Desmont Uses

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Consists of Desloratadine, Montelukast

What is Desloratadine (Desmont)?

Desloratadine (Desmont) is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Desloratadine (Desmont) is used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose. It is also used to treat skin hives and itching in people with chronic skin reactions.

Desloratadine (Desmont) may also be used for purposes not listed in this medication guide.

Desloratadine (Desmont) indications

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.
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1.1 Seasonal Allergic Rhinitis

Desloratadine (Desmont) Tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older.

1.2 Perennial Allergic Rhinitis

Desloratadine (Desmont) Tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older.

1.3 Chronic Idiopathic Urticaria

Desloratadine (Desmont) Tablets are indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older.

How should I use Desloratadine (Desmont)?

Use Desloratadine (Desmont) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Desloratadine (Desmont).

Uses of Desloratadine (Desmont) in details

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.
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Use: Labeled Indications

Allergic rhinitis: Relief of nasal and non-nasal symptoms of seasonal (SAR) and perennial (PAR) allergic rhinitis

Urticaria: Symptomatic relief of pruritus, reduction in number of hives, and reduction in size of hives associated with chronic idiopathic urticaria (CIU)

Off Label Uses

NSAID-associated urticaria (prophylaxis)

Data from a retrospective study with a limited number of patients suggest that Desloratadine (Desmont) may be beneficial for prophylactic therapy in patients with NSAID-associated urticaria prior to receiving a strong COX-1 inhibitor. Additional trials may be needed to further define the role of Desloratadine (Desmont) in this setting.

Desloratadine (Desmont) description

Desloratadine (Desmont) Tab: Each tablet contains 5.0 mg of Desloratadine (Desmont).

Desloratadine (Desmont) Syr: Each mL of Desloratadine (Desmont) syrup contains 500 mcg of Desloratadine (Desmont).

Excipients/Inactive Ingredients: Desloratadine (Desmont) Tab: Dibasic calcium phosphate dihydrate, microcrystalline cellulose, maize starch, talc, blue color film-coat material, clear film coat material, white wax and carnauba wax.

Desloratadine (Desmont) dosage

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Desloratadine (Desmont) Dosage

Generic name: Desloratadine (Desmont) 5mg

Dosage form: tablet, film coated; oral solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Although an orally disintegrating tablet formulation of Desloratadine (Desmont) may be available in the marketplace, Desloratadine (Desmont)® RediTabs® Tablets are no longer marketed.

Desloratadine (Desmont) Tablets,

Oral Solution, or RediTabs Tablets may be taken without regard to meals. Place Desloratadine (Desmont) (Desloratadine (Desmont)) RediTabs Tablets on the tongue and allow to disintegrate before swallowing. Tablet disintegration occurs rapidly. Administer with or without water. Take tablet immediately after opening the blister.

The age-appropriate dose of Desloratadine (Desmont)

Oral Solution should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (½ teaspoon).

Adults and Adolescents 12 Years of Age and Over

The recommended dose of Desloratadine (Desmont) Tablets or Desloratadine (Desmont) Tablets is one 5-mg tablet once daily. The recommended dose of Desloratadine (Desmont)

Oral Solution is 2 teaspoonfuls (5 mg in 10 mL) once daily.

Children 6 to 11 Years of Age

The recommended dose of Desloratadine (Desmont)

Oral Solution is 1 teaspoonful (2.5 mg in 5 mL) once daily. The recommended dose of Desloratadine (Desmont) Tablets is one 2.5-mg tablet once daily.

Children 12 Months to 5 Years of Age

The recommended dose of Desloratadine (Desmont)

Oral Solution is ½ teaspoonful (1.25 mg in 2.5 mL) once daily.

Children 6 to 11 Months of Age

The recommended dose of Desloratadine (Desmont)

Oral Solution is 2 mL (1 mg) once daily.

Adults with Hepatic or Renal Impairment

In adult patients with liver or renal impairment, a starting dose of one 5-mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data.

More about Desloratadine (Desmont) (Desloratadine (Desmont))

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Desloratadine (Desmont) interactions

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What other drugs will affect Desloratadine (Desmont)?

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Inhibitors Of Cytochrome P450 3A4

In controlled clinical studies co-administration of Desloratadine (Desmont) with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of Desloratadine (Desmont) and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Desloratadine (Desmont).

Fluoxetine

In controlled clinical studies co-administration of Desloratadine (Desmont) with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of Desloratadine (Desmont) and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Desloratadine (Desmont).

Cimetidine

In controlled clinical studies co-administration of Desloratadine (Desmont) with cimetidine, a histamine H2-receptor antagonist, resulted in increased plasma concentrations of Desloratadine (Desmont) and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Desloratadine (Desmont).

Drug Abuse And Dependence

There is no information to indicate that abuse or dependency occurs with Desloratadine (Desmont) Tablets.

Desloratadine (Desmont) side effects

See also:
What are the possible side effects of Desloratadine (Desmont)?

The following adverse reactions are discussed in greater detail in other sections of the label:

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.

Adults and Adolescents

Allergic Rhinitis: In multiple-dose placebo-controlled trials, 2834 patients ages 12 years or older received Desloratadine (Desmont) tablets at doses of 2.5 mg to 20 mg daily, of whom 1655 patients received the recommended daily dose of 5 mg. In patients receiving 5 mg daily, the rate of adverse events was similar between Desloratadine (Desmont) and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the Desloratadine (Desmont) group and 2.6% in the placebo group. There were no serious adverse events in these trials in patients receiving Desloratadine (Desmont). All adverse events that were reported by greater than or equal to 2% of patients who received the recommended daily dose of Desloratadine (Desmont) tablets (5 mg once daily), and that were more common with Desloratadine (Desmont) tablets than placebo, are listed in Table 1.

The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in Desloratadine (Desmont) and placebo-treated patients.

There were no differences in adverse events for subgroups of patients as defined by gender, age, or race.

Chronic Idiopathic Urticaria: In multiple-dose, placebo-controlled trials of chronic idiopathic urticaria, 211 patients ages 12 years or older received Desloratadine (Desmont) tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received Desloratadine (Desmont) tablets and that were more common with Desloratadine (Desmont) than placebo were (rates for Desloratadine (Desmont) and placebo, respectively): headache (14%, 13%), nausea (5%, 2%), fatigue (5%, 1%), dizziness (4%, 3%), pharyngitis (3%, 2%), dyspepsia (3%, 1%), and myalgia (3%, 1%).

Pediatrics

Two hundred and forty-six pediatric subjects 6 months to 11 years of age received Desloratadine (Desmont)

Oral Solution for 15 days in three placebo-controlled clinical trials. Pediatric subjects aged 6 to 11 years received 2.5 mg once a day, subjects aged 1 to 5 years received 1.25 mg once a day, and subjects 6 to 11 months of age received 1.0 mg once a day.

In subjects 6 to 11 years of age, no individual adverse event was reported by 2 percent or more of the subjects.

In subjects 2 to 5 years of age, adverse events reported for Desloratadine (Desmont) and placebo in at least 2 percent of subjects receiving Desloratadine (Desmont)

Oral Solution and at a frequency greater than placebo were fever (5.5%, 5.4%), urinary tract infection (3.6%, 0%) and varicella (3.6%, 0%).

In subjects 12 months to 23 months of age, adverse events reported for the Desloratadine (Desmont) product and placebo in at least 2 percent of subjects receiving Desloratadine (Desmont)

Oral Solution and at a frequency greater than placebo were fever (16.9%, 12.9%), diarrhea (15.4%, 11.3%), upper respiratory tract infections (10.8%, 9.7%), coughing (10.8%, 6.5%), appetite increased (3.1%, 1.6%), emotional lability (3.1%, 0%), epistaxis (3.1%, 0%), parasitic infection (3.1%, 0%), pharyngitis (3.1%, 0%), rash maculopapular (3.1%, 0%).

In subjects 6 months to 11 months of age, adverse events reported for Desloratadine (Desmont) and placebo in at least 2 percent of subjects receiving Desloratadine (Desmont)

Oral Solution and at a frequency greater than placebo were upper respiratory tract infections (21.2%, 12.9%), diarrhea (19.7%, 8.1%), fever (12.1%, 1.6%), irritability (12.1%, 11.3%), coughing (10.6%, 9.7%), somnolence (9.1%, 8.1%), bronchitis (6.1%, 0%), otitis media (6.1%, 1.6%), vomiting (6.1%, 3.2%), anorexia (4.5%, 1.6%), pharyngitis (4.5%, 1.6%), insomnia (4.5%, 0%), rhinorrhea (4.5%, 3.2%), erythema (3.0%, 1.6%), and nausea (3.0%, 0%).

There were no clinically meaningful changes in any electrocardiographic parameter, including the QTc interval. Only one of the 246 pediatric subjects receiving Desloratadine (Desmont)

Oral Solution in the clinical trials discontinued treatment because of an adverse event.

Post-Marketing Experience

Because adverse 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. The following spontaneous adverse events have been reported during the marketing of Desloratadine (Desmont): tachycardia, palpitations, rare cases of hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis), psychomotor hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures, and elevated liver enzymes including bilirubin, and very rarely, hepatitis.

Desloratadine (Desmont) contraindications

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What is the most important information I should know about Desloratadine (Desmont)?

You should not take this medication if you are allergic to Desloratadine (Desmont) or to loratadine (Claritin).

Before taking Desloratadine (Desmont), tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.

Do not give this medication to a child younger than 2 years old without the advice of a doctor.

Desloratadine (Desmont) disintegrating tablets (Desloratadine (Desmont)) may contain phenylalanine. Talk to your doctor before using this form of Desloratadine (Desmont) if you have phenylketonuria (PKU).

What is Montelukast (Desmont)?

Montelukast (Desmont) 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 (Desmont) is used to prevent asthma attacks in adults and children as young as 12 months old. Montelukast (Desmont) is also used to prevent exercise-induced bronchospasm in adults and children who are at least 6 years old.

Montelukast (Desmont) 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 (Desmont) 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 (Desmont) to prevent asthma or allergy symptoms, do not use an extra dose to treat exercise-induced bronchoconstriction.

Montelukast (Desmont) may also be used for purposes not listed in this medication guide.

Montelukast (Desmont) indications

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.

It is indicated for: The prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age or older; the prevention of exercise-induced bronchoconstriction in patients 15 years of age and older; the relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older, and perennial allergic rhinitis in adult and pediatric patients 6 months of age and older).

Montelukast (Desmont) 4 mg: Montelukast (Desmont) is indicated in the treatment of asthma as add­ on therapy in those 2 to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom as-needed short-acting β-agonists provide inadequate clinical control of asthma.

Montelukast (Desmont) may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids.

Montelukast (Desmont) is also indicated in the prophylaxis of asthma from 2 years of age to 5 years in which the predominant component is exercise-induced bronchoconstriction.

Montelukast (Desmont) 5 mg: Montelukast (Desmont) is indicated in the treatment of asthma as add­ on therapy in those 6 to 14 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom as-needed short-acting β-agonists provide inadequate clinical control of asthma.

Montelukast (Desmont) may also be an alternative treatment option to low-dose inhaled corticosteroids for 6 to 14 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids.

Montelukast (Desmont) is also indicated in the prophylaxis of asthma in those 6 to 14 years old which the predominant component is exercise-induced bronchoconstriction.

Montelukast (Desmont) 10 mg: Montelukast (Desmont) sodium (Montelukast (Desmont)) is indicated in the treatment of asthma as add-on therapy in patients 15 years and older with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom "as-needed" short-acting β-agonists provide inadequate clinical control of asthma. In those asthmatic patients in whom Montelukast (Desmont) sodium (Montelukast (Desmont)) is indicated in asthma, Montelukast (Desmont) sodium (Montelukast (Desmont)) can also provide symptomatic relief of seasonal allergic rhinitis.

Montelukast (Desmont) sodium (Montelukast (Desmont)) is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction in patients 15 years and older.

How should I use Montelukast (Desmont)?

Use Montelukast (Desmont) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Montelukast (Desmont).

Uses of Montelukast (Desmont) in details

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 (Desmont) 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 (Desmont) 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 (Desmont) 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 (Desmont) and cetirizine in patients with chronic urticaria and intolerance to food additives and/or aspirin supports the use of Montelukast (Desmont) in the treatment of patients experiencing urticaria related to the use of nonsteroidal anti-inflammatory drugs.

Montelukast (Desmont) description

Each 10-mg film-coated tablet contains 10.4 mg Montelukast (Desmont) sodium, which is the molar equivalent to 10.0 mg of free acid. Each 5-mg chewable tablet contains 5.2 mg Montelukast (Desmont) 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 (Desmont) sodium, which is the molar equivalent to 4.0 mg of free acid.

Montelukast (Desmont) is a selective and orally active leukotriene receptor antagonist that specifically inhibits the cysteinyl leukotriene CysLT1 receptor.

Montelukast (Desmont) 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 (Desmont) sodium is a hygroscopic, optically active, white to off-white powder. Montelukast (Desmont) sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile.

Montelukast (Desmont) dosage

Chewable Tablet 4-mg: Children 2 to 5 years: One 4 mg chewable tablet daily to be taken in the evening. Montelukast (Desmont) Chewable Tablet 4 mg should not be taken immediately with food. It should be taken at least 1 hour before or 2 hours after a meal.

Montelukast (Desmont) Chewable Tablets 4 mg are not recommended in children below 2 years of age.

Chewable Tablet 5-mg: Children 6 to 14 years: One 5 mg chewable tablet daily to be taken in the evening. Montelukast (Desmont) Chewable Tablet 5 mg should not be taken immediately with food. It should be taken at least 1 hour before or 2 hours after a meal.

Montelukast (Desmont) Chewable Tablets 5 mg are not recommended in children below 6 years of age.

Film-Coated Tablet 10-mg: Asthma or Asthma and Concomitant Seasonal Allergic Rhinitis: Adults and Adolescents ≥15 years: One 10-mg tablet daily to be taken in the evening.

Oral Granules:

Children 6 months to 5 years: 1 sachet each evening.

Missed Dose: Resume the usual schedule of 1 tablet/sachet once daily. Do not give double dose to make up for a missed dose.

Administration: For oral use.

Chewable Tablets: It should be given to a child under adult supervision. It should be taken even when the child has no symptoms or if he/she has an acute asthma attack.

If the child is taking Montelukast (Desmont) Chewable Tablet, be sure that he/she does not take any other medicines that contain the same active ingredient, i.e. Montelukast (Desmont).

If the child takes more Montelukast (Desmont) Chewable Tablet than he/she should, contact the child’s physician immediately for advice.

Discontinuation of Treatment: Montelukast (Desmont) Chewable Tablet can treat the child’s asthma only if the child continues taking it. It is important for the child to continue taking Montelukast (Desmont) Chewable Tablet for as long as the physician prescribes. It will help control the child’s asthma.

Film-Coated Tablet 10-mg: The therapeutic effect of Montelukast (Desmont) Film-Coated Tab 10 mg on parameters of asthma control occurs within one day. Montelukast (Desmont) Film-Coated Tab 10 mg may be taken with or without food. Patients should be advised to continue taking Montelukast (Desmont) even if asthma is under control, as well as during periods of worsening asthma.

Montelukast (Desmont) Film-Coated Tab 10 mg should not be used concomitantly with other products containing the same active ingredient, Montelukast (Desmont).

No dosage adjustment is necessary for the elderly or for the patients with renal insufficiency or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients.

Therapy with Montelukas Sandoz Film-Coated Tab 10 mg in relation to other treatment for asthma. It can be added to a patient's existing treatment regimen.

Inhaled Corticosteroids: Treatment with Montelukast (Desmont) Film-Coated Tab 10 mg can be used as add-on therapy in patients when inhaled corticosteroids plus "as needed" short-acting β-agonist provide inadequate clinical control. Montelukast (Desmont) Film-Coated Tab 10 mg should not be subtituted for inhaled corticosteriods.

Montelukast (Desmont) Film-Coated Tab 10 mg should not be used in children <15 years due to the high content of active substance.

Other dosage forms with appropriate strengths are available for young children.

Oral Granules:

Montelukast (Desmont) can be given either directly in the mouth or mixed with a spoonful of cold or room temperature soft food (eg, applesauce, ice cream, carrots and rice).

Do not dissolve granules in water. However, the patient may take liquids after swallowing the granules.

Montelukast (Desmont) interactions

See also:
What other drugs will affect Montelukast (Desmont)?

Montelukast (Desmont) may be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma, and in the treatment of allergic rhinitis. In drug-interactions studies, the recommended clinical dose of Montelukast (Desmont) did not have clinically important effects on the pharmacokinetics of the following drugs: Theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/norethindrone 35/1), terfenadine, digoxin and warfarin.

The area under the plasma concentration-time curve (AUC) for Montelukast (Desmont) was decreased approximately 40% in subjects with co-administration of phenobarbital. No dosage adjustment for Montelukast (Desmont) is recommended.

In vitro studies have shown that Montelukast (Desmont) is an inhibitor of CYP2C8. However, data from a clinical drug-drug interaction study involving Montelukast (Desmont) and rosiglitazone (a probe substrate representative of drugs primarily metabolized by CYP2C8) demonstrated that Montelukast (Desmont) does not inhibit CYP2C8 in vivo. Therefore, Montelukast (Desmont) is not anticipated to alter the metabolism of drugs metabolized by this enzyme (e.g. paclitaxel, rosiglitazone, and repaglinide.)

In vitro studies have shown that Montelukast (Desmont) is a substrate of CYP 2C8, 2C9, and 3A4. Data from a clinical drug-drug interaction study involving Montelukast (Desmont) and gemfibrozil (an inhibitor of both CYP 2C8 and 2C9) demonstrated that gemfibrozil increased the systemic exposure of Montelukast (Desmont) by 4.4-fold.

Co-administration of itraconazole, a strong CYP 3A4 inhibitor, with gemfibrozil and Montelukast (Desmont) did not further increase the systemic exposure of Montelukast (Desmont). The effect of gemfibrozil on systemic exposure of Montelukast (Desmont) is not considered to be clinically meaningful based on clinical safety data with doses greater than the 10 mg approved dose in adults (e.g., 200 mg/day to adult patients for 22 weeks, and up to 900 mg/day to patients for approximately one week) where clinically important adverse experiences were not observed. Therefore, no dosage adjustment of Montelukast (Desmont) is required upon co-administration with gemfibrozil. Based on in vitro data, clinically important drug interactions with other known inhibitors of CYP 2C8 (e.g., trimethoprim) are not anticipated. In addition, co-administration of Montelukast (Desmont) with itraconazole alone resulted in no significant increase in the systemic exposure of Montelukast (Desmont).

Montelukast (Desmont) side effects

See also:
What are the possible side effects of Montelukast (Desmont)?

Montelukast (Desmont) has been generally well tolerated. Side effects, which usually were mild, generally did not require discontinuation of therapy. The overall incidence of side effects reported with Montelukast (Desmont) was comparable to placebo.

Adults 15 Years of Age and Older with Asthma: Montelukast (Desmont) has been evaluated in approximately 2600 adult patients 15 years of age and older in clinical studies. In two similarly designed, 12-week placebo-controlled clinical studies, the only adverse experiences reported as drug related in ≥ 1% of patients treated with Montelukast (Desmont) and at a greater incidence than in patients treated with placebo were abdominal pain and headache. The incidences of these events were not significantly different in the two treatment groups.

Cumulatively, 544 patients were treated with Montelukast (Desmont) for at least 6 months, 253 for one year and 21 for 2 years in clinical studies. With prolonged treatment, the adverse experience profile did not change.

Pediatric Patients 6 to 14 Years of Age with Asthma: Montelukast (Desmont) has been evaluated in approximately 475 pediatric patients 6 to 14 years of age. The safety profile in pediatric patients is generally similar to the adult safety profile and to placebo.

In an 8-week, placebo-controlled clinical study, the only adverse experience reported as drug related in > 1% of patients treated with Montelukast (Desmont) and at a greater incidence than in patients treated with placebo was headache. The incidence of headache was not significantly different in the two treatment groups.

In studies evaluating growth rate, the safety profile in these pediatric patients was consistent with the safety profile previously described for Montelukast (Desmont).

Cumulatively, 263 pediatric patients 6 to 14 years of age were treated with Montelukast (Desmont) for at least 3 months and 164 for 6 months or longer. With prolonged treatment, the adverse experience profile did not change.

Pediatric Patients 2 to 5 Years of Age with Asthma: Montelukast (Desmont) has been evaluated in 573 pediatric patients 2 to 5 years of age. In a 12-week, placebo-controlled clinical study, the only adverse experience reported as drug related in > 1% of patients treated with Montelukast (Desmont) and at a greater incidence than in patients treated with placebo was thirst. The incidence of thirst was not significantly different in the two treatment groups.

Cumulatively, 426 pediatric patients 2 to 5 years of age were treated with Montelukast (Desmont) for at least 3 months, 230 for 6 months or longer, and 63 patients for 12 months or longer. With prolonged treatment, the adverse experience profile did not change.

Pediatric Patients 6 Months to 2 Years of Age with Asthma: Montelukast (Desmont) has been evaluated in 175 pediatric patients 6 months to 2 years of age. In a 6-week, placebo-controlled clinical study, the adverse experiences reported as drug related in > 1% of patients treated with Montelukast (Desmont) and at a greater incidence than in patients treated with placebo were diarrhea, hyperkinesia, asthma, eczematous dermatitis and rash.

The incidences of these adverse experiences were not significantly different in the two treatment groups.

Adults 15 Years of Age and Older with Seasonal Allergic Rhinitis: Montelukast (Desmont) has been evaluated in 2199 adult patients 15 years of age and older for the treatment of seasonal allergic rhinitis in clinical studies. Montelukast (Desmont) administered once daily in the morning or in the evening was generally well tolerated with a safety profile similar to that of placebo. In placebo-controlled clinical studies, no adverse experiences reported as drug related in 1% of patients treated with Montelukast (Desmont) and at a greater incidence than in patients treated with placebo were observed. 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 (Desmont) has been evaluated in 280 pediatric patients 2 to 14 years of age for the treatment of seasonal allergic rhinitis in a 2-week, placebo-controlled, clinical study. Montelukast (Desmont) administered once daily in the evening was generally well tolerated with a safety profile similar to that of placebo. In this study, no adverse experiences reported as drug related in 1% of patients treated with Montelukast (Desmont) and at a greater incidence than in patients treated with placebo were observed.

Adults 15 Years of Age and Older with Perennial Allergic Rhinitis: Montelukast (Desmont) has been evaluated in 3235 adult and adolescent patients 15 years of age and older with perennial allergic rhinitis in two, 6-week, placebo-controlled, clinical studies.

Montelukast (Desmont) administered once daily was generally well tolerated, with a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo. In these two studies, no adverse experiences reported as drug related in 1% of patients treated with Montelukast (Desmont) and at a greater incidence than in patients treated with placebo were observed. The incidence of somnolence was similar to that of placebo.

Pooled Analyses of Clinical Trials Experience: A pooled analysis of 41 placebo-controlled clinical studies (35 studies in patients 15 years of age and older; 6 studies in pediatric patients 6 to 14 years of age) was performed using a validated assessment method of suicidality. Among the 9929 patients who received Montelukast (Desmont) and 7780 patients who received placebo in these studies, there was one patient with suicidal ideation in the group taking Montelukast (Desmont). There were no completed suicides, suicide attempts or preparatory acts toward suicidal behavior in either treatment group.

A separate pooled analysis of 46 placebo-controlled clinical studies (35 studies in patients 15 years of age and older; 11 studies in pediatric patients 3 months to 14 years of age) assessing behavior-related adverse experiences (BRAEs) was performed. Among the 11,673 patients who received Montelukast (Desmont) and 8827 patients who received placebo in these studies, the frequency of patients with at least one BRAE was 2.73% in patients who received Montelukast (Desmont) and 2.27% in patients who received placebo; the odds ratio was 1.12 [95% CI (0.93; 1.36)].

The clinical trials included in these pooled analyses were not designed specifically to examine suicidality or BRAEs.

Postmarketing Experience: The following side effects have been reported in postmarketing use: Infections and Infestations: Upper respiratory infection.

Blood and Lymphatic System Disorders: Increased bleeding tendency.

Immune System Disorders: Hypersensitivity reactions including anaphylaxis, very rarely hepatic eosinophilic infiltration.

Psychiatric Disorders: Agitation including aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, memory impairment, psychomotor hyperactivity (including irritability, restlessness, and tremor) somnambulism, suicidal thinking and behavior (suicidality).

Nervous System Disorders: Dizziness, drowsiness, paraesthesia/hypoesthesia, very rarely seizure.

Cardiac Disorders: Palpitations.

Respiratory, Thoracic and Mediastinal Disorders: Epistaxis.

Gastrointestinal Disorders: Diarrhea, dyspepsia, nausea, vomiting; pulmonary eosinophilia.

Hepatobiliary Disorders: Increased ALT and AST, very rarely hepatitis (including cholestatic, hepatocellular, and mixed-pattern liver injury).

Skin and Subcutaneous Tissue Disorders: Angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, rash, urticaria.

Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia including muscle cramps.

Renal and Urinary Disorders: Enuresis in children.

General Disorders and Administration Site Conditions: Asthenia/fatigue, edema, pyrexia.

Montelukast (Desmont) contraindications

See also:
What is the most important information I should know about Montelukast (Desmont)?

Hypersensitivity to Montelukast (Desmont) sodium or to any of the excipients of Montelukast (Desmont).

Use in children: Montelukast (Desmont) should not be used in children <15 years due to high content of Montelukast (Desmont). Other dosage forms with appropriate strengths are available for younger children.

Active ingredient matches for Desmont:

Desloratadine/Montelukast in Turkey.


List of Desmont substitutes (brand and generic names)

Sort by popularity
Unit description / dosage (Manufacturer)Price, USD
ALLERDE M TABLET 1 strip / 10 tablets each (East West Pharma)$ 1.05
D MONTUS 400 MG/10 MG TABLET 1 strip / 10 tablets each (Fourrts India Laboratories Pvt Ltd)$ 1.98
D MONTUS 5MG/10MG TABLET 1 strip / 10 tablets each (Fourrts India Laboratories Pvt Ltd)$ 2.38
D Montus 5 mg/10 mg Tablet (Fourrts India Laboratories Pvt Ltd)$ 0.26
DAZIT M 5 MG/10 MG TABLET 1 strip / 10 tablets each (Sun Pharma Laboratories Ltd)$ 2.21
DEKAST-M tab 10's (Shinto Biotec)$ 1.41
DESTANO-M tab 10's (Shinto Biotec (TNT))$ 1.41
DEZLORID M TABLET 1 strip / 10 tablets each (Intas Pharmaceuticals Ltd)$ 2.21
Mondeslor Montelukast 10 mg, Desloratadine 5 mg. TAB / 10 (Sun)$ 2.19
10's (Sun)$ 2.19
MONDESLOR 5 MG/10 MG TABLET 1 strip / 10 tablets each (Sun)$ 2.21
MONDESLOR tab 10's (Sun)$ 2.21
MONTE FORTE tab 10's (Shinto Biotec (Gross Klin))$ 1.41
VENTIDOX DL 5 MG/10 MG TABLET 1 strip / 10 tablets each (Mankind Pharma Ltd)$ 1.27

References

  1. DailyMed. "DESLORATADINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "montelukast". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. PubChem. "Desloratadine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Desmont are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Desmont. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

2 consumers reported useful

Was the Desmont drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Users%
Useful1
50.0%
Not useful1
50.0%


Consumer reported price estimates

No survey data has been collected yet


5 consumers reported time for results

To what extent do I have to use Desmont before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 1 day and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Desmont. To get the time effectiveness of using Desmont drug by other patients, please click here.
Users%
1 day3
60.0%
1 month1
20.0%
5 days1
20.0%


17 consumers reported age

Users%
30-458
47.1%
> 603
17.6%
6-152
11.8%
46-602
11.8%
16-292
11.8%


Consumer reviews


There are no reviews yet. Be the first to write one!


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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