Componentes:
Medicamente revisado por Fedorchenko Olga Valeryevna, Farmácia Última atualização em 26.04.2022
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20 principais medicamentos com os mesmos componentes:
Rinite alérgica sazonal
O dicloridrato de levocetirizina (L-MONTUS) é indicado para o alívio dos sintomas associados à rinite alérgica sazonal em adultos e crianças com 2 anos de idade ou mais.
Rinite alérgica perene
O dicloridrato de levocetirizina (L-MONTUS) é indicado para o alívio dos sintomas associados à rinite alérgica perene em adultos e crianças com 6 meses de idade ou mais.
Urticária idiopática crônica
O dicloridrato de levocetirizina (L-MONTUS) é indicado para o tratamento das manifestações cutâneas não complicadas da urticária idiopática crônica em adultos e crianças com 6 anos de idade ou mais.
Uma indicação é um termo usado para a lista de condição ou sintoma ou doença para a qual o medicamento é prescrito ou usado pelo paciente. Por exemplo, acetaminofeno ou paracetamol é usado para febre pelo paciente ou o médico prescreve para dor de cabeça ou dores no corpo. Agora febre, dor de cabeça e dores no corpo são as indicações de paracetamol. Um paciente deve estar ciente das indicações de medicamentos usados em condições comuns, pois podem ser tomados sem receita médica na farmácia, ou seja, sem receita médica pelo médico.Asma
O montelucaste de sódio (L-MONTUS) sódio é indicado para a profilaxia e tratamento crônico da asma em adultos e pacientes pediátricos com 2 anos de idade ou mais.
Broncoconstrição induzida pelo exercício
O montelucaste de sódio (L-MONTUS) sódio é indicado para prevenção de broncoconstrição induzida por exercício (BEI) em pacientes com 15 anos de idade ou mais.
Informações de uso pediátrico para pacientes de 6 a 14 anos de idade para prevenção aguda de broncoconstrição induzida por exercício (BEI) são aprovadas para os produtos para comprimidos de Montelukast sódio (L-MONTUS) da Merck Sharp & Dohme Corp. No entanto, devido aos direitos de exclusividade de marketing da Merck Sharp & Dohme Corp, este medicamento não é rotulado com essas informações pediátricas.
Rinite alérgica
O montelucaste de sódio (L-MONTUS) sódio é indicado para o alívio dos sintomas da rinite alérgica sazonal em pacientes com 2 anos de idade e rinite alérgica mais antiga e perene em pacientes com 2 anos de idade ou mais.
Dicloridrato de levocetirizina (L-MONTUS) é um anti-histamínico que reduz os efeitos da histamina química natural no corpo. A histamina pode produzir sintomas de espirros, coceira, olhos lacrimejantes e coriza.
O dicloridrato de levocetirizina (L-MONTUS) é usado para tratar sintomas de alergias (perenes) durante todo o ano em adultos e crianças com pelo menos 6 meses de idade. Também é usado para tratar sintomas de alergias sazonais em adultos e crianças com pelo menos 2 anos de idade.
O dicloridrato de levocetirizina (L-MONTUS) também é usado no tratamento de prurido e inchaço causados por urticária crônica (urticária) em adultos e crianças com pelo menos 6 meses de idade.
O dicloridrato de levocetirizina (L-MONTUS) também pode ser usado para fins não listados neste guia de medicamentos.
Montelucaste de sódio (L-MONTUS) é um inibidor de leucotrieno (loo-koe-TRY-een). Leucotrienos são produtos químicos que seu corpo libera quando você respira um alérgeno (como pólen). Esses produtos químicos causam inchaço nos pulmões e aperto dos músculos ao redor das vias aéreas, o que pode resultar em sintomas de asma.
O montelucaste de sódio (L-MONTUS) é usado para prevenir ataques de asma em adultos e crianças a partir dos 12 meses de idade. O montelucaste de sódio (L-MONTUS) também é usado para evitar o broncoespasmo induzido por exercícios em adultos e crianças com pelo menos 6 anos de idade.
O montelucaste de sódio (L-MONTUS) também é usado para tratar sintomas de alergias (perenes) durante todo o ano em adultos e crianças com pelo menos 6 meses de idade. Também é usado para tratar sintomas de alergias sazonais em adultos e crianças com pelo menos 2 anos de idade.
Não dê este medicamento a uma criança sem o conselho de um médico.
O montelucaste de sódio (L-MONTUS) também é usado para evitar a broncoconstrição induzida por exercícios (estreitamento das passagens aéreas nos pulmões) em adultos e adolescentes com pelo menos 15 anos de idade e que ainda não estão tomando este medicamento para outras condições.
Se você já toma Montelukast sódio (L-MONTUS) para prevenir sintomas de asma ou alergia, não use uma dose extra para tratar a broncoconstrição induzida pelo exercício.
O montelucaste de sódio (L-MONTUS) também pode ser usado para fins não listados neste guia de medicamentos.
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 dicloridrato de levocetirizina (L-MONTUS) conforme indicado pelo seu médico. Verifique o rótulo do medicamento para obter instruções exatas sobre a dosagem.
- Tome o dicloridrato de levocetirizina (L-MONTUS) por via oral com ou sem alimentos. Tome-o à noite, a menos que o seu médico lhe diga o contrário.
- Use um dispositivo de medição marcado para dosagem de medicamentos. Peça ajuda ao seu farmacêutico se não tiver certeza de como medir sua dose.
- Se você perder uma dose de dicloridrato de levocetirizina (L-MONTUS), tome-o o mais rápido possível. Se estiver quase na hora da próxima dose, pule a dose e volte ao seu esquema posológico regular. Não tome 2 doses de uma só vez.
Faça ao seu médico qualquer dúvida sobre como usar o dicloridrato de levocetirizina (L-MONTUS).
Use grânulos de Montelukast sódio (L-MONTUS), conforme indicado pelo seu médico. Verifique o rótulo do medicamento para obter instruções exatas sobre a dosagem.
- Um folheto extra para pacientes está disponível com grânulos de Montelukast sódico (L-MONTUS). Fale com o seu farmacêutico se tiver dúvidas sobre esta informação.
- Tome grânulos de sódio Montelukast (L-MONTUS) por via oral com ou sem alimentos.
- Não abra o pacote até estar pronto para usá-lo.
- Os grânulos de montelucaste de sódio (L-MONTUS) podem ser colocados diretamente na boca, dissolvidos em 1 colher de chá (5 mL) de fórmula para bebês ou leite materno a frio ou em temperatura ambiente, ou misturados com uma colher de alimentos macios a frio ou temperatura ambiente antes de engolir . Os alimentos macios que podem ser usados incluem molho de maçã, purê de cenoura, arroz ou sorvete. Certifique-se de engolir a colher inteira imediatamente (dentro de 15 minutos). Não guarde remédios mistos para uso futuro.
- Não coloque os grânulos em líquido que não seja a fórmula do bebê ou o leite materno. No entanto, você pode beber líquidos após engolir a mistura de grânulos ou grânulos.
- Continue a usar grânulos de sódio Montelukast (L-MONTUS), mesmo que se sinta bem. Não perca nenhuma dose.
- Se você perder uma dose de grânulos de Montelukast sódio (L-MONTUS), pule a dose e volte ao seu esquema posológico regular. Não tome 2 doses de uma só vez.
Faça ao seu médico qualquer dúvida sobre como usar os grânulos de Montelukast sódico (L-MONTUS).
Existem usos específicos e gerais de um medicamento ou medicamento. Um medicamento pode ser usado para prevenir uma doença, tratar uma doença durante um período ou curar uma doença. Também pode ser usado para tratar o sintoma particular da doença. O uso do medicamento depende da forma que o paciente toma. Pode ser mais útil na forma de injeção ou, às vezes, na forma de comprimido. O medicamento pode ser usado para um único sintoma perturbador ou uma condição com risco de vida. Embora alguns medicamentos possam ser interrompidos após alguns dias, alguns medicamentos precisam ser continuados por um período prolongado para obter o benefício.O dicloridrato de levocetirizina (L-MONTUS) é usado para tratar sintomas de condições alérgicas, como febre alérgica (febre do feno), alergias durante todo o ano, como poeira ou alergias a animais de estimação e erupção cutânea crônica de urtiga.
Existem usos específicos e gerais de um medicamento ou medicamento. Um medicamento pode ser usado para prevenir uma doença, tratar uma doença durante um período ou curar uma doença. Também pode ser usado para tratar o sintoma particular da doença. O uso do medicamento depende da forma que o paciente toma. Pode ser mais útil na forma de injeção ou, às vezes, na forma de comprimido. O medicamento pode ser usado para um único sintoma perturbador ou uma condição com risco de vida. Embora alguns medicamentos possam ser interrompidos após alguns dias, alguns medicamentos precisam ser continuados por um período prolongado para obter o benefício.Uso: indicações rotuladas
Rinite alérgica (perene ou sazonal) : Alívio dos sintomas de rinite alérgica sazonal e rinite alérgica perene
Asma: Profilaxia e tratamento crônico da asma
Broncoconstrição induzida por exercício (prevenção) : Prevenção de broncoconstrição induzida por exercícios.
Nota: Recomenda-se as diretrizes da Academia Americana de Otorrinolaringologia, Cirurgia de Cabeça e Pescoço (AAO-HNS) e da Academia Americana de Alergia, Asma e Imunologia (AAAAI) e da Faculdade Americana de Alergia, Asma e Imunologia (ACAAI) contra O montelucaste de sódio (L-MONTUS) é utilizado como terapia de primeira linha para rinite alérgica (exceto em pacientes com asma simultânea) (Dykewicz 2017; Seidman 2015). A Iniciativa Global para Asma recomenda o Montelukast sódio (L-MONTUS) em pacientes com rinite alérgica concomitante ou naqueles que não podem tomar corticosteróides inalados (GINA 2019).
Usos fora do rótulo
Urticária crônica
Dados de ensaios controlados, duplo-cegos, relativos ao uso de Montelukast sódico (L-MONTUS) em combinação com anti-histamínicos para o gerenciamento de urticária crônica são conflitantes. Baseado nas diretrizes de prática clínica da Academia Americana de Alergia, Asma e Imunologia (AAAAI) o Colégio Americano de Alergia, Asma, e imunologia (ACAAI) Conselho Conjunto de Alergia, Asma e Imunologia (JCAAI) e a Organização Mundial de Alergia para o diagnóstico e manejo de urticária aguda e crônica, um antagonista do receptor de leucotrieno pode ser adicionado à terapia anti-histamínica em pacientes que não respondem a anti-histamínicos. Acesse a monografia completa da etiqueta
Urticária (induzida por drogas anti-inflamatórias não esteróides)
Dados de uma comparação duplo-cega e controlada por placebo de Montelukast sódico (L-MONTUS) e cetirizina em pacientes com urticária crônica e intolerância a aditivos alimentares e / ou aspirina apóiam o uso de Montelukast sódico (L-MONTUS) no tratamento de pacientes com urticária relacionada ao uso de anti-inflamatórios não esteróides.
Veja também:
Que outros medicamentos afetarão o dicloridrato de levocetirizina (L-MONTUS)?
Não foram realizados estudos de interação com dicloridrato de levocetirizina (L-MONTUS) (incluindo estudos com indutores do CYP3A4); estudos com o composto racemato cetirizina demonstraram que não houve interações adversas clinicamente relevantes (com pseudoefedrina, cimetidina, cetoconazol, eritromicina, azitromicina, glipizida e diazep.
Teofilina: Uma pequena diminuição na depuração da cetirizina (16%) foi observada em um estudo de doses múltiplas com teofilina (400 mg uma vez ao dia); enquanto a disposição da teofilina não foi alterada pela administração concomitante de cetirizina.
Ritonavir : Num estudo de doses múltiplas de ritonavir (600 mg duas vezes ao dia) e cetirizina (10 mg por dia), a extensão da exposição à cetirizina aumentou cerca de 40%, enquanto a disposição do ritonavir foi ligeiramente alterada (-11%), além da administração concomitante de cetirizina .
Comida: A extensão da absorção do dicloridrato de levocetirizina (L-MONTUS) não é reduzida com os alimentos, embora a taxa de absorção seja reduzida.
Álcool: Em pacientes sensíveis, a administração simultânea de cetirizina ou dicloridrato de levocetirizina (L-MONTUS) e álcool ou outros depressores do SNC pode ter efeitos no sistema nervoso central, embora tenha sido demonstrado que a cetirizina racemato não potencializa o efeito do álcool.
Veja também:
Que outros medicamentos afetarão o Montelukast sódico (L-MONTUS)?
O fenobarbital aumenta a concentração sanguínea de Montelukast sódio (L-MONTUS) em cerca de 40%. Rifampin pode ter o mesmo efeito. Portanto, a dose de Montelukast sódio (L-MONTUS) pode precisar ser reduzida quando administrada simultaneamente com esses medicamentos. Não é necessário ajuste da dose quando o Montelukast sódio (L-MONTUS) é co-administrado com teofilina, prednisona, prednisolona, contraceptivos orais, terfenadina, digoxina, varfarina, hormônios da tireóide, hipnóticos sedativos, agentes anti-inflamatórios não esteróides, benzodiazepínicos, descongestionantes e citocromo P4.
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.
O dicloridrato de levocetirizina (L-MONTUS) é um anti-histamínico não sedativo de terceira geração indicado para o alívio dos sintomas associados à rinite alérgica sazonal e perene e manifestações cutâneas não complicadas da urticária idiopática crônica. Foi desenvolvido a partir da segunda geração de cetirizina anti-histamínica. O dicloridrato de levocetirizina (L-MONTUS) é o enantiômero R do racemato de cetirizina. O dicloridrato de levocetirizina (L-MONTUS) é um agonista inverso que diminui a atividade nos receptores de histamina H1. Isso, por sua vez, impede a liberação de outros produtos químicos alérgicos e o aumento do suprimento sanguíneo para a área, além de aliviar os sintomas típicos da febre do feno. Não impede a liberação real de histamina dos mastócitos. O dicloridrato de levocetirizina (L-MONTUS) foi aprovado pela Food and Drug Administration dos Estados Unidos em 25 de maio de 2007 e é comercializado sob a marca dicloridrato de levocetirizina (L-MONTUS) ® pela sanofi-aventis U.S. LLC .
Cada comprimido revestido por película de 10 mg contém 10,4 mg de Montelukast sódio (L-MONTUS) de sódio, que é o equivalente molar a 10,0 mg de ácido livre. Cada comprimido para mastigar de 5 mg contém 5,2 mg de Montelukast sódio (L-MONTUS) de sódio, que é o equivalente molar a 5,0 mg de ácido livre. Cada comprimido para mastigar de 4 mg e cada pacote de grânulos orais de 4 mg contém 4,2 mg de Montelukast sódico (L-MONTUS) sódico, que é o equivalente molar a 4,0 mg de ácido livre.
O montelucaste de sódio (L-MONTUS) é um antagonista seletivo e ativo oralmente do receptor de leucotrieno que inibe especificamente o cisteinil leucotrieno CysLT1 receptor.
O montelucaste de sódio (L-MONTUS) é descrito quimicamente como [R- (E)] -1 - [[[1- [3- [2- (7-cloro-2-quinolinil) etenil] fenil] -3- [2 - (1-hidroxi-1-metiletil) fenil] propil] tio] metil] ácido acético de ciclopropano, sal monossódico.
A fórmula empírica é C35H35ClNNaO3S, e seu peso molecular é 608,18.
O montelucaste de sódio (L-MONTUS) sódio é um pó higroscópico, opticamente ativo, branco a esbranquiçado. O montelucaste de sódio (L-MONTUS) sódio é livremente solúvel em etanol, metanol e água e praticamente insolúvel em acetonitrila.