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Singulair® oral tablets

Manufacturer:
Merck Frosst

Generic Name:
montelukast sodium

Product Illustration Form:
tablet

Route:
oral


Why is it prescribed?

Singulair® oral tablets contains montelukast sodium.

Montelukast is indicated in adult and pediatric patients 2 years of age and older for the prevention and chronic treatment of asthma, including prevention of day- and night-time symptoms, the treatment of acetylsalicylic acid (ASA)-sensitive asthmatic patients, and the prevention of exercise-induced bronchoconstriction.
Montelukast is effective alone or in combination with other agents used in the maintenance treatment of chronic asthma. Montelukast and inhaled corticosteroids may be used concomitantly with additive effects to control asthma or to reduce the inhaled corticosteroid dose while maintaining clinical stability.
In patients who continue to experience asthma symptoms, Montelukast can be an additional treatment option following initial management with an “as needed” short-acting beta-agonist (SABA), an inhaled corticosteroid, or inhaled corticosteroid together with a long-acting beta agonist.
In adults, Montelukast can be a treatment option after “as needed” SABAs if patients remain symptomatic and cannot or will not use an inhaler device or would prefer not to be treated with an inhaled corticosteroid.
In children, Montelukast can be a treatment option after “as needed” SABAs if patients remain symptomatic and cannot appropriately use an inhaler device.
Montelukast can be a treatment option in patients who experience exercise-induced bronchoconstriction.
Montelukast is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years old or older. Montelukast should be considered when other treatments are not effective or not tolerated

 

Side Effects

Singulair® oral tablets contains montelukast sodium.

Along with its needed effects, montelukast may cause some unwanted or undesirable effects. Generally, montelukast is well tolerated and many people will not experience unwanted effects. The frequency and severity of these effects is dependant on many factors including dose, duration of therapy and individual susceptibility. Possible unwanted effects include:

  • stomach pain
  • headache
  • thirst
  • diarrhea
  • hyperactivity
  • skin rash
  • allergy

If these symptoms persist, are very troublesome, or if any unusual symptom appears consult with your pharmacist or doctor.
Very rarely, more serious adverse effects may occur. These include:
  • agitation including aggressive behavior (including temper tantrums in pediatric patients), very rarely reported as serious; anxiousness, depression, irritability, restlessness, sleep disorders including dream abnormalities and insomnia, suicidal thinking and behavior (suicidality), tremor, visual hallucinations.
  • increased bleeding tendency
  • hypersensitivity reactions including anaphylaxis, and very rarely, hepatic eosinophilic infiltration
  • dizziness, drowsiness, paraesthesia/hypoesthesia, and very rarely seizure
  • palpitations
  • nose bleeds
  • diarrhea, dyspepsia, nausea, vomiting

If any of the above, rare adverse reactions occur, they should be reported to your doctor.

 

Precautions and Warnings for Singulair® oral tablets

Singulair® oral tablets contains montelukast sodium

It is important to understand that montelukast is not a bronchodilator and should not be used as rescue medication in acute asthmatic episodes. You should have a short-acting bronchodilator (e.g. salbutamol) available for rescue purposes.
Monteleukast can be used alone or with inhaled and oral cortiosteroids (e.g. fluticasone) to prevent asthma attacks.
Do not stop taking or reduce the dosage of your other asthma medications without consulting your doctor.
Some people taking montelukast may be able to reduce or stop corticosteroid medication. If your doctor decides this is appropriate for you, reduce your corticosteroid dose gradually and report any increase in asthma symptoms to your doctor immediately.
Drug Interactions: To date, there have been no reports of drug interactions involving montelukast. However, it is still important that you inform your doctor and pharmacist of all the prescription and over-the counter medications that you are taking.
Use is not recommended in the following situations:

  • allergy to montelukast or any component of the formulation

Caution is recommended in the following situations:
  • severe liver disease
  • phenylketonuria (chewable tablets only)

Use in pregnanacy: If you suspect you are pregnant or you plan to become pregnant, consult your doctor or pharmacist.
Use while breastfeeding: It is not known whether or not montelukast is passed into breast-milk. Consult your doctor or pharmacist before using montelukast while breastfeeding.

 

Patient Information

Since Singulair® is used to prevent asthma attacks, it should be taken regularly as prescribed even when you are not experiencing asthma symptoms.
Keep a diary of the time, frequency, and severity of your asthma attacks for the first three months after starting Singulair®. This will help your doctor assess how well you are responding to the new medication and assist him/her in adjusting the therapy for maximum benefit.
Singulair® is taken once daily in the evening with or without food.
It is important not to adjust your dosage without first consulting your doctor. If you miss a dose, ignore the missed dose and take the next dose at the scheduled time. Never take two doses at once.
Store at room temperature (15 to 30 degrees centigrade) in a dry place.

 

Directions for Use

The recommeded dose of Singulair® tablets for adults and adolescents 15 years and older is 10 mg once daily in the evening.

 

Lung Diseases Treated with this Drug

  • allergic rhinitis
  • allergies
  • asthma
  • exercise-induced bronchospasm
  • seasonal allergies

 

Need More Information?

For more information contact your physician, pharmacist, other health care professional or for general questions call your local lung association.