Aminophylline Tablets BP 100mg

Aminophylline Tablets BP 100mg

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Aminophylline Tablets BP 100mg

Aminophylline may produce bronchodilation by inhibition of phosphodiesterase (thereby increasing cyclic adenosine monophosphate levels), inhibition of calcium ion influx into smooth muscle, prostaglandin antagonism, stimulation of endogenous catecholamines, adenosine receptor antagonism and inhibition of release of mediators from mast cells and leukocytes.

Pharmacokinetics

Aminophylline is rapidly and completely absorbed after oral administration. After a single dose of 5mg/kg in adults, Cmax of about 10mcg/ml (range 5-15 mcg/ml) can be expected 1-2 hr after the dose: 40% protein bound (primarily albumin). Vd is 0.45 L/kg (0.3 to 0.7 L/kg) based on ideal body weight. Freely passes across the placenta into breast milk and into CSF. About 90% of dose is metabolized in the liver in adults and children older than 1 year of age. Beyond first three months of life, approximately 10% of Aminophylline is excreted unchanged in urine. Aminophylline clearance is decreased by 50% or more in patients with hepatic insufficiency and congestive heart failure.

Indications

Treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung disease, e.g., emphysema and chronic bronchitis.

Contraindications

Contraindicated in patients with a history of hypersensitivity to Aminophylline or other components in the product including ethylenediamine.

It is also contraindicated in patients with porphyria, gastric ulceration, cardiac arrhythmias or seizure disorders.

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Special precautions and warnings

If a patient develops signs and symptoms of theophylline toxicity (e.g., persistent, repetitive vomiting), a serum level should be measured and subsequent doses held.

Use with caution in patients with active peptic ulcer disease, cardiac arrhythmias, hyperthyroidism or seizure disorders.

Pregnancy and lactation

Category C: There are no adequate and well controlled studies in pregnant women. Use with caution during lactation as excreted in breast milk.

Dosage and directions for use

Adult and children over 12 years: 1-2 tablets 3-4 times daily.

Adverse effects

Nausea, vomiting, hematenesis, diarrhea, anorexia, headache, restlessness, insomnia, nervousness, tremors, seizures, palpitation, sinus tachycardia, other supraventricular tachycardias, ventricular arrhythmias, extrasystoles, flushing, skin rash, allergic reaction.

Drug interactions

Fluvoxamine, cimetidine, enoxacin, ciprofloxacin, interferons, propranolol, tricopidine, thiabendazole and quinolone antibiotics, which may decrease the metabolism of theophylline.

Allopurinol, disulfiram, febuxostat, pentoxifulline, verapamil, propafenone and quinine which may increase the serum concentration of theophylline.

Aminoglutethimide, barbiturates, carbamazepine, phenytoin, rifampicin, thyroid products which may increase metabolism of theophylline.

Aminophylline may diminish the therapeutic effects of lithium, adenosine, benzodiazepine, lobenguane I 123, regadenoson.

Overdosage

Headache, anxiety, tremor, nausea, tonic cramp, palpitations, tachycardia, arrhythmia. A fall in blood pressure sometimes occurs. Treatment is usually supportive and withdrawal of the drug. Restoration of fluid and electrolyte balance is necessary.

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