Description
Release form
10 mg film-coated tablets, 28 pcs
Indications
Prevention and long-term treatment of asthma in children, including:
prevention of day and night symptoms of the disease (for children 2 years of age and older)
treatment of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid (for children from 6 years and older)
prevention of bronchospasm caused by physical exertion (for children from 2 years of age and older).
Relief of symptoms of seasonal and perennial allergic rhinitis in children from 2 years.
Contraindications
Hypersensitivity to the active or any auxiliary substance of the
preparation children under 2 years of age (for a dosage of 4 mg) and up to 6 years of age (for a dosage of 5 mg)
patients with rare hereditary diseases: galactose intolerance, lactase deficiency or glucose-galactose malabsorption
phenylketonuria (contains aspartame).
Use during pregnancy and lactation
Use of Montelast during pregnancy is possible if the intended benefit to the mother outweighs the potential risk to the fetus.
The decision to abolish breastfeeding for the period of use of the Montelast drug is made on the basis of an assessment of the expected benefits to the mother and the potential risk to the baby.
Special instructions
The drug Almont is not recommended for the treatment of acute attacks of bronchial asthma. Patients with asthma are advised to always have emergency medications with them. When an acute attack occurs, short-acting inhaled betag-adrenomimetics should be used. Patients should consult their doctor as soon as possible, if they need more short-acting beta-adrenergic agonist inhalations than usual.
Do not abruptly replace Almont with inhaled or oral corticosteroids. There is no evidence proving the possibility of reducing the dose of oral corticosteroids while taking montelukast.
In rare cases, patients who receive anti-asthma drugs, including montelukast, may develop systemic eosinophilia, which is sometimes accompanied by clinical signs of vasculitis, the so-called Charge-Strauss syndrome, a condition that is eliminated by taking systemic corticosteroids. These cases are usually associated with dose reduction or discontinuation of oral corticosteroids therapy. It is impossible to exclude or establish the probability that antagonists of leukotriene receptors may be associated with the development of Charge-Strauss syndrome. Therefore, doctors need to be warned about the possibility of eosinophilia, a vascular rash, an increase in the severity of pulmonary symptoms, heart complications and / or neuropathy in patients. Patients who develop the above symptoms need to be re-examined and their treatment regimen reviewed. Treatment with Almont does not prevent the development of bronchospasm in patients with hypersensitivity to acetylsalicylic acid when using acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.
Almont contains aspartame, a source of phenylalanine. This drug may be harmful to patients with phenylketonuria.
The drug contains lactose monohydrate and should not be taken by patients with rare hereditary diseases: galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Influence on the ability to drive vehicles and mechanisms
As a rule, montelukast does not affect the ability to drive vehicles or work with other mechanisms, but very rarely drowsiness and dizziness were noted in some patients, when these signs appear, patients are not recommended to drive vehicles and engage in other activities that require concentration and speed of psychomotor reactions.
Composition
1 film-coated tablet contains: active substance: montelukast 10.00 mg (in the form of montelukast sodium 10.40 mg)
excipients: the core is microcrystalline cellulose, type 102 89.30 mg, hyprolose 4, 00 mg, croscarmellose sodium 6.00 mg, lactose monohydrate 89.30 mg, magnesium stearate 1, 00 mg
film coat – Opadry II Beige 31F27012 (lactose monohydrate 1.440 mg, hypromellose 15cP 1.120 mg, titanium dioxide 1.011 mg, macrogol 4000 0.400 mg, iron oxide yellow oxide 0.026 mg, iron oxide red oxide 0.003 mg) 4.0 mg.
Dosage and administration
Inside, without chewing, with a sufficient amount of liquid, regardless of food intake.
Adults and adolescents over 15 years of age take 1 tablet of ALMONT 10 mg daily in the evening.
General recommendations
The therapeutic effect of ALMONT, which allows controlling asthma symptoms, is achieved within 24 hours after administration. The patient is recommended to continue taking the drug, both during periods of controlled course of bronchial asthma, and during an exacerbation of bronchial asthma.
ALMONT should not be taken in conjunction with other drugs containing the same active substance – montelukast.
elderly patients patients with renal failure and patients with hepatic insufficiency of mild to moderate severity special dose selection is not required.
No dose adjustment is required based on patient gender.
There is no data on the use of montelukast in patients with severely impaired liver function.
ALMONT can be added to the patient s treatment with bronchodilators and inhaled corticosteroids.
Inhaled GCS: ALMONT can be prescribed for the treatment of asthma as an additional therapy for patients in whom inhaled GCS and short-acting beta-adrenergic agonists do not provide the necessary clinical control of the disease. The drug ALMONT can not be abruptly replaced by treatment with inhaled GCS.
For the treatment of patients from 2 to 15 years, another dosage form of the drug is available – chewable tablets.
Side effects
Infectious and parasitic diseases: inf tion of the upper respiratory tract
Disturbances in the blood and lymphatic systems.: increasing tendency to bleeding, thrombocytopenia
Disorders Immune system:. hypersensitivity reactions including anaphylaxis, eosinophilic liver infiltration.
Mental disorders: pathological dreams, including nightmares, hallucinations, insomnia, somnambulism, irritability, anxiety, anxiety, agitation, including aggressive behavior or hostility, tremors, depression, disorientation, suicidal thoughts and behavior (suicidality).
Disorders of the nervous system: headache, dizziness, drowsiness, paresthesia / hypesthesia, convulsions.
Disorders of the heart: palpitations.
Disorders of the respiratory system, chest and mediastinal organs: nosebleeds.
Disorders of the gastrointestinal tract: diarrhea, dry mouth, dyspepsia, nausea, vomiting, abdominal pain, pancreatitis.
Disorders of the liver and biliary tract: increased activity of alanine aminotransferase and aspartate aminotransferase, hepatitis (including cholestatic, hepatocellular and mixed liver lesions).
Disorders of the skin and subcutaneous tissues: angioedema, tendency to hematomas, urticaria, pruritus, rash, erythema nodosum, erythema multiforme.
Disorders of the musculoskeletal and connective tissue: arthralgia, myalgia, including muscle cramps.
General disorders and disorders at the injection site: asthenia / fatigue, malaise, swelling, pyrexia, thirst.
In very rare cases, during the treatment with montelukast, the development of Charge-Strauss syndrome has been reported (see section Special instructions).
Drug Interactions
In patients simultaneously receiving phenobarbital, the area under the pharmacokinetic curve concentration-time of montelukast decreased by about 40%, however, correction of the dosage regimen in such patients is not required. Since montelukast is metabolized by the isoenzyme CYP3A4, caution should be exercised, especially in children, if montelukast is used simultaneously with inducers of the isoenzyme CYP3A4, such as phenytoin, phenobarbital and rifampicin.
Montelukast can be prescribed along with other drugs traditionally used for the prevention and long-term treatment of bronchial asthma and / or allergic rhinitis.
Montelukast at the recommended therapeutic dose did not have a clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisone, oral contraceptives (ethinyl estradiol / norethinodrel 35/1), terfenadine, digoxin and warfarin.
In vitro studies have found that montelukast is a potent inhibitor of the CYP2C8 isoenzyme. However, when studying the drug interaction in vivo of montelukast and rosiglitazone (a marker substrate, a representative of drugs that are primarily metabolized by the CYP2C8 isoenzyme), there is no confirmation of the inhibition of CYP2C8 isoenzyme by montelukast. Thus, in clinical practice, the effect of montelukast on SUR2C8-mediated metabolism of a number of drugs, including paclitaxel, rosiglitazone, repaglinide.
In vitro studies have shown that montelukast is a substrate of the CYP2C8 isoenzyme, and to a lesser extent the CYP2C9 and 3A4 isoenzymes. Data from a clinical study of drug interactions in relation to montelukast and gemfibrozil (an inhibitor of both CYP2C8 and 2C9) demonstrate that gemfibrozil increases the effect of systemic exposure to montelukast by 4.4 times. The combined administration of itraconazole, a potent inhibitor of the CYP3A4 isoenzyme, together with gemfibrozil and montelukast did not lead to an additional increase in the effect of systemic exposure to montelukast. The effect of gemfibrozil on the systemic effects of montelukast cannot be considered clinically significant based on safety data when used in doses exceeding the approved dose of 10 mg for adult patients (for example, 200 mg / day for adult patients for 22 weeks and up to 900 mg / day for patients taking the drug for about one week did not show clinically significant negative effects). Thus, when combined with gemfibrozil, dose adjustment of montelukast is not required. According to the results of in vitro studies, clinically significant drug interactions with other known inhibitors of the CYP2C8 isoenzyme (for example, with trimethoprim) are not expected. In addition, the combined administration of montelukast with itraconazole alone did not lead to a significant increase in the effect of systemic exposure to montelukast.
Combined treatment with bronchodilators
ALMONT is a reasonable supplement to monotherapy with bronchodilators, if the latter do not provide adequate control of bronchial asthma. Upon reaching the therapeutic effect of treatment with ALMONT, a gradual reduction in the dose of bronchodilators can begin.
Combined treatment with inhaled GCS
Treatment with ALMONT provides an additional therapeutic effect to patients using inhaled GCS. Upon reaching stabilization, a gradual decrease in the dose of corticosteroids can be started under the supervision of a physician. In some cases, the complete cancellation of inhaled GCS is acceptable, however, a sharp replacement of inhaled GCS with ALMONT is not recommended.
Overdose
Symptoms of drug overdose in patients with chronic bronchial asthma when used in a dose exceeding 200 mg per day for 22 weeks and at a dose of 900 mg per day for 1 week were not detected. There are reports of acute overdose of montelukast (when taking at least 1 g per day) in the post-marketing period and in clinical studies in adults and children. Clinical and laboratory data in this case indicate the compliance of the safety profile of the drug in children, adults and elderly patients. The most common symptoms were thirst, drowsiness, vomiting, psychomotor agitation, headache and abdominal pain. Treatment: symptomatic therapy.
Expiration
3 years.
active substance
active ingredient Mont lukast
Form of Treatment
tablets
Indications
Bronchial asthma, bronchospasm, runny
Possible Product Names
ALLOMEDIN 10.0 GEL
ALLOMEDIN GEL 10G
ALLOMEDIN GEL 10G (08.09)
Allomedin Gel 10g Nizhfarm
Allomedin srldkfrdff905 30gpfrdflp90 30gpfrdfdf9064 possible Almont tablets are coated. 10 mg 28 pcs.
Actavis Ltd, Iceland
