WINDFAR-L Tablet

For relief of symptoms of allergic rhinitis [seasonal or perennial], as prophylaxis in seasonal allergic rhinitis and treatment of comorbid asthma and allergic rhinitis in patients 15 years of age and over.

Windfar-L tablets are indicated for the relief of symptoms of allergic rhinitis [seasonal or perennial], as prophylaxis in seasonal allergic rhinitis and treatment of comorbid asthma and allergic rhinitis in patients 2-5 years of age.

Dosage and administration

Adults [>15 years]: 1 tablet once daily.

Children (2-5 years): 1 tablet once daily.

Due to the lack of clinical data, the administration of this product to infants less than 2 years of age is not recommended.

In patients with:

- known hypersensitivity to montelukast sodium, levocetirizine or cetirizine or to any other component of this product.

- severe renal impairment, at less than 10mL/min creatinine clearance.

- rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

See the package insert about the details below:

Montelukast

dyspepsia, abdominal pain, rash, dizziness, headache, fatigue, fever, trauma, cough, nasal congestion.

Levocetirizine

somnolence, fatigue, nasopharyngitis, dry mouth, pharyngitis, asthenia, abdominal pain

See the package insert about the details below:

Montelukast

Montelukast was used concomitantly with a wide range of commonly prescribed drugs in clinical studies without evidence of clinical adverse interactions. These medications included thyroid hormones, sedative hypnotics, NSAIDs, benzodiazepines, and decongestants.

Phenobarbital

It is reasonable to employ appropriate clinical monitoring when potent CYP450 enzyme inducers, such as phenobarbital or rifampin, are co-administered with montelukast.

Levocetirizine

Theophylline

Ritonavir

Pregnancy

There are no adequate and well-controlled studies of either montelukast or levocetirizine in pregnant women. Hence this combination should not be used during pregnancy.

Lactation

Since levocetirizine is excreted in breast-milk the combination is not recommended during lactation.

Montelukast

Eosinophilic conditions in rare cases, patients on therapy with Montelukast 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.

Levocetirizine

Patients should avoid engaging in hazardous occupation requiring complete mental alertness such as driving or operating machinery when taking levocetirizine. Precaution is recommended with intake of alcohol and in those who are on CNS depressants.

Windfar-L is a combination of Montelukast and Levocetirizine: the pharmacological properties of both the molecules are given separately:

Montelukast

Montelukast causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD4 in asthmatics. Doses as low cause substantial blockage of LTD4-induced bronchoconstriction.

Levocetirizine

Levocetirizine, the (R) enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptos.

Levocetirizine provide a similar pattern of inhibition of histamine-induced wheal and flare than 1-mg cetirizine. As for cetirizine, the action on histamine-induced skin reactions was out of phase with the plasma concentrations. ECGs did not show relevant effects of levocetirizine on QT interval.