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USP DI Vol. II - GABAPENTIN (Systemic)

GABAPENTIN (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Neurontin

In Canada?

  • Neurontin
  • Novo-Gabapentin

Another commonly used name is GBP.


Category

  • Anticonvulsant
  • Antineuralgic

Description

Gabapentin (GA-ba-pen-tin)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 seizuresfor 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, in the followingdosage form:

    Oral
  • Capsules (U.S. and Canada)
  • Oral Solution (U.S.)
  • Tablets (U.S. and Canada)


Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to gabapentin. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Gabapentin has not been studied in pregnant women.However, studies in pregnant animals have shown that gabapentin may causebone or kidney problems in offspring when given to the mother in doses largerthan the largest human dose. Before taking this medicine, make sure your doctorknows if you are pregnant or if you may become pregnant.

Breast-feeding?This medicine passes into breast milk and may causeunwanted effects in nursing babies. It may be necessary for you to take anothermedicine or to stop your breast feeding during treatment. Be sure you havediscussed the risks and benefits of the medicine with your doctor.

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

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

Older adults?Gabapentin is removed from the body more slowly inelderly people than in younger people. Higher blood levels may occur, whichmay increase the chance of unwanted effects. Your doctor may give you a differentgabapentin dose than a younger person would receive.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takinggabapentin, it is especially important that your health care professionalknow if you are taking any of the following:

  • Antacids (e.g., Maalox)?Lower blood levels of gabapentin mayoccur, so gabapentin may not work properly; gabapentin should be taken atleast 2 hours after any antacid is taken.
  • Morphine (e.g., Kadian, MS Contin)?Higher blood levels of gabapentinmay occur and there is an increased chance of side effects from the medicine.A lower dose of either medicine may be needed.

Other medical problems?The presence of other medicalproblems may affect the use of gabapentin. Make sure you tell your doctorif 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 tochange your dose

Proper Use of This Medicine

Take this medicine only as directed by your doctor, to help your conditionas much as possible. Do not take more or less of it, and do not take it moreor 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, takeit exactly as directed.

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

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

Dosing?The dose of gabapentin will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of gabapentin. If your dose is different,do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine.

  • For oral dosage form (capsules):
    • For epilepsy:
      • Adults and teenagers 12 years of age and older?At first, 300milligrams (mg) three times a day. Your doctor may increase the dose graduallyif 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 weighta 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 (18.1mg per pound) of body weight a day, divided into three doses.
      • Children less than 3 years of age?Use and dose must be determinedby your doctor.
      • Older adults?Dose must be determined by your doctor, but itis usually not more than 600 mg three times a day.
    • For postherpetic neuralgia
      • Adults and teenagers? At first, 300 milligrams (mg) on day1. 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 maximumdaily 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, 300milligrams (mg) three times a day. Your doctor may increase the dose graduallyif 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 weighta 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 (18.1mg per pound) of body weight a day, divided into three doses.
      • Children less than 3 years of age?Use and dose must be determinedby your doctor.
      • Older adults?Dose must be determined by your doctor, but itis usually not more than 600 mg three times a day.
    • For postherpetic neuralgia
      • Adults and teenagers? At first, 300 milligrams (mg) on day1. 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 maximumdaily 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, 300milligrams (mg) three times a day. Your doctor may increase the dose graduallyif 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 weighta 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 (18.1mg per pound) of body weight a day, divided into three doses.
      • Children less than 3 years of age?Use and dose must be determinedby your doctor.
      • Older adults?Dose must be determined by your doctor, but itis usually not more than 600 mg three times a day.
    • For postherpetic neuralgia
      • Adults and teenagers? At first, 300 milligrams (mg) on day1. 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 maximumdaily dose of 1800 milligrams (600 milligrams three times a day).

Note:

This medicine may be given as a combination of any of the forms itcomes in.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is less than 4 hours until your next dose, do not take the missed dose and return to your regular dosing schedule. Donot allow more than 12 hours to go by between doses. If this happens, callyour doctor right away. Do not double doses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store the capsule or tablet forms of this medicine in thebathroom, near the kitchen sink, or in other damp places. Heat or moisturemay cause the medicine to break down.
  • Store the liquid form of this medicine in the refrigerator. However,keep the medicine from freezing.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regularvisits, especially for the first few months you take gabapentin. Thisis 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 depressantsare 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 medicaldoctor 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 sureyou know how you react to this medicine before you drive, use machines, ordo 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 aretaking gabapentin. The results of dipstick tests for protein in the urinemay be affected by this medicine.

Do not stop taking gabapentin without first checkingwith your doctor. Stopping the medicine suddenly may cause your seizuresto return or to occur more often. Your doctor may want you to gradually reducethe 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 sideeffects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possibleif 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 andchange in school performance; crying; false sense of well-being; hyperactivityor 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 difficulturination; shortness of breath; sore throat; sores, ulcers, or white spots on lipsor in mouth; swollen glands; unusual bleeding or bruising; unusual tiredness orweakness

    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 tirednessor weakness; vomiting of blood; yellow eyes or skin

    Symptoms of overdose

      Diarrhea; double vision; drowsiness; sluggishness; slurred speech

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

    More common

      Blurred or double vision; cold or flu-likesymptoms; 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 fullfeeling; 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; feelingof warmth or heat; flushing or redness of skin, especiallyon face and neck; flushed, dry skin; frequent urination; fruit-like breathodor; impaired vision; increased hunger; increased sensitivity to pain; increased sensitivity to touch; increasedthirst; 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, swellingof eye, eyelid, or inner lining of eyelid; rednessor 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; unexplainedweight loss; voice changes; vomiting; weakness or loss of strength; weight gain; wheezing

Other side effects not listed abovealso may occur in some patients. If you notice any other effects, check withyour doctor.


Additional Information

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

  • To treat diabetic peripheral neuropathic pain.

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for this use.


Revised: 10/03/2003