Theophyllinum tablets


  • Active Ingredient: Theophylline
  • 400 mg
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What is Theophyllinum?

The active ingredient of Theophyllinum brand is theophylline. Theophylline is a bronchodilator. It works by relaxing muscles in the lungs and chest, making the lungs less sensitive to allergens and other causes of bronchospasm. Each extended-release tablet for oral administration contains either 300 mg or 450 mg of anhydrous Theophylline. Tablets also contain as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate and povidone.

Used for

Theophyllinum is used to treat diseases such as: Apnea of Prematurity, Asthma, acute, Asthma, Maintenance.

Side Effect

Possible side effects of Theophyllinum include: fainting; increase in urine volume; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; fever; seizures.

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Common Side Effects of Theophyllinum

Although these effects are common, they can be serious and are likely to mean your doctor should change your dosage.

Tell your doctor if you experience any of the following, and if the effect becomes severe, get immediate medical help:

  • Nausea and vomiting
  • Headache
  • Upset stomach
  • Loss of appetite
  • Fast, strong heartbeat
  • Irregular heartbeat (arrhythmia): usually there are no symptoms, but it can cause a fluttering feeling, dizziness, shortness of breath, chest pain, heartbeats that feel too fast or slow, or fainting
  • Symptoms similar to how you feel when you've had too much coffee, such as trouble falling asleep (insomnia), restlessness, and irritability.
  • Skin rash

Home » Theophyllinum for COPD

Theophyllinum is a bronchodilator that’s been used in the treatment of COPD for more than seven decades. It is used to treat wheezing or shortness of breath caused by asthma, bronchitis, emphysema and other breathing disorders. It works by relaxing the muscles in the lungs and chest, making it easier to breathe.

Forms and strengths

Generic: Theophyllinum

  • Form: extended-release tablet
  • Strengths: 100 mg, 200 mg, 300 mg, 400 mg, 450 mg, 600 mg

Theophyllinum as a bronchodilator

Traditionally, Theophyllinum was used as a bronchodilator in the treatment of airway disease but, to achieve significant bronchodilatation comparable with that of a β2 agonist, relatively high plasma concentrations are needed (10–20 mg/l). Theophyllinum relaxes human airway smooth muscle in vitro through inhibition of phosphodiesterases (PDE), enzymes that break down cyclic nucleotides in the cell resulting in increased cyclic AMP concentrations. Unfortunately, at doses of Theophyllinum that inhibit PDE, side effects that are also due to PDE inhibition are common so many patients are not able to tolerate Theophyllinum at these “therapeutic” concentrations.


Concurrent Illness: Theophyllinum 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 Theophyllinum Clearance: There are several readily > If the total daily dose is not appropriately reduced in the presence of these risk factors, severe and potentially fatal Theophyllinum toxicity can occur. Careful cons >

Age: Neonates (term and premature), Children 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

Cessation of Smoking Drug Interactions: Adding a drug that inhibits Theophyllinum metabolism (e.g., cimet >PRECAUTIONS, Drug Interactions, Table II ).

When Signs or Symptoms of Theophyllinum Toxicity Are Present: Whenever a patient receiving Theophyllinum develops nausea or vomiting, particularly repetitive vomiting, or other signs or symptoms consistent with Theophyllinum toxicity (even if another cause may be suspected), additional doses of Theophyllinum should be withheld and a serum Theophyllinum 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 healthcare professional may instruct the patient to resume the drug at a lower dosage (see DOSAGEAND ADMINISTRATION, Dosing Guidelines, Table VI ). Dosage Increases: Increases in the dose of Theophyllinum should not be made in response to an acute exacerbation of symptoms of chronic lung disease since Theophyllinum prov >2 -selective agonists and systemically administered cortico-stero >peak steady-state serum Theophyllinum 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 Theophyllinum dose on the basis of a low serum concentration, the healthcare professional should cons >PRECAUTIONS, Laboratory Tests ). As the rate of Theophyllinum 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 Theophyllinum concentration (see DOSAGE AND ADMINISTRATION, Table VI ).

What Is Theophyllinum and How Does It Work?

Theophyllinum is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema). It must be used regularly to prevent wheezing and shortness of breath. This medication belongs to a class of drugs known as xanthines. It works in the airways by relaxing muscles, opening breathing passages, and decreasing the lungs' response to irritants. Controlling symptoms of breathing problems can decrease time lost from work or school.

Theophyllinum must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.

Theophyllinum is available under the following different brand names: Theo 24, Theochron, Elixophyllin, aminophylline, and Uniphyl.


Theophyllinum remains one of the most widely prescribed drugs for the treatment of asthma and chronic obstructive pulmonary disease (COPD) worldwide, since it is inexpensive and widely available. In many industrialized countries, however, Theophyllinum has become a third-line treatment that is only used in poorly controlled patients. This has been reinforced by various national and international guidelines on asthma therapy. Some have even questioned whether Theophyllinum is indicated in any patients with asthma , although others have emphasized the special beneficial effects of Theophyllinum which still give it an important place in management of asthma . The frequency of side-effects at the previously recommended doses and the relatively low efficacy of Theophyllinum have recently led to reduced usage, since inhaled β2-agonists are far more effective as bronchodilators and inhaled corticosteroids have a greater anti-inflammatory effect. Despite the fact that Theophyllinum has been used in asthma therapy for over 70 years, there is still considerable uncertainty about its molecular mode of action in asthma and its logical place in therapy. Recently, novel mechanisms of action that may account for the effectiveness of Theophyllinum in severe asthma have been elucidated . Because of problems with side effects, there have been attempts to improve on Theophyllinum, and recently there has been increasing interest in selective phosphodiesterase (PDE) inhibitors, which have the possibility of improving the beneficial and reducing the adverse effects of Theophyllinum.

Carl P. Weiner MD, MBA, FACOG, Clifford Mason PhD, in Drugs for Pregnant and Lactating Women (Third Edition) , 2019


NDC 62332-025-30 Theophyllinum Extended-Release Tablets 300 mg Rx only 30 Tablets Alembic

Anxiety drugs

When you take these drugs with Theophyllinum, you may need a larger dose for them to work. Examples of these drugs include:

Clinical implications

It is predicted from the in vitro studies in COPD cells and (unpublished) animal studies that low dose Theophyllinum (giving a plasma concentration of ∼5 mg/l) will reverse steroid resistance in COPD patients and thus control inflammation. Theophyllinum may have a unique effect in the treatment of COPD by restoring reduced HDAC activity to normal levels, thus suppressing inflammation but also potentially making the patients responsive to corticosteroids. If this is correct this should improve symptoms, reduce exacerbations, and reduce the progression of the disease. Furthermore, at these low doses of Theophyllinum, side effects are not a problem. Moreover, this treatment would be relatively cheap and may be an appropriate approach to the global epidemic of COPD, although not popular with major pharmaceutical companies. Perhaps Theophyllinum will be reinstated in the future when long term clinical trials have been completed.

If the signal transduction pathways responsible for HDAC activation by Theophyllinum can be defined, this might lead to the development of new anti‐inflammatory therapies that are completely free of the side effects seen with high doses of Theophyllinum, providing a novel therapeutic approach to COPD.

Hormone problems/birth control drugs

These drugs may increase the levels of Theophyllinum in your body. This means that you may have more side effects. An example of these drugs is:

A methylxanthine derivative from tea with diuretic, smooth muscle relaxant, bronchial dilation, cardiac and central nervous system stimulant activities. Mechanistically, Theophyllinum acts as a phosphodiesterase inhibitor, adenosine receptor blocker, and histone deacetylase activator. Theophyllinum is marketed under several brand names such as Uniphyl and Theochron, and it is indicated mainly for asthma, bronchospasm, and COPD.

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