What Are the Most Common Montelukast Side Effects?

Montelukast sodium is a class A medication for medical insurance. Adverse reactions The drug is generally well tolerated with mild side effects and usually does not require discontinuation of treatment. The overall incidence of side effects with this drug is similar to placebo. Clinical studies have evaluated the use of this drug in 2,600 adult patients aged 15 years and older. In two similarly designed, placebo-controlled 12-week clinical trials, 1% of patients in the treatment group experienced abdominal pain and headache associated with the medication. Its incidence is higher than in patients receiving placebo. However, the incidence of the above-mentioned side effects was not significantly different between the two groups of patients. 544 patients have used the drug cumulatively in clinical trials for at least 6 months, 253 patients have used the drug for one year, and 21 patients have used it for 2 years. The above is no different.

Montelukast sodium

Chinese: montelukast sodium

English: Montelukast Sodium

Molecular formula: C ₃₅ H ₃₅ CINNaO ₃ S

Molecular weight: 608.17

CAS #: 151767-02-1

Dosage Adults aged 15 and over: 1 tablet (10mg) daily before bedtime. Pediatric patients 6-14 years old: Take 1 chewable tablet (5mg) daily before bedtime. Patients in this group do not need to adjust their dose by age. The safe and effective dose and usage of children under 6 years have not been determined. This medicine works within 1 day of treating asthma. This medicine can be taken with or without food. Patients should take this medicine for a long time, whether it is in the asthma control stage or the exacerbation stage. For elderly patients, patients with renal dysfunction or patients with mild to moderate liver damage do not need to adjust the dose, and the patient's gender is not related to the dose.

Pharmacological effects of montelukast sodium is an orally effective alternative

Suitable for adults and

[Contraindication] Those who are allergic to any component of this product are prohibited. [Caution] The efficacy of oral administration of this drug in treating acute asthma attacks has not been determined. Therefore, oral administration of this drug should not be used to treat acute asthma attacks. Patients should be advised to prepare necessary emergency medicines for backup. Although combined inhalation

This product is generally well tolerated, with minor adverse reactions, and usually does not require termination of treatment. The overall incidence of adverse effects of this product is similar to placebo.

15 years old and older

Clinical studies have been performed on approximately 2600 adult asthma patients aged 15 years and older to evaluate the safety of this product. In two similarly designed, placebo-controlled, 12-week clinical trials, drug-related incidences in the treatment group of this product were 1% and higher than those in the placebo group were abdominal pain and headache. However, the incidence of these adverse events was not significantly different between the two groups.

In clinical studies, 544 patients have been treated with this product for at least 6 months, 253 patients have been treated for 1 year, and 21 patients have been treated for 2 years. With the extension of the treatment time with this product, the occurrence of adverse events has not changed.

Patients aged 15 years and older with seasonal allergic rhinitis

Clinical studies have been performed on approximately 2199 adults with seasonal allergic rhinitis aged 15 years and over to evaluate the safety of this product. Taking this product every morning or night is well tolerated, and the incidence of adverse reactions is similar to taking placebo. In placebo-controlled clinical studies, the drug-related incidence in this product-treated group was 1%, which was higher than the adverse events in the placebo group. In the 4-week placebo-controlled clinical trial, the safety profile was consistent with the 2-week clinical trial. The incidence of drowsiness was similar in all clinical studies to the placebo group.

15 years and older patients with perennial allergic rhinitis

Two 6-week placebo-controlled clinical studies have been performed on 3235 patients with perennial allergic rhinitis aged 15 years and over to evaluate the safety of this product. Taking this product once a day is well tolerated, the incidence of adverse reactions is similar to that of the placebo group, and is consistent with the clinical research results of seasonal allergic rhinitis. In both clinical studies, the incidence of adverse reactions in the treatment group was less than 1%, and no drug-related adverse events were found, and the incidence was higher than in the placebo group. The incidence of drowsiness was similar to that in the placebo group.

The following adverse reactions have been reported after using this product:

Infections and infections: upper respiratory infections

Blood pressure and lymphatic disorders: increased tendency to bleed.

Immune system disorders: including hypersensitivity reactions to allergic reactions, rare liver eosinophil infiltration.

Mental system disorders: Including aggressive behavior or hostile excitement, anxiety, depression, abnormal nightmares, hallucinations, insomnia, irritability, restlessness, sleepwalking, suicidal thoughts and behaviors (suicide), tremor.

Neurological disorders: dizziness, drowsiness, paresthesia / hypertensiveness, and rare seizures.

Heart disorders: palpitations.

Respiratory, chest and mediastinal disorders: epistaxis.

Gastrointestinal disorders: diarrhea, indigestion, nausea, vomiting.

Hepatobiliary disorders: elevated ALT and AST, very rare hepatitis (including cholestasis, hepatocytes, and mixed liver damage).

Disorders of skin and subcutaneous tissue: angioedema, contusion, nodular erythema, itching, rash, urticaria.

Musculoskeletal and connective tissue disorders: joint pain, myalgia including muscle spasms.

Other disorders and site conditions: edema, fever