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ELIXOPHYLLIN
Asthma/COPD
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Drug Name:

ELIXOPHYLLIN Rx

Generic Name and Formulations:
Theophylline 80mg per 15mL; liq; contains alcohol 20%; tutti frutti flavor.

Company:
Caraco Pharmaceutical Laboratories, LTD.

Therapeutic Use:

Indications for ELIXOPHYLLIN:

Treatment of symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases (eg, emphysema, chronic bronchitis).

Adults and Children:

Individualize. Calculate based on ideal body weight. <1yr: premature neonates: <24 days: 1mg/kg every 12hrs; ≥24 days: 1.5mg/kg every 12hrs. Full term infants and infants up to 52 weeks old: total dose (mg) = [(0.2 x age in weeks) + 5] x kg body weight; up to age 26 weeks, divide dose into 3 equal amounts given at 8hr intervals; >26 weeks, divide dose into 4 equal amounts given at 6hr intervals. Adjust to maintain peak steady state serum theophylline concentration of 5–10mcg/mL in neonates and 10–15mcg/mL in older infants. Children (1–15yrs) and adults (16–60yrs) without risk factors for impaired clearance: children<45kg: initially 12–14mg/kg/day up to max 300mg/day divided every 4–6hrs; after 3 days, if tolerated, increase dose to 16mg/kg/day up to max 400mg/day divided every 4–6hrs; after 3 more days, if tolerated, increase to 20mg/kg/day up to max 600mg/day divided every 4–6hrs. Children >45kg and adults: initially 300mg/day divided every 6–8hrs; after 3 days, if tolerated, increase to 400mg/day divided every 6–8hrs; after 3 more days, if tolerated, increase to 600mg/day divided every 6–8hrs. Patients with risk factors for impaired clearance, elderly, and in those whom it is not feasible to monitor theophylline concentrations: 1–15yrs: final dose not exceed 16mg/kg/day up to max 400mg/day; ≥16yrs: final dose not exceed 400mg/day. Loading dose for acute bronchodilation: a single 5mg/kg dose. Dose adjustments based on theophylline concentrations: see literature.

Warnings/Precautions:

Active peptic ulcer. Arrhythmias. Seizure disorders. Hepatic dysfunction. CHF. Acute pulmonary edema. Cor pulmonale. Hypothyroidism. Fever. Sepsis. Shock. Monitor serum levels (blood sample should be obtained at time of expected peak serum theophylline concentration; 1–2 hours after a dose at steady-state); do not try to maintain non-tolerated doses. Monitor serum theophylline concentrations at 6 month intervals for rapidly growing children and yearly for all others. Acutely ill: monitor more frequently (eg, every 24 hours). Slow or rapid metabolizers. Reduced renal function in infants <3 months old. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

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, propranolol. ticlopidine, thiabendazole. Antagonized by aminoglutethimide, phenytoin, rifampin, barbiturates, carbamazepine, ritonavir, sucralfate, isoproterenol, moricizine, sulfinpyrazone. Avoid β-blockers. Antagonizes lithium, benzodiazepines, pancuronium, adenosine. Toxicity with sympathomimetics. Seizures with ketamine. Arrhythmias with halothane.

Pharmacological Class:

Xanthine.

Adverse Reactions:

GI upset, headache, CNS stimulation, diuresis, arrhythmias, seizures, others.

How Supplied:

Liq—473mL

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