Gabapentin is used to Treat Restless legs syndrome

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.

Symptoms of Restless Legs Syndrome

People with restless legs syndrome have uncomfortable sensations in their legs (and sometimes arms or other parts of the body) and an irresistible urge to move their legs to relieve the sensations. The condition causes an uncomfortable, “itchy,” “pins and needles,” or “creepy crawly” feeling in the legs. The sensations are usually worse at rest, especially when lying or sitting.

The severity of RLS symptoms ranges from mild to intolerable. Symptoms can come and go and severity can also vary. The symptoms are generally worse in the evening and at night. For some people, symptoms may cause severe nightly sleep disruption that can significantly impair their quality of life.

Who Gets Restless Legs Syndrome?

Restless legs syndrome may affect up to 10% of the U.S. population. It affects both sexes, but is more common in women and may begin at any age, even in young children. Most people who are affected severely are middle-aged or older.

RLS is often unrecognized or misdiagnosed. This is especially true if the symptoms are intermittent or mild. Once correctly diagnosed, RLS can often be treated successfully.

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, Neurontin, and Horizant.
Although there is no cure for restless legs syndrome, current treatments can help control the condition, decrease symptoms, and improve sleep.

Gabapentin is Used to Treat Anxiety

Anxiety disorders are different, though. They can cause such distress that it interferes with your ability to lead a normal life.

This type of disorder is a serious mental illness. For people who have one, worry and fear are constant and overwhelming, and can be disabling. But with treatment, many people can manage those feelings and get back to a fulfilling life.

How Are Anxiety Disorders Treated?

Fortunately, much progress has been made in the last two decades in the treatment of people with mental illnesses, including anxiety disorders. Although the exact treatment approach depends on the type of disorder, one or a combination of the following therapies may be used for most anxiety disorders:

  • Medication : Drugs used to reduce the symptoms of anxiety disorders include many antidepressants, certain anticonvulsant medicines and low-dose antipsychotics, and other anxiety-reducing drugs.
  • Psychotherapy : Psychotherapy (a type of counseling) addresses the emotional response to mental illness. It is a process in which trained mental health professionals help people by talking through strategies for understanding and dealing with their disorder.
  • Cognitive-behavioral therapy: This is a particular type of psychotherapy in which the person learns to recognize and change thought patterns and behaviors that lead to troublesome feelings.
  • Dietary and lifestyle changes
  • Relaxation therapy

How can I manage anxiety?

  • Go to counseling as directed. Cognitive behavioral therapy can help you understand and change how you react to events that trigger your symptoms.
  • Find ways to manage your symptoms. Activities such as exercise, meditation, or listening to music can help you relax.
  • Practice deep breathing. Breathing can change how your body reacts to stress. Focus on taking slow, deep breaths several times a day, or during an anxiety attack. Breathe in through your nose and out through your mouth.
  • Do not smoke. Nicotine can increase your anxiety. Do not use e-cigarettes or smokeless tobacco in place of cigarettes or to help you quit. They still contain nicotine. Ask your healthcare provider for information if you currently smoke and need help quitting.
  • Do not have caffeine. Caffeine can make your symptoms worse. Do not have foods or drinks that are meant to increase your energy level.
  • Limit or do not drink alcohol. Ask your healthcare provider if alcohol is safe for you. You may not be able to drink alcohol if you take certain anxiety or depression medicines. Limit alcohol to 1 drink per day if you are a woman. Limit alcohol to 2 drinks per day if you are a man. A drink of alcohol is 12 ounces of beer, 5 ounces of wine, or 1½ ounces of liquor.

On December 30, 1993, Gabapentin got final approval, which meant that it could be marketed in the United States. It is only marketed as an anticonvulsant. However, it has also been used for restless leg syndrome, pain issues, hot flashes, tremors, anxiety and a wide variety of psychiatric disorders.

more than 81% anxiety said Gabapentin is a good medicine for Anxiety. Tousant agrees Gabapentin is the only thing that has help with my anxiety, I tried others medications but it don’t work. I’m just taking it as needed for my anxiety and help me sleep. You can’t just stop it like that. You have to weaned yourself off it. My anxiety got worse when I lost my mother in 2014. I wish everyone the best. You do what works for you. Everybody is different.

I’ve suffered from bouts of severe anxiety since I was 5 years old. I’m 44 now. The Dr put me on Xanax, but that never seemed to do much for me except finally let me sleep for a few hours if I took more than my prescribed dosage. I also have degenerative disc disease in my lower back & was put on Gaba for nerve pain about a year ago. I couldn’t believe the effect it had on the anxiety. It’s like it snips some internal wire a)& cuts the anxiety off. It’s been a life saver for me, literally. HOWEVER, I say this with a warning. Obviously, not everyone gets this effect from Gaba. And, when I tried stopping cold turkey once, the anxiety came back worse than ever – like super bad. So, it’s a long term commitment, be aware.

Call 911 if:

  • You have chest pain, tightness, or heaviness that may spread to your shoulders, arms, jaw, neck, or back.
  • You feel like hurting yourself or someone else.

Diabetic Peripheral Neuropathy

diabetic-peripheral-neuropathy

Peripheral neuropathy is nerve damage caused by chronically high blood sugar and diabetes. It leads to numbness, loss of sensation, and sometimes pain in your feet, legs, or hands. It is the most common complication of diabetes.

About 60% to 70% of all people with diabetes will eventually develop peripheral neuropathy, although not all suffer pain. Yet this nerve damage is not inevitable. Studies have shown that people with diabetes can reduce their risk of developing nerve damage by keeping theirblood sugar levels as close to normal as possible.

What causes peripheral neuropathy? Chronically high blood sugar levels damage nerves not only in your extremities but also in other parts of your body. These damaged nerves cannot effectively carry messages between the brain and other parts of the body.

This means you may not feel heat, cold, or pain in your feet, legs, or hands. If you get a cut or sore on your foot, you may not know it, which is why it’s so important to inspect your feet daily. If a shoe doesn’t fit properly, you could even develop a foot ulcer and not know it.
The consequences can be life-threatening. An infection that won’t heal because of poor blood flow causes risk for developing ulcers and can lead to amputation, even death.

This nerve damage shows itself differently in each person. Some people feel tingling, then later feel pain. Other people lose the feeling in fingers and toes; they have numbness. These changes happen slowly over a period of years, so you might not even notice it.

Because the changes are subtle and happen as people get older, people tend to ignore the signs of nerve damage, thinking it’s just part of getting older.

But there are treatments that can help slow the progression of this condition and limit the damage. Talk to your doctors about what your options are, and don’t ignore the signs because with time, it can get worse.

Drugs associated with Diabetic Peripheral Neuropathy

 

Gabapentin can be used for Treatment of Alcohol Withdrawal

Alcohol withdrawal syndrome is a potentially life-threatening condition that can occur in people who have been drinking heavily for weeks, months, or years and then either stop or significantly reduce their alcohol consumption.

Alcohol withdrawal symptoms can begin as early as two hours after the last drink, persist for weeks, and range from mild anxiety and shakiness to severe complications, such as seizures and delirium tremens (also called DTs). The death rate from DTs — which are characterized by confusion, rapid heartbeat, and fever — is estimated to range from 1% to 5%.

If you have mild to moderate withdrawal symptoms, your doctor may prefer to treat you in an outpatient setting, especially if you have supportive family and friends. Outpatient detoxification is safe, effective, and less costly than inpatient detoxification at a hospital or other facility.

However, you may require inpatient treatment if you don’t have a reliable social network, are pregnant, or have a history of any of the following:

Severe withdrawal symptoms
Withdrawal seizures or DTs
Multiple previous detoxifications
Certain medical or psychiatric illnesses
The goals of treatment are threefold: reducing immediate withdrawal symptoms, preventing complications, and beginning long-term therapy to promote alcohol abstinence.

Alcohol Withdrawal Symptoms

  • If you are dependent on alcohol, you may experience any of these common and less severe withdrawal symptoms as early as 6 hours after your last intake of alcohol:
  • Insomnia.
  • Anxiety.
  • Headache.
  • Gastrointestinal disturbances.
  • Palpitations (rapid, irregular heart beats).
  • Sweating.

Theoretically, gabapentin’s ability to increase GABA production may be responsible for producing a calming effect on a number of these alcohol withdrawal symptoms.

Research studies have added further insights as to how gabapentin succeeds in relieving a number of these symptoms.

Prescription drugs of choice include benzodiazepines, such asdiazepam (Valium), chlordiazepoxide (Librium), lorazepam (Ativan), andoxazepam (Serax). Such medications can help control the shakiness, anxiety, and confusion associated with alcohol withdrawal and reduce the risk of withdrawal seizures and DTs. In patients with mild to moderate symptoms, the anticonvulsant drug carbamazepine(Tegretol) may be an effective alternative to benzodiazepines, because it is not sedating and has low potential for abuse.

To help manage withdrawal complications, your doctor may consider adding other drugs to a benzodiazepine regimen. These may include:

  • An antipsychotic drug, which can help relieve agitation and hallucinations
  • A beta-blocker, which may help curb a fast heart rate and elevatedblood pressure related to withdrawal and reduce the strain of alcohol withdrawal in people with coronary artery disease
  • Clonidine (Catapres), another blood pressure drug
  • Phenytoin (Dilantin), an anticonvulsant which doesn’t treat withdrawal seizures but may be useful in people with an underlying seizure disorder

If you have severe vomiting, seizures or delirium tremens, the safest place for you to be treated is in a hospital. For delirium tremens, treatment in an intensive care unit (ICU) is often required. In an ICU, your heart rate, blood pressure, and breathing can be monitored closely in case emergency life-support (such as artificial breathing by a machine) is needed.

Medicines called benzodiazepines can lessen alcohol withdrawal symptoms. Commonly used medicines in this group include chlordiazepoxide (Librium) and lorazepam (Ativan).

Most alcohol abusers who are having withdrawal symptoms have a shortage of several vitamins and minerals and can benefit from nutritional supplements. In particular, alcohol abuse can create a shortage of folate,thiamine, magnesium, zinc and phosphate. It also can cause low blood sugar.

What is the most important information I should know about Gabapentin?

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.

Neurontin Warnings

Make sure you tell your doctor about your complete medical history when he/she is prescribing this drug to you. This drug might not be suitable for you if you are suffering from kidney, liver or heart diseases. You should also inform your doctor if you have an allergic reaction to gabapentin. Avoid having alcohol while you are on this medicine. Antacids can interfere with the absorption of Neurontin; therefore, it is advisable not to have Antacids at least 2 hours before having this medicine. In case you are pregnant or are planning to become pregnant, do not forget to inform the same to your doctor. Doctors do not generally prescribe this drug to pregnant ladies unless there is an immediate and genuine need for it.

This medicine is not meant for children below the age of 12 years. Many people experience side effects like blurred vision and drowsiness after taking this drug. Therefore, it is advisable not to drive after taking the medicine. Allow your body to get adapted to this new drug. Visit the doctor frequently as he/she will want to carry out regular tests to see how your body is adapting to this drug.

Drug Reaction With Eosinophilia And Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has occurred with NEURONTIN. Some of these reactions have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis,nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved.

It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. NEURONTIN should be discontinued if an alternative etiologyfor the signs or symptoms cannot be established.

Anaphylaxis And Angioedema

NEURONTIN can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat, and tongue, andhypotension requiring emergency treatment. Patients should be instructed to discontinue NEURONTIN and seek immediate medical care should they experience signs or symptoms of anaphylaxis or angioedema.

Effects On Driving and Operating Heavy Machinery

Patients taking NEURONTIN should not drive until they have gained sufficient experience to assess whether NEURONTIN impairs their ability to drive. Driving performance studies conducted with a prodrug of gabapentin (gabapentin enacarbil tablet, extended release) indicate that gabapentin may cause significant driving impairment. Prescribers and patients should be aware that patients’ ability to assess their own driving competence, as well as their ability to assess the degree of somnolence caused by NEURONTIN, can be imperfect. The duration of driving impairment after starting therapy with NEURONTIN is unknown. Whether the impairment is related to somnolence or other effects of NEURONTIN is unknown.

Moreover, because NEURONTIN causes somnolence and dizziness , patients should be advised not to operate complex machinery until they have gained sufficient experience on NEURONTIN to assess whether NEURONTIN impairs their ability to perform such tasks.

Somnolence/Sedation And Dizziness

During the controlled epilepsy trials in patients older than 12 years of age receiving doses of NEURONTIN up to 1800 mg daily, somnolence, dizziness, and ataxia were reported at a greater rate in patients receiving NEURONTIN compared to placebo: i.e., 19% in drug versus 9% in placebo for somnolence, 17% in drug versus 7% in placebo for dizziness, and 13% in drug versus 6% in placebo for ataxia. In these trials somnolence, ataxia and fatigue were common adverse reactions leading to discontinuation of NEURONTIN in patients older than 12 years of age, with 1.2%, 0.8% and 0.6% discontinuing for these events, respectively.

During the controlled trials in patients with post-herpetic neuralgia, somnolence and dizziness were reported at a greater rate compared to placebo in patients receiving NEURONTIN, in dosages up to 3600 mg per day: i.e., 21% in NEURONTIN-treated patients versus 5% in placebo-treated patients for somnolence and 28% in NEURONTIN-treated patients versus 8% in placebo-treated patients for dizziness. Dizziness and somnolence were among the most common adverse reactions leading to discontinuation of NEURONTIN.

Patients should be carefully observed for signs of central nervous system(CNS) depression, such as somnolence and sedation, when NEURONTIN is used with other drugs with sedative properties because of potential synergy. In addition, patients who require concomitant treatment with morphine may experience increases in gabapentin concentrations and may require dose adjustment.

Withdrawal Precipitated Seizure, Status Epilepticus

Antiepileptic drugs should not be abruptly discontinued because of the possibility of increasing seizure frequency.

In the placebo-controlled epilepsy studies in patients > 12 years of age, the incidence of status epilepticus in patients receiving NEURONTIN was 0.6% (3 of 543) vs. 0.5% in patients receiving placebo (2 of 378). Among the 2074 patients > 12 years of age treated with NEURONTIN across all epilepsy studies (controlled and uncontrolled), 31 (1.5%) had status epilepticus. Of these, 14 patients had no prior history of status epilepticus either before treatment or while on other medications. Because adequate historical data are not available, it is impossible to say whether or not treatment with NEURONTIN is associated with a higher or lower rate of status epilepticus than would be expected to occur in a similar population not treated with NEURONTIN.

Suicidal Behavior And Ideation

Antiepileptic drugs (AEDs), including NEURONTIN, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed. Table 2 shows absolute and relative risk by indication for all evaluated AEDs.

TABLE 2 : Risk by Indication for Antiepileptic Drugs in the Pooled Analysis

 

INDICATION PLACEBO PATIENTS WITH EVENTS PER 1000 PATIENTS DRUG PATIENTS WITH EVENTS PER 1000 PATIENTS RELATIVE RISK: INCIDENCE OF EVENTS IN DRUG PATIENTS/INCIDENCE IN PLACEBO PATIENTS RISK DIFFERENCE: ADDITIONAL DRUG PATIENTS WITH EVENTS PER 1000 PATIENTS
Epilepsy 1.0 3.4 3.5 2.4
Psychiatric 5.7 8.5 1.5 2.9
Other 1.0 1.8 1.9 0.9
Total 2.4 4.3 1.8 1.9

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing NEURONTIN or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Neuropsychiatric Adverse Reactions (Pediatric Patients 3-12 Years of Age)

Gabapentin use in pediatric patients with epilepsy 3-12 years of age is associated with the occurrence of central nervous system related adverse reactions. The most significant of these can be classified into the following categories: 1) emotional lability (primarily behavioral problems), 2) hostility, including aggressive behaviors, 3) thought disorder, including concentration problems and change in school performance, and 4) hyperkinesia (primarily restlessness and hyperactivity). Among the gabapentin-treated patients, most of the reactions were mild to moderate in intensity.

In controlled clinical epilepsy trials in pediatric patients 3–12 years of age, the incidence of these adverse reactions was: emotional lability 6% (gabapentin-treated patients) vs. 1.3% (placebotreated patients); hostility 5.2% vs. 1.3%; hyperkinesia 4.7% vs. 2.9%; and thought disorder 1.7% vs. 0%. One of these reactions, a report of hostility, was considered serious. Discontinuation of gabapentin treatment occurred in 1.3% of patients reporting emotional lability and hyperkinesia and 0.9% of gabapentin-treated patients reporting hostility and thought disorder. One placebo-treated patient (0.4%) withdrew due to emotional lability.

Tumorigenic Potential

In an oral carcinogenicity study, gabapentin increased the incidence of pancreatic acinar cell tumors in rats . The clinical significance of this finding is unknown. Clinical experience during gabapentin’s premarketing development provides no direct means to assess its potential for inducing tumors in humans.

In clinical studies in adjunctive therapy in epilepsy comprising 2085 patient-years of exposure in patients > 12 years of age, new tumors were reported in 10 patients (2 breast, 3 brain, 2 lung, 1 adrenal, 1 non-Hodgkin’s lymphoma, 1 endometrial carcinoma in situ), and preexisting tumors worsened in 11 patients (9 brain, 1 breast, 1 prostate) during or up to 2 years following discontinuation of NEURONTIN. Without knowledge of the background incidence and recurrence in a similar population not treated with NEURONTIN, it is impossible to know whether the incidence seen in this cohort is or is not affected by treatment.

Sudden And Unexplained Death In Patients With Epilepsy

During the course of premarketing development of NEURONTIN, 8 sudden and unexplained deaths were recorded among a cohort of 2203 epilepsy patients treated (2103 patient-years of exposure) with NEURONTIN.

Some of these could represent seizure-related deaths in which the seizure was not observed, e.g., at night. This represents an incidence of 0.0038 deaths per patient-year. Although this rate exceeds that expected in a healthy population matched for age and sex, it is within the range of estimates for the incidence of sudden unexplained deaths in patients with epilepsy not receiving NEURONTIN (ranging from 0.0005 for the general population of epileptics to 0.003 for a clinical trial population similar to that in the NEURONTIN program, to 0.005 for patients with refractory epilepsy). Consequently, whether these figures are reassuring or raise further concern depends on comparability of the populations reported upon to the NEURONTIN cohort and the accuracy of the estimates provided.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Administration Information

Inform patients that NEURONTIN is taken orally with or without food. Inform patients that, should they divide the scored 600 mg or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Advise patients to discard half-tablets not used within 28 days of dividing the scored tablet.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

Prior to initiation of treatment with NEURONTIN, instruct patients that a rash or other signs or symptoms of hypersensitivity (such as fever or lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately .

Anaphylaxis and Angioedema

Advise patients to discontinue NEURONTIN and seek medical care if they develop signs or symptoms of anaphylaxis or angioedema .

Dizziness and Somnolence and Effects on Driving and Operating Heavy Machinery

Advise patients that NEURONTIN may cause dizziness, somnolence, and other symptoms and signs of CNS depression. Other drugs with sedative properties may increase these symptoms. Accordingly, although patients’ ability to determine their level of impairment can be unreliable, advise them neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on NEURONTIN to gauge whether or not it affects their mental and/or motor performance adversely. Inform patients that it is not known how long this effect lasts.

Suicidal Thinking and Behavior

Counsel the patient, their caregivers, and families that AEDs, including NEURONTIN, may increase the risk of suicidal thoughts and behavior. Advise patients of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct patients to report behaviors of concern immediately to healthcare providers .

Use in Pregnancy

Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy, and to notify their physician if they arebreast feeding or intend to breast feed during therapy

Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Gabapentin was administered orally to mice and rats in 2-year carcinogenicity studies. No evidence of drug-related carcinogenicity was observed in mice treated at doses up to 2000 mg/kg/day. At 2000 mg/kg, the plasma gabapentin exposure (AUC) in mice is approximately 2 times that in humans at the MRHD of 3600 mg/day. In rats, increases in the incidence of pancreatic acinar cell adenoma and carcinoma were found in male rats receiving the highest dose (2000 mg/kg), but not at doses of 250 or 1000 mg/kg/day. At 1000 mg/kg, the plasma gabapentin exposure (AUC) in rats is approximately 5 times that in humans at the MRHD.

Studies designed to investigate the mechanism of gabapentin-induced pancreatic carcinogenesis in rats indicate that gabapentin stimulates DNA synthesis in rat pancreatic acinar cells in vitro and, thus, may be acting as a tumor promoter by enhancing mitogenic activity. It is not known whether gabapentin has the ability to increase cell proliferation in other cell types or in other species, including humans.

Gabapentin did not demonstrate mutagenic or genotoxic potential in three in vitro and four in vivo assays. It was negative in the Ames test and the in vitroHGPRT forward mutation assay in Chinese hamster lung cells; it did not produce significant increases in chromosomal aberrations in the in vitroChinese hamster lung cell assay; it was negative in the in vivo chromosomal aberration assay and in the in vivo micronucleus test in Chinese hamster bone marrow; it was negative in the in vivo mouse micronucleus assay; and it did not induce unscheduled DNA synthesis in hepatocytes from rats given gabapentin.

No adverse effects on fertility or reproduction were observed in rats at doses up to 2000 mg/kg. At 2000 mg/kg, the plasma gabapentin exposure (AUC) in rats is approximately 8 times that in humans at the MRHD.

 

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. NEURONTIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

When pregnant mice received oral doses of gabapentin (500, 1000, or 3000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. The no-effect dose for embryo-fetal developmental toxicity in mice was 500 mg/kg/day or approximately ½ of the maximum recommended human dose (MRHD) of 3600 mg/kg on a body surface area (mg/m²) basis.

In studies in which rats received oral doses of gabapentin (500 to 2000 mg/kg/day), during pregnancy, adverse effect on offspring development (increased incidences of hydroureter and/or hydronephrosis) were observed at all doses. The lowest effect dose for developmental toxicity in rats is approximately equal to the MRHD on a mg/m² basis.

When pregnant rabbits were treated with gabapentin during the period of organogenesis, an increase in embryo-fetal mortality was observed at all doses tested (60, 300, or 1500 mg/kg). The lowest effect dose for embryo-fetal developmental toxicity in rabbits is less than the MRHD on a mg/m² basis.

In a published study, gabapentin (400 mg/kg/day) was administered byintraperitoneal injection to neonatal mice during the first postnatal week, a period of synaptogenesis in rodents (corresponding to the last trimester of pregnancy in humans). Gabapentin caused a marked decrease in neuronal synapse formation in brains of intact mice and abnormal neuronal synapse formation in a mouse model of synaptic repair. Gabapentin has been shownin vitro to interfere with activity of the α2δ subunit of voltage-activated calcium channels, a receptor involved in neuronal synaptogenesis. The clinical significance of these findings is unknown.

To provide information regarding the effects of in utero exposure to NEURONTIN, physicians are advised to recommend that pregnant patients taking NEURONTIN enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

Nursing Mothers

Gabapentin is secreted into human milk following oral administration. A nursed infant could be exposed to a maximum dose of approximately 1 mg/kg/day of gabapentin. Because the effect on the nursing infant is unknown, NEURONTIN should be used in women who are nursing only if the benefits clearly outweigh the risks.

Pediatric Use

Safety and effectiveness of NEURONTIN in the management of postherpetic neuralgia in pediatric patients have not been established.

Effectiveness as adjunctive therapy in the treatment of partial seizures in pediatric patients below the age of 3 years has not been established

Geriatric Use

The total number of patients treated with NEURONTIN in controlled clinical trials in patients with postherpetic neuralgia was 336, of which 102 (30%) were 65 to 74 years of age, and 168 (50%) were 75 years of age and older. There was a larger treatment effect in patients 75 years of age and older compared with younger patients who received the same dosage. Since gabapentin is almost exclusively eliminated by renal excretion, the larger treatment effect observed in patients ≥ 75 years may be a consequence of increased gabapentin exposure for a given dose that results from an age-related decrease in renal function. However, other factors cannot be excluded. The types and incidence of adverse reactions were similar across age groups except for peripheral edema and ataxia, which tended to increase in incidence with age.

Clinical studies of NEURONTIN in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients

Gabapentin Dosing Information

Usual Adult Dose of Gabapentin for Epilepsy:

Initial dose: 300 mg orally on day one, 300 mg orally twice a day on day two, then 300 mg orally 3 times a day on day three.
Maintenance dose: 900 to 1800 mg orally in 3 divided doses. If necessary, the dose may be increased using 300 mg or 400 mg capsules three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the three times a day schedule should not exceed 12 hours.

The safety and effectiveness of gabapentin available under the trade name Gralise (R) or Horizant (R) in patients with epilepsy has not been studied.

Usual Adult Dose for Postherpetic Neuralgia:

Initial dose: 300 mg orally on day one, 300 mg orally twice a day on day two, then 300 mg orally 3 times a day on day three.

The dose may be titrated up as needed for pain relief to a daily dose of 1800 mg.
Maintenance dose: 900 to 1800 mg orally in 3 divided doses.

Efficacy was demonstrated in clinical studies over a range of 1800 mg/day to 3600 mg/day. However, no additional benefit was demonstrated from the use of doses over 1800 mg/day.

Gabapentin available under the trade name Gralise (R):

Maintenance dose: Gralise (R) should be titrated to 1800 mg orally once daily with the evening meal.

Recommended titration schedule:
Day 1: 300 mg orally with the evening meal
Day 2: 600 mg orally with the evening meal
Days 3 through 6: 900 mg orally with the evening meal
Days 7 through 10: 1200 mg orally with the evening meal
Days 11 through 14: 1500 mg orally with the evening meal
Day 15: 1800 mg orally with the evening meal

Gralise (R) is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

Gabapentin enacarbil extended release tablets available under the trade name Horizant (R):

The recommended dosage is 600 mg orally twice daily. Therapy should be initiated at a dose of 600 mg orally in the morning for 3 days of therapy, then increased to 600 mg twice daily (1,200 mg/day) on day four.

Gabapentin enacarbil extended release tablets available under the trade name Horizant (R) and gabapentin are not interchangeable.

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

Usual Pediatric Dose for Epilepsy:

Less than 3 years: Effectiveness has not been established.

Greater than or equal to 3 and less than 12 years:
Starting Dose: ranges from 10 to 15 mg/kg/day in 3 divided doses.
Effective Dose: reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin in patients 5 years of age and older is 25 to 35 mg/kg/day and given in divided doses (three times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day). Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long term clinical study. The maximum time interval between doses should not exceed 12 hours.

Greater than 12 years:
Initial dose: 300 mg orally on day one, 300 mg orally twice a day on day two, then 300 mg orally 3 times a day on day three.
Maintenance dose: 900 to 1800 mg orally in 3 divided doses. If necessary, the dose may be increased using 300 mg or 400 mg capsules three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the three times a day schedule should not exceed 12 hours.

Gabapentin Overdose

A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8000 mg/kg. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation.

Acute oral overdoses of NEURONTIN up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy, and diarrhea were observed. All patients recovered with supportive care. Coma, resolving with dialysis, has been reported in patients with chronic renal failure who were treated with NEURONTIN.

 

Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient’s clinical state or in patients with significant renal impairment.

If overexposure occurs, call your poison control center at 1-800-222-1222.

Gabapentin Side Effects

Neurontin is the trade name for the generic drug gabapentin. It is useful as an anti-epileptic drug and as an analgesic, particularly for pain of the neuropathic or neurogenic type. (pain from irritation or inflammation of nerves). When used for controlling epilepsy, it is usually used in conjunction with another anti-epileptic drug. It is used much more extensively in the medical field to treat pain than it is to treat epilepsy.

The chemical structure of gabapentin is related that of gamma-aminobutyric acid (GABA) which is a neurotransmitter in the brain. The exact mechanism as to how gabapentin controls epilepsy and relieves pain is unknown, but it probably acts like the neurotransmitter GABA.

Gabapentin side effects

gabapentin800mgtabGet emergency medical help if you have any of these signs of an allergic reaction to gabapentin: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

Call your doctor at once if you have:

  • increased seizures;
  • fever, swollen glands, body aches, flu symptoms;
  • skin rash, easy bruising or bleeding, severe tingling, numbness, pain, muscle weakness;
  • upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • chest pain, irregular heart rhythm, feeling short of breath;
  • confusion, nausea and vomiting, swelling, rapid weight gain, urinating less than usual or not at all;
  • new or worsening cough, fever, trouble breathing;
  • rapid back and forth movement of your eyes; or
  • severe skin reaction — fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Some side effects are more likely in children taking gabapentin. Contact your doctor if the child taking this medication has any of the following side effects:

  • changes in behavior;
  • memory problems;
  • trouble concentrating; or
  • acting restless, hostile, or aggressive.

Common gabapentin side effects may include:

  • dizziness, drowsiness;
  • dry mouth, blurred vision;
  • headache;
  • diarrhea; or
  • swelling in your hands or feet.

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.

 

What Is Gabapentin Off Label Usages ?

Neurontin is the trade name for the generic drug gabapentin. It is useful as an anti-epileptic drug and as an analgesic, particularly for pain of the neuropathic or neurogenic type. (pain from irritation or inflammation of nerves). When used for controlling epilepsy, it is usually used in conjunction with another anti-epileptic drug. It is used much more extensively in the medical field to treat pain than it is to treat epilepsy.

Gabapentin belongs to a class of drugs known as anticonvulsants, used to help control seizures in the treatment of epilepsy. Neurontin will only be able to control seizures for as long as you take it. It can’t cure epilepsy. Gabapentin capsules, tablets, and oral solution are used to help control certain types of seizures in people who have epilepsy.

Gabapentin capsules, tablets, and oral solution are also used to relieve the pain of postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Gabapentin extended-release tablets (Horizant) are used to treat restless legs syndrome (RLS; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down). Gabapentin is in a class of medications called anticonvulsants. It has also been reported to be helpful in controlling the pain of fibromyalgia.

Gabapentin treats seizures by decreasing abnormal excitement in the brain. Gabapentin relieves the pain of PHN by changing the way the body senses pain. It is not known exactly how gabapentin works to treat restless legs syndrome.

gabapentin800mgtabGabapentin is also sometimes used to relieve the pain of diabetic neuropathy (numbness or tingling due to nerve damage in people who have diabetes), and to treat and prevent hot flashes (sudden strong feelings of heat and sweating) in women who are being treated for breast cancer or who have experienced menopause (”change of life”, the end of monthly menstrual periods). Talk to your doctor about the risks of using this medication for your condition.

Pregabalin (Lyrica), a drug similar to gabapentin, was the first medication approved by the Food and Drug Administration (FDA) to treat fibromyalgia. While gabapentin hasn’t been approved by the FDA for the treatment of fibromyalgia, some doctors may prescribe it off-label for such use.

Gabapentin and pregabalin were originally approved to treat certain types of epilepsy and nerve pain. Both drugs work by limiting the release of pain-communicating chemicals by nerve cells in the brain and spinal cord. The most common side effects of both drugs are dizziness and drowsiness.

It is also used to control pain associated with shingles and has been evaluated for pain conditions, including migraine, as its pain-modulating properties may regulate the perception of pain.

Anticonvulsant drugs, such as gabapentin, are becoming increasingly popular for migraine prevention.

Efficacy of gabapentin in migraine prophylaxis research on a history of migraine episodes for a mean of about 21 years shows that Gabapentin is an effective prophylactic agent for patients with migraine. In addition, gabapentin appears generally well tolerated with mild to moderate somnolence and dizziness.

Gabapentin is generally well tolerated. The main side effects are dizziness and drowsiness. Occasionally there maybe some fluid retention, unsteadiness or G.I upset, mainly diarrhea.

The effective dose of gabapentin varies greatly. Some persons need only 200-300 mg a day whereas others may need 3000 mg or more a day. It may take several weeks to become effective, so it is important to stay on it for an adequate length of time.

Gabapentin has a lot of off-label usage. It is widely used nerve related diseases. Most of them are reviewed by patients and reviewed high.


General speaking, Gabapentin can be off label used to treat Cough, Hot Flashes, Occipital Neuralgia, Trigeminal Neuralgia, Transverse Myelitis,
Alcohol Withdrawal, Pruritus, Bipolar Disorder, Migraine, Anxiety, Postherpetic Neuralgia, Insomnia, Restless Legs Syndrome, Vulvodynia, Benign Essential Tremor, Peripheral Neuropathy, Fibromyalgia, Diabetic Peripheral Neuropathy, Pain, Neuropathic Pain, Reflex Sympathetic Dystrophy Syndrome, Epilepsy, Hiccups, Syringomyelia, Periodic Limb Movement Disorder, Spondylolisthesis, Burning Mouth Syndrome, Pudendal Neuralgia, Small Fiber Neuropathy, Nausea/Vomiting, Chemotherapy Induced.