What is Zypraxa Velotab?
Zypraxa Velotab is a medicine that contains 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 range of symptoms, including thought and speech disorders, hallucinations, suspiciousness and delusions. Zypraxa Velotab is also effective in maintaining improvement in patients who have responded positively to initial treatment.
Zypraxa Velotab is also used to treat severe manic episodes (particularly high mood) in adults. It can also be used to prevent the recurrence of manic episodes (recurrence of symptoms) in adults with bipolar disorder (a mental illness characterized by alternating manic and depressive phases) in patients who have responded to the initial treatment.
The medicine can only be obtained with a prescription.
How is Zypraxa Velotab used?
The recommended starting dosage of Zypraxa Velotab depends on the disease being treated: for schizophrenia and the prevention of manic episodes it is 10 mg per day; for the treatment of manic episodes is 15 mg per day, unless used in combination with other medicines, in which case the starting dose may be 10 mg per day. The dosage should be adjusted according to the patient's response and 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 rapidly disperse in saliva, or they can be dissolved in water before being taken. The initial dosage (5 mg per day) should be reduced in patients over 65 years of age and in subjects with liver or kidney problems.
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 older antipsychotic drugs available since the 1950s. While its exact mechanism of action is not known, it is nonetheless connected to a few different receptors on the surface of nerve cells in the brain, which disrupts the signals transmitted between brain cells through "neurotransmitters" - the chemicals that allow nerve cells to communicate with each other. the beneficial effect of olanzapine is due to its ability to block the receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine. Since these neurotransmitters are implicated in schizophrenia and bipolar disorder, olanzapine contributes to the normalization of brain activity, reducing the symptoms of these diseases.
How has Zypraxa Velotab been studied?
Zypraxa Velotab contains the same active ingredient as another medicine called Zyprexa, which has already been 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. Those 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?
Similar to Zyprexa, Zypraxa Velotab was more effective in improving symptoms than placebo (a dummy treatment). Zypraxa Velotab was as effective as the drugs it was compared to for treating adults with schizophrenia, treating moderate to severe manic episodes in adults, and preventing relapse in adults with bipolar disorder.
What is the risk associated with Zypraxa Velotab?
The most common side effects with Zypraxa Velotab (seen in more than 1 in 10 patients) are sleepiness, weight gain and increased levels of prolactin (a hormone). For the full list of side effects reported with Zypraxa Velotab, see the package leaflet.
Zypraxa Velotab should not be used by 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 demonstrated a positive response to initial treatment, for the treatment of moderate to severe manic episode and for the prevention of new episodes in patients with bipolar disorder. The Committee recommended that Zypraxa Velotab be given a marketing authorization.
More information about Zypraxa Velotab
On 3 February 2000, the European Commission issued Eli Lilly Nederland B.V. a "Marketing Authorization" for Zypraxa Velotab, valid throughout the EU. The "Marketing Authorization" was renewed on February 3, 2005 and September 27, 2006.
For the full evaluation version (EPAR) of Zypraxa Velotab, click here.
Last update of this summary: 09-2008.
The information on Zypraxa Velotab - olanzapine published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
