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Antihistamines & Antiallergics

Asthmatin 10

 

Pack size:

Box of 3 blisters x 10 film-coated tablets.
 

Composition:

Each film-coated tablets contains montelukast (as montelukast sodium) 10 mg.


Shelf-life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry  place. Do not store above 30oC.
 
 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • The prophylasis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.
  • The relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older, and perennial allergic rhinitis in adults and pediatric patients 6 months of age and older).
     
  • Asthmatin should be taken once daily. For asthma, the dose 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 tablet daily in the evening.
    Adult and adolescents 15 years of age and older with asthma or allergic rhinitis: 10 mg once daily.
    Pediatric patients 6 to 14 years of age with asthma or allergic rhinitis: 5 mg once daily.
    Pediatric patients 2 to 5 years of age with asthma or allergic rhinitis: 4 mg once daily.
    Pediatric patients 12 to 23 months of age with asthma: 4 mg once daily.
    Pediatric patients 6 to 23 months of age with perennial allergic rhinitis: 4 mg once daily.
    Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis and in patients less than 12 months of age with asthma have not established.


Or as prescribed by physicians.

 

  • Known hypersensitivity to any ingredient of the drug.
     

 

Very Common:

  • Upper respiratory infection.

Common:

  • Diarrhoea, nausea, vomiting.
  • Elevated levels of serum transaminases (ALT, AST).
  • Rash.
  • Pyrexia.

Uncommon:

  • Hypersensitivity reactions including anaphylaxis.
  • Dream abnormalities including nightmares, insomnia, somnambulism, anxiety, agitation including aggressive behaviour or hostility, depression, psychomotor hyperactivity (including irritability, restlessness, tremor).
  • Dizziness, drowsiness, paraesthesia/hypoesthesia, seizure.
  • Epistaxis.
  • Dry mouth, dyspepsia.
  • Bruising, urticaria, pruritus.
  • Arthralgia, myalgia including muscle cramps.
  • Asthenia/fatigue, malaise, oedema.

Rare:

  • Increased bleeding tendency.
  • Disturbance in attention, memory impairment.
  • Palpitations.
  • Angiooedema.

Very rare:

  • Hepatic eosinophilic infiltration.
  • Hallucinations, disorientation, suicidal thinking and behavior (suicidality).
  • Churg-Strauss Syndrome (CSS), pulmonary eosinophilia.
  • Hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury).
  • Erythema nodosum, erythema multiforme.

     

  • In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: Theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/ 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 CYP3A4, 2C8 and 2C9, caution should be exercised, particularly in children, when montelukast is co-administered with inducers of CYP3A4, 2C8 and 2C9, such as phenytoin, phenobarbital and rifampicin.
  • In vitro studies have shown that montelukast is a potent inhibitor of CYP2C8. However, data from a clinical drug-drug interaction study involving montelukast and rosiglitazone (a probe substrate representative of drugs primarily metabolized by CYP2C8) demonstrated that montelukast does not inhibit CYP2C8 in vivo. Therefore, montelukast is not anticipated to markedly alter the metabolism of drugs metabolized by this enzyme (e.g., paclitaxel, rosiglitazone, and repaglinide).
     
  • There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, montelukast should be used during pregnancy only if clearly essential.
  • Lactation: It is not known if montelukast is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when montelukast is given to a nursing mother.
     
  • Montelukast is not expected to affect a patient's ability to drive a car or operate machinery.  However, in very rare cases, individuals have reported drowsiness or dizziness.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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