Molukat 4

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Description

Keep out of reach of children.

Read all of this leaflet carefully before you start taking this medicine.

For prescription only.

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Active ingredients:

Montelukast (as montelukast sodium) ……….………. 4 mg

Excipients: Mannitol, microcrystalline cellulose type 101, aspartame, red ferric oxide, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, strawberry-flavored powder, tutti fruiti flavor, povidone.

PHARMACEUTICAL FORM: Chewable tablet.

Product description: An oval, brownish orange, chewable tablet, plain on one side, a sign ┼ on the other, intact edges.

THERAPEUTIC INDICATIONS: Montelukast is indicated in the treatment of asthma as add-on therapy in those 2 to 5 years old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short-acting β-agonists provide inadequate clinical control of asthma.

Montelukast may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 years old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids.

Montelukast is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction.

Montelukast is indicated for the relief of symptoms of daytime and night-time allergic rhinitis (seasonal allergic rhinitis in adults and children who are at least 2 years old and perennial allergic rhinitis in adults and children who are at least 6 months old).

POSOLOGY AND METHOD OF ADMINISTRATION:

The tablets are to be chewed or ground before oral administration.

The dosage for paediatric patients 2 - 5 years of age is one 4 mg chewable tablet daily.

For asthma, motelukast should be taken in the evening. For allergic rhinitis, the time of administration may be individualized to suit patient needs. Patients with both asthma and allergic rhinitis should take only one montelukast dose daily in the evening.

If taken in connection with food, montelukast should be taken 1 hour before or 2 hours after food.

General recommendations:

The therapeutic effect of montelukast on parameters of asthma control occurs within one day. Patients should be advised to continue taking montelukast even if their asthma is under control, as well as during periods of worsening asthma.

No dosage adjustment is necessary for paediatric patients in each age group and each sex, for elderly patients, those with renal insufficiency, or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment.

Therapy with montelukast in relation to other treatments for asthma:

Montelukast may be used in combination for patients are following other therapies. The combination dose should be reduced:

Bronchodilators: Montelukast can be added to therapy for patients who are not adequately controlled with bronchodilators only. When there is evidence of clinical response, usually after the first dose, the dose of bronchodilator may be reduced if tolerated.

Inhaled corticosteroids are used concurrently with montelukast to have more treatment benefits for patients receiving inhaled corticosteroids. The dose of corticosteroids may be reduced if tolerated. However, the dose of corticosteroids must be gradually reduced under medical supervision. Montelukast should not be abruptly substituted for inhaled corticosteroids.

CONTRAINDICATIONS:

Hypersensitivity to any components of the drug.

SPECIAL WARNING AND PRECAUTIONS FOR USE:

Patients should be advised that oral montelukast is not for the treatment of acute asthma attacks.

While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, montekulast should not be abruptly substituted for inhaled or oral corticosteroids.

Neuropsychiatric events have been reports in patients taking montelukast. Patients and prescribers should be discussed about the neuropsychiatric events. Patients should be instructed to notify their prescriber if these changes occur.

Some events have been sometimes associated with the reduction of systemic corticosteroid therapy in patients taking other anti-asthma medications, including leukotriene receptor antagonists. They include eosinophilia, rash, shortness of breath, cardiac complications and/or neuropathy, presenting with Churg-Strauss syndrome, a systemic vasculitis associated with eosinophilia. A causal association with leukotriene receptor antagonists has not been established, caution and closely clinical monitor should be exercised when reducing systemic corticosteroids dose in patients taking montelukast.

The drug contains aspartame, a source of phenylalanine. Patients with phenylketonuria should not take this medicine.

USE IN PREGNANCY AND LACTATION:

There are no adequate and well-controlled studies in pregnant women. Montelukast may be used during pregnancy only if clearly needed.

It is not known if montelukast is excreted in human milk. It is used with caution in breast-feeding mothers.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

No evidence shows that the drug affects the ability to drive and use machines.

INTERACTIONS:

Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma and allergic rhinitis. In drug-interactions studies, the recommended dose of montelukast did not have important effects on the pharmacokinetics of the following medicinal products: theophylline, prednisolone, oral contraceptives (ethinyl oestradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.

The area under the plasma concentration curve (AUC) for montelukast was decreased approximately 40% in subjects with co-administration of phenobarbital. Since montelukast is metabolised by CYP 3A4, caution should be exercised, particularly in children, when montelukast is co-administered with inducers of CYP 3A4 such as phenytoin, phenobarbital and rifampicin.

In vitro studies have shown that montelukast is a potent inhibitor of CYP 2C8. However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate representative of medicinal products primarily metabolised by CYP 2C8) demonstrated that montelukast does not inhibit CYP 2C8 in vivo. Therefore, montelukast is not anticipated to markedly alter the metabolism of medicinal products metabolised by this enzyme (eg., paclitaxel, rosiglitazone, and repaglinide).

UNDESIRABLE EFFECTS:

Adverse reactions reported in post-marketing use are recorded by frequency and system organ class.

Very common (ADR ≥ 1/ 10)

Infections: upper respiratory infection.

Common (1/ 100 ≤ ADR <1/ 10)

Gastrointestinal disorders: diarrhoea, nausea, vomiting. Skin and subcutaneous tissue disorders: rash. Hepatobiliary disorders: elevated levels of serum transaminases (ALT, AST). General disorders and administration site conditions: fever.

Uncommon (1/ 1 000 ≤ ADR <1/ 100)

Immune system disorders: hypersensitivity reactions. Psychiatric disorders: agitation including aggressive behaviour or hostility, anxiety, depression, disorientation, illusion, insomnia, excitement. Nervous system disorders: dizziness, drowsiness, paraesthesia. Respiratory, thoracic and mediastinal disorders: epistaxis. Gastrointestinal disorders: dry mouth, dyspepsia. Skin and subcutaneous tissue disorders: bruising, urticaria, pruritus. Musculoskeletal and connective tissue disorders: arthralgia, myalgia. General disorders and administration site conditions: asthenia, fatigue, oedema.

Rare (1/ 10 000 ≤ ADR <1/ 1 000)

Blood and lymphatic system disorders: increased bleeding tendency. Psychiatric disorders: disturbance in attention, memory impairment. Cardiac disorders: palpitations. Skin and subcutaneous tissue disorders: angioedema.

Very rare (ADR < 1/ 10 000)

Immune system disorders: hepatic eosinophilic infiltration. Psychiatric disorders: hallucinations, disorientation, suicidal thinking and behaviour (suicidality). Respiratory, thoracic and mediastinal disorders: Churg-Strauss Syndrome (CSS), pulmonary eosinophilia. Hepatobiliary disorders: hepatitis. Skin and subcutaneous tissue disorders: erythema nodosum, erythema multiforme.

Please inform your physician of all adverse effects upon drug administration.

OVERDOSE:

No specific information is available on the treatment of overdose with montelukast. There were no adverse experiences in the majority of overdose reports. The most frequently occurring adverse experiences included somnolence, abdominal pain, thirst, headache, vomiting, and psychomotor hyperactivity. It is not known whether montelukast is dialysable by peritoneal- or haemo-dialysis.

PHARMACODYNAMICS:

ATC Code: R03D C03

The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are important pro-asthmatic mediators bind to cysteinyl leukotriene receptors (CysLT). CysLT1 is found in the human airway. In asthma, leukotriene-medicated effects include airway actions, including bronchoconstriction, mucous secretion, vascular permeability, and eosinophil recruitment. In allergic rhinitis, CysLTs are released from the nasal musosa after allergen exposure and are associated with symptoms of allergic rhinitis. CysLT in nose increases in airway resistance and symptoms of nasal obstruction.

Montelukast has an anti-inflammatory property. Montelukast strongly inhibits physiologic actions of LTC4, LTD4, LTE4 at the CysLT1; so it reduces the symptoms of asthma and allergic rhinitis. In asthmatics, montelukast causes bronchiectasis in 2 hours after ingestion.

PHARMACOKINETICS:

Montelukast is rapidly absorbed following oral administration. Food did not clinically affect when taking the drug for a long time. After administration of the 4 mg chewable tablet to paediatric patients 2 to 5 years of age in the fasted state, Cmax is achieved 2 hours after administration. Montelukast is more than 99% bound to plasma proteins. Montelukast is extensively metabolized. Montelukast and its metabolites are excreted almost exclusively via the bile. The mean plasma half-life of montelukast ranged from 2.7 to 5.5 hours in healthy young adults.

PRESENTATION:

Box of 3 blisters x 10 chewable tablets.

SHELF-LIFE: 36 months from the manufacturing date.

STORAGE CONDITIONS: Store in dry places, not exceeding 30oC, protect from light.

SPECIFICATIONS: Manufacturer’s.

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