Theophylline

Theophylline

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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:

Age

Neonates (term and premature), children <1 year, elderly (>60 years).

Concurrent Diseases

Acute pulmonary edema, congestive heart failure, cor-pulmonale, fever (≥ 102° for 24 hours or more; or lesser temperature elevations for longer periods), reduced renal function in infants <3 months of age, sepsis with multi-organ failure, and shock.

Cessation of Smoking
Drug Interactions

Adding 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 cortico-steroids 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.

Uses

Theophylline extended-release tablets are 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.

History

There is currently no drug history available for this drug.

Other Information

Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine-2,6-dione,3,7-dihydro-1,3-dimethyl-, and is represented by the following structural formula:

Theophylline Structural Formula

                                   C7H8N4O2                                           M.W. 180.17

This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations).

Each extended-release tablet for oral administration contains either 100 mg, 200 mg, 300 mg or 450 mg of anhydrous theophylline. Tablets also contain as inactive ingredients: hypromellose, anhydrous lactose, magnesium stearate and povidone.

Theophylline Manufacturers


  • American Health Packaging
    Theophylline Tablet, Extended Release [American Health Packaging]
  • Avkare, Inc.
    Theophylline (Theophylline) Tablet, Extended Release [Avkare, Inc.]
  • Actavis Mid Atlantic Llc
    Theophylline (Theophylline, Anhydrous) Liquid [Actavis Mid Atlantic Llc]
  • Inwood Laboratories, Inc.
    Theophylline (Theophylline, Anhydrous) Capsule, Extended Release [Inwood Laboratories, Inc.]
  • Nostrum Laboratories, Inc.
    Theophylline (Anhydrous) (Theophylline) Tablet, Extended Release [Nostrum Laboratories, Inc.]
  • State Of Florida Doh Central Pharmacy
    Theophylline (Anhydrous) (Theophylline) Tablet, Extended Release [State Of Florida Doh Central Pharmacy]
  • Remedyrepack Inc.
    Theophylline Tablet, Extended Release [Remedyrepack Inc. ]
  • Heritage Pharmaceuticals Inc.
    Theophylline Tablet, Extended Release [Heritage Pharmaceuticals Inc.]
  • Remedyrepack Inc.
    Theophylline Tablet [Remedyrepack Inc. ]
  • Physicians Total Care, Inc.
    Theophylline Tablet, Extended Release [Physicians Total Care, Inc.]
  • Major Pharmaceuticals
    Theophylline Tablet, Extended Release [Major Pharmaceuticals]
  • Cardinal Health
    Theophylline Tablet, Extended Release [Cardinal Health]
  • Pharmaceutical Associates, Inc.
    Theophylline (Theophylline Anhydrous) Solution [Pharmaceutical Associates, Inc.]
  • Bryant Ranch Prepack
    Theophylline Tablet, Extended Release [Bryant Ranch Prepack]
  • Lake Erie Medical Dba Quality Care Products Llc
    Theophylline Tablet, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Theophylline Tablet, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • A-s Medication Solutions Llc
    Theophylline Tablet, Extended Release [A-s Medication Solutions Llc]
  • Clinical Solutions Wholesale
    Theophylline Tablet, Extended Release [Clinical Solutions Wholesale]
  • Pliva Inc.
    Theophylline Tablet, Extended Release [Pliva Inc.]
  • Alembic Pharmaceuticals Limited
    Theophylline Tablet, Extended Release [Alembic Pharmaceuticals Limited]
  • Glenmark Generics Inc., Usa
    Theophylline Tablet, Extended Release [Glenmark Generics Inc., Usa]
  • State Of Florida Doh Central Pharmacy
    Theophylline Tablet, Extended Release [State Of Florida Doh Central Pharmacy]
  • Bryant Ranch Prepack
    Theophylline Tablet, Extended Release [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Theophylline Tablet, Extended Release [Bryant Ranch Prepack]
  • Carilion Materials Management
    Theophylline (Anhydrous) (Theophylline) Tablet, Extended Release [Carilion Materials Management]
  • Preferred Pharmaceuticals, Inc.
    Theophylline Tablet, Extended Release [Preferred Pharmaceuticals, Inc.]

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