur while using Accolate (see PRECAUTIONS, Neuropsychiatric Events). Women who are breast-feeding should be instructed not to take Accolate (see PRECAUTIONS, Nursing Mothers). Alternative antiasthma medication should be considered in such patients.
The bioavailability of Accolate may be decreased when taken with food. Patients should be instructed to take Accolate at least 1 hour before or 2 hours after meals.
In rare cases, patients with asthma on Accolate may present with systemic eosinophilia, eosinophilic pneumonia, or clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic steroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. These events have usually, but not always, been associated with reductions and/or withdrawal of steroid therapy. The possibility that Accolate may be associated with emergence of Churg-Strauss syndrome can neither be excluded nor established (see ADVERSE REACTIONS).
Neuropsychiatric events have been reported in adult, adolescent and pediatric patients taking Accolate. Post-marketing reports with Accolate include insomnia and depression. The clinical details of some post-marketing reports involving Accolate appear consistent with a drug-induced effect. Patients and prescribers should be alert for neuropsychiatric events. Patients should be instructed to notify their prescriber if these changes occur. Prescribers should carefully evaluate the risks and benefits of continuing treatment with Accolate if such events occur (see ADVERSE REACTIONS).
In a drug interaction study in 16 healthy male volunteers, coadministration of multiple doses of zafirlukast (160 mg/day) to steady-state with a single 25 mg dose of warfarin resulted in a significant increase in the mean AUC (+ 63%) and half-life (+36%) of S-warfarin. The mean prothrombin time (PT) increased by approximately 35%. This interaction is probably due to an inhibition by zafirlukast of the cytochrome P450 2C9 isoenzyme system. Patients on oral warfarin anticoagulant therapy and Accolate should have their prothrombin times monitored closely and anticoagulant dose adjusted accordingly (see WARNINGS, Concomitant Warfarin Administration). No formal drug-drug interaction studies with Accolate and other drugs known to be metabolized by the cytochrome P450 2C9 isoenzyme (eg, tolbutamide, phenytoin, carbamazepine) have been conducted; however, care should be exercised when Accolate is coadministered with these drugs.
In a drug interaction study in 11 asthmatic patients, coadministration of a single dose of zafirlukast (40 mg) with erythromycin (500 mg three times daily for 5 days) to steady-state resulted in decreased mean plasma levels of zafirlukast by approximately 40% due to a decrease in zafirlukast bioavailability.
Coadministration of zafirlukast (20 mg/day) or placebo at steady-state with a single dose of sustained release theophylline preparation (16 mg/kg) in 16 healthy boys and girls (6 through 11 years of age) resulted in no significant differences in the pharmacokinetic parameters of theophylline.
Coadministration of zafirlukast (80 mg/day) at steady-state with a single dose of a liquid theophylline preparation (6 mg/kg) in 13 asthmatic patients, 18 to 44 years of age, resulted in decreased mean plasma levels of zafirlukast by approximately 30%, but no effect on plasma theophylline levels was observed.
Rare cases of patients experiencing increased theophylline levels with or without clinical signs or symptoms of theophylline toxicity after the addition of Accolate to an existing theophylline regimen have been reported. The mechanism of the interaction between Accolate and theophylline in these patients is unknown (see ADVERSE REACTIONS).
Coadministration of zafirlukast (40 mg/day) with aspirin (650 mg four times daily) resulted in mean increased plasma levels of zafirlukast by approximately 45%.
In a single-blind, parallel-group, 3-week study in 39 healthy female subjects taking oral contraceptives, 40 mg twice daily of zafirlukast had no significant effect on ethinyl estradiol plasma concentrations or contraceptive efficacy.
Coadministration of zafirlukast with fluconazole, a moderate CYP2C9 inhibitor, resulted in increased plasma levels of zafirlukast, by approximately 58% (90% CI:28, 95). The clinical significance of this interaction is unknown. Zafirlukast exposure is likely to be increased by other moderate and strong CYP2C9 inhibitors. Coadministration of zafirlukast with itraconazole, a strong CYP3A4 inhibitor, caused no change in plasma levels of zafirlukast.
No other formal drug-drug interaction studies between Accolate and marketed drugs known to be metabolized by the P450 3A4 (CYP3A4) isoenzyme (eg, dihydropyridine calcium-channel blockers, cyclosporin, cisapride) have been conducted. As Accolate is known to be an inhibitor of CYP3A4 in vitro, it is reasonable to employ appropriate clinical monitoring when these drugs are coadministered with Accolate.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In two-year carcinogenicity studies, zafirlukast was administered at dietary doses of 10, 100, and 300 mg/kg to mice and 40, 400, and 2000 mg/kg to rats. Male mice at an oral dose of 300 mg/kg/day (approximately 30 times the maximum recommended daily oral dose in adults and in children on a mg/m2 basis) showed an increased incidence of hepatocellular adenomas; female mice at this dose showed a greater incidence of whole body histocytic sarcomas. Male and female rats at an oral dose of 2000 mg/kg/day (resulting in approximately 160 times the exposure to drug plus metabolites from the maximum recommended daily oral dose in adults and in children based on a comparison of the plasma area-under the curve [AUC] values) of zafirlukast showed an increased incidence of urinary bladder transitional cell papillomas. Zafirlukast was not tumorigenic at oral doses up to 100 mg/kg (approximately 10 times the maximum recommended daily oral dose in adults and in children on a mg/m2 basis) in mice and at oral doses up to 400 mg/kg (resulting in approximately 140 times the exposure to drug plus metabolites from the maximum recommended daily oral dose in adults and in children based on a comparison of the plasma AUC values) in rats. The clinical significance of these findings for the long-term use of Accolate is unknown.
Zafirlukast showed no evidence of mutagenic potential in the reverse microbial assay, in 2 forward point mutation (CHO-HGPRT and mouse lymphoma) assays or in two assays for chromosomal aberrations (the in vitro human peripheral blood lymphocyte clastogenic assay and the in vivo rat bone marrow micronucleus assay).
No evidence of impairment of fertility and reproduction was seen in male and female rats treated with zafirlukast at oral doses up to 2000 mg/kg (approximately 410 times the maximum recommended daily oral dose in adults on a mg/m2 basis)
Pregnancy Category B:
No teratogenicity was observed at oral doses up to 1600 mg/kg/day in mice (approximately 160 times the maximum recommended daily oral dose in adults on a mg/m2 basis), up to 2000 mg/kg/day in rats (approximately 410 times the maximum recommended daily oral dose in adults on a mg/m2 basis) and up to 2000 mg/kg/day in cynomolgus monkeys (which resulted in approximately 20 times the exposure to drug plus metabolites compared to that from the maximum recommended daily oral dose in adults based on comparison of the AUC values). At an oral dose of 2000 mg/kg/day in rats, maternal toxicity and deaths were seen with increased incidence of early fetal resorption. Spontaneous abortions occurred in cynomolgus monkeys at the maternally toxic oral dose of 2000 mg/kg/day. There are no adequate and well-controlled trials in pregnant women. Because animal reproductive studies are not always predictive of human response, Accolate should be used during pregnancy only if clearly needed.
Zafirlukast is excreted in breast milk. Following repeated 40 mg twice-a-day dosing in healthy women, average steady-state concentrations of zafirlukast in breast milk were 50 ng/mL compared to 255 ng/mL in plasma. Because of the potential for tumorigenicity shown for zafirlukast in mouse and rat studies and the enhanced sensitivity of neonatal rats and dogs to the adverse effects of zafirlukast, Accolate should not be administered to mothers who are breast-feeding.
The safety of Accolate at doses of 10 mg twice daily has been demonstrated in 205 pediatric patients 5 through 11 years of age in placebo-controlled trials lasting up to six weeks and with 179 patients in this age range participating in 52 weeks of treatment in an open-label extension.
The effectiveness of Accolate for the prophylaxis and chronic treatment of asthma in pediatric patients 5 through 11 years of age is based on an extrapolation of the demonstrated efficacy of Accolate in adults with asthma and the likelihood that the disease course, and pathophysiology and the drug’s effect are substantially similar between the two populations. The recommended dose for the patients 5 through 11 years of age is based upon a cross-study comparison of the pharmacokinetics of zafirlukast in adults and pediatric subjects, and on the safety profile of zafirlukast in both adult and pediatric patients at doses equal to or higher than the recommended dose.
The safety and effectiveness of zafirlukast for pediatric patients less than 5 years of age has not been established. The effect of Accolate on growth in children has not been determined.
Based on cross-study comparison, the clearance of zafirlukast is reduced in patients 65 years of age and older such that Cmax and AUC are approximately 2- to 3-fold greater than those of younger patients (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY).
A total of 8094 patients were exposed to zafirlukast in North American and European short-term placebo-controlled clinical trials. Of these, 243 patients were elderly (age 65 years and older). No overall difference in adverse events was seen in the elderly patients, except for an increase in the frequency of infections among zafirlukast-treated elderly patients compared to placebo-treated elderly patients (7.0% vs. 2.9%). The infections were not severe, occurred mostly in the lower respiratory tract, and did not necessitate withdrawal of therapy.
An open-label, uncontrolled, 4-week trial of 3759 asthma patients compared the safety and efficacy of Accolate 20 mg given twice daily in three patient age groups, adolescents (12-17 years), adults (18-65 years), and elderly (greater than 65 years). A higher percentage of elderly patients (n=384) reported adverse events when compared to adults and adolescents. These elderly patients showed less improvement in efficacy measures. In the elderly patients, adverse events occurring in greater than 1% of the population included headache (4.7%), diarrhea and nausea (1.8%), and pharyngitis (1.3%). The elderly reported the lowest percentage of infections of all three age groups in this study.
Cases of life-threatening hepatic failure have been reported in patients treated with ACCOLATE. Cases of liver injury without other attributable cause have been reported from post-marketing adverse event surveillance of patients who have received the recommended dose of ACCOLATE (40 mg/day). In most, but not all post-marketing reports, the patient's symptoms abated and the liver enzymes returned to normal or near normal after stopping ACCOLATE. In rare cases, patients have either presented with fulminant hepatitis or progressed to hepatic failure, liver transplantation and death. In extremely rare postmarketing cases, no clinical symptoms or signs suggestive of liver dysfunction were reported to precede the latter observations.
Physicians may consider the value of liver function testing. Periodic serum transaminase testing has not proven to prevent serious injury but it is generally believed that early detection of drug-induced hepatic injury along with immediate withdrawal of the suspect drug enhances the likelihood for recovery.
Patients should be advised to be alert for signs and symptoms of liver dysfunction (eg, right upper quadrant abdominal pain, nausea, fatigue, lethargy, pruritus, jaundice, flu-like symptoms, and anorexia) and to contact their physician immediately if they occur. Ongoing clinical assessment of patients should govern physician interventions, including diagnostic evaluations and treatment.
If liver dysfunction is suspected based upon clinical signs or symptoms (eg, right upper quadrant abdominal pain, nausea, fatigue, lethargy, pruritus, jaundice, flu-like symptoms, anorexia, and enlarged liver), ACCOLATE should be discontinued.
Liver function tests, in particular serum ALT, should be measured immediately and the patient managed accordingly. If liver function tests are consistent with hepatic dysfunction, ACCOLATE therapy should not be resumed. Patients in whom ACCOLATE was withdrawn because of hepatic dysfunction where no other attributable cause is identified should not be re-exposed to ACCOLATE (see PRECAUTIONS, PATIENT INFORMATION and ADVERSE REACTIONS).Bronchospasm
ACCOLATE is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Therapy with ACCOLATE can be continued during acute exacerbations of asthma.Concomitant Warfarin Administration
Coadministration of zafirlukast with warfarin results in a clinically significant increase in prothrombin time (PT). Patients on oral warfarin anticoagulant therapy and ACCOLATE should have their prothrombin times monitored closely and anticoagulant dose adjusted accordingly (see PRECAUTIONS: DRUG INTERACTIONS).
No deaths occurred at oral zafirlukast doses of 2000 mg/kg in mice (approximately 210 times the maximum recommended daily oral dose in adults and children on a mg/m² basis), 2000 mg/kg in rats (approximately 420 times the maximum recommended daily oral dose in adults and children on a mg/m² basis), and 500 mg/kg in dogs (approximately 350 times the maximum recommended daily oral dose in adults and children on a mg/m² basis).
Overdosage with ACCOLATE has been reported in four patients surviving reported doses as high as 200 mg. The predominant symptoms reported following ACCOLATE overdose were rash and upset stomach. There were no acute toxic effects in humans that could be consistently ascribed to the administration of ACCOLATE. It is reasonable to employ the usual supportive measures in the event of an overdose; eg, remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.
Accolate Drug Class
Accolate is part of the drug class:
Leukotriene receptor antagonists
Take Accolate exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The dose of Accolate prescribed for you or your child's asthma is based on age:
- The recommended dose of Accolate in adults and children 12 years and older is 20 mg twice daily.
- The recommended dose of Accolate in children 5 through 11 years of age is 10 mg twice daily.
- Store Accolate at 68°F to 77°F (20°C -25°C).
- Keep Accolate tablets dry.
- Keep Accolate in a tight closed container and keep Accolate out of the light.
- Keep Accolate and all medicines out of the reach of children.
What happens if i miss a dose (accolate)?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Adults And Children 12 Years Of Age And Older
The safety database for ACCOLATE consists of more than 4000 healthy volunteers and patients who received ACCOLATE, of which 1723 were asthmatics enrolled in trials of 13 weeks duration or longer. A total of 671 patients received ACCOLATE for 1 year or longer. The majority of the patients were 18 years of age or older; however, 222 patients between the age of 12 and 18 years received ACCOLATE.
A comparison of adverse events reported by ≥ 1% of zafirlukast-treated patients, and at rates numerically greater than in placebo-treated patients, is shown for all trials in the table below.
|Adverse Event||ACCOLATE |
The frequency of less common adverse events was comparable between ACCOLATE and placebo.
Rarely, elevations of one or more liver enzymes have occurred in patients receiving ACCOLATE in controlled clinical trials. In clinical trials, most of these have been observed at doses four times higher than the recommended dose. The following hepatic events (which have occurred predominantly in females) have been reported from postmarketing adverse event surveillance of patients who have received the recommended dose of ACCOLATE (40 mg/day): cases of symptomatic hepatitis (with or without hyperbilirubinemia) without other attributable cause; and rarely, hyperbilirubinemia without other elevated liver function tests. In most, but not all postmarketing reports, the patient's symptoms abated and the liver enzymes returned to normal or near normal after stopping ACCOLATE. In rare cases, patients have presented with fulminant hepatitis or progressed to hepatic failure, liver transplantation and death (see WARNINGS, Hepatotoxicity and PRECAUTIONS, PATIENT INFORMATION).
In clinical trials, an increased proportion of zafirlukast patients over the age of 55 years reported infections as compared to placebo-treated patients. A similar finding was not observed in other age groups studied. These infections were mostly mild or moderate in intensity and predominantly affected the respiratory tract. Infections occurred equally in both sexes, were dose-proportional to total milligrams of zafirlukast exposure, and were associated with coadministration of inhaled corticosteroids. The clinical significance of this finding is unknown.
In rare cases, patients with asthma on ACCOLATE may present with systemic eosinophilia, eosinophilic pneumonia, or clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic steroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. These events have usually, but not always, been associated with reductions and/or withdrawal of steroid therapy. The possibility that ACCOLATE may be associated with emergence of Churg-Strauss syndrome can neither be excluded nor established (see PRECAUTIONS, Eosinophilic Conditions).
Neuropsychiatric adverse events, including insomnia and depression, have been reported in association with ACCOLATE therapy (see PRECAUTIONS, Neuropsychiatric Events). Hypersensitivity reactions, including urticaria, angioedema and rashes, with or without blistering, have also been reported in association with ACCOLATE therapy. Additionally, there have been reports of patients experiencing agranulocytosis, bleeding, bruising, or edema, arthralgia, myalgia, malaise, and pruritus in association with ACCOLATE therapy.
Rare cases of patients experiencing increased theophylline levels with or without clinical signs or symptoms of theophylline toxicity after the addition of ACCOLATE to an existing theophylline regimen have been reported. The mechanism of the interaction between ACCOLATE and theophylline in these patients is unknown and not predicted by available in vitro metabolism data and the results of two clinical drug interaction studies (see CLINICAL PHARMACOLOGY and PRECAUTIONS: DRUG INTERACTIONS).Pediatric Patients 5 Through 11 Years Of Age
ACCOLATE has been evaluated for safety in 788 pediatric patients 5 through 11 years of age. Cumulatively, 313 pediatric patients were treated with ACCOLATE 10 mg twice daily or higher for at least 6 months, and 113 of them were treated for one year or longer in clinical trials. The safety profile of ACCOLATE 10 mg twice daily-versus placebo in the 4- and 6-week double-blind trials was generally similar to that observed in the adult clinical trials with ACCOLATE 20 mg twice daily.
In pediatric patients receiving ACCOLATE in multi-dose clinical trials, the following events occurred with a frequency of ≥ 2% and more frequently than in pediatric patients who received placebo, regardless of causality assessment: headache (4.5 vs. 4.2%) and abdominal pain (2.8 vs. 2.3%).
The post-marketing experience in this age group is similar to that seen in adults, including hepatic dysfunction, which may lead to liver failure.
Read the entire FDA prescribing information for Accolate (Zafirlukast)Read More »
For the Consumer
Applies to zafirlukast: oral tablet
Along with its needed effects, zafirlukast (the active ingredient contained in Accolate) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking zafirlukast:Less common
- Cough or hoarseness
- fever or chills
- lower back or side pain
- painful or difficult urination
- Abdominal or stomach pain
- clay-colored stools
- dark urine
- loss of appetite
- unpleasant breath odor
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
- Attack, assault, or force
- attempts at killing oneself
- dry mouth
- fear or nervousness
- feeling sad or empty
- fever with or without chills
- general feeling of tiredness or weakness
- irregular heartbeats
- lack of appetite
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of interest or pleasure
- seeing, hearing, or feeling things that are not there
- shakiness in the legs, arms, hands, or feet
- shortness of breath
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- trembling or shaking of the hands or feet
- trouble with concentrating
- trouble with sleeping
- unable to sleep
- unusual bleeding or bruising
Some side effects of zafirlukast may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Less common
- Acid or sour stomach
- back pain
- difficulty with moving
- joint pain
- lack or loss of strength
- muscle aching or cramping
- muscle pains or stiffness
- stomach discomfort or upset
- swollen joints
- Hives or welts
- redness of the skin