Overview

ALLRJAZ BL

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PRODUCT INTRODUCTION ALLRJAZ BL

ALLRJAZ BL combines bilastine, a second-generation non-sedating antihistamine, with montelukast, a leukotriene receptor antagonist. The fixed-dose combination targets two complementary pathways in allergic inflammation: histamine-mediated symptoms and leukotriene-driven nasal congestion and bronchial hyperreactivity. The formulation is intended to improve overall symptom control in patients with allergic rhinitis and in selected patients with allergic airway disease where montelukast is appropriate.

Indications and clinical use

ALLRJAZ BL is indicated for symptomatic relief of allergic rhinitis (seasonal or perennial) when combined antihistamine plus leukotriene receptor antagonist therapy is deemed appropriate by the treating clinician. It may be used as adjunctive therapy in patients with coexisting allergic airway disease or where single-agent therapy provides incomplete symptom control. Use should follow a physician’s assessment and prescription.

Mechanism of action

Bilastine is a selective H1 histamine receptor antagonist that reduces the effects of histamine on target tissues, relieving sneezing, rhinorrhea, itching and ocular symptoms without causing significant sedation. Montelukast is a selective antagonist of cysteinyl leukotriene receptors (CysLT1) and inhibits leukotriene-mediated bronchoconstriction, mucosal oedema and mucus secretion. By combining these two mechanisms, ALLRJAZ BL addresses both immediate histaminergic symptoms and leukotriene-mediated components of allergic inflammation.

Dosage and administration

Adults and adolescents (typically 12 years and older): one tablet containing bilastine 20 mg and montelukast 10 mg once daily. The usual practice is to take the tablet once daily, with timing (morning or evening) determined by prescriber preference and clinical response. For children under 12 years, elderly patients, or those with hepatic or renal impairment, dosing adjustments or alternative regimens should be guided by a healthcare professional. Do not exceed the recommended dose.

Adverse effects and safety information

Bilastine is generally well tolerated and, being non-sedating, has a low incidence of somnolence; occasional adverse events include headache, dizziness or dry mouth. Montelukast is usually well tolerated but has been associated with neuropsychiatric reactions in some patients (such as agitation, sleep disturbances, mood changes and, rarely, suicidal ideation). Monitor patients and caregivers for any new or worsening behavioural or mood symptoms. If severe or persistent adverse effects occur, discontinue and consult a physician.

Contraindications and precautions

Do not use ALLRJAZ BL in patients with known hypersensitivity to bilastine, montelukast, or any excipient. Use caution in patients with a history of severe psychiatric illness due to the potential for neuropsychiatric adverse events associated with montelukast. Patients with significant hepatic impairment should be evaluated before prescribing; dose modifications or alternative therapies may be needed. As with all antiallergic therapies, if symptoms persist or worsen, medical reassessment is required.

Drug interactions

Bilastine has a low potential for cytochrome P450–mediated interactions but clinicians should review concomitant medications. Montelukast is primarily metabolised by hepatic pathways and may have interactions with strong CYP inducers (which can reduce montelukast exposure). There are no widely reported clinically important pharmacokinetic interactions between bilastine and montelukast when coadministered in recommended doses, but a full review of the patient’s medicines is recommended before starting therapy.

Warnings and monitoring

Advise patients and caregivers to observe for any changes in mood, behaviour or sleep patterns after starting montelukast and to report such changes promptly. If neuropsychiatric symptoms develop, reassess the need for continued montelukast therapy. In patients with severe or worsening respiratory symptoms, prompt medical evaluation is essential. Use with caution in patients who require activities demanding full alertness until individual response to therapy is known.

Use in pregnancy and lactation

Data in pregnancy and lactation are limited. ALLRJAZ BL should be used during pregnancy or breastfeeding only if the potential benefit justifies the potential risk to the mother and infant; prescribers should consult current clinical guidance when treating pregnant or lactating patients.

Storage

Store below 25–30°C in a dry place away from direct sunlight. Keep in the original packaging to protect from moisture. Keep out of reach of children and do not use beyond the expiry date printed on the pack.

When to consult a healthcare professional

Seek immediate medical attention for signs of a severe allergic reaction (difficulty breathing, facial or throat swelling, severe rash). Consult a healthcare professional if mood or behavioural changes occur, if symptoms of allergic rhinitis or asthma worsen, or if there is inadequate control of symptoms despite therapy.