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Tablets containing 225 mg of aminophylline hydrate Ph Eur. PHARMACEUTICAL FORM
Pale yellow, film-coated, modified-release tablet with the Napp logo on one side and SA on Should not be given concomitantly with ephedrine in children. Use in patients with known hypersensitivity to the xanthine group of drugs. CLINICAL PARTICULARS
Special Warnings and Special Precautions for Use
Therapeutic Indications
A reduction of dosage may be necessary in the elderly patient. Alternative treatment is In the treatment and prophylaxis of bronchospasm and inflammation associated with asthma, advised for patients with a history of seizure activity. Caution should be exercised in patients chronic bronchitis and emphysema. Also indicated in adults for the treatment of cardiac asthma and left ventricular or congestive cardiac failure. Severe side effects (cramps, convulsions, supraventricular tachycardia) may appear at very Posology and Method of Administration
Route of Administration
Oral: A controlled-release tablets are not to be chewed or crushed, because that may lead to a It is not possible to ensure bioequivalence between different controlled release theophylline rapid release of aminophylline with the potential for toxicity. The tablets may be halved, if products. Therefore, patients once titrated to an effective dose, should not be changed from required, during the initial week of therapy or for dose titration. theophylline tablets preparations to other slow or sustained release xanthine preparations without re-titration and clinical assessment. Children: The maintenance dose (expressed as mg aminophylline) is 12 mg/kg twice daily adjusted to the nearest 125 mg. It is recommended that half the maintenance dose be given Interaction with Other Medicaments and Other Forms of Interaction
for the first week of therapy if the patient has not previously been receiving xanthine The following increase clearance, and it may, therefore, be necessary to increase dosage of preparations. Some children with chronic asthma require and tolerate much higher doses theophylline to ensure a therapeutic effect: aminoglutethimide, carbamazepine, isoprenaline, (13-20 mg/kg twice daily). Lower doses (based on the usual adult doe) may be required by moracizine, phenytoin, rifampicin, sulphinpyrazone, barbiturates and hypericum perforatum. adolescents. Not recommended for children under 3 years of age. Plasma concentrations of theophylline can be reduced by the concomitant use of the herbal preparation St John’s Wort (hypericum perforatum). Smoking and alcohol consumption can also increase clearance of theophylline. The usual dose is two PHYLLOCONTIN CONTINUS tablets 225 mg twice-daily following an initial week of therapy on one tablet twice-daily. The following reduce clearance of theophylline and a reduced dosage of theophylline may, therefore, be necessary to avoid side-effects: allopurinol, carbimazole, cimetidine, ciprofloxacin, clarithromycin, diltiazem, disulfiram, erythromycin, fluconazole, interferon, The dose should be adjusted following the response to the initial week of therapy on one isoniazid, methotrexate, mexiletine, nizatidine, norfloxacin, propafenone, propranolol, oxpentifylline, ofloxacin, thiabendazole, verapamil, viloxazine hydrochloride and oral contraceptives. The concomitant use of theophylline and fluvoxamine should usually be avoided. Where this is not possible, patients should have their theophylline dose halved and Patients vary in their response to xanthines and it may be necessary to titrate dosage plasma theophylline should be monitored closely. individually. Steady state theophylline levels are generally attained 3-4 days after dose adjustments. If a satisfactory clinical response is not achieved, serum theophylline should be Factors such as viral infections, liver disease and heart failure also reduce theophylline measured 4-6 hours after the last dose. Based on serum theophylline assay results dosage clearance. There are conflicting reports concerning the potentiation of theophylline by should be titrated using the following as a guide: influenza vaccine, and physicians should be aware that interaction may occur. A reduction of dosage may also be necessary in elderly patients. Thyroid disease or associated treatment may alter theophylline plasma levels. There is also a pharmacological interaction with Peak serum theophylline level Dosage adjustment to nearest 125 mg adenosine, benzodiazepines, halothane, lomustine and lithium; these drugs should be used Care should be taken in its concomitant use with β-adrenergic agonists, glucagon and other congestive heart failure leading to marked increase in cardiac output. xanthine drugs, as these will potentiate the effects of theophylline. The incidence of toxic effects may be enhanced by the concomitant use of ephedrine. Pharmacokinetic Properties
Theophylline is distributed through all body compartments, approximately 60% is bound to Hypokalemia resulting from β2 agonist therapy, steroids, diuretics and hypoxia may be plasma proteins. It is metabolised in the liver and excreted mainly in the urine as 1, 3 potentiated by xanthines. Particular care is advised in patients suffering from severe asthma dimethyluric acid, 1 methyluric acid and 3–methylxanthine; approximately 10% is excreted who require hospitalisation. It is recommended that serum concentrations are monitored in such situations. Theophylline may decrease steady state phenytoin levels. The predominant factors which alter theophylline clearance are: age, body weight, diet, A possible drug interaction should be caution in concomitant use of grapefruit or grapefruit smoking habits, other drugs and cardiorespiratory or hepatic disease. Preclinical Safety Data
Pregnancy and Lactation
There are no pre-clinical data of relevance to the prescriber, which are additional to that Safety in human pregnancy has not been established but it has been in use for many years already included in other sections of the leaflets. PHARMACEUTICAL PARTICULARS
Theophylline crosses the placental barrier and is secreted in breast milk and should be given List of Excipients
to breastfeeding women only when the anticipated benefits outweigh the risk to the child. Hydroxyethylcellulose, povidone[k25], cetostearyl alcohol, purifed talc and magensium Use of theophylline during the third trimester, or during breast feeding, may be associated with irritability in the infant. Use in pregnancy only when there is no safe alternative, or Film coat: hypromellose[E646], polyethylene glycol 400, opaspray M-1-3058 (containing when the disease itself carries risk for the mother or child. industrial methylated spirit, hypromellose [E464], titanium dioxide [E171],iron oxide [E172]. Effects on Ability to Drive and Use Machines
Shelf Life
Undesirable Effects
Special Precautions for Storage
The risk of adverse drug reactions usually associated with theophylline and xanthine derivatives are nausea, gastric irritation, headache, CNS stimulation, tachycardia, palpitations, arrhythmias and convulsions. Packaging
4 to 1000 tablets per securitainer or blister pack.
Overdose with theophylline may be manifested by symptoms such as vomiting, abdominal
pain, acid/base disturbance, rhabdomyolysis, sinus tachycardia, ventricular arrhythmias,
Cambridge Science Park, Milton Road, Cambridge CB4 0GW U,K. Empty stomach contents. Monitor electrocardiogram and maintain fluid balance. Oral activated charcoal has been found to reduce high theophylline serum concentrations. In MARKETING AUTHORIZATION HOLDER
severe poisoning, employ charcoal-column haemoperfusion. Treat symptoms on appearance. Controlled release tablets may release medication for hours. Cambridge Science Park, Milton Road, Cambridge CB4 0GW U,K. In the event of hypokalaemia, potassium chloride should be given by slow intravenous DISTRIBUTOR
infusion. Repeated measurements of plasma potassium should be made. Char Deh Drugs Enterprise Co. Ltd. 5F, 176, Min Sheng E. Rd., Sec 2, Taipei 104, Taiwan PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
Theophylline is a bronchodilator. In addition it affects the function of a number of cells involved in the inflammatory processes associated with asthma and chronic obstructive  PHYLLOCONTIN and CONTINUS are Registered Trademark. airways disease. Of most importance may be enhanced suppressor T-lymphocyte activity and The Trademark CONTINUS distinguishes the controlled release preparations of reduction of eosinophil and neutrophil function. These actions may contribute to anti-inflammatory prophylactic activity in asthma and chronic obstructive airways disease. Licensed by MUNDIPHARMA Medical Company, Bermuda. Theophylline stimulates the myocardium and produces a diminution of venous pressure in

Source: http://www.chardeh.com.tw/file/Product/201302191409116042.pdf


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