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Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 26.04.2022
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Seasonal Allergic Rhinitis
Levocetirizine dihydrochloride (L-MONTUS) is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.
Perennial Allergic Rhinitis
Levocetirizine dihydrochloride (L-MONTUS) is indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older.
Chronic Idiopathic Urticaria
Levocetirizine dihydrochloride (L-MONTUS) is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.Asthma
Montelukast sodium (L-MONTUS) sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
Exercise-Induced Bronchoconstriction
Montelukast sodium (L-MONTUS) sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s Montelukast sodium (L-MONTUS) tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Allergic Rhinitis
Montelukast sodium (L-MONTUS) sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older.
Levocetirizine dihydrochloride (L-MONTUS) is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Levocetirizine dihydrochloride (L-MONTUS) is used to treat symptoms of year-round (perennial) allergies in adults and children who are at least 6 months old. It is also used to treat symptoms of seasonal allergies in adults and children who are at least 2 years old.
Levocetirizine dihydrochloride (L-MONTUS) is also used to treat itching and swelling caused by chronic urticaria (hives) in adults and children who are at least 6 months old.
Levocetirizine dihydrochloride (L-MONTUS) may also be used for purposes not listed in this medication guide.
Montelukast sodium (L-MONTUS) is a leukotriene (loo-koe-TRY-een) inhibitor. Leukotrienes are chemicals your body releases when you breathe in an allergen (such as pollen). These chemicals cause swelling in your lungs and tightening of the muscles around your airways, which can result in asthma symptoms.
Montelukast sodium (L-MONTUS) is used to prevent asthma attacks in adults and children as young as 12 months old. Montelukast sodium (L-MONTUS) is also used to prevent exercise-induced bronchospasm in adults and children who are at least 6 years old.
Montelukast sodium (L-MONTUS) is also used to treat symptoms of year-round (perennial) allergies in adults and children who are at least 6 months old. It is also used to treat symptoms of seasonal allergies in adults and children who are at least 2 years old.
Do not give this medicine to a child without a doctor's advice.
Montelukast sodium (L-MONTUS) is also used to prevent exercise-induced bronchoconstriction (narrowing of the air passages in the lungs) in adults and teenagers who are at least 15 years old and are not already taking this medicine for other conditions.
If you already take Montelukast sodium (L-MONTUS) to prevent asthma or allergy symptoms, do not use an extra dose to treat exercise-induced bronchoconstriction.
Montelukast sodium (L-MONTUS) may also be used for purposes not listed in this medication guide.
Levocetirizine dihydrochloride (L-MONTUS) is available as 2.5 mg/5 mL (0.5 mg/mL) oral solution and as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride (L-MONTUS) can be taken without regard to food consumption.
Adults And Children 12 Years Of Age and Older
The recommended dose of Levocetirizine dihydrochloride (L-MONTUS) is 5 mg (1 tablet or 2 teaspoons [10 mL] oral solution) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (½ tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening.
Children 6 To 11 Years Of Age
The recommended dose of Levocetirizine dihydrochloride (L-MONTUS) is 2.5 mg (½ tablet or 1 teaspoon [5 mL] oral solution) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of adults.
Children 6 Months To 5 Years Of Age
The recommended initial dose of Levocetirizine dihydrochloride (L-MONTUS) is 1.25 mg (½ teaspoon oral solution) [2.5mL] once daily in the evening. The 1.25 mg once daily dose should not be exceeded based on comparable exposure to adults receiving 5 mg.
Dose Adjustment For Renal And Hepatic Impairment
In adults and children 12 years of age and older with:
- Mild renal impairment (creatinine clearance [CLCR] = 50-80 mL/min): a dose of 2.5 mg once daily is recommended;
- Moderate renal impairment (CLCR = 30-50 mL/min): a dose of 2.5 mg once every other day is recommended;
- Severe renal impairment (CLCR = 10-30 mL/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended;
- End-stage renal disease patients (CLCR < 10 mL/min) and patients undergoing hemodialysis should not receive Levocetirizine dihydrochloride (L-MONTUS).
No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.
How supplied
Dosage Forms And Strengths
Levocetirizine dihydrochloride (L-MONTUS) oral solution is a clear, colorless liquid containing 0.5 mg of Levocetirizine dihydrochloride (L-MONTUS) per mL.
Levocetirizine dihydrochloride (L-MONTUS) tablets are white, film-coated, oval-shaped, scored, imprinted (with the letter Y in red color on both halves of the scored tablet) and contain 5 mg Levocetirizine dihydrochloride (L-MONTUS).
Storage And Handling
Levocetirizine dihydrochloride (L-MONTUS) tablets are white, film-coated, oval-shaped, scored, imprinted (with the letter Y in red color on both halves of the scored tablet) and contain 5 mg Levocetirizine dihydrochloride (L-MONTUS). They are supplied in unit of use HDPE bottles.
90 Tablets (NDC 50474-920-90)
Levocetirizine dihydrochloride (L-MONTUS) oral solution is a clear, colorless liquid containing 0.5 mg of Levocetirizine dihydrochloride (L-MONTUS) per mL.
Oral Solution in 5 oz polypropylene bottles (
NDCStorage
Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F).
Manufactured for: UCB, Inc., Smyrna, GA 30080. Revised: June 2016
Asthma
Montelukast sodium (L-MONTUS) sodium 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.
For pediatric patients 6 to 14 years of age: one 5 mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4 mg chewable tablet.
Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of Montelukast sodium (L-MONTUS) are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when Montelukast sodium (L-MONTUS) was administered in the evening without regard to time of food ingestion.
Exercise-Induced Bronchoconstriction (EIB)
For prevention of EIB, a single 10 mg dose of Montelukast sodium (L-MONTUS) sodium should be taken at least 2 hours before exercise. An additional dose of Montelukast sodium (L-MONTUS) should not be taken within 24 hours of a previous dose. Patients already taking Montelukast sodium (L-MONTUS) sodium daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist. Safety and effectiveness in patients younger than 15 years of age have not been established. Daily administration of Montelukast sodium (L-MONTUS) sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.
Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s Montelukast sodium (L-MONTUS) tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Allergic Rhinitis
For allergic rhinitis, Montelukast sodium (L-MONTUS) sodium should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when Montelukast sodium (L-MONTUS) 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.
For pediatric patients 6 to 14 years of age: one 5 mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4 mg chewable 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.
For pediatric patients 6 to 14 years of age: one 5 mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4 mg chewable tablet.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
Asthma and Allergic Rhinitis
Patients with both asthma and allergic rhinitis should take only one Montelukast sodium (L-MONTUS) sodium dose daily in the evening.
See also:
What is the most important information I should know about Levocetirizine dihydrochloride (L-MONTUS)?
The use of Levocetirizine dihydrochloride (L-MONTUS) tablets is contraindicated in:
Patients With Known Hypersensitivity
Patients with known hypersensitivity to Levocetirizine dihydrochloride (L-MONTUS) or any of the ingredients of Levocetirizine dihydrochloride (L-MONTUS) tablets, or to cetirizine. Observed reactions range from urticaria to anaphylaxis.
Patients With End-Stage Renal Disease
Patients with end-stage renal disease (CLCR < 10 mL/min) and patients undergoing hemodialysis.
Pediatric Patients With Impaired Renal Function
Children 6 months to 11 years of age with impaired renal function.
See also:
What is the most important information I should know about Montelukast sodium (L-MONTUS)?
Montelukast sodium (L-MONTUS) is contra-indicated in patients hypersensitive to the drug or any ingredient in the formulation.
Use Levocetirizine dihydrochloride (L-MONTUS) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Levocetirizine dihydrochloride (L-MONTUS) by mouth with or without food. Take it in the evening unless your doctor tells you otherwise.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- If you miss a dose of Levocetirizine dihydrochloride (L-MONTUS), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Levocetirizine dihydrochloride (L-MONTUS).
Use Montelukast sodium (L-MONTUS) granules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Montelukast sodium (L-MONTUS) granules. Talk to your pharmacist if you have questions about this information.
- Take Montelukast sodium (L-MONTUS) granules by mouth with or without food.
- Do not open the packet until you are ready to use it.
- Montelukast sodium (L-MONTUS) granules may be placed directly in the mouth, dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of soft food at cold or room temperature before swallowing. Soft foods that may be used include applesauce, mashed carrots, rice, or ice cream. Be sure to swallow the entire spoonful right away (within 15 minutes). Do not store mixed medicine for future use.
- Do not put the granules in liquid other than baby formula or breast milk. However, you may drink liquids after swallowing the granules or granule mixture.
- Continue to use Montelukast sodium (L-MONTUS) granules even if you feel well. Do not miss any doses.
- If you miss a dose of Montelukast sodium (L-MONTUS) granules, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Montelukast sodium (L-MONTUS) granules.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Levocetirizine dihydrochloride (L-MONTUS) is used to treat symptoms of allergic conditions such as allergic fever (hay fever), year-round allergies like dust or pet allergies and chronic nettle rash.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Allergic rhinitis (perennial or seasonal): Relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis
Asthma: Prophylaxis and chronic treatment of asthma
Bronchoconstriction, exercise-induced (prevention): Prevention of exercise-induced bronchoconstriction.
Note: American Academy of Otolaryngology, Head and Neck Surgery (AAO-HNS) and American Academy of Allergy, Asthma, and Immunology (AAAAI) and American College of Allergy, Asthma, and Immunology (ACAAI) guidelines recommend against Montelukast sodium (L-MONTUS) use as first-line therapy for allergic rhinitis (except in patients with concurrent asthma) (Dykewicz 2017; Seidman 2015). The Global Initiative for Asthma recommends Montelukast sodium (L-MONTUS) in patients with concomitant allergic rhinitis or those who cannot take inhaled corticosteroids (GINA 2019).
Off Label Uses
Chronic urticaria
Data from controlled, double-blind trials regarding the use of Montelukast sodium (L-MONTUS) in combination with antihistamines for the management of chronic urticaria are conflicting. Based on clinical practice guidelines from the American Academy of Allergy, Asthma and Immunology (AAAAI); the American College of Allergy, Asthma, and Immunology (ACAAI); the Joint Council of Allergy, Asthma and Immunology (JCAAI); and the World Allergy Organization for the diagnosis and management of acute and chronic urticaria, a leukotriene receptor antagonist may be added to antihistamine therapy in patients who do not respond to antihistamines. Access Full-Off Label Monograph
Urticaria (nonsteroidal anti-inflammatory drug-induced)
Data from a double-blind, placebo-controlled comparison of Montelukast sodium (L-MONTUS) and cetirizine in patients with chronic urticaria and intolerance to food additives and/or aspirin supports the use of Montelukast sodium (L-MONTUS) in the treatment of patients experiencing urticaria related to the use of nonsteroidal anti-inflammatory drugs.
See also:
What other drugs will affect Levocetirizine dihydrochloride (L-MONTUS)?
No interaction studies have been performed with Levocetirizine dihydrochloride (L-MONTUS) (including no studies with CYP3A4 inducers); studies with the racemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions (with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam).
Theophylline: A small decrease in the clearance of cetirizine (16%) was observed in a multiple dose study with theophylline (400 mg once a day); while the disposition of theophylline was not altered by concomitant cetirizine administration.
Ritonavir: In a multiple dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the extent of exposure to cetirizine was increased by about 40% while the disposition of ritonavir was slightly altered (-11%) further to concomitant cetirizine administration.
Food: The extent of absorption of Levocetirizine dihydrochloride (L-MONTUS) is not reduced with food, although the rate of absorption is decreased.
Alcohol: In sensitive patients the simultaneous administration of cetirizine or Levocetirizine dihydrochloride (L-MONTUS) and alcohol or other CNS depressants may have effects on the central nervous system, although it has been shown that the racemate cetirizine does not potentiate the effect of alcohol.
See also:
What other drugs will affect Montelukast sodium (L-MONTUS)?
Phenobarbital increases the blood concentration of Montelukast sodium (L-MONTUS) by about 40%. Rifampin may have the same effect. Therefore, the dose of Montelukast sodium (L-MONTUS) may need to be reduced when given concurrently with these drugs. No dose adjustment is needed when Montelukast sodium (L-MONTUS) is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, digoxin, warfarin, thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, and Cytochrome P450 (GYP) enzyme inducers.
See also:
What are the possible side effects of Levocetirizine dihydrochloride (L-MONTUS)?
Use of Levocetirizine dihydrochloride (L-MONTUS) has been associated with somnolence, fatigue, asthenia, and urinary retention.
Clinical Trials Experience
The safety data described below reflect exposure to Levocetirizine dihydrochloride (L-MONTUS) in 2708 patients with seasonal or perennial allergic rhinitis or chronic idiopathic urticaria in 14 controlled clinical trials of 1 week to 6 months duration.
The short-term (exposure up to 6 weeks) safety data for adults and adolescents are based upon eight clinical trials in which 1896 patients (825 males and 1071 females aged 12 years and older) were treated with Levocetirizine dihydrochloride (L-MONTUS) 2.5, 5, or 10 mg once daily in the evening.
The short-term safety data from pediatric patients are based upon two clinical trials in which 243 children with seasonal or perennial allergic rhinitis (162 males and 81 females 6 to 12 years of age) were treated with Levocetirizine dihydrochloride (L-MONTUS) 5 mg once daily for 4 to 6 weeks, one clinical trial in which 114 children (65 males and 49 females 1 to 5 years of age) with allergic rhinitis or chronic idiopathic urticaria were treated with Levocetirizine dihydrochloride (L-MONTUS) 1.25 mg twice daily for 2 weeks, and one clinical trial in which 45 children (28 males and 17 females 6 to 11 months of age) with symptoms of allergic rhinitis or chronic urticaria were treated with Levocetirizine dihydrochloride (L-MONTUS) 1.25 mg once daily for 2 weeks.
The long-term (exposure of 4 or 6 months) safety data in adults and adolescents are based upon two clinical trials in which 428 patients (190 males and 238 females) with allergic rhinitis were exposed to treatment with Levocetirizine dihydrochloride (L-MONTUS) 5 mg once daily. Long term safety data are also available from an 18-month trial in 255 Levocetirizine dihydrochloride (L-MONTUS)-treated subjects 12 to 24 months of age.
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 trial of another drug and may not reflect the rates observed in practice.
Adults and Adolescents 12 Years of Age and Older
In studies up to 6 weeks in duration, the mean age of the adult and adolescent patients was 32 years, 44% of the patients were men and 56% were women, and the large majority (more than 90%) was Caucasian.
In these trials 43% and 42% of the subjects in the Levocetirizine dihydrochloride (L-MONTUS) 2.5 mg and 5 mg groups, respectively, had at least one adverse event compared to 43% in the placebo group.
In placebo-controlled trials of 1 to 6 weeks in duration, the most common adverse reactions were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis, and most were mild to moderate in intensity. Somnolence with Levocetirizine dihydrochloride (L-MONTUS) showed dose ordering between tested doses of 2.5, 5 and 10 mg and was the most common adverse reaction leading to discontinuation (0.5%).
Table 1 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 12 years and older exposed to Levocetirizine dihydrochloride (L-MONTUS) 2.5 mg or 5 mg in eight placebo-controlled clinical trials and that were more common with Levocetirizine dihydrochloride (L-MONTUS) than placebo.
Additional adverse reactions of medical significance observed at a higher incidence than in placebo in adults and adolescents aged 12 years and older exposed to Levocetirizine dihydrochloride (L-MONTUS) are syncope (0.2%) and weight increased (0.5%).
Pediatric Patients 6 to 12 Years of Age
A total of 243 pediatric patients 6 to 12 years of age received Levocetirizine dihydrochloride (L-MONTUS) 5 mg once daily in two short-term placebo controlled double-blind trials. The mean age of the patients was 9.8 years, 79 (32%) were 6 to 8 years of age, and 50% were Caucasian. Table 2 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 6 to 12 years exposed to Levocetirizine dihydrochloride (L-MONTUS) 5 mg in placebo-controlled clinical trials and that were more common with Levocetirizine dihydrochloride (L-MONTUS) than placebo.
Pediatric Patients 1 to 5 Years of Age
A total of 114 pediatric patients 1 to 5 years of age received Levocetirizine dihydrochloride (L-MONTUS) 1.25 mg twice daily in a two week placebo-controlled double-blind safety trial. The mean age of the patients was 3.8 years, 32% were 1 to 2 years of age, 71% were Caucasian and 18% were Black. Table 3 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 1 to 5 years exposed to Levocetirizine dihydrochloride (L-MONTUS) 1.25 mg twice daily in the placebo-controlled safety trial and that were more common with Levocetirizine dihydrochloride (L-MONTUS) than placebo.
Pediatric Patients 6 to 11 Months of Age
A total of 45 pediatric patients 6 to 11 months of age received Levocetirizine dihydrochloride (L-MONTUS) 1.25 mg once daily in a two week placebo-controlled double-blind safety trial. The mean age of the patients was 9 months, 51% were Caucasian and 31% were Black. Adverse reactions that were reported in more than 1 subject (i.e. greater than or equal to 3% of subjects) aged 6 to 11 months exposed to levoceterizine dihydrochloride 1.25 mg once daily in the placebo-controlled safety trial and that were more common with levoceterizine dihydrochloride than placebo included diarrhea and constipation which were reported in 6 (13%) and 1 (4%) and 3 (7%) and 1 (4%) children in the Levocetirizine dihydrochloride (L-MONTUS) and placebo-treated groups, respectively.
Long-Term Clinical Trials Experience
In two controlled clinical trials, 428 patients (190 males and 238 females) aged 12 years and older were treated with Levocetirizine dihydrochloride (L-MONTUS) 5 mg once daily for 4 or 6 months. The patient characteristics and the safety profile were similar to that seen in the short-term studies. Ten (2.3%) patients treated with Levocetirizine dihydrochloride (L-MONTUS) discontinued because of somnolence, fatigue or asthenia compared to 2 (< 1%) in the placebo group.
There are no long term clinical trials in children below 12 years of age with allergic rhinitis or chronic idiopathic urticaria.
Laboratory Test Abnormalities
Elevations of blood bilirubin and transaminases were reported in < 1% of patients in the clinical trials. The elevations were transient and did not lead to discontinuation in any patient.
Postmarketing Experience
In addition to the adverse reactions reported during clinical trials and listed above, adverse events have also been identified during post-approval use of Levocetirizine dihydrochloride (L-MONTUS). Because these events 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. Adverse events of hypersensitivity and anaphylaxis, increased appetite, angioedema, fixed drug eruption, pruritus, rash and urticaria, convulsion, paraesthesia, dizziness, tremor, dysgeusia, vertigo, movement disorders (including dystonia and oculogyric crisis), aggression and agitation, hallucinations, depression, insomnia, suicidal ideation, visual disturbances, blurred vision, palpitations, tachycardia, dyspnea, nausea, vomiting, hepatitis, dysuria, urinary retention, myalgia, and edema have been reported.
Besides these events reported under treatment with Levocetirizine dihydrochloride (L-MONTUS), other potentially severe adverse events have been reported from the postmarketing experience with cetirizine. Since Levocetirizine dihydrochloride (L-MONTUS) is the principal pharmacologically active component of cetirizine, one should take into account the fact that the following adverse events could also potentially occur under treatment with Levocetirizine dihydrochloride (L-MONTUS): orofacial dyskinesia, severe hypotension, cholestasis, glomerulonephritis, still birth, tic, myoclonus, and extrapyramidal symptoms.
See also:
What are the possible side effects of Montelukast sodium (L-MONTUS)?
Clinical Trials Experience
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: Montelukast sodium (L-MONTUS) sodium has been evaluated for safety in approximately 2950 adult and adolescent patients 15 years of age and older in clinical trials. In placebo-controlled clinical trials, the following adverse experiences reported with Montelukast sodium (L-MONTUS) sodium occurred in greater than or equal to 1% of patients and at an incidence greater than that in patients treated with placebo:
The frequency of less common adverse events was comparable between Montelukast sodium (L-MONTUS) sodium and placebo.
The safety profile of Montelukast sodium (L-MONTUS) 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 (L-MONTUS) sodium.
Cumulatively, 569 patients were treated with Montelukast sodium (L-MONTUS) 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.
Pediatric Patients 6 to 14 Years of Age with Asthma: Montelukast sodium (L-MONTUS) sodium has been evaluated for safety in 476 pediatric patients 6 to 14 years of age. Cumulatively, 289 pediatric patients were treated with Montelukast sodium (L-MONTUS) sodium for at least 6 months, and 241 for one year or longer in clinical trials. The safety profile of Montelukast sodium (L-MONTUS) sodium in the 8-week, double-blind, pediatric efficacy trial was generally similar to the adult safety profile. In pediatric patients 6 to 14 years of age receiving Montelukast sodium (L-MONTUS) sodium, the following events occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: pharyngitis, influenza, fever, sinusitis, nausea, diarrhea, dyspepsia, otitis, viral infection, and laryngitis. The frequency of less common adverse events was comparable between Montelukast sodium (L-MONTUS) sodium and placebo. With prolonged treatment, the adverse experience profile did not significantly change.
Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s Montelukast sodium (L-MONTUS) tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
In studies evaluating growth rate, the safety profile in these pediatric patients was consistent with the safety profile previously described for Montelukast sodium (L-MONTUS) sodium. In a 56-week, double-blind study evaluating growth rate in pediatric patients 6 to 8 years of age receiving Montelukast sodium (L-MONTUS) sodium, the following events not previously observed with the use of Montelukast sodium (L-MONTUS) sodium in this age group occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: headache, rhinitis (infective), varicella, gastroenteritis, atopic dermatitis, acute bronchitis, tooth infection, skin infection, and myopia.
Pediatric Patients 2 to 5 Years of Age with Asthma: Montelukast sodium (L-MONTUS) sodium has been evaluated for safety in 573 pediatric patients 2 to 5 years of age in single- and multiple-dose studies. Cumulatively, 426 pediatric patients 2 to 5 years of age were treated with Montelukast sodium (L-MONTUS) sodium for at least 3 months, 230 for 6 months or longer, and 63 patients for one year or longer in clinical trials. In pediatric patients 2 to 5 years of age receiving Montelukast sodium (L-MONTUS) sodium, the following events occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: fever, cough, abdominal pain, diarrhea, headache, rhinorrhea, sinusitis, otitis, influenza, rash, ear pain, gastroenteritis, eczema, urticaria, varicella, pneumonia, dermatitis, and conjunctivitis.
Adults and Adolescents 15 Years of Age and Older with Seasonal Allergic Rhinitis: Montelukast sodium (L-MONTUS) sodium has been evaluated for safety in 2199 adult and adolescent patients 15 years of age and older in clinical trials. Montelukast sodium (L-MONTUS) sodium administered once daily in the morning or in the evening had a safety profile similar to that of placebo. In placebo-controlled clinical trials, the following event was reported with Montelukast sodium (L-MONTUS) sodium with a frequency ≥1% and at an incidence greater than placebo: upper respiratory infection, 1.9% of patients receiving Montelukast sodium (L-MONTUS) sodium vs. 1.5% of patients receiving placebo. In a 4-week, placebo-controlled clinical study, the safety profile was consistent with that observed in 2-week studies. The incidence of somnolence was similar to that of placebo in all studies.
Pediatric Patients 2 to 14 Years of Age with Seasonal Allergic Rhinitis: Montelukast sodium (L-MONTUS) sodium has been evaluated in 280 pediatric patients 2 to 14 years of age in a 2-week, multicenter, double-blind, placebo-controlled, parallel-group safety study. Montelukast sodium (L-MONTUS) sodium administered once daily in the evening had a safety profile similar to that of placebo. In this study, the following events occurred with a frequency ≥2% and at an incidence greater than placebo: headache, otitis media, pharyngitis, and upper respiratory infection.
Adults and Adolescents 15 Years of Age and Older with Perennial Allergic Rhinitis: Montelukast sodium (L-MONTUS) sodium has been evaluated for safety in 3357 adult and adolescent patients 15 years of age and older with perennial allergic rhinitis of whom 1632 received Montelukast sodium (L-MONTUS) sodium in two, 6-week, clinical studies. Montelukast sodium (L-MONTUS) sodium administered once daily had a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo. In these two studies, the following events were reported with Montelukast sodium (L-MONTUS) sodium with a frequency ≥1% and at an incidence greater than placebo: sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, and increased ALT. The incidence of somnolence was similar to that of placebo.
Pediatric Patients 2 Years to 14 Years of Age with Perennial Allergic Rhinitis: The safety in patients 2 to 14 years of age with perennial allergic rhinitis is supported by the safety in patients 2 to 14 years of age with seasonal allergic rhinitis.
Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of Montelukast sodium (L-MONTUS) 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.
Blood and lymphatic system disorders: increased bleeding tendency, thrombocytopenia.
Immune system disorders: hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration.
Psychiatric disorders: agitation including aggressive behavior or hostility, anxiousness, depression, disorientation, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), tremor.
Nervous system disorders: drowsiness, paraesthesia/hypoesthesia, seizures.
Cardiac disorders: palpitations.
Respiratory, thoracic and mediastinal disorders: epistaxis.
Gastrointestinal disorders: diarrhea, dyspepsia, nausea, pancreatitis, vomiting.
Hepatobiliary disorders: Cases of cholestatic hepatitis, hepatocellular liver-injury, and mixed-pattern liver injury have been reported in patients treated with Montelukast sodium (L-MONTUS) sodium. Most of these occurred in combination with other confounding factors, such as use of other medications, or when Montelukast sodium (L-MONTUS) sodium was administered to patients who had underlying potential for liver disease such as alcohol use or other forms of hepatitis.
Skin and subcutaneous tissue disorders: angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, Stevens-Johnson syndrome/toxic epidermal necrolysis, urticaria.
Musculoskeletal and connective tissue disorders: arthralgia, myalgia including muscle cramps.
General disorders and administration site conditions: edema.
Patients with asthma on therapy with Montelukast sodium (L-MONTUS) sodium may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.
Levocetirizine dihydrochloride (L-MONTUS) is a third-generation non-sedative antihistamine indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis and uncomplicated skin manifestations of chronic idiopathic urticaria. It was developed from the second-generation antihistamine cetirizine. Levocetirizine dihydrochloride (L-MONTUS) is the R-enantiomer of the cetirizine racemate. Levocetirizine dihydrochloride (L-MONTUS) is an inverse agonist that decreases activity at histamine H1 receptors. This in turn prevents the release of other allergy chemicals and increased blood supply to the area, and provides relief from the typical symptoms of hay fever. It does not prevent the actual release of histamine from mast cells. Levocetirizine dihydrochloride (L-MONTUS) was approved by the United States Food and Drug Administration on May 25, 2007 and is marketed under the brand Levocetirizine dihydrochloride (L-MONTUS)® by sanofi-aventis U.S. LLC.
Each 10-mg film-coated tablet contains 10.4 mg Montelukast sodium (L-MONTUS) sodium, which is the molar equivalent to 10.0 mg of free acid. Each 5-mg chewable tablet contains 5.2 mg Montelukast sodium (L-MONTUS) sodium, which is the molar equivalent to 5.0 mg of free acid. Each 4-mg chewable tablet and each packet of 4-mg oral granules contains 4.2 mg Montelukast sodium (L-MONTUS) sodium, which is the molar equivalent to 4.0 mg of free acid.
Montelukast sodium (L-MONTUS) is a selective and orally active leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast sodium (L-MONTUS) is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropane acetic acid, monosodium salt.
The empirical formula is C35H35ClNNaO3S, and its molecular weight is 608.18.
Montelukast sodium (L-MONTUS) sodium is a hygroscopic, optically active, white to off-white powder. Montelukast sodium (L-MONTUS) sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile.