Bilagra M 20mg/10mg Tablet
Prescription Required
Marketer
Lupin Ltd
SALT COMPOSITION
Bilastine (20mg) + Montelukast (10mg)
Storage
Store below 30°C
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Product Introduction
Bilagra M 20mg/10mg Tablet is an innovative fixed-dose combination medication that brings together two powerful agents for comprehensive relief from allergic conditions. This unique formulation combines Bilastine 20mg, a second-generation non-sedating antihistamine, with Montelukast 10mg, a selective leukotriene receptor antagonist, to provide a multi-pathway approach to allergy management.
Bilastine works by selectively blocking H1 histamine receptors, effectively inhibiting the allergic response triggered by histamine release during allergen exposure. Unlike first-generation antihistamines, Bilastine does not readily cross the blood-brain barrier, resulting in minimal sedation and cognitive impairment. This makes it particularly suitable for patients who need to remain alert and functional during their daily activities.
Montelukast complements this action by blocking the effects of leukotrienes, another set of inflammatory mediators involved in allergic reactions and asthma. By targeting the leukotriene pathway, Montelukast helps reduce inflammation, bronchoconstriction, and mucus production, particularly in the respiratory tract.
Together, these active ingredients provide comprehensive relief from a wide range of allergic symptoms, including seasonal allergic rhinitis (hay fever), perennial allergic rhinitis, allergic conjunctivitis, and urticaria (hives). The dual-action approach targets multiple inflammatory pathways involved in allergic responses, providing more complete relief than either component alone.
Bilagra M is typically prescribed for patients with moderate to severe allergic conditions, especially those with both upper and lower respiratory symptoms who may not find adequate relief with single-agent therapy. This combination is particularly beneficial for patients who suffer from allergic rhinitis complicated by asthmatic symptoms or those who experience allergic manifestations in multiple body systems simultaneously.
The once-daily dosing regimen enhances patient compliance, while the complementary modes of action provide 24-hour relief from allergic symptoms without significant sedation. This makes Bilagra M an excellent choice for adults and adolescents seeking effective allergy management without compromising daily performance and quality of life.
Key Composition & Ingredients
- Bilastine (20mg): A second-generation, non-sedating H1-antihistamine
- Montelukast (10mg): A selective leukotriene receptor antagonist
- Inactive ingredients may include microcrystalline cellulose, sodium starch glycolate, magnesium stearate, and film coating materials
Uses of Bilagra M Tablet
- Treatment of seasonal allergic rhinitis (hay fever)
- Management of perennial allergic rhinitis
- Relief from allergic conjunctivitis
- Treatment of urticaria (hives)
- Adjunctive therapy in allergic asthma
- Management of allergic rhinitis with asthmatic components
- Relief from multiple allergic manifestations
- Prevention of exercise-induced bronchoconstriction
Benefits of Bilagra M Tablet
- Comprehensive relief from multiple allergic symptoms
- Dual-action approach targeting different allergic pathways
- Non-sedating formula allows normal daily activities
- Once-daily dosing improves compliance
- Reduces nasal congestion better than antihistamines alone
- Helps improve sleep quality disrupted by nighttime allergic symptoms
- Decreases requirement for rescue medications
- Effective for both upper and lower respiratory allergic symptoms
- Extended 24-hour symptom control
- Reduces both early and late-phase allergic responses
How Bilagra M Tablet Works
How the Drug Works (Mechanism of Action)
Bilastine (20mg):
- Selectively binds to peripheral H1 histamine receptors
- Blocks the action of histamine released during allergic reactions
- Inhibits histamine-mediated symptoms like sneezing, itching, rhinorrhea
- Does not readily cross the blood-brain barrier, minimizing sedation
- Has no significant affinity for other receptor types, reducing side effects
Montelukast (10mg):
- Binds selectively to cysteinyl leukotriene receptors (CysLT1)
- Blocks the action of leukotrienes (particularly LTD4)
- Reduces inflammation in the airways
- Decreases mucus production
- Relaxes bronchial smooth muscle
- Reduces airway edema and inflammatory cell recruitment
The combination provides comprehensive coverage by targeting both histamine and leukotriene pathways involved in allergic responses.
Dosage of Bilagra M Tablet
Dosage (Daily Dose, Missed Dose, Overdose)
Standard Adult Dosage:
- One tablet (Bilastine 20mg + Montelukast 10mg) once daily
- Best taken at the same time each day, preferably in the evening
- For allergic rhinitis: take at least 1 hour before or 2 hours after meals
Adolescents (12-17 years):
- Same as adult dosing
- Weight-based adjustments may be necessary in some cases
Missed Dose:
- Take as soon as remembered if on the same day
- Do not take a double dose to make up for a missed dose
- If it's almost time for the next dose, skip the missed dose and continue with the regular schedule
Overdose:
- Symptoms may include headache, drowsiness, increased thirst, and gastrointestinal disturbances
- Seek immediate medical attention if overdose is suspected
- Treatment is mainly supportive and symptomatic
Mode of Action of Bilagra M Tablet
Bilagra M works through complementary mechanisms:
Bilastine competes with histamine for H1-receptor sites, preventing histamine from binding to these receptors and initiating allergic responses. This action effectively reduces symptoms like sneezing, itching, watery eyes, and rhinorrhea.
Montelukast targets a different inflammatory pathway by blocking cysteinyl leukotriene receptors. Leukotrienes are potent inflammatory mediators that cause bronchoconstriction, increased vascular permeability, and mucus secretion. By blocking their action, Montelukast reduces inflammation and constriction in the airways.
The dual-action approach provides more complete control of allergic symptoms by addressing multiple inflammatory pathways simultaneously.
How to Use Bilagra M Tablet
Directions for Use
- Take exactly as prescribed by your healthcare provider
- Swallow the tablet whole with a glass of water
- Take Bilagra M at least 1 hour before or 2 hours after food intake
- Take at the same time each day to maintain consistent blood levels
- For best results in allergic rhinitis with asthmatic components, take in the evening
- Do not crush, chew, or break the tablet
- Complete the full course of treatment even if symptoms improve
Side Effects of Bilagra M Tablet
Side Effects & How to Manage Them
Common Side Effects:
- Headache (usually mild and transient, take appropriate pain reliever if necessary)
- Fatigue (ensure adequate rest)
- Dry mouth (sip water frequently, chew sugar-free gum)
- Mild gastrointestinal disturbances (take with a small amount of food if persistent)
- Dizziness (avoid driving or operating machinery until effect is known)
Less Common Side Effects:
- Increased appetite
- Mood changes or vivid dreams
- Mild abdominal pain
- Elevated liver enzymes
- Prolonged QT interval (rare)
Serious Side Effects (Seek medical attention immediately):
- Severe allergic reactions (rash, itching, swelling)
- Liver problems (yellowing of skin/eyes, dark urine)
- Neuropsychiatric events (agitation, depression, suicidal thoughts)
- Churg-Strauss syndrome (rare: numbness, flu-like symptoms, severe sinusitis)
- Irregular heartbeat
Safety Advice for Bilagra M Tablet
Alcohol: Avoid alcohol as it may increase the risk of side effects.
Pregnancy: Generally not recommended unless clearly necessary. Category B - Animal studies show no risk but human studies inadequate.
Breastfeeding: Not recommended during breastfeeding. Alternative feeding methods should be considered.
Driving: May cause dizziness in some patients. Avoid driving until you know how the medicine affects you.
Kidney: Use with caution in patients with severe renal impairment. Dose adjustment may be required.
Liver: Use with caution in patients with hepatic impairment. Monitoring of liver function may be necessary.
Children: Not recommended for children under 12 years of age.
Older Patients: No specific dose adjustment required for elderly patients with normal organ function.
Lactation: Not recommended during breastfeeding.
Allergy: Contraindicated in patients with known hypersensitivity to bilastine, montelukast, or any component of the formulation.
Warnings & Precautions of Bilagra M Tablet
- Not intended for the treatment of acute asthma attacks
- May cause neuropsychiatric events (behavior changes, depression)
- Not a substitute for inhaled or oral corticosteroids in asthma management
- Patients with phenylketonuria should be aware montelukast contains phenylalanine
- Caution in patients with history of liver disease
- May interfere with allergy skin testing results
- Eosinophilic conditions including Churg-Strauss syndrome have been reported rarely
- Report any unusual mood changes or behavior to your healthcare provider
- Not recommended for use with strong CYP3A4 inhibitors
- Take on an empty stomach for optimal absorption of bilastine
Interactions with Bilagra M Tablet
Drug-Drug & Drug-Food Interactions
Drug Interactions:
- Ketoconazole, erythromycin, diltiazem (increase bilastine levels)
- Rifampicin (may decrease bilastine effectiveness)
- Phenobarbital, phenytoin (may decrease montelukast levels)
- Gemfibrozil (increases montelukast exposure)
- QT interval-prolonging drugs (potential additive effect with bilastine)
- Sedatives (potential additive effects on alertness)
Food Interactions:
- Food reduces bilastine absorption (take at least 1 hour before or 2 hours after meals)
- Grapefruit juice may increase bilastine levels
- High-fat meals may affect the absorption of montelukast
Contraindications of Bilagra M Tablet
- Hypersensitivity to bilastine, montelukast, or any component of the formulation
- Severe renal impairment with creatinine clearance <30 ml/min
- Patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Pregnancy and breastfeeding
- Children under 12 years of age
- Patients with rare hereditary problems of galactose intolerance
- Concomitant use with strong CYP3A4 inhibitors in patients with moderate to severe renal impairment
Safety Measures & FDA Pregnancy Category
- FDA Pregnancy Category B: Animal studies show no risk but human studies inadequate
- FDA added Boxed Warning for serious neuropsychiatric events with montelukast
- Regular monitoring for mood changes and behavioral symptoms
- Periodic liver function testing may be advised during long-term use
- Discontinue if eosinophilic conditions or severe skin reactions develop
- ECG monitoring may be recommended in patients at risk for QT prolongation
Diet & Lifestyle Advice
- Identify and avoid known allergens when possible
- Keep windows closed during high pollen seasons
- Use air purifiers in living spaces
- Wash bedding regularly in hot water
- Shower and change clothes after outdoor activities during allergy season
- Consider wearing a mask when doing yard work
- Keep indoor humidity between 30-50% to prevent mold growth
- Regular exercise, but be aware of exercise-induced symptoms
- Adequate hydration helps keep mucous membranes moist
- Consider nasal irrigation with saline solution as an adjunct therapy
Why Doctors Recommend This Medicine
Healthcare providers prescribe Bilagra M Tablet for:
- Patients with inadequate response to antihistamines alone
- Those experiencing both upper and lower respiratory allergic symptoms
- Patients who need 24-hour symptom control
- Those who need non-sedating allergy relief
- Allergic rhinitis patients with asthmatic components
- Patients with multiple allergic manifestations
- Cases where single-agent therapy provides insufficient relief
- Patients seeking improved quality of life during allergy seasons
Substitutes of Bilagra M Tablet & Alternative Medicines
Alternative combinations with similar actions include:
- Montair Plus (Montelukast + Levocetirizine)
- Montek LC (Montelukast + Levocetirizine)
- Allegra M (Fexofenadine + Montelukast)
- Aerius M (Desloratadine + Montelukast)
Single-ingredient alternatives:
- Bilastine alone: Bilaz, Bilargen
- Montelukast alone: Singulair, Montair
- Other antihistamines: Cetirizine, Loratadine, Fexofenadine
Storage Guidelines
- Store at room temperature between 15-30°C (59-86°F)
- Keep away from direct sunlight and moisture
- Keep in the original packaging until ready to use
- Store in a dry place
- Keep out of reach of children
- Do not use after the expiration date
- Do not store in the bathroom
User Feedback & Patient Concerns
Common patient questions include:
- How quickly will I notice improvement in my symptoms?
- Can I take this medication long-term?
- Will it affect my alertness or ability to drive?
- What should I do if I experience mood changes?
- How does this compare to using separate medications?
- Can I take this with my other medications?
- Should I continue taking it during symptom-free periods?
Quick Tips for Bilagra M Tablet
- Take on an empty stomach for optimal absorption
- Best taken in the evening for managing nighttime and early morning symptoms
- Allow at least 1 hour before or 2 hours after meals
- Maintain consistent timing for best results
- Continue regular use even when symptoms improve
- Monitor for any unusual mood changes
- Keep track of allergen exposure and symptom patterns
- Report any serious side effects to your healthcare provider immediately
Fact Box
Chemical Class:
- Bilastine: Second-generation piperidine antihistamine
- Montelukast: Leukotriene receptor antagonist
Habit Forming: No
Therapeutic Class: Antiallergic combination
Action Class: H1-antihistamine and leukotriene receptor antagonist
Useful Diagnostic Tests
Before or during treatment, the following tests may be recommended:
- Allergy skin testing (before starting therapy)
- IgE levels
- Complete blood count
- Liver function tests
- Pulmonary function tests in patients with asthmatic components
- Renal function tests in patients with kidney disorders
More Information & References
For more information, consult reputable medical resources such as:
- World Allergy Organization guidelines
- American Academy of Allergy, Asthma & Immunology
- European Academy of Allergy and Clinical Immunology
- Global Initiative for Asthma (GINA)
- British Society for Allergy and Clinical Immunology
Disclaimer
This information is for educational purposes only and not a substitute for professional medical advice. Always consult your healthcare provider before starting or changing any medication regimen. Individual responses to medication may vary. The recommended dosage may be adjusted based on individual patient factors and concurrent medical conditions.
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