Montelukast Sodium and Levocetirizine Hydrochloride Tablets (10mg+5mg) Technical Specification:

Product Name:
Montelukast Sodium and Levocetirizine Hydrochloride Tablets (10mg+5mg)
Brand Name:Xeglyart
Strength:(10mg+5mg), (4mg+2.5mg)
Dosage Form:Tablet (Film-coated, Uncoated)
Route of Administration:Via oral Route
Packing:10s, 30s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics).
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-asthmatic
Indication: Levocetirizine + Montelukast is a combination of two medicines: Levocetirizine and Montelukast, which relieves sneezing and runny nose due to allergies. Levocetirizine is an antiallergic which blocks a chemical messenger (histamine) responsible for runny nose, watery eyes and sneezing.
Storage:
Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Montelukast Sodium and Levocetirizine Hydrochloride Tablets (10mg+5mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Montelukast Sodium and Levocetirizine Hydrochloride Tablets (10mg+5mg)
    Each film coated tablet contains:
    Levocetirizine Hydrochloride USP……………………………5mg
    Montelukast Sodium USP
    equivalent to Montelukast.…………………………….10mg
    Excipients…………………………………. q.s.
    Colours: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

Levocetirizine + Montelukast is a combination of two medicines: Levocetirizine and Montelukast, which relieves sneezing and runny nose due to allergies. Levocetirizine is an antiallergic which blocks a chemical messenger (histamine) responsible for runny nose, watery eyes and sneezing.

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

Read enclosed leaflet before use.

WARNING: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage:  Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

Dosage:  As directed by the Physician.

Note: 1 Tablet daily.

Why Taj Pharmaceuticals?

Taj Pharma stands as the preferred choice for Montelukast Sodium and Levocetirizine Hydrochloride Tablets due to its unwavering commitment to providing effective relief from respiratory conditions and allergies. These tablets combine the power of Montelukast Sodium, an asthma and allergy symptom manager, with Levocetirizine Hydrochloride, a proven antihistamine, offering comprehensive relief from a range of symptoms. Taj Pharma’s dedication to quality, global recognition, and a patient-centric approach ensures that these medications are of the highest quality and accessible to all. With competitive pricing and a reputation for excellence in the pharmaceutical industry, Taj Pharma prioritizes the well-being of its customers, making it the trusted partner for a healthier, allergy-free life. why Taj Pharma is your trusted choice for Montelukast Sodium and Levocetirizine Hydrochloride Tablets. Our commitment to quality, effectiveness, and affordability ensures optimal relief from allergies and respiratory conditions. With a reputation for excellence in the pharmaceutical industry and a patient-centered approach, Taj Pharma is your partner for a healthier, allergy-free life.

What is Montelukast Sodium and Levocetirizine Hydrochloride Tablets and its use?

Montelukast Sodium and Levocetirizine Hydrochloride Tablets are a combination medication that contains two active ingredients: Montelukast Sodium and Levocetirizine Hydrochloride. These tablets are used to address a variety of respiratory and allergy-related conditions. Here’s more information about Montelukast Sodium and Levocetirizine Hydrochloride Tablets and their common uses:

  • Montelukast Sodium: Montelukast is a leukotriene receptor antagonist. It works by blocking the action of leukotrienes, which are chemicals in the body that play a role in inflammatory and allergic reactions. By inhibiting leukotrienes, Montelukast helps manage symptoms of asthma, including wheezing and shortness of breath. It is also effective in treating allergic rhinitis, reducing symptoms such as sneezing, runny or itchy nose, and itchy or watery eyes.
  • Levocetirizine Hydrochloride: Levocetirizine is an antihistamine. It works by blocking the action of histamine, a chemical released by the body during an allergic reaction. Levocetirizine helps alleviate allergy symptoms such as sneezing, runny or itchy nose, itchy or watery eyes, and itching of the throat or nose.

Uses:

  • Asthma: These tablets are used as part of a comprehensive asthma management plan to help control and prevent asthma symptoms, particularly in individuals with allergic asthma.
  • Allergic Rhinitis: They are effective in providing relief from allergic rhinitis symptoms, including sneezing, nasal congestion, runny nose, and itchy or watery eyes.
  • Seasonal and Perennial Allergies: Montelukast Sodium and Levocetirizine Hydrochloride Tablets can be used to manage allergy symptoms triggered by seasonal allergens (e.g., pollen) or perennial allergens (e.g., dust mites, pet dander) throughout the year.
  • Other Allergic Reactions: They may also be prescribed for the relief of allergy symptoms caused by various allergens.

It’s essential to use Montelukast Sodium and Levocetirizine Hydrochloride Tablets as directed by a healthcare professional and to follow the prescribed dosage. This combination medication provides comprehensive relief from respiratory and allergy-related symptoms and can significantly improve the quality of life for individuals affected by these conditions. However, it should only be used under the guidance of a healthcare provider to ensure appropriate treatment.

How does Montelukast Sodium and Levocetirizine Hydrochloride Tablets Work?

Montelukast Sodium and Levocetirizine Hydrochloride Tablets work through their respective active ingredients to provide relief from respiratory and allergy-related symptoms. Here’s how each component of the combination medication works:

Montelukast Sodium:

  • Leukotriene Receptor Antagonist: Montelukast Sodium is a leukotriene receptor antagonist. Leukotrienes are chemical compounds produced by the body’s immune system in response to allergens and other triggers. They play a significant role in causing inflammation and constriction of airways in conditions like asthma and allergic rhinitis.
  • Mechanism of Action: Montelukast Sodium works by blocking the action of leukotrienes, specifically the leukotriene receptor CysLT1. By inhibiting these receptors, Montelukast reduces the effects of leukotrienes on the airways and nasal passages. This action results in decreased inflammation, relaxation of bronchial smooth muscles, and reduced production of mucus, leading to improved breathing and alleviation of asthma and allergy symptoms.

Levocetirizine Hydrochloride:

  • Antihistamine: Levocetirizine Hydrochloride is an antihistamine. Histamine is a chemical released by the body during an allergic reaction. It binds to histamine receptors on cells, causing symptoms like sneezing, itching, runny nose, and watery eyes.
  • Mechanism of Action: Levocetirizine works by blocking histamine receptors (specifically the H1 receptors) in the body. By inhibiting histamine’s action, Levocetirizine reduces or prevents the allergic response, thereby relieving symptoms like sneezing, itching, nasal congestion, and watery eyes.

Combination Synergy:

The combination of Montelukast Sodium and Levocetirizine Hydrochloride in a single tablet provides a comprehensive approach to managing respiratory and allergy-related conditions. Montelukast targets the underlying inflammation and bronchoconstriction seen in asthma and allergic rhinitis by inhibiting leukotrienes, while Levocetirizine effectively addresses the acute allergic symptoms caused by histamine release. Together, they offer a more comprehensive relief from a wide range of symptoms associated with these conditions.

It’s important to use Montelukast Sodium and Levocetirizine Hydrochloride Tablets as directed by a healthcare professional to ensure that the medications work effectively and provide the desired symptom relief.

Benefits and Side effects of Montelukast Sodium and Levocetirizine Hydrochloride Tablets:

Montelukast Sodium and Levocetirizine Hydrochloride Tablets offer several benefits in the management of respiratory and allergy-related conditions. However, like all medications, they can have potential side effects. Here’s an overview of the benefits and common side effects associated with this combination medication:

Benefits:

  • Comprehensive Symptom Relief: One of the primary benefits of Montelukast Sodium and Levocetirizine Hydrochloride Tablets is their ability to provide comprehensive relief from a wide range of symptoms associated with asthma, allergic rhinitis, and other allergy-related conditions. These may include sneezing, runny or itchy nose, itchy or watery eyes, nasal congestion, coughing, and wheezing.
  • Dual Mechanisms of Action: This combination medication combines the anti-inflammatory and bronchodilatory effects of Montelukast with the antihistamine action of Levocetirizine. This dual approach addresses both the underlying inflammation and acute allergic symptoms, offering more effective relief.
  • Convenience: Montelukast Sodium and Levocetirizine Hydrochloride Tablets are available as a single tablet, simplifying dosing and enhancing patient compliance, as patients do not need to take multiple medications separately.
  • Improvement in Quality of Life: By effectively managing symptoms, these tablets can significantly improve the quality of life for individuals affected by asthma and allergies, allowing them to lead a more active and comfortable life.

Common Side Effects:

  • Drowsiness: Levocetirizine, being an antihistamine, can cause drowsiness in some individuals. However, Levocetirizine is considered a second-generation antihistamine and is less likely to cause drowsiness compared to older antihistamines.
  • Headache: Some people may experience mild to moderate headaches while taking this combination medication.
  • Gastrointestinal Disturbances: Common gastrointestinal side effects may include nausea, diarrhea, and abdominal discomfort.
  • Dry Mouth: Dry mouth can occur in some individuals as a side effect of Levocetirizine.
  • Fatigue: While less common, some people may feel fatigued or experience reduced alertness while taking Levocetirizine.
  • Uncommon Side Effects: In rare cases, more serious side effects may occur, such as mood changes, behavior changes, and severe allergic reactions. If you experience any unusual or severe symptoms, seek medical attention promptly.

It’s crucial to use Montelukast Sodium and Levocetirizine Hydrochloride Tablets as directed by a healthcare professional and to report any unusual or severe side effects to your healthcare provider. Additionally, inform your healthcare provider of any other medications or medical conditions you have to minimize potential drug interactions or contraindications. These tablets can provide effective relief when used appropriately and under medical supervision.

Frequently asked questions (FAQs) about Montelukast Sodium and Levocetirizine Hydrochloride Tablets:

  1. What are Montelukast Sodium and Levocetirizine Hydrochloride Tablets used for?

Montelukast Sodium and Levocetirizine Hydrochloride Tablets are used to manage respiratory conditions like asthma and allergic rhinitis (hay fever). They provide relief from symptoms such as wheezing, sneezing, runny nose, and itchy or watery eyes.

  1. How do these tablets work?

Montelukast Sodium inhibits leukotrienes, chemicals that cause inflammation and bronchoconstriction in conditions like asthma. Levocetirizine Hydrochloride is an antihistamine that blocks the effects of histamine, which is responsible for allergy symptoms.

  1. Is this combination medication suitable for children?

Montelukast Sodium and Levocetirizine Hydrochloride Tablets are often prescribed for children, but the dosage should be determined by a healthcare provider based on the child’s age and weight.

  1. Can I take Montelukast Sodium and Levocetirizine Hydrochloride Tablets with other medications?

It’s important to inform your healthcare provider about all medications, supplements, or herbal products you are taking to avoid potential interactions. They can assess the safety of combining this medication with others.

  1. Are there any known allergies associated with these tablets?

If you are allergic to Montelukast Sodium, Levocetirizine Hydrochloride, or any other ingredients in the tablets, you should not use this medication. Be sure to inform your healthcare provider of any known allergies.

  1. How should I take these tablets?

Follow the dosing instructions provided by your healthcare provider. Typically, they are taken orally with or without food. It’s important to stick to the prescribed dosage and schedule.

  1. Can I drive or operate heavy machinery while taking Montelukast Sodium and Levocetirizine Hydrochloride Tablets?

Montelukast Sodium is not associated with drowsiness, but Levocetirizine Hydrochloride may cause mild drowsiness in some individuals. If you experience drowsiness, it’s advisable to avoid activities that require mental alertness until you know how the medication affects you.

  1. Can I consume alcohol while taking these tablets?

It’s generally recommended to avoid alcohol while taking any medication, as it can potentially interact with the drug and may increase the risk of drowsiness or other side effects.

  1. How long does it take for these tablets to start working?

The onset of action can vary among individuals. Some may experience relief from symptoms within hours, while others may take a few days. Consistent use of the medication is essential for optimal results.

  1. What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

As Montelukast Sodium and Levocetirizine Hydrochloride Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Montelukast Sodium and Levocetirizine Hydrochloride Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Montelukast Sodium and Levocetirizine Hydrochloride Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Montelukast Sodium and Levocetirizine Hydrochloride Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Montelukast Sodium and Levocetirizine Hydrochloride Tablets (10mg+5mg)
B. Montelukast Sodium and Levocetirizine Hydrochloride Tablets (4mg+2.5mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Montelukast Sodium and Levocetirizine Hydrochloride Tablets (10mg+5mg)
Each film coated tablet contains:
Levocetirizine Hydrochloride USP……………………………5mg
Montelukast Sodium USP
equivalent to Montelukast.…………………………….10mg
Excipients…………………………………. q.s.
Colours: Sunset Yellow FCF


B. Montelukast Sodium and Levocetirizine Hydrochloride Tablets (4mg+2.5mg)
Each uncoated tablet contains:
Levocetirizine Hydrochloride USP……………………………2.5mg
Montelukast Sodium USP
equivalent to Montelukast.…………………………….4mg
Excipients…………………………………. q.s.

THERAPEUTIC INDICATIONS:

Levocetirizine + Montelukast is a combination of two medicines: Levocetirizine and Montelukast, which relieves sneezing and runny nose due to allergies. Levocetirizine is an antiallergic which blocks a chemical messenger (histamine) responsible for runny nose, watery eyes and sneezing.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C.
Do not freeze.
Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Note: 1 Tablet daily.