Safety in Lactation: Anti-infective eye preparations

30 October 2020Anti-infective preparations for ophthalmic use have limited systemic absorption in the mother, and pose negligible risk to a breastfed infant. Systemic absorption from eye drops…

Safety in Lactation: Herpes simplex and varicella-zoster infection

21 September 2020Although there is limited evidence for the use of these antivirals during breastfeeding, aciclovir is the preferred choice. Valaciclovir is also an acceptable choice since…

Sexual Health Patient Group Direction (PGD) Templates

9 April 2020SPS and the British Association of Sexual Health and HIV (BASHH)/British Association of HIV (BHIVA), with the support of specialist stakeholders working within clinical practice,…

How should medicines be dosed in children who are obese?

18 October 2018Review on how to calculate medicine doses in children who are obese which includes a table on commonly prescribed medicines.

What advice should be given to people with porphyria who are undergoing dental procedures?

17 March 2017An indication of the safety of various medicines commonly used by dentists in patients with acute porphyria is given. When considering the safety of medicines…
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Medicine Compliance Aid Stability

ZoviraxGlaxoSmithKline UK

GlaxoSmithKline UK
Tablets dispersible 200mg, 800mg
R1 · Red 1Stability data indicates that the drug is not suitable for CAs.
Store in airtight containers. Protect from light and moisture. Disintegrates outside packaging
29 July 2015

genericActavis UK Ltd

Actavis UK Ltd
Tablets 200mg, 400mg, 800mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Airtight container
Protect from light
Protect from moisture
Store in airtight containers. Protect from light and moisture
18 August 2015

Lactation Safety Information

Oral / Intravenous

Oral / Intravenous
Small amounts in breast milk
Used in full-term neonates from birth
Moderate level of evidence of use in breastfeeding
Poor oral bioavailability
17 September 2020

For ophthalmic use

For ophthalmic use
Eye ointment discontinued globally December 2018
17 September 2020

For topical use

For topical use
No published evidence of safety
Remove product from the breast before feeding (creams are easier to remove than ointments)
16 October 2020

New Medicines

SitavigRecurrent orofacial herpes simplex in immunocompetent patients


New formulation

Development and Regulatory status

Licensed but not launched
Jan 21Vectans intends to continue to develop its international presence in 2021 - no specific details have been announced as to whether its is pursuing commercial arrangements to bring Sitavig to the UK [13].
Jan 19Sitavig was launched in France in 2018, but no details are available yet regarding launch in other EU countries [12].
Jul 17Onxeo divests Sitavig to Vectans Pharma. Vectans Pharma specialises in commercialisation of drugs for oral pathologies [11].
May 16Bruno Farmaceutici will launch Labiriad® (name of Sitavig® in Italy) under its current regulatory status (prescription) and manage the regulatory procedure to obtain an over-the-counter (OTC) designation [10].
May 16Onxeo states on its website that Sitavig is to be marketed by international partners, mainly via licensing agreements, contributing towards the funding of other development projects [8].
Jul 15Onxeo sign a license agreement for Sitavig® with specialty pharmaceutical company Bruno Farmaceutici for commercialisation in Italy [8].
Aug 14BioAlliance Pharma merges with TopoTarget to form Onxeo [7].
Apr 13Sitavig® approved in US for treatment of recurring Herpes labialis [4].
Apr 13The first 8 EU countries in which Sitavig was approved include Sweden, the UK, Spain, Italy, Denmark, Finland, Norway & Poland. BioAlliance Pharma planned to submit registration dossiers in other European countries as soon as the 1Q 2013. The evaluation by the agencies should then last 4 to 6 months [5].
Feb 13Approved in the UK [6].
Dec 12Recommended for approval for treatment of recurrent labial herpes in immunocompetent pts presenting with more than four episodes a year, in 8 European countries including the UK, following a decentralised prcedure with Sweden as the refererence member state [3].
May 12US FDA has accepted the registration dossier for Sitavig (Sitavir) [2].
May 12US FDA has registration dossier for Sitavig (Sitavir). FDA has 60 days to conduct preliminary review and confirm validity for substantial review. Dossier is based on results of pivotal PIII clinical trial. [2]
Oct 11Filed in EU [1].


DNA polymerase inhibitor
According to a survey in 2000 patients, more than 33% suffered recurrent herpes (4 episodes and more a year) with an annual average of 6.3 episodes. [1]
Recurrent orofacial herpes simplex in immunocompetent patients

Trial or other data

Oct 11The EU filing is based on results PIII trial in 775 patients where one single application of Sitavir® 50mg significantly reduced the occurrence of vesicular lesions (p=0.043), the duration of the herpes episode (p=0.0038) and the severity of symptoms (p=0.008). A 9-month follow-up showed that Sitavir® had an effect on the long term, delaying the time to occurrence of the following herpes episode (p=0.04). [1]
Oct 11Mucoadhesive buccal tablet delivering very high concentrations of the active ingredient in mucosa and lips.