Pregabalin was originally FDA approved in 2004 as an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Pregabalin also affects chemicals in the brain that send pain signals across the nervous system.

Pregabalin is used to treat pain caused by fibromyalgia, or nerve pain in people with diabetes (diabetic neuropathy), herpes zoster (post-herpetic neuralgia), or spinal cord injury.

Pregabalin is also used with other medications to treat partial-onset seizures in adults and children aged at least 1 month.

Pregabalin can cause a severe allergic reaction. Stop taking pregabalin and seek emergency medical help if you have hives or blisters on your skin, trouble breathing, or swelling in your face, mouth, or throat.

Some people have thoughts about suicide while taking pregabalin. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

If you have diabetes or heart problems, call your doctor if you have weight gain or swelling in your hands or feet while taking pregabalin.

Do not stop using pregabalin suddenly, even if you feel fine. Stopping suddenly may cause withdrawal symptoms.

Before taking this medicine

You should not use pregabalin if you are allergic to it.

Tell your doctor if you have ever had:

• lung disease, such as chronic obstructive pulmonary disease (COPD);

• a mood disorder, depression, or suicidal thoughts;

• heart problems (especially congestive heart failure);

• a bleeding disorder, or low levels of platelets in your blood;

• kidney disease (or if you are on dialysis);

• diabetes (unless you are taking pregabalin to treat diabetic neuropathy);

• drug or alcohol addiction; or

• a severe allergic reaction (angioedema).

Do not give this medicine to a child without medical advice.

• Pregabalin is not approved for use by anyone younger than 18 years old to treat nerve pain caused by fibromyalgia, diabetes, herpes zoster, or spinal cord injury.

• Pregabalin is not approved for seizures in anyone younger than 1 month old.

Some people have thoughts about suicide while taking pregabalin. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking pregabalin without your doctor's advice, and tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of pregabalin on the baby.

Pregabalin can decrease sperm count and may affect fertility in men (your ability to have children). In animal studies, pregabalin also caused birth defects in the offspring of males treated with this medicine. However, it is not known whether these effects would occur in humans. Ask your doctor about your risk.

You should not breastfeed while using pregabalin.

Pregabalin comes as a capsule, an oral solution, and as an extended-release tablet to take by mouth. Pregabalin capsules and oral solution are usually taken with or without food two or three times a day. Pregabalin extended-release tablets are usually taken once daily after an evening meal. Take pregabalin at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Swallow the extended-release tablets whole; do not cut, chew, or crush them.

Your doctor will probably start you on a low dose of pregabalin and may gradually increase your dose during the first week of treatment.

Take pregabalin exactly as directed. Pregabalin may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

Pregabalin may help control your symptoms but will not cure your condition. It may take several weeks or longer before you feel the full benefit of pregabalin. Continue to take pregabalin even if you feel well. Do not stop taking pregabalin without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking pregabalin, you may experience withdrawal symptoms, including trouble falling asleep or staying asleep, nausea, diarrhea, headaches, or seizures. Your doctor will probably decrease your dose gradually over at least 1 week.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with pregabalin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

Take pregabalin exactly as prescribed by your doctor and read all medication guides or instruction sheets about pregabalin. Your doctor may occasionally change your dose.

Take pregabalin at the same time each day, with or without food.

Swallow extended-release pregabalin tablets whole and do not crush, chew, or break them.

Measure pregabalin liquid medicine carefully. Use the dosing syringe provided or a medicine dose-measuring device (not a kitchen spoon).

Call your doctor if your symptoms do not improve, or if they get worse.

Do not stop using pregabalin suddenly, even if you feel fine. Stopping suddenly may cause increased seizures or unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose for at least 1 week before stopping completely.

In case of emergency, wear or carry medical identification to let others know you take seizure medication.

Store at room temperature away from moisture, heat, and light.

You should not use pregabalin if you are allergic to it.

Tell your doctor if you have ever had:

• lung disease, such as chronic obstructive pulmonary disease (COPD);

• a mood disorder, depression, or suicidal thoughts;

• heart problems (especially congestive heart failure);

• a bleeding disorder, or low levels of platelets in your blood;

• kidney disease (or if you are on dialysis);

• diabetes (unless you are taking pregabalin to treat diabetic neuropathy);

• drug or alcohol addiction; or

• a severe allergic reaction (angioedema).

Do not give this medicine to a child without medical advice.

• Pregabalin is not approved for use by anyone younger than 18 years old to treat nerve pain caused by fibromyalgia, diabetes, herpes zoster, or spinal cord injury.

• Pregabalin is not approved for seizures in anyone younger than 1 month old.

Some people have thoughts about suicide while taking pregabalin. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking pregabalin without your doctor's advice, and tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of pregabalin on the baby.

Pregabalin can decrease sperm count and may affect fertility in men (your ability to have children). In animal studies, pregabalin also caused birth defects in the offspring of males treated with this medicine. However, it is not known whether these effects would occur in humans. Ask your doctor about your risk.

You should not breastfeed while using pregabalin.

If you miss a dose of pregabalin, then take that dose as soon as you remember. If it is almost time for your next dose, then skip the missed dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid drinking alcohol. It may increase certain side effects of pregabalin.

Avoid driving or hazardous activity until you know how pregabalin will affect you. Your reactions could be impaired.

Pregabalin can cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have: hives or blisters on your skin; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Pregabalin may cause serious side effects. Call your doctor at once if you have:

• weak or shallow breathing;

• blue-colored skin, lips, fingers, and toes;

• confusion, extreme drowsiness or weakness;

• vision problems;

• skin sores (if you have diabetes);

• easy bruising, unusual bleeding;

• swelling in your hands or feet, rapid weight gain (especially if you have diabetes or heart problems); or

• unexplained muscle pain, tenderness, or weakness (especially if you also have fever or don't feel well).

Pregabalin can cause life-threatening breathing problems. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. Breathing problems may be more likely in older adults or in people with COPD.

If you have diabetes, tell your doctor right away if you have any new sores or other skin problems.

Common side effects of pregabalin may include:

• dizziness, drowsiness;

• swelling in your hands and feet;

• trouble concentrating;

• increased appetite;

• weight gain;

• dry mouth; or

• blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using pregabalin with other drugs that slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, cold or allergy medicine, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• oral diabetes medicine--pioglitazone, rosiglitazone; or

• an ACE inhibitor--benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.

This list is not complete. Other drugs may affect pregabalin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to pregabalin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.