Almont, 10 mg 98 pcs.

How to take, the dosage

Therapeutic effect of the drug ALMONT, allowing to control asthma symptoms, is achieved within 24 hours after intake. The patient is recommended to continue taking the drug both during periods of controlled bronchial asthma and during exacerbation of bronchial asthma.

The drug ALMONT should not be taken together with other drugs containing the same active ingredient, montelukast.

Elderly patients, patients with renal impairment and patients with mild to moderate hepatic impairment do not require special dose adjustments.

There is no need to adjust the dose depending on the gender of the patient.

There are no data on the use of montelukast in patients with severe hepatic impairment.

The drug ALMONT can be added to a patient’s treatment with bronchodilators and inhaled GCS.

Inhaled GCS: ALMONT can be indicated as adjunctive therapy for patients with bronchial asthma for whom inhaled GCS and short-acting beta-adrenomimetics do not provide adequate clinical control. ALMONT should not be abruptly replaced by treatment with inhaled GCS.

A different dosage form of the drug, chewable tablets, is available to treat patients from 2 to 15 years of age.

Interaction

In patients who received phenobarbital concomitantly, the area under the pharmacokinetic curve “concentration-time” of montelukast decreased by about 40%, but dosing regimen adjustment is not required in these patients. Since montelukast is metabolized by CYP3A4 isoenzyme, caution should be exercised, especially in children, if montelukast is simultaneously used with CYP3A4 isoenzyme inducers, such as phenytoin, phenobarbital and rifampicin.

Montelukast can be prescribed together 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 had no clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinylestradiol/noretinodrel 35/1), terfenadine, digoxin and warfarin.

In in vitro studies it was found that montelukast is a strong inhibitor of CYP2C8 isoenzyme. However, in the study of drug interaction in vivo of montelukast and rosiglitazone (marker substrate, a representative of drugs primarily metabolized by CYP2C8 isoenzyme) there was no confirmation of inhibition of CYP2C8 isoenzyme by montelukast. Thus, in clinical practice, the effect of montelukast on CYP2C8-mediated metabolism of a number of drugs, including paclitaxel, rosiglitazone, repaglinide is not expected.

In vitro studies have shown that montelukast is a substrate of CYP2C8 isoenzyme, and to a lesser extent, CYP2C9 and 3A4 isoenzymes. Data from a clinical drug interaction study regarding montelukast and gemfibrozil (an inhibitor of both CYP2C8 and 2C9) demonstrate that gemfibrozil increases the systemic effect of montelukast by 4.4 times.

Co-administration of itraconazole, a strong CYP3A4 isoenzyme inhibitor, together with gemfibrozil and montelukast did not result in an additional increase in the effect of systemic effects of montelukast.

The effect of gemfibrozil on the systemic effects of montelukast cannot be considered clinically significant based on safety data when used at doses greater than the approved dose of 10 mg for adult patients (e.g., 200 mg/day for adult patients for 22 weeks and up to 900 mg/day for patients taking the drug for approximately one week no clinically significant adverse effects were observed).

Thus, no dose adjustment of montelukast is required when coadministered with gemfibrozil. According to the results of in vitro studies, no clinically significant drug interactions with other known CYP2C8 isoenzyme inhibitors (e.g., trimethoprim) are expected. In addition, co-administration of montelukast with itraconazole alone did not result in a significant increase in the systemic effect of montelukast.

Combination treatment with bronchodilators

The drug ALMONT is a reasonable addition to monotherapy with bronchodilators, if the latter do not provide adequate control of bronchial asthma. Upon achieving therapeutic effect of ALMONT treatment it is possible to start gradual reduction of the dose of bronchodilators.

Combined treatment with inhaled GCS

The treatment with ALMONT provides additional therapeutic effect for patients using inhaled GCS. Once the condition is stabilized, a gradual reduction in the dose of GCS under medical supervision may be started. In some cases, complete abolition of inhaled GCS is acceptable, but abrupt replacement of inhaled GCS by ALMONT is not recommended.

Special Instructions

Almont is not recommended for the treatment of acute attacks of bronchial asthma. Patients with bronchial asthma are recommended to always carry emergency medications. When an acute attack occurs, short-acting inhaled beta-adrenomimetics should be used. Patients should consult their physician as soon as possible if they need more inhaled short-acting beta-adrenomimetics than usual.

Do not abruptly replace Almont with inhaled or oral GCS therapy. There are no data proving the possibility of reducing the dose of oral GCS against the background of concomitant administration of Montelukast.

In rare cases patients who receive anti-asthmatic drugs, including Montelukast, may develop systemic eosinophilia, which is sometimes accompanied by clinical signs of vasculitis, the so-called Churg-Strauss syndrome, a condition that is treated by taking systemic GCS.

These cases are usually associated with dose reduction or withdrawal of oral GCS therapy. The possibility that leukotriene receptor antagonists may be associated with the development of Churg-Strauss syndrome cannot be excluded or established.

Therefore, physicians should be alerted to the possibility of eosinophilia, vascular rash, increased severity of pulmonary symptoms, cardiac complications, and/or neuropathy in patients. Patients who have developed the above symptoms should be re-examined, and their treatment regimen should be reviewed.

Treatment with the drug Almont does not prevent bronchospasm in patients with hypersensitivity to acetylsalicylic acid, when using acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.

The drug Almont contains aspartame, a source of phenylalanine.

The drug contains lactose monohydrate and should not be taken by patients with rare hereditary diseases: galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Effect on the ability to drive vehicles and mechanisms
As a rule, montelukast does not affect the ability to drive vehicles or operate other mechanisms, but very rarely in some patients drowsiness and dizziness were noted, if these symptoms appear, patients should not drive vehicles and engage in other activities that require concentration and rapid psychomotor reactions.

Contraindications

• Hypersensitivity to the active ingredient or any excipient of the product
• children under 2 years of age (for 4 mg doses) and under 6 years of age (for 5 mg doses);
• Patients with rare hereditary diseases: galactose intolerance, lactase deficiency or glucose-galactose malabsorption;
• phenylketonuria (contains aspartame).

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Side effects

Infectious and parasitic diseases: upper respiratory tract infections.
Blood and lymphatic system disorders: increased susceptibility to bleeding, thrombocytopenia.

Immune system disorders: hypersensitivity reactions, including anaphylaxis, eosinophilic liver infiltration.

Mental disorders: abnormal dreams, including nightmares; hallucinations, insomnia, somnambulism, irritability, anxiety, restlessness; agitation, including aggressive behavior or hostility; tremor, depression, disorientation, suicidal thoughts and behavior (suicidality).

Nervous system disorders: headache, dizziness, somnolence, paresthesia/hypoesthesia, seizures.

Heart disorders: palpitations.

Respiratory system, chest and mediastinum disorders: nasal bleeding.
Gastrointestinal disorders: diarrhea, dry mouth, dyspepsia, nausea, vomiting, abdominal pain, pancreatitis.

Liver and biliary tract disorders: increased alanine aminotransferase and aspartate aminotransferase activity, hepatitis (including cholestatic, hepatocellular and mixed liver lesions).

Skin and subcutaneous tissue disorders: angioedema, tendency to haematoma, urticaria, pruritus, rash, erythema multiforme.

Musculoskeletal and connective tissue disorders: arthralgia, myalgia including muscle cramps.

General disorders and disorders at the injection site: asthenia/fatigue, malaise, edema, pyrexia, thirst.
In very rare cases the development of Churg-Strauss syndrome has been reported during treatment with montelukast (see section “Special Precautions”).

Overdose

Symptoms of drug overdose in patients with chronic bronchial asthma when administered at a dose greater than 200 mg per day for 22 weeks and at a dose of 900 mg per day – for 1 week have not been identified.

There have been reports of acute overdose of montelukast (when administered at least 1 g per day) in the post-marketing period and in clinical studies in adults and children.