Elixophyllin 80mg/15ml Elixir
It is used to treat breathing problems. Do not use this drug to treat intense flare-ups of shortness of breath. Use a rescue inhaler. If you have questions, talk with the doctor.
Drug Class
Bronchodilator
Pharmacologic Class
Methylxanthine
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Theophylline is a medicine used to help open up the airways in your lungs, making it easier to breathe. It's often used for conditions like asthma or COPD. It works by relaxing the muscles around your airways. Because the amount of medicine in your body needs to be just right, your doctor will likely do blood tests to check your levels.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at the same time every day to establish a routine.
Certain foods may interact with your medication, affecting how it works or increasing the risk of side effects. Discuss with your doctor how to take your medication in relation to food consumption.
Measuring Your Dose
If you are taking a liquid form of this medication, it's essential to measure your dose accurately. Use the measuring device that comes with your medication. If one is not provided, ask your pharmacist for a suitable measuring device to ensure you take the correct dose.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, away from direct light.
Keep it in a dry place to prevent damage.
Do not store your medication in a bathroom, as the moisture and temperature fluctuations can affect its potency.
Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or misuse.
What to Do If You Miss a Dose
If you miss a dose, do not attempt to catch up by taking an extra dose. Instead:
Skip the missed dose and continue with your regular dosing schedule.
Never take two doses at the same time or take extra doses, as this can increase the risk of side effects.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at the same time every day to establish a routine.
Certain foods may interact with your medication, affecting how it works or increasing the risk of side effects. Discuss with your doctor how to take your medication in relation to food consumption.
Measuring Your Dose
If you are taking a liquid form of this medication, it's essential to measure your dose accurately. Use the measuring device that comes with your medication. If one is not provided, ask your pharmacist for a suitable measuring device to ensure you take the correct dose.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, away from direct light.
Keep it in a dry place to prevent damage.
Do not store your medication in a bathroom, as the moisture and temperature fluctuations can affect its potency.
Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or misuse.
What to Do If You Miss a Dose
If you miss a dose, do not attempt to catch up by taking an extra dose. Instead:
Skip the missed dose and continue with your regular dosing schedule.
Never take two doses at the same time or take extra doses, as this can increase the risk of side effects.
Lifestyle & Tips
- Avoid sudden changes in smoking habits (including marijuana) as this can significantly affect how your body handles the medicine.
- Limit caffeine intake (coffee, tea, soda, energy drinks) as it can increase side effects like nervousness and heart palpitations.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, as many can interact with theophylline.
- Take the medicine exactly as prescribed, do not skip doses or take extra doses.
- Do not crush or chew extended-release tablets/capsules; swallow them whole.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 300-400 mg/day in divided doses (e.g., 150-200 mg twice daily or 100 mg three to four times daily). Adjust based on serum concentrations.
Dose Range:
300 - 600 mg
Condition-Specific Dosing:
non-smokers:
Initial: 300-400 mg/day. Max: 600 mg/day.
smokers:
May require higher doses due to increased clearance. Initial: 400-600 mg/day. Max: 900 mg/day.
acute_bronchospasm:
Loading dose: 5 mg/kg IV (or oral equivalent if not on theophylline). Maintenance: 0.5-0.7 mg/kg/hr IV (or oral equivalent). Adjust to achieve serum concentration of 10-20 mcg/mL.
Pediatric Dosing
Neonatal:
Not established for routine use; specific dosing for apnea of prematurity (usually caffeine is preferred). If used: Loading dose 5 mg/kg, then maintenance 1-2 mg/kg/day divided every 12 hours. Adjust based on serum levels.
Infant:
6 weeks to 6 months: Initial 12 mg/kg/day. Max 24 mg/kg/day. Adjust based on serum levels.
Child:
1-9 years: Initial 16 mg/kg/day. Max 24 mg/kg/day. Adjust based on serum levels. 9-12 years: Initial 16 mg/kg/day. Max 20 mg/kg/day. Adjust based on serum levels.
Adolescent:
12-16 years: Initial 13 mg/kg/day. Max 18 mg/kg/day. Adjust based on serum levels.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, but monitor serum levels closely.
Moderate:
No specific adjustment, but monitor serum levels closely.
Severe:
No specific adjustment, but monitor serum levels closely. Theophylline is primarily metabolized by the liver, but metabolites may accumulate.
Dialysis:
Theophylline is dialyzable. Supplemental dose may be needed after dialysis. Monitor serum levels.
Hepatic Impairment:
Mild:
Reduce dose by 25-50%. Monitor serum levels closely.
Moderate:
Reduce dose by 50% or more. Monitor serum levels closely.
Severe:
Reduce dose by 50-75%. Monitor serum levels closely. Avoid if possible.
Pharmacology
Mechanism of Action
Theophylline is a methylxanthine derivative that acts as a non-selective phosphodiesterase inhibitor, leading to increased intracellular cyclic AMP (cAMP). This results in bronchodilation by relaxing bronchial smooth muscle. It also has anti-inflammatory effects, enhances diaphragmatic contractility, and stimulates the central nervous system. It may also act as an adenosine receptor antagonist.
Pharmacokinetics
Absorption:
Bioavailability:
90-100% (oral)
Tmax:
1-2 hours (liquid/immediate-release)
FoodEffect:
Food may alter the rate but not the extent of absorption for immediate-release formulations. High-fat meals may delay absorption.
Distribution:
Vd:
0.4-0.6 L/kg
ProteinBinding:
40-60% (lower in neonates and patients with liver disease)
CnssPenetration:
Yes
Elimination:
HalfLife:
Adults: 7-9 hours (non-smokers), 4-5 hours (smokers). Children: 1-5 hours. Neonates: 10-30 hours.
Clearance:
Highly variable, influenced by age, smoking, liver disease, heart failure, fever, and drug interactions.
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Approximately 10% (adults), 50% (neonates)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (oral liquid)
PeakEffect:
1-2 hours (oral liquid)
DurationOfAction:
6-8 hours (oral liquid)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of acidosis (too much acid in the blood), including:
+ Confusion
+ Rapid breathing
+ Rapid heartbeat
+ Irregular heartbeat
+ Severe stomach pain
+ Nausea or vomiting
+ Feeling extremely sleepy
+ Shortness of breath
+ Feeling very tired or weak
Abnormal heartbeat
Severe dizziness or fainting
Shakiness
Confusion
Seizures
Changes in behavior
Irritability
Muscle spasms
Muscle pain or weakness, dark urine, or difficulty urinating
Common Side Effects: Notify Your Doctor
If you experience any of the following side effects, inform your doctor:
Upset stomach
Nausea or vomiting
Persistent headache
Trouble sleeping
Rapid heartbeat
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. Many individuals may not experience any side effects or only minor ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Feeling nervous or excitable
Restlessness
Headache
Diarrhea
* Frequent urination
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of acidosis (too much acid in the blood), including:
+ Confusion
+ Rapid breathing
+ Rapid heartbeat
+ Irregular heartbeat
+ Severe stomach pain
+ Nausea or vomiting
+ Feeling extremely sleepy
+ Shortness of breath
+ Feeling very tired or weak
Abnormal heartbeat
Severe dizziness or fainting
Shakiness
Confusion
Seizures
Changes in behavior
Irritability
Muscle spasms
Muscle pain or weakness, dark urine, or difficulty urinating
Common Side Effects: Notify Your Doctor
If you experience any of the following side effects, inform your doctor:
Upset stomach
Nausea or vomiting
Persistent headache
Trouble sleeping
Rapid heartbeat
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. Many individuals may not experience any side effects or only minor ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Feeling nervous or excitable
Restlessness
Headache
Diarrhea
* Frequent urination
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe nausea or vomiting
- Persistent headache
- Insomnia or extreme restlessness
- Tremors or muscle twitching
- Fast or irregular heartbeat (palpitations)
- Seizures
- Confusion
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking St. John's wort, as it is not recommended to take this medication concurrently with St. John's wort. If you have been taking St. John's wort, consult with your doctor before discontinuing it to ensure a safe transition.
This medication can interact with various substances, so it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
By sharing this information, you can help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking St. John's wort, as it is not recommended to take this medication concurrently with St. John's wort. If you have been taking St. John's wort, consult with your doctor before discontinuing it to ensure a safe transition.
This medication can interact with various substances, so it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
By sharing this information, you can help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug may interfere with certain laboratory tests, so be sure to notify your healthcare providers and lab personnel that you are taking it.
To ensure your safety, wear a medical alert identification (ID) and follow your doctor's instructions for regular blood work and laboratory tests.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels while taking this medication.
To minimize potential side effects, limit your consumption of caffeine-containing products, such as tea, coffee, and cola, as well as chocolate, as combining these with this drug may cause nervousness, shakiness, and a rapid heartbeat.
Before consuming alcohol, consult with your doctor to discuss any potential risks.
If you start or stop using tobacco or marijuana, inform your doctor, as this may require an adjustment to your medication dosage.
If you become ill, develop a fever, or experience a worsening of a chronic condition, consult with your doctor promptly.
Individuals 60 years or older should exercise caution when taking this medication, as they may be more susceptible to side effects.
When administering this drug to children, use caution, as the risk of certain side effects may be higher in this population.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
To ensure your safety, wear a medical alert identification (ID) and follow your doctor's instructions for regular blood work and laboratory tests.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels while taking this medication.
To minimize potential side effects, limit your consumption of caffeine-containing products, such as tea, coffee, and cola, as well as chocolate, as combining these with this drug may cause nervousness, shakiness, and a rapid heartbeat.
Before consuming alcohol, consult with your doctor to discuss any potential risks.
If you start or stop using tobacco or marijuana, inform your doctor, as this may require an adjustment to your medication dosage.
If you become ill, develop a fever, or experience a worsening of a chronic condition, consult with your doctor promptly.
Individuals 60 years or older should exercise caution when taking this medication, as they may be more susceptible to side effects.
When administering this drug to children, use caution, as the risk of certain side effects may be higher in this population.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe nausea and vomiting (often intractable)
- Abdominal pain
- Diarrhea
- Headache
- Insomnia
- Irritability
- Restlessness
- Tremor
- Hyperreflexia
- Tachycardia
- Cardiac arrhythmias (e.g., supraventricular tachycardia, ventricular ectopy)
- Hypotension
- Seizures (generalized tonic-clonic)
- Hypokalemia
- Hyperglycemia
- Metabolic acidosis
What to Do:
Call 911 or Poison Control (1-800-222-1222) immediately. Treatment may involve activated charcoal, gastric lavage, supportive care, antiarrhythmics, benzodiazepines for seizures, and hemoperfusion for severe toxicity.
Drug Interactions
Contraindicated Interactions
- Tizanidine (increased tizanidine levels)
- Zileuton (increased theophylline levels)
Major Interactions
- Cimetidine (increased theophylline levels)
- Erythromycin (increased theophylline levels)
- Clarithromycin (increased theophylline levels)
- Fluoroquinolones (e.g., Ciprofloxacin, Enoxacin, Norfloxacin, Ofloxacin - increased theophylline levels)
- Fluvoxamine (increased theophylline levels)
- Propafenone (increased theophylline levels)
- Ritonavir (increased theophylline levels)
- Mexiletine (increased theophylline levels)
- Oral contraceptives (increased theophylline levels)
- Phenytoin (decreased theophylline levels, increased phenytoin levels)
- Carbamazepine (decreased theophylline levels)
- Phenobarbital (decreased theophylline levels)
- Rifampin (decreased theophylline levels)
- St. John's Wort (decreased theophylline levels)
- Allopurinol (increased theophylline levels, especially with high doses of allopurinol)
- Disulfiram (increased theophylline levels)
- Interferon alfa (increased theophylline levels)
- Influenza vaccine (increased theophylline levels)
Moderate Interactions
- Beta-blockers (may antagonize bronchodilator effect)
- Lithium (increased lithium excretion, decreased lithium levels)
- Diuretics (increased renal excretion of theophylline)
- Ketoconazole (increased theophylline levels)
- Itraconazole (increased theophylline levels)
- Thyroid hormones (increased theophylline clearance)
- Isoniazid (increased theophylline levels)
- Corticosteroids (variable effect on theophylline clearance)
- Sympathomimetics (additive CNS and cardiovascular effects)
Minor Interactions
- Caffeine (additive CNS stimulation)
- Tobacco smoking (decreased theophylline levels)
- Marijuana smoking (decreased theophylline levels)
Monitoring
Baseline Monitoring
Liver function tests (LFTs)
Rationale: Theophylline is primarily metabolized by the liver; impairment can significantly alter clearance.
Timing: Prior to initiation, especially in patients with suspected liver disease.
Renal function tests (RFTs)
Rationale: Although primarily hepatic, severe renal impairment can affect metabolite excretion.
Timing: Prior to initiation, especially in patients with suspected renal disease.
Smoking status
Rationale: Smoking significantly increases theophylline clearance.
Timing: Prior to initiation and regularly during treatment.
Concurrent medications
Rationale: Many drugs interact with theophylline, altering its metabolism.
Timing: Prior to initiation and with any new medication.
Routine Monitoring
Serum Theophylline Concentration (STC)
Frequency: Initially 3 days after starting therapy or dose change, then every 6-12 months or as clinically indicated.
Target: 10-20 mcg/mL (therapeutic range for bronchodilation); some sources suggest 5-15 mcg/mL for optimal balance of efficacy and safety.
Action Threshold: >20 mcg/mL (increased risk of toxicity); <10 mcg/mL (subtherapeutic, consider dose increase).
Heart rate, rhythm, blood pressure
Frequency: Regularly, especially during dose titration or in patients with cardiovascular disease.
Target: Normal limits
Action Threshold: Tachycardia, arrhythmias, hypotension/hypertension (signs of toxicity).
Electrolytes (especially potassium)
Frequency: Periodically, especially if co-administered with beta-agonists or corticosteroids.
Target: Normal limits
Action Threshold: Hypokalemia (can exacerbate arrhythmias).
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Headache
- Insomnia
- Irritability
- Restlessness
- Tremor
- Palpitations
- Seizures (severe toxicity)
- Arrhythmias (severe toxicity)
Special Patient Groups
Pregnancy
Use with caution during pregnancy. Theophylline crosses the placenta. Benefits should outweigh risks. Monitor maternal serum levels closely, as clearance may increase during pregnancy, requiring dose adjustments. Neonates may experience irritability or withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk for major malformations.
Second Trimester:
Clearance may increase, requiring dose adjustments.
Third Trimester:
Clearance may increase. Monitor for neonatal irritability, jitteriness, or withdrawal symptoms if mother is on high doses near term.
Lactation
Theophylline is excreted into breast milk. Monitor breastfed infants for signs of toxicity (irritability, insomnia, jitteriness, poor feeding). Consider administering the dose immediately after breastfeeding or using a different bronchodilator if possible. L3 (moderately safe).
Infant Risk:
Moderate risk of irritability, insomnia, jitteriness, poor feeding, and tachycardia in the infant, especially with high maternal doses or in premature infants.
Pediatric Use
Dosing is highly individualized based on age, weight, and clinical response, with careful monitoring of serum concentrations due to variable clearance. Neonates and young infants have significantly reduced clearance compared to older children and adults. Not recommended as first-line therapy for asthma in children due to narrow therapeutic index and availability of safer alternatives.
Geriatric Use
Reduced clearance is common in elderly patients due to age-related decline in liver function and potential for comorbidities (e.g., heart failure). Start with lower doses and titrate slowly with close monitoring of serum concentrations and for adverse effects.
Clinical Information
Clinical Pearls
- Theophylline has a narrow therapeutic index; therapeutic drug monitoring (TDM) is essential to optimize efficacy and minimize toxicity.
- Many factors influence theophylline clearance, including age, smoking status, diet, fever, and concurrent medications. Always re-evaluate dosing with changes in these factors.
- Oral liquid formulations (like Elixophyllin) are immediate-release and have a faster onset and shorter duration compared to extended-release formulations.
- Symptoms of toxicity (nausea, vomiting, headache, tremor, palpitations) can occur even within the therapeutic range, especially at the higher end.
- Avoid abrupt discontinuation, especially in patients with severe asthma or COPD, as it may lead to worsening of symptoms.
- Caffeine intake should be consistent or limited, as it can contribute to theophylline-like side effects and potentially increase serum levels.
Alternative Therapies
- Beta-2 adrenergic agonists (e.g., albuterol, salmeterol, formoterol) - preferred bronchodilators.
- Inhaled corticosteroids (e.g., fluticasone, budesonide) - preferred anti-inflammatory agents for asthma/COPD.
- Leukotriene receptor antagonists (e.g., montelukast, zafirlukast).
- Long-acting muscarinic antagonists (LAMAs) (e.g., tiotropium, umeclidinium).
- Caffeine (for apnea of prematurity, preferred over theophylline).
Cost & Coverage
Average Cost:
Varies widely per 473 mL bottle (Elixophyllin 80mg/15ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.