Lyrica is Pfizer’s trade name for a drug called pregabalin. Pregabalin is an anticonvulsant (anti-seizure) drug.

Lyrica is used to treat a number of symptoms and conditions; it works by slowing impulses across the brain that are involved in seizures. It also affects chemicals involved in pain signals. Here we will explore the most common uses for the drug, as well as the potential side effects. We will also explain dosage, and the potential risk for abuse.

Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35.

Lyrica (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide.

In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present  (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.

Lyrica is the brand name for the drug pregabalin, an anticonvulsant that reduces the number of pain signals from damaged nerves.

Doctors prescribe Lyrica to treat a number of conditions, including:

• Pain from neuropathy, or damaged nerves in the arms, hands, fingers, legs, feet, or toes
• Pain from nerves damaged by shingles, a rash that occurs after infection with the herpes zoster virus
• Fibromyalgia, a chronic condition that may cause pain, muscle stiffness, fatigue, and trouble sleeping
• Pain from nerves damaged by spinal cord injury

People with epilepsy may take Lyrica in combination with other medications to treat certain types of seizures.

A study published in the New England Journal of Medicine in 2014 found that pregabalin significantly improved treatment outcomes and could be an effective alternative therapy for restless legs syndrome (RLS).

Pfizer developed Lyrica, and the Food and Drug Administration (FDA) approved it in 2007.

In 2012, the agency approved generic versions made by Lupin Pharmaceuticals, Teva Pharmaceuticals, and Watson Laboratories. However, due to a ruling in federal court, these drugs are not yet available in the United States.

In February 2014, a federal Appeals Court upheld a lower court ruling that Pfizer’s patent for Lyrica (pregabalin) remains valid, thus preventing generic competition for the drug through 2018.

Dosage Forms & Strengths

 capsule: Schedule V

• Lyrica
• 25mg
• 50mg
• 75mg
• 100mg
• 150mg
• 200mg
• 225mg
• 300mg

oral solution: Schedule V

• Lyrica
• 20mg/mL

tablet, extended-release: Schedule V

• Lyrica CR
• 82.5 mg
• 165 mg
• 330 mg

Adult:

≥18yrs: initially 75mg twice daily, may increase to 150mg twice daily within 1 week as tolerated; max 450mg/day. Renal impairment (CrCl <60mL/min): reduce dose (see literature); hemodialysis: give supplemental dose after session.

Children:

18yrs: not recommended.

Warnings/Precautions:

Avoid abrupt cessation (taper over ≥1 week). Discontinue if angioedema, hypersensitivity reactions, myopathy or markedly elevated creatine kinase levels occur. CHF. Ocular conditions. Diabetes (monitor skin integrity). Suicidal tendencies (monitor). Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Potentiates CNS depression with alcohol, other CNS depressants. Additive edema, weight gain with thiazolidinediones.

Pharmacological Class:

Alpha-2 delta ligand.

Adverse Reactions:

Dizziness, somnolence, other CNS effects, dry mouth, edema, ocular/visual effects (eg, blurring), weight gain, thinking abnormal (primarily difficulty with concentration/attention), infection, asthenia, paresthesias, elevated creatine kinase, decreased platelets, arrhythmias (PR prolongation); male-mediated teratogenicity; may be tumorigenic.

How Supplied:

Caps—90; Soln—16oz

Important Safety Information

LYRICA may cause serious, even life threatening, allergic reactions. Stop taking LYRICA and call your doctor right away if you have any signs of a serious allergic reaction. Some signs are swelling of your face, mouth, lips, gums, tongue, throat or neck or if you have any trouble breathing, or have a rash, hives or blisters.

Drugs used to treat seizures increase the risk of suicidal thoughts or behavior. LYRICA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients, family members or caregivers should call the doctor right away if they notice suicidal thoughts or actions, thoughts of self harm, or any unusual changes in mood or behavior. These changes may include new or worsening depression, anxiety, restlessness, trouble sleeping, panic attacks, anger, irritability, agitation, aggression, dangerous impulses or violence, or extreme increases in activity or talking. If you have suicidal thoughts or actions, do not stop LYRICA without first talking to your doctor.

LYRICA may cause swelling of your hands, legs and feet, which can be serious for people with heart problems.  Also, tell your doctor right away about muscle pain or problems along with feeling sick and feverish, or any changes in your eyesight including blurry vision or if you have any kidney problems or get dialysis.

Some of the most common side effects of LYRICA are dizziness, blurry vision, weight gain, sleepiness, trouble concentrating, swelling of your hands and feet, dry mouth, and feeling “high.” If you have diabetes, tell your doctor about any skin sores.

You may have a higher chance for swelling and hives if you are also taking angiotensin-converting enzyme (ACE) inhibitors so tell your doctor if you are taking these medications. You may have a higher chance of swelling of your hands or feet or gaining weight if you are also taking certain diabetes medicines. Do not drink alcohol while on LYRICA. You may have a higher chance for dizziness and sleepiness if you take LYRICA with alcohol, narcotic pain medicines, or medicines for anxiety.

Before you start LYRICA, tell your doctor if you are planning to father a child, or if you are pregnant, or plan to become pregnant. Breastfeeding is not recommended while taking LYRICA. If you have had a drug or alcohol problem, you may be more likely to misuse LYRICA.

In studies, a specific type of blood vessel tumor was seen in mice, but not in rats. The meaning of these findings in humans is not known.

Do not stop taking LYRICA without talking to your doctor. If you stop suddenly you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy, you may have seizures more often.

Uses

This medication is used to treat pain caused by nerve damage due to diabetes, shingles (herpes zoster) infection, or spinal cord injury. This medication is also used to treat pain in people with fibromyalgia.

It is also used with other medications to treat certain types of seizures (focal seizures).

How to use Lyrica

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using pregabalin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually 2 to 3 times a day with or without food. Dosage is based on your medical condition, kidney function, and response to treatment.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

To reduce your risk of side effects (such as dizziness and drowsiness), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. This drug works best when the amount of medicine in your body is kept at a constant level. Therefore it is best to take pregabalin at evenly spaced intervals throughout the day and night.

Do not stop taking this medication without consulting your doctor. Some conditions (such as seizures) may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as difficulty sleeping, nausea, headache and diarrhea. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Report any new or worsening symptoms right away.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your condition persists or worsens.

Side Effects

• dizziness,
• drowsiness,
• dry mouth (xerostomia),
• edema (accumulation of fluid),
• blurred vision,
• double vision (diplopia),
• weight gain,
• fatigue (tiredness),
• abnormal gait (ataxia),
• tremor, and
• difficulty concentrating.

Other side effects include

• constipation,
• increased appetite,
• nausea,
• flatulence,
• amnesia,
• disorientation,
• myoclonus (sudden, involuntary jerking of a muscle or muscle groups),
• heart failure,
• low blood pressure,
• vomiting,
• reduced blood platelet counts, and
• increased blood creatinine kinase levels.

Increased creatinine kinase can be a sign of muscle injury, and in clinical trials three patients experienced rhabdomyolysis (severe muscle injury). Therefore, patients should report unexplainedmuscle pain, tenderness or weakness to their doctors, especially if associated with fever and malaise (reduced well-being). Lyrica has rarely been associated with angioedema (swelling of the face, tongue, lips, and gums, throat and larynx).

Drowsiness, dizziness, dry mouth, constipation, difficulty concentrating, swollen arms/legs, and weight gain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any unlikely but serious side effects, including: blurred vision, unusual bleeding/bruising, unsteadiness, confusion, muscle pain/tenderness/weakness (especially if you are tired or have a fever), swelling of hands/legs/feet, signs of kidney problems (such as change in the amount of urine).

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidalthoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Before taking pregabalin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart failure), kidney disease, history of an allergic reaction which included itching/swelling of the face/lips/tongue/throat (angioedema), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, unsteadiness, and confusion. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others. It is against the law.

Laboratory tests may be done to measure kidney function.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

What is the dosage for Lyrica (pregabalin)?

• Lyrica may be taken with or without food.
• Treating diabetic peripheral neuropathy: The initial dose for neuropathic pain associated with diabetic peripheral neuropathy is 50 mg three times a day (150 mg/day). The dose may be increased to a maximum dose of 100 mg 3 times daily (300 mg/day) after one week.
• Treating postherpetic neuralgia: The recommended dose for postherpetic neuralgia is 75-150 mg twice daily or 50-100 mg three times daily. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 100 mg 3 times daily (300 mg/day) after one week. If pain relief is inadequate after 2-4 weeks of treatment at 300 mg/day, the dose may be increased to 300 mg twice daily or 200 mg three times daily. Doses greater than 300 mg cause more side effects.
• Treating neuropathic pain associated with spinal cord injury: The dose for treating neuropathic pain associated with spinal cord injury is 150 to 600 mg daily. Begin dosing at 75 mg two times a day an increase to 150 mg two times daily after one week if response is inadequate. May increase to 300 mg twice daily if response is inadequate after 2 to 3 weeks.
• Treating seizures: The recommended dose for treating seizures is 150-600 mg/day divided into 2 or 3 doses, starting at 150 mg daily and increasing based on response and tolerability. The maximum dose is 600 mg/day.
• Treating fibromyalgia: Fibromyalgia is treated with 300-450 mg/day in 2 or 3 divided doses.

Before taking this medicine

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

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

• a mood disorder, depression, or suicidal thoughts;
• heart problems (especially congestive heart failure);
• a bleeding disorder;
• low levels of platelets in your blood;
• kidney disease (or if you are on dialysis);
• diabetes (unless you are taking Lyrica to treat diabetic neuropathy);
• drug or alcohol addiction; or
• a severe allergic reaction (angioedema).

Some people have thoughts about suicide while taking Lyrica. Your doctor will need to check your progress at regular visits while you are using topiramate. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Follow your doctor’s instructions about taking seizure medication if you are pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking this medicine without your doctor’s advice, and tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Lyrica on the baby.

This medication 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.

It is not known whether pregabalin passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Lyrica is not approved for use by anyone younger than 18 years old.

How should I take Lyrica?

Take Lyrica 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.

Take the medicine at the same time each day.

You may take Lyrica with or without food.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not stop using Lyrica suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine. Call your doctor if your symptoms do not improve, or if they get worse.

Wear a medical alert tag or carry an ID card stating that you take Lyrica. Any medical care provider who treats you should know that you take seizure medication. Store at room temperature away from moisture, light, and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Lyrica Warnings

Lyrica may help control your symptoms, but it’s not a cure. It could take several weeks or longer for you to experience the full benefits of the drug. Lyrica may cause serious allergic reactions. In extreme cases, these reactions could be fatal.

While taking Lyrica, your mental health may change unexpectedly, and you may develop suicidal thoughts or behaviors.

If you have diabetes, you should monitor your skin carefully for sores while taking Lyrica. Be sure to contact your doctor right away if you develop any sores, redness, or skin problems.

The drug may also cause a buildup of fluid in your lower limbs.

Tell your doctor immediately if have or have ever had:

• Swelling of the eyes, face, lips, tongue, or throat
• Vision problems
• Blood disorders or bleeding problems, such as a low platelet count
• Heart disease
• Kidney disease
• Depression, mood problems, or suicidal thoughts

It’s also important to tell your doctor if you have any type of surgery planned, including a dental procedure.

What other drugs will affect Lyrica?

Taking Lyrica with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic (opioid) medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, 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 interactions are listed in this medication guide.

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