- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Immunology and vaccination, Infectious disease, and Respiratory disease and allergy
Healthcare professionals should advise patients and/or carers of the changes in the dose, packaging, dose dispenser and leaflet.
Article date: September 2012
Oseltamivir (Tamiflu) is licensed to treat patients aged 1 year and above with symptoms of influenza when the virus is circulating in the community. It is also licensed to prevent influenza in individuals who have been in contact with a clinically diagnosed case of influenza when the virus is circulating in the community. Tamiflu should not be given to infants aged below 12 months except during pandemic outbreaks of influenza. Tamiflu is available as hard capsules and an oral suspension.
Changes to concentration of oral suspension
The 12 mg/mL suspension which is used for children, and for those who find it difficult to swallow tablets, has been withdrawn and will be replaced in October 2012 by a more dilute 6 mg/mL suspension. The new strength will make it possible to dispense the dose with greater accuracy. At the same time, a new dosing dispenser, calibrated in millilitres will be introduced and the dosing tables in the product information will include a new column showing the volume in millilitres based on the new 6 mg/mL concentration.
In August 2012 aletter was sent to healthcare professionals informing them of the new changes. It is important for clinicians and their patients to be aware of these changes in the concentration of the oral suspension and in the way the dose dispenser is calibrated.
Advice for health care professionals:
- Tamiflu oral suspension 12 mg/mL is no longer available. It will be replaced by a 6 mg/mL suspension from early October 2012. Please note that from end July 2012 – early October 2012 there will be no Tamiflu oral suspension products available in the UK; however, Tamiflu hard capsules remain available in this period and these can be used to prepare a suspension
When prescribing Tamiflu oral suspension, state the dose in millilitres (mL). The dosing tables in the Summary of Product Characteristics for the 6 mg/mL suspension include a column showing this dosage.
- Ensure that patients and/or carers are made aware that the product is different from what they may have used in the past and that the dose dispenser, carton packaging and packaging leaflet have changed.
Please remember to report suspected adverse reactions to Tamiflu, or any medicine or vaccine, on a Yellow Card at www.mhra.gov.uk/yellowcard
BNF section 5.3 Antiviral drugs
Summary of Product Characteristics for Tamiflu oral suspension 6 mg/mL
Article citation: Drug Safety Update September 2012, vol 6, issue 2: A2