Theophylline Elixir Side effects

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

What are the possible side effects of Theophylline Elixir?

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 Elixir 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 Elixir in details

Adverse reactions associated with Theophylline Elixir are generally mild when peak serum Theophylline Elixir 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 Elixir concentrations exceed 20 mcg/mL, however, Theophylline Elixir 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 Elixir 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 Elixir therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of Theophylline Elixir 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 Elixir 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 Elixir therapy and the potential therapeutic benefit of alternative treatment.

Other adverse reactions that have been reported at serum Theophylline Elixir 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 Elixir concentrations ≥ 15 mcg/mL. There have been a few isolated reports of seizures at serum Theophylline Elixir 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 Elixir concentrations < 20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum Theophylline Elixir concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum Theophylline Elixir concentrations < 20 mcg/mL have generally been milder than seizures associated with excessive serum Theophylline Elixir 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 Elixir toxicity.*

	Percentage of Patients Reported With Sign or Symptom
Acute Overdose (Large Single Ingestion)	Chronic Overdosage (Multiple Excessive Doses)
Sign/Symptom	Study 1 (n=157)	Study 2 (n=14)	Study 1 (n=92)	Study 2 (n=102)
Asymptomatic	NR**	0	NR**	6
Gastrointestinal
Vomiting	73	93	30	61
Abdominal Pain	NR**	21	NR**	12
Diarrhea	NR**	0	NR**	14
Hematemesis	NR**	0	NR**	2
Metabolic/Other
Hypokalemia	85	79	44	43
Hyperglycemia	98	NR**	18	NR**
Acid/base disturbance	34	21	9	5
Rhabdomyolysis	NR**	7	NR**	0
Cardiovascular
Sinus tachycardia	100	86	100	62
Other supraventricular tachycardias	2	21	12	14
Ventricular premature beats	3	21	10	19
Atrial fibrillation or flutter	1	NR**	12	NR**
Multifocal atrial tachycardia	0	NR**	2	NR**
Ventricular arrhythmias with hemodynamic instability	7	14	40	0
Hypotension/shock	NR**	21	NR**	8
Neurologic
Nervousness	NR**	64	NR**	21
Tremors	38	29	16	14
Disorientation	NR**	7	NR**	11
Seizures	5	14	14	5
Death	3	21	10	4
* These data are derived from two studies in patients with serum Theophylline Elixir concentrations > 30 mcg/mL. In the first study (Study #1 –Shanon, Ann Intern Med 1993; 119: 1161-67), data were prospectively collected from 249 consecutive cases of Theophylline Elixir toxicity referred to a regional poison center for consultation. In the second study (Study #2 –Sessler, Am J Med 1990; 88: 567-76), data were retrospectively collected from 116 cases with serum Theophylline Elixir concentrations > 30 mcg/mL among 6000 blood samples obtained for measurement of serum Theophylline Elixir concentrations in three emergency departments. Differences in the incidence of manifestations of Theophylline Elixir toxicity between the two studies may reflect sample selection as a result of study design (e.g., in Study #1, 48%of the patients had acute intoxications versus only 10% in Study #2) and different methods of reporting results. ** NR =Not reported in a comparable manner.

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

• Drinking alcohol may increase the risk of side effects of Theophylline Elixir elixir. Talk to your doctor before drinking alcohol while you are taking Theophylline Elixir elixir.
• Tell your doctor or dentist that you take Theophylline Elixir 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 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 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 elixir.
• Diabetes patients - Theophylline Elixir 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 elixir may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Theophylline Elixir elixir.
• Lab tests, including blood Theophylline Elixir levels, may be performed while you use Theophylline Elixir 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 elixir with caution in the ELDERLY; they may be more sensitive to its effects.
• Caution is advised when using Theophylline Elixir 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 elixir while you are pregnant. Theophylline Elixir elixir is found in breast milk. If you are or will be breast-feeding while you use Theophylline Elixir elixir, check with your doctor. Discuss any possible risks to your baby.

Theophylline Elixir contraindications

Do not take Theophylline Elixir in larger or smaller amounts or for longer than recommended. Theophylline Elixir 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 Elixir, 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 Elixir. 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 Elixir 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. 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).
3. European Chemicals Agency - ECHA. "Aminophylinne Hydrate: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Theophylline Elixir are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Theophylline Elixir. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology