LEVOMONT Montelukast Sodium / Levocetirizine Hydrochloride 10mg / 5mg Film-Coated Tablet 1's
RXDRUG-DR-XY44802-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
It is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis.
Dosage/Direction for Use
Dosage Regimen: Product doses are defined depending on severity of infections, species of organism, patient's age, body weight and renal function.
The recommended dose of the tablet of Montelukast and levocetirizine combination for adults 1 tablet once daily or as prescribed by the physician. Due to the lack of data, the administration of this product to infants and toddlers aged less than 2 years is not recommended.
The recommended dose of the tablet of Montelukast and levocetirizine combination for adults 1 tablet once daily or as prescribed by the physician. Due to the lack of data, the administration of this product to infants and toddlers aged less than 2 years is not recommended.
Overdosage
At this time, there is no experience of overdose to permit definition of the consequence is found. Symptoms of overdose may include drowsiness in adults and initially agitation and restlessness, followed by drowsiness in children. There is no known specific antidote to LEVOMONT. If should overdose occur, symptomatic or supportive treatment is recommended. LEVOMONT is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.
Administration
May be taken with or without food.
Contraindications
LEVOMONT Tablets are contraindicated in patients with known hypersensitivity to Montelukast-levocetirizine, to other piperazine derivatives, or no to any of the excipients. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine and also contraindicated in patients with severe renal impairment at less than 10 mL/min creatinine clearance.
Special Precautions
Special Instructions: Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available. Therapy with Montelukast and Levocetirizine can be continued during exacerbations of asthma. While the dose of inhaled corticosteroid may be reduced gradually under medical supervision. In combination should not be abruptly substituted for inhaled or oral corticosteroids. Montelukast should not be used as monotherapy for the treatment and management of exercise induced bronchospasm. Patients who have exacerbations of asthma after exercise should continue to use their usual regimen of inhaled β-agonist. Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking Montelukast.
Eosinophilic Conditions: In rare cases, patients on therapy with Montelukast may present with systematic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition, which is often treated with systematic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy.
Levocetirizine: Precaution is recommended with intake of alcohol. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Eosinophilic Conditions: In rare cases, patients on therapy with Montelukast may present with systematic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition, which is often treated with systematic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy.
Levocetirizine: Precaution is recommended with intake of alcohol. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use In Pregnancy & Lactation
The combination should be used in pregnancy only if clearly needed but should not be continued during lactation. Since it is excreted in breast milk the combination is not recommended during breast feeding.
Adverse Reactions
Montelukast & Levocetirizine are generally well tolerated.
Common side effects, which might be seen with the combination, are dyspepsia, abdominal pain, rash, dizziness, headache, fatigue, and somnolence.
Sometimes, hypersensitivity, irritability, restlessness, insomnia, vomiting and diarrhea may occur. In rare cases, patients may present with the systemic eosinophilia, sometimes presenting with clinical features of consistent with Churg-Strauss Syndrome.
Common side effects, which might be seen with the combination, are dyspepsia, abdominal pain, rash, dizziness, headache, fatigue, and somnolence.
Sometimes, hypersensitivity, irritability, restlessness, insomnia, vomiting and diarrhea may occur. In rare cases, patients may present with the systemic eosinophilia, sometimes presenting with clinical features of consistent with Churg-Strauss Syndrome.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacotherapeutic group: Montelukast sodium is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene (CysLT 1), receptor, Levocetirizine is the R-enantiomer of cetirizine. Levocetirizine is an orally active, potent, selective and long acting H1 histamine receptor antagonist with no anticholinergic activity.
Pharmacology: Pharmacodynamics: Montelukast causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD 4 in asthmatics. Doses as low as 5 mg cause substantial blockage of LTD 4 induced bronchoconstriction. Antihistamine for systemic use, piperazine derivative, Levocetirizine, the (R) enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1 receptors. Binding studies revealed that levocetirizine has an affinity 2-fold higher than that of cetirizine. Levocetirizine dissociates from H1 receptors with half-life of 115 A,A≠38 min.
Pharmacodynamics studies in healthy volunteers demonstrate that, at half the dose, levocetirizine has comparable activity to cetirizine, both in the skin and in the nose.
Pharmacokinetics: Absorption: In combination administration of the 10 mg film-coated tablet to fasted adults, the mean peak montelukast.
Plasma concentration (Cmax) is achieved in 3 to 4 hours (Tmax). The mean oral biovailability is 64%. The oral bioavailability and Cmax are not influenced by a standard meal in the morning. Levocetirizine is rapidly and extensively absorbed following oral administration. Peak plasma concentrations are achieved 0.9 g h after dosing. Steady state is achieved after two days. Peak concentrations are typically 270 mg/mL and 308 mg/mL following a single and a repeated 5 mg o.d. dose, respectively.
The extent of absorption is dose-independent and is not altered by food, but the peak concentration is reduced and delayed.
Distribution: Montelukast and levocetirizine is more than 90%-99% bound proteins. The steady-state volume of distribution of montelukast averages 8 to 11 liters and it bounds to plasma proteins. The distribution of is restrictive, as the volume of distribution is 0.41/kg.
Metabolism: the extent of metabolism of Montelukast and levocetirizine is less than 14% of the dose and therefore differences resulting from genetic polymorphism or concomitant intake of enzyme inhibitors are expected to be negligible. Metabolic pathways include aromatic oxidation, N- and O-dealkylation and taurine conjugation. Dealkylation pathways are primarily mediated by CYP 3A4 while aromatic oxidation involved multiple and/or unidentified CYP isoforms. In combination had no effect on the activities of CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, and 3A4 at concentrations well above peak concentrations achieved following a 5 mg oral dose. Due to its low metabolism and absence of metabolic inhibition potential, the interaction of Montelukast and levocetirizine with other substances, or vice versa, is unlikely.
Elimination: Excretion via faeces accounts for only 12.9% of the dose. Montelukast and levocetirizine is excreted both by glomerular filtration and active tubular secretion.
Pharmacology: Pharmacodynamics: Montelukast causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD 4 in asthmatics. Doses as low as 5 mg cause substantial blockage of LTD 4 induced bronchoconstriction. Antihistamine for systemic use, piperazine derivative, Levocetirizine, the (R) enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1 receptors. Binding studies revealed that levocetirizine has an affinity 2-fold higher than that of cetirizine. Levocetirizine dissociates from H1 receptors with half-life of 115 A,A≠38 min.
Pharmacodynamics studies in healthy volunteers demonstrate that, at half the dose, levocetirizine has comparable activity to cetirizine, both in the skin and in the nose.
Pharmacokinetics: Absorption: In combination administration of the 10 mg film-coated tablet to fasted adults, the mean peak montelukast.
Plasma concentration (Cmax) is achieved in 3 to 4 hours (Tmax). The mean oral biovailability is 64%. The oral bioavailability and Cmax are not influenced by a standard meal in the morning. Levocetirizine is rapidly and extensively absorbed following oral administration. Peak plasma concentrations are achieved 0.9 g h after dosing. Steady state is achieved after two days. Peak concentrations are typically 270 mg/mL and 308 mg/mL following a single and a repeated 5 mg o.d. dose, respectively.
The extent of absorption is dose-independent and is not altered by food, but the peak concentration is reduced and delayed.
Distribution: Montelukast and levocetirizine is more than 90%-99% bound proteins. The steady-state volume of distribution of montelukast averages 8 to 11 liters and it bounds to plasma proteins. The distribution of is restrictive, as the volume of distribution is 0.41/kg.
Metabolism: the extent of metabolism of Montelukast and levocetirizine is less than 14% of the dose and therefore differences resulting from genetic polymorphism or concomitant intake of enzyme inhibitors are expected to be negligible. Metabolic pathways include aromatic oxidation, N- and O-dealkylation and taurine conjugation. Dealkylation pathways are primarily mediated by CYP 3A4 while aromatic oxidation involved multiple and/or unidentified CYP isoforms. In combination had no effect on the activities of CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, and 3A4 at concentrations well above peak concentrations achieved following a 5 mg oral dose. Due to its low metabolism and absence of metabolic inhibition potential, the interaction of Montelukast and levocetirizine with other substances, or vice versa, is unlikely.
Elimination: Excretion via faeces accounts for only 12.9% of the dose. Montelukast and levocetirizine is excreted both by glomerular filtration and active tubular secretion.
MedsGo Class
Antihistamines & Antiallergics
Features
Brand
Levomont
Full Details
Dosage Strength
10 mg / 5 mg
Drug Ingredients
- Levocetirizine
- Montelukast
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Montelukast Sodium / Levocetirizine Hydrochloride
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY44802
Drug Classification
Prescription Drug (RX)
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