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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

SINGULAIR Tablet / Chewable Tablet / Granule (2020)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Merck Sharp & Dohme Corp.

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1. Indications and Usage

1.1 Asthma SINGULAIR is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 1.2 Exercise-Induced Bronchoconstriction (EIB) SINGULAIR ...

2. Dosage and Administration

2.1 Asthma SINGULAIR should be taken once daily in the evening. The following doses are recommended: <u>For adults and adolescents 15 years of age and older:</u> one 10-mg tablet. <u>For pediatric patients ...

3. Dosage Forms and Strengths

SINGULAIR 10-mg Film-Coated Tablets are beige, rounded square-shaped tablets, with code MSD 117 on one side and SINGULAIR on the other. SINGULAIR 5-mg Chewable Tablets are pink, round, bi-convex-shaped ...

4. Contraindications

Hypersensitivity to any component of this product.

5. Warnings and Precautions

5.1 Neuropsychiatric Events Serious neuropsychiatric (NP) events have been reported with use of SINGULAIR. These postmarketing reports have been highly variable and included, but were not limited to, agitation, ...

6.1. 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 ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of SINGULAIR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

No dose adjustment is needed when SINGULAIR is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, ...

8.1. Pregnancy

Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects ...

8.2. Lactation

Risk Summary A published clinical lactation study reports the presence of montelukast in human milk. Data available on the effects of the drug on infants, either directly <em>[see Use in Specific Populations ...

8.4. Pediatric Use

Safety and efficacy of SINGULAIR have been established in adequate and well-controlled studies in pediatric patients with asthma 6 to 14 years of age. Safety and efficacy profiles in this age group are ...

8.5. Geriatric Use

Of the total number of subjects in clinical studies of montelukast, 3.5% were 65 years of age and over, and 0.4% were 75 years of age and over. No overall differences in safety or effectiveness were observed ...

8.6. Renal Impairment

No dosage adjustment is recommended in patients with renal insufficiency <em>[see Clinical Pharmacology (12.3)]</em>.

8.6. Hepatic Impairment

No dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency <em>[see Clinical Pharmacology (12.3)]</em>.

10. Overdosage

No specific information is available on the treatment of overdosage with SINGULAIR. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material ...

11. Description

Montelukast sodium, the active ingredient in SINGULAIR, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT<sub>1</sub> receptor. Montelukast ...

12.1. Mechanism of Action

The cysteinyl leukotrienes (LTC<sub>4</sub>, LTD<sub>4</sub>, LTE<sub>4</sub>) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These ...

12.2. Pharmacodynamics

Montelukast causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD<sub>4</sub> in asthmatics. Doses as low as 5 mg ...

12.3. Pharmacokinetics

Absorption Montelukast is rapidly absorbed following oral administration. After administration of the 10-mg film-coated tablet to fasted adults, the mean peak montelukast plasma concentration (C<sub>max ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of tumorigenicity was seen in carcinogenicity studies of either 2 years in Sprague-Dawley rats or 92 weeks in mice at oral gavage doses up to 200 mg/kg/day or 100 mg/kg/day, respectively. The ...

14. Clinical Studies

14.1 Asthma Adults and Adolescents 15 Years of Age and Older with Asthma Clinical trials in adults and adolescents 15 years of age and older demonstrated there is no additional clinical benefit to montelukast ...

16.1. How Supplied

No. 3841 SINGULAIR Oral Granules, 4 mg, are white granules with 500 mg net weight, packed in a child-resistant foil packet. They are supplied as follows: NDC 0006-3841-30 unit of use carton with 30 packets. ...

16.2. Storage and Handling

Store SINGULAIR 4-mg oral granules, 4-mg chewable tablets, 5-mg chewable tablets and 10-mg film-coated tablets at 20°C to 25°C (68°F to 77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled ...

17. Patient Counseling Information

For the tablets and chewable tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). For the oral granules, advise the patient and/or caregiver to read ...

BOXED WARNING SECTION

<b>WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS</b> <b>Serious neuropsychiatric (NP) events have been reported with the use of SINGULAIR. The types of events reported were highly variable, and included, but ...