MONLET

Each film coated tablets contains:

(Montelukast Sodium equivalent to Montelukast IP 10 mg and Levocetirizine Hydrochloride IP 5mg)

Tablet for Oral Use

Levocetirizine blocks the effects of a chemical messenger known as ‘histamine,’ which is naturally involved in allergic reactions. It helps relieve allergy symptoms such as sneezing, running nose, watery eyes, itching, swelling, congestion, or stiffness. Montelukast is a leukotriene antagonist, which blocks a chemical messenger (leukotriene) and reduces inflammation and swelling in the nose. Collectively, both of them help to improve symptoms and relieve allergic symptoms.

Absorption: Montelukast is quickly absorbed following oral administration with the mean peak plasma concentration (C max) achieved in 3 to 4 hours (T max). The mean oral bioavailability is 64%. Levocetrizine is rapidly and extensively absorbed from the GI tract (oral); peak plasma concentration in 0.9 hours.

Distribution: Montelukast is approximately 99% bound to plasma proteins. Protein-binding of Levocetrizine: 91-92%. Metabolism &Excretion: Montelukast is primarily metabolized by the liver and metabolites are excreted almost singly via the bile. Levocetirizine is poorly metabolized and mostly excreted via urine (85.4%), via faeces (12.9%), as metabolites and unchanged drug.

Half Life: The mean plasma half-life of Montelukast varies from 2.7 to 5.5 hours and Levocetrizine is 8 hours.

• Relief of symptoms of allergic rhinitis [seasonal or perennial]
• As prophylaxis in seasonal allergic rhinitis
• Treatment of comorbid asthma and allergic rhinitis in patients 15 years of age and over

ADVERSE EFFECTS:

Nausea, Skin rash, Diarrhoea, Vomiting, Dry mouth, Headache, Skin rash, Fatigue (Weakness)

DOSAGE AND ADMINISTRATION: One tablet once daily

CONTRAINDICATIONS:

• Contraindicated in patients with known hypersensitivity to Montelukast sodium, Levocetirizine or to any other component of this product.
• It is also contraindicated in patients with severe renal impairment at less than 10 mL/min creatinine clearance.

WARNINGS AND PRECAUTIONS

• Should not be used during Pregnancy and breast feeding
• Kidney problems may require dose adjustment
• LEVOCETIRIZINE+MONTELUKAST should be stopped 72 hour before skin testing as it decreases response to skin prick test
• Please consult your doctor immediately if you experience aggression, anxiety, or depression after taking LEVOCETIRIZINE+MONTELUKAST
• Concurrent use of LEVOCETIRIZINE+MONTELUKAST with alcohol or other antidepressants should be avoided to reduce your mental alertness

Pregnancy Category: B

Drug Interaction:

LEVOCETIRIZINE+MONTELUKAST may have an interaction with other anti-allergic drugs, pain killers (ibuprofen, naproxen, diclofenac), blood thinners (aspirin), antifungals (fluconazole, miconazole, or voriconazole), heart medications (amiodarone)