The Role of Fexofenadine - Pseudoephedrine Combination in Pre - and Post-operative ENT Practice

Clinico-epidemiological Profile of ENT Disorders: Global and Indian Perspective

Ear, nose, and throat (ENT) diseases affecting all ages are prevalent globally, accounting for >20% of healthcare visits and posing a significant public health issue in resource-limited regions, including India^[1,2]. In India, ENT disorders account for approximately 4.3% of overall morbidity, according to the National Health Systems Resource Centre^[3].

Among common ENT disorders, approximately 23.5% of Indian adolescents and 9.8% of adults suffer from allergic rhinitis (AR)^[4-6]. The 2022 Global Asthma Network Phase I study in India found an AR prevalence of 7.7% among children^[6]. Patients with AR can develop comorbidities due to ongoing inflammation that affects other systems, such as the pulmonary, auditory, and growth systems. These include asthma, chronic middle ear effusions, rhinosinusitis (RS), lymphoid hyperplasia, obstructive sleep apnea, adenoid hypertrophy (AH), tonsillar hypertrophy (TH), and otitis media with effusion (OME)^[7].

Surgical options such as inferior turbinate surgery, posterior nerve resection, vidian neurectomy, septoplasty, and endoscopic sinus surgery (ESS) may be considered for patients with AR and related conditions who do not respond to medical treatment^[8]. Moreover, AR is associated with chronic rhinosinusitis (CRS), eustachian tube dysfunction, and conductive hearing loss^[8]. For moderate to severe CRS, especially with nasal polyps, medical therapy alone may be inadequate, and functional endoscopic sinus surgery (FESS) is often required, particularly in cases with persistent AR symptoms or deformities^[9].

Nasal Inflammation and Persistent Congestion: Key Determinants for Improving ENT Procedural Outcomes

Successful ENT surgery relies on a thorough understanding of nasal anatomy, physiology, and perioperative and postoperative changes, especially mucosal inflammation and edema^[10]. Postoperative symptoms such as nasal obstruction, rhinorrhea, pain, and bleeding are mainly caused by inflammatory responses^[11]. Surgical handling of the nasal mucosa can lead to edema, crusting, and clot formation, resulting in obstruction. This activates the release of inflammatory mediators, causing vasodilation and nasal congestion (Fig. 1)^[11–14].

These changes may persist for 1–2 weeks and significantly affect nasal patency, airflow, and comfort. Therefore, maintaining adequate nasal patency is essential for optimal recovery. International guidelines emphasize the importance of pharmacological management in ENT surgery to control inflammation and congestion. Commonly used therapies include antihistamines, decongestants, intranasal corticosteroids, and saline irrigation (Fig. 1)^[15–18].

Fig 1: Nasal inflammation and persistent congestion as key determinants in ENT surgical peri-operative settings

The figure is created using content from ref 11-18

Abbreviations: ENT-Ear, nose and throat

Decongestants and Antihistamines in Peri- and Post-operative ENT Care: Current Evidence

Decongestants in Peri- and Post-operative ENT Care

• Nasal decongestants treat epistaxis by reducing mucosal congestion and inducing vasoconstriction. After decongestant treatment, turbinate fracture migration, radiofrequency ablation, and partial resection surgeries become feasible^[19].

• A randomized study involving 74 rhinoplasty patients compared dexamethasone with pseudoephedrine. While corticosteroids were initially effective, pseudoephedrine (60 mg thrice daily) showed superior reduction in edema and ecchymosis beyond one week^[20].

• In pediatric patients undergoing FESS, rapid-acting decongestants (oxymetazoline 0.05%) have been used as vasoconstrictors^[21,22].

• A randomized double-blind study demonstrated that saline combined with the decongestant oxymetazoline significantly reduced postoperative bleeding and crusting and lowered nasal resistance during the edematous phase (days 5 and 12; p < 0.005)^[23].

Antihistamines in Peri- and Post-operative ENT Care

• A retrospective study of 202 patients who underwent superficial parotidectomy found that oral antihistamines (clemastine) significantly reduced the incidence of salivary fistulas (3.0% vs. 13.2%; p = 0.022)^[24].

• Among patients who underwent rhino-septoplasty with or without turbinate reduction, oral antihistamines provided effective symptom control at 90 days postoperatively^[25].

These findings suggest that antihistamines can play a supportive role in postoperative recovery when clinically indicated.

Oral Fexofenadine and Pseudoephedrine Combination: A Practical Advantage Over Topical Agents

Clinical guidelines recommend the use of decongestants, either alone or in combination with antihistamines, for severe nasal congestion. When obstruction persists, oral combinations of decongestants and antihistamines are particularly effective because they simultaneously address both inflammation and congestion. Oral decongestants also carry a lower risk of rebound rhinitis than topical agents. Therefore, oral combination therapy with antihistamines and decongestants is often preferred for sustained symptom control in perioperative ENT care^[26,27]. Additionally, Combination therapies have demonstrated superior efficacy in symptom improvement compared to monotherapy, including improved compliance, resulting in a better quality of life^[28].

Oral Fexofenadine and Pseudoephedrine Peri-operative Use for Improving ENT Procedural Outcomes – A Feasible Therapeutic Approach

The combination of fexofenadine, a second-generation antihistamine, and pseudoephedrine, an oral decongestant, provides synergistic control of symptoms. Fexofenadine has antihistaminic action with a favorable safety profile, whereas pseudoephedrine induces vasoconstriction via α-adrenergic stimulation. This combination (fexofenadine 60 mg/pseudoephedrine 120 mg extended-release) improves nasal congestion, sneezing, rhinorrhea, and itching^[29-31]. Additionally, the time to reach Cmax after extended-release pseudoephedrine administration is 2–6 hours, with peak plasma concentration around 6 hours. This controlled release provides sustained decongestant effects, potentially improving tolerability and reducing peak-related side effects^[30,31]. As current evidence supports the symptomatic benefits of this combination, it may also play a supportive role in combating additional comorbid symptoms and complications in perioperative ENT surgical settings.

An Asian clinical survey of otolaryngologists reported that many clinicians prescribe antihistamines and decongestants peri- and postoperatively, particularly after sinus surgery for chronic rhinosinusitis^[32]. These findings suggest the potential clinical applications and promise of these agents in perioperative ENT surgery.

Key Takeaways

• Nasal inflammation and mucosal edema are critical determinants of ENT surgeries and significantly influence perioperative conditions and postoperative outcomes [11-18].
• Decongestants play a well-established role in enhancing surgical field visibility, minimizing perioperative bleeding, and facilitating postoperative recovery^[19-23].
• Antihistamines may be considered to reduce the postoperative symptom burden in patients undergoing ENT procedures when indicated^[24,25].
• Combination therapy with an antihistamine and decongestant may improve nasal symptoms, as supported by guidelines for managing nasal congestion and inflammation^[15-28].
• Fexofenadine and pseudoephedrine have demonstrated efficacy, both individually and in combination, in controlling nasal inflammation and congestion^[29-31].

Abbreviations

FDC-Fixed Dose Combination; ENT-Ear, Nose and Throat; RS- Rhinosinusitis; AH- Adenoid Hypertrophy; AR- Allergic Rhinitis; TH- Tonsillar Hypertrophy; OME- Otitis Media with Effusion; CRS- Chronic Rhino-Sinusitis; FESS- Functional Endoscopic Sinus Surgery; ESS- Endoscopic Sinus Surgery

MAT- IN- 2600461- v1.0- 15/04/2026