Pronunciation:

GA-ba-pen-tin

Brand Names:

• Gabarone
• Neurontin

Dosage Forms:

• Tablet
• Capsule
• Solution

Classifications:

Therapeutic—

Anticonvulsant

Chemical—

Gamma Aminobutyric Acid (class)

Uses of This Medicine:

Gabapentin is used to help control some types of seizures in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

This medicine is also used to manage a condition called postherpetic neuralgia (pain after “shingles”).

Gabapentin is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, gabapentin is used in certain patients:

• To treat diabetic peripheral neuropathic pain.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

This medicine has been tested in children 3 years to 12 years of age. Children may be sensitive to the effects of gabapentin. This may increase the chance of side effects during treatment. Certain side effects may be especially likely to occur in children. It is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it..

This medicine has been tested in a small number of patients 12 to 18 years of age. In effective doses, gabapentin has not been shown to cause different side effects or problems than it does in adults.

Older adults—

Gabapentin is removed from the body more slowly in elderly people than in younger people. Higher blood levels may occur, which may increase the chance of unwanted effects. Your doctor may give you a different gabapentin dose than a younger person would receive.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Higher blood levels of gabapentin may occur, which may increase the chance of unwanted effects; your doctor may need to change your dose

Proper Use of This Medicine:

Take this medicine only as directed by your doctor, to help your condition as much as possible. Do not take more or less of it, and do not take it more or less often than your doctor ordered.

Gabapentin may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

When taking gabapentin 3 times a day, do not allow more than 12 hours to pass between any 2 doses.

If you have trouble swallowing capsules, you may open the gabapentin capsule and mix the medicine with applesauce or juice. Mix only one dose at a time just before taking it. Do not mix any doses to save for later, because the medicine may change over time and may not work properly.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For epilepsy:
    • Adults and teenagers 12 years of age and older—At first, 300 milligrams (mg) three times a day. Your doctor may increase the dose gradually if needed. However, the dose is usually not more than 1800 mg a day.
    • Children 3 to 12 years of age—Dose is based on body weight. To start, 10 to 15 mg per kilogram (4.5 to 6.8 mg per pound) of body weight a day, divided into three doses. Your doctor may increase your dose as needed. The usual dose for children 5 years of age and older is 25 to 35 mg per kilogram (11.3 to 15.9 mg per pound) of body weight a day, divided into three doses. The usual dose for children 3 to 5 years of age is 40 mg per kilogram (18.1 mg per pound) of body weight a day, divided into three doses.
    • Children less than 3 years of age—Use and dose must be determined by your doctor.
    • Older adults—Dose must be determined by your doctor, but it is usually not more than 600 mg three times a day.
  • For postherpetic neuralgia
    • Adults and teenagers— At first, 300 milligrams (mg) on day 1. On day 2, 300 milligrams (mg) two times a day. On day 3, 300 milligrams (mg) three times a day. Your doctor may want to increase your dose to a maximum daily dose of 1800 milligrams (600 milligrams three times a day).
• For oral dosage form (oral solution):
  • For epilepsy:
    • Adults and teenagers 12 years of age and older—At first, 300 milligrams (mg) three times a day. Your doctor may increase the dose gradually if needed. However, the dose is usually not more than 1800 mg a day.
    • Children 3 to 12 years of age—Dose is based on body weight. To start, 10 to 15 mg per kilogram (4.5 to 6.8 mg per pound) of body weight a day, divided into three doses. Your doctor may increase your dose as needed. The usual dose for children 5 years of age and older is 25 to 35 mg per kilogram (11.3 to 15.9 mg per pound) of body weight a day, divided into three doses. The usual dose for children 3 to 5 years of age is 40 mg per kilogram (18.1 mg per pound) of body weight a day, divided into three doses.
    • Children less than 3 years of age—Use and dose must be determined by your doctor.
    • Older adults—Dose must be determined by your doctor, but it is usually not more than 600 mg three times a day.
  • For postherpetic neuralgia
    • Adults and teenagers— At first, 300 milligrams (mg) on day 1. On day 2, 300 milligrams (mg) two times a day. On day 3, 300 milligrams (mg) three times a day. Your doctor may want to increase your dose to a maximum daily dose of 1800 milligrams (600 milligrams three times a day).
• For oral dosage form (tablets):
  • For epilepsy:
    • Adults and teenagers 12 years of age and older—At first, 300 milligrams (mg) three times a day. Your doctor may increase the dose gradually if needed. However, the dose is usually not more than 1800 mg a day.
    • Children 3 to 12 years of age—Dose is based on body weight. To start, 10 to 15 mg per kilogram (4.5 to 6.8 mg per pound) of body weight a day, divided into three doses. Your doctor may increase your dose as needed. The usual dose for children 5 years of age and older is 25 to 35 mg per kilogram (11.3 to 15.9 mg per pound) of body weight a day, divided into three doses. The usual dose for children 3 to 5 years of age is 40 mg per kilogram (18.1 mg per pound) of body weight a day, divided into three doses.
    • Children less than 3 years of age—Use and dose must be determined by your doctor.
    • Older adults—Dose must be determined by your doctor, but it is usually not more than 600 mg three times a day.
  • For postherpetic neuralgia
    • Adults and teenagers— At first, 300 milligrams (mg) on day 1. On day 2, 300 milligrams (mg) two times a day. On day 3, 300 milligrams (mg) three times a day. Your doctor may want to increase your dose to a maximum daily dose of 1800 milligrams (600 milligrams three times a day).

Note: This medicine may be given as a combination of any of the forms it comes in.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not allow more than 12 hours to go by between doses. If this happens, call your doctor right away.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the liquid form of this medicine in the refrigerator.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits, especially for the first few months you take gabapentin. This is necessary to allow dose adjustments and to reduce any unwanted effects.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; other medicines for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking gabapentin .

Gabapentin may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, drowsiness, or trouble in thinking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well. If these reactions are especially bothersome, check with your doctor.

Before you have any medical tests, tell the doctor in charge that you are taking gabapentin. The results of dipstick tests for protein in the urine may be affected by this medicine.

Do not stop taking gabapentin without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Clumsiness or unsteadiness

continuous, uncontrolled, back-and-forth and/or rolling eye movements

More common in patients 3 to 12 years of age

Aggressive behaviors or other behavior problems

anxiety

concentration problems and change in school performance

crying

false sense of well-being

hyperactivity or increase in body movements

mental depression

reacting too quickly, too emotionally, or overreacting

rapidly changing moods

restlessness

suspiciousness or distrust

Less common

Black, tarry stools

chills

chest pain

cough

depression, irritability, or other mood or mental changes

fever

loss of memory

pain or swelling in arms or legs

painful or difficult urination

shortness of breath

sore throat

sores, ulcers, or white spots on lips or in mouth

swollen glands

unusual bleeding or bruising

unusual tiredness or weakness

Frequency not determined

abdominal or stomach pain

blistering, peeling, loosening of skin

clay-colored stools

coma

confusion

convulsions

dark urine

decreased urine output

diarrhea

dizziness

fast or irregular heartbeat

headache

increased thirst

itching

joint pain

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

loss of appetite

muscle ache or pain

nausea

red irritated eyes

red skin lesions, often with a purple center

skin rash

sores, ulcers, or white spots in mouth or on lips

unpleasant breath odor

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Symptoms of overdose

Diarrhea

double vision

drowsiness

sluggishness

slurred speech

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Blurred or double vision

cold or flu-like symptoms

delusions

dementia

drowsiness

hoarseness

lack or loss of strength

lower back or side pain

swelling of hands, feet, or lower legs

trembling or shaking

Less common or rare

Accidental injury

appetite increased

back pain

bloated full feeling

body aches or pain

burning, dry or itching eyes

change in vision

change in walking and balance

clumsiness, or unsteadiness

congestion

constipation

cough producing mucus

decrease in sexual desire or ability

dementia

difficulty breathing

dryness of mouth or throat

earache

excess air or gas in stomach or intestines

excessive tearing

eye discharge

feeling faint, dizzy, or lightheadedness

feeling of warmth or heat

flushing or redness of skin, especially on face and neck

flushed, dry skin

frequent urination

fruit-like breath odor

impaired vision

increased hunger

increased sensitivity to pain

increased sensitivity to touch

increased thirst

incoordination

indigestion

low blood pressure

nervousness

noise in ears

pain, redness, rash, swelling, or bleeding where the skin is rubbed off

passing gas

redness, pain, swelling of eye, eyelid, or inner lining of eyelid

redness or swelling in ear

runny nose

shortness of breath

slurred speech

sneezing

sweating

tender, swollen glands in neck

tightness in chest

tingling in the hands and feet

troubled breathing

trouble in sleeping

trouble in swallowing

trouble in thinking

twitching

unexplained weight loss

voice changes

vomiting

weakness or loss of strength

weight gain

wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.