Monas 10mg ( Montelukast USP )

Description

COMPOSITION
Monas® 10: Each film coated tablet contains Montelukast Sodium USP equivalent to 10 mg Montelukast.
Monas® 5 OFT: Each Oroflash tablet contains Montelukast Sodium USP equivalent to 5 mg Montelukast.
Monas® 4 OFT: Each Oroflash tablet contains Montelukast Sodium USP equivalent to 4 mg Montelukast.
Monas® 5: Each chewable tablet contains Montelukast Sodium USP equivalent to 5 mg Montelukast.
Monas® 4: Each chewable tablet contains Montelukast Sodium USP equivalent to 4 mg Montelukast.
PHARMACOLOGY
Monas® (Montelukast) is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.
INDICATIONS
Monas® is indicated for the prophylaxis and chronic treatment of Asthma, prevention of Exercise-Induced Asthma (EIA) & Relief of symptoms of Allergic Rhinitis (AR) in adults & children.
DOSAGE AND ADMINISTRATION
Route of administration : Oral 6 months – 6 years : 4 mg/day in the evening
6 years – 15 years : 5 mg/day in the evening 15 years and older : 10 mg/day in the evening Monas® (Montelukast) may be taken with or without food.
OR AS DIRECTED BY THE PHYSICIAN.
CONTRAINDICATIONS
Montelukast is contraindicated in patients who are hypersensitive to any component of this product.
WARNING & PRECAUTIONS
Montelukast is not indicated for use in acute asthma attacks. Therapy with montelukast can be continued during acute exacerbations of asthma. Montelukast should not be used as monotherapy for the treatment and management of exercise-induced bronchospasm.
SIDE-EFFECTS
Common side effects : Montelukast has been generally well tolerated. Side effects, which usually are mild, including Diarrhoea, Fever, Gastrointestinal discomfort, Headache,Nausea, Upper respiratory tract infection, Vomiting, dizziness, irritability. The overall incidence of side effects reported with montelukast was comparable to placebo. Rare side effects : Angioedema, impaired concentration, Disorientation, Hallucination, hepatic disorders, memory loss, palpitations.
ADVERSE DRUG REACTION
Blood and lymphatic system disorders: increased bleeding tendency, thrombocytopenia.Immune system disorders: hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration.Neuropsychiatric disorders: agitation, aggressive behavior, anxiousness, depression, insomnia, disorientation, dream abnormalities, hallucinations, irritability, restlessness, somnambulism, suicidal thinking, tremor. Nervous system disorders: drowsiness, paraesthesia/hypoesthesia, seizures.
USE IN PREGNANCY AND LACTATION
There are no adequate and well controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in milk. So caution should be exercised when montelukast is given to a nursing mother.
DRUG INTERACTIONS
With medicine: No dose adjustment is needed when Montelukast is co-administered with Theophylline, Prednisone, Prednisolone, Oral contraceptives, Terfenadine, Digoxin, Warfarin,Gemfibrozil, Itraconazole, Thyroid hormones, Sedative hypnotics, non-steroidal anti-inflammatory agents, Benzodiazepines, Decongestants, and Cytochrome P450 (CYP) enzyme inducers. With food & others: Drug-Food interactions have not been established.
OVERDOSE
No specific information is available on the treatment of overdosage with Montelukast. In chronic asthma studies, Montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and, in short-term studies, up to 900 mg/day to patients for approximately a week without clinically important adverse experiences.
STORAGE
Store below 30º C temperature, protected from light & moisture.
Keep all medicines out of reach of children.