Sanofi Consumer Healthcare India Limited, one of India's leading consumer healthcare organisations, has announced the launch of Allegra-D, a dual-action formulation providing fast, effective nasal decongestion with non-drowsy allergy relief for patients with allergic rhinitis in India.
Allegra-D tablets is a fixed-dose combination (FDC) of Fexofenadine Hydrochloride IP (60 mg), a non-drowsy antihistamine, and Pseudoephedrine Hydrochloride IP (120 mg), a potent nasal decongestant. The formulation has received approval from the Drug Controller General of India (DCGI) for use in adults and children aged 12 years and older1.
Allergic rhinitis affects approximately 20–30% of the Indian population and is commonly triggered by indoor and outdoor allergens such as pollen, dust mites, and pet dander2. Nearly 85% of those patients3 identify nasal congestion as their most bothersome symptom.
While Fexofenadine, a second-generation antihistamine, ensures fast, long-lasting antihistaminic action with minimal anticholinergic effects, pseudoephedrine works by reducing nasal edema and clearing congestion4,5. Pseudoephedrine improves ability to perform daily activities and boosts productivity at work5. Further, Fexofenadine does not cross the blood brain barrier, ensuring effective symptom control without causing sedation. The combination offers comprehensive symptom relief, including sneezing, nasal congestion, runny nose, itchy or watery eyes, and nasal pruritus. Together, Fexofenadine and pseudoephedrine provide comprehensive relief from allergy symptoms and congestion, helping patients breathe freely.
Indian as well as global guidelines on management of allergic rhinitis recommend addition of oral decongestant to oral antihistamine in both intermittent and persistent AR with nasal congestion. International guidelines specifically recommend adding pseudoephedrine to nonsedating, second generation antihistamine to treat AR with congestion6,7.
A prospective, randomized, parallel-group study involving 24 adult patients with at least a 2-year history of allergic rhinitis and nasal obstruction evaluated the efficacy of Fexofenadine 60mg combined with Pseudoephedrine 120mg versus Fexofenadine 60mg alone. The combination demonstrated a significant and sustained improvement in nasal obstruction by enhancing nasal airflow, with a rapid onset of action within 30 minutes and long-lasting relief for up to 12 hours8.
Clinical studies and meta-analysis also support the FDC’s favorable safety profile, with proven cardio safety- showing no significant effects on ECG parameters, vital signs and laboratory findings or increase in ventricular arrhythmias5,9,10.
Speaking at the launch, Nupur Gurbaxani, Brand and Innovation Head, Sanofi Consumer Healthcare India Limited said, “Having demonstrated consistent clinical outcomes in the US over the past three decades, Sanofi Consumer Healthcare India is proud to bring Allegra-D to India, this trusted, dual-action formulation pairs a non-sedating antihistamine with an effective decongestant, delivering fast and reliable relief to individuals suffering from allergic rhinitis. With an estimated 22% of Indian adolescents affected by allergic rhinitis, Allegra-D endeavors to serve a breakthrough relief to help manage this growing health concern”.
About Sanofi Consumer Healthcare India Limited
Sanofi Consumer Healthcare India Limited (SCHIL) has emerged as a distinct legal entity following its demerger from Sanofi India Limited. This demerger, executed under the Scheme of Arrangement, was sanctioned by the Mumbai bench of the National Company Law Tribunal and became effective on 1st June 2024. In alignment with Sanofi's global strategy, SCHIL is now operating independently, with a dedicated focus on the Consumer Healthcare sector.
With an agile business model and strong brands, SCHIL is one of the leading players in India's consumer healthcare market. Leveraging its global experience in consumer healthcare, SCHIL aims to enhance customer wellbeing through its portfolio of products which encompasses Allergy, Digestive Wellness, Pain Care and Vitamin D Supplement. SCHIL’s key brands include Allegra®, DePURA®, Avil®, and Combiflam®. They are dedicated to building a healthier future for their consumers by empowering people to take control of their health, through self-care and by addressing their everyday health concerns.
References:
1) CDSCO approval date: 19th March 2021 vide permission no IMP-42/2021
2) Chandrika, D. (2016). Allergic rhinitis in India: an overview. International Journal of Otorhinolaryngology and Head and Neck Surgery, 3(1), 1–6.
3) Shedden A. Impact of nasal congestion on quality of life and work productivity in allergic rhinitis: Findings from a large online survey. Treat Respir Med. 2005;4(6):439–446.
4) Allegra D Prescribing information. Available at Resources for healthcare professionals - Sanofi India
5) Sussman GL, Mason J, Compton D, Stewart J, Ricard N. The efficacy and safety of fexofenadine HCl and pseudoephedrine, alone and in combination, in seasonal allergic rhinitis. Journal of allergy and clinical immunology. 1999 Jul 1;104(1):100-6.
6) Hellings PW, et al. Rhinology. 2020;58(6):618–622. 2. Okubo K, et al. Allergol Int. 2020;69(3):331–345. 3. Scadding GK, et al. Clin Exp Allergy. 2017;47(7):856–889.
7) Indian Guidelines on allergic rhinitis. Available at: https://www.aoihns.in/wp-content/uploads/AOI-AR-Guidelines.pdf. Accessed on: 04 February 2025.
8) Nakamura Y,et.al. Effect of fexofenadine/pseudoephedrine combination tablet on nasal obstruction in patients with allergic rhinitis using rhinomanometry: A randomized controlled trial. Asian Pac J Allergy Immunol. 2024 Jun;42(2):147-153.
9) Berkowitz RB, McCafferty F, Lutz C, et al. Fexofenadine HCl 60 mg/ pseudoephedrine HCl 120 mg has a 60-minute onset of action in the treatment of seasonal allergic rhinitis symptoms, as assessed in an allergen exposure unit. Allergy Asthma Proc. 2004;25(5):335-343.
10) Ansotegui IJ, Bousquet J, Canonica GW, Demoly P, Gómez RM, Meltzer EO, Murrieta-Aguttes M, Naclerio RM, Rosario Filho N, Scadding GK. Why fexofenadine is considered as a truly non-sedating antihistamine with no brain penetration: a systematic review. Current Medical Research and Opinion. 2024 Aug 2;40(8):1297-309.
Disclaimer:
This article is intended for informational purposes only and is directed toward medical practitioners. The content is based on currently available scientific literature and regulatory approvals in India. Medical practitioners are advised to refer to the full prescribing information before recommending or prescribing this product.
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