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Montelukast Sandoz

Montelukast Sandoz 10 mg film-coated tablets

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.

Film-coated tablet.
Beige, squared, biconvex, film-coated tablet, encoded 10 on one side.

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 allergic rhinitis.

4.2 Posology and method of administration
Recommended Dosage
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 Rhinitis
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 Allergic Rhinitis
The dosage for pediatric patients 6 to 14 years of age is one 5-mg chewable tablet daily.

Pediatric Patients 2 to 5 Years of Age with Asthma and/or Seasonal Allergic Rhinitis
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.

General Recommendations
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 worsening asthma.

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

4.3 Contraindications
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 available.

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 caregivers.

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 sensitivity.

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 interaction
Montelukast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma, and in the treatment of allergic rhinitis.

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 peripheral edema.

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.

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