Theophylline Side effects

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• Side effects of Theophylline in details
• Theophylline contraindications
• Theophylline reviews

What are the possible side effects of Theophylline?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Theophylline and call your doctor at once if you have a serious side effect such as:

• severe or continued vomiting;

• rapid or uneven heartbeats;

• seizure (convulsions);

• confusion, tremors or shaking;

• nausea and vomiting, severe headache, rapid heart rate;

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Less serious side effects may include:

• stomach pain, diarrhea, upset stomach;

• headache;

• sweating;

• sleep problems (insomnia); or

• feeling restless, nervous, or irritable;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Theophylline in details

Adverse reactions associated with Theophylline are generally mild when peak serum Theophylline concentrations are < 20 mcg/ mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When peak serum Theophylline concentrations exceed 20 mcg/mL, however, Theophylline produces a wide range of adverse reactions including persistent vomiting, cardiac arrhythmias, and intractable seizures which can be lethal. The transient caffeine-like adverse reactions occur in about 50%of patients when Theophylline therapy is initiated at doses higher than recommended initial doses (e.g., > 300 mg/day in adults and > 12 mg/kg/day in children beyond 1 year of age). During the initiation of Theophylline therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of Theophylline therapy at a low dose with subsequent slow titration to a predetermined age-related maximum dose will significantly reduce the frequency of these transient adverse effects. In a small percentage of patients ( < 3%of children and < 10%of adults)the caffeine-like adverse effects persist during maintenance therapy, even at peak serum Theophylline concentrations within the therapeutic range (i.e., 10-20 mcg/mL). Dosage reduction may alleviate the caffeine-like adverse effects in these patients, however, persistent adverse effects should result in a reevaluation of the need for continued Theophylline therapy and the potential therapeutic benefit of alternative treatment.

Other adverse reactions that have been reported at serum Theophylline concentrations < 20 mcg/mL include diarrhea, irritability, restlessness, fine skeletal muscle tremors, and transient diuresis. In patients with hypoxia secondary to COPD, multifocal atrial tachycardia and flutter have been reported at serum Theophylline concentrations ≥ 15 mcg/mL. There have been a few isolated reports of seizures at serum Theophylline concentrations < 20 mcg/mL in patients with an underlying neurological disease or in elderly patients. The occurrence of seizures in elderly patients with serum Theophylline concentrations < 20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum Theophylline concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum Theophylline concentrations < 20 mcg/mL have generally been milder than seizures associated with excessive serum Theophylline concentrations resulting from an overdose (i.e., they have generally been transient, often stopped without anticonvulsant therapy, and did not result in neurological residua).

Table IV. Manifestations of Theophylline toxicity.*

What is the most important information I should know about Theophylline?

• Drinking alcohol may increase the risk of side effects of Theophylline elixir. Talk to your doctor before drinking alcohol while you are taking Theophylline elixir.
• Tell your doctor or dentist that you take Theophylline elixir before you receive any medical or dental care, emergency care, or surgery.
• Do not take more than the recommended dose or use more often than prescribed without checking with your doctor. If your symptoms become worse, contact your doctor.
• Carry an ID card at all times that says you take Theophylline elixir.
• Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate).
• Notify your doctor if you develop a new illness, especially if it is accompanied by fever; if a chronic illness becomes worse; or if you start or stop smoking cigarettes or marijuana.
• Tell your doctor if another doctor prescribes a new medicine or tells you to stop using a medicine that you have already been taking. Tell your doctor if you start or stop any medicine, either prescription or over the counter.
• Theophylline elixir will not stop an asthma attack once one has started. Be sure to always carry appropriate rescue medicine (eg, bronchodilator inhaler) with you in case of an asthma attack.
• If you have more than one doctor, be sure to tell each of your doctors that you are taking Theophylline elixir.
• Diabetes patients - Theophylline elixir may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Theophylline elixir may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Theophylline elixir.
• Lab tests, including blood Theophylline levels, may be performed while you use Theophylline elixir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Theophylline elixir with caution in the ELDERLY; they may be more sensitive to its effects.
• Caution is advised when using Theophylline elixir in CHILDREN, especially children younger than 1 year old; they may be more sensitive to its effects. Children may be more likely to experience mild, temporary behavior changes.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Theophylline elixir while you are pregnant. Theophylline elixir is found in breast milk. If you are or will be breast-feeding while you use Theophylline elixir, check with your doctor. Discuss any possible risks to your baby.

Theophylline contraindications

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.

References

1. DailyMed. "THEOPHYLLINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DailyMed. "GUAIFENESIN; HYDROCODONE BITARTRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
3. DTP/NCI. "theophylline: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology