Generic Name: Singulair

What is Singulair?

Children: The safety and effectiveness of montelukast have not been established for children under 2 years old. Montelukast can be used to treat asthma in children aged 2 years and older and to treat seasonal allergies in adolescents 15 years and older.

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed. Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter non-prescriptionand herbal medications you are taking.

Also tell them about any supplements you take.

In an 8-week study in paediatric patients 6 to 14 years of age, montelukast 5 mg once daily, compared with placebo, significantly improved respiratory function FEV1 8.

Significant reduction of exercise-induced bronchoconstriction EIB was demonstrated in a 12-week study in adults maximal fall in FEV1 22. Cytochrome P450 2C8 is the major enzyme in the metabolism of montelukast. Additionally CYP 3A4 and 2C9 may have a minor contribution, although itraconazole, an inhibitor of CYP 3A4, was shown not to change pharmacokinetic variables of montelukast in healthy subjects that received 10 mg montelukast daily.

Based on in vitro results in human liver microsomes, therapeutic plasma concentrations of montelukast do not inhibit cytochromes P450 3A4, 2C9, 1A2, 2A6, 2C19, or 2D6. The contribution of metabolites to the therapeutic effect of montelukast is minimal. Coupled with estimates of montelukast oral bioavailability, this indicates that montelukast and its metabolites are excreted almost exclusively via the bile.

Characteristics in PatientsNo dosage adjustment is necessary for the elderly or mild to moderate hepatic insufficiency. Studies in patients with renal impairment have not been undertaken. Because montelukast and its metabolites are eliminated by the biliary route, no dose adjustment is anticipated to be necessary in patients with renal impairment. With high doses of montelukast 20- and 60-fold the recommended adult dosedecrease in plasma theophylline concentration was observed. Therapy with Singulair in relation to other treatments for asthma Singulair can be added to a patient's existing treatment regimen.

Paediatric population Do not give Singulair 10 mg film-coated tablets to children less than 15 years of age.

How should I take Singulair?

Can taking montelukast during pregnancy cause other pregnancy complications. A few studies have reported a decrease in infant birth weight when the mother used montelukast during pregnancy. However, this decrease may be the due to more severe or poorly controlled asthma and not the montelukast itself.

The women in these studies who needed montelukast often had severe asthma and sometimes needed more than one medication. One study did not notice a difference in birth weight of babies whose mothers used montelukast when compared to babies whose mothers used other asthma treatments. More studies are needed to confirm the cause of the low birth weight sometimes seen in babies of women with asthma. Is there a concern if my partner was taking montelukast when I got pregnant.

There are no studies looking at paternal use of montelukast prior to or at the time of conception.

What should I avoid while taking Singulair?

This includes any possible side effects not listed in this leaflet. You can also report side effects directly see details below. By reporting side effects you can help provide more information on the safety of this medicine.

Alternatively phone the Asthma UK Adviceline on 08457 010203, Monday to Friday 9 am to 5 pm, calls charged at local rate. Alternatively phone The Asthma Live Line on 01 8788122, Monday, Wednesday, Thursday 10am to 1pm, or 01 8788511 9am to 5pm, or The Asthma Line on callsave 1850 44 5464.

Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

Singulair side effects

The safety of SINGULAIR 4-mg and 5-mg chewable tablets in pediatric patients aged 2 to 14 years with allergic rhinitis is supported by data from studies conducted in pediatric patients aged 2 to 14 years with asthma.

The safety of SINGULAIR 4-mg oral granules in pediatric patients as young as 6 months of age with perennial allergic rhinitis is supported by extrapolation from safety data obtained from studies conducted in pediatric patients 6 months to 23 months of age with asthma and from pharmacokinetic data comparing systemic exposures in patients 6 months to 23 months of age to systemic exposures in adults. The safety and effectiveness in pediatric patients below the age of 12 months with asthma, 6 months with perennial allergic rhinitis, and 6 years with exercise-induced bronchoconstriction have not been established.

A 56-week, multi-center, double-blind, randomized, active- and placebo-controlled parallel group study was conducted to assess the effect of SINGULAIR on growth rate in 360 patients with mild asthma, aged 6 to 8 years. Treatment groups included SINGULAIR 5 mg once daily, placebo, and beclomethasone dipropionate administered as 168 mcg twice daily with a spacer device. For each subject, a growth rate was defined as the slope of a linear regression line fit to the height measurements over 56 weeks.

Common Singulair ide effects may include:

  • A 56-week, multi-center, double-blind, randomized, active- and placebo-controlled parallel group study was conducted to assess the effect of SINGULAIR on growth rate in 360 patients with mild asthma, aged 6 to 8 years.

  • For patients with seasonal allergic rhinitis, take SINGULAIR once a day as prescribed by your doctor.

  • Do not stop any medication or change the dose without first talking to your provider.

  • In vitro studies using human liver microsomes indicate that CYP3A4, 2C8, and 2C9 are involved in the metabolism of montelukast.

Montelukast may also be used for purposes not listed in this medication guide. Montelukast 10 mg-TORround, brown, imprinted with 10MG, 1081Montleukast 4 mg Chew-TORoval, pink, imprinted with 4MG, 1079Montleukast 5 mg Chew-TORround, pink, imprinted with 5 MG, 1080Singulair 10 mgsquare, beige, imprinted with SINGULAIR, MRK 117Singulair 4 mg chewableoval, pink, cherry, imprinted with SINGULAIR, MRK 711Singulair 5 mground, pink, cherry, imprinted with SINGULAIR, MRK 275 featuredcontentslider.

Next Page:What should I discuss with my healthcare provider before taking montelukast Singulair.

Where can I get more information?

  • It is important to remember that 5 mg and 10 mg tablets are not equivalent multiples of each other and should not be interchanged.

  • The safety and efficacy of SINGULAIR in patients with seasonal allergic rhinitis were demonstrated in clinical trials in which the 10-mg film-coated tablet was administered in the morning or evening without regard to the time of food ingestion.