Levocetirizine Tablets 5 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 5 mg

Reference Brands: Xyzal(US)

Category: ENT

Levocetirizine 5 mg film-coated tablets, a once-daily second-generation antihistamine for allergic rhinitis and chronic urticaria. For importers, distributors, pharmacy chains and tender buyers sourcing registered generic supply.

Product Description:

Levocetirizine is the active R-enantiomer of cetirizine, a second-generation antihistamine. It blocks peripheral H1 receptors, and little of it enters the brain at the usual dose, so it is far less sedating than older antihistamines. This page lists 5 mg film-coated tablets. Because the enantiomer carries the activity, it is given at half the milligram dose of cetirizine.

It is licensed for seasonal and perennial allergic rhinitis and for chronic idiopathic urticaria, often alongside a nasal corticosteroid when nasal symptoms persist. One tablet is taken daily with or without food, and US labelling suggests the evening. Dosing for children aged 6 to 11 differs between labels, so the local SmPC decides. It is cleared mainly by the kidneys: doses are spaced out in moderate renal impairment, and it is contraindicated in end-stage renal disease. Drowsiness and dry mouth are the commonest effects, and patients are warned about alcohol.

Sourcing notes. A CTD or ACTD dossier with bioequivalence against the reference tablet is the normal requirement for this mature generic. Ask for zone IVb stability if goods are going to hot, humid climates. Tablets come in Alu-Alu or aluminium-PVC blisters at room temperature. Request a CoA for every batch, a current GMP certificate and a CoPP issued by the exporting regulator. It is sold without prescription in some markets and on prescription in others, which changes label text and pack size. In the enquiry, give blister count per carton, artwork language and shelf life needed on arrival.

Also known as: levocetirizina (Spanish), lévocétirizine (French), Levocetirizin (German), левоцетиризин (Russian), ليفوسيتريزين (Arabic), 左西替利嗪 (Chinese), 레보세티리진 (Korean), เลโวเซทิริซีน (Thai).