Akolat
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Akolat is an antagonist (blocker) of leukotriene receptors, a drug for the treatment of allergic rhinitis and bronchial asthma.
Release form and composition
Dosage form - coated tablets: round, convex on both sides, almost white or white, on one side - engraving "ACCOLATE 20" (in blisters of 14 pcs., 2 blisters in a cardboard box).
1 tablet contains:
- Active ingredient: zafirlukast - 20 mg;
- Additional components: hypromellose, magnesium stearate, titanium dioxide, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone.
Indications for use
Akolat is used for basic maintenance therapy and prevention of bronchial asthma attacks.
Contraindications
- Children up to age 7;
- Lactation period;
- Hypersensitivity to any component of the drug.
It is recommended not to prescribe, if possible, the drug to patients with impaired liver function.
Clinical experience of using Akolat in patients over 65 years of age is limited, therefore, the drug should be used with caution in old age.
The safety of using zafirlukast in pregnant women has not been established; the drug can be prescribed only if the intended benefit to the woman outweighs the potential risks to the fetus.
Method of administration and dosage
Akolat tablets should be taken orally.
Recommended doses:
- Adults and adolescents over 12 years old - 1 tablet 2 times a day;
- Children 7-11 years old - ½ tablet 2 times a day.
In case of impaired renal function, dose adjustment is not required.
In case of impaired liver function, the clearance of zafirlukast is reduced. At the beginning of treatment, such patients are usually prescribed 1 tablet 2 times a day, then the dose is adjusted based on the clinical response.
Acolat should be taken for a long time.
Side effects
- From the side of the central nervous system: often - headache, insomnia;
- From the gastrointestinal tract: often - abdominal pain, nausea and vomiting;
- On the part of the liver and biliary tract: rarely - hyperbilirubinemia without an increased content of liver enzymes, symptomatic hepatitis, including hyperbilirubinemia; very rarely - fulminant hepatitis, liver failure;
- From the hematological system: rarely - the formation of hematomas with bruises, thrombocytopenia, bleeding (including hypermenorrhea); very rarely - agranulocytosis;
- From the musculoskeletal system: rarely - arthralgia and myalgia;
- From the side of the skin: not often - edema; rarely - itchy skin, rash (including vesicular), hypersensitivity reactions, incl. urticaria and angioedema;
- Others: often - weakness; in older people - an increase in the frequency of infections, more often of the respiratory tract (usually proceed easily and do not require discontinuation of treatment).
These side effects usually disappear after the drug is discontinued. Headache and disorders of the digestive system that occur when taking Akolat are usually mild and do not require discontinuation of therapy.
special instructions
To achieve the maximum effect, Akolat should be taken regularly, even during periods when the symptoms of bronchial asthma do not bother. The drug, as a rule, must be continued during the exacerbation of the disease.
Like inhaled glucocorticosteroids (GCS), Akolat is not intended for the relief of acute asthmatic attacks (bronchospasm).
When switching to Akolat, oral or inhaled GCS should not be abruptly canceled.
In intermittent or unstable bronchial asthma, the effect of zafirlukast has not been studied.
There are isolated cases of development during treatment with this drug of eosinophilic conditions, including eosinophilic pneumonia and Churg-Strauss syndrome (Churg-Strauss syndrome). Their manifestations can affect various organs and systems of the body, for example, cardiac complications, the development of vasculitis and neuropathy, and deterioration of lung function are possible. And although it was not possible to establish the causal relationship of these complications with Akolat's intake, in the event of the appearance of eosinophilic conditions, the drug should be discontinued and not resumed, even to establish the cause of the developed eosinophilia.
Patients receiving warfarin concomitantly need to control prothrombin time.
Akolat can increase the level of hepatic transaminases, which is asymptomatic and transient, but is an early symptom of hepatotoxicity of the drug, and in some cases - associated with more serious hepatocellular disorders, liver failure and fulminant course of hepatitis. In the course of post-marketing studies, very rare cases of acute liver dysfunction were identified, which were not preceded by signs of dysfunction or clinical symptoms.
Acolat should be discontinued immediately if any symptoms or signs indicating liver dysfunction appear, such as right upper abdominal pain, nausea, vomiting, anorexia, liver enlargement, apathy, lethargy, fatigue, flu-like symptoms, itching, and jaundice. Next, it is necessary to determine the level of serum transaminases, especially alanine aminotransferase, as soon as possible.
Given the possible liver problems described above, serum transaminases should be monitored regularly during treatment with Akolat. And although regular monitoring will not prevent the development of serious liver disorders, doctors will be able to take into account the values obtained during periodic studies of liver enzymes and timely identify functional liver disorders. Together with the urgent withdrawal of the drug, this can improve the patient's condition.
The drug should be discontinued immediately and if signs of hepatotoxicity are detected. If it is not associated with any other cause, re-appointment of Akolat to this category of patients is contraindicated.
There is no information that zafirlukast has a negative effect on the speed of reactions and the ability to concentrate.
Drug interactions
Akolat can be used in combination with other types of drug therapy for the treatment of allergies and bronchial asthma, for example, inhaled GCS, oral and inhaled bronchodilators, antihistamines and antibiotics without signs of unwanted interactions.
Acetylsalicylic acid (in a daily dose of 2600 mg - 650 mg 4 times a day) can increase the plasma level of zafirlukast by about 45%, erythromycin can be reduced by about 40%.
In clinical studies of the use of zafirlukast simultaneously with theophylline, a decrease in the plasma concentration of zafirlukast by about 30% was noted without changing the level of theophylline. However, in post-marketing studies, there were isolated cases of an increase in the concentration of and theophylline.
With the simultaneous use of terfenadine, the total concentration of zafirlukast decreases by 54%.
Acolate, used in combination with warfarin, increases prothrombin time by 35%, therefore, this indicator should be monitored during treatment.
In smokers, it is possible to increase the clearance of zafirlukast by about 20%.
Akolat does not interact with oral contraceptives.
Analogs
There is no information about Akolat's analogues.
Terms and conditions of storage
Store out of the reach of children at temperatures below 30 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
