Pregabalin

Follow your doctor’s directions. Call if you have any questions. Lyrica usually needs to be taken two or three times a day.

It's OK to take Lyrica either with food or without food, but it’s best to be consistent day after day. Swallow the capsules whole. As the doctor increases the amount of Lyrica that you take, you may be prescribed a higher-strength capsule. Be careful! For example, if you've been using 150-mg capsules and the new prescription is for 300-mg capsules, be careful to use the correct number of capsules. Don't automatically continue to use the same number of capsules as before.

Store the capsules at room temperature, away from dampness. Keep Lyrica out of the reach of children.

Take only the amount that your doctor tells you to take. If you think you've taken one extra capsule, call the doctor for advice. For a larger overdose, call the poison control center or your hospital's emergency room unless you have special instructions from the doctor. The very few people who have taken large doses have all recovered, with appropriate medical care.

Don't stop taking Lyrica or change the amount you take without talking to your doctor first. Stopping any seizure medicine all at once can cause serious problems. The package insert states that discontinuation of Lyrica should be done gradually over a minimum of one week.

In general, if you forget a dose, take it as soon as you remember. If it is almost time for the next dose, you should delay that dose for a few hours, instead of taking two doses very close together. If you’re not sure what to do, call the doctor’s office for more advice.

Do your best to follow the doctor's directions. The more capsules that must be taken, the greater the chance of forgetting. If you forget doses often, it may be a good idea to get a special pillbox or watch with an alarm to remind you.

Taking the right amount of seizure medicine on time every single day is the most important step in preventing seizures!

Brain cells need to work (fire) at a certain rate to function normally. During a seizure, brain cells are forced to work much more rapidly than normal. Lyrica helps prevent brain cells from working as fast as a seizure requires them to. In this way, seizures can be stopped when they are just beginning. We don’t completely understand how Lyrica works in the brain to stop seizures.

After medicine is swallowed, it must be absorbed into the blood so it can move throughout the body. The process of absorbing a medicine or food, digesting it, and eliminating it from the body is called metabolism. The way the body metabolizes a particular medicine affects how often it must be taken. It also determines whether it will interact with other medicines or be affected by conditions such as disease of the liver or kidneys.

Many other medicines are metabolized by the liver, but Lyrica is not. This is why it does not affect the way other medicines work, and they do not affect Lyrica. People with liver disease should be able to use it without trouble.

The body removes Lyrica through the kidneys, so people with kidney disorders need to be careful. To prevent too much Lyrica from building up in the body, they usually need to take less Lyrica and take it less often.

Doctors have studied large numbers of people with epilepsy to find out how well Lyrica controls seizures. When it was used as an add-on with another seizure medicine, a number of adults had large reductions in their seizures, and side effects were not much trouble.

Lyrica is not the best add-on seizure medicine for everyone. Sometimes, a series of combinations must be tried before finding what is best for the individual. Lyrica does have an advantage over some other medicines used for add-on therapy, because the doctor won't have to change how much of the first medicine is prescribed. The lack of interactions also makes Lyrica a good choice for people who need to take medicines for other disorders.

Patients with partial seizures who took Lyrica in the clinical studies and discontinued because of side effects most often mentioned:

• dizziness
• imbalance
• tiredness, sleepiness

Less common reasons for discontinuing Lyrica in the clinical studies were:

• weakness
• double or blurred vision
• trouble concentrating/thinking
• nausea
• tremor
• headache
• confusion

Other side effects that can occur when Lyrica is taken in combination with other seizure medicines include:

• accidental injury
• pain
• increased appetite
• dry mouth
• constipation
• weight gain
• swelling in the extremities (edema)
• trouble with memory
• trouble with speech
• twitching
• euphoria (feeling “high”)

If you notice problems like any of these while you are taking Lyrica, it's probably a good idea to discuss them with your doctor or nurse. Don't stop taking Lyrica or any other seizure medicine without the doctor's advice. Sometimes the doctor can help with these side effects by changing the prescription:

• reducing the overall amount
• prescribing smaller doses, to be taken more often
• changing the amount taken at certain times, such as taking a greater proportion at bedtime to reduce daytime sleepiness

Allergic reactions
There do not appear to be any allergic reactions to Lyrica.

Long-term side effects
The long-term side effects of Lyrica are not known.

Although Lyrica has been taken by over 10,000 patients, less than 1,000 patients have taken Lyrica for epilepsy, and as of 2005, less than 2,000 patients had taken Lyrica for any reason for more than 2 years. At this time, Lyrica has not been found to injure the liver, kidneys, or blood cells. (Injuries of this type have occurred with some other seizure medicines.)

Most people who take Lyrica have mild side effects that go away with no lasting harm, or even no side effects at all. Lyrica appears to be a safe medicine, and no life-threatening reactions have been attributed to it. As with any medication, patients should consult the package insert for further details.

One other warning—it's not unusual for Lyrica to make people feel a bit sleepy or uncoordinated. If you've just started taking Lyrica or have just had your dosage increased, be careful when doing things that could be dangerous (like driving or operating machinery) until you know how it will affect you. Be particularly cautious if you tend to be sensitive to medications.

If you believe that you have experienced a serious side effect from a medication, you or your physician can bring it to the attention of the FDA, through their MedWatch program, by completing an adverse event report form. MedWatch is the FDA's program for reporting serious reactions and problems with medical products, such as drugs and medical devices. To learn more about the Medwatch program go to:
www.fda.gov/medwatch/report/consumer/consumer.htm

On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10.

• Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;
• Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
• Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
• Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions

We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

Medicines are often useful for more than one purpose. Besides controlling seizures, Lyrica is also approved by the Food and Drug Administration (FDA) to treat a condition called postherpetic neuralgia, which is pain that follows the viral rash commonly known as shingles, and for nerve pain in patients with diabetes who have nerve damage. Lyrica is also approved in Europe, but not the United States, as treatment for generalized anxiety disorder.

Lyrica is not effective for two types of generalized seizures called absence and myoclonic seizures. Lyrica, which is closely related to Neurontin, may even worsen absence and myoclonic seizures, so people with these types of seizures should not take Lyrica.

Also, people who are allergic to pregabalin or other ingredients in Lyrica should not take it.

The safety and effectiveness of Lyrica in children has not yet been established.

The U.S. Food and Drug Administration (FDA) lists Lyrica in Pregnancy Category C. This indicates that caution is advised, but the benefits of the medication may outweigh the potential risks. There have been no good scientific studies in women, but studies in animals have shown some harm to the fetus.

Talk to your doctor or another health professional if you are pregnant or plan to become pregnant. We don't yet have enough information to be able to estimate the risk of various types of birth defects that might occur if Lyrica is taken during pregnancy. We also don't know enough to compare the risk with Lyrica to the risk with other seizure medicines.

In general, the risk of birth defects is higher for women who take combinations of seizure medicines during their pregnancy and for women with a family history of birth defects. Whether this applies to Lyrica is not yet known.

Women who are capable of becoming pregnant should take at least 400 micrograms (0.4 mg) of folic acid (folate) daily to help prevent a type of birth defect called a neural tube defect. (The best-known of these is spina bifida, in which the spinal cord is not completely enclosed.) Women at high risk, such as those with a history of this kind of defect in a previous pregnancy, should take 4000 micrograms (4 mg) daily, beginning before they become pregnant.

About 20% to 35% of women have seizures more often during pregnancy because of changes in hormones or changes in how their seizure medicine is handled by the body. Even though this may not apply to Lyrica, the doctor may recommend checking the level of medication in the blood regularly during pregnancy so that the dosage can be adjusted as needed.

It is not yet known if Lyrica is found in human breast milk, but it is likely to be. The effect, if any, on the infant is unknown.

In clinical studies of patients with epilepsy, only 10 patients over the age of 65 took Lyrica. More patients over the 65 took Lyrica in the clinical studies for postherpetic neuralgia and painful diabetic neuropathy (see Besides epilepsy, what else is Lyrica used for?). There were no apparent differences in safety or effectiveness in patients over 65 compared to younger patients.

Still, because older people have diminished kidney function and tend in general to be more sensitive to medication side effects, it's reasonable for the doctor to prescribe a low dose at the beginning and increase it more slowly than for a younger person.

Some common side effects of Lyrica, such as trouble with coordination, may worsen pre-existing problems of seniors, and their greater risk of injury from falls or other accidents makes this an area of concern.

Because Lyrica generally does not interact with other medications, it can be a good choice for people (such as many seniors with epilepsy) who also are being treated for other disorders.

To reduce side effects, the doctor will probably prescribe a low dose of Lyrica to start and then be very cautious about any increases. It’s especially important for seniors to keep the doctor informed about any changes that they notice.

The best amount is the amount that completely controls seizures without causing troublesome side effects. It depends on many factors, which are different for every individual. Follow the doctor's directions. Call if you have any questions.

No one should stop taking Lyrica or change the amount they take without talking to the doctor first. Stopping any seizure medicine all at once can cause a problem that may be life-threatening.

Lyrica at doses of 150 to 600 mg/day have been shown to be effective as add-on (adjunctive) therapy in the treatment of adults with partial seizures. Lyrica is usually started at 75 mg two times a day or 50 mg three times a day. Based on how well Lyrica is tolerated, the dose is gradually increased to a maximum dose of 600 mg/day. Doses higher than 600 mg/day have been taken, but have not been assessed by the FDA for safety and effectiveness.

People over age 65 and others with kidney dysfunction generally require a lower dosage and longer intervals between doses.

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for Lyrica (pregabalin) is found at:

• http://labeling.pfizer.com/ShowLabeling.aspx?id=561

Some of the information may differ in other countries.

To learn how to read and understand a package insert, see How to read a package insert.