Generic Name: pregabalin (pre-GA-ball-in)

Brand Names: Lyrica®

Classification: Antiepileptic, Analgesic

Issue Date: 2001

Lyrica affects chemicals and nerves in the body that are involved in the cause of seizures and some types of pain. The exact way that it works is unknown.

Lyrica is used with other drugs in the treatment of some types of seizures. It is also used for the management of postherpetic neuralgia (nerve pain caused by the herpes virus or shingles) and for diabetic peripheral neuropathy (pain from damaged nerves that happen with diabetes).

As of June 21, 2007, Lyrica® (pregabalin) has been approved by the FDA for treatment of FM. The effectiveness of Lyrica® in treating FM was established in two clinical trials. Lyrica was used for the reduction of fibromyalgia symptoms, patients showed significant improvement in pain, sleep, fatigue and quality of life. Lyrica is a structural derivative of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter. Manufactured by Pfizer, Inc., Lyrica has received FDA approval for the treatment of diabetic neuropathic pain, postherpetic neuralgia and the adjunctive treatment of partial onset seizures in adults with epilepsy.

If you are taking Lyrica for seizures, do not stop taking Lyrica even if you feel better. It is important to continue taking the medication to prevent seizures from recurring.

Do not stop taking Lyrica without talking to your doctor. Stopping suddenly may result in insomnia, nausea, headache, or diarrhea.

Lyrica may cause problems with your vision including blurry vision. Contact your doctor if you experience any changes in vision.

Talk to your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, excessive tiredness or fever.

Use caution when driving, operating machinery, or performing other hazardous activities. Lyrica may cause dizziness, sleepiness or blurred vision. If you experience any of these symptoms avoid these activities.

Take Lyrica exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose of Lyrica with a full glass of water. Lyrica can be taken with or without food. Do not stop taking Lyrica without talking to your doctor. Suddenly stopping Lyrica may cause side effects.

Store Lyrica tablets and capsules at room temperature away from moisture and heat.

Before taking this medication, tell your doctor if you have any other medical conditions including:

• kidney problems
• heart problems
• bleeding problems or a low blood platelet count
• if you are pregnant or plan to become pregnant
• if you are breast-feeding

Tell your doctor, if you have abused prescription medicines, street drugs, or alcohol in the past.

Tell your doctor about all the medicines you take including prescription or non-prescription medicines, vitamins or herbal supplements. Lyrica and other medicines may affect each other. Especially tell your doctor if you take:

• rosiglitazone (Avandia®)
• pioglitazone (Actos®)
• any narcotic pain medicine (such as oxycodone)
• tranquilizers or medicines for anxiety (such as lorazepam)
• any medicines that make you sleepy

Tell your doctor if you plan to father a child. Animal studies showed that Lyrica made animals less fertile. Also, in animal studies, birth defects occurred in the offspring of male animals who were treated with Lyrica. It is not known if these effects would happen in people.

It is not known whether Lyrica will be harmful to an unborn baby. Do not take Lyrica without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known if Lyrica passes into breast milk and if it can harm your baby. You and your doctor should decide whether you should take Lyrica or breast-feed, but not both.

Use caution when driving, operating machinery, or performing other hazardous activities. Lyrica may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Lyrica will cause drowsiness and fatigue. Avoid alcohol, sleeping pills, antihistamines, sedatives, and tranquilizers that may also make you drowsy except under the supervision of your doctor.

Take the missed dose as soon as you remember. However, if several hours have passed and it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of the medication to catch up.

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction:

• skin rash or hives
• difficulty breathing
• swelling of your face, lips, tongue, or throat

Other, side effects may be more likely to occur. Talk to your doctor if you experience:

• dizziness, poor coordination, or drowsiness
• blurred or double vision
• weight gain and swelling of the hands and feet
• unexplained muscle problems, such as muscle pain, soreness, or weakness
• dry mouth
• tremor

Lyrica caused skin sores in animals. Although skin sores were not seen in studies in people, if you have diabetes, you should pay extra attention to your skin while taking Lyrica and tell your doctor of any sores or skin problems.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Tell your doctor about all the medicines you take including prescription or non-prescription medicines, vitamins or herbal supplements. Lyrica and other medicines may affect each other. Especially tell your doctor if you take:

• rosiglitazone (Avandia®)
• pioglitazone (Actos®)
• narcotic pain medicine (such as oxycodone)
• tranquilizers or medicines for anxiety (such as lorazepam)
• medicines that make you sleepy

Drugs other than those listed here may also interact with Lyrica or affect your condition. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.