Montelukast Sodium & Levocetirizine Hydrochloride Tablet

Therapeutic Class:

Dosage Forms:

Brand Name: LEVOLUKAST 5-12

How it works?

Montelukast Sodium & Levocetirizine Hydrochloride Tablets are indicated for relief and/or prevention of symptoms of allergic rhinitis (seasonal or perennial).

Children (5-12 years): One LEVOLUKAST 5-12 tablet once daily.
Method of administration
For oral administration only.

Common side effects include dyspepsia, abdominal pain, rash, dizziness, headache, fatigue, fever, trauma, cough, nasal congestion.
Use of levocetirizine has been associated with somnolence, fatigue, nasopharyngitis, dry mouth, and pharyngitis in subjects 12 years of age and older. Further uncommon incidences of adverse reactions like asthenia or abdominal pain were observed.

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.
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.
Renal Impairment
As levocetrizine is mainly excreted through urine, dosage adjustment may be required in patients with impaired renal function. Hence this combination should be used with caution in such patients.
Hepatic Impairment
As montelukast is mainly excreted through bile, caution is to be exercised while prescribing this combination in patients with impaired hepatic function.

Store below 30oC and protect from light and moisture.
Keep out of reach of children.

10 x 10 Alu/Alu blister pack
Montelukast Sodium & Levocetirizine Hydrochloride Tablets is available in an Alu/Alu blister of 10 tablets. Such 10 blisters in a unit carton with package insert.

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F. A. Q

Frequently Asked Questions

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We have below MOQ for:

  1. Tablet, Capsules & Softgel: 200000 Units
  2. Ampoules : 100000 Units
  3. Vials: 10000 Units
  4. Ointment and Cream: 15000 Units
  5. Suppository: 50000 Units
  6. Syrup and Liquid: 10000 Units
  7. Sachets : 50000 Units

We do ready the product within 45-60 days after product artwork confirmation from your side. So, including transit time you can get the product within 90 days maximum, either by Air or Sea route.

A product's “shelf life” generally means the length of time you can expect a product to look and act as expected and to stay safe for use. This length of time varies, depending on the type of product, how it is used, and how it is stored.

Our products come with a minimum of 24 months to a maximum of 36 months of shelf life.

For, Primary packaging we use aluminium foil with 20 to 50 micron size and PVC foil with 350 to 400 micron depending on product characteristics and stability.

For, Secondary packing we do use 300 to 400 GSM FFB Card board.

For, Tertiary packing we do us 7 ply 150 GSM corrugated boxes to prevent the damage during transits.

Yes, we do have available for all dossier documents according to GMP guidelines for the respective country. We do also provide COPP and Free sale certificates (FSC) on demand to customers for special import permit type of commercial orders.