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Theophylline: Drug information

Theophylline: Drug information
(For additional information see "Theophylline: Patient drug information" and see "Theophylline: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Elixophyllin;
  • Theo-24
Brand Names: Canada
  • AA-Theo LA;
  • Theo ER;
  • Theolair;
  • Uniphyl [DSC]
Pharmacologic Category
  • Phosphodiesterase Enzyme Inhibitor, Nonselective
Dosing: Adult
Bradycardia, heart transplantation

Bradycardia, heart transplantation (off-label use): Note: Individualize dose based on steady-state serum concentrations; use ideal body weight to calculate dose (theophylline has limited distribution into body fat). Based on limited data and clinical experience.

Oral: Initial: 100 to 150 mg twice daily; titrate as needed based on heart rate response and tolerability; daily doses of up to 900 mg/day have been reported (ACC/AHA/HRS [Kusumoto 2019]; Bertolet 1996; Kooij 2022; Redmond 1993).

Dipyridamole- or regadenoson-induced adverse reactions during nuclear cardiac stress testing, reversal

Dipyridamole- or regadenoson-induced adverse reactions during nuclear cardiac stress testing, reversal (off-label use): Note: Theophylline administration is very rarely required for adenosine-induced adverse reactions because adenosine-induced side effects are short lived after discontinuation of the infusion (ASNC [Henzlova 2016]).

IV: 50 mg over 1 minute; may repeat dose if necessary (Johnson 2011).

Reversible airflow obstruction, acute symptoms

Reversible airflow obstruction, acute symptoms: Note: Routine use of theophylline is not recommended for the treatment of acute asthma exacerbations or chronic obstructive pulmonary disease exacerbations (GINA 2022; GOLD 2022). Individualize dose based on steady-state serum concentrations; use ideal body weight to calculate dose (theophylline has limited distribution into body fat).

Loading dose: Note: Doses presented are intended to achieve a serum theophylline level of ~10 mcg/mL.

Patients who have not received theophylline or aminophylline in the previous 24 hours:

IV (preferred route): 4.6 mg/kg once.

Oral (immediate-release solution): 5 mg/kg once.

Patients who have received theophylline or aminophylline in the previous 24 hours: Note: Loading dose should NOT be given before obtaining a serum theophylline concentration.

Calculate loading dose based on serum theophylline concentrations as follows:

IV, Oral (immediate-release solution): Loading dose = (desired serum theophylline concentration − measured serum theophylline concentration) × (Vd); where Vd = 0.5 L/kg [example: (10 mcg/mL [desired] − 5 mcg/mL [measured]) × 0.5 L/kg × 70 kg = 175 mg loading dose].

Maintenance dose: Note: Dosing presented is to achieve a target theophylline concentration of 10 mcg/mL. Lower initial doses may be required in patients with reduced theophylline clearance. Adjust dose according to serum level measurements.

Adults ≤60 years of age: Continuous infusion: IV: 0.4 mg/kg/hour; maximum daily dose: 900 mg/day unless serum theophylline concentrations indicate need for larger dose.

Adults >60 years of age: Continuous infusion: IV: 0.3 mg/kg/hour; maximum daily dose: 400 mg/day unless serum theophylline concentrations indicate need for larger dose.

Cardiac decompensation, cor pulmonale, sepsis with multiorgan failure, or shock: Continuous infusion: IV: 0.2 mg/kg/hour; maximum daily dose: 400 mg/day, unless serum theophylline concentrations indicate need for larger dose.

Dosage adjustment based on serum theophylline concentrations : Note: Recheck serum theophylline concentrations 3 days (oral dosing) or 24 hours (IV dosing) after dosage adjustment. Patients maintained with oral therapy should be reassessed at 6- to 12-month intervals, when clinically indicated, or if concomitant medication is added that may affect theophylline serum concentration.

IV, Oral:

<9.9 mcg/mL: If dosage is tolerated, but symptoms are not controlled, increase oral dose or IV infusion rate by ~25%; recheck serum theophylline concentration after 24 hours (IV) or 3 days (oral) for further dosage adjustment.

10 to 14.9 mcg/mL: If symptoms are controlled and current dose tolerated, maintain dose and recheck serum theophylline concentrations at 24-hour intervals (IV) or 6- to 12-month intervals (oral); if symptoms are not controlled and current dose is tolerated, consider adding additional medications.

15 to 19.9 mcg/mL: Consider 10% dose reduction in oral dose or IV infusion rate to improve safety margin even if dose is tolerated.

20 to 24.9 mcg/mL: Decrease oral dose or IV infusion rate by 25% even if no adverse effects present; recheck serum theophylline concentrations after 24 hours (IV) or 3 days (oral) to guide further dosage adjustment.

25 to 30 mcg/mL: Stop IV infusion for 24 hours or skip next oral dose; decrease subsequent oral doses or infusion rate at least 25% even if no adverse effects present; recheck serum theophylline concentrations after 24 hours (IV) or 3 days (oral) to guide further dosage adjustments; if symptomatic or signs of toxicity, discontinue infusion and consider if overdose treatment is needed.

>30 mcg/mL: Stop IV infusion or oral therapy and treat overdose; if theophylline is resumed, decrease subsequent infusion rate or oral dose at least 50% and recheck serum theophylline concentrations after 24 hours (IV) or 3 days (oral) to guide further dosage adjustment.

Reversible airflow obstruction, chronic conditions

Reversible airflow obstruction, chronic conditions: Note: Consider lowering dose or using a slower titration if caffeine-like adverse events occur. May use smaller doses more frequently in patients requiring higher than average doses to prevent breakthrough symptoms. If at risk for impaired theophylline clearance or not feasible to monitor serum theophylline concentrations, do not exceed maximum dose of 400 mg/day. Individualize dose based on steady-state serum concentrations; use ideal body weight to calculate dose (theophylline has limited distribution into body fat).

Immediate release (oral solution) (without risk factors for impaired clearance): Oral: Initial: 300 mg/day in divided doses every 6 to 8 hours; if tolerated, after 3 days increase to 400 mg/day divided every 6 to 8 hours; if tolerated, after 3 more days increase to 600 mg/day divided every 6 to 8 hours.

Extended release (without risk factors for impaired clearance):

12-hour formulation (tablets): Oral: Initial: 300 mg/day in divided doses every 12 hours; if tolerated, after 3 days increase to 400 mg/day in divided doses every 12 hours; if tolerated, after 3 days, increase to 600 mg/day in divided doses every 12 hours

24-hour formulation (capsules and tablets): Oral: Initial: 300 mg once daily; if tolerated after 3 days increase to 400 to 600 mg once daily; if doses >600 mg are needed, titrate according to serum theophylline concentration.

Dosage adjustment based on serum theophylline concentrations: Note: Recheck serum theophylline concentrations 3 days (oral dosing) or 24 hours (IV dosing) after dosage adjustment. Patients maintained with oral therapy should be reassessed at 6- to 12-month intervals, when clinically indicated, or if concomitant medication is added that may affect theophylline serum concentration.

IV, Oral:

<9.9 mcg/mL: If dosage is tolerated, but symptoms are not controlled, increase oral dose or IV infusion rate by ~25%; recheck serum theophylline concentration after 24 hours (IV) or 3 days (oral) for further dosage adjustment.

10 to 14.9 mcg/mL: If symptoms are controlled and current dose tolerated, maintain dose and recheck serum theophylline concentrations at 24-hour intervals (IV) or 6- to 12-month intervals (oral); if symptoms are not controlled and current dose is tolerated, consider adding additional medications.

15 to 19.9 mcg/mL: Consider 10% dose reduction in oral dose or IV infusion rate to improve safety margin even if dose is tolerated.

20 to 24.9 mcg/mL: Decrease oral dose or IV infusion rate by 25% even if no adverse effects present; recheck serum theophylline concentrations after 24 hours (IV) or 3 days (oral) to guide further dosage adjustment.

25 to 30 mcg/mL: Stop IV infusion for 24 hours or skip next oral dose; decrease subsequent oral doses or infusion rate at least 25% even if no adverse effects present; recheck serum theophylline concentrations after 24 hours (IV) or 3 days (oral) to guide further dosage adjustments; if symptomatic or signs of toxicity, discontinue infusion and consider if overdose treatment is needed.

>30 mcg/mL: Stop IV infusion or oral therapy and treat overdose; if theophylline is resumed, decrease subsequent infusion rate or oral dose at least 50% and recheck serum theophylline concentrations after 24 hours (IV) or 3 days (oral) to guide further dosage adjustment.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Oral, IV: No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

Oral: There are no specific dosage adjustments provided in manufacturer's labeling. Dose reduction and frequent monitoring of serum theophylline concentration are required; risk of severe and potentially fatal toxicity may occur. Maximum dose: 400 mg/day.

IV: Initial: 0.2 mg/kg/hour; maximum total daily dose: 400 mg/day unless serum theophylline concentrations indicate need for larger dose. Use with caution and monitor serum theophylline concentrations frequently; risk of severe and potentially fatal toxicity may occur.

Dosing: Pediatric

(For additional information see "Theophylline: Pediatric drug information")

Note: Doses should be individualized based on steady-state serum concentrations; theophylline pharmacokinetics have age-dependent factors which may alter required doses particularly in pediatric patients. For obese patients, ideal body weight should be used for dosage calculation.

Reversible airway obstruction, acute symptoms

Reversible airway obstruction, acute symptoms:

Note: Not recommended for the treatment of asthma exacerbations (GINA 2020; NAEPP 2007). Theophylline is a weak bronchodilator and other agents are more effective for acute bronchospasm. If other agents unavailable, the following doses are recommended (manufacturer's labeling).

Loading dose: Note: Doses presented intended to achieve a serum level of approximately 10 mcg/mL; loading doses should be given intravenously (preferred) or with a rapidly absorbed oral product (not an extended release product). On the average, for every 1 mg/kg theophylline given, blood concentrations will rise 2 mcg/mL.

Patients not currently receiving methylxanthines:

IV: 4.6 mg/kg/dose.

Oral: Immediate-release product: 5 mg/kg.

Patients currently receiving methylxanthines: A loading dose is not recommended without first obtaining a serum theophylline concentration in patients who have received aminophylline or theophylline within the past 24 hours. The loading dose should be calculated as follows:

Dose = (C desired – C measured) (Vd)

C desired = desired serum theophylline concentration

C measured = measured serum theophylline concentration

Maintenance dose: Continuous IV infusion: Note: Dosing presented is to achieve a target concentration of 10 mcg/mL. Lower initial doses may be required in patients with reduced theophylline clearance. Dosage should be adjusted according to serum concentration measurements during the first 12- to 24-hour period.

Infants 4 to 6 weeks: 1.5 mg/kg/dose every 12 hours.

Infants 6 to 52 weeks: Dose (mg/kg/hour) = (0.008 x age in weeks) + 0.21

Children 1 to <9 years: 0.8 mg/kg/hour.

Children 9 to <12 years: 0.7 mg/kg/hour.

Adolescents 12 to <16 years (otherwise healthy, nonsmokers): 0.5 mg/kg/hour; maximum daily dose: 900 mg/day unless serum concentrations indicate need for larger dose.

Adolescents 12 to <16 years (cigarette or marijuana smokers): 0.7 mg/kg/hour.

Adolescents 16 to 18 years (otherwise healthy, nonsmokers): 0.4 mg/kg/hour; maximum dose: 900 mg/day unless serum concentrations indicate need for larger dose.

Cardiac decompensation, cor pulmonale, hepatic dysfunction, sepsis with multiorgan failure, shock: Initial: 0.2 mg/kg/hour; maximum dose: 400 mg/day unless serum concentrations indicate need for larger dose.

Reversible airflow obstruction, chronic conditions

Reversible airflow obstruction, chronic conditions:

Note: Increase dose only if tolerated. Consider lowering dose or using a slower titration if caffeine-like adverse events occur. Smaller doses given more frequently may be used in patients with a more rapid metabolism to prevent breakthrough symptoms which could occur due to low trough concentration prior to the next dose.

Immediate-release formulation: Oral: Note: If at risk for impaired clearance or not feasible to monitor serum theophylline concentrations then do not exceed 16 mg/kg/day; maximum daily dose: 400 mg/day.

Infants: Total daily dose (mg/day) = [(0.2 x age in weeks) + 5] x (weight in kg); frequency is based on age.

Dosing interval (frequency based on age):

≤26 weeks: Divide in 3 equal doses and administer every 8 hours.

>26 weeks: Divide in 4 equal doses and administer every 6 hours.

Children and Adolescents ≤15 years and ≤45 kg:

Initial:

Days 1 to 3: 12 to 14 mg/kg/day in divided doses every 4 to 6 hours; maximum daily dose: 300 mg/day.

Days 4 to 6: 16 mg/kg/day in divided doses every 4 to 6 hours; maximum daily dose: 400 mg/day.

Maintenance: 20 mg/kg/day in divided doses every 4 to 6 hours; maximum daily dose: 600 mg/day.

Children and Adolescents >45 kg or Adolescents ≥16 years:

Initial:

Days 1 to 3: 300 mg/day in divided doses every 6 to 8 hours.

Days 4 to 6: 400 mg/day in divided doses every 6 to 8 hours.

Maintenance: 600 mg/day in divided doses every 6 to 8 hours.

Note: For maintenance treatment of asthma, experts have recommended lower doses to reduce incidence of adverse events: Initial: ~10 mg/kg/day in infants >6 months, children and adolescents (maximum daily dose: 300 mg/day); if after at least 3 days the initial dose is tolerated, increase to ~13 mg/kg/day (maximum daily dose: 450 mg/day); if after at least 3 days dose increase is tolerated, increase to ~16 mg/kg/day (maximum daily dose: 600 mg/day) (Weinberger 1996).

Extended-release formulations: Oral: Note: If at risk for impaired clearance or not feasible to monitor serum theophylline concentrations then do not exceed 16 mg/kg/day; maximum daily dose: 400 mg/day.

Children ≥6 years and Adolescents <16 years, weighing ≤45 kg:

Initial:

Days 1 to 3: 12 to 14 mg/kg/day; maximum daily dose: 300 mg/day.

Days 4 to 6: 16 mg/kg/day; maximum daily dose: 400 mg/day.

Maintenance: 20 mg/kg/day; maximum daily dose: 600 mg/day.

Dosing interval (product specific):

12-hour extended-release tablets: Children ≥6 years and Adolescents: Divide in 2 equal doses and administer every 12 hours.

24-hour extended-release tablets: Children ≥12 years and Adolescents: Administer every 24 hours.

Children ≥6 years and Adolescents, weighing >45 kg or Adolescents ≥16 years:

12-hour extended-release tablets: Children ≥6 years and Adolescents, weighing >45 kg or Adolescents ≥16 years:

Initial:

Days 1 to 3: 300 mg/day in divided doses every 12 hours.

Days 4 to 6: 400 mg/day in divided doses every 12 hours.

Maintenance: 600 mg/day in divided doses every 12 hours.

24-hour extended-release tablets: Children ≥12 years and Adolescents, weighing >45 kg or Adolescents ≥16 years:

Initial:

Days 1 to 3: 300 to 400 mg once daily.

Days 4 to 6: 400 to 600 mg once daily.

Maintenance: Titrate according to serum concentrations.

Note: For maintenance treatment of asthma, experts have recommended lower doses to reduce incidence of adverse events: Initial: ~10 mg/kg/day in children and adolescents (maximum daily dose: 300 mg/day); if after at least 3 days the dose is tolerated, increase to ~13 mg/kg/day (maximum daily dose: 450 mg/day); if after at least 3 days dose increase is tolerated, increase to ~16 mg/kg/day (maximum daily dose: 600 mg/day) (Weinberger 1996).

Dosage adjustment based on peak serum theophylline concentrations (Weinberger 1996; manufacturer's labeling): Infants, Children, and Adolescents:

Note: Recheck serum theophylline concentrations after 3 days when using oral dosing, or after 12 hours (children) or 24 hours (adults) when dosing intravenously. Patients maintained with oral therapy should be reassessed at 6- to 12-month intervals, when clinically indicated, or if concomitant medication is added which may affect theophylline serum concentration.

<10 mcg/mL: If symptoms not controlled and current dose tolerated, increase dose by ~25%. Recheck serum theophylline concentrations.

10 to 15 mcg/mL: If symptoms controlled and current dose tolerated, maintain dosage; recheck serum concentrations at 24-hour intervals (IV) or at 6- to 12-month intervals (oral). If symptoms are not controlled and current dose is tolerated, consider adding additional medications.

15.1 to 19.9 mcg/mL: Consider 10% dose reduction to improve safety margin even if dose is tolerated.

20 to 24.9 mcg/mL: Withhold next dose, decrease dose by ~25% even if no adverse effect present. Recheck serum concentrations.

25 to 30 mcg/mL: Skip next 1 to 2 doses (oral) or stop infusion for 12 hours (children) or 24 hours (adults) and decrease subsequent doses by at least 25% even if no adverse effect present. Recheck serum concentrations.

>30 mcg/mL: Stop dosing and treat overdose; if resumed, decrease subsequent doses by at least 50%. Recheck serum concentrations.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Oral, IV:

Infants 1 to 3 months: Due to reduced clearance, consider dose reduction and frequent monitoring of serum theophylline concentrations.

Infants >3 months, Children, and Adolescents: No adjustment necessary.

Dosing: Hepatic Impairment: Pediatric

Oral: Infants, Children, and Adolescents: There are no specific dosage adjustments provided in the manufacturer's labeling. Dose reduction and frequent monitoring of serum theophylline concentration are required in patients with decreased hepatic function (eg, cirrhosis, acute hepatitis, cholestasis).

IV: Infants, Children, and Adolescents: Initial: 0.2 mg/kg/hour; maximum daily dose: 400 mg/day unless serum concentrations indicate need for larger dose.

Dosing: Older Adult

Reversible airflow obstruction, acute symptoms: IV, Oral: Refer to adult dosing. Maximum total daily dose: 400 mg/day unless serum theophylline levels indicate need for larger dose.

Reversible airflow obstruction, chronic conditions: Oral: Starting doses in older adults should be reduced by 25% compared to younger adult populations (Brodeur 2015). Maximum total daily dose: 400 mg/day (unless symptomatic and the peak steady-state serum theophylline concentration is <10 mcg/mL).

Cardiac decompensation, cor pulmonale, sepsis with multiorgan failure, shock: Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule Extended Release 24 Hour, Oral:

Theo-24: 100 mg [contains fd&c yellow #6 (sunset yellow)]

Theo-24: 200 mg [contains quinoline yellow (d&c yellow #10)]

Theo-24: 300 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye)]

Theo-24: 400 mg [contains fd&c red #40 (allura red ac dye)]

Elixir, Oral:

Elixophyllin: 80 mg/15 mL (473 mL [DSC]) [contains alcohol, usp, fd&c red #40 (allura red ac dye), saccharin sodium]

Elixophyllin: 80 mg/15 mL (473 mL) [contains alcohol, usp, fd&c red #40 (allura red ac dye), saccharin sodium; mixed fruit flavor]

Generic: 80 mg/15 mL (15 mL, 473 mL)

Solution, Intravenous:

Generic: 400 mg (500 mL)

Solution, Oral:

Generic: 80 mg/15 mL (473 mL)

Tablet Extended Release 12 Hour, Oral:

Generic: 100 mg [DSC], 200 mg [DSC], 300 mg, 450 mg

Tablet Extended Release 24 Hour, Oral:

Generic: 400 mg, 600 mg

Generic Equivalent Available: US

May be product dependent

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Elixir, Oral:

Generic: 80 mg/15 mL (500 mL, 4500 mL)

Solution, Oral:

Theolair: 80 mg/15 mL (500 mL) [contains methylparaben, propylparaben]

Tablet Extended Release 12 Hour, Oral:

Generic: 100 mg, 200 mg, 300 mg

Tablet Extended Release 24 Hour, Oral:

Uniphyl: 400 mg [DSC], 600 mg [DSC]

Generic: 400 mg, 600 mg

Administration: Adult

IV: Administer loading dose over 30 minutes; follow with a continuous infusion as appropriate. For patients with cor pulmonale, cardiac decompensation, hepatic impairment, patients >60 years of age, or patients taking drugs that reduce theophylline clearance, the maximum initial maintenance infusion rate should not exceed 17 mg/hour unless patient continues to be symptomatic, steady-state serum theophylline concentration is <10 mcg/mL, and serum theophylline concentrations can be monitored at 24-hour intervals. Do not administer solutions containing dextrose simultaneously through the same administration set as blood, as this may result in pseudoagglutination or hemolysis.

Oral:

Immediate-release formulations: Oral solution: Administer with an accurate measuring device (calibrated oral syringe or measuring cup); do not use a household teaspoon or tablespoon to measure dose (overdosage may occur).

Extended release: Administer consistently with or without food (to maintain a consistent drug level); do not chew or crush tablets; may split tablet if scored. An intact matrix tablet may pass in stool.

12-hour formulation: May be administered as once daily dosing in non-smokers (with appropriate total body clearance) and patients with low dosage requirements; consider only after titrated to therapeutic levels. Base once-daily dosing on the twice daily dosing and initiate at the end of the last every 12-hour dosing interval. Once-daily dosing should not be administered at night (after the evening meal).

24-hour formulation: Administer each morning at approximately the same time; avoid administration at night (after the evening meal). Patients who require a high dose (ie, ≥900 mg or 13 mg/kg, whichever is less), should take medication less than 1 hour before a high-fat meal (significant increase in peak serum theophylline concentration and absorption may occur). Patients should consistently take theophylline with food or in fasting state. Twice-daily dosing may be considered in patients who metabolize theophylline rapidly (eg, younger patients, smokers, and some nonsmoking adults) and who have symptoms at the end of a dosing interval; administer one dose in the morning and the second dose 10 to 12 hours later (but before the evening meal); avoid administration at night (after the evening meal).

Bariatric surgery: Capsule and tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. ER capsule and tablet should be swallowed. Do not crush or chew. IR oral solution, oral elixir, and injectable formulations are available. If safety and efficacy can be effectively monitored, no change in formulation or administration is required after bariatric surgery; however, if swallowing is an issue after surgery, capsule formulations may be opened and sprinkled on soft foods.

Administration: Pediatric

Oral:

Immediate-release formulations: Oral solution: Administer with an accurate measuring device (calibrated oral syringe or measuring cup); do not use a household teaspoon or tablespoon to measure dose (overdosage may occur).

Extended-release formulations:

Capsules: Administer at approximately the same time each morning; avoid administration at night (after the evening meal). Patients who require a high dose (ie, 13 mg/kg or ≥900 mg, whichever is less), should not take medication <1 hour before a high-fat meal (significant increase in peak serum level and absorption may occur). Twice-daily dosing may be considered in patients who metabolize theophylline rapidly (eg, younger patients, smokers, some nonsmoking adults) and who repeatedly have symptoms at the end of a dosing interval; administer 1 dose in the morning and the second dose 10 to 12 hours later (but before the evening meal); avoid administration at night (after the evening meal).

Tablets: Administer consistently with or without food (to maintain a consistent drug level); do not chew or crush tablets; may split tablet if scored. An intact matrix tablet may pass in stool.

Parenteral: IV: Administer loading dose over 30 minutes; follow with continuous IV infusion as appropriate.

Use: Labeled Indications

Reversible airflow obstruction:

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

Injection: As an adjunct to inhaled beta-2 selective agonists and systemic corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases (eg, chronic bronchitis, emphysema).

Use: Off-Label: Adult

Bradycardia, heart transplantation; Dipyridamole- or regadenoson-induced adverse reactions during nuclear cardiac stress testing, reversal

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined. Adverse events observed at therapeutic serum levels.

Cardiovascular: Cardiac flutter, tachycardia

Central nervous system: Headache, hyperactivity (children), insomnia, restlessness, seizure, status epilepticus (nonconvulsive)

Endocrine & metabolic: Hypercalcemia (with concomitant hyperthyroid disease)

Gastrointestinal: Gastroesophageal reflux (aggravation), gastrointestinal ulcer (aggravation), nausea, vomiting

Genitourinary: Difficulty in micturition (males with prostatism), diuresis (transient)

Neuromuscular & skeletal: Tremor

Contraindications

Hypersensitivity to theophylline or any component of the formulation; allergy to corn-related products (injection only).

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to xanthine derivatives; coronary artery disease (where cardiac stimulation might prove harmful); peptic ulcers; coadministration with ephedrine in children.

Warnings/Precautions

Concerns related to adverse effects:

• Theophylline toxicity: Severe and potentially fatal theophylline toxicity may occur if reduced theophylline clearance occurs. Theophylline clearance may be decreased in patients with acute pulmonary edema, heart failure, cor pulmonale, fever (≥102°F for ≥24 hours or lesser temperature elevations for longer periods), hepatic disease, acute hepatitis, cirrhosis, hypothyroidism, sepsis with multiorgan failure, shock, neonates (term and premature), infants <3 months of age with decreased kidney function, infants <1 year of age, patients >60 years of age, and patients following cessation of smoking. Consider benefits versus risks and the need for more intensive monitoring in these patients; reduced infusion rate required. If a patient develops signs and symptoms of theophylline toxicity (eg, nausea or persistent, repetitive vomiting), a serum theophylline concentration should be measured immediately and subsequent doses withheld.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiac arrhythmias (excluding bradyarrhythmias); use may exacerbate arrhythmias.

• Cystic fibrosis: Use with caution in patients with cystic fibrosis; increased theophylline clearance may occur.

• Hepatic impairment: Use with caution in patients with hepatic impairment (eg, cirrhosis, acute hepatitis, cholestasis); risk of severe and potentially fatal theophylline toxicity is increased; theophylline clearance is decreased ≥50% in these patients. Dose reduction and frequent monitoring of serum theophylline concentration are required.

• Hyperthyroidism: Use with caution in patients with hyperthyroidism; increased theophylline clearance may occur.

• Peptic ulcer disease: Use with caution in patients with active peptic ulcer disease; use may exacerbate peptic ulcer.

• Seizure disorder: Use with caution in patients with seizure disorders; use may exacerbate seizure disorder.

Special populations:

• Older adult: Use extreme caution in patients >60 years of age; these patients are at greater risk of serious theophylline toxicity.

• Pediatric: Select dose with caution and with frequent monitoring of concentrations (especially <1 year); rate of clearance is highly variable in these patients.

Dosage form specific issues:

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).

Other warnings/precautions:

• Appropriate use: Do not increase dose in response to acute exacerbation of symptoms unless steady state serum theophylline concentration is <10 mcg/mL. As the rate of theophylline clearance may be dose-dependent, an increase in dose based upon a subtherapeutic serum theophylline concentration measurement should be limited to ~25% increase of the previous infusion rate or daily dose.

Metabolism/Transport Effects

Substrate of CYP1A2 (major), CYP2E1 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acebrophylline: May enhance the stimulatory effect of Theophylline Derivatives. Risk X: Avoid combination

Adalimumab: May decrease the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Adenosine: Theophylline Derivatives may diminish the therapeutic effect of Adenosine. Management: Consider alternatives to this combination if possible. Theophylline may decrease adenosine efficacy and higher adenosine doses may be required. When using adenosine for diagnostic studies, discontinue theophylline derivatives 5 half-lives prior to test. Risk D: Consider therapy modification

Alcohol (Ethyl): May increase the serum concentration of Theophylline. Risk C: Monitor therapy

Allopurinol: May increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Risk C: Monitor therapy

Antipsychotic Agents: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Antithyroid Agents: May increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Barbiturates: May decrease the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Benzodiazepines: Theophylline Derivatives may diminish the therapeutic effect of Benzodiazepines. Risk C: Monitor therapy

Beta2-Agonists: May enhance the adverse/toxic effect of Theophylline Derivatives. Specifically, sympathomimetic effects may be increased. Theophylline Derivatives may enhance the hypokalemic effect of Beta2-Agonists. Risk C: Monitor therapy

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Theophylline Derivatives. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Theophylline Derivatives. Risk C: Monitor therapy

Broccoli: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Risk C: Monitor therapy

BuPROPion: May enhance the neuroexcitatory and/or seizure-potentiating effect of Agents With Seizure Threshold Lowering Potential. Risk C: Monitor therapy

Cambendazole: May increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Cannabis: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Risk C: Monitor therapy

CarBAMazepine: May decrease the serum concentration of Theophylline Derivatives. Theophylline Derivatives may decrease the serum concentration of CarBAMazepine. Management: Seek alternatives to this combination when possible. If these agents are used together, monitor closely for decreased serum concentrations/therapeutic effects of both medications. Risk D: Consider therapy modification

Clarithromycin: May increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modification

CYP1A2 Inducers (Moderate): May decrease the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

CYP1A2 Inhibitors (Moderate): May increase the serum concentration of Theophylline Derivatives. Management: Consider avoidance of this combination. If coadministration is necessary, monitor for increased theophylline serum concentrations and toxicities when combined. Theophylline dose reductions will likely be required. Risk D: Consider therapy modification

CYP1A2 Inhibitors (Strong): May increase the serum concentration of Theophylline Derivatives. Management: Consider avoidance of this combination. If coadministration is necessary, consider an empiric theophylline dose reduction to one-third of the original theophylline dose. Monitor for increased theophylline serum concentrations and toxicities when combined. Risk D: Consider therapy modification

CYP1A2 Inhibitors (Weak): May increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Dichlorphenamide: Theophylline may enhance the hypokalemic effect of Dichlorphenamide. Risk C: Monitor therapy

Disulfiram: May increase the serum concentration of Theophylline. Risk C: Monitor therapy

Doxofylline: Theophylline Derivatives may enhance the adverse/toxic effect of Doxofylline. Risk X: Avoid combination

EPHEDrine (Systemic): Theophylline may enhance the stimulatory effect of EPHEDrine (Systemic). Risk C: Monitor therapy

Erythromycin (Systemic): May increase the serum concentration of Theophylline Derivatives. Theophylline Derivatives may decrease the serum concentration of Erythromycin (Systemic). Management: Consider alternatives to this combination. If combined, monitor for increased serum concentrations/toxic effects of theophylline derivatives.Theophylline derivative dose reductions may be needed. Also monitor for reduced erythromycin efficacy. Risk D: Consider therapy modification

Febuxostat: May increase serum concentrations of the active metabolite(s) of Theophylline Derivatives. Specifically, concentrations of 1-methylxanthine, a metabolite of unknown clinical importance, may become elevated. Risk C: Monitor therapy

Filgotinib: May increase the serum concentration of CYP1A2 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy

Fluconazole: May increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Formoterol: Theophylline Derivatives may enhance the adverse/toxic effect of Formoterol. Theophylline Derivatives may enhance the hypokalemic effect of Formoterol. Risk C: Monitor therapy

Fosphenytoin: May decrease the serum concentration of Theophylline Derivatives. Theophylline Derivatives may decrease the serum concentration of Fosphenytoin. Management: Seek alternatives when possible. If used together, monitor for decreased concentrations/effects of phenytoin or theophylline if the other agent is initiated/dose increased, or increased concentrations/effects if the other is discontinued/dose decreased. Risk D: Consider therapy modification

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Indacaterol: Theophylline Derivatives may enhance the adverse/toxic effect of Indacaterol. Theophylline Derivatives may enhance the hypokalemic effect of Indacaterol. Risk C: Monitor therapy

Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Isoniazid: May increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Isoproterenol: May decrease the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Ketamine: May enhance the adverse/toxic effect of Theophylline Derivatives. Specifically, the risk for seizures may be increased. Risk C: Monitor therapy

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Risk D: Consider therapy modification

Lithium: Theophylline Derivatives may decrease the serum concentration of Lithium. Risk C: Monitor therapy

Methacholine: Theophylline may diminish the therapeutic effect of Methacholine. Management: Hold theophylline for 12 to 48 hours before methacholine use. Risk D: Consider therapy modification

Methotrexate: May increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Methotrimeprazine: Products Containing Ethanol may enhance the adverse/toxic effect of Methotrimeprazine. Specifically, CNS depressant effects may be increased. Management: Avoid products containing alcohol in patients treated with methotrimeprazine. Risk X: Avoid combination

Nirmatrelvir and Ritonavir: May decrease the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Norfloxacin: May increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Olodaterol: Theophylline Derivatives may enhance the adverse/toxic effect of Olodaterol. Theophylline Derivatives may enhance the hypokalemic effect of Olodaterol. Risk C: Monitor therapy

Ornidazole: May enhance the adverse/toxic effect of Products Containing Ethanol. Specifically, a disulfiram-like reaction may occur. Risk X: Avoid combination

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Pacritinib: May increase the serum concentration of CYP1A2 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination

Pancuronium: Theophylline Derivatives may enhance the adverse/toxic effect of Pancuronium. Theophylline Derivatives may diminish the neuromuscular-blocking effect of Pancuronium. Risk C: Monitor therapy

Pentoxifylline: May increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Phenytoin: May decrease the serum concentration of Theophylline Derivatives. Theophylline Derivatives may decrease the serum concentration of Phenytoin. Management: Seek alternatives when possible. If used together, monitor for decreased concentrations/effects of phenytoin or theophylline if the other agent is initiated/dose increased, or increased concentrations/effects if the other is discontinued/dose decreased. Risk D: Consider therapy modification

QuiNINE: Theophylline Derivatives may increase the serum concentration of QuiNINE. QuiNINE may decrease the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Regadenoson: Theophylline may enhance the neuroexcitatory and/or seizure-potentiating effect of Regadenoson. Theophylline may diminish the vasodilatory effect of Regadenoson. Management: Avoid using theophylline or other methylxanthines (eg, caffeine) for at least 12 hours prior to the administration of regadenoson. Methylxanthines may be administered after regadenoson to diminish adverse events. Monitor for seizures. Risk D: Consider therapy modification

RifAMPin: May decrease the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Riociguat: Theophylline Derivatives may enhance the hypotensive effect of Riociguat. Risk X: Avoid combination

Ritonavir: May decrease the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Secnidazole: Products Containing Ethanol may enhance the adverse/toxic effect of Secnidazole. Risk X: Avoid combination

Sodium Phosphates: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Sodium Phosphates. Specifically, the risk of seizure or loss of consciousness may be increased in patients with significant sodium phosphate-induced fluid or electrolyte abnormalities. Risk C: Monitor therapy

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

Sulfinpyrazone: May decrease the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Telithromycin: May increase the serum concentration of Theophylline Derivatives. Management: Consider separating administration of telithromycin and theophylline derivatives by at least one hour to prevent gastrointestinal adverse effects. Monitor for theophylline toxicities and consider monitoring of serum theophylline levels. Risk D: Consider therapy modification

Thyroid Products: May increase the metabolism of Theophylline Derivatives. Risk C: Monitor therapy

Tobacco (Smoked): May decrease the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Verapamil: May increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Viloxazine: May increase the serum concentration of Theophylline Derivatives. Risk X: Avoid combination

Zafirlukast: Theophylline Derivatives may decrease the serum concentration of Zafirlukast. Zafirlukast may increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy

Food Interactions

Ethanol: Ethanol may decrease theophylline clearance. Management: Monitor theophylline concentrations, particularly when alcohol consumption patterns change.

Food: Theophylline clearance is increased and half-life decreased by low carbohydrate/high protein diets, parenteral nutrition, and daily consumption of charcoal-broiled beef; a high carbohydrate/low protein diet can decrease the clearance and prolong the half-life of theophylline. Management: Avoid extremes of dietary protein and carbohydrate intake.

Pregnancy Considerations

Theophylline crosses the placenta.

Maternal use of theophylline is not associated with an increased risk of fetal malformations (ERS/TSANZ [Middleton 2020]; GINA 2022). Infants exposed to theophylline during the third trimester should be monitored for adverse events (irritability, tachycardia, vomiting) (ERS/TSANZ [Middleton 2020]).

Uncontrolled asthma is associated with adverse events in pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes) (ERS/TSANZ [Middleton 2020]; GINA 2022).

Theophylline is considered compatible for use during pregnancy (ERS/TSANZ [Middleton 2020]). Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of theophylline are altered. The half-life is similar to that observed in otherwise healthy, nonsmoking adults with asthma during the first and second trimesters (~8.7 hours) but may increase to 13 hours (range: 8 to 18 hours) during the third trimester. The volume of distribution is also increased during the third trimester. Monitor serum theophylline concentrations. In addition, maternal asthma symptoms should be monitored monthly during pregnancy. Use at term may inhibit uterine contractions (ERS/TSANZ [Middleton 2020]).

Breastfeeding Considerations

Theophylline is present in breast milk.

The concentration of theophylline in breast milk is similar to the maternal serum theophylline concentration. Irritability may be observed in the breastfeeding infant. Serious adverse events in the infant are unlikely unless toxic serum theophylline concentrations are present in the mother. Maternal use of theophylline is considered compatible with breastfeeding (ERS/TSANZ [Middleton 2020]; WHO 2002). Infants exposed to theophylline via breast milk should be monitored for adverse events (irritability, tachycardia, vomiting). Mothers may consider breastfeeding their infant just prior to taking their regular dose of theophylline (ERS/TSANZ [Middleton 2020]).

Dietary Considerations

Premixed injection may contain corn-derived dextrose and its use is contraindicated in patients with allergy to corn-related products.

Monitoring Parameters

Heart rate, CNS effects (insomnia, irritability); respiratory rate; arterial or capillary blood gases (if applicable); fluid balance, electrolyte concentrations, and acid-base balance during prolonged IV therapy.

Theophylline levels: Serum theophylline concentrations should be monitored after initiation of therapy, prior to making dose increases; in the presence of signs or symptoms of toxicity; or when a new illness, worsening of a present illness, or change in patient's treatment regimen occur that may alter theophylline clearance (eg, fever >102°F or sustained for 24 hours or more, hepatitis, or drugs that are added or discontinued).

Oral: Monitor serum theophylline concentrations at 6-month intervals for rapidly growing children and at yearly intervals for all others (if symptoms are well controlled).

IV:

Loading dose: Measure serum theophylline concentrations 30 minutes after the end of an IV loading dose in patients who have received no theophylline in the previous 24 hours to determine the need for an additional loading (serum theophylline concentration <10 mcg/mL) or to delay starting the maintenance IV infusion (serum theophylline concentration >20 mcg/mL).

Continuous infusion: Measure serum theophylline concentrations one expected half-life (eg, ~4 hours in children 1 to 9 years of age or 8 hours in nonsmoking, otherwise healthy adults) after starting a continuous infusion, then every 12 to 24 hours to determine if further adjustments are necessary, and then at 24-hour intervals for duration of infusion.

Reference Range

Therapeutic levels:

Children: 5 to 15 mcg/mL

Adults: 10 to 20 mcg/mL

Toxic concentration: >20 mcg/mL

Mechanism of Action

Theophylline has two distinct actions; smooth muscle relaxation (ie, bronchodilation) and suppression of the response of the airways to stimuli (ie, non-bronchodilator prophylactic effects). Bronchodilation is mediated by inhibition of two isoenzymes, phosphodiesterase (PDE III and, to a lesser extent, PDE IV) while non-bronchodilation effects are mediated through other molecular mechanisms. Theophylline increases the force of contraction of diaphragmatic muscles through enhancement of calcium uptake through adenosine-mediated channels.

Pharmacokinetics

Absorption: Oral (solution and immediate release): Rapid and complete.

Distribution: ~0.45 L/kg based on ideal body weight; distributes poorly into body fat; Vd may increase in premature neonates, hepatic cirrhosis, acidemia (uncorrected), patients >60 years of age, and third trimester of pregnancy.

Metabolism: Hepatic via demethylation (CYP 1A2) and hydroxylation (CYP 2E1 and 3A4); forms active metabolites (caffeine and 3-methylxanthine).

Protein binding: ~40%, primarily to albumin; decreased in neonates (due to a greater percentage of fetal albumin), hepatic cirrhosis, acidemia (uncorrected), third trimester of pregnancy, and patients >60 years of age.

Half-life elimination (Hendeles 1995): Highly variable and dependent upon age, hepatic function, cardiac function, lung disease, and smoking history.

Premature infants, postnatal age 3 to 15 days: 30 hours (range: 17 to 43 hours); Premature infants, postnatal age 25 to 57 days: 20 hours (range: 9.4 to 30.6 hours); Term infants, postnatal age 1 to 2 days: 25.7 hours (range: 25 to 26.5 hours); Term infants, postnatal age 3 to 30 weeks: 11 hours (range: 6 to 29 hours); Children 1 to 4 years: 3.4 hours (range: 1.2 to 5.6 hours); Children and Adolescents 6 to 17 years: 3.7 hours (range: 1.5 to 5.9 hours); Adults ≥18 years to ≤60 years of age (nonsmoking, asthmatic, otherwise healthy): 8.7 hours (range: 6.1 to 12.8 hours); patients >60 years of age (nonsmoking, healthy): 9.8 hours (range: 1.6 to 18 hours).

Time to peak, serum: Oral (solution and immediate release): 1 to 2 hours; IV: Within 30 minutes.

Excretion: Urine (~50% as unchanged drug [Neonates]; ~10% as unchanged drug [Infants >3 months, Adolescents, and Adults]).

Clearance: Certain conditions may significantly alter theophylline clearance; severe and potentially fatal theophylline toxicity may occur if reduced theophylline clearance occurs.

Decreased theophylline clearance: Neonates; infants <3 months with decreased kidney function; infants <1 year; patients >60 years of age; acute pulmonary edema, cor pulmonale; fever (≥ 102°F for ≥24 hours or lesser temperature elevations for longer periods); heart failure; hepatic impairment (eg, cirrhosis, acute hepatitis, cholestasis); hypothyroidism; patients following cessation of smoking; sepsis with multiple organ failure; shock; third trimester of pregnancy.

Increased theophylline clearance: Hyperthyroidism; cystic fibrosis; smoking (ie, marijuana or tobacco).

Pricing: US

Capsule ER 24 Hour Therapy Pack (Theo-24 Oral)

100 mg (per each): $3.50

200 mg (per each): $5.20

300 mg (per each): $6.39

400 mg (per each): $8.99

Elixir (Elixophyllin Oral)

80 mg/15 mL (per mL): $0.83

Elixir (Theophylline Oral)

80 mg/15 mL (per mL): $0.83

Solution (Theophylline Oral)

80 mg/15 mL (per mL): $0.24 - $1.14

Tablet, 12-hour (Theophylline ER Oral)

300 mg (per each): $4.30

450 mg (per each): $6.04

Tablet, 24-hour (Theophylline ER Oral)

400 mg (per each): $1.36

600 mg (per each): $1.96

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Amriphylline (EG);
  • Austyn (KR);
  • Bronchoretard (DE);
  • Bronsolvan (ID);
  • Bufabron (ID);
  • Contine (BD);
  • Diaphyllin (VN);
  • Duralyn-CR (TH);
  • Egifilin (HU);
  • Elixifilin (ES);
  • Elixine (CL);
  • Eteophyl (KR);
  • Etipramid (CN);
  • Euphyllin (BE, CZ, PL, ZA);
  • Euphyllin Retard (ID);
  • Euphyllin Retard Mite (ID);
  • Euphylline (FR, UA);
  • Euphylong (AE, BH, CY, HU, IQ, IR, JO, LY, OM, SA, SY, YE);
  • Franol (TH);
  • Frezma (BD);
  • Lasma (AE, BH, CY, GB, IQ, IR, JO, LY, OM, SA, SY, YE);
  • Meridian AP (UY);
  • Minophylline (EG);
  • Nefoben (AR);
  • Neoffilin (UA);
  • Neulin SA (MT);
  • Neulin-SR (NZ);
  • Nosma (TW);
  • Nuelin (AU, BB, BM, BS, BZ, DK, FI, GY, JM, LK, NO, NZ, PH, PR, SG, SR, TT, VE, ZA);
  • Nuelin SA (AE, BF, BH, BJ, CI, CY, ET, GH, GM, GN, IQ, IR, JO, KE, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZM, ZW);
  • Nuelin SR (AE, BH, CY, HK, IQ, IR, JO, KW, LY, MY, OM, SA, SG, SY, TH, YE);
  • Pediaphyllin (BE);
  • Pediaphyllin PL (LU);
  • Pellapenta (LK);
  • Pharmafil (MX);
  • Phylobid (BF, BJ, CI, ET, GH, GM, GN, IN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZA, ZM, ZW);
  • Quibron T SR (ID);
  • Quibron TSR (LK);
  • Respicur retard (AT);
  • Retafyllin (EE, FI, HU);
  • Slo-Phyllin (AE, BH, CY, GB, IQ, IR, JO, LY, OM, SA, SY, YE);
  • Slo-Theo (HK);
  • Somofillina (IT);
  • Talofilina (BR);
  • Teoclear (KR);
  • Teofilina Retard (CO, EC);
  • Teolex (BD);
  • Teolex CR (BD);
  • Teolex SR (BD);
  • Teolin (HR);
  • Teolong (BR, CR, DO, GT, HN, NI, PA, PY, SV);
  • Teosona (AR);
  • Teotard (BG, EE, HR, LV, RO, RU);
  • Teromol Retard (ES);
  • Theo PA (IN);
  • Theo-2 (BE, LU);
  • Theo-24 (IT);
  • Theo-Bros (GR);
  • Theo-Dur (DK, ES, GR, IT, JP, LU, MT, MY, NO, PK, SA, SE, TR);
  • Theobron (ID);
  • Theoclear (KR);
  • Theodex (LB);
  • Theofol (FI);
  • Theolair (IT, NL);
  • Theolair LA (LU);
  • Theolair S (PE);
  • Theolan (KR);
  • Theolin (AE, BH, CY, IQ, IR, JO, LY, OM, SA, SY, YE);
  • Theolin SR (SG);
  • Theolong (JP);
  • Theonate (BD);
  • Theophar (AE, BH, KW, QA, SA);
  • Theophen (ZA);
  • Theophtard (HU);
  • Theophyllin-ratiopharm (LU);
  • Theophylline Bruneau (LU);
  • Theoplus (CZ);
  • Theoplus Retard (AT);
  • Theosol Elixir (LB);
  • Theospirex (HU);
  • Theospirex Retard (AT);
  • Theostat (LU);
  • Theostat LP (FR);
  • Theotard (IL, UA);
  • Theotrim (IL);
  • Uni-Dur (HR);
  • Unicontin (PT);
  • Unicontin-400 Continus (IN);
  • Unidur (AE);
  • Unifyl (AT);
  • Unifyl Retard (CH);
  • Uniphyl (ZA);
  • Uniphyllin (TW);
  • Uniphyllin Continus (AE, BF, BH, BJ, CI, CY, EG, ET, GB, GH, GM, GN, IE, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZA, ZM, ZW);
  • Uniphylline (JO);
  • UniXan (DK);
  • Unuohyllin (GR);
  • Ventophyl (EG);
  • Xanthium (BE, FR, LU);
  • Zepholin (IE)


For country code abbreviations (show table)
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  29. Theo-24 (theophylline) anhydrous capsules, extended-release [prescribing information]. Malvern, PA: Endo Pharmaceuticals Inc; November 2016.
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