Neurontin (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

NEURONTIN (gabapentin) capsules, tablets, and oral solution are supplied as follows:

100 mg capsules:

  • White hard gelatin capsules printed with “PD” on the body and “Neurontin/100 mg” on the cap; available in:
    Bottles of 100: NDC 0071-0803-24

300 mg capsules:

  • Yellow hard gelatin capsules printed with “PD” on the body and “Neurontin/300 mg” on the cap; available in:
    Bottles of 100: NDC 0071-0805-24
    Unit dose 50′s: NDC 0071-0805-40

400 mg capsules:

  • Orange hard gelatin capsules printed with “PD” on the body and “Neurontin/400 mg” on the cap; available in:
    Bottles of 100: NDC 0071-0806-24
    Unit dose 50′s: NDC 0071-0806-40

600 mg tablets:

  • White elliptical film-coated scored tablets debossed with “NT” and “16″ on one side; available in:
    Bottles of 100: NDC 0071-0513-24

800 mg tablets:

  • White elliptical film-coated scored tablets debossed with “NT” and “26″ on one side; available in:
    Bottles of 100: NDC 0071-0401-24

250 mg per 5 mL oral solution:

  • Clear colorless to slightly yellow solution; each 5 mL of oral solution contains 250 mg of gabapentin; available in:
    Bottles containing 470 mL: NDC 0071-2012-23

Store NEURONTIN Tablets and Capsules at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Store NEURONTIN Oral Solution refrigerated, 2°C to 8°C (36°F to 46°F).

17 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 [see Warnings and Precautions (5.1)].

Anaphylaxis and Angioedema

Advise patients to discontinue NEURONTIN and seek medical care if they develop signs or symptoms of anaphylaxis or angioedema [ see Warnings and Precautions (5.2)].

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 [see Warnings and Precautions (5.3) and Warnings and Precautions (5.4)] .

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 [see Warnings and Precautions (5.6)] .

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 are breast feeding or intend to breast feed during therapy [see Use in Specific Populations (8.1) and (8.2)] .

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 [see Use in Specific Populations (8.1)] .

This product’s label may have been updated. For full prescribing information, please visit www.pfizer.com.

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LAB-0106-24.0

MEDICATION GUIDE

NEURONTIN (Neu rŏn’ tĭn) (Gabapentin)

Capsules, Tablets, and Oral Solution

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

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:

  • 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.
  • 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.
  • NEURONTIN may cause serious or life-threatening allergic reactions that 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.

What is NEURONTIN?

NEURONTIN is a prescription medicine used to treat:

  • Pain from damaged nerves (postherpetic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults.
  • Partial seizures when taken together with other medicines in adults and children 3 years of age and older with seizures.

Who should not take NEURONTIN?

Do not take NEURONTIN if you are allergic to gabapentin or any of the other ingredients in NEURONTIN. See the end of this Medication Guide for a complete list of ingredients in NEURONTIN.

What should I tell my healthcare provider before taking NEURONTIN?

Before taking NEURONTIN, tell your healthcare provider if you:

  • have or have had kidney problems or are on hemodialysis
  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have diabetes
  • are pregnant or plan to become pregnant. It is not known if NEURONTIN can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking NEURONTIN. You and your healthcare provider will decide if you should take NEURONTIN while you are pregnant.
    • Pregnancy Registry: If you become pregnant while taking NEURONTIN, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
  • are breast-feeding or plan to breast-feed. NEURONTIN can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take NEURONTIN.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking NEURONTIN with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take NEURONTIN?

  • Take NEURONTIN exactly as prescribed. Your healthcare provider will tell you how much NEURONTIN to take.
    • Do not change your dose of NEURONTIN without talking to your healthcare provider.
    • If you take NEURONTIN tablets and break a tablet in half, the unused half of the tablet should be taken at your next scheduled dose. Half tablets not used within 28 days of breaking should be thrown away.
    • Take NEURONTIN capsules with water.
  • NEURONTIN tablets can be taken with or without food. If you take an antacid containing aluminum and magnesium, such as Maalox ® , Mylanta ® , Gelusil ® , Gaviscon ® , or Di-Gel ® , you should wait at least 2 hours before taking your next dose of NEURONTIN.

    If you take too much NEURONTIN, call your healthcare provider or your local Poison Control Center right away at 1-800-222-1222.

What should I avoid while taking NEURONTIN?

  • Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking NEURONTIN without first talking with your healthcare provider. Taking NEURONTIN with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how NEURONTIN affects you. NEURONTIN can slow your thinking and motor skills.

What are the possible side effects of NEURONTIN?

NEURONTIN may cause serious side effects including:

See ” What is the most important information I should know about NEURONTIN?”

  • problems driving while using NEURONTIN. See ” What I should avoid while taking Neurontin?”
  • sleepiness and dizziness, which could increase the occurrence of accidental injury, including falls
  • The most common side effects of NEURONTIN include:
    • lack of coordination
    • viral infection
    • feeling drowsy
    • nausea and vomiting
    • difficulty with speaking
    • tremor
    • swelling, usually of legs and feet
    • feeling tired
    • fever
    • jerky movements
    • difficulty with coordination
    • double vision
    • unusual eye movement

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of NEURONTIN. For more information, ask your healthcare provider or pharmacist.

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

How should I store NEURONTIN?

  • Store NEURONTIN Capsules and Tablets between 68°F to 77°F (20°C to 25°C).
  • Store NEURONTIN Oral Solution in the refrigerator between 36°F to 46°F (2°C to 8°C).

Keep NEURONTIN and all medicines out of the reach of children.

General information about the safe and effective use of NEURONTIN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NEURONTIN for a condition for which it was not prescribed. Do not give NEURONTIN to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about NEURONTIN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about NEURONTIN that was written for healthcare professionals.

For more information go to http://www.pfizer.com or call 1-800-438-1985.

What are the ingredients in NEURONTIN?

Active ingredient: gabapentin

Inactive ingredients in the capsules: lactose, cornstarch, talc, gelatin, titanium dioxide and FD&C Blue No. 2.

The 300-mg capsule shell also contains: yellow iron oxide.

The 400-mg capsule shell also contains: red iron oxide, and yellow iron oxide.

Inactive ingredients in the tablets: poloxamer 407, copovidone, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, and candelilla wax

Inactive ingredients in the oral solution: glycerin, xylitol, purified water, and artificial flavor.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com.

LAB-0397-9.0 Revised October 2017

DRUG: Neurontin

GENERIC: gabapentin

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-1405-0

COLOR: yellow

SHAPE: CAPSULE

SCORE: No score

SIZE: 19 mm

IMPRINT: PD;Neurontin;300;mg

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • GABAPENTIN 300mg in 1

INACTIVE INGREDIENT(S):

  • FD&C BLUE NO. 2
  • FERRIC OXIDE YELLOW
  • TITANIUM DIOXIDE
  • GELATIN, UNSPECIFIED
  • LACTOSE, UNSPECIFIED FORM
  • STARCH, CORN
  • TALC
Remedy_Label
(click image for full-size original)
NEURONTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-1405(NDC:0071-0805)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 300 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
STARCH, CORN
TALC
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code PD;Neurontin;300;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-1405-0 30 CAPSULE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020235 09/07/2018
Labeler — REMEDYREPACK INC. (829572556)

Revised: 09/2019 REMEDYREPACK INC.

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