What is Pregabalin Pfizer and what is it used for?
Pregabalin Pfizer is a medicine that contains the active substance pregabalin. It is used to treat adults with the following conditions:
- neuropathic pain (caused by damage to the nervous system). Pregabalin Pfizer can be used to treat peripheral neuropathic pain, for example in diabetic patients or patients with herpes zoster (St. Anthony's fire), and central neuropathic pain, which affects for example patients who have suffered a spinal injury;
- epilepsy. Pregabalin Pfizer is given as an add-on to existing therapy in patients with partial seizures (seizures starting in a specific "area of the brain) that cannot be controlled with current therapy;
- generalized anxiety disorder (chronic anxiety or nervousness about issues related to everyday life).
This medicine is the same as Lyrica, which is already authorized in the European Union (EU). The company that makes Lyrica has agreed that its scientific data can be used for Pregabalin Pfizer (“informed consent”).
How is Pregabalin Pfizer used?
Pregabalin Pfizer can only be obtained with a prescription and is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg). The recommended starting dose of Pregabalin Pfizer is 150 mg per day, divided into two or three doses. After three to seven days, the dose can be increased to 300 mg per day. Doses can be increased up to more than twice as much until the most effective dose is reached. The maximum dose is 600 mg / day. Stopping treatment with Pregabalin Pfizer should also be done gradually, over at least one week. The capsules should be swallowed whole with water. In patients with kidney problems the dosage is lower.
How does Pregabalin Pfizer work?
The active substance in Pregabalin Pfizer, pregabalin, is similar in structure to the body's "neurotransmitter" gamma-amino butyric acid (GABA), but has very different biological effects. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. The precise modes of action of pregabalin are not fully known, but pregabalin is thought to affect the way calcium enters nerve cells. This reduces the activity of some nerve cells in the brain and spinal cord, with a consequent reduction in the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.
What benefit has Pregabalin Pfizer shown during the studies?
Pregabalin Pfizer was compared with placebo (a dummy treatment) in 22 studies. For neuropathic pain, the benefits of Pregabalin Pfizer were evaluated for up to 12 weeks, using a standard pain questionnaire. In 10 studies involving over 3,000 patients with peripheral neuropathic pain (diabetic pain or St. Anthony's focus), 35% of patients treated with Pregabalin Pfizer had a 50% or more decrease in pain score compared to 18% of patients treated with placebo. In a smaller study of 137 patients with central neuropathic pain due to spinal cord injury, 22% of patients treated with Pregabalin Pfizer had a 50% or more decrease in pain score compared to 8%. of patients treated with placebo. The benefits of Pregabalin Pfizer in epilepsy were evaluated in 3 studies involving a total of 1 000 patients, which measured the change in the number of seizures after a period of 11- 12 weeks. About 45% of patients taking 600 mg of Pregabalin Pfizer per day and about 35% of subjects taking 300 mg of Pregabalin Pfizer per day experienced a reduction in seizures of 50% or more compared to a reduction of about 10% observed in subjects treated with placebo. Pregabalin Pfizer was more effective than placebo in generalized anxiety disorder: in 8 studies involving over 3,000 patients In 52% of subjects taking Pregabalin Pfizer there was an improvement of 50% or more in anxiety, as measured by a standard anxiety questionnaire, compared to 38% of patients treated with placebo.
What is the risk associated with Pregabalin Pfizer?
The most common side effects with Pregabalin Pfizer (which may affect more than 1 in 10 patients) are dizziness and sleepiness. For the full list of side effects and limitations, see the package leaflet.
Why has Pregabalin Pfizer been approved?
The CHMP decided that Pregabalin Pfizer's benefits are greater than its risks and recommended that it be given a Marketing Authorization for this medicine.
What measures are being taken to ensure the safe and effective use of Pregabalin Pfizer?
A risk management plan has been developed to ensure that Pregabalin Pfizer is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Pregabalin Pfizer, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found in the summary of the risk management plan.
More information about Pregabalin Pfizer
On 10 April 2014, the European Commission issued a "Marketing Authorization" for Pregabalin Pfizer, valid throughout the European Union. For the full version of the EPAR and the summary of the Pregabalin Pfizer Risk Management Plan, please consult the Agency website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Pregabalin Pfizer therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. Last update of this summary: 04-2014.
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