Pregabalin

Pregabalin, also known as β-isobutyl-γ-aminobutyric acid (beta-isobutyl-GABA), is a medication used to treat epilepsy, neuropathic pain, fibromyalgia, andgeneralized anxiety disorder. Its use for epilepsy is as an add-on therapy for partial seizures with or without secondary generalization in adults.

Common side effects include: sleepiness, confusion, trouble with memory, poor coordination, dry mouth, problem with vision, and weight gain.Potentially serious side effects include angioedema, drug misuse, and an increased suicide risk.

Pregabalin is a derivative of the neurotransmitter γ-aminobutyric acid (GABA) and a potent gabapentinoid. It is a close structural analogue of GABA (see GABA analogue), as well as of gabapentin, GABOB, baclofen, and phenibut. It is a ion channel modulator that has rapid analgesic, anticonvulsant, and anxiolytic effects. Pregabalin is acentral nervous system depressant that has potential for abuse. The Drug Enforcement Administration (DEA) placed pregabalin, including its salts, and all products containing pregabalin into Schedule V of the Controlled Substances Act (CSA).

Pregabalin was originally marketed as Lyrica and is marketed under a number of brand names worldwide. As of 2016 no generic version is available in the United States. In the United States it costs about 300-400 USD per month.

Pregabalin is an anticonvulsant and neuropathic pain agent. Exactly how pregabalin works is not known. It is thought to bind to certain areas in the brain that help reduce seizures, nerve pain, and anxiety. It is used to treat fibromyalgia or nerve pain caused by certain conditions (eg, shingles, diabetic nerve problems, spinal cord injury). It is also used in combination with other medicines to treat certain types of seizures. It may also be used for other conditions as determined by your doctor.

Do NOT use pregabalin if:

  • you are allergic to any ingredient in pregabalin

Contact your doctor or health care provider right away if any of these apply to you.

Why is this medication prescribed?

Pregabalin is used to relieve neuropathic pain (pain from damaged nerves) that can occur in your arms, hands, fingers, legs, feet, or toes if you have diabetes or in the area of your rash if you have had shingles (a painful rash that occurs after infection with herpes zoster). It is also used to treat fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). Pregabalin is used with other medications to treat certain types of seizures in people with epilepsy. Pregabalin is in a class of medications called anticonvulsants. It works by decreasing the number of pain signals that are sent out by damaged nerves in the body.

How should this medicine be used?

Pregabalin comes as a capsule to take by mouth. It is usually taken with or without food two or three times a day. Take pregabalin at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

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 one 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.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking pregabalin,

  • tell your doctor and pharmacist if you are allergic to pregabalin, any other medications, or any of the ingredients in pregabalin capsules. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiotensin converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec, in Vaseretic, Lexxel), fosinopril (Monopril), lisinopril (Prinivil, Zestril, in Prinzide, Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon), quinapril (Accupril, in Accuretic, Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); antidepressants; antihistamines; medications for anxiety, including lorazepam (Ativan); medications for mental illness or seizures; certain medications for diabetes such as pioglitazone (Actos, in Duetact) and rosiglitazone (Avandia, in Avandaryl, Avandamet); narcotic pain medications, including oxycodone (OxyContin, in Percocet, others); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications. Also tell your doctor if you have or have ever had swelling of the eyes, face, lips, tongue, or throat; problems with your vision, bleeding problems or a low number of platelets (type of blood cell needed for blood clotting) in your blood, or heart or kidney disease.
  • tell your doctor if you are pregnant, or if you or your partner plans to become pregnant. Also tell your doctor if you are breast-feeding. If you or your partner becomes pregnant while you are taking pregabalin, call your doctor. Pregabalin has caused decreased fertility in male animals and birth defects in the offspring of male and female animals who were treated with the medication. There is not enough information to tell if pregabalin causes these problems in humans.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pregabalin.
  • you should know that pregabalin may make you dizzy or drowsy. Do not drive a car operate machinery, or do other dangerous activities until you know how this medication affects you. Ask your doctor when you may do these activities.
  • do not drink alcohol while taking pregabalin. Alcohol can add to the drowsiness caused by this medication.
  • you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking pregabalin for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as pregabalin to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as pregabalin, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

What special dietary instructions should I follow?

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

What should I do if I forget a dose?

If you forget to take a dose and remember a few hours later, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Pregabalin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • tiredness
  • dizziness
  • headache
  • dry mouth
  • nausea
  • vomiting
  • constipation
  • gas
  • bloating
  • ”high” or elevated mood
  • speech problems
  • difficulty concentrating or paying attention
  • confusion
  • difficulty remembering or forgetfulness
  • anxiety
  • lack of coordination
  • loss of balance or unsteadiness
  • uncontrollable shaking or jerking of a part of the body
  • muscle twitching
  • weakness
  • increased appetite
  • weight gain
  • swelling of the arms, hands, feet, ankles, or lower legs
  • back pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

  • blurred vision, double vision, or other changes in eyesight
  • hives
  • rash
  • itching
  • blisters
  • swelling of the eyes face, throat, mouth, lips, gums, tongue, head or neck
  • shortness of breath
  • wheezing
  • muscle pain, tenderness, soreness, or weakness, especially if it comes along with fever
  • chest pain

If you have diabetes, you should know that pregabalin has caused skin sores in animals. Pay extra attention to your skin while taking pregabalin, and tell your doctor if you have any sores, redness, or skin problems.

Pregabalin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

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.

Brand names

  • Lyrica®

Last Revised – 09/01/2009

Pregabalin (Lyrica) is an anticonvulsant drug derived from gabapentin, approved in the European Union and in the US in 2004. Currently, it has well definedindications:

  • Neuropathic pain.
  • Epilepsy in patients who have partial seizures that cannot be controlled with their current treatment.
  • Generalized anxiety disorder.

In June 21, 2007; the US Food and Drug Administration approved Lyrica as the first drug for the treatment of fibromyalgia, a year later duloxetine (Cymbalta) became the second.

On 23 April 2009, the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of an extension of indication that would include fibromyalgia treatment as a new indication for Lyrica.

Pfizer requested a re-examination of the opinion. After considering the grounds for this request,
the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation
on 23 July 2009.

The CHMP was concerned that the benefits of Lyrica in fibromyalgia had not been shown in either the short or the long term. There were no consistent or relevant reductions in pain or other symptoms in the short-term studies, and the maintenance of Lyrica’s effect was not shown in the longer study. The Committee was also concerned that the safety and effectiveness of Lyrica had not been shown in patients from the EU.

Bottom line:

EMEA didn’t approve an extension of indication for Lyrica to include the treatment of fibromyalgia.

Other approved indications (neuropathic pain, generalized anxiety disorder, epilepsy) for Lyrica remain with no changes.

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