Syrup Manufacturer/Distributor: Aristopharma Limited Generic Name: Theophylline 100 ml Syrup
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Indications
Theophylline is used to treat acute asthma attacks.
Chronic asthma management (For both Symptomatic and prophylactic treatment).
For overnight asthma and early morning wheeze management.
Acute exacerbation of chronic obstructive pulmonary disease (Chronic bronchitis and emphysema) and management of chronic obstructive pulmonary disease (Chronic bronchitis and emphysema).
Control of prematurity apnea.
Pharmacology
Theophylline is a bronchodilator, structurally classified as a Methylxanthine. Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation and suppression of the response of the airways to stimuli. Theophylline also increases the force of contraction of diaphragmatic muscles. The half-life of Theophylline is influenced by a number of known variables. In adult nonsmokers with uncomplicated asthma, the half-life ranges from 3 to 9 hours
Dosage and Administration
The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects. Most of the sustained release preparations may be administered every 12 hours in adults while administration every 8 hours may be necessary for some children with markedly rapid hepatic
metabolism of theophylline. The recommended maintenance dose within the accepted therapeutic range is as follows :
16 years or older: 10 mg/Kg/day (Do not exceed 900 mg/day)
12 years-15 years: 13 mg/Kg/day
9-11 years: 16 mg/Kg/day
1 year-8 years: 24-24 mg/Kg/day
6 months-1 year: 12-18 mg/Kg/day
1-6 months: 10 mg/Kg/day.
Interaction
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 therefore be necessary to increase the dosage. On the other hand, the clearance of the drug is reduced by allopurinol, cimetidine, ciprofloxacin, corticosteroids, erythromycin, frusemide, isoprenaline, oral contraceptive, and thiabendazole and a reduced dosage may therefore be needed to avoid side effects. Theophylline can potentiate hypokalemia resulting from beta-2-agonist therapy, steroids, diuretics, and hypoxia, so serum potassium levels should be monitored in such instances.
Contraindications
Patients who are hypersensitive to theophylline or any other component of the product should avoid using it.
Side Effects
Generally, side effects are rare at normal dosages. It may include gastrointestinal discomfort, headache, nausea, insomnia, and hypotension. CNS stimulation and diuresis may also occur, especially in children.
Pregnancy & Lactation
It is not known whether Theophylline can cause fetal harm when administered to pregnant women. Xanthines should be given to a pregnant woman only if clearly needed. Theophylline is excreted into breast milk and may cause irritability or other signs of mild toxicity in nursing human infants. Serious adverse effects in the infant are unlikely unless the mother has toxic serum Theophylline concentrations.
Precautions & Warnings
Various interacting medicines and physiologic circumstances that can affect Theophylline clearance must be carefully considered. Before starting Theophylline therapy, prior to increasing the Theophylline dose, and throughout follow-up, dosage adjustments are required. The dose of Theophylline used for the commencement of therapy should be low and gradually raised over time if tolerated.
Storage Conditions
Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.
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