Lyrica CR is an anti-epileptic drug, also called an anticonvulsant. Pregabalin works by slowing down nerve impulses in the brain and affects chemicals that send pain signals across the nervous system.

Lyrica CR is a prescription medicine used to treat pain caused by damaged nerves in people with diabetes (diabetic neuropathy). Lyrica CR is also used to treat pain caused by damaged nerves (neuropathic pain) that follows healing of shingles (herpes zoster). This condition is called post-herpetic neuralgia.

It is not known if Lyrica CR is effective when used for the treatment of fibromyalgia, or when taken with other seizure medicines for adults with partial onset seizures.

Lyrica CR is supplied as extended-release tablets in the following strengths: 82.5 mg, 165 mg, and 330 mg.

Lyrica CR can cause a severe allergic reaction. Stop taking Lyrica CR and seek emergency medical help if you have hives or blisters on your skin, trouble breathing, or swelling in your face, mouth, or throat.

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

If you have diabetes or heart problems, call your doctor if you have weight gain or swelling in your hands or feet while taking Lyrica CR.

Do not stop using Lyrica CR suddenly, even if you feel fine. Stopping suddenly may cause withdrawal symptoms.

Before taking this medicine

You should not use Lyrica CR if you are allergic to pregabalin.

To make sure Lyrica CR is safe for you, tell your doctor if you have::

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

• a mood disorder, depression, or suicidal thoughts;

• heart problems (especially congestive heart failure);

• a bleeding disorder, or low levels of platelets in your blood;

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

• diabetes (unless you are taking pregabalin to treat diabetic neuropathy);

• drug or alcohol addiction; or

• a severe allergic reaction (angioedema).

Do not give this medicine to a child without medical advice.

• Lyrica CR is not approved for use by anyone younger than 18 years old to treat nerve pain caused by diabetes or shingles (herpes zoster).

Some people have thoughts about suicide while taking Lyrica CR. Your doctor will need to 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 if pregabalin will harm your unborn baby. You and your healthcare provider will have to decide if you should take Lyrica CR while you are pregnant.

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

Lyrica CR can decrease sperm count and may affect fertility in men (your ability to have children). In animal studies, pregabalin also caused birth defects in the offspring of males treated with this medicine. However, it is not known whether these effects would occur in humans. Ask your doctor about your risk.

You should not breastfeed while using Lyrica CR.

Take Lyrica CR exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take the medicine at the same time each day, with or without food.

Swallow an extended-release tablet whole and do not crush, chew, or break it.

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

Call your doctor if your symptoms do not improve, or if they get worse.

Do not stop using Lyrica CR suddenly, even if you feel fine. Stopping suddenly may cause unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose for at least 1 week before stopping completely.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Diabetic Neuropathy:

Extended-release:
Initial dose: 165 mg orally once a day after the evening meal
-Dose may be increased to 330 mg orally once a day within 1 week based on efficacy and tolerability
Maximum dose: 330 mg per day
Comment:
-Doses of 600 mg per day have been studied and do not appear to confer additional significant benefit; treatment with doses above 300 mg per day (immediate-release) or 330 mg per day (extended-release) are not recommended due to dose-dependent adverse reactions.

Use: Management of neuropathic pain associated with diabetic peripheral neuropathy

Usual Adult Dose for Postherpetic Neuralgia:

Extended-release:
Initial dose: 165 mg orally once a day after the evening meal
-Dose may be increased to 330 mg orally once a day within 1 week based on efficacy and tolerability
-If, after 2 to 4 weeks of therapy at 330 mg per day, there is insufficient pain relief and patient is tolerating therapy, dose may be increased up to 660 mg per day
Maximum dose: 660 mg per day
Comment:
-Treatment with doses above 300 mg per day (immediate-release) or 330 mg per day (extended-release) should be reserved for patients with on-going pain who have demonstrated tolerability at lower doses due to the high rate of discontinuation from adverse reactions at higher doses.

Use: Management of postherpetic neuralgia

You should not use Lyrica CR if you are allergic to pregabalin.

To make sure Lyrica CR is safe for you, tell your doctor if you have::

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

• a mood disorder, depression, or suicidal thoughts;

• heart problems (especially congestive heart failure);

• a bleeding disorder, or low levels of platelets in your blood;

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

• diabetes (unless you are taking pregabalin to treat diabetic neuropathy);

• drug or alcohol addiction; or

• a severe allergic reaction (angioedema).

Do not give this medicine to a child without medical advice.

• Lyrica CR is not approved for use by anyone younger than 18 years old to treat nerve pain caused by diabetes or shingles (herpes zoster).

Some people have thoughts about suicide while taking Lyrica CR. Your doctor will need to 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 if pregabalin will harm your unborn baby. You and your healthcare provider will have to decide if you should take Lyrica CR while you are pregnant.

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

Lyrica CR can decrease sperm count and may affect fertility in men (your ability to have children). In animal studies, pregabalin also caused birth defects in the offspring of males treated with this medicine. However, it is not known whether these effects would occur in humans. Ask your doctor about your risk.

You should not breastfeed while using Lyrica CR.

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 drinking alcohol. It may increase certain side effects of pregabalin.

Avoid driving or hazardous activity until you know how Lyrica CR will affect you. Your reactions could be impaired.

Pregabalin can cause a severe allergic reaction. Stop taking Lyrica CR and get emergency medical help if you have: hives or blisters on your skin; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), 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;

• vision problems;

• skin sores (if you have diabetes);

• easy bruising, unusual bleeding;

• swelling in your hands or feet, rapid weight gain (especially if you have diabetes or heart problems); or

• unexplained muscle pain, tenderness, or weakness (especially if you also have fever or don't feel well).

Pregabalin 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.

If you have diabetes, tell your doctor right away if you have any new sores or other skin problems.

Common Lyrica CR side effects may include:

• dizziness, drowsiness;

• swelling in your hands and feet;

• trouble concentrating;

• increased appetite;

• weight gain;

• dry mouth; or

• blurred vision.

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 Lyrica CR with other drugs that 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.

Tell your doctor about all your other medicines, especially:

• oral diabetes medicine - pioglitazone, rosiglitazone; or

• an ACE inhibitor - benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.

This list is not complete. Other drugs may interact with pregabalin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.