Do not take NEURONTIN if you are allergic to gabapentin or any of the other ingredients in NEURONTIN. See the end of this Medication Guide for a complete list of ingredients in NEURONTIN.
Tell your doctor about all other medicines you use, especially:
hydrocodone (Lortab, Vicodin, Vicoprofen, and others);
morphine (Kadian, MS Contin, Oramorph, and others); or
naproxen (Naprosyn, Aleve, Anaprox, and others).
This list is not complete and other drugs may interact with gabapentin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Gabapentin is an anti-epileptic medication, also called an anticonvulsant. It affects chemicals and nerves in the body that are involved in the cause of seizures and some types of pain.
Gabapentin is used in adults to treat nerve pain caused by herpes virus or shingles (herpes zoster).
The Horizant brand of gabapentin is also used to treat restless legs syndrome (RLS).
The Neurontin brand of gabapentin is also used to treatseizures in adults and children who are at least 3 years old.
NEURONTIN is a prescription medicine used to treat:
Pain from damaged nerves (postherpetic pain) that follows healing ofshingles (a painful rash that comes after a herpes zoster infection) in adults.
Partial seizures when taken together with other medicines in adults and children 3 years of age and older with seizures.
Do not stop taking NEURONTIN without first talking to your healthcare provider. Stopping NEURONTIN suddenly can cause serious problems.
NEURONTIN can cause serious side effects including:
1. Suicidal Thoughts. Like other antiepileptic drugs, NEURONTIN may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
thoughts about suicide or dying
attempts to commit suicide
new or worse depression
new or worse anxiety
feeling agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not stop taking NEURONTIN without first talking to a healthcare provider.
Stopping NEURONTIN suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
2. Changes in behavior and thinking –Using NEURONTIN in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, restlessness, changes in school performance, and hyperactivity.
3. NEURONTIN may cause serious or life-threatening allergic reactionsthat may affect your skin or other parts of your body such as your liver or blood cells. This may cause you to be hospitalized or to stop NEURONTIN. You may or may not have a rash with an allergic reaction caused by NEURONTIN. Call a healthcare provider right away if you have any of the following symptoms:
skin rash
hives
difficulty breathing
fever
swollen glands that do not go away
swelling of your face, lips, throat, or tongue
yellowing of your skin or of the whites of the eyes
unusual bruising or bleeding
severe fatigue or weakness
unexpected muscle pain
frequent infections
These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking NEURONTIN.
The most common side effects of NEURONTIN include:
lack of coordination
feeling tired
viral infection
fever
feeling drowsy
jerky movements
nausea and vomiting
difficulty with coordination
difficulty with speaking
double vision
tremor
unusual eye movement
swelling, usually of legs and feet
SIDE EFFECTS: Drowsiness, dizziness, loss of coordination, tiredness, blurred/double vision, unusual eye movements, or shaking (tremor) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: swelling of the hands/ankles/feet, signs of infection (such as fever, cough, persistent sore throat).
A small number of people who take anticonvulsants for any condition (such as seizures, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.
Get medical help right away if you have any serious side effects, including: unusual fever, swollen glands, yellowing skin/eyes, unusual tiredness, dark urine, change in the amount of urine, chest pain.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Before taking NEURONTIN, tell your healthcare provider if you:
have or have had kidney problems or are on hemodialysis
have or have had depression, mood problems, or suicidal thoughts or behavior
have diabetes
are pregnant or plan to become pregnant. It is not known if NEURONTIN can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking NEURONTIN. You and your healthcare provider will decide if you should take NEURONTIN while you are pregnant.
If you become pregnant while taking NEURONTIN, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
are breast-feeding or plan to breast-feed. NEURONTIN can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take NEURONTIN.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking NEURONTIN with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
Gabapentin oral capsule comes with several warnings. Call your doctor if you start having more seizures or a different kind of seizure while taking this drug.
gabapentin warning
Suicide prevention
If you think someone is at immediate risk of self-harm or hurting another person:
• Call 911 or your local emergency number.
• Stay with the person until help arrives.
• Remove any guns, knives, medications, or other things that may cause harm.
• Listen, but don’t judge, argue, threaten, or yell.
If you or someone you know is considering suicide, get help from a crisis or suicide prevention hotline. Try the National Suicide Prevention Lifeline at 800-273-8255.
Drowsiness warning
Gabapentin can slow your thinking and motor skills and cause drowsiness and dizziness. It’s not known how long these effects last. You should not drive or use heavy machinery while taking this drug until you know how it affects you.
Depression warning
Using this drug increases your risk of suicidal thoughts and behavior. Talk to your doctor if you feel depressed or notice any changes in your mood or behavior. Also talk to your doctor if you are having thoughts of harming yourself, including suicide.
Multiorgan hypersensitivity/DRESS warning
This medication can cause multiorgan hypersensitivity. This is also known as a drug reaction with eosinophilia and systemic symptoms (DRESS). This syndrome can be life-threatening. Call your doctor right away if you have symptoms such as a rash, a fever, or swollen lymph nodes.
Allergy warning
Gabapentin can cause a severe allergic reaction. Symptoms can include:
trouble breathing
swelling of your throat or tongue
hives
rash
Don’t take this drug again if you have ever had an allergic reaction to it before. Taking it a second time after any allergic reaction to it could be fatal (cause death).
Alcohol interaction warning
Avoid drinking alcohol while taking gabapentin. Gabapentin can cause sleepiness, and drinking alcohol can make you even more sleepy. Alcohol can also make you more likely to feel dizzy and have trouble concentrating.
Warnings for people with certain health conditions
For people with epilepsy: Don’t stop taking gabapentin suddenly. Doing this can increase your risk of having a condition called status epilepticus. This is a medical emergency during which short or long seizures occur for 30 minutes or more.
Gabapentin can cause problems in children aged 3–12 years who have epilepsy. It raises their risk of thought problems as well as behavioral problems, such as being hyper and acting hostile or restless.
For people with kidney problems: Your body processes this drug more slowly than normal. This may cause the drug to increase to dangerous levels in your body. Talk to your doctor about whether this drug is safe for you.
Warnings for other groups
For pregnant women: The use of gabapentin has not been studied in humans during pregnancy. Research in animals has shown negative effects to the fetus when the mother takes the drug. However, animal studies don’t always predict the way humans would respond.
Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should only be used if the potential benefit justifies the potential risk to the fetus. Call your doctor if you become pregnant while taking this drug.
If your doctor prescribes gabapentin for you while you’re pregnant, ask about the NAAED Pregnancy Registry. This registry tracks the effects of anti-seizure drugs on pregnancy. Information can be found at aedpregnancyregistry.org.
For women who are breastfeeding: Gabapentin may pass into breast milk and cause serious side effects in a breastfeeding child. Tell your doctor if you are breastfeeding. You should decide together if you should stop taking this drug or stop breastfeeding.
For seniors: Kidney function may decrease with age. You may process this drug more slowly than younger people. Your doctor may start you on a lowered dose so that too much of this drug does not build up in your body. Too much of the drug in your body can be dangerous.
For children: Gabapentin has not been studied in children for the management of postherpetic neuralgia. It should not be used in people younger than 18 years. This drug should not be used to treat partial seizures in children younger than 3 years.
The gabapentin dosage your doctor prescribes will depend on several factors. These include:
the type and severity of the condition you’re using gabapentin to treat
your age
the form of gabapentin you take
other medical conditions you may have
Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage that’s right for you. They’ll ultimately prescribe the smallest dosage that provides the desired effect.
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.
Forms and strengths
Generic: Gabapentin
Form: oral capsule
Strengths: 100 mg, 300 mg, 400 mg
Brand: Neurontin
Form: oral capsule
Strengths: 100 mg, 300 mg, 400 mg
Dosage for postherpetic neuralgia
Adult dosage (ages 18–64 years)
Typical starting dosage: Day 1, 300 mg; day 2, 600 mg (300 mg two times per day, spaced evenly throughout the day); day 3, 900 mg (300 mg, three times per day, spaced evenly throughout the day). Your doctor may further increase your dosage after day 3.
Maximum dosage: 1,800 mg per day (600 mg, three times per day, spaced evenly throughout the day)
Child dosage (ages 0–17 years)
Dosage for people younger than 18 years has not been established.
Senior dosage (ages 65 years and older)
Your kidney function may decrease with age. Your body may get rid of this drug more slowly. Your doctor may start you on a lower dose so that too much of this drug does not build up in your body. Too much of the drug in your body can be dangerous. Your doctor may change your dose based on how well your kidneys are working.
Dosage for partial-onset seizures
Adult dosage (ages 18–64 years)
Typical starting dosage: 900 mg per day (300 mg, three times per day, spaced evenly throughout the day). Your doctor may increase your dose to 2,400–3,600 mg per day.
Child dosage (ages 12–17 years)
Typical starting dosage: 300 mg, three times per day, spaced evenly throughout the day. This can increase to 2,400–3,600 mg per day.
Child dosage (ages 3–11 years)
Typical starting dosage: 10–15 mg/kg/day, divided into three doses, spaced evenly throughout the day. Your child’s doctor may increase the dosage to meet your child’s needs.
Maximum dosage: 50 mg/kg/day.
Child dosage (ages 0–2 years)
Dosage for people younger than 3 years has not been established.
Senior dosage (ages 65 years and older)
Your kidney function may decrease with age. Your body may get rid of this drug more slowly. Your doctor may start you on a lower dose so that too much of this drug does not build up in your body. Too much of the drug in your body can be dangerous. Your doctor may change your dose based on how well your kidneys are working.
Special considerations
Kidney problems: If you are older than 12 years and have kidney problems or are on hemodialysis, your dose of gabapentin will need to be changed. This will be based on how well your kidneys are working.
BACKGROUND:Gabapentin and pregabalin are FDA-approved for a variety of conditions, including seizures, nerve pain, and restless legs syndrome.
ISSUE:FDA is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease that reduce lung function. The elderly are also at higher risk.
FDA is requiring new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids. FDA has also required the drug manufacturers to conduct clinical trials to further evaluate their abuse potential, particularly in combination with opioids, because misuse and abuse of these products together is increasing, and co-use may increase the risk of respiratory depression.
RECOMMENDATION:Patients and caregivers should seek medical attention immediately if you or someone you are caring for experiences symptoms of respiratory problems, because these can be life-threatening. Symptoms to watch for include:
Confusion or disorientation
Unusual dizziness or lightheadedness
Extreme sleepiness or lethargy
Slowed, shallow, or difficult breathing
Unresponsiveness, which means a person doesn’t answer or react normally or you can’t wake them up
Bluish-colored or tinted skin, especially on the lips, fingers, and toes
Always inform your health care professional about all the drugs you are taking, including prescription and over-the-counter medicines and other substances such as alcohol.
Health care professionals should start gabapentinoids at the lowest dose and monitor patients for symptoms of respiratory depression and sedation when co-prescribing gabapentinoids with an opioid or other central nervous system depressant such as a benzodiazepine.
Restless legs syndrome (RLS) is a disorder of the part of thenervous system that causes an urge to move the legs. Because it usually interferes with sleep, it also is considered a sleep disorder.
Causes of Restless Legs Syndrome
In most cases, doctors do not know the cause of restless legs syndrome; however, they suspect that genes play a role. Nearly half of people with RLS also have a family member with the condition.
Other factors associated with the development or worsening of restless legs syndrome include:
Chronic diseases. Certain chronic diseases and medical conditions, including iron deficiency, Parkinson’s disease, kidney failure,diabetes, and peripheral neuropathy often include symptoms of RLS. Treating these conditions often gives some relief from RLS symptoms.
Medications. Some types of medications, including antinausea drugs, antipsychotic drugs, some antidepressants, and cold and allergymedications containing sedating antihistamines, may worsen symptoms.
Pregnancy. Some women experience RLS during pregnancy, especially in the last trimester. Symptoms usually go away within a month after delivery.
Other factors, including alcohol use and sleep deprivation, may trigger symptoms or make them worse. Improving sleep or eliminating alcohol use in these cases may relieve symptoms.
Treatment for Restless Legs Syndrome
Treatment for RLS is targeted at easing symptoms. In people with mild to moderate restless legs syndrome, lifestyle changes, such as beginning a regular exercise program, establishing regular sleep patterns, and eliminating or decreasing the use of caffeine, alcohol, and tobacco, may be helpful. Treatment of an RLS-associated condition also may provide relief of symptoms.
Other non-drug RLS treatments may include:
Leg massages
Hot baths or heating pads or ice packs applied to the legs
Good sleep habits
A vibrating pad called Relaxis
Medications may be helpful as RLS treatments, but the same drugs are not helpful for everyone. In fact, a drug that relieves symptoms in one person may worsen them in another. In other cases, a drug that works for a while may lose its effectiveness over time.
Drugs used to treat RLS include:
Dopaminergic drugs, which act on the neurotransmitter dopamine in the brain.
Mirapex, Neupro, and Requip are FDA-approved for treatment of moderate to severe RLS. Others, such as levodopa, may also be prescribed.
Benzodiazepines, a class of sedative medications, may be used to help with sleep, but they can cause daytime drowsiness.
Narcotic pain relievers may be used for severe pain.
Anticonvulsants, or antiseizure drugs, such as Tegretol, Lyrica, Gabapentin ( Neurontin ), and Horizant.
Although there is no cure for restless legs syndrome, current treatments can help control the condition, decrease symptoms, and improve sleep.
Usual Adult Dose for Restless Legs Syndrome
Gabapentin enacarbil available under the trade name Horizant (R):
600 mg orally once daily with food at about 5 PM
Nerve pain can be a symptom of many different conditions, includingcancer, HIV, diabetes, and shingles.
For some, nerve pain is frustrating; for others, nerve pain is devastating and life-changing.
Whether it feels like burning, pinpricks, or sudden shocks of electricity, nerve pain can disrupt your life at home and at work. It can limit your ability to get around. Over time, it can grind you down. Studies show that people with nerve pain have higher rates of sleep problems,anxiety, and depression.Your nervous system is involved in everything your body does, from regulating your breathing to controlling your muscles and sensing heat and cold.
There are three types of nerves in the body:
Autonomic nerves. These nerves control the involuntary or partially voluntary activities of your body, including heart rate, blood pressure, digestion, and temperature regulation.
Motor nerves. These nerves control your movements and actions by passing information from your brain and spinal cord to your muscles.
Sensory nerves. These nerves relay information from your skin and muscles back to your spinal cord and brain. The information is then processed to let you feel pain and other sensations.
Because nerves are essential to all you do, nerve pain and damage can seriously affect your quality of life.
When you have a serious medical condition such as cancer or HIV, dealing with the additional misery of nerve pain can be especially hard. But there is good news. While nerve pain can’t always be cured, it can be treated — and there are a lot of good options available.
Experts believe that 40 million Americans are living with nerve pain. The impact of nerve pain is tremendous. Both the costs to the healthcare system as well as loss of wages and productivity are staggering.
How Are Nerve Pain and Nerve Damage Treated?
In many instances, nerve damage cannot be cured entirely. But there are various treatments that can reduce your symptoms. Because nerve damage is often progressive, it is important to consult with a doctor when you first notice symptoms. That way you can reduce the likelihood of permanent damage.
Often, the first goal of treatment is to address the underlying condition that’s causing your nerve pain or nerve damage. This may mean:
Regulating blood sugar levels for people with diabetes
Correcting nutritional deficiencies
Changing medications when drugs are causing nerve damage
Physical therapy or surgery to address compression or trauma to nerves
Medications to treat autoimmune conditions
Additionally, your doctor may prescribe medications aimed at minimizing the nerve pain you are feeling. These may include:
Pain relievers
Tricyclic antidepressants
Certain anti-seizure drugs – Gabapentin
Complementary and alternative approaches may also help alleviate your nerve pain and discomfort. These include:
