Neurontin

DRUG DESCRIPTION

Neurontin® (gabapentin) Capsules, Neurontin (gabapentin) Tablets, and Neurontin (gabapentin) Oral Solution are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin, elliptical film-coated tablets containing 600 mg and 800 mg of gabapentin or an oral solution containing 250 mg/5 mL of gabapentin.

The inactive ingredients for the capsules are lactose, cornstarch, and talc. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains FD&C Blue No. 2 and titanium dioxide.

The inactive ingredients for the tablets are poloxamer 407, copolyvidonum, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, candelilla wax and purified water.

The inactive ingredients for the oral solution are glycerin, xylitol, purified water and artificial cool strawberry anise flavor.

Gabapentin is described as l-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is:

Neurontin®
  (gabapentin) Capsules Structural Formula Illustration

Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25.

What are the possible side effects of gabapentin (Gabarone, Neurontin)?

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

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, 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 any...

Read All Potential Side Effects and See Pictures of Neurontin »

What are the precautions when taking gabapentin (Neurontin)?

Before taking gabapentin, tell your doctor or pharmacist if you are allergic to it; or to gabapentin enacarbil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, mental/mood problems (such as depression, thoughts of suicide).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the...

Read All Potential Precautions of Neurontin »


Neurontin Consumer (continued)

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.

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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking gabapentin, tell your doctor or pharmacist if you are allergic to it; or to gabapentin enacarbil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, mental/mood problems (such as depression, thoughts of suicide).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially swelling of the hands/ankles/feet and loss of coordination.

Children may be more sensitive to the side effects of this drug, especially mental/mood/behavior changes (such as hostility, problems concentrating, restlessness).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Gabapentin passes into breast milk. Consult your doctor before breast-feeding.


Neurontin Patient Information Including Side Effects

Brand Names: Gabarone, Neurontin

Generic Name: gabapentin (Pronunciation: GA ba PEN tin)

  • What is gabapentin (Neurontin)?
  • What are the possible side effects of gabapentin (Neurontin)?
  • What is the most important information I should know about gabapentin (Neurontin)?
  • What should I discuss with my healthcare provider before taking gabapentin (Neurontin)?
  • How should I take gabapentin (Neurontin)?
  • What happens if I miss a dose (Neurontin)?
  • What happens if I overdose (Neurontin)?
  • What should I avoid while taking gabapentin (Neurontin)?
  • What other drugs will affect gabapentin (Neurontin)?
  • Where can I get more information?

What is gabapentin (Neurontin)?

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 alone or in combination with other medications to treat seizures caused by epilepsy in adults and children who are at least 12 years old. Gabapentin is also used with other medications to treat partial seizures in children who are 3 to 12 years old.

Gabapentin is also used to treat nerve pain caused by herpes virus or shingles (herpes zoster).

Gabapentin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of gabapentin (Neurontin)?

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

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, 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 any of these serious side effects:

  • increased seizures;
  • fever, chills, body aches, flu symptoms;
  • swelling of your ankles or feet;
  • confusion;
  • rapid back and forth movement of your eyes;
  • tremor; or
  • easy bruising.

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.

Less serious side effects may include:

  • dizziness, drowsiness, weakness, tired feeling;
  • lack of coordination;
  • blurred vision;
  • nausea, vomiting, stomach pain, loss of appetite;
  • diarrhea, constipation;
  • dry mouth;
  • runny or stuffy nose, sore throat;
  • headache;
  • sleep problems (insomnia), unusual dreams; or
  • acne, mild skin rash.

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 the most important information I should know about gabapentin (Neurontin)?

You should not use this medication if you are allergic to gabapentin.

Before taking gabapentin, tell your doctor if you have kidney, liver, or heart disease.

You may have thoughts about suicide while taking gabapentin. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

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

Do not stop taking gabapentin for seizures without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking gabapentin suddenly. You will need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking gabapentin.

Carry an ID card or wear a medical alert bracelet stating that you are taking gabapentin, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

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