Monograph Details
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Respiratory Tract
> Asthma/COPD
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UNIPHYL |
| Manufacturer |
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Purdue Pharma L.P. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Xanthine. |
| Generic Name |
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Theophylline 400 mg, 600 mg; controlled-release, scored tabs. |
| Indications |
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Asthma. Chronic bronchitis. Emphysema. |
| Children |
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Not recommended. |
| Adults |
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Do not crush or chew. Take once daily, consistently with regard to meals, preferably with meals. Stabilized patients may be transferred from an immediate-release or controlled-release theophylline to once-daily dosing with Uniphyl on a mg/mg basis. Max without serum level monitoring: 12–15 years: 16 mg/kg (max 400 mg) per day; ≥16 years: 400 mg/day. |
| Contraindications |
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Active peptic ulcer. Arrhythmias. Seizure disorders. Not for primary treatment of acute attack. |
| Precautions |
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Hepatic dysfunction. CHF. Acute pulmonary edema. Cor pulmonale. Peptic ulcer. Hypothyroidism. Fever. Sepsis. Shock. Monitor serum levels; do not try to maintain non-tolerated doses. Rapid metabolizers. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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See literature. Smokers have increased metabolism. Potentiated by quinolones, macrolides, cimetidine, alcohol, allopurinol, estrogen oral contraceptives, tacrine, interferon alpha, disulfiram, fluvoxamine, verapamil, mexiletine, methotrexate, pentoxifylline, propafenone, ticlopidine, thiabenazole. Antagonized by phenytoin, rifampin, barbiturates, carbamazepine, ritonavir, sucralfate, isoproterenol, sulfinpyrazone. Avoid β-blockers. Antagonizes lithium, benzodiazepines, pancuronium, adenosine. Toxicity with sympathomimetics. Seizures with ketamine. Arrhythmias with halothane. |
| Adverse Reactions |
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GI upset, headache, CNS stimulation, diuresis, arrhythmias, seizures. |
| How Supplied |
Tabs 400 mg—100, 500
600 mg—100 |
| Additional Resources |
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• Related Prescribing Note |
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