Gabapentin enacarbil (Oral)

August 1st, 2021 | drugs

Generic name: gabapentin enacarbil (gab-a-PEN-tin en-a-KAR-bil)
Drug class: Gamma-aminobutyric acid analogs

Commonly used brand name(s)

In the U.S.

Horizant

Available Dosage Forms:

Tablet, Extended Release

Therapeutic Class: Analgesic

Chemical Class: Gamma Aminobutyric Acid (class)

Uses for gabapentin enacarbil

Gabapentin enacarbil is used to treat moderate-to-severe primary Restless Legs Syndrome (RLS). RLS is a neurologic disorder that makes the legs feel uncomfortable. This results in an irresistible feeling of wanting to move your legs to make them comfortable.

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

Gabapentin enacarbil is available only with your doctor's prescription.

Before using gabapentin enacarbil

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 gabapentin enacarbil, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to gabapentin enacarbil 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 have not been performed on the relationship of age to the effects of gabapentin enacarbil in the pediatric population. 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 enacarbil in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving gabapentin enacarbil.

Breastfeeding

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

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. When you are taking gabapentin enacarbil, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

Acepromazine
Alfentanil
Alprazolam
Amobarbital
Anileridine
Aripiprazole
Asenapine
Baclofen
Benperidol
Benzhydrocodone
Bromazepam
Buprenorphine
Buspirone
Butabarbital
Butorphanol
Calcifediol
Calcium Oxybate
Cannabidiol
Carbinoxamine
Carisoprodol
Carphenazine
Chloral Hydrate
Chlordiazepoxide
Chlorpromazine
Chlorzoxazone
Clobazam
Clonazepam
Clorazepate
Clozapine
Codeine
Cyclobenzaprine
Dexmedetomidine
Diacetylmorphine
Diazepam
Dichloralphenazone
Difenoxin
Dihydrocodeine
Diphenhydramine
Diphenoxylate
Doxylamine
Droperidol
Enflurane
Esketamine
Estazolam
Eszopiclone
Ethchlorvynol
Ethopropazine
Ethylmorphine
Fentanyl
Flibanserin
Fluphenazine
Flurazepam
Fluspirilene
Fospropofol
Gabapentin
Halazepam
Haloperidol
Halothane
Hexobarbital
Hydrocodone
Hydromorphone
Hydroxyzine
Isoflurane
Ketamine
Ketazolam
Ketobemidone
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
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

Using gabapentin enacarbil 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper use of gabapentin enacarbil

Take gabapentin enacarbil 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.

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

Swallow the extended-release tablet whole. Do not crush, break, or chew it. It should be taken with food.

For patients with restless legs syndrome: Do not use gabapentin enacarbil if you are required to sleep during the daytime and remain awake at night.

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

Dosing

The dose of gabapentin enacarbil 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 gabapentin enacarbil. 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 (extended-release tablets):
- For restless legs syndrome:
  - Adults—600 milligrams (mg) as a single dose at about 5 PM. Your doctor may adjust your dose as needed and tolerated.
  - Children—Use and dose must be determined by your doctor.
- For postherpetic neuralgia:
  - Adults—At first, 600 milligrams (mg) once a day taken in the morning for 3 days. Then, your doctor will increase your dose to 600 mg two times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 1,200 mg per day.
  - Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of gabapentin enacarbil, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

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

Precautions while using gabapentin enacarbil

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Gabapentin enacarbil may cause dizziness, drowsiness, or sleepiness. Make sure you know how you react to gabapentin enacarbil before you drive, use machines, or do anything else that could be dangerous if you are not alert. If these side effects are especially bothersome, check with your doctor.

Gabapentin enacarbil 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, restless, or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

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

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

Do not stop using gabapentin enacarbil without checking with your doctor. Stopping the medicine suddenly may cause seizures. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely.

Do not drink alcohol while you are using gabapentin enacarbil.

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.

Gabapentin enacarbil 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:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet
discouragement
feeling sad or empty
irritability
lack of appetite
loss of interest or pleasure
rapid weight gain
tingling of the hands or feet
tiredness
trouble concentrating

Incidence not known

Black, tarry stools
bloody or cloudy urine
changes in behavior
chest pain or discomfort
chills or fever
confusion
difficulty with breathing
dizziness or lightheadedness
fainting
fast heartbeat
nausea or vomiting
painful or difficult urination
rapid, shallow breathing
rash
sore throat
sores, ulcers, or white spots on the lips or in the mouth
swelling of the face, feet, or lower legs
swollen, painful, or tender lymph glands in the neck, armpit, or groin
thoughts of killing oneself
unusual bleeding or bruising
upper right abdominal or stomach pain
yellow eyes and 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 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

Lack or loss of strength
sleepiness or unusual drowsiness

Less common

Blurred vision
decreased interest in sexual intercourse
dry mouth
excess air or gas in the stomach or intestines
inability to have or keep an erection
sensation of spinning
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.

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