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 suffering from 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 patients with diabetes or shingles (S. Antonio fire), and central neuropathic pain, which affects, for example, patients who have suffered a spinal cord injury;
- epilepsy. Pregabalin Pfizer is administered as an adjunctive therapy to ongoing therapy in patients with partial seizures (seizures that begin in a specific area of the brain) that cannot be controlled with ongoing therapy;
- generalized anxiety disorder (chronic anxiety or nervousness in everyday life)
This medicine is the same as Lyrica, 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 a day. Doses can be increased up to twice the dosage until the most effective dose is reached. The maximum dose is 600 mg / day. The suspension of treatment with Pregabalin Pfizer must also take place gradually, over at least a 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 ingredient of Pregabalin Pfizer, pregabalin, is similar in structure to the "neurotransmitter" of the organism 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 mode of action of pregabalin is not entirely known, but pregabalin is believed to affect the way calcium penetrates 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 intervene 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 up to a maximum of 12 weeks, using a standard pain questionnaire. In 10 studies involving over 3, 000 patients with peripheral neuropathic pain (diabetic pain or S. Antonio fire), 35% of patients treated with Pregabalin Pfizer experienced 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 receiving Pregabalin Pfizer experienced a 50% or greater decrease in pain score compared to 8% of patients treated with placebo. In epilepsy the benefits of Pregabalin Pfizer were evaluated in 3 studies out of a total of 1, 000 patients, in which the change in the number of seizures was measured after a period of 11 to 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 due to a reduction in 10% approximately observed in subjects treated with placebo. In generalized anxiety disorder Pregabalin Pfizer was more effective than placebo: in 8 studies performed on over 3, 000 patients, in 50% of subjects receiving Pregabalin Pfizer an improvement of 50% or more was observed in the anxiety measured based on 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 patient in 10) are dizziness and drowsiness. 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 marketing authorization.
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 included in the summary of product characteristics and the package leaflet for Pregabalin Pfizer, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
Further information on Pregabalin Pfizer
On 10 April 2014, the European Commission issued a marketing authorization for Pregabalin Pfizer, valid throughout the European Union. For the full EPAR and Pregabalin risk management plan summary, see Pfizer on the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Pregabalin Pfizer, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 04-2014.
