KASTAIR 10MGTAB (TABLET)

Dosage / Direction for Use: Adults and children 15 years and older: Orally, 1 tablet once daily. Or as prescribed by a physician. Directions for Use: For patients with allergic rhinitis: The time of administration may be individualized to suit patient needs. Take everyday, at about the same time each day, or, as prescribed by a physician. For patients with asthma with or without coexisting allergic rhinitis: The dose should be taken in the evening to obtain simultaneous peak plasma concentration and peak airway reactivity in the morning. Take at regular intervals (i.e., daily) to be therapeutically effective, even if the patient has no asthma symptoms, or, as prescribed by a physician. For the prevention of exercise-induced bronchoconstriction: Take at least 2 hours before exercise. Do not take an additional dose within 24 hours of a previous dose. Do not take an additional dose to prevent exercise-induced bronchoconstriction if the patient is taking Montelukast daily for chronic asthma or allergic rhinitis. Consult a physician about treatment of exercise-induced bronchoconstriction. Overdosage: Montelukast given in doses up to 200 mg/day for 22 weeks and up to 900 mg/day for approximately a week to adult patients showed no clinically important adverse reactions. Acute overdosages in adults and children given montelukast with a dose as high as 1000 mg have been reported. There were no adverse effects reported in majority of overdosage reports. The most frequent adverse effects observed were abdominal pain, headache, psychomotor hyperactivity, somnolence, thirst, vomiting, and less frequently convulsion. There is no specific information available on the treatment of overdosage with montelukast. In case of overdose, institute supportive and symptomatic therapy, i.e., remove unabsorbed material from the gastrointestinal tract. There is no adequate evidence to support the use of dialysis in the treatment of montelukast overdose. Administration: May be taken with or without food. Contraindications: Hypersensitivity. Special Precautions: Acute Asthma: Montelukast is not indicated for the treatment of acute asthma attacks, including status asthmaticus. Patients should have appropriate short-acting inhaled beta-agonist medication available to treat asthma exacerbations. However, therapy with montelukast can be continued during acute asthmatic attacks. Patients taking montelukast should not discontinue or reduce the dosage of other medicines for asthma unless directed by a physician. Aspirin Sensitivity: Avoid aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) while taking montelukast in patients with known aspirin sensitivity. Neuropsychiatric Events: Neuropsychiatric events have been reported in patients taking montelukast. These postmarketing reports include agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. Patients should inform their physician if these changes occur. Eosinophilic Conditions: Eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy consistent with Churg-Strauss syndrome have been reported in patients with asthma being treated with montelukast. Effects on Ability to Drive and Use Machines: Montelukast is not expected to affect patients' physical coordination (e.g., driving, operating machinery). However, in very rare cases, individuals have reported dizziness or drowsiness. Use in Children: The safety and efficacy of montelukast in infants younger than 6 months old have not been established. Use in Elderly: There were no age-related differences in the efficacy or safety profile of montelukast, but greater sensitivity of some older individuals cannot be ruled out. Use In Pregnancy & Lactation: No adequate and well-controlled studies in pregnant women are available for montelukast. Montelukast should only be used during pregnancy when clearly needed. There have been reports of congenital limb defects in children of patients treated with montelukast. Some of the mothers, however, were receiving various medications in the course of their pregnancies. Since there is no consistent pattern of congenital abnormality development, a relationship between the use of montelukast and the development of congenital anomalies cannot be established. Lactation: It is not known if montelukast is excreted in human milk. Therefore, do not administer to breastfeeding women unless, in the opinion of a physician, the potential benefit of the drug justifies the possible risk to the infant. Adverse Reactions: The most frequently reported adverse effects with montelukast include upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, and otitis. Infection and infestations: Pyuria, skin infection, tooth infection, varicella, viral infection. Blood and lymphatic system disorders: Increased bleeding tendency, thrombocytopenia. Immune system disorders: Hypersensitivity reactions including anaphylaxis. Psychiatric disorders: Agitation including aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide), tic, tremor. Nervous system disorders: Dizziness, drowsiness, hyperkinesia, hypoesthesia, paresthesia, seizure. Eye disorders: Conjunctivitis, myopia. Ear and labyrinth disorders: Ear pain. Cardiac disorders: Palpitations. Vascular disorders: Vasculitis. Respiratory, thoracic and mediastinal disorders: Acute bronchitis, asthma, Churg-Strauss syndrome, epistaxis, laryngitis, nasal congestion, pneumonia, pulmonary eosinophilia, rhinitis/infective rhinitis, sinus headache, tonsillitis, wheezing. Gastrointestinal disorders: Dry mouth, dyspepsia, gastroenteritis/infectious gastroenteritis, nausea, pancreatitis, vomiting. Hepatobiliary disorders: Hepatic infiltration eosinophilic, hepatitis cholestatic, hepatocellular liver injury, mixed-pattern liver injury, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Skin and subcutaneous tissue disorders: Angioedema, atopic dermatitis, bruising, dermatitis, eczema, erythema multiforme, erythema nodosum, Stevens-Johnson syndrome, pruritus, rash, toxic epidermal necrolysis, urticaria. Musculoskeletal and connective tissue disorders: Arthralgia, myalgia including muscle cramps. Renal and urinary disorders: Enuresis in children. General disorders and administration site conditions: Asthenia, dental pain, edema, fatigue, leg pain, malaise, thirst. Injury, poisoning and procedural complications: Trauma.