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Theophylline Sodium Glysinate USP
|NAME||STRENGTH||PACK SIZE||DOSAGE FORM|
|Unikon||55 mg / 5 ml||100 ml||Syrup|
Unikon (Theophylline) is a Xanthine derivative bronchodilator; it directly relaxes the smooth muscle of the bronchial airways and smooth pulmonary blood vessels, thus acting mainly as a bronchodilator and smooth muscle relaxant.
Unikon 400 SR Tablet: Each film-coated tablet contains Theophylline USP 400 mg in a sustained release formulation. Unikon Syrup: Each 5 ml syrup contains Theophyline Sodium Glycinate USP 120 mg which is equivalent to 60 mg of Theophyline.
Indications And Uses
1) Control of acute asthma 2) Management of chronic asthma (For both Symptomatic and prophylactic treatment) 3) For controlling nocturnal asthma and early morning wheezing 4) Management of chronic obstructive lung disease (Chronic bronchitis and emphysema) and acute exacerbation of chronic obstructive lung disease 5) Control of apnea of pre-maturity
Dosage And Administration
Dosage & administration: For age: 1-6 months: Dose: 10 (mg/kg/day) For age: 6 months-1 year: Dose: 15 (mg/kg/day) For age:1-9 years: Dose: 18 (mg/kg/day) For age: 10-16 years: Dose:24 (mg/kg/day) For Adults: Dose:10-15 (mg/kg/day)
These usually occur when Theophylline blood levels exceed 20 mgm/ml and include gastric irritation, nausea, vomiting, abdominal discomfort and palpitations, a fall in blood pressure, headache, occasional diarrhoea and insomnia. CNS stimulation and diuresis may also occur.
Use In Pregnancy Lactation
Safety in human pregnancy has not been established. Theophylline crosses the placental barrier & is secreted in breast milk. Theophylline should be used with caution in pregnancy & lactation.
Smoking and alcohol consumption can increase the clearance of Theophylline and a higher dosage may be necessary. Careful monitoring is recommended for patients with congestive heart failure, chronic alcoholism, hepatic dysfunction or viral infections as they may have lower total clearance of Theophylline which could lead to higher than normal plasma levels.
Theophylline should not be used concurrently with other preparations containing xanthine derivatives. The clearance of Theophylline is increased by barbiturates, carbamazepine, lithium, phenytoin, rifampicin and sulphinpyrazone and it may be therefore be necessary to increase dosage. On the other hand the clearance of the drug is reduced by allopurinol, cimetidine, ciprofloxacin, corticosteroids, erythromycin, Frusemide, isoprenaline, oral contraceptives and thiabendazole and a reduced dosage may therefore be needed to avoid side-effects.
Theophylline is contraindicated in individuals who have shown hypersensitivity to Theophylline or other Xanthines. It is also contraindicated in patients with active peptic ulcer disease and in individuals with underlying seizure.
Unikon 400 SR Tablet: Each box contains 10x10 tablets in blister pack. Unikon Syrup: Bottle contains 100 ml syrup and a measuring spoon.