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Horizant (gabapentin enacarbil) is a prescription medicine used to treat adults with restless legs syndrome and pain from damaged nerves. It affects chemicals and nerves in the body that are involved in the cause of some types of pain.
Horizant is used in adults to treat nerve pain (postherpetic neuralgia) caused by herpes virus or shingles (herpes zoster).
Horizant is also used to treat restless legs syndrome (RLS).
Use only the brand and form of gabapentin your doctor has prescribed. Check your medicine each time you get a refill to make sure you receive the correct form.
Some people have thoughts about suicide while taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
Do not stop using Horizant suddenly, even if you feel fine.
You should not use Horizant if you are allergic to gabapentin.
To make sure Horizant is safe for you, tell your doctor if you have ever had:
kidney disease (or if you are on dialysis);
diabetes;
depression, a mood disorder, or suicidal thoughts or actions;
a seizure (unless you take gabapentin to treat seizures);
liver disease;
heart disease; or
(for patients with RLS) if you are a day sleeper or work a night shift.
Some people have thoughts about suicide while taking this medicine. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Gabapentin enacarbil can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.
Take Horizant exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Do not crush, chew, or break an extended-release Horizant tablet. Swallow the tablet whole.
If your doctor changes your brand, strength, or type of gabapentin, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of gabapentin you receive at the pharmacy.
Do not stop using Horizant suddenly, even if you feel fine. Follow your doctor's instructions about tapering your dose.
This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using gabapentin enacarbil.
Store Horizant extended-release tablets at room temperature away from light and moisture.
Usual Adult Dose of Horizant for Postherpetic Neuralgia:
The recommended dosage is 600 mg orally 2 times a day. Therapy should be initiated at a dose of 600 mg orally in the morning for 3 days of therapy, then increased to 600 mg 2 times a day (1200 mg/day) on day four.
Gabapentin enacarbil extended release tablets available under the trade name Horizant and gabapentin are not interchangeable.
Use: Postherpetic neuralgia
Usual Adult Dose of Horizant for Restless Legs Syndrome:
600 mg orally once daily with food at about 5 PM. A dose of 1,200 mg once daily provided no additional benefit compared with the 600-mg dose, but caused an increase in adverse reactions.
Use: For the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults
Take the missed dose as soon as you remember. Be sure to take the medicine with food. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Gabapentin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Drinking alcohol with this medicine can cause side effects.
Get emergency medical help if you have signs of an allergic reaction to Horizant: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using Horizant.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
seizures;
severe weakness or tiredness;
problems with balance or muscle movement;
upper stomach pain;
chest pain, new or worsening cough with fever, trouble breathing;
severe tingling or numbness;
rapid eye movement; or
kidney problems - little or no urination, painful or difficult urination, swelling in your feet or ankles.
Common Horizant side effects may include:
headache, dizziness, drowsiness, tiredness;
swelling in your hands or feet;
problems with your eyes;
coordination problems; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Taking Horizant with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.
Other drugs may interact with gabapentin enacarbil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Horizant only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Horizant (www.drugs.com/horizant.html).
Note: This document contains side effect information about gabapentin enacarbil. Some of the dosage forms listed on this page may not apply to the brand name Horizant.
Common side effects of Horizant include: dizziness, drowsiness, and sedated state. Other side effects include: irritability. See below for a comprehensive list of adverse effects.
Applies to gabapentin enacarbil: oral tablet extended release
Along with its needed effects, gabapentin enacarbil (the active ingredient contained in Horizant) 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 while taking gabapentin enacarbil:
More common
Incidence not known
Some side effects of gabapentin enacarbil 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
Less common
Applies to gabapentin enacarbil: compounding powder, oral capsule, oral solution, oral tablet, oral tablet extended release
Common (1% to 10%): Peripheral edema, vasodilation, hypertension
Rare (less than 0.1%): Atrial fibrillation, heart failure, myocardial infarction, cerebrovascular accident, ventricular extrasystoles, bradycardia, premature atrial contraction, pericardial rub, heart block, pericardial effusion, pericarditis
Postmarketing reports: Cardiac arrest, chest pain, palpitation, tachycardia
Common (1% to 10%): Abrasion, facial edema, purpura, rash, pruritus, acne
Uncommon (0.1% to 1%): Alopecia, eczema, dry skin, increased sweating, urticaria, hirsutism, seborrhea, cyst, herpes simplex
Rare (less than 0.1%): Stevens-Johnson syndrome, angioedema, erythema multiforme, drug rash (with eosinophilia and systemic symptoms), herpes zoster, skin discolor, skin papules, photosensitive reaction, psoriasis, desquamation, maceration, skin nodules, subcutaneous nodule, melanosis, skin necrosis, local swelling
Frequency not reported: DRESS/multiorgan hypersensitivity
Rare (less than 0.1%): Hyperthyroid, hypothyroid, goiter, hypoestrogenism, ovarian failure, epididymitis, cushingoid appearance
Common (1% to 10%): Diarrhea, dry mouth or throat, constipation, nausea, vomiting, dyspepsia, dental abnormalities, gingivitis, abdominal pain, flatulence
Uncommon (0.1% to 1%): Glossitis, gum hemorrhage, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stools, fecal incontinence
Rare (less than 0.1%): Pancreatitis, dysphagia, eructation, pancreatitis, peptic ulcer, colitis, blisters in mouth, tooth discoloration, perlèche, salivary gland enlarged, lip hemorrhage, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal hemorrhage, esophageal spasm
Frequency not reported: Dehydration
The most common adverse reactions associated with the use of this drug were dizziness, somnolence, and peripheral edema.
Common (1% to 10%): Incontinence, impotence
Uncommon (0.1% to 1%): Hematuria, dysuria, urinary frequency, cystitis, urinary retention, vaginal hemorrhage, amenorrhea, dysmenorrhea, menorrhagia
Frequency not reported: Breast hypertrophy, gynecomastia, sexual dysfunction (including changes in libido, ejaculation disorders, and anorgasmia)
Common (1% to 10%): Leucopenia, purpura
Uncommon (0.1% to 1%): Anemia, lymphadenopathy
Rare (less than 0.1%): Thrombocytopenia, thrombophlebitis, leukocytosis, lymphocytosis, increased bleeding time
Frequency not reported: Blood creatine phosphokinase increased, coagulation defect
Rare (less than 0.1%): Hepatitis, jaundice, elevated liver function tests SGOT (AST), SGPT (ALT), and bilirubin, hepatomegaly, hepatotoxicity
Very rare (less than 0.01%): Hypersensitivity syndrome, a systemic reaction with a variable presentation that can include fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs and symptoms
Common (1% to 10%): Weight gain, hyperglycemia
Postmarketing reports: Hyponatremia
Common (1% to 10%): Back pain, arthralgia, myalgia, twitching
Uncommon (0.1% to 1%): Tendonitis, arthritis, joint stiffness, joint swelling
Frequency not reported: Rhabdomyolysis, myoclonus
Postmarketing reports: Elevated creatine kinase, rhabdomyolysis
Very common (10% or more): Somnolence (21%), dizziness (17%), ataxia (13%)
Common (1% to 10%): Abnormal gait, incoordination, neuralgia, tremor, dysarthria, hyperkinesia, seizures, dysarthria, paresthesia, hypesthesia, coordination abnormal, increased/decreased/absent reflexes, vertigo
Uncommon (less than 1%): Hypokinesia
Rare (less than 0.1%): Movement disorders (e.g., choreoathetosis, dyskinesia, dystonia), loss of consciousness
Frequency not reported: Withdrawal precipitated seizure/status epilepticus
Postmarketing reports: Movement disorder
Common (1% to 10%): Amblyopia, conjunctivitis, diplopia, nystagmus
Uncommon (0.1% to 1%): Cataract, dry eyes, eye pain, visual field defect, photophobia, bilateral or unilateral ptosis, eye hemorrhage, hordeolum, eye twitching
Rare (less than 0.1%): Eye itching, abnormal accommodation, eye focusing problem, watery eyes, retinopathy, glaucoma, iritis, corneal disorders, lacrimal dysfunction, degenerative eye changes, blindness, retinal degeneration, miosis, chorioretinitis, strabismus
Uncommon (0.1% to 1%): Breast cancer
Rare (less than 0.1%): Non-Hodgkin's lymphoma
Very common (10% or more): Fatigue (11%), fever (11%)
Common (1% to 10%): Asthenia, accidental injury, otitis media, tremor, pain
Rare (0.01% to 0.1%): Tinnitus
Very rare (less than 0.01%): Sudden unexplained death in patients with epilepsy
Frequency not reported: Sleepwalking, withdrawal symptoms, hearing loss, earache, tinnitus, inner ear infection, otitis, taste loss, unusual taste, ear fullness, perforated ear drum, sensitivity to noise, eustachian tube dysfunction, otitis externa, odd smell, labyrinthitis
Common (1% to 10%): Abnormal thinking, amnesia, depression, hostility, confusion, emotional liability, anxiety, nervousness, insomnia
Uncommon (0.1% to 1%): Mental impairment
Rare (less than 0.1%): Hallucinations
Frequency not reported: Suicidal behavior and ideation, hypomania
Rare (less than 0.1%): Acute renal failure
Common (1% to 10%): Pharyngitis, dyspnea, cough, bronchitis, respiratory infection, rhinitis
Rare (less than 0.1%): Pulmonary thrombosis, pulmonary embolism
Frequency not reported: Pseudo-croup, hoarseness
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Horizant (www.drugs.com/horizant.html).
March 28, 2020
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