Respiratory tract drugs

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    Anhydrous Theophylline 200 mg

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Mechanism Of Action Theophylline directly relaxes the bronchiolar smooth muscle (relieves bronchospasm) and pulmonary blood vessels. Theophylline may exerts this action by altering the calcium levels of smooth muscle, blocking adenosine receptors, inhibiting the effect of prostaglandins on smooth muscle, and inhibiting the release of slow-reacting substance of anaphylaxis and histamine.
INDICATIONS TRIO-PHILLIN tablets is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
CONTRAINDICATIONS Hypersensitivity to any xanthine, peptic ulcer, seizure disorders (unless on medication), hypotension, cardiac arrhythmias, angina pectoris.
Side EFFECTS Side effects usually occur when theophylline blood levels exceed 20 micrograms/ml and include gastric irritation, nausea, vomiting, abdominal discomfort, palpitations, a fall in blood pressure, headache, occasional diarrhoea and insomnia. CNS stimulation and diuresis may also occur, especially in children.
WARNINGS Careful consideration of the various interacting drugs and physiologic conditions that can alter theophylline clearance and require dosage adjustment should occur prior to initiation of theophylline therapy, prior to increases in theophylline dose, and during follow up. The dose of theophylline selected for initiation of therapy should be low and, if tolerated, increased slowly over a period of a week or longer with the final dose guided by monitoring serum theophylline concentrations and the patient's clinical response. For most patients, steady-state will be reached after 3 days of dosing when no doses have been missed, no extra doses have been added, and none of the doses have been taken at unequal intervals. The patient should be instructed to seek medical advice whenever nausea, vomiting, persistent headache, insomnia or rapid heart beat occurs during treatment with theophylline, even if another cause is suspected. The patient should be instructed to contact their clinician if they develop a new illness, especially if accompanied by a persistent fever, if they experience worsening of a chronic illness, if they start or stop smoking cigarettes, or if another clinician gives a new medication or discontinues a previously prescribed medication. Patients should be instructed to not alter the dose, timing of the dose, or frequency of administration without first consulting their clinician. If a dose is missed, the patient should be instructed to take the next dose at the usually scheduled time and to not attempt to make up for the missed dose. The maintenance dose of theophylline must be selected with caution in pediatric patients since the rate of theophylline clearance is highly variable across the age range of neonates to adolescents. The maximum daily dose of theophylline in patients greater than 60 years of age ordinarily should not exceed 400 mg/day unless the patient continues to be symptomatic and the peak steady state serum theophylline concentration is <10 mcg/ml. Theophylline doses greater than 400 mg/d should be prescribed with caution in elderly patients.
DRUG INTERACTIONS Concurrent use of cimetidine, antibiotics of the macrolid type (e.g. erythromycin), lincomycin, allopurinol, furosemide and oral contraceptives may enhance the effect of TRIO-PHILLIN. While barbiturates, phenytoin, carbamazepine and sulphinpyrazone may weaken it.Theophylline weakens the effect of lithium carbonate. Additional medication with beta-sympathomimetics, other theophylline-containing preparations and ephedrine may produce untoward effects or potentiate existing ones. Drug \ Clinical Laboratory Test Interactions: Increase in plasma free fatty acids, glucose, uric acid, total cholesterol, bilirubin, urinary catecholamines, ESR. Interference with uric acid tests and tests for furosemide and probenecid.
Dosage And Administration -Bronchodilator, acute attacks, in clients not currently on theophylline therapy. Adults, loading dose: 5 mg/kg. Maintenance, Adults, nonsmoking: 3 mg/kg every 8 hr; Older clients, those with cor pulmonale: 2 mg/kg every 8 hr. Clients with CHF: 1-2 mg/kg every 12 hr; Children, 9-16 years of age and young adult smokers: 3 mg/kg every 6 hr; Children. - Bronchodilator, acute attacks, in clients currently receiving theophylline. Adults: If possible, a serum theophylline level should be obtained first. Then, base loading dose on the premise that each 0.5 mg theophylline/kg lean body weight will result in a 0.5-1.6-mcg/mL increase in serum theophylline levels. If immediate therapy is needed and a serum level cannot be obtained, a single dose of the equivalent of 2.5 mg/kg of anhydrous theophylline in a rapidly absorbed form can be given. -Chronic therapy, based on anhydrous theophylline. Adults and children, initial: 16 mg/kg/24 hr, up to a maximum of 400 mg/day in three to four divided doses at 6-8-hr intervals; then, dose can be increased in 25% increments at 2-3 day intervals up to a maximum, as follows: Adults and children over 16 years of age: 13 mg/kg, not to exceed 900 mg/day; 12-16 years: 18 mg/kg/day; 9-12 years: 20 mg/kg/day.
OVERDOSE Signs and symptoms: Headache, nausea, vomiting, restlessness, hypotension, tachycardia, arrhythmias (usually supraventricular tachyarrhythmias), hypokalaemia, CNS depression, convulsions, dehydration and coma may occur. Massive overdosage may result in cardiac inhibition, circulatory and respiratory failure. Treatment: The stomach should be emptied by gastric lavage and emesis. Repeated doses of activated charcoal should be considered. Blood glucose, electrolytes, arterial gases and pH should be monitored. Serum theophylline should be measured 4 hours after ingestion and at 4 to 12 hourly intervals thereafter if symptoms are severe. Intensive supportive therapy may be required to maintain respiration and cardiovascular function. Convulsions may be controlled by diazepam. Haemoperfusion may be necessary.
Storage Conditions Store below 30°C in a dry place keep out of reach of children