What is Lamivudine / Zidovudine Teva?
Lamivudine / Zidovudine Teva is a medicine containing two active substances: lamivudine (150 mg) and zidovudine (300 mg). It is available as white capsule-shaped tablets.
Lamivudine / Zidovudine Teva is a 'generic medicine'. This means that Lamivudine / Zidovudine Teva is similar to a 'reference medicine' already authorized in the European Union (EU) called Combivir.
What is Lamivudine / Zidovudine Teva used for?
Lamivudine / Zidovudine Teva is used in combination with at least one other antiviral medicine to treat patients infected with human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS).
The medicine can only be obtained with a prescription.
How is Lamivudine / Zidovudine Teva used?
Lamivudine / Zidovudine Teva therapy should be started by a physician experienced in the treatment of HIV infection. The recommended dose of Lamivudine / Zidovudine Teva for patients over 12 years of age weighing at least 30 kg is one tablet twice per day. In children (under 12 years of age) weighing 14 to 30 kg, the number of tablets and half tablets to take depends on their weight. Children weighing less than 14 kg should use separate oral solutions containing lamivudine and zidovudine. Children taking Lamivudine / Zidovudine Teva should be monitored closely for any side effects.
It is recommended to swallow the tablets without crushing them. Patients who are unable to do this can crush the tablets and add them to a small amount of food or drink immediately before ingesting them. In case of patients who have to stop taking lamivudine or zidovudine or who have to vary their doses due to kidney, liver or blood problems, medicines containing lamivudine or zidovudine should be used separately.
For more information, see the package leaflet.
How does Lamivudine / Zidovudine Teva work?
Both active substances in Lamivudine / Zidovudine Teva are nucleoside reverse transcriptase inhibitors (NRTIs). They exert a similar action, blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and reproduce. Lamivudine / Zidovudine Teva, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level. Lamivudine / Zidovudine Teva does not cure HIV infection or AIDS, but it can delay damage to the immune system and the onset of AIDS-associated infections and diseases.
Both active substances have been available in the European Union (EU) for several years: lamivudine has been authorized as Epivir since 1996 and zidovudine has been available in the EU since the mid-1980s.
How has Lamivudine / Zidovudine Teva been studied?
As Lamivudine / Zidovudine Teva is a generic medicine, the patient studies have been limited to evidence designed to show that the medicine is bioequivalent to the reference medicine, Combivir. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
What are the risks and benefits associated with Lamivudine / Zidovudine Teva?
Since Lamivudine / Zidovudine Teva is a generic medicine, the benefits and risks are assumed to be the same as the reference medicine.
Why has Lamivudine / Zidovudine Teva been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in accordance with EU requirements, Lamivudine / Zidovudine Teva has been shown to have comparable quality and to be bioequivalent to Combivir. Therefore, the CHMP considered that, as in the case of Combivir, the benefits outweigh the identified risks. The Committee recommended that the marketing authorization be given for Lamivudine / Zidovudine Teva.
More information about Lamivudine / Zidovudine Teva
On 28 February 2011, the European Commission released Teva Pharma B.V. a "Marketing Authorization" for Lamivudine / Zidovudine Teva, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
Last update of this summary: 12/2010.
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