Almont
Almont: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Almont
ATX code: R03DC03
Active ingredient: montelukast (Montelukast)
Manufacturer: Actavis, Ltd. (Actavis, Ltd.) (Malta)
Description and photo update: 2019-09-07
Prices in pharmacies: from 526 rubles.
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Almont is an anti-inflammatory anti-bronchoconstrictor drug.
Release form and composition
Dosage forms of Almont:
- chewable tablets, dosage 4 mg: oval, biconvex, pink with splashes, on one side - marking "M4" (10 pcs. in a blister, in a cardboard box 3 blisters; 14 pcs. in a blister, in a cardboard box 2 or 7 blisters);
- chewable tablets, dosage 5 mg: round, biconvex, pink interspersed, on one side - marking "M5" (7 pcs. in a blister, in a cardboard box 4 or 14 blisters; 10 pcs. in a blister, in a cardboard box a pack of 3 blisters);
- film-coated tablets, dosage 10 mg: square, biconvex, with rounded corners, beige, on one side - marking "M" (10 pcs. in a blister, in a cardboard box 3 blisters; 14 pcs. in a blister, in a cardboard box 2 or 7 blisters).
Each pack also contains instructions for the use of Almont.
Composition of 1 chewable tablet:
- active substance: montelukast (in the form of montelukast sodium salt) - 4 or 5 mg;
- auxiliary components: croscarmellose sodium, hyprolose, microcrystalline cellulose, mannitol, aspartame, magnesium stearate, Pigment Blend PB-24880 dye (lactose monohydrate, iron oxide red dye), cherry flavor (Silarom Cherry Flavor 1219813182).
Composition of 1 film-coated tablet:
- active substance: montelukast (in the form of montelukast sodium salt) - 10 mg;
- auxiliary components: lactose monohydrate, hyprolose, magnesium stearate, croscarmellose sodium, microcrystalline cellulose;
- film casing: Opadray II beige 31F27012 (hypromellose 15cP, macrogol 4000, titanium dioxide, lactose monohydrate, iron dye red oxide, iron dye yellow oxide).
Pharmacological properties
Pharmacodynamics
Almont's active ingredient - montelukast - is an antagonist of leukotriene receptors. Cysteinyl Leukotrienes (LTC 4, LTD 4, LTE 4) are potent pro-inflammatory eicosanoids released from a variety of cells, including eosinophils and mast cells. These important pro-asthmatic mediators bind to cysteinyl leukotriene (CysLT) receptors, which are located in the airways and are responsible for the increase in eosinophil count, vascular permeability, sputum production and bronchospasm response.
Montelukast has a high affinity and selectivity for CysLT 1 receptors. At a dose of up to 5 mg, the drug relieves bronchospasm caused by inhalation of LTD 4. After taking the tablet inside, the bronchodilating effect develops within 2 hours.
Almont suppresses both early and late stages of bronchospasm caused by exposure to antigens. Reduces the number of eosinophils in the peripheral blood, significantly reduces the number of eosinophils in the respiratory tract.
Montelukast enhances the bronchodilatory effect of beta 2 -adrenomimetics.
In patients with hypersensitivity to acetylsalicylic acid (ASA) receiving oral and / or inhaled glucocorticosteroids (GCS), the addition of montelukast to therapy improves disease control.
Pharmacokinetics
Absorption of montelukast after oral administration is rapid and almost complete.
After taking chewable tablets at a dose of 5 mg on an empty stomach in adults, the maximum plasma concentration (C max) is observed after 2 hours. Bioavailability averages 73%, but decreases to 63% if Almont is taken with food.
In adults, after taking on an empty stomach coated tablets at a dose of 10 mg, the average C max is reached within 3 hours. The average bioavailability is 64%. With the simultaneous intake of food, the values of C max and bioavailability do not change.
After taking chewable tablets at a dose of 4 mg on an empty stomach in children 2-5 years of age, C max is observed after 2 hours. In this age category, the Average C max is 66% higher, and the average value of the minimum plasma concentration (C min) is lower than in adults after taking coated tablets at a dose of 10 mg.
Montelukast is characterized by a high bond with blood plasma proteins - more than 99%. At equilibrium, the volume of distribution (V d) is approximately 8–11 liters. In preclinical studies, it was revealed that the drug penetrates through the blood-brain barrier in minimal amounts. In other tissues, 24 hours after administration, the drug is determined in low concentrations.
Montelukast is extensively metabolized in the liver. Equilibrium plasma concentration (C ss) of metabolites when using Almont in therapeutic doses is not determined either in adults or in children.
In vitro studies have shown that cytochrome P 450 isoenzymes (2A6, 2C9 and 3A4) are involved in the metabolism of montelukast. The drug at therapeutic concentrations does not inhibit cytochrome P 450 isoenzymes: 2A6, 2C9, 3A4, 2D6, 2C19, 1A2. The montelukast metabolites have little therapeutic activity.
In healthy adult volunteers, the plasma clearance of the drug averages 45 ml / min. About 86% of the total amount of montelukast is excreted within 5 days through the intestines. No more than 0.2% is excreted by the kidneys. These data, along with information on bioavailability, confirm the excretion of montelukast and its metabolites mainly in the bile.
In young healthy adult volunteers, the half-life (T 1/2) is 2.7–5.5 hours.
Special clinical cases:
- gender: in men and women, the pharmacokinetic characteristics of montelukast are the same;
- old age: the pharmacokinetics of the drug does not change, therefore dose adjustment is not required:
- renal function: in renal failure, the use of montelukast has not been studied, however, dose adjustment is not required, since the kidneys practically do not participate in the elimination of the drug;
- liver function: in case of mild and moderate hepatic insufficiency, dose adjustment of Almont is not required. There is no information on the pharmacokinetics of montelukast in patients with severe liver functional impairment (more than 9 points on the Child-Pugh scale).
In the case of taking very high doses of montelukast (20 and 60 times the recommended doses for adults), a decrease in the plasma concentration of theophylline is noted. If you take Almont in the recommended therapeutic doses, this effect is absent.
Indications for use
Almont is intended for long-term treatment and prevention of bronchial asthma, including:
- prevention of the development of bronchospasm against the background of physical activity in children from 2 years of age (chewable tablets 4 mg and 5 mg), in adolescents from 15 years and adults (film-coated tablets 10 mg);
- prevention of day and night symptoms of bronchial asthma in children from 2 years of age (chewable tablets 4 mg and 5 mg), in adolescents from 15 years and adults (film-coated tablets 10 mg);
- treatment of bronchial asthma with hypersensitivity to acetylsalicylic acid in children over the age of 6 years (chewable tablets 4 mg and 5 mg), in adolescents from 15 years old and adults (film-coated tablets 10 mg).
Almont tablets are also used to relieve symptoms of perennial and seasonal allergic rhinitis in children from 2 years of age (chewable tablets 4 mg and 5 mg), in adolescents from 15 years old and adults (film-coated tablets 10 mg).
Contraindications
- glucose-galactose malabsorption, galactose intolerance, lactase deficiency;
- phenylketonuria - for chewable tablets;
- children under 2 years of age - for 4 mg chewable tablets, up to 6 years - for 5 mg chewable tablets, up to 15 years - for 10 mg film-coated tablets;
- hypersensitivity to any component of Almont tablets.
Almont, instructions for use: method and dosage
Almont should be taken orally:
- Film-coated tablets: Swallow whole with plenty of water, regardless of meals;
- chewable tablets: chew in the mouth until completely dissolved, 1 hour before meals or 2 hours after meals.
Teenagers from 15 years old and adults are prescribed 1 film-coated tablet (10 mg) 1 time per day.
For children under 14 years old, Almont is prescribed in the form of chewable tablets: for children 2-6 years old - at a dosage of 4 mg, for children 6-14 years old - at a dosage of 5 mg. Multiplicity of receptions - 1 time per day. In case of bronchial asthma or bronchial asthma with allergic rhinitis, the drug should be taken in the evening. With allergic rhinitis, the time of taking the drug does not matter, the treatment regimen is determined individually, depending on the period of the greatest exacerbation of the symptoms of the disease.
Children should be supervised by an adult.
In patients with bronchial asthma, the therapeutic effect of Almont, which makes it possible to control symptoms, develops within 24 hours after administration. It is recommended to continue using the drug not only during the period of exacerbation of the disease, but also at the stage of controlled asthma.
Side effects
- respiratory system: nosebleeds;
- hepatobiliary system: increased activity of hepatic transaminases, hepatitis (including hepatocellular, cholestatic and mixed liver damage);
- blood system: increased tendency to bleeding, thrombocytopenia;
- cardiovascular system: palpitations;
- nervous system and psyche: paresthesia / hypesthesia, drowsiness, dizziness, headache, convulsions, tremors, irritability, agitation (including aggressive behavior or hostility), anxiety, anxiety, hallucinations, insomnia, pathological dreams (including nightmares), somnambulism, disorientation, depression, suicidality (suicidal thoughts and behavior);
- immune system: hypersensitivity, including eosinophilic liver infiltration, anaphylaxis;
- digestive system: nausea, abdominal pain, dyspepsia, dry mouth, vomiting, diarrhea, pancreatitis;
- musculoskeletal system: arthralgia, myalgia, including muscle cramps;
- skin and subcutaneous fat: urticaria, erythema nodosum, rash, pruritus, tendency to hematomas, angioedema, erythema multiforme;
- infectious and parasitic diseases: upper respiratory tract infections;
- others: thirst, swelling, malaise, fatigue, fever; in very rare cases - Churg-Strauss syndrome.
Overdose
It has been reported that patients with chronic bronchial asthma have taken montelukast for 1 week at a daily dose of 900 mg, and for 22 weeks at a daily dose of more than 200 mg. No adverse events were observed.
In clinical studies and the post-marketing period, cases of acute overdose of Almont (after taking at least 1000 mg per day) have been reported. According to clinical and laboratory data, the safety profile of montelukast is similar in children, adults and the elderly. The most common symptoms were: thirst, abdominal pain, vomiting, headache, agitation, drowsiness.
In case of overdose, symptomatic therapy is indicated. There is no information on the effectiveness of hemodialysis or peritoneal dialysis in removing the drug from the body.
special instructions
Almont is not intended for relief of acute attacks of bronchial asthma. Patients are advised to always have an emergency drug with them - short-acting inhaled beta 2 -adrenomimetics. If the need for these funds increases, patients should consult their doctor as soon as possible.
You should not abruptly switch from Almont to therapy with oral / inhaled GCS. There is no information proving the possibility of reducing the dose of oral GCS when added to therapy with montelukast.
Against the background of anti-asthma therapy, in rare cases, systemic eosinophilia develops, sometimes accompanied by clinical symptoms of vasculitis - the so-called Churg-Strauss syndrome. This condition is eliminated by taking systemic GCS. Such cases are usually noted against the background of dose reduction or cancellation of oral GCS. The connection of antagonists of leukotriene receptors with the development of Churge-Strauss syndrome cannot be either confirmed or refuted. Patients should be warned about the need to control the following symptoms: the occurrence of vascular rash and eosinophilia, an increase in the severity of neuropathy, pulmonary symptoms and / or cardiac complications. With their development, re-examination and revision of the treatment regimen are indicated.
Almont does not prevent the development of bronchospasm in patients with hypersensitivity to ASA when using ASA and other non-steroidal anti-inflammatory drugs (NSAIDs).
Influence on the ability to drive vehicles and complex mechanisms
In rare cases, against the background of montelukast therapy, dizziness and drowsiness are noted - undesirable effects that can negatively affect the speed of reactions and the ability to concentrate. Such patients are advised to refrain from performing potentially hazardous work and driving a car.
Application during pregnancy and lactation
Almont can be prescribed to pregnant women if the doctor determines that the benefits to the mother are higher than the potential risks to the fetus.
When treatment is required during lactation, it is recommended to assess the possible risks during therapy, if necessary, to stop breastfeeding.
Pediatric use
Age contraindications to prescribing the drug, depending on the dosage form of Almont:
- 4 mg chewable tablets - up to 2 years;
- chewable tablets 5 mg - up to 6 years;
- coated tablets 10 mg - up to 15 years.
With impaired renal function
The kidneys practically do not participate in the elimination of Almont, therefore, no correction of the dosage regimen of montelukast for patients with renal failure is required.
For violations of liver function
In case of mild and moderate hepatic insufficiency, dose adjustment of Almont is not required.
There is no experience of using montelukast in patients with severe functional disorders of the liver (more than 9 points on the Child-Pugh scale).
Use in the elderly
The pharmacokinetics of the drug in elderly patients does not change, so there is no need to adjust the dose of Almont.
Drug interactions
Almont can be prescribed in conjunction with other drugs that are traditionally used for the prevention of bronchospasm and long-term treatment of bronchial asthma and / or allergic rhinitis.
Almont is considered a reasonable addition to monotherapy with bronchodilators if their use does not adequately control bronchial asthma. After a stable therapeutic effect is achieved with the addition of montelukast, the dose of bronchodilators can be gradually reduced.
Almont provides an additional effect to patients receiving inhaled GCS. After achieving a stable therapeutic effect when adding montelukast, under the supervision of a physician, you can begin to gradually reduce the dose of corticosteroids. In some cases, inhaled GCS can be canceled completely. It is not recommended to abruptly replace inhalation therapy with Almont.
At the recommended therapeutic dose, montelukast does not have a clinically significant effect on the pharmacokinetics of the following drugs: digoxin, terfenadine, prednisolone, prednisone, theophylline, warfarin, oral contraceptives (ethinylestradiol / norethinodrel 35 ÷ 1).
With the simultaneous use of phenobarbital, the AUC of montelukast slightly decreases (the area under the concentration-time curve), but this does not require a dose change.
Care should be taken, especially when treating children, in the case of the simultaneous use of inducers of the isoenzyme CYP3A4, such as phenobarbital, phenytoin, rifampicin.
In vitro, information has been obtained that montelukast is a potent inhibitor of the isoenzyme CYP2C8. However, in an in vivo study of the interaction of montelukast and rosiglitazone (a marker substrate that is primarily metabolized by the CYP2C8 isoenzyme), confirmation of these data has not been obtained. Thus, the effect of montelukast on the CYP2C8-mediated metabolism of a number of drugs, including paclitaxel, repaglinide and rosiglitazone, is not expected in clinical practice.
Under in vitro conditions, it has been established that montelukast is a substrate of the CYP2C8 isoenzyme, to a lesser extent, of CYP3A4 and CYP2C9 isoenzymes. In clinical studies of the interaction of montelukast and gemfibrozil (an inhibitor of both CYP2C9 and CYP2C8), the latter increased the effect of systemic exposure to montelukast 4.4 times. When itraconazole (a potent inhibitor of the CYP3A4 isoenzyme) was added to gemfibrozil and montelukast, no additional increase in the effect of systemic exposure to montelukast was noted. Given the safety data when using the drug in doses exceeding the recommended adult dose of 10 mg, the effect of gemfibrozil on the systemic exposure to montelukast cannot be considered clinically significant. Thus, with the combined use of these drugs, there is no need to adjust the dose.
Based on the results of in vitro studies, clinically significant drug interactions with other known inhibitors of the CYP2C8 isoenzyme (for example, trimethoprim) are not expected. Moreover, the simultaneous use of itraconazole alone with montelukast did not cause a significant increase in the effect of systemic exposure to montelukast.
Analogs
Almont's analogues are Monax, Montler, Monkasta, Montelar, Monte-R, Montelukast, Singlon, Simplier, Singular, Ectalust, etc.
Terms and conditions of storage
Store in its original packaging out of the reach of children at a temperature: chewable tablets - up to 30 ° С, film-coated tablets - up to 25 ° С.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Almonte
According to reviews, Almont is an effective drug that prevents the development of bronchospasm, and also eliminates the symptoms of allergic rhinitis. The treatment is well tolerated, there are no reports of the development of adverse reactions.
The drug is considered by many to be expensive. However, many patients indicate that the price of Almont is lower than the cost of many medicines with a similar active ingredient.
Price for Almont in pharmacies
The price of Almont depends on the dosage form and dosage, as well as on the pharmacy chain and the region of sale.
The approximate cost of the drug may be:
- chewable tablets, dosage 4 mg - 455–873 rubles. per pack of 28 pcs., 1550–2080 rubles. per pack of 98 pcs.;
- chewable tablets, dosage 5 mg - 555–957 rubles. per pack of 28 pcs., 1529–2640 rubles. per pack of 98 pcs.;
- film-coated tablets, dosage 10 mg - 602–1000 rubles. per pack of 28 pcs., 1570–2600 rubles. per pack of 98 pcs.
Almont: prices in online pharmacies
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Drug name Price Pharmacy |
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Almont 4 mg chewable tablets 28 pcs. 526 r Buy |
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Almont 5 mg chewable tablets 28 pcs. 634 RUB Buy |
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Almont 10 mg film-coated tablets 28 pcs. 639 RUB Buy |
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Almont tablets chewable. 4mg 28 pcs. 692 RUB Buy |
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Almont tablets chewable. 5mg 28 pcs. 773 r Buy |
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Almont 4 mg chewable tablets 98 pcs. 800 RUB Buy |
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Almont tablets p.p. 10mg 28 pcs. RUB 977 Buy |
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Almont 5 mg chewable tablets 98 pcs. 1677 RUB Buy |
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Almont 10 mg film-coated tablets 98 pcs. 1960 RUB Buy |
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Almont tablets chewable. 5mg 98 pcs. 2387 RUB Buy |
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Almont tablets p.p. 10mg 98 pcs. 2853 RUB Buy |
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Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
