Gabarone

Generic Name: gabapentin (Oral route)

gab-a-PEN-tin

Commonly used brand name(s):

In the U.S.

• Gabarone
• Neurontin

Available Dosage Forms:

• Capsule
• Tablet
• Solution

Therapeutic Class: Anticonvulsant

Chemical Class: Gamma Aminobutyric Acid (class)

Uses For Gabarone

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

Gabapentin is also used to manage a condition called postherpetic neuralgia, which is pain that occurs after “shingles.”

Gabapentin is an anticonvulsant. It increases the amount of a chemical called gamma-aminobutyric acid (GABA) in the brain. It is felt that some epileptic seizures occur when there are low levels of GABA in the brain. By increasing the amount of GABA, gabapentin reduces the number of seizures.

Gabapentin also works to relieve pain for certain conditions in the nervous system. It is not used for routine pain caused by minor injuries or arthritis.

This medicine 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 with the following medical condition:

• Diabetic peripheral neuropathy

Before Using Gabarone

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gabapentin for treating partial seizures in children. However, safety and efficacy have not been established in children younger than 3 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of gabapentin for treating postherpetic neuralgia in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gabapentin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving gabapentin.

Pregnancy

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.

Interactions with Medicines

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Ginkgo
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate

Interactions with Food/Tobacco/Alcohol

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:

• Cancer, history of or
• Depression, history of or
• Mental illness, history of—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of gabapentin

This section provides information on the proper use of a number of products that contain gabapentin. It may not be specific to Gabarone. Please read with care.

Take this medicine only as directed by your doctor, to help your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

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

For patients with epilepsy who take gabapentin three times per day, do not allow more than 12 hours to pass between any 2 doses. The medicine works best if a constant amount is in the blood.

If you or your child have trouble swallowing capsules, talk to your doctor about using the tablet or solution form. This medicine may also be given as a combination with any of the forms, such as tablets with solution.

You may break the scored tablets into two pieces, but make sure you or your child use the second half of the tablet as the next dose. Ask your doctor or pharmacist if you have any questions.

Measure the oral solution using a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Gabapentin may be used together with other seizure medicines. Keep using all of your medicines unless your doctor tells you to stop.

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 forms (capsules, solution, and tablets):
  • For epilepsy:
    • Adults and teenagers 12 years of age and older—At first, 300 milligrams (mg) three times per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1800 mg per day.
    • Children 3 to 12 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 10 to 15 milligrams (mg) per kilogram (kg) of body weight per day, divided into three doses. Your doctor may adjust your dose as needed. The usual dose for children 5 years of age and older is 25 to 35 mg per kg of body weight per day, divided into three doses. The usual dose for children 3 and 4 years of age is 40 mg per kg of body weight per day, divided into three doses.
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.
  • For postherpetic neuralgia:
    • Adults— At first, 300 milligrams (mg) taken as a single dose on day 1. On day 2, 300 mg two times per day. On day 3, 300 mg three times per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1800 mg per day.
    • Children—Use and dose must be determined by your doctor.

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.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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

You should store the oral solution in the refrigerator. Do not freeze.

Precautions While Using Gabarone

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

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for pregnant patients taking seizure medicines.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, or feeling nervous or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.

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, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; other medicines for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you or your child are using gabapentin.

Gabapentin may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, drowsiness, or trouble with 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 side effects are especially bothersome, check with your doctor.

Before you have any medical tests, tell the doctor in charge that you or your child are taking gabapentin. The results of certain medical tests may be affected by this medicine.

Do not stop using 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 or your child to gradually reduce the amount you are taking before stopping it completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Gabarone Side Effects

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 immediately if any of the following side effects occur:

• Clumsiness or unsteadiness
• continuous, uncontrolled, back-and-forth or rolling eye movements

• Aggressive behavior or other behavior problems
• anxiety
• concentration problems and change in school performance
• crying
• depression
• false sense of well-being
• hyperactivity or increase in body movements
• rapidly changing moods
• reacting too quickly, too emotionally, or overreacting
• restlessness
• suspiciousness or distrust

• Black, tarry stools
• chest pain
• chills
• cough
• depression, irritability, or other mood or mental changes
• fever
• loss of memory
• pain or swelling in the arms or legs
• painful or difficult urination
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness

• Abdominal or stomach pain
• blistering, peeling, or loosening of the 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 the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• muscle ache or pain
• nausea
• red irritated eyes
• red skin lesions, often with a purple center
• skin rash
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• 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:

• Blurred vision
• cold or flu-like symptoms
• delusions
• dementia
• hoarseness
• lack or loss of strength
• lower back or side pain
• swelling of the hands, feet, or lower legs
• trembling or shaking

• 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 with breathing
• dryness of the 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 the skin, especially on the face and neck
• flushed, dry skin
• frequent urination
• fruit-like breath odor
• impaired vision
• incoordination
• increased hunger
• increased sensitivity to pain
• increased sensitivity to touch
• increased thirst
• indigestion
• low blood pressure
• nervousness
• noise in the ears
• pain, redness, rash, swelling, or bleeding where the skin is rubbed off
• passing gas
• redness or swelling in the ear
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• runny nose
• shortness of breath
• sneezing
• sweating
• tender, swollen glands in the neck
• tightness in the chest
• tingling in the hands and feet
• troubled breathing
• trouble with sleeping
• trouble with swallowing
• trouble with 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.

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

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