FusePaq Fanatrex (Oral)

Gabapentin is used to help control partial seizures (convulsions) in people with epilepsy. This medicine cannot cure epilepsy and will only help control seizures as long as you keep taking it.

Gabapentin is also used to manage postherpetic neuralgia, which is pain that occurs after shingles.

Gabapentin works in the brain to prevent seizures and relieve pain for specific conditions in the nervous system. It is not used for everyday pain from minor injuries or arthritis. Gabapentin is an anticonvulsant.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits, especially in the first few months if you have epilepsy. This will help your doctor see if the medicine is working properly and decide if you should keep taking it.

Check with your doctor right away if you have a fever, rash, swollen, painful, or tender lymph glands in your neck, armpit, or groin, unusual bleeding or bruising, or yellow eyes or skin. These may be signs of a serious and life-threatening allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) or multiorgan hypersensitivity.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and need immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Gabapentin may cause changes in vision, clumsiness, unsteadiness, dizziness, drowsiness, sleepiness, or trouble with thinking. Make sure you know how this medicine affects you 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 clearly. If these side effects are especially bothersome, talk to your doctor.

This medicine may cause some people to feel agitated, irritable, or show other unusual behaviors, such as feeling sad or hopeless, getting upset easily, or feeling nervous, restless, or hostile. It may also lead some people to have thoughts of suicide 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 increase the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, other medicines for seizures (e.g., barbiturates), muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor or dentist before taking any of these while you or your child are using gabapentin.

This medicine may cause respiratory depression, a serious breathing problem that can be life-threatening, when used with narcotic pain medicines. Check with your doctor right away if you have pale or blue lips, fingernails, or skin, difficulty breathing, or irregular, fast, slow, or shallow breathing.

Do not stop using gabapentin without talking to your doctor. Stopping the medicine suddenly may lead to seizures. Your doctor may want you or your child to gradually reduce the amount you are taking before stopping it completely.

Make sure any doctor or dentist treating you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

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

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it may provide. This is a decision you will make with your doctor. For this medicine, consider the following:

Allergies

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

Pediatric

Studies have not shown any specific problems in children aged 3 years and older that would limit the use of gabapentin for treating partial seizures. However, safety and effectiveness have not been established for children younger than 3 years.

Studies have not been done to see how age affects gabapentin's use for treating postherpetic neuralgia in children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in elderly patients that would limit the usefulness of gabapentin. However, older adults are more likely to experience unwanted effects (like balance or walking issues, swelling in the feet or legs) and age-related kidney problems, which may require caution and changes in the dose for patients taking gabapentin.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might occur. In these cases, your doctor may change the dose, or other precautions may be necessary. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected for their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Acepromazine
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aripiprazole
• Asenapine
• Baclofen
• Benperidol
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Buspirone
• Butabarbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Cyclobenzaprine
• Daridorexant
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Doxylamine
• Droperidol
• Enflurane
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fentanyl
• Flibanserin
• Flunitrazepam
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fospropofol
• Gabapentin Enacarbil
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Isoflurane
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Levocetirizine
• Levorphanol
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Meclizine
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Midazolam
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Olanzapine
• Opium
• Opium Alkaloids
• Orlistat
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Quazepam
• Quetiapine
• Ramelteon
• Remifentanil
• Remimazolam
• Remoxipride
• Ropeginterferon Alfa-2b-njft
• Secobarbital
• Sertindole
• Sodium Oxybate
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Using this medicine with any of the following medicines may increase the 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

Some medicines should not be taken around meal times or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Depression, history of or
• Lung or breathing problems (like respiratory depression) or
• Mood or mental changes, history of—Use with caution. May worsen these conditions.

• Kidney disease (like patients receiving dialysis)—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

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

Check with your doctor immediately if any of the following side effects occur:

More common

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

More common in children

• Aggressive behavior or other behavior problems
• Anxiety
• Concentration problems and changes in school performance
• Crying
• Depression
• False sense of well-being
• Hyperactivity or increased body movements
• Rapidly changing moods
• Reacting too quickly, being too emotional, or overreacting
• Restlessness
• Suspiciousness or distrust

Less common

• 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
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Swollen glands
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Incidence not known

• Blistering, peeling, or loosening of the skin
• Clay-colored stools
• Coma
• Confusion
• Dark urine
• Decreased urine output
• Diarrhea
• Difficult or troubled breathing
• Dizziness
• Fast or irregular heartbeat
• Headache
• Increased thirst
• Irregular, fast or slow, or shallow breathing
• Itching or skin rash
• 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
• Pale or blue lips, fingernails, or skin
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Seizures
• Stomach pain
• Unpleasant breath odor
• Vomiting of blood
• Yellow eyes or skin

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 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 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

Less common or rare

• Accidental injury
• Increased appetite
• Back pain
• Body aches or pain
• Burning, dry, or itching eyes
• Change in vision
• Change in walking and balance
• Chest tightness
• Clumsiness or unsteadiness
• Congestion
• Constipation
• Cough producing mucus
• Decrease in sexual desire or ability
• Dryness of the mouth or throat
• Earache
• Excessive tearing
• Eye discharge
• Feeling faint, dizzy, or lightheaded
• Feeling of warmth or heat
• Flushed, dry skin
• Flushing or redness of the skin, especially on the face and neck
• Frequent urination
• Fruit-like breath odor
• Impaired vision
• Incoordination
• Increased hunger
• Increased sensitivity to pain
• Increased sensitivity to touch
• Increased thirst
• Noise in the ears
• Pain, redness, rash, swelling, or bleeding where the skin is rubbed off
• Redness or swelling in the ear
• Redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• Runny nose
• Sneezing
• Sweating
• Tender, swollen glands in the neck
• Tingling in the hands and feet
• Trouble sleeping
• Trouble swallowing
• Trouble thinking
• Twitching
• Unexplained weight loss
• Voice changes
• Vomiting
• Weakness or loss of strength
• Weight gain

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.

In the U.S.

• FusePaq Fanatrex
• Gabarone
• Gralise
• Neurontin

Available Dosage Forms:

• Capsule
• Tablet
• Tablet, Extended Release, 24 HR
• Solution
• Suspension

Therapeutic Class: Anticonvulsant

Pharmacologic Class: Gabapentinoid

Chemical Class: Gamma Aminobutyric Acid (class)

Take this medicine only as directed by your doctor. 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.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you are using Gralise® tablets:

• These should be taken with the evening meal.
• Swallow the tablet whole. Do not crush, break, or chew it.

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.

Neurontin® capsules, tablets, and solution may be taken with or without food.

You may break the scored Neurontin® tablets into two pieces, but make sure you use the second half of the tablet as the next dose. Do not use the half-tablet if the whole tablet has been cut or broken after 28 days. Ask your doctor or pharmacist if you have any questions.

Swallow the capsule whole with plenty of water. Do not open, crush, or chew it.

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

If you take an antacid that contains aluminum or magnesium, wait at least 2 hours before taking gabapentin. Some examples of these antacids are Di-Gel®, Gaviscon®, Gelusil®, Maalox® and Mylanta®.

Only use the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

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, liquid, and tablets): For epilepsy: Adults and children 12 years of age and older—At first, 300 milligrams (mg) 3 times per day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 1800 mg per day (600 mg 3 times per day). Children 3 to 11 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 and divided in 3 doses. Your doctor may adjust your dose as needed and tolerated. 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) as a single dose in the evening. Your doctor may adjust your dose as needed and tolerated. 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 Neurontin® oral liquid in the refrigerator. Do not freeze.

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