Montelukast Sodium Tablets USP 5mg Technical Specification:

Product Name:Montelukast Sodium Tablets USP 5mg
Brand Name:Generic
Strength:(5mg), (10mg)
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
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: Montelukast helps stop your airways from narrowing (caused by inflammation). This makes breathing easier and prevents asthma attacks. Most people take montelukast once a day in the evening. If you take it for asthma, it’s important to take it even when you have no symptoms.
Storage:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in dry place protected from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Montelukast Sodium Tablets USP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Montelukast Sodium Tablets USP 5mg
    Each Film-coated tablet contains:
    Montelukast Sodium USP 5.2mg
    Equivalent to Montelukast……….4mg
    Excipients………………………………..q.s
    Colour: Sunset yellow FCF

THERAPEUTIC INDICATIONS:

Montelukast helps stop your airways from narrowing (caused by inflammation). This makes breathing easier and prevents asthma attacks. Most people take montelukast once a day in the evening. If you take it for asthma, it’s important to take it even when you have no symptoms.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.

Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Experience Exceptional Healthcare with Taj Pharmaceuticals. We take pride in offering Montelukast Sodium Tablets, a trusted solution for respiratory conditions. With a legacy of excellence and unwavering commitment to your well-being, Taj Pharmaceuticals stands as your premier choice. Montelukast Sodium Tablets, a proven treatment for asthma and allergic rhinitis, are manufactured to the highest quality standards by Taj Pharmaceuticals. Our dedication to pharmaceutical innovation ensures that you receive a reliable and effective solution to manage these conditions. At Taj Pharmaceuticals, your health is our top priority. Our Montelukast Sodium Tablets are backed by rigorous research, stringent quality control, and a team of dedicated professionals who strive to provide you with optimal relief. Trust us to empower your journey toward a healthier life. Join countless individuals who have benefited from Taj Pharmaceuticals’ Montelukast Sodium Tablets. We are more than a pharmaceutical company; we are your partners in wellness. Choose Taj Pharmaceuticals for a brighter, healthier future.

What is Montelukast Sodium Tablets and its uses?

Montelukast Sodium Tablets are a medication renowned for their effectiveness in treating a range of respiratory and allergic conditions. The active ingredient, Montelukast, acts by blocking leukotrienes, which are chemicals in the body responsible for triggering allergic reactions and airway inflammation. These tablets find widespread application in several key healthcare domains. One prominent use of Montelukast Sodium Tablets is in the management of asthma. These tablets are pivotal in controlling and preventing asthma symptoms like wheezing, shortness of breath, and coughing. Often employed as a long-term maintenance treatment, Montelukast helps individuals with asthma lead more comfortable lives.

Additionally, Montelukast is a valuable tool in combating allergic rhinitis. It effectively alleviates symptoms like sneezing, nasal congestion, itching, and watery eyes that commonly accompany allergic reactions, especially during seasonal changes. For those affected by exercise-induced bronchoconstriction, Montelukast offers respite. By preventing bronchoconstriction triggered by physical activity, it empowers individuals to engage in exercise without the fear of asthma symptoms.

Montelukast Sodium Tablets also extend their benefits to chronic idiopathic urticaria sufferers. This condition, characterized by recurrent hives and itching with an unknown cause, can be managed effectively with Montelukast. Lastly, Montelukast might be prescribed for allergic conjunctivitis, providing relief from redness, itching, and watering of the eyes due to allergies. It’s imperative to remember that the prescription and usage of Montelukast Sodium Tablets should always be guided by a healthcare professional. Dosage and duration can vary depending on the specific condition and individual characteristics, and patients should consult their healthcare provider for personalized advice and any questions related to Montelukast or other medications.

How do Montelukast Sodium Tablets work?

Montelukast Sodium Tablets operate by targeting and blocking leukotrienes, a group of chemicals in the body responsible for instigating inflammatory and allergic responses, particularly in the respiratory system. The active ingredient, Montelukast, acts as a leukotriene receptor antagonist, binding to leukotriene receptors found on the surface of cells in the airways and other tissues. By doing so, it impedes leukotrienes from attaching to these receptors, effectively reducing airway inflammation, mucus production, and swelling.

Moreover, Montelukast aids in mitigating smooth muscle contraction within the airways, a common issue in conditions like asthma and allergic rhinitis. Leukotrienes can induce the tightening of smooth muscles, making breathing challenging. Montelukast’s action relaxes these muscles, widening the airways and facilitating easier breathing. Furthermore, Montelukast plays a pivotal role in preventing allergic responses by interfering with the body’s immune and inflammatory reactions to allergens, such as pollen or dust mites. It disrupts the inflammatory processes initiated by leukotrienes upon allergen exposure.

Montelukast Sodium Tablets are a crucial component in managing respiratory conditions like asthma and allergic rhinitis due to their capacity to quell inflammation, alleviate bronchoconstriction, and relieve symptoms associated with these conditions. However, it’s essential to recognize that Montelukast is not intended for use during acute asthma attacks but rather as a maintenance therapy under the guidance of a healthcare provider to prevent symptoms.

Benefits of Montelukast Sodium Tablets:

  • Effective Symptom Control: Montelukast Sodium Tablets are highly effective in controlling and preventing symptoms of respiratory conditions such as asthma and allergic rhinitis. They can help reduce wheezing, shortness of breath, coughing, nasal congestion, sneezing, and itching.
  • Long-Term Management: Montelukast is often used as a long-term maintenance treatment, providing continuous relief for individuals with chronic respiratory conditions. It helps in managing these conditions over an extended period, reducing the frequency and severity of symptoms.
  • Improved Quality of Life: By preventing and alleviating symptoms associated with asthma and allergies, Montelukast can significantly improve the quality of life for affected individuals. It allows them to engage in daily activities and enjoy a better overall well-being.
  • Prevention of Exercise-Induced Bronchoconstriction: For those who experience asthma symptoms triggered by exercise, Montelukast can be a valuable tool. It helps prevent exercise-induced bronchoconstriction, enabling individuals to engage in physical activities without discomfort.

Side Effects of Montelukast Sodium Tablets:

  • Common Side Effects: While Montelukast is generally well-tolerated, some individuals may experience common side effects such as headache, stomach upset, nausea, diarrhea, or dizziness. These side effects are usually mild and temporary.
  • Behavioral Changes: In some cases, Montelukast has been associated with behavioral changes, particularly in children. These changes may include mood swings, anxiety, depression, and even thoughts of self-harm or suicide. It’s essential for caregivers and healthcare providers to monitor for such changes, especially in pediatric patients.
  • Allergic Reactions: Although rare, allergic reactions to Montelukast can occur. Signs of an allergic reaction may include rash, itching, swelling, severe dizziness, or difficulty breathing. Immediate medical attention is necessary if these symptoms occur.
  • Neuropsychiatric Events: Montelukast has been linked to neuropsychiatric events in some individuals, including nightmares, hallucinations, and insomnia. If these symptoms arise, it’s crucial to consult a healthcare professional.
  • Liver Function Changes: In rare cases, Montelukast has been associated with changes in liver function. If you experience symptoms like dark urine, yellowing of the skin or eyes, or persistent fatigue, contact your healthcare provider.

It’s important to note that while these side effects are possible, many individuals experience no adverse effects from Montelukast Sodium Tablets. Always use this medication under the guidance of a healthcare provider who can assess its appropriateness for your specific condition and monitor for any potential side effects. If you experience unusual or severe side effects, seek medical attention promptly.

Frequently Asked Questions About Montelukast Sodium Tablets:

Certainly, here are some frequently asked questions (FAQs) about Montelukast Sodium Tablets:

  1. What are Montelukast Sodium Tablets used for?

Montelukast Sodium Tablets are primarily used to treat respiratory conditions such as asthma and allergic rhinitis. They can also be prescribed for exercise induced bronchoconstriction and chronic idiopathic urticaria.

  1. How do Montelukast Sodium Tablets work?

Montelukast works by blocking leukotriene receptors, reducing airway inflammation, relaxing smooth muscles in the airways, and preventing allergic responses triggered by leukotrienes.

  1. Are Montelukast Sodium Tablets suitable for children?

Montelukast can be prescribed for children as young as 6 months old, depending on the specific condition and the child’s age. It’s essential to follow the healthcare provider’s guidance for pediatric use.

  1. What is the typical dosage for Montelukast Sodium Tablets?

The dosage varies depending on the age and condition being treated. It’s crucial to follow the prescribed dosage instructions provided by your healthcare provider.

  1. Are there any common side effects of Montelukast Sodium Tablets?

Common side effects may include headache, stomach upset, nausea, diarrhea, or dizziness. These side effects are usually mild and temporary.

  1. Can Montelukast Sodium Tablets be used during an asthma attack?

Montelukast is not a rescue medication for acute asthma attacks. It is typically used as a long-term maintenance therapy to prevent symptoms. Short acting bronchodilators (e.g., albuterol) are used for quick relief during an asthma attack.

  1. Can Montelukast Sodium Tablets be taken with other medications?

Montelukast can often be used in conjunction with other asthma or allergy medications, but it’s important to inform your healthcare provider about all the medications you are taking to ensure there are no potential interactions.

  1. How long does it take for Montelukast Sodium Tablets to start working?

The onset of action can vary from person to person. Some individuals may experience symptom relief within a few days, while for others, it may take several weeks of consistent use to see the full benefits.

  1. Are there any potential serious side effects of Montelukast Sodium Tablets?

While rare, serious side effects can include neuropsychiatric events, allergic reactions, and changes in liver function. If you experience unusual or severe symptoms, contact your healthcare provider immediately.

  1. Can Montelukast Sodium Tablets be used during pregnancy or breastfeeding?

It’s essential to consult with a healthcare provider before using Montelukast if you are pregnant, planning to become pregnant, or breastfeeding, as the risks and benefits need to be carefully assessed.

Always consult your healthcare provider for personalized information and guidance regarding the use of Montelukast Sodium Tablets based on your specific health condition and needs.

As Montelukast Sodium Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Montelukast Sodium 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 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 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 Tablets USP 5mg
B. Montelukast Sodium Tablets USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Montelukast Sodium Tablets USP 5mg
Each Film-coated tablet contains:
Montelukast Sodium USP 5.2mg
Equivalent to Montelukast……….4mg
Excipients………………………………..q.s
Colour: Sunset yellow FCF


B. Montelukast Sodium Chewable Tablets USP 10mg
Each Film-coated tablet contains:
Montelukast Sodium USP 10.4mg
Equivalent to Montelukast……….5mg
Excipients………………………………..q.s
Colour: Sunset yellow

THERAPEUTIC INDICATIONS:

Montelukast helps stop your airways from narrowing (caused by inflammation). This makes breathing easier and prevents asthma attacks. Most people take montelukast once a day in the evening. If you take it for asthma, it's important to take it even when you have no symptoms.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.