Montelukast sodium and levocetirizine hydrochloride tablets combine two active ingredients that act on different parts of the allergic response. Levocetirizine is an antihistamine that helps relieve symptoms such as sneezing, a runny nose and itching. Montelukast is a leukotriene receptor antagonist used for certain allergic and respiratory conditions, including allergic rhinitis and, in some circumstances, asthma.
The exact indications, suitability and directions depend on the specific product label and on the advice of a qualified healthcare professional. Montelukast also carries an important safety warning about changes in mood, behaviour and sleep, so it is worth understanding the benefits and risks before use. This guide explains the general uses, how the ingredients work, possible side effects, precautions and when to seek medical help. It is for information only and does not replace medical advice.
What Are Montelukast Sodium and Levocetirizine Hydrochloride Tablets?
These are fixed-dose combination tablets: a single tablet that contains both medicines. Each ingredient has a different job.
- Levocetirizine is an antihistamine. It blocks histamine, a substance the body releases during an allergic reaction that causes sneezing, itching and a runny nose.
- Montelukast blocks leukotrienes, other substances involved in allergic and airway inflammation. It is used to help control symptoms of allergic rhinitis and asthma, but it does not cure either condition.
Because the two medicines work through different pathways, some manufacturers combine them in one tablet. This can be more convenient than taking two separate tablets when a doctor has decided that both ingredients are appropriate. It does not mean the combination is right for every person or every allergy.
Products with similar ingredients can differ in strength, indications and directions, so always check the exact composition on the carton and leaflet. A commonly marketed strength in India is levocetirizine 5 mg with montelukast 10 mg, but other strengths and formulations exist. Labels may also name the salt forms differently, for example montelukast sodium and levocetirizine hydrochloride or dihydrochloride. Prescribing information for comparable Indian brands is written for registered medical practitioners, which is a reminder that these are not products to start on your own.
Montelukast Sodium and Levocetirizine Hydrochloride Tablets Uses
Product information for this combination centres mainly on allergic rhinitis (hay fever), whether seasonal or year-round. Some brand information also refers to people who have asthma alongside allergic rhinitis. Which uses apply to a particular tablet is set out in that product’s own labelling.
The two ingredients contribute in different ways:
- Levocetirizine is used for allergy symptoms such as sneezing, a runny nose, itching of the nose or throat, and red, itchy or watery eyes. On its own it is also used for hives. Whether a specific combination tablet is indicated for hives should be confirmed on its label.
- Montelukast is used for the nasal symptoms of allergic rhinitis, including sneezing, a blocked or runny nose and nasal itching. It is also used for long-term asthma control and to prevent exercise-induced breathing difficulty. Where a combination label mentions asthma, the tablet belongs to ongoing management, not emergency relief.
This medicine is not a general remedy for every cold, cough or breathing problem. It does not treat bacterial or viral infections, and it does not cure allergies or asthma. It controls symptoms only while treatment continues. A doctor decides whether the combination fits a person’s symptoms and history.
How Do Montelukast and Levocetirizine Work?
During an allergic reaction, the body releases chemical messengers. Histamine acts quickly and drives sneezing, itching and a runny nose. Leukotrienes add to inflammation, swelling and airway sensitivity. Levocetirizine blocks the action of histamine, and montelukast blocks the action of leukotrienes. Together they act on two separate pathways.
| Ingredient | General role | Important consideration |
|---|---|---|
| Levocetirizine | Antihistamine that helps relieve certain allergy symptoms | May cause drowsiness or fatigue |
| Montelukast | Leukotriene receptor antagonist used for specific allergic or respiratory indications | Carries an important warning about possible neuropsychiatric effects |
Neither ingredient is a rescue treatment. Montelukast is taken regularly to help control symptoms over time. It is not meant to stop a sudden asthma attack that has already started.
Montelukast and Levocetirizine Tablet Side Effects
Not everyone gets side effects, and how likely or severe they are varies from person to person. The lists below are not complete. The patient leaflet for your exact product is the full reference.
Effects linked to levocetirizine
- Sleepiness, drowsiness or tiredness, which are among the most commonly reported effects
- Dry mouth and headache
- Dizziness, which appears in prescribing information for comparable Indian combination products
If you feel drowsy or dizzy, avoid driving or operating machinery until you know how the medicine affects you. Alcohol can add to drowsiness. Levocetirizine labelling also notes that severe itching can appear within a few days of stopping, mainly after months or years of regular use. Speak to your doctor if this happens.
Effects linked to montelukast
- Headache, which usually settles within the first week
- Stomach pain, feeling sick, diarrhoea and a raised temperature
- A mild rash
Rarer effects reported with montelukast include allergic reactions and liver problems. Contact a doctor promptly for yellowing of the skin or eyes, an unusual or fast heartbeat, or a flu-like illness with pins and needles or numbness in the arms or legs, a rash, or worsening asthma symptoms.
Montelukast and the neuropsychiatric warning
Montelukast carries a boxed warning, the strongest type of warning in US labelling, about serious neuropsychiatric events. The US Food and Drug Administration (FDA) required this warning in March 2020 after reviewing reports of mood and behaviour changes, including suicidal thoughts and actions. The UK regulator, the MHRA, has also strengthened the warnings in montelukast leaflets. Indian prescribing information for comparable combination products likewise lists neuropsychiatric events among its warnings.
Reported changes include:
- Agitation, aggression, irritability or restlessness
- Anxiety or depression
- Trouble sleeping, vivid or bad dreams, or sleepwalking
- Problems with attention or memory, or confusion
- Seeing or hearing things that are not there
- Tremor, stuttering or uncontrolled movements
- Suicidal thoughts or actions
Some important points to keep in perspective:
- These events have been reported in people with and without a history of mental health problems.
- Most reports occurred during treatment, but some occurred after stopping.
- The FDA states that it cannot determine how likely any individual is to be affected. Some observational studies it reviewed did not find a higher risk than with inhaled corticosteroids, although those studies had limitations.
- Not everyone who takes montelukast will experience these effects.
For allergic rhinitis in particular, the FDA advises that montelukast should be reserved for people who do not respond to, or cannot tolerate, other allergy medicines. A US FDA Drug Safety Communication sets out the full details. Because this combination contains montelukast, it is worth discussing the benefits and risks with a doctor, especially when the tablet is being considered for allergic rhinitis alone.
When to get help for side effects
- Contact your doctor immediately if you or your child notice new or worsening mood, behaviour, sleep or memory changes. The FDA advises stopping montelukast and speaking to a healthcare professional right away if such changes occur, and the NHS advises calling a doctor straight away for these symptoms.
- Seek emergency help at once for thoughts of harming yourself. In India, the national emergency number is 112, and the free Tele-MANAS mental health helpline (14416) is available 24 hours a day. Ask someone to stay with you.
- Seek emergency help at once for signs of a serious allergic reaction, such as swelling of the lips, mouth, tongue or throat, difficulty breathing or swallowing, or sudden confusion, faintness or collapse.
The NHS guide to montelukast side effects gives a clear breakdown of which symptoms need urgent attention.
Precautions Before Using This Combination
This medicine is not safe or suitable for everyone. Speak to a doctor or pharmacist before use, particularly if any of the following apply.
- Kidney problems. Levocetirizine is cleared through the kidneys. Prescribing information for a comparable Indian brand lists severe kidney impairment as a contraindication and recommends dose adjustment in some people with kidney impairment. A doctor needs to know about any kidney disease.
- Previous medicine allergies. A known allergy to levocetirizine, montelukast or any ingredient of the tablet is a reason not to use the product.
- Other medicines. Tell your doctor about everything you take. Sedating medicines and alcohol can add to drowsiness. One Indian brand’s information advises caution with medicines that speed up liver metabolism, such as phenytoin, phenobarbital and rifampicin.
- Other conditions. The same brand’s warnings also mention epilepsy and difficulty passing urine.
- Pregnancy, planning pregnancy or breastfeeding. Tell your doctor. Sources word the breastfeeding advice differently, so individual advice matters.
- Driving or operating machinery. Take care if you feel drowsy or dizzy.
- Mood, behaviour or sleep history. Tell your doctor about any history of mental health or sleep concerns before starting a montelukast-containing medicine.
- Aspirin-sensitive asthma. If your asthma is made worse by aspirin or similar painkillers, ask your doctor whether you should avoid them.
Can Children Take Montelukast and Levocetirizine Tablets?
Suitability for a child depends on the exact product, its strength, the child’s age, the reason for treatment and a healthcare professional’s assessment. An adult tablet strength should not be assumed to be appropriate for a child, and this article does not give any paediatric dose.
Product information for one comparable Indian brand lists its tablet for adults and adolescents aged 15 and above, with a separate suspension for younger children. That applies to that brand only, so check the leaflet of the exact product and ask a doctor.
The neuropsychiatric warning applies to children too. The FDA advises parents and caregivers to stop montelukast and contact a healthcare professional right away if a child shows behaviour or mood changes.
Dosage and Directions for Use
The correct dose and duration depend on the product label, the approved indication, individual circumstances and a healthcare professional’s advice. No universal schedule applies to every tablet, and this article does not offer one.
For the Rosette Pharma product described below, the product page states that the dose is decided by the doctor according to the patient’s condition, age and symptom severity. It states that the tablet is taken by mouth with water, with or without food, that evening dosing is often recommended as directed by a doctor, and that the length of treatment follows medical advice. It also advises that a missed dose can be taken when remembered unless the next dose is close, and that doses should not be doubled. These directions come from the manufacturer’s product page and are not a substitute for the printed leaflet.
Do not change your dose or stop a prescribed medicine without medical advice. The exception is a serious reaction: stop and seek help immediately if you have mood or behaviour changes, thoughts of self-harm or signs of a serious allergic reaction, as described above.
Montelukast and Levocetirizine vs Other Allergy Medicines
There is no single best allergy medicine. The FDA notes that many other safe and effective options exist for allergic rhinitis, including:
- Antihistamines taken by mouth, such as levocetirizine on its own, cetirizine, loratadine and fexofenadine
- Steroid nasal sprays
- Allergen immunotherapy (allergy shots)
- Reducing exposure to known triggers
Treatment choice depends on the type and severity of symptoms, relevant medical history, other medicines, previous response to treatment and professional assessment. Because the FDA advises reserving montelukast for allergic rhinitis in people who have not responded to, or cannot tolerate, other medicines, a doctor may reasonably start with an antihistamine or a nasal spray. This article does not claim that the combination is stronger, safer, faster or better than any alternative, and it does not recommend a treatment plan for any individual.
Product Information: Levocetirizine 5 mg + Montelukast 10 mg Tablet by Rosette Pharma
The levocetirizine 5 mg and montelukast 10 mg tablet by Rosette Pharma is listed under the brand name Lezet MT. According to the product page, it contains levocetirizine 5 mg and montelukast 10 mg per tablet, with a pack presentation of Alu Alu, 10x1x10. The page presents the tablet for allergic conditions, including allergic rhinitis, and states that it should be used under the guidance of a qualified healthcare professional.
The page lists drowsiness, possible mood changes or sleep disturbances linked to montelukast, caution in kidney and liver conditions, avoiding alcohol, and medical advice in pregnancy and breastfeeding. It names the active ingredients without stating their salt forms, so check the carton and leaflet for the exact composition. This article reports what the page states and does not extend those statements into claims about superiority, suitability for every patient or clinical evidence.
When Should You Consult a Healthcare Professional?
See a doctor or pharmacist for routine advice if:
- Allergy symptoms persist or get worse despite treatment
- Symptoms interfere with daily activities or sleep
- You notice side effects that bother you or do not go away
- You are unsure whether this combination suits you
Get prompt medical advice if you notice:
- New or worsening mood or behaviour changes
- Significant sleep disturbances, nightmares or sleepwalking
- Unusual psychological symptoms, such as seeing or hearing things that are not there
Seek emergency help immediately for:
- Thoughts of suicide or self-harm
- Severe allergic reactions
- Sudden or severe difficulty breathing
This medicine should not be used as a substitute for emergency treatment of sudden breathing difficulty.
Frequently Asked Questions
1. What are montelukast sodium and levocetirizine hydrochloride tablets used for?
They are generally used to relieve symptoms of allergic rhinitis, such as sneezing, a runny or blocked nose and itching. Some brand information also refers to people with asthma. The exact uses depend on the product label and a doctor’s assessment.
2. Does this combination help with allergy symptoms?
Levocetirizine helps relieve histamine-driven symptoms, and montelukast helps with leukotriene-driven nasal and airway symptoms. The combination is used to manage symptoms. It does not cure allergies, and it is not always the first choice.
3. What are the common side effects of montelukast and levocetirizine?
Commonly reported effects include drowsiness, tiredness, headache, dry mouth, stomach pain and diarrhoea. This is not a complete list, so check the leaflet of your exact product.
4. Can this combination cause sleepiness?
Yes. Levocetirizine can cause sleepiness or tiredness in some people, and alcohol can add to it. Avoid driving or operating machinery if you feel drowsy.
5. Can children take montelukast and levocetirizine tablets?
Only if a healthcare professional decides it is appropriate for that child and the exact product. Adult tablet strengths should not be assumed to suit children.
6. What is the neuropsychiatric warning associated with montelukast?
Montelukast has been linked to serious mood, behaviour and sleep changes, including suicidal thoughts and actions, in people of all ages. They have been reported in people with and without a history of mental health problems. Stop the medicine and contact a healthcare professional right away if such changes occur, and seek emergency help for thoughts of self-harm.
7. Can this combination be used for sudden asthma symptoms?
No. Montelukast is not meant to treat a sudden asthma attack, and this combination is not a rescue medicine. It does not replace inhalers or other asthma treatment prescribed by a doctor.
8. What precautions should be considered before taking this medicine?
Tell your doctor or pharmacist about kidney problems, medicine allergies, other medicines, alcohol use, pregnancy or breastfeeding, and any history of mood, behaviour or sleep concerns. Take care with driving if you feel drowsy.
Conclusion
Levocetirizine helps block histamine, which drives sneezing, itching and a runny nose. Montelukast blocks leukotrienes, which contribute to nasal and airway inflammation. Together they may help control symptoms in people for whom a doctor judges both ingredients appropriate. The key safety points are possible drowsiness from levocetirizine and the serious warning about mood, behaviour and sleep changes with montelukast. For allergic rhinitis, regulators advise that montelukast be considered mainly when other treatments have not worked or are not tolerated.
Whether this combination suits you should be decided using the product information and advice from a qualified healthcare professional, and reading this article does not replace that advice. If you would like product-specific details, you can view the Rosette Pharma product page linked earlier in this article, then discuss any questions with your doctor or pharmacist.
