MONTELUKAST- montelukast_tablet, film coated

The cysteinyl leukotrienes (LTC 4 4 4 1 1 4 1 Montelukast causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD 4 4 [see Clinical Studies (14)]. Absorption max max max Distribution Metabolism In vitro Elimination Special Populations Hepatic Insufficiency: Renal Insufficiency Gender: Race: Adolescents and Pediatric Patients Drug-Drug Interactions Theophylline, Prednisone, and Prednisolone: Oral Contraceptives, Terfenadine, Digoxin, and Warfarin: Thyroid Hormones, Sedative Hypnotics, Non-Steroidal Anti-Inflammatory Agents, Benzodiazepines, and Decongestants: Cytochrome P450 (CYP) Enzyme Inducers: Effect of Montelukast on Cytochrome P450 (CYP) Enzymes: in vitro in vivo in vitro Cytochrome P450 (CYP) Enzyme Inhibitors: In vitro [see Overdosage (10)].

Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: (1. Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older. Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with reserve use for patients who have an inadequate response or intolerance to alternative therapies. Montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5. 1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies.

Administration (by indications): (2. 3): (2): (2. Montelukast sodium tablets should be taken once daily in the evening. The following doses are recommended: For adults and adolescents 15 years of age and older: one 10 mg tablet. Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established. who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion. Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time. For prevention of EIB, a single dose of montelukast sodium tablets should be taken at least 2 hours before exercise. For allergic rhinitis, montelukast sodium tablets should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs. The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended: For adults and adolescents 15 years of age and older: one 10 mg tablet. Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established. The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended: For adults and adolescents 15 years of age and older: one 10 mg tablet. Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established. Patients with both asthma and allergic rhinitis should take only one montelukast sodium tablets dose daily in the evening.

Most common adverse reactions (incidence >=5% and greater than placebo listed in descending order of frequency): upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis (6. To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www. gov/medwatch. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the following description of clinical trials experience, adverse reactions are listed regardless of causality assessment. The most common adverse reactions (incidence >=5% and greater than placebo; listed in descending order of frequency) in controlled clinical trials were: upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis. Adults and Adolescents 15 Years of Age and Older with Asthma Table 1: Adverse Experiences Occurring in >=1% of Patients with an Incidence Greater than that in Patients Treated with Placebo Montelukast sodium Placebo Body As A Whole Pain, abdominal 2. 5 Trauma Digestive System Disorders 1. 1 Pain, dental 1. 0 Gastroenteritis, infectious 1. 5 Nervous System/Psychiatric Headache 18. 1 Dizziness 1. 4 Respiratory System Disorders Influenza 4. 4 Congestion, nasal 1. 3 Skin/Skin Appendages Disorder Rash 1. 2 Laboratory Adverse Experiences * ALT increased 2. 0 AST increased 1. 9 *Number of patients tested (montelukast sodium and placebo, respectively): ALT and AST, 1935, 1170; pyuria, 1924, 1159. The safety profile of montelukast sodium, when administered as a single dose for prevention of EIB in adult and adolescent patients 15 years of age and older, was consistent with the safety profile previously described for montelukast sodium. Cumulatively, 569 patients were treated with montelukast sodium for at least 6 months, 480 for one year, and 49 for two years in clinical trials. With prolonged treatment, the adverse experience profile did not significantly change. Adults and Adolescents 15 Years of Age and Older with Seasonal Allergic Rhinitis Adults and Adolescents 15 Years of Age and Older with Perennial Allergic Rhinitis The following adverse reactions have been identified during post-approval use of montelukast sodium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. [see Boxed Warning, Warnings and Precautions (5. [see Warnings and Precautions (5.

Hypersensitivity to any component of this product. Hypersensitivity to any component of this product (4).

Risk Summary [see Data]. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Data Human Data Animal Data Risk Summary [see Use in Specific Populations (8. 4)] The safety and effectiveness in pediatric patients below the age of 12 months with asthma, 6 months with perennial allergic rhinitis, and 6 years with exercise-induced bronchoconstriction have not been established. Of the total number of subjects in clinical studies of montelukast, 3. 5% were 65 years of age and over, and 0. 4% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. The pharmacokinetic profile and the oral bioavailability of a single 10 mg oral dose of montelukast are similar in elderly and younger adults. The plasma half-life of montelukast is slightly longer in the elderly. No dosage adjustment in the elderly is required. No dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency [see Clinical Pharmacology ( 12. No dosage adjustment is recommended in patients with renal insufficiency [see Clinical Pharmacology (12.

No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (CYP) enzyme inducers [see Clinical Pharmacology (12.3)].

OVERDOSAGE
No specific information is available on the treatment of overdosage with montelukast sodium. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. It is not known whether montelukast is removed by peritoneal dialysis or hemodialysis.
NONCLINICAL TOXICOLOGY
No evidence of tumorigenicity was seen in carcinogenicity studies of either 2 years in Sprague-Dawley rats or 92 weeks in mice at oral gavage doses up to 200 mg/kg/day or 100 mg/kg/day, respectively. The estimated exposure in rats was approximately 120 and 75 times the AUC for adults and children, respectively, at the maximum recommended daily oral dose. The estimated exposure in mice was approximately 45 and 25 times the AUC for adults and children, respectively, at the maximum recommended daily oral dose. Montelukast demonstrated no evidence of mutagenic or clastogenic activity in the following assays: the microbial mutagenesis assay, the V-79 mammalian cell mutagenesis assay, the alkaline elution assay in rat hepatocytes, the chromosomal aberration assay in Chinese hamster ovary cells, and in the in vivo In fertility studies in female rats, montelukast produced reductions in fertility and fecundity indices at an oral dose of 200 mg/kg (estimated exposure was approximately 70 times the AUC for adults at the maximum recommended daily oral dose). No effects on female fertility or fecundity were observed at an oral dose of 100 mg/kg (estimated exposure was approximately 20 times the AUC for adults at the maximum recommended daily oral dose). Montelukast had no effects on fertility in male rats at oral doses up to 800 mg/kg (estimated exposure was approximately 160 times the AUC for adults at the maximum recommended daily oral dose).
CLINICAL STUDIES
Adults and Adolescents 15 Years of Age and Older with Asthma Clinical trials in adults and adolescents 15 years of age and older demonstrated there is no additional clinical benefit to montelukast doses above 10 mg once daily. 1 1 1 1 1 1 Figure 2: FEV 1 (U. Trial: Montelukast sodium N=406; Placebo N=270) (ANOVA Model) The effect of montelukast sodium on other primary and secondary endpoints, represented by the Multinational study is shown in TABLE 2. Results on these endpoints were similar in the US study. Table 2: Effect of Montelukast Sodium on Primary and Secondary Endpoints in a Multinational Placebo-controlled Trial (ANOVA Model) * * * * * * p<0. 001, compared with placebo Onset of Action and Maintenance of Effects Effects in Patients on Concomitant Inhaled Corticosteroids 1 1 1 [see Warnings and Precautions (5. jpg Exercise-Induced Bronchoconstriction (Adults and Adolescents 15 years of age and older) The efficacy of montelukast sodium, 10 mg, when given as a single dose 2 hours before exercise for the prevention of EIB was investigated in three (U. and Multinational), randomized, double-blind, placebo-controlled crossover studies that included a total of 160 adult and adolescent patients 15 years of age and older with EIB. Exercise challenge testing was conducted at 2 hours, 8. 5 or 12 hours, and 24 hours following administration of a single dose of study drug (montelukast sodium 10 mg or placebo). The primary endpoint was the mean maximum percent fall in FEV 1 Table 3 : Mean Maximum Percent Fall in FEV 1 Time of exercise challenge following medication administration Mean Maximum percent fall in FEV 1 * Treatment Montelukast sodium Placebo 2 hours 13 22 -9 (-12, -5) 8. 5 hours 12 17 -5 (-9, -2) 24 hours 10 14 -4 (-7, -1) *Least squares-mean 1 1 1 1 Seasonal Allergic Rhinitis The efficacy of montelukast sodium tablets for the treatment of seasonal allergic rhinitis was investigated in 5 similarly designed, randomized, double-blind, parallel-group, placebo- and active-controlled (loratadine) trials conducted in North America. The 5 trials enrolled a total of 5029 patients, of whom 1799 were treated with montelukast sodium tablets. Patients were 15 to 82 years of age with a history of seasonal allergic rhinitis, a positive skin test to at least one relevant seasonal allergen, and active symptoms of seasonal allergic rhinitis at study entry. Table 5: Effects of Montelukast Sodium on Daytime Nasal Symptoms Score* in a Placebo- and Active-controlled Trial in Patients with Seasonal Allergic Rhinitis (ANCOVA Model) Treatment Group (N) Baseline Mean Score Mean Change from Baseline Difference Between Treatment and Placebo (95% CI) Montelukast sodium 2. 13 dagger Placebo (351) 2. Active Control double dagger 2. 46 dagger * Average of individual scores of nasal congestion, rhinorrhea, nasal itching, sneezing as assessed by patients on a 0 to 3 categorical scale. dagger double dagger Perennial Allergic Rhinitis Table 6: Effects of Montelukast Sodium on Daytime Nasal Symptoms Score* in a Placebo-controlled Trial in Patients with Perennial Allergic Rhinitis (ANCOVA Model) Treatment Group (N) Baseline Mean Change from Baseline Difference Between Treatment and Placebo (95% CI) Montelukast sodium 2. 08 dagger Placebo 2. * dagger The other 6-week study evaluated montelukast sodium 10 mg (n=626), placebo (n=609), and an active-control (cetirizine 10 mg; n=120). The primary analysis compared the mean change from baseline in daytime nasal symptoms score for montelukast sodium vs. placebo over the first 4 weeks of treatment; the study was not designed for statistical comparison between montelukast sodium and the active-control. The primary outcome variable included nasal itching in addition to nasal congestion, rhinorrhea, and sneezing. The estimated difference between montelukast sodium and placebo was -0. 04 with a 95% CI of (-0. The estimated difference between the active-control and placebo was -0. 10 with a 95% CI of (-0.
MEDICATION GUIDE
Montelukast Sodium Tablets, USP (mon" te loo'' kast soe'' dee um) What is the most important information I should know about montelukast sodium tablets? Serious mental health problems have happened in people taking montelukast sodium tablets agitation, including aggressive behavior or hostility What are montelukast sodium tablets? Montelukast sodium tablets are a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and inflammation of the lining of the nose (allergic rhinitis). Montelukast sodium tablets do not contain a steroid. Montelukast sodium tablets are used to: 1. Do not take montelukast sodium tablets if you need relief right away for a sudden asthma attack. and Do not Before taking montelukast sodium tablets, tell your healthcare provider about all your medical conditions, including if you: are allergic to aspirin Tell your healthcare provider about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements. Some medicines may affect how montelukast sodium tablets work, or montelukast sodium tablets may affect how your other medicines work. How should I take montelukast sodium tablets? For anyone when to take it. If you or your child misses a dose of montelukast sodium tablets, just take the next dose at your regular time. For adults and adolescents 15 years of age and older with asthma: Take montelukast sodium tablets 1 time each day, in the evening. Continue to take montelukast sodium tablets every day for as long as your healthcare provider prescribes it, even if you have no asthma symptoms. Always have your rescue inhaler medicine with you for asthma attacks. For people 15 years of age and older for the prevention of exercise-induced asthma: do not Do not take 2 doses of montelukast sodium tablets within 24 hours (1 day). For anyone 15 years of age and older with seasonal allergic rhinitis, or for anyone 15 years of age and older with perennial allergic rhinitis: What should I avoid while taking montelukast sodium tablets? What are the possible side effects of montelukast sodium tablets? Montelukast sodium tablets may cause serious side effects, including: "What is the most important information I should know about montelukast sodium tablets?" Increase in certain white blood cells (eosinophils) and possible inflamed blood vessels throughout the body (systemic vasculitis). Tell your healthcare provider right away if you get one or more of these symptoms: The most common side effects of montelukast sodium tablets include: These are not all the possible side effects of montelukast sodium tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store montelukast sodium tablets? Store montelukast sodium tablets at room temperature between 68° to 77°F (20° to 25° C). Keep montelukast sodium tablets and all medicines out of reach of children. General information about the safe and effective use of montelukast sodium tablets For more information, call Hetero Labs Limited at 1-866-495-1995. What are the ingredients in montelukast sodium tablets? Active ingredient: Inactive ingredients: This Medication Guide has been approved by the U. Food and Drug Administration Medication Guide available at http://camberpharma. com/medication-guides Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: HETERO TM Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar en dash 509 301, India. or By: HETERO TM Packaged and Distributed by: MAJORregistered PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor''s NDC Number Distributed By: Cardinal Health Dublin, OH 43017 L55348700225 Revised: 08/2020 camberlogo2.

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