Anthropometric Measurements as Predictors of Low Birth Weight Among Tanzanian Neonates: A Hospital-Based Study
November 7, 2025
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Brand Name :
N/A
Synonyms :
batefenterol
Class :
Adrenergic beta-Agonists, Muscarinic Antagonists
Brand Name :
N/A
Synonyms :
batefenterol
Class :
Adrenergic beta-Agonists, Muscarinic Antagonists
Dosage forms and strengths
powder inhaler
batefenterol
(300 µg)
Chronic Obstructive Pulmonary Disease (COPD)
(off-label):
By using a dry powder inhaler, The administration of batefenterol at a dose of 300 µg for a duration of 42 days
Note: The dosage of 300 µg of batefenterol could be considered as the most suitable for clinical trials (phase III)
not indicated
refer to adult dosing
When batefenterol is used together with aclidinium, there is an elevated risk of experiencing more severe adverse events
combining batefenterol with alfentanil can enhance the risk or seriousness of adverse events
long-acting muscarinic antagonists decrease the efficacy of methacholine
Actions and Spectrum:
Action:
It combines the beneficial bronchodilatory effects of β2-adrenoceptor agonists with the antagonism of muscarinic receptors, thereby targeting multiple pathways involved in airway obstruction. This dual mechanism of action makes batefenterol a promising option in the management of various obstructive airway diseases.
Spectrum:
Chronic Obstructive Pulmonary Disease (COPD): As COPD is characterized by persistent airflow limitation, batefenterol’s combined β2-adrenergic agonism and muscarinic receptor antagonism effectively alleviate bronchoconstriction and airway inflammation.
Frequency not defined
Limited information available
Black Box Warning:
batefenterol may cause a significant increase in heart rate and blood pressure, leading to adverse cardiovascular effects.
batefenterol is not indicated for the treatment of asthma, and its use in asthma patients may increase the risk of asthma-related deaths. Therefore, batefenterol should not be prescribed to patients with asthma.
Contraindication/Caution:
Severe Hypersensitivity to β2-Adrenergic Agonists: Patients who have experienced severe hypersensitivity reactions (e.g., angioedema, urticaria, bronchospasm) to other β2-adrenergic agonists should not receive batefenterol due to the potential risk of cross-reactivity and exacerbation of symptoms.
Uncontrolled Asthma: batefenterol should not be used in patients with asthma, especially during acute exacerbations or when asthma is uncontrolled. LABAs like batefenterol can increase the risk of asthma-related adverse events and should not be used as monotherapy for asthma.
Children: batefenterol is not indicated for use in children under the age of 18 years. The safety and efficacy of batefenterol in pediatric populations have not been established, and its use in this age group is contraindicated.
Pregnancy: The safety of batefenterol during pregnancy has not been adequately studied, and The utilization of this is not advised for expectant mothers. unless the potential benefits outweigh the risks. Healthcare providers should carefully consider alternative treatments for pregnant patients with COPD.
Breastfeeding: It is not known whether batefenterol is excreted in human milk. Due to potential risks to the nursing infant, women should either discontinue batefenterol or breastfeeding, considering the importance of the drug to the mother’s treatment.
Cardiovascular Disorders: Caution should be exercised when administering batefenterol to patients with severe cardiovascular conditions, including arrhythmias, coronary insufficiency, or hypertension. LABAs may lead to cardiovascular effects, including an increase in heart rate and blood pressure.
Diabetes: Patients with diabetes mellitus should use batefenterol with caution, as LABAs can exacerbate changes in blood glucose levels.
Pregnancy warnings:
Pregnancy category: N/A
Lactation: Excreted into human milk is unknown
Pregnancy Categories:
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
batefenterol is a novel bronchodilator that belongs to the class of long-acting beta2-adrenergic agonists (LABAs) with muscarinic receptor antagonistic properties.
Pharmacodynamics:
batefenterol exerts its pharmacological effects through a dual mechanism of action, combining the activation of beta2-adrenergic receptors and the antagonism of muscarinic receptors. By binding to beta2-adrenergic receptors on airway smooth muscle cells, it stimulates the production of cyclic adenosine monophosphate (cAMP). The increased cAMP levels trigger a cascade of intracellular events, ultimately leading to smooth muscle relaxation and bronchodilation, thereby improving airflow in the lungs.
Pharmacokinetics:
Absorption
batefenterol is orally administered and is rapidly absorbed from the gastrointestinal tract. Following ingestion, it undergoes partial hydrolysis in the gut to yield its active metabolites, which are responsible for its pharmacological effects. The absolute bioavailability of batefenterol is approximately 40%, and it exhibits linear pharmacokinetics over the therapeutic dose range.
Distribution
batefenterol demonstrates moderate plasma protein binding, primarily to albumin. It has a relatively large volume of distribution, indicating extensive tissue distribution. The compound readily crosses the blood-brain barrier, but the clinical relevance of its central nervous system penetration remains to be fully elucidated.
Metabolism
Hepatic metabolism plays a crucial role in the biotransformation of batefenterol. The primary metabolic pathways involve oxidation and subsequent glucuronidation or sulfation. The cytochrome P450 (CYP) enzymes, particularly CYP3A4 and CYP2D6, are the major contributors to its metabolism.
Excretion and Elimination
batefenterol and its metabolites are predominantly eliminated through the renal route. Following metabolism, the parent drug and its metabolites are excreted into the urine. Most of the total clearance can be attributed to renal clearance. making adequate renal function crucial for proper elimination of the compound. A small fraction of the drug is excreted in the feces.
Administration:
batefenterol is primarily administered via inhalation, ensuring direct delivery to the lungs for targeted therapeutic effects. Inhalation offers several advantages, such as rapid onset of action, reduced systemic side effects, and improved patient compliance.
Patient information leaflet
Generic Name: batefenterol
Why do we use batefenterol?
Asthma: batefenterol has shown efficacy in the treatment of asthma, characterized by recurrent episodes of breathlessness, wheezing, and coughing. By acting on the β2-adrenergic receptors in the airway smooth muscles, batefenterol induces relaxation, leading to bronchodilation and improved airflow. It is particularly beneficial in patients with moderate to severe persistent asthma, enhancing lung function and reducing the frequency of exacerbations.
Chronic Obstructive Pulmonary Disease (COPD): Patients suffering from COPD, a progressive lung disease primarily caused by smoking, often experience compromised airflow due to chronic bronchitis and emphysema. batefenterol’s bronchodilatory effects offer relief to COPD patients, facilitating improved lung function and exercise tolerance. Additionally, it can reduce the frequency and severity of COPD exacerbations, enhancing the overall quality of life in these individuals.
Chronic Bronchitis: batefenterol can be a valuable therapeutic option for individuals diagnosed with chronic bronchitis, a subtype of COPD characterized by persistent inflammation of the bronchi. By promoting bronchial smooth muscle relaxation, batefenterol effectively relieves bronchoconstriction, eases breathing efforts, and decreases mucus production. This leads to improved lung function and a reduction in the frequency of respiratory exacerbations.
Emphysema: In patients with emphysema, a condition characterized by the destruction of alveolar walls, batefenterol’s broncho dilatory properties help alleviate air trapping and improve lung ventilation. By targeting the β2-adrenergic receptors, this drug can reduce hyperinflation and enhance overall respiratory function, thereby contributing to enhanced exercise capacity and improved quality of life in emphysema patients.
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