Aminophylline Recall

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Questions & Answers

Side Effects & Adverse Reactions

Concurrent Illness:

Theophylline should be used with extreme caution in patients with the following clinical conditions due to the increased risk of exacerbation of the concurrent condition:

Active peptic ulcer disease

Seizure disorders

Cardiac arrhythmias (not including bradyarrhythmias)

Conditions That Reduce Theophylline Clearance:

There are several readily identifiable causes of reduced theophylline clearance. If the total daily dose is not appropriately reduced in the presence of these risk factors, severe and potentially fatal theophylline toxicity can occur.Careful consideration must be given to the benefits and risks of theophylline use and the need for more intensive monitoring of serum theophylline concentrations in patients with the following risk factors:


Neonates (term and premature)

Children <1 year

Elderly (>60 years)

Concurrent Diseases

Acute pulmonary edema

Congestive heart failure


Fever; ≥102º for 24 hours or more; or lesser temperature elevations for longer periods


Liver disease; cirrhosis, acute hepatitis

Reduced renal function in infants <3 months of age

Sepsis with multi-organ failure


Cessation of Smoking

Drug InteractionsAdding a drug that inhibits theophylline metabolism (e.g., cimetidine, erythromycin, tacrine) or stopping a concurrently administered drug that enhances

theophylline metabolism (e.g., carbamazepine, rifampin). (see PRECAUTIONS, Drug Interactions, Table II).

When Signs or Symptoms of Theophylline Toxicity Are Present:

Whenever a patient receiving theophylline develops nausea or vomiting, particularly repetitive vomiting, or other signs or symptoms consistent with theophylline toxicity

(even if another cause may be suspected), additional doses of theophylline should be withheld and a serum theophylline concentration measured immediately.Patients

should be instructed not to continue any dosage that causes adverse effects and to withhold subsequent doses until the symptoms have resolved, at which time the clinician may instruct the patient to resume the drug at a lower dosage (see DOSAGE AND ADMINISTRATION, Dosing Guidelines, Table VI).

Dosage Increases:

Increases in the dose of theophylline should not be made in response to an acute exacerbation of symptoms of chronic lung disease since theophylline provides little added benefit to inhaled beta2-selective agonists and systemically administered corticosteroids in this circumstance and increases the risk of adverse effects. A peak steady-state serum theophylline concentration should be measured before increasing the dose in response to persistent chronic symptoms to ascertain whether an increase in dose is safe. Before increasing the theophylline dose on the basis of a low serum concentration, the clinician should consider whether the blood sample was obtained at an appropriate time in relationship to the dose and whether the patient has adhered to the prescribed regimen (see PRECAUTIONS, Laboratory Tests).

As the rate of theophylline clearance may be dose-dependent (i.e., steady-state serum concentrations may increase disproportionately to the increase in dose), an increase in dose based upon a sub-therapeutic serum concentration measurement should be conservative. In general, limiting dose increases to about 25% of the previous total daily dose will reduce the risk of unintended excessive increases in serum theophylline concentration (see DOSAGE AND ADMINISTRATION, Table VI).

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.


There is currently no drug history available for this drug.

Other Information

Aminophylline is a 2:1 complex of theophylline and ethylenediamine. Theophylline is structurally classified as a methylxanthine. Aminophylline occurs as a white or slightly yellowish granule or powder, with a slight ammoniacal odor. Aminophylline has the chemical name 1H-Purine-2,6-dione,3,7-dihydro-1,3-dimethyl-, compound with 1,2-ethanediamine (2:1) and is represented by the following structural formula:

Image from Drug Label Content

The molecular formula of anhydrous aminophylline is C16H24N10O4 with a molecular weight of 420.43.

Aminophylline Oral Liquid is available as a solution intended for oral administration, containing 105 mg of anhydrous aminophylline per 5 mL (equivalent to 90 mg of anhydrous theophylline per 5 mL).

Inactive Ingredients: Ethylenediamine, raspberry flavor, purified water, and saccharin sodium.

Aminophylline Manufacturers

  • Actavis Mid Atlantic Llc
    Aminophylline (Aminophylline) Solution [Actavis Mid Atlantic Llc]
  • General Injectables & Vaccines, Inc.
    Aminophylline Injection, Solution [General Injectables & Vaccines, Inc.]
  • General Injectables & Vaccines, Inc
    Aminophylline Injection, Solution [General Injectables & Vaccines, Inc]
  • West-ward Pharmaceutical Corp
    Aminophylline (Aminophylline Dihydrate) Tablet [West-ward Pharmaceutical Corp]
  • Cardinal Health
    Aminophylline (Aminophylline Dihydrate) Injection, Solution [Cardinal Health]
  • Hospira, Inc.
    Aminophylline (Aminophylline Dihydrate) Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Aminophylline (Aminophylline Dihydrate) Injection, Solution [Hospira, Inc.]

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