What is Zypraxa Velotab?
Zypraxa Velotab is a medicine containing the active substance olanzapine. The medicine is available in yellow and round orodispersible tablets (5, 10, 15 and 20 mg). Orodispersible tablets are tablets that dissolve in the mouth.
What is Zypraxa Velotab used for?
Zypraxa Velotab is indicated for the treatment of adults with schizophrenia. Schizophrenia is a mental illness characterized by a series of symptoms, including thought and speech disorders, hallucinations, suspiciousness and delusions. Zypraxa Velotab is also effective for maintaining improvement in patients who have responded positively to initial treatment.
Zypraxa Velotab is also used for the treatment of severe manic episodes (particularly euphoric mood) in adults. It can also be used to prevent the recurrence of manic episodes (reappearance of symptoms) in adults with bipolar disorder (a mental illness characterized by the alternation of manic and depressive phases) in patients who have responded to initial treatment.
The medicine can only be obtained with a prescription.
How is Zypraxa Velotab used?
The recommended initial dosage of Zypraxa Velotab depends on the disease to be treated: for schizophrenia and the prevention of manic episodes it is 10 mg a day; for the treatment of manic episodes it is 15 mg a day, unless it is used in combination with other drugs, in which case the starting dose may be 10 mg a day. The dosage should be adjusted according to the patient's response and the degree of tolerance of the therapy within a range of 5 to 20 mg per day. The orodispersible tablets must be placed on the tongue, where they are rapidly dispersed in the saliva, or they can be dissolved in the water before being taken. It is necessary to reduce the initial dosage (5 mg per day) in patients over 65 and in subjects with problems affecting the liver or kidneys.
How does Zypraxa Velotab work?
The active substance in Zypraxa Velotab, olanzapine, is an antipsychotic drug, Known as an "atypical" antipsychotic, as it differs from the old antipsychotic drugs available since the 1950s. Although its exact mechanism of action is not known, it is linked to some different receptors on the surface of nerve cells in the brain. In this way the signals transmitted between the brain cells are interrupted through the "neurotransmitters", ie the chemical substances that allow nerve cells to communicate with each other. It is believed that the beneficial effect of olanzapine is due to its ability to block receptors for neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine. Because these neurotransmitters are involved in schizophrenia and bipolar disorder, olanzapine contributes to the normalization of brain activity, reducing the symptoms of these diseases.
What studies have been carried out on Zypraxa Velotab?
Zypraxa Velotab contains the same active ingredient as another drug called Zyprexa, already authorized in the European Union since 1996. As a result, studies carried out for Zyprexa have been used to support the use of Zypraxa Velotab. These studies have also shown that, when taken orally, the two drugs produce equivalent levels of olanzapine in the blood.
What benefit has Zypraxa Velotab shown during the studies?
Similarly to Zyprexa, Zypraxa Velotab was more effective in improving symptoms than placebo (a dummy treatment). Zypraxa Velotab has proved to be as effective as the drugs compared to the treatment of adults with schizophrenia, the treatment of moderate to severe manic episodes in adults and the prevention of relapse in adults with bipolar disorders.
What is the risk associated with Zypraxa Velotab?
The most common side effects with Zypraxa Velotab (seen in more than 1 patient in 10) are drowsiness, increased body weight and increased levels of prolactin (a hormone). For the full list of all side effects reported with Zypraxa Velotab, see the Package Leaflet.
Zypraxa Velotab should not be used in people who are hypersensitive (allergic) to olanzapine or any of the other ingredients. Zypraxa Velotab should not be used in patients at risk of narrow-angle glaucoma (increased pressure in the eye).
Why has Zypraxa Velotab been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Zypraxa Velotab's benefits are greater than its risks for the treatment of schizophrenia in adults, for the maintenance of clinical improvement in follow-up therapy in patients who have shown a positive response to initial treatment, for the treatment of moderate to severe mania episode and for the prevention of new episodes in patients with bipolar disorder. The Committee recommended the granting of the marketing authorization for Zypraxa Velotab.
More information on Zypraxa Velotab
On 3 February 2000, the European Commission granted an EU-wide marketing authorization for Zypraxa Velotab to Eli Lilly Nederland BV. The marketing authorization was renewed on 3 February 2005 and 27 September 2006.
For the full version of the evaluation (EPAR) of Zypraxa Velotab, click here.
Last update of this summary: 09-2008.
