Horizant

Horizant is a prescription medication used to treat adults with nerve pain caused by shingles. Shingles is a painful rash that is caused by the varicella-zoster virus, the virus that also causes chickenpox. Horizant is also used to treat restless legs syndrome. 

Horizant belongs to a group of drugs called anticonvulsants and relieves nerve pain post shingles by changing the way the body senses pain. It is not known exactly how Horizant works to treat restless legs syndrome.

This medication comes in extended release tablets and is taken up to 2 times a day, depending on what is being treated. Take Horizant with food. 

Do not cut, crush, or chew tablets. Swallow tablets whole. 

Common side effects of Horizant include headache, dizziness, and drowsiness. Do not drive a car or operate heavy machinery until you know how this medication affects you.

Horizant 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.
• Restless legs syndrome (RLS) which is a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Xenoport, Inc.

Serious side effects have been reported with Horizant. See “Drug Precautions” section.

The most common side effects of Horizant include:

• dizziness
• headache
• lack of coordination
• viral infection
• feeling drowsy
• feeling tired
• fever
• jerky movements
• difficulty with speaking
• temporary loss of memory (amnesia)
• tremor
• 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 Horizant 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.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• morphine (found in medications such as Kadian and MS Contin)
• alcohol

This is not a complete list of Horizant drug interactions. Ask your doctor or pharmacist for more information.

Horizant can cause serious side effects including:

1.  Do not drive after taking your dose of Horizant until you know how Horizant affects you, including the morning after you take your dose. Do not operate heavy machinery or do other dangerous activities until you know how Horizant affects you. Horizant can cause sleepiness, dizziness, slow thinking, and can affect your coordination. Ask your healthcare provider when it would be okay to do these activities.

 

2. Horizant 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 you can 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.

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.

3.  Horizant may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have a rash when you get this type of reaction. It may cause you to be hospitalized or to stop Horizant. Call a healthcare provider right away if you have any of the following symptoms:

• skin rash
• hives
• fever
• swollen glands that do not go away
• swelling of your lip and 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 Horizant.

Do not take Horizant if you are allergic to Horizant or any of the other ingredients in Horizant.

Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking Horizant without first talking with your healthcare provider. Taking Horizant with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

Do not take other medicines that make you sleepy or dizzy while taking Horizant without first talking with your healthcare provider. Taking Horizant with medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

Do not take other gabapentin drugs (for example, NEURONTIN) while you take Horizant.

Do not stop taking Horizant without first talking to your healthcare provider. Stopping Horizant suddenly can cause serious problems.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Horizant there are no specific foods that you must exclude from your diet when receiving Horizant.

Before taking Horizant, tell your healthcare provider if you:

• are allergic to Horizant or to any of its ingredients 
• have or have had kidney problems or are on hemodialysis
• have or have had depression, mood problems, or suicidal thoughts or behavior
• have or have had seizures.
• have a history of drug abuse.
• have any other medical conditions.
• are pregnant or plan to become pregnant. 
• are breastfeeding or plan to breastfeed. 

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

Taking Horizant 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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. There are no adequate and well controlled studies with Horizant in pregnant women. It is not known if Horizant can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Horizant. You and your healthcare provider will decide if you should take Horizant while you are pregnant.

• If you become pregnant while taking Horizant, 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.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. 

Horizant can pass into breast milk. It is not known if this can harm your baby. You and your healthcare provider should decide if you will take Horizant or breastfeed. You should not do both. You and your healthcare provider should decide how you will feed your baby while you take Horizant.

Take Horizant exactly as prescribed. Your healthcare provider will tell you how much Horizant to take.

• Do not change your dose of Horizant without talking to your healthcare provider. 
• Take Horizant tablets whole. Do not cut, crush, or chew your tablet.
• Take Horizant tablets with food.
• Do not stop taking Horizant without talking to your healthcare provider first. If you stop taking Horizant suddenly, you may develop side effects.
• If you forget to take your medicine at the time recommended by your healthcare provider, just skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at one time.

Take Horizant exactly as prescribed. 

The dose your doctor prescribes will be based on the following:

• your condition
• how you respond to the medication
• your renal function

Restless Legs Syndrome (RLS):

The recommended dose of Horizant for RLS is 600 mg once daily taken at about 5 PM. (If the dose is not taken at the recommended time, the next dose should be taken the following day as prescribed.)

Postherpetic Neuralgia:

The recommended starting dose of Horizant to treat nerve pain after shingles is 600 mg in the morning for 3 days, then increase to 600 mg twice daily beginning on day 4. (If the dose is not taken at the recommended time, skip this dose, and the next dose should be taken at the time of next scheduled dose.)

The dose may be reduced for patients with renal dysfunction. 

If you take too much Horizant, call your healthcare provider or your local Poison Control Center right away.

• Store Horizant between 59°F to 86°F (15°C to 30°C).
• Store Horizant dry and away from moisture.
• Keep Horizant tightly closed in the bottle provided to you. Do not remove any moisture control packs that may come in the bottle.

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