ZELITREX Tablet Ref.[50340] Active ingredients: Valaciclovir

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2013  Publisher: LITHA PHARMA (PTY) LTD, 106 16th Road, Midrand, 1685, South Africa

Product name and form

ZELITREX 250 Tablets.

ZELITREX 500 Tablets.

Pharmaceutical Form

Tablet.

ZELITREX 250: Biconvex, elongated, white film-coated tablet with a white to off-white core. Unscored and branded GXCE7 by engraving.

ZELITREX 500: Biconvex, elongated, white film-coated tablet with a white to off-white core. Unscored and branded GXCF1 and printed with blue-green or blue ink.

Qualitative and quantitative composition

ZELITREX 250 Tablets contain: valaciclovir hydrochloride equivalent to 250 mg valaciclovir per tablet.

ZELITREX 500 Tablets contain: valaciclovir hydrochloride equivalent to 500 mg valaciclovir per tablet.

Active Ingredient Description
Valaciclovir

Valaciclovir, an antiviral, is the L-valine ester of aciclovir. Valaciclovir is rapidly and almost completely converted in man to aciclovir and valine. Aciclovir is a specific inhibitor of the herpes viruses with in vitro activity against herpes simplex viruses (HSV) type 1 and type 2, varicella zoster virus (VZV), cytomegalovirus (CMV), Epstein-Barr Virus (EBV), and human herpes virus 6 (HHV-6).

List of Excipients

The tablet core also contains microcrystalline cellulose, crospovidone, povidone K90, magnesium stearate and colloidal anhydrous silica.

The film-coat contains hydroxypropylmethylcellulose titanium dioxide, polyethylene glycol 400. The 500 mg film-coat also contains polysorbate and blue printing ink.

Pack sizes and marketing

ZELITREX 250: Blister pack of 60 tablets.

ZELITREX 500: Blister packs of 42 tablets.

Blister packs of 30 tablets.

Blister packs of 10 tablets.

Marketing authorization holder

LITHA PHARMA (PTY) LTD, 106 16th Road, Midrand, 1685, South Africa

Marketing authorization dates and numbers

ZELITREX 250: 32/20.2.8/0465

ZELITREX 500: 29/20.2.8/0442

Drugs

Drug Countries
ZELITREX Australia, France, Italy, Netherlands, Tunisia, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.