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ETC / RX - Anti-asthmatic - Opesinkast 4, 5, 10

COMPOSITION:

Montelukast 4 mg; 5 mg; 10 mg

Per each film coated tablet.


INDICATIONS:

The prophylaxis and treatment of chronic asthma in adults and children from 6 months and older, including the prevention of day and night-time asthma symptoms, treatment of aspirin-sensitive asthmatic patients, and the prevention of exercise-induced bronchoconstriction.

Relief of day and night-time symptoms of allergic rhinitis (seasonal allergic rhinitis in adult and children from 2 years of age and older, and perennial allergic rhinitis in adult and children from 6 months and older).


ADMINISTRATION AND DOSAGE:

OPESINKAST is taken once daily with or without food. To treat asthma, should be taken in the evening. For allergic rhinitis, the period of treatment depends on requirement of each patient. For patients with both asthma and allergic rhinitis, should take one tablet daily in the evening.
Patients 15 years of age and older with asthma and/or allergic rhinitis: one 10 mg tablet or two 5 mg tablets daily.
Children 6 to 14 years of age with asthma and/or allergic rhinitis: one 5 mg tablet daily.
Children 2 to 5 years of age with asthma and/or allergic rhinitis: one 4 mg tablet daily.
Children 6 months to 2 years of age with asthma and/or perennial allergic rhinitis: one 4 mg tablet daily.

OPESINKAST may be used as add-on therapy for patients who taking other therapies.

Reduce the dose of combined medicines: Bronchoectasia drugs, inhaled or oral corticosteroids. OPESINKAST should not be abruptly substituted for inhaled or oral corticosteroids.


CONTRAINDICATIONS:

Hypersensitivity to any components of this drug.


WARNINGS AND PRECAUTIONS:

If asthma or breathing gets worse, tell your physician immediately.
Not to be used oral montelukast to treat acute asthma attacks. Patients should be advised to keep their usual appropriate rescue medication for this purpose readily available.
May reduce gradually inhaled corticosteroids under physician’s close supervision, but montelukast should not be abruptly substituted for inhaled or oral corticosteroids.
Be alert for any signs of Churg-Strauss syndrome.
Should not take aspirin or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs) if they make asthma worse.
No study about safety and effectiveness of montelukast in pediatric patients less than 6 months.
Pregnancy: No study in pregnant women. Montelukast may be used during pregnancy only if it is considered to be clearly essential.
Lactation: It is not known if montelukast is excreted in human milk. Therefore, this drug may be used in breast-feeding mothers only if it is considered to be clearly essential.


SIDE EFFECTS:

Allergic reactions (including anaphylaxis, angiooedema, pruritus, rash, urticaria, and very rarely hepatic eosinophilic infiltration), dizziness, headache, dream abnormalities, hallucination, drowsiness, excitement, insomnia, paraesthesia or hypoesthesia, seizure (very rare), nausea, vomiting, dyspepsia, diarrhea, abdominal pain, increased AST and ALT, cholestatic hepatitis (very rare), arthralgia, myalgia including muscle cramps, increased bleeding tendency, bruising; palpitation and edema.


INTERACTIONS:

In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following medicinal products: theophylline, prednisone, prednisolone, oral contraceptives (norethindrone 1 mg/ethinyl estradiol 35 mcg), 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.


PRESENTATION:

OPESINKAST 4:   Box of 3 blisters x 10 tablets.

OPESINKAST 5:   Box of 4 blisters x 7 tablets.

OPESINKAST 10: Box of 4 blisters x 7 tablets.