Montelukast Sodium Tablets

Active Ingredients: Montelukast Sodium

Montelukast Sodium Tablets are a drug used to control and prevent symptoms caused by asthma or exercise-induced asthma. This medication is not used to prevent an acute asthma attack. This drug is also indicated as a second-line treatment in the management of allergic rhinitis and allergies.

Montelukast sodium is a potent leukotriene receptor antagonist. It blocks the effects of leukotrienes, a substance produced by the body in response to specific triggers or allergens. This decreases inflammation and nasal congestion, which helps to keep the airways to the lungs open.

Montelukast Sodium Tablets are available with a dose of 10mg. Tablets are packaged on blisters, and the product is available for distribution as a box of 10 tablets.

AdvaCare Pharma produces and distributes Montelukast + Levocetirizine Syrup, a fixed-dose combination medicine intended for persistent allergies.

AdvaCare Pharma is a global supplier of Montelukast Sodium Tablets. AdvaCare excels at the production of high-quality yet cost-effective medical treatments. These Tablets have been manufactured in our GMP-certified facilities located in China, India, and the USA.

AdvaCare Pharma is a trusted Montelukast manufacturer committed to providing quality-assured, cost-effective pharmaceuticals for an ever-changing global market. Manufacturing a wide range of 200+ pharmaceutical products in tablet form, we ensure that all of our oral solid dosage forms adhere to stringent GMP standards.

We operate according to a unique "vested supplier-distributor relationship" business model, in which we tie our success in a market to that of our distributor. Such a model facilitates a closer relationship by working together to achieve pre-defined goals for market entry and expansion. As a Montelukast manufacturer and global supplier, we implement unique strategies to ensure successful distribution.

What is Montelukast Sodium used for?

It is used to prevent wheezing, shortness of breath, and other symptoms caused by asthma. It is also used to prevent exercise-induced asthma (bronchospasm). Montelukast Sodium is used to relieve symptoms caused by allergies, but it is typically not used unless safer medications are unavailable or other treatments have failed.

How are Montelukast Sodium Tablets used?

This medication is intended to be taken orally. The tablets are typically taken in the evening. They may be taken with or without food.

What dose should be taken?

Recommended dosage of Montelukast may vary based on different medical conditions and age.

Renal Dosing No adjustments are recommended for patients with renal impairment or who are on HD/PD.

Hepatic Dosing For patients with mild to moderate impairment, no adjustments are recommended. Guidelines are not defined for those with severe hepatic impairment.

This drug should be used only for patients who have an intolerance or have not had adequate relief from an alternative therapy. The tablet form of this medication may not be appropriate for younger children who are unable to swallow.

The dosage is based on medical condition, response to treatment, age, and weight. Refer to a doctor or pharmacist for guidelines on dosage. Do not exceed what they advise.

What happens if a dose a missed?

The missed dose of Montelukast Sodium should be skipped. Take the next dose at the scheduled time. Never use 2 doses at the same time.

Who can use Montelukast Sodium?

Montelukast Sodium Tablets can be given to adults and children, but caution is advised for specific groups of patients.

Pregnant This drug’s benefits must be weighed against the risks when considering its use in pregnant women. Based on limited human data and animal data a100x the recommended human dose, there is no known risk of teratogenicity.

Breastfeeding This drug’s benefits must be weighed against the risks when considering its use in women who are breastfeeding. It has been reported that Montelukast Sodium is passed in milk. Based on limited human data, there is no known risk of infant harm. No data is available to assess the effects on milk production.

Children This drug is considered safe and generally well-tolerated when used to treat asthma in children. It is important to note that the conventional tablet is only suitable for adolescents and children who are able to swallow pills.

Geriatric Studies have shown specific problems that would affect elderly patients. This demographic may be more sensitive to the side effects of this drug compared with younger adults.

How should Montelukast Sodium Tablets be stored?

It is recommended to keep this medication in a location that is protected from moisture and heat.

Other warnings

This drug is associated with neuropsychiatric events, including agitation, hostility, and suicidal behaviors. If a patient suffers from such an event, it is recommended to carefully consider the risks and benefits of ongoing treatment with this drug.

If switching from an inhaled corticosteroid to this drug, it is recommended to gradually reduce the inhaled corticosteroids. Do not abruptly switch from a corticosteroid to this medication.

There have been reports of systemic eosinophilia, though these are mostly (but not always) associated with Montelukast Sodium while tapering corticosteroid therapy.

Can Montelukast Sodium Tablets be used for an acute asthma attack?

Montelukast Sodium Tablets should not be used for an acute asthma attack or immediate breathing problems. This drug is not a fast-acting rescue medicine and must be used regularly for it to be effective. It is recommended to seek medical attention in the event of an immediate breathing problem in which other rescue medications, such as albuterol inhalation, are not working.

As with all pharmaceuticals, some unwanted effects can occur from the use of Montelukast Sodium Tablets.

For a comprehensive understanding of all potential side effects, consult a medical professional.

If any symptoms persist or worsen, or you notice any other symptoms, please call your doctor immediately.

Before treatment, consult your doctor regarding any medications you are taking to address potential drug interactions.Montelukast sodium is known to interact with medications such as apalutamide, fexinidazole, idelalisib, ivosidenib, tucatinib, and voxelotor. It is also important to bring up any supplements or herbal products you are taking, as montelukast sodium is also known to interact with certain supplements or herbal products, such as St. John’s wort.

It is advised to avoid activities that may trigger an asthma attack.

Comparative clinical evaluation of ketotifen and montelukast sodium in asthmatic Iraqi patients

This study aimed to assess the efficacy of ketotifen and montelukast sodium in asthmatic patients.

A single-blinded randomized clinical trial was conducted including 100 participants asthmatic patients. Patients were randomly assigned to two groups: the first group (50 patients) received ketotifen for 4 weeks, while the second group (50 patients) received montelukast sodium for the same duration. Asthma symptom scores and wheezing were documented at the beginning (first visit) and end of the study (after one month). Pulmonary function tests (PFTs) were conducted using spirometry, and asthma drug usage and symptom severity were monitored at each visit.

The results revealed improvements in asthma symptoms, chest wheezing, and PFT values in both groups by the study's end compared to the initial visit (p < 0.05). All symptoms were significantly reduced, and PFT values were higher in the second group compared to the first group (p < 0.05).

The conclusion is that both ketotifen and montelukast sodium led to significant improvements in asthma symptoms and PFT values after one month of treatment, but the montelukast sodium group led to better results.