Description
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.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Extended Release
Before Using
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 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.
Drug Interactions
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 this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Isocarboxazid
Using this medicine 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
- Butalbital
- Butorphanol
- Calcifediol
- Calcium Oxybate
- Cannabidiol
- Cannabis
- Carbamazepine
- Carbidopa
- Carbinoxamine
- Carisoprodol
- Carphenazine
- Chloral Hydrate
- Chlordiazepoxide
- Chlorpromazine
- Chlorzoxazone
- Clobazam
- Clomipramine
- Clonazepam
- Clorazepate
- Clozapine
- Codeine
- Cyclobenzaprine
- Cyproheptadine
- Daridorexant
- Dexmedetomidine
- Diacetylmorphine
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
Other Interactions
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.
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:
- Depression, history of or
- Lung or breathing problems (eg, respiratory depression) or
- Mental illness, history of—Use with caution. May make these conditions worse.
- Kidney disease (eg, patients receiving dialysis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Patients who need to sleep during daytime and remain awake at night—Use is not recommended.
Proper Use
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.
Swallow the extended-release tablet whole. Do not crush, cut, or chew it. It should be taken with food.
For patients with restless legs syndrome: Do not use this medicine if you are required to sleep during the daytime and remain awake at night.
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 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 2 times a day on Day 4. 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.
- For restless legs syndrome:
Missed Dose
If you miss a dose of this medicine, 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
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 this medicine 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.
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, restless, or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed, even after stopping the medicine. If you or your caregiver notice any of these side effects, tell your doctor right away.
This medicine 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 this medicine without checking with your doctor. Stopping the medicine suddenly may increase the risk for 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 this medicine.
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.
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
- loss of bladder control
- muscle spasm or jerking of all extremities
- nausea or vomiting
- painful or difficult urination
- rapid, shallow breathing
- rash
- shakiness in the legs, arms, or feet
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sudden loss of consciousness
- swelling of the face, feet, or lower legs
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- thoughts of killing oneself
- trembling or shaking of the hands or feet
- 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.
DRG-20122596
