Akolat

Akolat is the antagonist (blocker) of leukotriene receptors, drug for treatment of allergic rhinitis and bronchial asthma.

Form of release and structure

Dosage form – tablets, coated: round, convex from two parties, almost white or white color, on one of the parties – an engraving of "ACCOLATE 20" (in blisters on 14 pieces, 2 blisters in a pack cardboard).

Contains in 1 tablet:

• Active agent: зафирлукаст – 20 mg;
• Additional components: gipromelloza, magnesium stearate, titanium dioxide, microcrystallic cellulose, lactoses monohydrate, sodium of a kroskarmelloz, povidone.

Indications to use

Akolat is applied to a basic maintenance therapy and prevention of attacks of bronchial asthma.

Contraindications

• Children's age up to 7 years;
• Lactation period;
• Hypersensitivity to any component which is a part of drug.

It is recommended not to appoint, whenever possible, medicine to patients with abnormal liver functions.

Clinical experience of use of Akolat for patients is more senior than 65 years is limited therefore at advanced age drug should be used with care.

Safety of use of a zafirlukast for pregnant women is not established, drug can be appointed only if the estimated advantage for the woman exceeds potential risks for a fruit.

Route of administration and dosage

Pill Akolat should be taken inside.

The recommended doses:

• Adults and teenagers are more senior than 12 years – on 1 tablet 2 times a day;
• Children of 7-11 years – on ½ tablets 2 times a day.

At renal failures dose adjustment is not required.

At abnormal liver functions the clearance of a zafirlukast is reduced. In an initiation of treatment to such patients usually appoint on 1 tablet 2 times a day, further adjust a dose on the basis of the clinical answer.

Akolat has to be accepted is long.

Side effects

• From the central nervous system: often – a headache, sleeplessness;
• From digestive tract: often – abdominal pains, nausea and vomiting;
• From a liver and biliary tract: seldom – a hyperbilirubinemia without the increased content of liver enzymes, symptomatic hepatitis, including with a hyperbilirubinemia; very seldom – fulminantny hepatitis, a liver failure;
• From hematologic system: seldom – formation of hematomas at bruises, thrombocytopenia, bleedings (including a hypermenorrhea); very seldom – an agranulocytosis;
• From a musculoskeletal system: seldom – an arthralgia and a mialgiya;
• From integuments: not often – hypostasis; seldom – a skin itch, rash (including vesicular), hypersensitivity reactions, including a small tortoiseshell and a Quincke's disease;
• Others: often – weakness; elderly people have an increase in frequency of infections, is more often than a respiratory path (proceed usually easily and do not demand the treatment termination).

The specified side effects, as a rule, pass after drug withdrawal. The headache and disturbances from the alimentary system arising at Akolat's reception usually have moderate character and do not demand the therapy termination.

Special instructions

For achievement of the maximum effect Akolat it is necessary to accept regularly, even during the periods when symptoms of bronchial asthma do not disturb. Drug, as a rule, needs to continue to be accepted also during an exacerbation of a disease.

As well as inhalation glucocorticosteroids (GKS), Akolat is not intended for stopping of bad asthmatic attacks (bronchospasms).

Upon transition on Akolat it is not necessary to cancel peroral or inhalation GKS sharply.

At intermittent or unstable bronchial asthma action of a zafirlukast was not studied.

Separate cases of development are known during treatment for this drug of eosinophilic states, including eosinophilic pneumonia and Churg-Strauss syndrome syndrome. Their manifestations can affect various bodies and systems of an organism, for example, cordial complications, development of a vasculitis and neuropathy, deterioration in function of lungs are possible. And though it was not succeeded to establish relationship of cause and effect of these complications with Akolat's reception, in case of eosinophilic states it is necessary to cancel drug and not to resume its reception, even for establishment of the reason for the developed eosinophilia.

The patients receiving at the same time warfarin need to control a prothrombin time.

Akolat can promote the increase in level of hepatic transaminases which is proceeding asymptomatically and having passing character, but being early a drug hepatotoxic symptom, and in hotel cases – associated with more serious hepatocellular violations, a liver failure and the fulminant course of hepatitis. During the post-market researches very exceptional cases of acute disorders of function of a liver to which symptoms of dysfunction or clinical symptoms did not precede were revealed.

Akolat's reception should be stopped immediately in case of any symptoms or signs indicating dysfunction of a liver such as pain in the right upper quadrant of a stomach, nausea, vomiting, anorexia, increase in a liver, apathy, slackness, increased fatigue, grippopodobny symptoms, an itch and jaundice. Further it is necessary to determine as soon as possible the level of serumal transaminases, especially alaninaminotranspherases.

Considering the possible problems with a liver described above, it is regularly necessary to control during treatment by Akolat serumal transaminases. And though regular control will not prevent development of serious violations from a liver, doctors will be able to consider the values received during the periodic researches of liver enzymes and to timely reveal functional disturbances of a liver. Along with urgent drug withdrawal it can promote improvement of a condition of the patient.

It is necessary to cancel drug immediately and in case of identification of signs of a hepatotoxic. If it is not connected with any other reason, repeated appointment of Akolat of this category of patients is contraindicated.

Not data that зафирлукаст exerts a negative impact on the speed of reactions and ability to concentration of attention.

Medicinal interaction

Akolat can be applied in a combination with other types of the medicamentous therapy intended for treatment of an allergy and bronchial asthma, for example, by inhalation GKS, peroral and inhalation bronchodilators, antihistamines and antibiotics without signs of undesirable interaction.

Acetylsalicylic acid (in a daily dose of 2600 mg – on 650 mg 4 times a day) can increase the level of a zafirlukast in plasma approximately for 45%, erythromycin – to lower approximately by 40%.

In clinical trials of use of a zafirlukast simultaneous with theophylline decrease in plasma concentration of a zafirlukast approximately for 30% without change of level of theophylline was noted. However in post-market researches separate cases of increase in concentration and theophylline were noted.

At simultaneous use of a terfenadin total concentration of a zafirlukast decreases by 54%.

Akolat applied in a combination with warfarin promotes increase in a prothrombin time by 35% therefore during treatment it is necessary to control this indicator.

At the smoking people increase in clearance of a zafirlukast approximately for 20% is possible.

Akolat does not interact with oral contraceptives.

Terms and storage conditions

To store in the place unavailable to children, at a temperature below 30 °C.

Period of validity – 3 years.