Theo-Time

Name: Theo-Time

Theo-Time Overview

Theophylline is a prescription medication used to treat chronic (ongoing) lung diseases such as asthma, emphysema, and chronic bronchitis. This medication belongs to a group of drugs called methylxanthines. It works by relaxing the muscles of the airways, which opens airway passages and allows more air to get into the lungs. This action relieves wheezing, shortness of breath, and chest tightness.

Theophylline comes in a sustained-release tablet. It is usually taken once or twice daily. Take this medication on an empty stomach, unless your doctor tells you otherwise. Swallow tablets whole. Do not crush or chew theophylline sustained-release tablets.

Common side effects include nausea, headache, and insomnia.

Uses For Theo-Time

Theophylline is used together with other medicines to treat the symptoms of asthma, bronchitis, emphysema, and other lung diseases.

Theophylline belongs to a group of medicines known as bronchodilators. Bronchodilators are medicines that relax the muscles in the bronchial tubes (air passages) of the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor's prescription.

Proper Use of theophylline

This section provides information on the proper use of a number of products that contain theophylline. It may not be specific to Theo-Time. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep the blood level constant, take this medicine at the same time each day and do not miss any doses.

After you or your child begin taking theophylline, it is very important that your doctor check the level of the medicine in the blood at regular intervals to decide if the dose needs to be changed. Keep all appointments for testing the blood level.

Take the extended-release capsule or tablet every morning at the same time each day. You may take your second dose 10 to 12 hours after the morning dose and before the evening meal, unless your doctor tells you otherwise.

Swallow the extended-release tablet whole. Do not break, crush, or chew it. You may take the extended-release tablet with or without food.

It is best to take the extended-release capsule one hour before a high-fat meal or without food.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • To treat symptoms of asthma, bronchitis, and emphysema:
    • For oral dosage form (elixir or tablets):
      • Adults, teenagers, and children above 1 year of age weighing more than 45 kilograms (kg)—At first, 300 milligrams (mg) per day, divided and given every 6 to 8 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day.
      • Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day, divided and given every 6 to 8 hours.
      • Children and teenagers 1 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day, divided and given every 4 to 6 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day.
      • Infants younger than 1 year of age—Dose is based on body weight and age and must be determined by your doctor.
    • For oral dosage form (extended-release capsules):
      • Adults, teenagers, and children 12 years of age and older weighing more than 45 kilograms (kg)—At first, 300 to 400 milligrams (mg) as a single dose, usually in the morning, or divided and given two times per day. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day.
      • Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day as a single dose, usually in the morning, or divided and given two times per day.
      • Children and teenagers 12 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day as a single dose, usually in the morning, or divided and given two times per day. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (extended-release tablets):
      • Adults, teenagers, and children 6 years of age and older weighing more than 45 kilograms (kg)—At first, 300 milligrams (mg) per day, divided and given every 12 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day.
      • Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day, divided and given every 12 hours.
      • Children and teenagers 6 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day, divided and given every 12 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

For Healthcare Professionals

Applies to theophylline: compounding powder, intravenous solution, oral capsule, oral capsule extended release, oral elixir, oral solution, oral syrup, oral tablet, oral tablet extended release

General

The majority of side effects have been dependent on the serum concentration. Generally, serum concentrations of theophylline (the active ingredient contained in Theo-Time) ranging from 10 to 20 mcg/mL are considered therapeutic, and serum concentrations greater than 20 mcg/mL are associated with greater toxicity.[Ref]

There are several factors which may predispose a patient to higher serum concentrations and, thus, toxicity. These factors may include increased age, concomitant drugs which reduce the clearance of theophylline, hypothyroidism, congestive heart failure, liver disease, renal failure, and alterations in smoking habits. One series of patients with theophylline intoxication had recent upper respiratory tract infections.

The nature of acute toxicity of theophylline differs from chronic toxicity. Acute overdose is associated with higher theophylline concentrations and younger patients. In acute overdose the severity of toxicity is correlated with peak serum concentrations. Chronic overdosage is seen more commonly in older patients, and severe toxicity may occur with serum concentrations which are much lower than those seen in severe acute toxicity. In these patients, age is a predictor of severe toxicity.[Ref]

Gastrointestinal

Gastrointestinal side effects have included anorexia, nausea, vomiting, and abdominal pain. Theophylline (the active ingredient contained in Theo-Time) may also cause locally-mediated gastrointestinal upset.[Ref]

Nervous system

Nervous system side effects have included generalized seizures, most commonly in patients with elevated serum concentrations, although seizures have occurred at therapeutic concentrations. Theophylline (the active ingredient contained in Theo-Time) may also cause nervousness and tremor at therapeutic dosages, which become worse as serum concentrations increase.[Ref]

The mechanism of theophylline-induced seizures has not been determined. Seizures are generally focal with secondary generalization. Permanent neurologic deficits have been reported and morbidity may be high, especially in the elderly, patients with severe underlying disease, and patients with prolonged, uncontrolled seizure activity. The onset of seizures is not always preceded by less severe symptoms of theophylline toxicity. Patients with an abnormal neurologic history, including a history of seizures, cerebral infarct, or head trauma, may be predisposed to seizure activity. If theophylline is used in these types of patients, serum concentrations should be monitored closely and maintained in the low, therapeutic range.[Ref]

Cardiovascular

Cardiovascular side effects have included increases in heart rate which have progressed to supraventricular tachycardia or ventricular tachycardia. Patients with a history of arrhythmias may be predisposed to this effect. Hypotension has occurred with rapid intravenous administration.[Ref]

Theophylline serum concentrations have been a significant predictor of arrhythmias. One study reported multifocal atrial tachycardia in 8% and 16% of patients with a serum concentration between 10 and 20 mcg/mL and greater than 20 mcg/mL, respectively. The onset of serious arrhythmias is not always preceded by less severe signs of theophylline toxicity.

Elevated serum CK-MB levels have been associated with theophylline toxicity in the absence of cardiac disease. CK-MB levels have returned to normal following discontinuation of theophylline therapy.[Ref]

Metabolic

Metabolic side effects have included hypokalemia, hyperglycemia, respiratory alkalosis, hypophosphatemia, and hypomagnesemia, especially in the situation of acute overdosage. The magnitude of these abnormalities have been correlated with theophylline (the active ingredient contained in Theo-Time) concentrations. Hypercalcemia has been reported in a patient with hyperthyroid disease with theophylline at therapeutic concentrations.[Ref]

In one group of patients with theophylline concentrations greater than 20 mcg/mL, hyperglycemia was present in approximately 50%, hypokalemia in 15%, and hypomagnesemia in 20%. Hyponatremia and hypophosphatemia were seen less frequently.[Ref]

Genitourinary

Genitourinary side effects have included urinary retention.[Ref]

Some side effects of Theo-Time may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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