Abridged Prescribing Information
Composition: UNICONTIN® 400/200 CONTINUSTM tablets for oral administration contain 400mg/200mg of theophylline BP in a CONTINUSTM controlled release system which allows a 24-hour dosing interval for appropriate patients. Each white tablet bears the symbol (MB) on one side and is marked ‘U/400’ ‘U/200′ on the other side.
Indications: For the treatment and prophylaxis of bronchospasm associated with asthma and chronic obstructive pulmonary disease. Dosage and Administration: UNICONTIN® 400/200mg CONTINUSTM tablets may be taken once a day in the morning or evening. It is recommended that UNICONTIN® CONTINUSTM tablets be taken with meals. Patients should be advised that if they choose to take UNICONTIN® CONTINUSTM tablets with food it should be taken consistently with food and if they take it in a fasted condition, it should routinely be taken fasted. It is important that the product whenever dosed be dosed consistently with or without food. UNICONTIN® CONTINUSTM tablets must be swallowed and NOT chewed.
Side Effects: Side effects are usually associated with the serum concentration of theophylline. Serum theophylline concentration (<20 mcg/mL): Adverse reactions- nausea, vomiting, headache, insomnia, tachypnea, epigastric pain, palpitation, hypotension, irritability. Serum theophylline concentration (>20 mcg/mL): Adverse reactions- persistent vomiting, cardiac arrhythmias, intractable seizures, tachycaridia. Contraindications: Patients with a history of hypersensitivity to theophylline or other components in the product; porphyria; concomitant administration with ephedrine in children.
Pregnancy and Lactation: Category C, There are no adequate and well controlled studies in pregnant women and there are no teratogenicity studies in non-rodents. Theophylline is secreted in breast milk and may cause irritability or other signs of toxicity in nursing infants. Because of the potential for serious adverse reactions in nursing infants from theophylline, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother. Warnings & Precautions: Serum levels above 20mcg/mL are rarely found after appropriate administration of the recommended doses. However, in individuals in whom theophylline plasma clearance is reduced for any reason, even conventional doses may result in increased serum levels and potential toxicity. Reduced theophylline clearance has been documented in the following readily identifiable groups : 1) patients with impaired liver function, 2) patients over 60 years of age, particularly males and those with chronic lung disease, 3) those with cardiac failure from any cause, 4) patients with acute febrile illness, 5) neonates and infants, 6) hypothyroidism, 7) shock, 8) sepsis with multi-organ failure, and 9) those patients taking certain drugs. Toxic accumulation may occur in above cases. Frequently, such patients have markedly prolonged theophylline serum levels following discontinuation of the drug. Reduction of dosage and laboratory monitoring are especially appropriate in the above individuals. Severe side effects (cramps, convulsions, supraventricular tachycardia) may appear at very high serum concentrations. Patients once titrated to an effective dose, should not be changed from theophylline tablets preparations to other slow or sustained release xanthine preparations without re-titration and clinical assessment.
Overdose: Overdose with theophylline may be manifested by symptoms such as vomiting, abdominal pain, acid/base disturbance, rhabdomyolysis, sinus tachycardia, ventricular arrhythmias, nervousness and seizures. Special Precautions for Storage: Store at or below 25°C, in a dry place, protected from light. Keep out of the reach of children.
Packaging : UNICONTIN® 400 : Box of 100 tablets (10 x 10’s blister strips), UNICONTIN® 200: Box of 100 tablets (10 x 10’s blister strips).