Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 10mg+5mg Technical Specification:

Product Name:                                                  Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 10mg+5mg
Brand Name:Montutaj-LC
Strength:(10mg+5mg), (2.5mg+4mg)
Dosage Form:Tablet (film-coated)
Route of Administration:Via oral Route
Packing:10s, 30s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antiallergic
Indication: Combination therapy (montelukast + levocetirizine) is a more effective strategy than monotherapy in the treatment of persistent allergic rhinitis.
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:

  • Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 10mg+5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 10mg+5mg
    Each film-coated tablet contains:
    Montelukast Sodium I.P.
    equivalent to Montelukast …………………………….10mg
    Levocetirizine Dihydrochloride I.P……………………………5mg
    Excipients…………………………………. q.s.
    Colours: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

It’s usually prescribed when asthma is mild and can stop it from getting worse. It can also help people with asthma who have breathing difficulties when they exercise (exercise-induced asthma) and seasonal allergies, such as sneezing, itchiness and a blocked or runny nose (allergic rhinitis).

CAUTION & SCHEDULE :

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

Read enclosed leaflet before use.

SCHEDULE “H” Prescription Drug -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.

Why Taj Pharmaceuticals?

Taj Pharma stands as the trusted choice for Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP, offering a compelling combination of quality, effective allergy relief, and a commitment to your well-being. With a steadfast dedication to pharmaceutical excellence, Taj Pharma ensures that these tablets meet the highest international standards, prioritizing your health and safety. This medication provides potent relief from allergy symptoms, including sneezing, runny nose, and itchy eyes, thanks to its antihistamine and anti-inflammatory properties. Taj Pharma’s convenient and consistent dosage form makes it easy to manage allergies and asthma, ensuring you receive the relief you need. Choose Taj Pharma as your healthcare partner for a healthier, symptom-free life.

Taj Pharma is your go-to choice for Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP. With a steadfast commitment to quality assurance, their products undergo rigorous testing to meet the highest international standards, ensuring your health and safety. These tablets offer effective relief from allergy symptoms, combining the power of Levocetirizine Dihydrochloride and Montelukast Sodium to address sneezing, runny nose, itchy eyes, and other discomforts. Taj Pharma provides a convenient and reliable dosage form, making it easy to incorporate allergy management into your daily routine. As a trusted healthcare partner, Taj Pharma is dedicated to enhancing the lives of those dealing with allergies and respiratory conditions, offering a path to a symptom-free and healthier life. Choose Taj Pharma for quality, relief, and well-being in allergy management.

What is Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP and its use?

Levocetirizine dihydrochloride and Montelukast sodium tablets are a combination medication used to treat various allergic and respiratory conditions. Let’s break down the components and their uses:

Levocetirizine Dihydrochloride:

This is an antihistamine. It is a second-generation antihistamine, which means it is less likely to cause drowsiness compared to first-generation antihistamines. Levocetirizine is primarily used to relieve symptoms associated with allergies, such as:

  • Runny or stuffy nose
  • Sneezing
  • Itchy or watery eyes
  • Itchy or sore throat
  • Skin itching and hives (urticaria)

Montelukast Sodium:

This is a leukotriene receptor antagonist. It works by blocking the action of certain natural substances in the body that cause inflammation, bronchoconstriction (narrowing of the airways), and other allergic reactions. Montelukast is typically used for the prevention and long-term management of:

  • Asthma: It can help prevent asthma symptoms and attacks.
  • Allergic Rhinitis: It can alleviate symptoms like sneezing, runny or stuffy nose, and itching associated with allergic rhinitis.

Combining these two medications in a single tablet can be beneficial for individuals who have both allergy and asthma symptoms. It can provide relief from allergic reactions while also helping to manage asthma symptoms.

How does Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP work?

Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP work through different mechanisms to alleviate allergy and asthma symptoms. Let’s discuss how each component works:

Levocetirizine Dihydrochloride:

  • Antihistamine: Levocetirizine is an antihistamine, specifically a second-generation antihistamine. When you are exposed to allergens (substances that trigger allergies), your body releases histamine, a natural chemical that causes allergic symptoms. Levocetirizine works by blocking the effects of histamine. It does this by binding to histamine receptors on cells, preventing histamine from binding to these receptors. By blocking histamine, Levocetirizine reduces or prevents allergy symptoms, such as itching, sneezing, runny nose, and watery eyes.

Montelukast Sodium:

  • Leukotriene Receptor Antagonist: Montelukast sodium is a leukotriene receptor antagonist. Leukotrienes are substances produced by the body in response to allergens and irritants, and they play a significant role in triggering allergic and asthmatic responses. Montelukast works by blocking the action of leukotrienes, specifically leukotriene D4, which causes inflammation, bronchoconstriction (narrowing of the airways), and other allergy-related symptoms. By inhibiting leukotrienes, Montelukast helps to reduce inflammation and prevent or relieve asthma and allergy symptoms.

In combination, Levocetirizine and Montelukast work synergistically to provide relief from both allergic and asthmatic symptoms. Levocetirizine targets histamine-related symptoms, while Montelukast focuses on reducing inflammation and bronchoconstriction associated with allergic reactions and asthma. This combination can be particularly effective for individuals who experience both types of symptoms concurrently or have conditions like allergic rhinitis and asthma. However, the use of this medication should be under the guidance and prescription of a healthcare professional, as they will determine the appropriate dosage and treatment plan based on the individual’s specific condition.

Benefits and Side effects of Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP?

Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP offer several benefits in the treatment of allergies and asthma. However, like any medication, they can also come with potential side effects. Here’s an overview of the benefits and possible side effects:

Benefits:

  • Relief from Allergy Symptoms: These tablets can effectively relieve a range of allergy symptoms, including sneezing, runny or stuffy nose, itching, and watery eyes. Levocetirizine targets histaminerelated symptoms, while Montelukast helps reduce inflammation and other allergic responses.
  • Management of Allergic Rhinitis: They are particularly useful for individuals with allergic rhinitis, a condition characterized by nasal congestion, sneezing, and itching caused by allergens like pollen, dust mites, or pet dander.
  • Asthma Management: Montelukast, in particular, is beneficial for asthma management. It can help prevent asthma attacks, reduce inflammation in the airways, and improve breathing in individuals with asthma.
  • Convenience: Combining both medications into one tablet can be more convenient for individuals who need relief from both allergy and asthma symptoms, as it reduces the need to take multiple medications.

Side Effects:

It’s essential to be aware of potential side effects when taking Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP. Not everyone will experience these side effects, and they can vary in severity:

  • Drowsiness (more common with Levocetirizine): While Levocetirizine is a secondgeneration antihistamine and is less likely to cause drowsiness compared to firstgeneration antihistamines, some individuals may still experience mild drowsiness. It’s advisable not to operate heavy machinery or drive if you feel drowsy after taking these tablets.
  • Headache: Some people may experience headaches as a side effect.
  • Gastrointestinal issues: This can include stomach pain, nausea, or diarrhea.
  • Mood or behavioral changes: Rarely, Montelukast has been associated with mood changes, including agitation, aggressive behavior, and mood swings. If you experience these symptoms, it’s crucial to seek medical attention.
  • Allergic reactions: In very rare cases, individuals may experience severe allergic reactions to these medications, which can include hives, difficulty breathing, swelling of the face, lips, tongue, or throat. Seek immediate medical attention if you experience any of these symptoms.
  • Neuropsychiatric effects (Montelukast): In rare cases, Montelukast has been associated with neuropsychiatric events such as nightmares, depression, and suicidal thoughts. If you notice any mood or behavioral changes, especially in children or adolescents, it’s important to consult a healthcare professional.

Frequently asked questions about Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP?

Frequently asked questions (FAQs) about Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP typically revolve around their uses, dosage, side effects, and precautions. Here are some common questions and their answers:

  1. What are Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP used for?

These tablets are used to relieve allergy symptoms like sneezing, runny or stuffy nose, itching, and watery eyes, as well as to manage conditions like allergic rhinitis and asthma.

  1. How should I take these tablets?

Follow the dosage instructions provided by your healthcare provider. Typically, they are taken orally with or without food. It’s important to take them as prescribed.

  1. Can I take these tablets if I have asthma but no allergies?

Montelukast, one of the components, is primarily used for asthma management. If you have asthma and no allergies, you may still benefit from this medication as prescribed by your healthcare provider.

  1. Do Levocetirizine & Montelukast cause drowsiness?

While Levocetirizine is a second-generation antihistamine with less potential for drowsiness, some individuals may still experience mild drowsiness. Be cautious when driving or operating heavy machinery until you know how these medications affect you.

  1. What are the common side effects of these tablets?

Common side effects can include drowsiness (more with Levocetirizine), headache, stomach discomfort, and nausea. However, not everyone experiences these side effects.

  1. Are there any serious side effects I should watch for?

Rare but serious side effects can include severe allergic reactions or neuropsychiatric effects like mood changes or suicidal thoughts (more with Montelukast). Seek immediate medical attention if you experience any severe symptoms.

  1. Can I drink alcohol while taking these tablets?

It’s generally advisable to avoid or limit alcohol consumption when taking these medications, as alcohol can increase the risk of drowsiness and may exacerbate side effects.

  1. Can I take these tablets during pregnancy or while breastfeeding?

Consult your healthcare provider before using these tablets during pregnancy or while breastfeeding, as they can provide guidance on the risks and benefits based on your individual situation.

  1. Can I stop taking these tablets once my symptoms improve?

It’s essential to follow your healthcare provider’s instructions regarding the duration of treatment. Stopping the medication abruptly may lead to a return of symptoms. Consult your healthcare provider before discontinuing treatment.

  1. Are there any drug interactions I should be aware of?

Inform your healthcare provider about all the medications you are taking, including over-the-counter drugs and supplements, to check for potential interactions.

As Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP Exporters; We can cater to export business queries from the following geographies. We are exporting our Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 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

Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 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 Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP, 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. Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 10mg+5mg
B. Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 2.5mg+4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 10mg+5mg
Each film-coated tablet contains:
Montelukast Sodium I.P.
equivalent to Montelukast …………………………….10mg
Levocetirizine Dihydrochloride I.P……………………………5mg
Excipients…………………………………. q.s.
Colours: Sunset Yellow FCF


B. Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP 2.5mg+4mg
Each film-coated tablet contains:
Montelukast Sodium
equivalent to Montelukast…………………………….2.5mg
Levocetirizine Hydrochloride……………………………5mg
Excipients…………………………………. q.s.
Colours: Quinoline Yellow

THERAPEUTIC INDICATIONS:

It's usually prescribed when asthma is mild and can stop it from getting worse. It can also help people with asthma who have breathing difficulties when they exercise (exercise-induced asthma) and seasonal allergies, such as sneezing, itchiness and a blocked or runny nose (allergic rhinitis).

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
SCHEDULE “H” Prescription Drug -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.