Monocast 10

Generic

Montelukast Sodium

 

Indications

Monocast 10 is indicated for the prophylaxis and chronic treatment of asthma in adults and paediatric patients 12 months of age and older. Monocast is indicated for the relief of symptoms of seasonal allergic rhinitis in adults and paediatric patients 2 years of age and older.

 

Pharmacology

Montelukast is an orally active, selective leukotriene receptor antagonist that inhibits the cysteyl leukotriene receptor (CysLT1). Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Occupation of cysteinyl leukotrienes and leukotrienes receptors is related to the pathophysiology of asthma and allergic rhinitis, including airway edema, smooth muscle contraction, and changes in cellular activity related to inflammatory processes, which contribute to to the signs and symptoms of asthma.

 

Dosage & Administration

General information : Monocast should be taken once daily. For asthma, the dose should be taken in the evening. For seasonal allergic rhinitis, the time of administration may be individualised to suit patients’ needs.Patients with both asthma and seasonal allergic rhinitis should take only one tablet daily in the evening.
Adults and adolescents 15 years of age and older with asthma or seasonal

allergic rhinitis : The dosage is one 10 mg tablet daily. Paediatric patients 6 to 14 years of age with asthma or seasonal allergic

rhinitis : The dosage is one 5 mg chewable tablet daily. No dosage adjustment within this age group is necessary. Paediatric patients 2 to 5 years of age with asthma or seasonal allergic

rhinitis : The dosage is one 4 mg chewable tablet daily. Paediatric patients 12 to 23 months of age with asthma : The dosage is one 4 mg chewable tablet daily to be taken in the evening. Safety and effectiveness in paediatric patients younger than 12 months of age have not been established

 

Interaction

Monocast 10 has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions. In drug interaction studies, the recommended clinical dose of montelukast did not have clinically
important effects on the pharmacokinetics of the following drugs: Theophylline, Prednisolone, oral contraceptives (Norethindrone 1 mg/Ethinyl Oestradiol 35 mg), Terfenadine, Digoxin, and Warfarin. Although additional specific interaction studies were not performed,

Montelukast was used concomitantly with a wide range of commonly prescribed drugs in clinical studies without clinically evident adverse interactions. These medications included thyroid hormones, sedative-hypnotic, non-steroidal anti-inflammatory agents, benzodiazepines, and decongestants. Phenobarbital, which induces hepatic metabolism, decreased the AUC of Montelukast by approximately 40% following a single 10 mg dose of Montelukast. No dosage adjustment for Montelukast is recommended. It is reasonable to employ appropriate clinical monitoring when potent cytochrome P450 enzyme inducers, such as Phenobarbital or Rifampin, are co-administered with Monocast 10.

 

Contraindications

Hypersensitivity to any component of this product.

 

Side Effects

Adolescents and Adults 15 years of age and older : In placebo-controlled clinical trials, Monocast 10 has been evaluated for safety in approximately 2600 adolescent and adult patients of 15 years and older, the following adverse experiences reported with Montelukast occurred in greater than or equal to 1% of patients.

General : Asthenia/fatigue, Fever, Pain;

Gastrointestinal : Dyspepsia, Gastroenteritis;

Nervous System/Psychiatric : Dizziness, Headache;

Respiratory System : Congestion, Cough, Influenza;

Skin : Rash;

Laboratory adverse experiences : ALT increase, AST increase,Pyuria. Paediatric patients 6 to 14 years of age : In paediatric patients receiving montelukast, the following events occurred with a frequency ³ 2% are diarrhoea, laryngitis, pharyngitis, nausea, otitis, sinusitis, and viral infection. With prolonged treatment, the adverse profile did not change significantly.

 

Pregnancy & Lactation

There are no adequate and well-controlled studies of pregnant women. Monocast 10 should be used during pregnancy only when clearly necessary. Montelukast is excreted in human milk. Therefore, caution should be exercised when administering montelukast to breastfeeding mothers.

 

Precautions & Warnings

General : Monocast 10 is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available. Therapy with Montelukast can be continued during acute exacerbation 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.

Monocast 10 should not be used as monotherapy for the treatment and management of exercise induced bronchospasm. Patients who have exacerbation of asthma after exercise should continue to use their usual regimen of inhaled b agonist as prophylaxis and have available for rescue a short acting inhaled b agonist. 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 non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients.

Eosinophilic Conditions : In rare cases, patients on therapy with Monocast 10 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 usually, but not always, have been 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. A causal association between Monocast 10 and these underlying conditions has not been established. 

 

Therapeutic Class

Leukotriene Receptor Antagonist

 

Storage Conditions

Store in a cool, dry place below 30 ° C, protected from light and moisture. Keep this product out of the reach of children.

 

Pharmaceutical Name

Beximco Pharmaceuticals Ltd.

 

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