Sedocast 4 mg 7 chewable tablets

Sedocast 4 mg — 7 Chewable Tablets

Composition:
Each chewable tablet contains:
Montelukast 4 mg.
Excipients:
Mannitol, microcrystalline cellulose, croscarmellose sodium, hypromellose, aspartame, strawberry flavor, magnesium stearate.
Properties:
Selectively blocks leukotriene receptors. Specifically inhibits the CysLT1 receptors of cysteinyl leukotrienes (LTC4, LTD4, and LTE4), which are powerful mediators of chronic persistent inflammation responsible for maintaining bronchial hyperreactivity in bronchial asthma.
When taken orally, montelukast is rapidly and sufficiently absorbed.
Cmax is reached in 2–3 hours.
Bioavailability: 64–73%.
Protein binding: 99%.
Metabolism: in the liver.
Excretion: primarily via bile.
Plasma clearance: 45 ml/min.
It reduces the severity of bronchial and vascular smooth muscle spasms, edema, and the migration of eosinophils and macrophages. Decreases mucus secretion and improves mucociliary clearance.
The bronchodilatory effect begins within one day and lasts for an extended period.
Indications:
Prevention and long-term treatment of bronchial asthma, including day and night symptoms.
Treatment of asthma in patients sensitive to acetylsalicylic acid.
Prevention of exercise-induced bronchospasm.
Relief of symptoms of seasonal and perennial allergic rhinitis.
Method of Administration and Dosage:
Taken orally once daily, regardless of food.
The tablet may be chewed or swallowed whole.
For asthma:
Take in the evening.
For allergic rhinitis:
Can be taken at any time of the day.
For patients with both conditions:
Take 1 tablet once daily in the evening.
Children aged 6 to 14 years:
1 chewable tablet (4 mg) once daily.
No dose adjustment required.
Adults and children over 15 years:
10 mg montelukast once daily.
The therapeutic effect begins within the first day.
Continue treatment during both controlled and exacerbated phases of asthma.
Elderly patients, patients with renal impairment, or with mild to moderate hepatic dysfunction:
No dosage adjustment required.
Sedocast may be used alongside bronchodilators and inhaled corticosteroids.
Contraindications:
Hypersensitivity to any component of the drug.
Children under 6 years of age.
Phenylketonuria.
Precautions:
The effectiveness of oral montelukast for acute asthma attacks has not been established. Therefore, it should not be used to treat acute attacks. Patients should always carry emergency medications (e.g., short-acting inhaled beta2-agonists).
Do not discontinue montelukast during asthma exacerbations or while using emergency asthma medications.
Side Effects:
Usually mild and do not require discontinuation.
Nervous system:
Headache, dizziness, drowsiness, paresthesia/dysesthesia, seizures.
Cardiovascular system:
Palpitations.
Respiratory system and chest:
Epistaxis, pulmonary eosinophilia.
Psychiatric disorders:
Agitation (including aggression or hostility), anxiety, depression, disorientation, attention disturbances, vivid dreams, hallucinations, insomnia, memory issues, irritability, restlessness, tremor, somnambulism, suicidal thoughts and behavior.
Gastrointestinal tract:
Diarrhea, dyspepsia, nausea, vomiting, pancreatitis, abdominal pain.
Liver and biliary tract:
Elevated ALT/AST, hepatitis (cholestatic, hepatocellular, or mixed forms).
Musculoskeletal system:
Arthralgia, myalgia, muscle cramps.
Blood and lymphatic system:
Bleeding tendency, thrombocytopenia.
Skin and subcutaneous tissue:
Bruising tendency, erythema nodosum, erythema multiforme, itching, rash, urticaria, angioedema.
Immune system:
Hypersensitivity reactions, including anaphylaxis and eosinophilic liver infiltration.
Storage Conditions:
Store at a temperature not exceeding 30°C.
Packaging:
A cardboard box contains a blister pack of 7 chewable tablets.