- Theo-24 side effects
- Theo-24 drug
- Theo-24 action
- Theo-24 used to treat
- Theo-24 uses
- Theo-24 missed dose
- Theo-24 serious side effects
- Theo-24 effects of
- Theo-24 the effects of
- Theo-24 theo-24 side effects
- Theo-24 theo-24 dosage
- Theo-24 900 mg
- Theo-24 dosage
- Theo-24 dosage forms
- Theo-24 average dose
- Theo-24 adverse effects
Theo-24 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.
Theo-24 comes in an extended release capsule. It is usually taken once a day. Take this medication on an empty stomach, unless your doctor tells you otherwise. Swallow capsules whole. Do not crush or chew capsules.
Common side effects include nausea, headache, and insomnia.
Actient Pharmaceuticals, LLC.
If OVERDOSE is suspected
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
What is the most important information I should know about Theo-24 (theophylline)?
Do not take theophylline in larger or smaller amounts or for longer than recommended. Theophylline overdose can occur if you accidentally take too much at one time, or if your daily doses are too high. To be sure you are using the correct dose, your blood will need to be tested often.
Do not start or stop smoking without first talking to your doctor. Smoking changes the way your body uses theophylline, and you may need to use a different dose.
Sometimes it is not safe to use certain drugs at the same time. Many drugs can interact with theophylline. Tell your doctor about all other medicines you use. Also tell your doctor if you start or stop using any of your other medications.
Stop using theophylline and call your doctor at once if you have severe or continued vomiting, rapid heartbeats, confusion, tremors, or seizure.
What should I discuss with my healthcare provider before taking Theo-24 (theophylline)?
You should not use theophylline if you are allergic to it.
To make sure theophylline is safe for you, tell your doctor if you have any of these conditions:
a gastric or peptic ulcer;
epilepsy or other seizure disorder;
heart disease, high blood pressure, a heart rhythm disorder;
a high fever (102 degrees or higher);
any chronic or recurrent illness;
fluid in your lungs;
a thyroid disorder;
liver disease (especially cirrhosis or hepatitis);
serious infection called sepsis;
enlarged prostate or urination problems;
a history of alcoholism; or
if you smoke or have recently quit smoking cigarettes or marijuana.
FDA pregnancy category C. It is not known whether theophylline will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Theophylline can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Do not give this medication to anyone under 18 years old without medical advice.
Serious side effects may be more likely in older adults taking theophylline.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Uses For Theo-24
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.
Before Using Theo-24
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of theophylline in children. However, children younger than 1 year of age are more likely to have serious side effects, which may require caution and an adjustment in the dose for patients receiving theophylline.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of theophylline in the elderly. However, elderly patients may be more sensitive to the effects of theophylline than younger adults, and are more likely to have kidney, liver, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving theophylline.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Estradiol Cypionate
- Estradiol Valerate
- Ethinyl Estradiol
- Ethynodiol Diacetate
- Medroxyprogesterone Acetate
- Peginterferon Alfa-2a
- Peginterferon Alfa-2b
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Interferon Alfa-2a
- St John's Wort
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Congestive heart failure or
- Cor pulmonale (heart condition) or
- Fever of 102 degrees F or higher for 24 hours or more or
- Hypothyroidism (underactive thyroid) or
- Infection, severe (e.g., sepsis) or
- Kidney disease in infants younger than 3 months of age or
- Liver disease (e.g., cirrhosis, hepatitis) or
- Pulmonary edema (lung condition) or
- Shock (serious condition with very little blood flow in the body)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Heart rhythm problems (e.g., arrhythmia) or
- Seizures, or history of or
- Stomach ulcer—Use with caution. May make these conditions worse.
Theo-24 Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Incidence not known
- Chest pain or discomfort
- fast, slow, or irregular heartbeat
- increase in urine volume
- persistent vomiting
- pounding or rapid pulse
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
- Abdominal or stomach pain
- blurred vision
- confusion about identity, place, and time
- dark-colored urine
- decrease in frequency of urination
- decreased urine
- difficulty in passing urine (dribbling)
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- fast, pounding, or irregular heartbeat or pulse
- increased thirst
- irregular heartbeat
- loss of appetite
- mood changes
- muscle cramps or spasms
- muscle pain or stiffness
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- pain or discomfort in the arms, jaw, back, or neck
- painful urination
- shakiness in the legs, arms, hands, or feet
- shortness of breath
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Incidence not known
- trouble sleeping
- unable to sleep
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Theo-24 Dosage and Administration
Theo-24, like other extended-release theophylline products, is intended for patients with relatively continuous or recurring symptoms who have a need to maintain therapeutic serum levels of theophylline. It is not intended for patients experiencing an acute episode of bronchospasm (associated with asthma, chronic bronchitis, or emphysema). Such patients require rapid relief of symptoms and should be treated with an immediate-release or intravenous theophylline preparation (or other bronchodilators) and not with extended-release products.
Patients who metabolize theophylline at a normal or slow rate are reasonable candidates for once-daily dosing with Theo-24. Patients who metabolize theophylline rapidly (e.g., the young, smokers, and some nonsmoking adults) and who have symptoms repeatedly at the end of a dosing interval, will require either increased doses given once a day or preferably, are likely to be better controlled by a schedule of twice-daily dosing. Those patients who require increased daily doses are more likely to experience relatively wide peak-trough differences and may be candidates for twice-a-day dosing with Theo-24.
Patients should be instructed to take this medication each morning at approximately the same time and not to exceed the prescribed dose.
Recent studies suggest that dosing of extended-release theophylline products at night (after the evening meal) results in serum concentrations of theophylline which are not identical to those recorded during waking hours and may be characterized by early trough and delayed peak levels. This appears to occur whether the drug is given as an immediate-release, extended-release, or intravenous product. To avoid this phenomenon when two doses per day are prescribed, it is recommended that the second dose be given 10 to 12 hours after the morning dose and before the evening meal.
Food and posture, along with changes associated with circadian rhythm, may influence the rate of absorption and/or clearance rates of theophylline from extended-release dosage forms administered at night. The exact relationship of these and other factors to nighttime serum concentrations and the clinical significance of such findings require additional study. Therefore, it is not recommended that Theo-24 (when used as a once-a-day product) be administered at night.
Patients who require a relatively high dose of theophylline (i.e., a dose equal to or greater than 900 mg or 13 mg/kg, whichever is less) should not take Theo-24 less than 1 hour before a high-fat-content meal since this may result in a significant increase in peak serum level and in the extent of absorption of theophylline as compared to administration in the fasted state (see PRECAUTIONS, Drug/Food Interactions).
The steady-state peak serum theophylline concentration is a function of the dose, the dosing interval, and the rate of theophylline absorption and clearance in the individual patient. Because of marked individual differences in the rate of theophylline clearance, the dose required to achieve a peak serum theophylline concentration in the 10 - 20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter theophylline clearance (e.g., 400 - 1600 mg/day in adults <60 years old and 10 - 36 mg/kg/day in children 1 - 9 years old). For a given population there is no single theophylline dose that will provide both safe and effective serum concentrations for all patients. Administration of the median theophylline dose required to achieve a therapeutic serum theophylline concentration in a given population may result in either sub-therapeutic or potentially toxic serum theophylline concentrations in individual patients. For example, at a dose of 900 mg/day in adults <60 years or 22 mg/kg/day in children 1-9 years, the steady-state peak serum theophylline concentration will be <10 mcg/mL in about 30% of patients, 10 - 20 mcg/mL in about 50% and 20 - 30 mcg/mL in about 20% of patients. The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects.
Transient caffeine-like adverse effects and excessive serum concentrations in slow metabolizers can be avoided in most patients by starting with a sufficiently low dose and slowly increasing the dose, if judged to be clinically indicated, in small increments (See Table V). Dose increases should only be made if the previous dosage is well tolerated and at intervals of no less than 3 days to allow serum theophylline concentrations to reach the new steady state. Dosage adjustment should be guided by serum theophylline concentration measurement (see PRECAUTIONS, Laboratory Tests and DOSAGE AND ADMINISTRATION, Table VI). Health care providers should instruct patients and care givers to discontinue any dosage that causes adverse effects, to withhold the medication until these symptoms are gone and to then resume therapy at a lower, previously tolerated dosage (see WARNINGS).
If the patient's symptoms are well controlled, there are no apparent adverse effects, and no intervening factors that might alter dosage requirements (see WARNINGS and PRECAUTIONS), serum theophylline concentrations should be monitored at 6 month intervals for rapidly growing children and at yearly intervals for all others. In acutely ill patients, serum theophylline concentrations should be monitored at frequent intervals, e.g., every 24 hours.
Theophylline distributes poorly into body fat, therefore, mg/kg dose should be calculated on the basis of ideal body weight.
Table V contains theophylline dosing titration schema recommended for patients in various age groups and clinical circumstances. Table VI contains recommendations for theophylline dosage adjustment based upon serum theophylline concentrations. Application of these general dosing recommendations to individual patients must take into account the unique clinical characteristics of each patient. In general, these recommendations should serve as the upper limit for dosage adjustments in order to decrease the risk of potentially serious adverse events associated with unexpected large increases in serum theophylline concentration.
| * Patients with more rapid metabolism, clinically identified by higher than average dose |
requirements, should receive a smaller dose more frequently to prevent breakthrough
symptoms resulting from low trough concentrations before the next dose. A reliably
absorbed slow-release formulation will decrease fluctuations and permit longer dosing
|A.||Children (12-15 years) and adults (16-60 years) without risk factors for impaired clearance.|
|Titration Step||Children <45 kg||Children >45 kg and adults|
|1.||Starting Dosage|| 12 - 14 mg/kg/day up to a |
maximum of 300 mg/day
divided Q 24 hrs*
| 300 - 400 mg/day1 divided Q |
|2.|| After 3 days, if |
| 16 mg/kg/day up to a |
maximum of 400 mg/day
divided Q 24 hrs*
| 400 - 600 mg/day1 divided Q |
|3.|| After 3 more days, if |
tolerated and if
needed, increase dose
| 20 mg/kg/day up to a |
maximum of 600 mg/day
divided Q 24 hrs*
| As with all theophylline |
products, doses greater than
600 mg should be titrated
according to blood level
(see Table VI)
|1|| If caffeine-like adverse effects occur, then consideration should be given to a lower |
dose and titrating the dose more slowly (see ADVERSE REACTIONS).
|B.|| Patients with risk factors for impaired clearance, the elderly (>60 Years), and |
those in whom it is not feasible to monitor serum theophylline concentrations:
In children 12-15 years of age, the final theophylline dose should not exceed 16
mg/kg/day up to a maximum of 400 mg/day in the presence of risk factors for reduced
theophylline clearance (see WARNINGS) or if it is not feasible to monitor serum
In adolescents ≥16 years and adults, including the elderly, the final theophylline dose
should not exceed 400 mg/day in the presence of risk factors for reduced theophylline
clearance (see WARNINGS) or if it is not feasible to monitor serum theophylline
|Peak Serum |
| * Dose reduction and/or serum theophylline concentration measurement is indicated whenever adverse effects are present, |
physiologic abnormalities that can reduce theophylline clearance occur (e.g., sustained fever), or a drug that interacts with
theophylline is added or discontinued (see WARNINGS).
|<9.9 mcg/mL|| If symptoms are not controlled and current dosage is tolerated, increase dose about 25%. |
Recheck serum concentration after three days for further dosage adjustment.
|10 - 14.9 mcg/mL|| If symptoms are controlled and current dosage is tolerated, maintain dose and recheck serum |
concentration at 6-12 month intervals.* If symptoms are not controlled and current dosage
is tolerated consider adding additional medication(s) to treatment regimen.
|15 - 19.9 mcg/mL|| Consider 10% decrease in dose to provide greater margin of safety even if current dosage is |
|20 - 24.9 mcg/mL|| Decrease dose by 25% even if no adverse effects are present. Recheck serum concentration after |
3 days to guide further dosage adjustment.
|25 - 30 mcg/mL|| Skip next dose and decrease subsequent doses at least 25% even if no adverse effects are present. |
Recheck serum concentration after 3 days to guide further dosage adjustment. If symptomatic,
consider whether overdosage treatment is indicated (see recommendations for chronic overdosage).
|>30 mcg/mL|| Treat overdose as indicated (see recommendations for chronic overdosage). If theophylline is |
subsequently resumed, decrease dose by at least 50% and recheck serum concentration after 3
days to guide further dosage adjustment.