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Antihistamines & Antiallergics

Asthmatin 4

 

Pack size:

Box of 3 blisters x 10 chewable tablets.

 

Composition:

Each chewable tablet contains montelukast (as montelukast sodium) 4 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 prophylaxis 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, efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.  
     
  • Dosage 
    Asthma
    Adults and adolescents 15 years of age and older: one 10-mg tablet.
    Pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
    Pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one packet of 4-mg oral granules.
    Pediatric patients 12 to 23 months of age with asthma: one packet of 4-mg oral granules.
    Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
    Allergic rhinitis
    Seasonal allergic rhinitis:
    Adults and adolescents 15 years of age and older: one 10-mg tablet.
    Pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
    Pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one packet of 4-mg oral granules.
    Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.
    Perennial allergic rhinitis:
    Adults and adolescents 15 years of age and older: one 10-mg tablet.
    Pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
    Pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one packet of 4-mg oral granules.
    Pediatric patients 6 to 23 months of age with asthma: one packet of 4-mg oral granules.
    Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.

Using suitable dosage forms for each age is recommended.

Or as prescribed by physicians.

 

  • Known hypersensitivity to any ingredient in the formulation.

     

  • Blood and lymphatic system disorders:
    ncreased bleeding tendency.
  • Immune system disorders:
    Hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration.
  • Psychiatric disorders:
    Dream abnormalities including nightmares, hallucinations, psychomotor hyperactivity (including irritability, restlessness, agitation including aggressive behavior, and tremor), depression, insomnia, suicidal thinking and behavior.
  • Nervous system disorders:
    Dizziness, drowsiness, paraesthesia/hypoesthesia, seizures.
  • Cardiac disorders:
    Palpitations.
  • Respiratory disorders:
    Epistaxis, Churg-Strauss syndrome.
  • Gastrointestinal disorders: 
    Diarrhoea, dry mouth, dyspepsia, nausea, vomiting.
  • Hepatobiliary disorders:
    Elevated levels of serum transaminases (ALT, AST), cholestatic hepatitis.
  • Skin and subcutaneous tissue disorders:
    Angioedema, bruising, urticaria, pruritus, rash, erythema nodosum.
  • Musculoskeletal and connective tissue disorders:
    Arthralgia, myalgia including muscle cramps.
  • General disorders:
    Asthenia/fatigue, malaise, oedema.
     

  • Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Patients should be advised to have appropriate rescue medication available. Therapy with montelukast can be continued during acute exacerbations of asthma.
  • While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, montelukast should not be abruptly substituted for inhaled or oral corticosteroids.
  • Montelukast should not be used as monotherapy for the treatment and management of exercise-induced bronchospasm. Patients who have exacerbations of asthma after exercise should continue to use their usual regimen of inhaled beta-agonists as prophylaxis and have available for rescue a short- acting inhaled beta-agonist. 
  • Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-flammatory agents while taking montelukast. Although montelukast is effective in improving airway function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other non-steroidal anti-flammatory drugs in aspirin-sensitive asthmatic patients. 
  • Neuropsychiatric events: Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking Asthmatin. Reports of using montelukast use include agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. Patients and prescribers should be alert for neuropsychiatric events. Patients should be instructed to notify their prescriber if these changes occur. Prescribers should carefully evaluate the risks and benefits of continuing treatment with Asthmatin if such events occur.
  • Eosinophilic conditions: Patients with asthma on therapy with Asthmatin may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events have been sometimes associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. 
  • Phenylketonuria: Phenylketonuric patients should be informed that Asthmatin contains aspartame 0.4 mg per Asthmatin 4 tablets.
  • 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.
  • 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. 
  • Because montelukast causes some adverse reactions in psychiatry and nervous system (see “adverse reaction” below), in very rare cases, individuals have reported drowsiness or dizziness. Therefore, caution should be exercised when patients drive or operate machinery.

     

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

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Email : stada@stada.com.vn
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