1. NAME OF THE MEDICINAL
Montelukast Sandoz 10 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains montelukast sodium, which is equivalent to
10 mg montelukast.
Excipient: Lactose 84.7 mg per tablet
For a full list of excipients, see 6.1.
3. PHARMACEUTICAL FORM
Beige, squared, biconvex, film-coated tablet, encoded 10 on one side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the prophylaxis and chronic treatment of asthma in adults and pediatric
patients 12 months of age and older.
Montelukast is indicated in adults and pediatric patients 2 years of age
and older for the relief of daytime and nighttime symptoms of seasonal
4.2 Posology and method of administration
Montelukast 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.
Adults 15 Years of Age and Older with Asthma and/or Seasonal Allergic
The dosage for adults 15 years of age and older is one 10-mg tablet daily.
Pediatric Patients 6 to 14 Years of Age with Asthma and/or Seasonal
The dosage for pediatric patients 6 to 14 years of age is one 5-mg chewable
Pediatric Patients 2 to 5 Years of Age with Asthma and/or Seasonal
The dosage for pediatric patients 2 to 5 years of age is one 4-mg chewable
tablet daily or one packet of 4-mg oral granules daily.
Pediatric Patients 12 months to 2 Years of Age with Asthma
The dosage for pediatric patients 12 months to 2 years of age is one packet
of 4-mg oral granules daily.
Administration of oral granules:
Montelukast oral granules can be administered either directly in the mouth,
or mixed with a spoonful of cold or room temperature soft food (e.g.,
applesauce) or dissolved in 1 teaspoonful (5 ml) of cold or room temperature
baby formula or breast milk. The packet should not be opened until ready to
use. After opening the packet, the full dose of Montelukast oral granules
must be administered immediately (within 15 minutes). If mixed with food or
dissolved in baby formula or breast milk, Montelukast oral granules must not
be stored for future use. Montelukast oral granules are not intended to be
dissolved in any liquid other than baby formula or breast milk for
administration. However, liquids may be taken subsequent to administration.
The therapeutic effect of Montelukast on parameters of asthma control occurs
within one day. Montelukast tablets, chewable tablets, and oral granules can
be taken with or without food. Patients should be advised to continue taking
Montelukast while their asthma is controlled, as well as during periods of
No dosage adjustment is necessary for pediatric patients, for the
elderly, for patients with renal insufficiency, or mild-to-moderate hepatic
impairment, or for patients of either gender.
Montelukast is a long term-controller medication which should not be
substituted for short acting beta-agonists. It is effective alone or in
combination with other prophylactic agent.
Montelukast is a preventive agent, which should be used in addition to
other drugs for the management of asthma.
Therapy with Montelukast in Relation to Other Treatments for Asthma
Montelukast can be added to a patient's existing treatment regimen.
Reduction in Concomitant Therapy:
Bronchodilator Treatments: Montelukast can be added to the treatment regimen
of patients who are not adequately alone. When a clinical response is
evident (usually after the first dose), the patient's bronchodilator therapy
can be reduced as tolerated.
Inhaled Corticosteroids: Treatment with Montelukast provides additional
clinical benefit to patients treated with inhaled corticosteroids. A
reduction in the corticosteroid dose can be made as tolerated. The dose
should be reduced gradually with medical supervision. In some patients, the
dose of inhaled corticosteroids can be tapered off completely. Montelukast
should not be abruptly substituted for inhaled corticosteroids.
Mode of Administration
Hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings and precautions for use
The efficacy of oral Montelukast for the treatment of acute asthma attacks
has not been established. Therefore. oral Montelukast treat acute asthma
attacks. Patients should be advised to have appropriate rescue medication
While the dose of concomitant inhaled corticosteroid may be reduced
gradually under medical supervision, Montelukast should not be abruptly
substituted for inhaled or oral corticosteroids.
Neuropsychiatric events (eg, agitation, aggression, anxiousness, dream
abnormalities, hallucinations, depression, disorientation, insomnia,
irritability, restlessness, suicidal thinking and behavior (including
suicide), tremor) have occurred. Since other factors may have contributed to
these events, it is not known if they are related to Montelukast. Physicians
should discuss these adverse experiences with their patients and/or
Patients and/or caregivers should be instructed to notify their physician
if these changes occur.
The reduction in systemic corticosteroid dose in patients receiving
anti-asthma agents including leukotriene receptor antagonists has been
followed in rare cases by the occurrence of one or more of the following:
eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac
complications, and/or neuropathy sometimes diagnosed as Churg-Strauss
syndrome, a systemic eosinophilic vasculitis. Although a causal relationship
with leukotriene receptor antagonism has not been established, caution and
appropriate clinical monitoring are recommended when systemic corticosteroid
reduction is considered in patients receiving Montelukast.
Patients with known aspirin sensitivity should continue avoidance of
aspirin or non-steroidal anti-inflammatory 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 documented aspirin
This medicinal product contains lactose. Patients with rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of
Montelukast may be administered with other therapies routinely used in the
prophylaxis and chronic treatment of asthma, and in the treatment of
Montelukast is not anticipated to alter the metabolism of drugs
metabolized by this enzyme (e.g., paclitaxel, rosiglitazone, repaglinide).
Concurrent use of gemfibrozil and montelukast may result in elevated
montelukast plasma concentrations montelukast.
Concurrent use of prednisone and montelukast may result in severe
Concurrent use of montelukast and repaglinide may result in increased
repaglinide plasma concentrations.
Montelukast is metabolised by CYP 3A4, caution should be exercised,
particularly in children, when montelukast is coadministered with inducers
of CYP 3A4, such as phenytoin, phenobarbital and rifampicin.
Concurrent use of montelukast and phenobarbital may result in decreased
bioavailability of montelukast.
Concurrent use of montelukast and rifampin may result in decreased
bioavailability of montelukast.
4.6 Pregnancy and lactation
The safety and efficacy of montelukast have not been determined in pregnant
women. Rarely, congenital limb defects have been reported during
postmarketing surveillance; however, causality has not been established.
Due to the lack of human safety information, montelukast should be used
in pregnant women only if the potential benefit outweighs the potential risk
to the fetus.
Lactation studies with montelukast in humans have not been conducted.
Montelukast is excreted into the milk of lactating rats. Until further data
are available, caution is advised if montelukast is used in nursing women.
Available evidence and/or expert consensus is inconclusive or is
inadequate for determining infant risk when used during breastfeeding. Weigh
the potential benefits of drug treatment against potential risks before
prescribing this drug during breastfeeding.