Montos 10

Montelukast Sodium Tablets USP 10 mg

PHARMACODYNAMICS:

Pharmacotherapeutic group:

Montelukast:- Leukotriene receptor antagonists

ATC code:

Montelukast:- R03D C03

PHARMACOKINETICS:

Montelukast:-

Absorption:-

Montelukast is rapidly absorbed following oral administration. For the 10 mg, the mean peak plasma concentration (Cmax) is achieved three hours (Tmax) after administration in adults in the fasted state. The mean oral bioavailability is 64%.

The oral bioavailability and Cmax are not influenced by a standard meal. Safety and efficacy were demonstrated in clinical trials where the 10 mg film-coated tablet was administered without regard to the timing of food ingestion.

Distribution:-

Montelukast is more than 99% bound to plasma proteins. The steady-state volume of distribution of montelukast averages 8-11 liters.

Biotransformation:-

Montelukast is extensively metabolised. In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in

adults and children.

Elimination:-

The plasma clearance of montelukast averages 45 ml/min in healthy adults.

Following an oral dose of radiolabelled montelukast, 86% of the radioactivity was recovered in 5-day faecal collections and <0.2% was recovered in urine.

INDICATIONS:

Montelukast tablets is used for sneezing and runny nose due to allergies, Hay fever and Allergic skin conditions.

RECOMMENDED DOSE:

Adults and adolescents (>15 years):- 1 tablet once daily.

No dosage adjustment is necessary for the elderly, or for 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.

METHOD OF ADMINISTRATION:

For oral use.

CONTRAINDICATIONS:

Hypersensitivity to the active substance or to any of the excipients used in the

formulation.

WARNING AND PRECAUTIONS:

Montelukast:-

Patients should be advised never to use oral montelukast to treat acute asthma attacks and to keep their usual appropriate rescue medication for this purpose readily available. If an acute attack occurs, a short-acting inhaled β-agonist should be used. Montelukast should not be abruptly substituted for inhaled or oral corticosteroids.

INTERACTIONS WITH OTHER MEDICAMENTS:

Montelukast:-

In drug-interactions studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following medicinal products: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol/ norethindrone 35/1), terfenadine, digoxin and warfarin.

PREGNANCY AND LACTATION:

Montelukast:-

Pregnancy:-

Montelukast may be used during pregnancy only if it is considered to be clearly

essential.

Lactation:-

It is unknown whether montelukast is excreted in human milk. Studies in rats have shown that montelukast is excreted in milk. Montelukast may be used in breast-feeding only if it is considered to be clearly essential

UNDESIRABLE EFFECTS:

Montelukast:-

Headache, abdominal pain, hallucinations, disorientation, suicidal thinking and

behaviour (suicidality), Dysphemia, diarrhoea, nausea, vomiting, pyrexia.

OVERDOSE AND TREATMENT:

Montelukast:-

No specific information is available on the treatment of overdose with montelukast. There were no adverse experiences in the majority of overdose reports. The most frequently occurring adverse experiences were consistent with the safety profile of montelukast and included abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity.

STORAGE CONDITION:

Store below 30°C.

Protect from light and moisture.

Keep the medicine out of reach of children.

DOSAGE FORM AND PACKAGING AVAILABLE

DOSAGE FORM: Tablet

PRESENTATION:

30 Tablets in a pack.

 

Marketed by :

272 Bath Street Glasgow,

United Kingdom G2 4JR