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Filotempo

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Filotempo

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Filotempo

Quick Facts

Property Description
Active Ingredient Aminophylline
Form Solution for injection, Oral tablets, Rectal suppositories
Pharmacological Class Xanthine Derivative; Bronchodilator
Common Use Relief of reversible airway obstruction
Origin Synthetic derivative of Theophylline

What Type of Medicine is Filotempo?

Filotempo is a systemic prescription medication classified within the xanthine derivative pharmacological class, clinically recognized for its function as a potent bronchodilator and a smooth muscle relaxant. This substance is a synthetic derivative of the alkaloid Theophylline designed for systemic absorption. While historically vital, the clinical use of xanthine derivatives has largely been superseded by more targeted alternatives in modern practice.

Active Ingredients and Available Forms

The active substance in Filotempo is Aminophylline, which is a combination compound of Theophylline and Ethylenediamine in a 2:1 ratio. This specific combination is essential for the drug's character, as the Ethylenediamine component enhances the solubility and chemical stability of the therapeutic agent, Theophylline, making it suitable for various administration routes. Filotempo and similar Aminophylline formulations are prepared as an aqueous solution for injection, oral tablets (including both immediate-release and sustained-release versions), and rectal suppositories.

General Purpose and Benefit

The overarching general purpose of this medication is to facilitate unimpeded airflow and provide symptomatic relief by mitigating reversible airway obstruction. By acting to relax the involuntary spasms of the smooth muscle surrounding the bronchial tubes, Filotempo helps to move air through the lungs more effectively when the airways are narrowed.

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What side effects are possible with Filotempo?

Possible Side Effects and Safety Information

The safety profile of Filotempo (Aminophylline) is structured around the inherent stimulatory effects on several body systems, which are consistently documented in official regulatory labeling. The frequency and severity of adverse reactions are strongly concentration-dependent, with the risk of toxicity increasing significantly if the medicine's level in the blood exceeds the officially defined limit.

Officially Documented Adverse Reactions

Adverse effects are grouped by system-organ class in regulatory documents:

  • Nervous System and Psychiatric Disorders: Commonly reported effects include headache, tremor, insomnia (sleeplessness), irritability, and restlessness.
  • Gastrointestinal Disorders: Nausea, vomiting, and abdominal pain are frequently listed.
  • Cardiac and Vascular Disorders: Palpitations (irregular or racing heartbeat) and tachycardia (fast heart rate) are officially documented.

Serious Adverse Reactions and Safety Constraints

The most clinically significant adverse events are related to dose-dependent toxicity and are listed as uncommon or rare. These include seizures and serious cardiac arrhythmias (abnormal heart rhythms), which may lead to cardiovascular collapse. Regulatory documents strictly contraindicate the use of Filotempo in patients with a known hypersensitivity to theophylline, ethylenediamine, or related xanthine derivatives.

Population-Specific Safety Notes

The medicine's clearance may be reduced in certain populations, increasing the risk of toxicity, which is a key safety consideration in official documents. This applies particularly to older adults and patients with pre-existing conditions such as liver (hepatic) impairment or congestive heart failure. Acute conditions like fever may also temporarily reduce clearance.

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Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory guidance specifies that immediate medical attention is required for any suspected overdose of Filotempo (Aminophylline). Regulatory sources mandate contacting emergency services right away if an individual has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened. Overdose can lead to severe and potentially life-threatening clinical manifestations.

Documented Overdose Manifestations

Overdose presentations documented in official prescribing information primarily involve the central nervous system (CNS), cardiovascular system, and gastrointestinal system. CNS effects range from restlessness, tremor, and confusion to severe outcomes such as seizures and status epilepticus. Cardiovascular signs include palpitations, tachycardia, and serious ventricular arrhythmias, which carry a risk of sudden death. Gastrointestinal manifestations often include severe and persistent vomiting.

Severe Outcomes and Required Management

Severe toxicity may occur without preceding milder symptoms. Documented life-threatening outcomes include neurological emergencies, severe hypotension, and profound metabolic disturbances, such as hypokalemia and hyperglycemia. The elderly and patients with underlying conditions that impair clearance, such as liver or heart failure, are listed as being at a significantly greater risk of serious toxicity.

Management focuses on supportive care, as no specific antidote is known. Officially described procedures include the use of activated charcoal to enhance elimination and comprehensive monitoring of vital signs, blood chemistry, and ECG.

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Therapeutic Uses of Filotempo

What Filotempo Treats: Main Uses and Benefits

The compound Filotempo is considered relevant in the symptomatic management of chronic obstructive respiratory conditions. This class of medication is commonly used to help with symptoms associated with lung diseases, including asthma, chronic bronchitis, and emphysema.

This medication is applied across domains where additional symptomatic support is needed for distressing symptoms like wheezing, shortness of breath, and chest tightness. It is generally considered relevant for conditions characterized by periods of heightened symptoms and is often used during phases when symptoms become disruptive.

This support contributes to easing the overall symptom load and helps improve day-to-day comfort during symptomatic periods. This medicine is applied in settings where symptoms become temporarily overwhelming, providing supportive relief.

“Filotempo is commonly used to help with symptoms that interfere with daily comfort, and is relevant in situations involving recurrent respiratory episodes.”

This medicine may assist with symptoms that interfere with daily functioning, which contributes to maintaining a sense of stability.

Quick Fact: Support for Symptoms Related to Physical Discomfort

Regulatory References

  1. NIH MedlinePlus Drug Information
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Eligibility and Restrictions for Use

The eligibility for using Filotempo (Aminophylline) is strictly defined by regulatory criteria, particularly concerning hypersensitivity and underlying health conditions.

Populations for Whom Use is Contraindicated

  • Patients with known hypersensitivity or allergy to theophylline, ethylenediamine, or any other xanthine derivatives (e.g., caffeine, theobromine).
  • Patients currently receiving other xanthine-containing drugs due to the hazard of serious toxicity.
  • Individuals with acute porphyria.

Age-Specific Eligibility

Age Group Regulatory Status Condition
Adults & Older Children Established Use Standard use is permitted.
Infants (<6 months) Not Recommended IV use is not generally recommended due to varied and reduced drug elimination.
Older Adults (typically ge60) Use with Caution Increased risk of toxicity and slower drug clearance; requires close monitoring.

Condition-Based Restrictions

Use of Filotempo requires extreme caution and close monitoring in patients with conditions that reduce drug clearance, such as congestive heart failure, liver disease (hepatic impairment), severe infection (sepsis), or hypothyroidism. Caution is also required for individuals with active peptic ulcers or a history of seizure disorders, as the medicine may exacerbate these conditions. The drug should be used in pregnant women and breastfeeding mothers only when clearly necessary, as it is known to cross the placenta and enter breast milk.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Filotempo, whose active component is Theophylline, has a regulatory-documented interaction profile based largely on its hepatic clearance mechanisms, primarily through the CYP1A2 enzyme system.

Contraindicated Combinations

Co-administration with Tizanidine is a formal contraindication due to the potential for a significant increase in Theophylline plasma concentration, which poses a serious risk of toxicity, as documented in regulatory labels.

Pharmacokinetic Clearance Modification

The clearance of Theophylline is officially documented to be altered by various agents that inhibit or induce its metabolism, leading to clinically significant exposure changes.

Interaction Effect Examples of Documented Interacting Substances
Increased Plasma Levels (Reduced Clearance) Macrolide and Quinolone antibiotics (e.g., Ciprofloxacin, Erythromycin), Cimetidine, Verapamil, Propranolol, Oral Contraceptives.
Decreased Plasma Levels (Increased Clearance) Anticonvulsants (e.g., Phenytoin, Phenobarbital, Carbamazepine), Rifampicin, the herbal product St. John’s Wort.

Pharmacodynamic and Other Effects

  • Pharmacodynamic interactions are documented with agents like beta-agonists (risk of additive cardiovascular effects) and Halothane (enhanced risk of cardiac arrhythmias).
  • Alcohol consumed with sustained-release oral forms is officially noted to cause an increase in Theophylline plasma concentration.
  • Dietary factors such as high-protein or charcoal-broiled meats are documented to increase Theophylline clearance.

Population-Specific Notes

The official documents note that patients with hepatic impairment and elderly patients often have decreased clearance, making them more susceptible to toxicity from exposure-increasing interactions. Furthermore, cigarette smoke is documented to increase clearance, which acts as an environmental inducer of metabolism.

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Mechanism of Action

How Filotempo Works: The Mechanism

The physiological effects of Filotempo are driven by its active component, Theophylline, which employs a non-selective, dual-action mechanism to modulate cellular signaling and muscle tone.

Non-Selective Inhibition of cAMP-Degrading Enzymes

Filotempo's active substance acts as a non-selective inhibitor of Phosphodiesterase (PDE) enzymes, primarily isoforms mathbfPDE3 and mathbfPDE4. This enzymatic inhibition prevents the breakdown of the critical cellular messenger cyclic AMP ( cAMP). The resulting sustained elevation of cAMP initiates a molecular cascade that lowers the concentration of free intracellular calcium ( Ca^2+) in the bronchial tissue. This pathway modulation results directly in the relaxation of bronchial smooth muscle.

Antagonism of Adenosine and Systemic Modulation

The mechanism includes non-selective antagonism of Adenosine Receptors. This blocks the activity of endogenous Adenosine, an endogenous signaling molecule that influences muscle tone and immune cell function. This receptor antagonism, alongside cAMP elevation in non-airway tissue, also enhances the force of diaphragmatic contractility and inherently produces a stimulatory effect on the central nervous system.

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Dosage and Administration Information

Filotempo (Aminophylline) is used according to highly specified administration protocols that vary depending on whether the treatment is for acute stabilization or long-term management. The approved routes of administration include intravenous (IV) infusion, oral ingestion (P.O.) via tablets, and rectal administration (P.R.) via suppositories.

The central principle of usage is that all dosing must be highly individualized and calculated based on the patient's ideal body weight. Due to the narrow therapeutic window of the drug, subsequent doses are guided by monitoring serum theophylline concentrations to ensure the dose maintains the level within the 10 to 20 mcg/mL target range.

For acute care, the IV route is utilized, beginning with a standard loading dose of 6 mg/kg followed by a continuous hourly maintenance infusion. A critical administration constraint is that the intravenous solution must be infused very slowly, at a rate that must not exceed 25 mg/minute. Oral formulations, which are used for maintenance, are administered in divided daily doses; specifically, extended-release tablets must be swallowed whole and cannot be crushed or chewed. Furthermore, certain patient populations require mandatory dose reductions; for instance, older adults or patients with concurrent liver impairment or heart failure typically receive significantly lower IV maintenance doses.

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Recent Clinical Evidence

Evidence for use in Acute Exacerbation of Asthma (Severe)

Research has evaluated Filotempo for acute and severe asthma flare-ups in adults and children. Short-term Randomized Controlled Trials (RCTs) explored adding intravenous Filotempo to standard care (e.g., inhaled bronchodilators and steroids). Researchers monitored key airflow markers (FEV₁, PEF) and outcomes reflecting daily functioning, such as hospital admission rates. Systematic reviews describe that findings were often mixed or inconsistent. Evidence contributes to understanding symptom patterns but does not definitively indicate that adding this medicine provides a consistent, measurable difference compared to standard care for these specific endpoints. Follow-up was limited to the acute phase, and long-term effects are not fully established.

Evidence for use in Acute Exacerbation of COPD (A-ECOPD)

Filotempo was evaluated in research focusing on conditions involving periods of heightened symptoms in adults with Chronic Obstructive Pulmonary Disease (COPD). The evidence relies on a combination of small RCTs and Observational Studies, primarily focusing on patients with persistent high carbon dioxide (∓CO₂) levels. Studies monitored outcomes related to systemic or functional imbalance (blood gas parameters) over short-term intervals.

The evidence is limited by small sample sizes and the highly specific patient subgroups studied, meaning results apply only to the populations studied. Certainty remains low, and comparative evidence is lacking against newer alternatives.

Evidence Quality and Research Gaps

The research was studied for both adults and children with severe acute asthma, monitoring the same key outcomes. However, data for certain groups remain insufficient, such as pregnant populations or those with specific kidney co-existing conditions. Research provides context but not individual predictions of response, and the overall evidence quality varies across studies, reinforcing that study results reflect the specific conditions under which they were conducted.

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Frequently Asked Questions (FAQ)

Common questions about Filotempo (FAQ)


Q: What is the main difference between Filotempo and other medicines for the same condition?

A: Filotempo’s active substance, Theophylline, is classified as a xanthine derivative and a bronchodilator with a dual mechanism of action. Official sources note that newer, more targeted treatments have largely superseded this class of medicine in clinical practice.


Q: How quickly can a person expect to notice the effects of Filotempo?

A: The onset of action depends on the method of administration. Intravenous infusions are typically used for acute, immediate needs in a clinical setting. Oral tablets, especially sustained-release forms, are administered as maintenance therapy to keep a consistent level of the drug in the body over time.


Q: Does taking Filotempo require regular lab tests or monitoring?

A: Official documents state that dosage needs to be highly individualized due to the drug's properties. For this reason, dosage guidance relies on monitoring the level of the drug in the bloodstream, known as serum theophylline concentrations, to help maintain an appropriate level.


Q: Can Filotempo affect fertility in men or women?

A: Regulatory documents indicate that animal studies have examined the effects of the active substance on reproduction. Non-clinical animal studies have indicated that high oral doses may cause impairment of fertility in male and female mice. The official labeling does not detail clinical data regarding this effect in humans.


Q: What is the difference between the brand name and the generic version of Filotempo?

A: Filotempo is the brand name used for the generic active substance, Aminophylline. Aminophylline is chemically a specific compound consisting of the therapeutic agent Theophylline combined with Ethylenediamine, which helps with its stability and solubility for different forms.


Q: Does Filotempo cause weight gain, weight loss, or changes in appetite?

A: Official reports on possible side effects note that loss of appetite (anorexia) is a documented adverse effect of the medicine. The standard adverse reactions sections do not typically specify reports of weight gain or significant weight loss.


Q: Can Filotempo cause changes in mood or sleep patterns?

A: Yes, regulatory documents indicate that Filotempo can affect the Central Nervous System. Commonly reported adverse reactions include psychiatric and nervous system effects such as insomnia (sleeplessness), irritability, restlessness, and nervousness.


Q: How long does Filotempo typically stay in the body after the last dose?

A: The time it takes for the body to clear half of the drug, known as the half-life, is noted to be highly variable. For healthy, non-smoking adults, the half-life is typically around 8.7 hours. Official product information notes that factors like liver function, age, and smoking status can significantly speed up or slow down this clearance time.


Q: Is Filotempo safe to use during pregnancy or while breastfeeding?

A: The active substance has been categorized in some regulatory systems as Pregnancy Category A. This classification describes that studies have not shown an increased risk of fetal harm. When breastfeeding, the medicine is known to pass into human milk, which may cause irritability or other minor effects in the nursing infant.


Q: Why is Filotempo prescribed for a condition other than its primary use?

A: Official regulatory documents clearly indicate that this medicine is approved only for the treatment of reversible airway obstruction (e.g., in asthma or COPD exacerbations). Official regulatory guidance focuses on use for the approved indications.


Q: Why do some people experience better results with Filotempo than others?

A: The medicine's effects are highly dependent on the level it reaches in the bloodstream. Official sources note that the rate at which the body clears the drug is highly variable among individuals. Differences in patient outcomes can be related to factors like liver health, age, or whether the person smokes, all of which affect the concentration achieved in the body.


Q: Are there any specific lifestyle changes recommended while taking Filotempo?

A: Regulatory documents describe factors that can affect how the body processes the medicine. Specifically, cigarette smoke is known to increase the rate at which the body clears the drug. Certain dietary factors, such as eating high-protein or charcoal-broiled meats, are also documented to increase this clearance rate.


Q: Does Filotempo cause changes in blood pressure or heart rate?

A: The official product information documents that Filotempo can affect the cardiovascular system. Adverse reactions listed include palpitations (feeling a fast or irregular heartbeat) and tachycardia (a fast heart rate).


Q: Are there any age limits for who can use Filotempo, like for older adults or children?

A: Official documents state that the medicine is not generally used in infants under six months due to varied and slow drug elimination. Older adults (typically ge 60 years) require caution and closer monitoring because they are more susceptible to toxicity due to slower drug clearance.


Q: Does Filotempo have any known interactions with birth control pills?

A: Yes, official drug-interaction documents indicate that oral contraceptives can reduce the body's rate of clearing the active substance. This change in clearance can potentially lead to an increase in the medicine's level in the bloodstream.


Q: Do children or teenagers experience different side effects from Filotempo?

A: Official documents do not list entirely different adverse effects for children compared to adults. However, they do note that infants and adolescents generally have faster drug clearance than adults, which may influence the risk of dose-related adverse events.


Q: Is Filotempo described as a first-line or second-line treatment option?

A: Current major clinical guidelines for the conditions Filotempo is approved to treat, such as asthma and COPD, do not support the medicine as a first-line treatment option. This position reflects the findings from clinical guidelines regarding the drug’s role in treatment.


Q: What are the different forms or strengths of Filotempo available?

A: Filotempo is available in several forms, which allows for different routes of administration. These forms include an aqueous solution for injection, oral tablets (immediate-release and sustained-release), and rectal suppositories. These forms are available in various standardized strengths.

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How should Filotempo be stored and disposed of?

How to Store and Dispose of Filotempo?

The official regulatory documents specify storage and disposal requirements to maintain product stability and ensure public safety.

Item Official Regulatory Statement
Storage Temperature Store at Controlled Room Temperature (20 C to 25 C), with permitted excursions to 15 C to 30 C.
Environmental Protection Keep away from excess heat, moisture, and direct light; storage in the bathroom is prohibited.
Container & Safety Keep the medicine in the original container, which must be kept tightly closed. The product must be stored out of sight and reach of children.
Disposal Instructions Do not flush the product. Unused or expired medication should be discarded through a medicine take-back program. If a program is unavailable, mix the medicine with an undesirable substance (e.g., used coffee grounds) and seal it for household trash disposal.
Single-Use Stability The unused portion of any single-dose injection must be discarded immediately after use.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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