Each film coated tablet contains:
Montelukast sodium 10.37 mg
Eq. to Montelukast 10 mg
kokast is indicated in adults and pediatris for the prophylaxis and chronic treatment of asthma ,including the prevention of day-and night time symptoms , the treatment of aspirin-asthmatic patients, and the prevention of exercise –induced broncho constriction.
Kokast is indicated for the relief of daytime and nighttime symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older).
Kokast 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 12 years of Age and Older with Asthma and/or Seasonal Allergic Rhinitis The dosage for adults 12 years of age and older is one 10-mg tablet daily.
The therapeutic effect of Kokast on parameters of asthma control occurs within one day.
Kokast tablets, chewable tablets can be taken with or without food.
Patients should be advised to continue taking Kokast while their asthma is controlled, as well as during periods of worsening asthma.
No dose adjustment is necessary for pediatric patients, for the elderly, for patients
with renal insufficiency, or mild to moderate hepatic impairment or for patients of other gender.
Therapy with kokast in relation to other treatments for asthma
Kokast can be added to patients existing treatment regimen.
Reduction in concomitant:
Bronchodilator treatments: Kokast can be added to treatment regimen of patients who are not adequately controlled on bronchodilator 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 KOKAST 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. KOKAST should not be abruptly substituted for inhaled corticosteroids.
Hypersensitivity to any component of this product.
The efficacy of oral KOKAST for the treatment of acute asthma attacks has not been established therefore, oral KOKAST should not be used to 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, KOKAST should not be abruptly substituted for inhaled or oral corticosteroids.
The reduction in systemic corticosteroid dose in patients receiving anti-asthma agents including leukotriene receptor antagonists has been following in rare cases by the occurrence if one or more of the following: eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy sometimes diagnosed as chug 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 KOKAST.
Treatment with montelukast doesn’t alter the need for patients with aspirin-sensitive asthma to avoid taking aspirin and other non-steroidal anti-inflammatory drugs.
Patients with rare hereditary problems of galactose intolerance, the lapp lactose
deficiency or glucose-galactose malabsorption should not take this medicine.
Psychiatric disorder including suicidal risk
Psychological and neurological effects as Symptoms of anxiety, Thinner, Hallucination, Agitation In addition to a mile and a desire to commit suicide.
Montelukast has been evaluated in clinical studies as follows:
• 10 mg film-coated tablets in approximately 4000 adult asthmatic patients 15 years of age and older.
• 10 mg film-coated tablets in approximately 400 adult asthmatic patients with seasonal allergic rhinitis 15 years of age and older.
• 5 mg chewable tablets in approximately 1750 pediatric asthmatic patients 6 to 14 years of age.
The following drug-related adverse reactions in clinical studies were reported commonly (>1/100 to <1/10) in asthmatic patients treated with montelukast and at a greater incidence than in patients treated with placebo:
Body System Class
15 years and older
(two 12-week studies;
6 to 14 years old
(one 8-week study;
(two 56-week studies;
With prolonged treatment in clinical trials with a limited number of patients for up to 2 years for adults, and up to 12 months for pediatric patients 6 to 14 years of age,
The following adverse reactions have been reported in post-marketing use:
Infections and infestations: upper respiratory infection.
Blood and lymphatic system disorders: increased bleeding tendency.
Immune system disorders: hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration.
Psychiatric disorders: dream abnormalities including nightmares, hallucinations, insomnia, somnambulism, irritability, anxiety, restlessness, agitation including aggressive behavior or hostility, tremor, depression, suicidal thinking and behavior (suicidality) in very rare cases.
Nervous system disorders: dizziness drowsiness, paraesthesia/hypoesthesia, seizure.
Cardiac disorders: palpitations.
Respiratory, thoracic and mediastinal disorders: epistaxis
Gastro-intestinal disorders: diarrhea, dry mouth, dyspepsia, nausea, vomiting.
Hepatobiliary disorders: elevated levels of serum transaminases (ALT, AST), hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury).
Skin and subcutaneous tissue disorders: angioedema, bruising, urticaria, pruritus, rash, erythema nodosum.
Musculoskeletal and connective tissue disorders: arthralgia, myalgia including muscle cramps.
General disorders and administration site conditions: asthenia/fatigue, malaise, oedema, pyrexia.
Very rare cases of Churg-Strauss Syndrome (CSS) have been reported during montelukast treatment in asthmatic patients (see section 4.4).
No specific information is available on the treatment of overdosage with Kokast in chronic asthma studies; Kokast has been administered at doses up to 900 mg/day to patients for approximately one week without clinically important adverse experience.
There have been reports of acute overdosage in children in post marketing experience and clinical studies of up at least 150 mg/day with Kokast. The clinical and laboratory findings observed were consistent with the safety profile in adults and older pediatric patients. There were no adverse experiences reported in the majority of overdosage reports. The most frequent adverse experience observed was thirst, somnolence, mydriasis, hyperkinesias and abdominal pain
It is not known whether montelukast is dialyzable by periloneal or hemodialysis.
KOKAST has not been studied in pregnant women KOKAST should be used during pregnancy only if clearly needed.
It is not known if KOKAST is excreted in human milk because many drugs are excreted in human milk, caution should be exercised when KOKAST is given to a nursing mother.
kokast may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma, and in the treatment of allergic rhinitis. In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisone, oral contraceptives (ethiny1 estradiol / norethindrone 35/1) terfenadin, digoxin and warfarin.
The area under the plasma concentration-time curve (AUC) for montelukast was deceased approximately 40%in subjects with co-administration of Phenobarbital no dosage adjustment for kokast is recommended.
In vitro studies have shown that montelukast is an inhibitor of CYP 2 C8. montelukast may inhibit the metabolism of drugs primarily metabolized by CYP 2C8. (eg .. pacitaxel, rosiglitazone, repaglinide), however no in vivo interaction studies have been performed.
The therapeutic effect of kokast on parameters of asthma control occurs within one day. kokast tablets chewable tablets’ can be taken with or without food.
Patients should be advised to continue taking kokast 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 either gender.
Therapy with kokast in Relation to Other treatments for Asthma, kokast can be added to patient’s existing treatment regimen.
Bronchodilator treatments: kokast can be added to the treatment regimen of patients who are not adequately controlled on bronchodilator alone. When a clinical response is evident (usually after the first dose) the patient’s bronchodilator therapy can be reduced as tolerated.
Kokast 10 mg film coated tablets:
Box containing (Al/PVC) strip of 10 tablets.
Kokast 4mg chewable tablets:
Box containing (Al/PVC) strip of 7 chewable tablets.
Store at temperature not exceeding 30º C in a dry place.
Keep out of the reach of children.