Gralise is a prescription medicine that affects chemicals in the body that are involved in some types of pain.

Gralise is used in adults to treat pain from damaged nerves (neuropathic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection).

It is not known if Gralise is safe and effective in people with seizure problems (epilepsy).

Gralise is not interchangeable with other gabapentin products.

Avoid driving or hazardous activity until you know how Gralise will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Gabapentin can cause life-threatening breathing problems, especially if you already have a breathing disorder or if you use other medicines that can make you drowsy or slow your breathing. Seek emergency medical attention if you have very slow breathing.

Some people have thoughts about suicide or behavior changes while taking Gralise. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before taking this medicine

You should not use Gralise if you are allergic to gabapentin.

To make sure Gralise is safe for you, tell your doctor if you have ever had:

• breathing problems or lung disease, such as chronic obstructive pulmonary disease (COPD);

• kidney disease (or if you are on dialysis);

• diabetes;

• depression, a mood disorder, or suicidal thoughts or actions;

• a drug addiction;

• a seizure (unless you take Gralise 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. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of gabapentin on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take Gralise 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.

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.

Both Gralise should be taken with food.

Swallow the tablet whole and do not crush, chew, break, or open it.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Do not stop using Gralise suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

In case of emergency, wear or carry medical identification to let others know you have seizures.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from light and moisture.

Store the liquid medicine in the refrigerator. Do not freeze.

Usual Adult Dose for Postherpetic Neuralgia:

-Gralise should be titrated to 1800 mg orally once daily with the evening meal.
-Recommended titration schedule:
Day 1: 300 mg orally with the evening meal
Day 2: 600 mg orally with the evening meal
Days 3 through 6: 900 mg orally with the evening meal
Days 7 through 10: 1200 mg orally with the evening meal
Days 11 through 14: 1500 mg orally with the evening meal
Day 15: 1800 mg orally with the evening meal
COMMENT:
-Gralise is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

You should not use Gralise if you are allergic to gabapentin.

To make sure Gralise is safe for you, tell your doctor if you have ever had:

• breathing problems or lung disease, such as chronic obstructive pulmonary disease (COPD);

• kidney disease (or if you are on dialysis);

• diabetes;

• depression, a mood disorder, or suicidal thoughts or actions;

• a drug addiction;

• a seizure (unless you take Gralise 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. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of gabapentin on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid taking an antacid within 2 hours before you take Gralise. Antacids can make it harder for your body to absorb gabapentin.

Avoid drinking alcohol while taking Gralise.

Get emergency medical help if you have signs of an allergic reaction to Gralise: 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, muscle aches, severe weakness, unusual bruising, upper stomach pain, or yellowing of your skin or eyes.

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:

• weak or shallow breathing;

• blue-colored skin, lips, fingers, and toes;

• confusion, extreme drowsiness or weakness;

• problems with balance or muscle movement;

• unusual or involuntary eye movements; or

• increased seizures.

Gabapentin can cause life-threatening breathing problems. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. Breathing problems may be more likely in older adults or in people with COPD.

Common Gralise side effects may include:

• fever, chills, sore throat, body aches, unusual tiredness;

• jerky movements;

• headache;

• double vision;

• swelling of your legs and feet;

• tremors;

• trouble speaking;

• dizziness, drowsiness, tiredness;

• problems with balance or eye movements; or

• nausea, vomiting.

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.

Using Gralise with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, cold or allergy medicine, a muscle relaxer, or medicine for anxiety or seizures.

other drugs may interact with gabapentin, 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.