What is lyrica

Lyrica active drug ingredient is pregabalin and Lyrica (pregabalin) works by slowing down impulses in the brain that cause seizures. Lyrica (pregabalin) also affects chemicals in the brain that send pain signals across the nervous system. Lyrica (pregabalin) works by decreasing the number of pain signals that are sent out by damaged nerves in the body. Lyrica (pregabalin) is a gamma-aminobutyric acid (GABA) derivative that functions as a calcium channel blocker and is used as an anticonvulsant as well as an anti-anxiety agent. Lyrica (pregabalin) is also used as an analgesic in the treatment of neuropathic pain (pain from damaged nerves) that can occur in your arms, hands, fingers, legs, feet, or toes. Lyrica (pregabalin) is also used to treat nerve pain in people with diabetes (diabetic neuropathy), in people who develop pain following the rash of shingles (post-herpetic neuralgia), or spinal cord injury and fibromyalgia.

Lyrica works in different ways:

1. In epilepsy it stops seizures by reducing the abnormal electrical activity in the brain
2. With nerve pain it blocks pain by interfering with pain messages traveling through the brain and down the spine
3. In anxiety it stops your brain from releasing the chemicals that make you feel anxious

Lyrica is only available on prescription. It comes as capsules or a liquid that you drink.

In June 2007, Lyrica (pregabalin) became the first U.S. Food and Drug Administration (FDA) approved drug for specifically treating fibromyalgia ¹. Lyrica reduces pain and improves function in some people with fibromyalgia. While those with fibromyalgia have been shown to experience pain differently from other people, the mechanism by which Lyrica (pregabalin) produces its effects is unknown. There is data suggesting that Lyrica (pregabalin) affects the release of neurotransmitters in the brain. Neurotransmitters are chemicals that transmit signals from one neuron to another. Treatment with Lyrica may reduce the level of pain experienced by some people with fibromyalgia.

Key facts

• Lyrica is usually taken 2 or 3 times a day. You can take it with or without food.
• You don’t have to have epilepsy for Lyrica to help with pain or anxiety.
• It takes at least a few weeks for Lyrica to work.
• The side effects of Lyrica are usually mild and go away by themselves. The most common ones are feeling sleepy, dizziness and headaches.
• Pregabalin is also called by the brand names Lyrica, Alzain, Lecaent and Rewisca.

Side effects of Lyrica include sleepiness, dizziness, blurry vision, weight gain, trouble concentrating, swelling of the hands and feet, and dry mouth. Allergic reactions, although rare, can occur. Therapy with Lyrica (pregabalin) is not associated with serum aminotransferase elevations, and clinically apparent liver injury from Lyrica (pregabalin) has been reported but appears to be quite rare.

Lyrica is also used with other medications as an adjunct therapy to treat partial seizures and in generalized anxiety disorder in adults and children who are at least 4 years old.

Lyrica (pregabalin) was designed as a more potent successor to gabapentin. Lyrica (pregabalin) is considered to have a dependence liability if misused, and is classified as a Schedule V drug in the U. S.

How does Lyrica work?

It’s not clear exactly how Lyrica works. It has been reported that its action presents the function of modulating the release of many excitatory neurotransmitters such as glutamate, norepinephrine, subtance-P and calcitonin gene related peptide.This modulation can cause an inhibitory modulation of overexcited neurons allowing them to get back to a normal state, including te decrease on the hyper excitability caused by tissue damage. The neurotransmitter modulation allows pregabalin to present antiallodynic, anxiolytic and anticonvulsant activity.

In epilepsy, it’s thought that it stops seizures by reducing the abnormal electrical activity in the brain.

With nerve pain, it’s thought to block pain by interfering with pain messages traveling through the brain and down the spine.

In anxiety, it’s thought that it stops your brain from releasing the chemicals that make you feel anxious.

How long will I take Lyrica for?

If you have epilepsy, it is likely that once your illness is under control you will continue to take Lyrica for many years.

If you are taking Lyrica for nerve pain or anxiety it is likely that once your symptoms have gone you will continue to take it for several months to stop them coming back.

Are there any long term side effects of Lyrica?

There’s no evidence that Lyrica has lasting harmful effects, even if you take it for many months or years.

Can I get addicted to Lyrica?

Some people have become addicted to Lyrica after taking it for a long time. If this happens, you will have withdrawal symptoms after you stop taking the medicine. Talk to your doctor if you’re concerned you are becoming physically dependent on Lyrica.

What happens when I come off Lyrica?

• Do not stop taking Lyrica suddenly even if you feel fine.
• Don’t stop taking Lyrica without talking to your doctor. Stopping Lyrica suddenly can cause serious problems.

If you have epilepsy, stopping Lyrica suddenly can cause seizures that will not stop.

If you are taking it for any reason and stop suddenly, you may have a severe withdrawal syndrome. This can have unpleasant symptoms, including:

• anxiety
• difficulty sleeping
• feeling sick
• pain
• sweating

It’s possible to prevent withdrawal seizures and other symptoms by gradually reducing the dose of Lyrica.

How should I take Lyrica?

You can take Lyrica with or without food, but it’s best to be consistent each day. Try to space your doses evenly through the day.

Swallow Lyrica capsules whole with a drink of water or juice. Do not chew them.

If you are taking Lyrica as a liquid, it will come with a syringe or spoon to measure your dose. If you don’t have a syringe or spoon, ask your pharmacist for one.

Can I take Lyrica with alcohol?

Alcohol can add to the drowsiness caused by Lyrica.

You can drink alcohol with Lyrica but it may make you feel sleepy or make you lose your focus.

During the first few days of taking Lyrica, it might be best to stop drinking alcohol until you see how the medicine affects you.

Can I drive or ride a bike whilst taking Lyrica?

You may feel sleepy, tired or dizzy when you first start taking Lyrica. This can also happen if your dose has increased. If this happens to you, don’t drive or ride a bike until you feel more alert.

If you have epilepsy, you are not allowed to drive until you have had no seizures for 1 year, or if you only have seizures while you are asleep. You are also not allowed to drive if your epilepsy medicine has changed and for 6 months after.

Will Lyrica affect my contraception?

Lyrica doesn’t stop contraception working. You can safely use any type of contraception, including contraceptive pills, alongside Lyrica.

Will Lyrica affect my fertility?

Lyrica does not reduce fertility in men or women.

Will recreational drugs affect Lyrica?

Lyrica can intensify the highs of recreational drugs like cannabis and heroin. So, if you use recreational drugs alongside Lyrica, there may be more chance of unpleasant side effects like panic attacks, anxiety and memory loss.

Will my Lyrica dose go up or down?

To prevent side effects, your doctor will prescribe a low Lyrica dose to start with and then increase it over a few days.

Once you find a Lyrica dose that suits you, it will usually then stay the same.

Are there similar medicines to Lyrica?

Gabapentin (also called Neurontin) is a medicine that works in a similar way to Lyrica. Like Lyrica, it is taken to treat epilepsy and nerve pain. It is also be taken for migraines.

However, there are other differences between Lyrica and gabapentin. Gabapentin is taken in different doses to Lyrica.

If you need to change to gabapentin treatment, your doctor will explain how to safely swap from Lyrica.

How should Lyrica be used?

Lyrica (pregabalin) comes as a capsule, an oral solution, and as an extended-release tablet to take by mouth. Lyrica (pregabalin) capsules and oral solution are usually taken with or without food two or three times a day. Lyrica (pregabalin) extended-release tablets are usually taken once daily after an evening meal. Take pregabalin at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Swallow the extended-release tablets whole; do not cut, chew, or crush them.

Your doctor will probably start you on a low dose of Lyrica (pregabalin) and may gradually increase your dose during the first week of treatment.

Take Lyrica (pregabalin) exactly as directed. Lyrica (pregabalin) may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

Lyrica (pregabalin) may help control your symptoms but will not cure your condition. Lyrica (pregabalin) may take several weeks or longer before you feel the full benefit of pregabalin. Continue to take Lyrica (pregabalin) even if you feel well. Do not stop taking Lyrica (pregabalin) without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking Lyrica (pregabalin), you may experience withdrawal symptoms, including trouble falling asleep or staying asleep, nausea, diarrhea, headaches, or seizures. Your doctor will probably decrease your dose gradually over at least 1 week.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with Lyrica (pregabalin) and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm) or the manufacturer’s website to obtain the Medication Guide.

Who can and can’t take Lyrica

Lyrica is only for adults. Do not give it to children under the age of 18.

Lyrica isn’t suitable for some people:

• Lyrica capsules contain gelatin so they may not be suitable for vegetarians and vegans.
• Lyrica liquid contains sodium. If you are on a controlled sodium diet, or your kidneys don’t work well, speak to your doctor before taking this liquid.

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

• have ever had an allergic reaction to Lyrica or another medicine in the past
• have kidney problems
• have ever abused or been addicted to a medicine
• are trying to become pregnant, are already pregnant or are breastfeeding

Pregnancy and breastfeeding

There is no firm evidence that Lyrica is harmful to an unborn baby but for safety you’re usually only advised to take it in pregnancy if the benefits outweigh the risks.

If you take Lyrica for epilepsy and become pregnant, do not stop the medicine without talking to your doctor first. It’s very important that epilepsy is treated during pregnancy as seizures can harm you and your unborn baby.

If you’re trying to get pregnant or have become pregnant, you’re routinely recommended to take at least 400mcg of a vitamin called folic acid every day. It helps the unborn baby grow normally.

Pregnant women who take Lyrica are recommended to take a higher dose of folic acid. Your doctor might prescribe a high dose of folic acid (5mg a day) for you to take during the first 12 weeks of pregnancy.

If you take Lyrica around the time of giving birth, your baby may need extra monitoring for a few days after they’re born. This is because they may have Lyrica withdrawal symptoms.

Lyrica and breastfeeding

Tiny amounts of Lyrica can get into breast milk, but it’s not clear whether it can harm the baby.

Talk to your doctor, as other drugs might be better while you’re breastfeeding.

If pregabalin is required by the mother of an older infant, it is not a reason to discontinue breastfeeding, but until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Maternal Drug Levels: In one woman, the breastmilk pregabalin level was about equal to the maternal serum concentration ².

Ten women who averaged 35.6 weeks postpartum (range 20 to 43 weeks) were given pregabalin 150 mg every 12 hours for 4 doses. Milk samples were obtained before the last dose and 5 times during the 24 hours after the last dose. Three additional collections were made between 24 and 48 hours after the last dose in 5 of the subjects. The average peak breastmilk pregabalin concentration was 4.63 mg/L and the average breastmilk pregabalin concentration was 2.05 mg/L. The average daily infant dosage was 0.31 mg/kg, or about 7% of the maternal weight-adjusted dosage ³.

Infant Drug Levels: The breastfed infant of a woman who was taking pregabalin (dose not specified) as an anticonvulsant during pregnancy and breastfeeding had a pregabalin serum concentration of 429 mcg/L at 48 hours postpartum, which was about 8% of the mother’s serum concentration. Some of the infant’s serum concentration could have been derived from transplacental passage, because the pregabalin half-life in this and another newborn averaged 17 hours ².

A study randomized pregnant women to either a single dose of pregabalin 150 mg (n = 45), 300 mg (n = 45), or placebo (n = 45) orally 1 hour before induction of anesthesia for an elective cesarean section to reduce postoperative analgesia requirements. Three infants of mothers in the pregabalin 300 mg group had difficulty latching on for breastfeeding for 8 hours after delivery, although none were sedated ³.

Lyrica special precautions

Before taking Lyrica:

• tell your doctor and pharmacist if you are allergic to Lyrica, any other medications, or any of the ingredients in Lyrica preparations. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiotensin converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec, in Vaseretic, Lexxel), fosinopril (Monopril), lisinopril (Prinivil, Zestril, in Prinzide, Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon), quinapril (Accupril, in Accuretic, Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); antidepressants; antihistamines; medications for anxiety including lorazepam (Ativan); medications for mental illness or seizures; certain medications for diabetes such as pioglitazone (Actos, in Duetact) and rosiglitazone (Avandia, in Avandaryl, Avandamet); narcotic pain medications including oxycodone (OxyContin, in Percocet, others); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications. Also tell your doctor if you have or have ever had swelling of the eyes, face, lips, tongue, or throat; vision problems; heart failure; bleeding problems or a low number of platelets (type of blood cell needed for blood clotting) in your blood, or heart or kidney disease.

• tell your doctor if you are pregnant or if you or your partner plans to become pregnant. Also tell your doctor if you are breastfeeding. If you or your partner becomes pregnant while you are taking Lyrica, call your doctor. Pregabalin has caused decreased fertility in male animals and birth defects in the offspring of male and female animals who were treated with the medication. There is not enough information to tell if Lyrica causes these problems in humans.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Lyrica.

• you should know that Lyrica may make you dizzy or drowsy. Do not drive a car operate machinery, or do other dangerous activities until you know how this medication affects you. Ask your doctor when you may do these activities.

• do not drink alcohol while taking Lyrica. Alcohol can add to the drowsiness caused by this medication.

• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking Lyrica for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as Lyrica to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as 1 week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as Lyrica, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Cautions with other medicines

Lyrica can usually be safely mixed with other medicines.

For safety, tell your doctor if you’re taking these medicines before your start Lyrica:

• strong painkillers such as morphine
• medicines which make you feel sleepy or dizzy (Lyrica can worsen these side effects)

Mixing Lyrica with herbal remedies and supplements

There are no known problems with taking herbal remedies and supplements with Lyrica.

However, for safety, speak to your pharmacist before taking Lyrica if you routinely take any herbal or alternative remedies.

Lyrica uses

Lyrica capsules, oral solution (liquid), and extended-release (long-acting) tablets are used to treat epilepsy and anxiety.

Lyrica is also taken to treat nerve pain or neuropathic pain (pain from damaged nerves) that can occur in your arms, hands, fingers, legs, feet, or toes. Nerve pain can be caused by different illnesses including diabetes (diabetic peripheral neuropathy) and shingles (postherpetic neuralgia; the burning, stabbing pain or aches that may last for months or years after an attack of shingles).

Lyrica capsules and oral solution are also used to relieve neuropathic pain that can occur after a spinal cord injury and to treat fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). Lyrica capsules and oral solution are used along with other medications to treat certain types of seizures in adults and children 4 years of age and older.

Lyrica dosage

The usual dose of Lyrica is between 150mg and 600mg a day split into 2 or 3 separate doses.

If you are taking Lyrica as a liquid, 2.5ml is usually the same as taking a single 50mg capsule.

Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

The maximum recommended dose of Lyrica is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Because Lyrica is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function.

Although Lyrica was also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 300 mg/day is not recommended.

Postherpetic Neuralgia

The recommended dose of Lyrica is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Because Lyrica is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function.

Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day, and who are able to tolerate Lyrica, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day). In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, reserve dosing above 300 mg/day for those patients who have on-going pain and are tolerating 300 mg daily.

Adjunctive Therapy for Adult Patients with Partial Onset Seizures

Lyrica at doses of 150 to 600 mg/day has been shown to be effective as adjunctive therapy in the treatment of partial onset seizures in adults. Both the efficacy and adverse event profiles of Lyrica have been shown to be dose-related. Administer the total daily dose in two or three divided doses. In general, it is recommended that patients be started on a total daily dose no greater than 150 mg/day (75 mg two times a day, or 50 mg three times a day). Based on individual patient response and tolerability, the dose may be increased to a maximum dose of 600 mg/day.

Both the efficacy and adverse event profiles of Lyrica have been shown to be dose-related.

Because Lyrica is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function.

The effect of dose escalation rate on the tolerability of Lyrica has not been formally studied.

The efficacy of add-on Lyrica in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of Lyrica with gabapentin cannot be offered.

Table 1: Recommended Dosage for Adults and Pediatric Patients 4 Years and Older

Lyrica for Fibromyalgia

The recommended dose of Lyrica for fibromyalgia is 300 to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Although Lyrica was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended. Because Lyrica is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function.

Neuropathic Pain Associated with Spinal Cord Injury

The recommended dose range of Lyrica for the treatment of neuropathic pain associated with spinal cord injury is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Lyrica may be treated with up to 300 mg two times a day. Because Lyrica is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function.

Patients with Renal Impairment

In view of dose-dependent adverse reactions and since Lyrica is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function. Base the dose adjustment in patients with renal impairment on creatinine clearance (CLcr), as indicated in Table 2. To use this dosing table, an estimate of the patient’s CLcr in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the Cockcroft and Gault equation.

Next, refer to the Dosage and Administration section to determine the recommended total daily dose based on indication, for a patient with normal renal function (CLcr greater than or equal to 60 mL/min). Then refer to Table 2 to determine the corresponding renal adjusted dose.

(For example: A patient initiating Lyrica therapy for postherpetic neuralgia with normal renal function (CLcr greater than or equal to 60 mL/min), receives a total daily dose of 150 mg/day pregabalin. Therefore, a renal impaired patient with a CLcr of 50 mL/min would receive a total daily dose of 75 mg/day pregabalin administered in two or three divided doses.)

For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment (see Table 2).

Table 2. Pregabalin Dosage Adjustment Based on Renal Function

What should I do if I forget a dose?

If you are taking the capsules or the oral solution and forget to take a dose and remember a few hours later, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

If you are taking the extended-release tablets and forget to take a dose after your evening meal, take the missed dose before bedtime after a snack. If you miss taking the dose prior to bedtime, take your dose the following day after breakfast. If you miss taking the dose after breakfast, take your dose at the usual time after an evening meal and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

If you have epilepsy, it’s important to take this medicine regularly. Missing doses may trigger a seizure.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much Lyrica?

Taking too much Lyrica by accident may cause unpleasant side effects including:

• feeling sleepy
• feeling confused or agitated
• seizures
• passing out

If you need to go to hospital, take the Lyrica packet or leaflet inside it plus any remaining medicine with you.

Lyrica side effects

Not everyone will get side effects with Lyrica, it seems to be a very safe medicine.

Common side effects:

These common side effects may happen in more than 1 in 100 people. They are usually mild and go away by themselves. Keep taking the medicine but tell your doctor if they bother you or don’t go away:

• headaches
• feeling sleepy
• dizziness
• diarrhea
• mood changes
• feeling sick
• swollen hands, arms, legs and feet
• blurred vision
• for men, difficulties with getting an erection
• weight gain – because Lyrica can make you feel hungry

If you have diabetes, Lyrica can upset your blood sugar control. Monitor your blood sugar more often for the first few weeks of treatment with Lyrica and adjust your diabetes treatment if you need to. Talk to your doctor or diabetes nurse if you want more advice on what to do.

Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• dizziness
• headache
• dry mouth
• nausea
• vomiting
• constipation
• gas
• bloating
• ”high” or elevated mood
• speech problems
• difficulty concentrating or paying attention
• confusion
• difficulty remembering or forgetfulness
• anxiety
• lack of coordination
• loss of balance or unsteadiness
• uncontrollable shaking or jerking of a part of the body
• muscle twitching
• weakness
• increased appetite
• weight gain
• back pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• blurred vision, double vision, or other changes in eyesight
• hives
• rash
• itching
• blisters
• swelling of the eyes, face, throat, mouth, lips, gums, tongue, head or neck
• swelling of the arms, hands, feet, ankles, or lower legs
• shortness of breath
• wheezing
• muscle pain, tenderness, soreness, or weakness, especially if it comes along with fever
• chest pain

If you have diabetes, you should know that Lyrica has caused skin sores in animals. Pay extra attention to your skin while taking Lyrica, and tell your doctor if you have any sores, redness, or skin problems.

Serious side effects

Very few people taking Lyrica have serious problems.

Tell a doctor straight away if you get:

• thoughts of harming or killing yourself – a small number of people taking Lyrica have had suicidal thoughts that can happen after only a week of treatment
  difficulties breathing
• severe dizziness or pass out
• problems going to the toilet, including blood in your pee, needing to pee more often, or constipation

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Lyrica. A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue, or throat

These are not all the side effects of Lyrica. For a full list see the leaflet inside your medicines packet. Call your doctor if you have any unusual problems while taking this medication.

Nervous system

Among pediatric patients receiving this drug for the treatment of partial onset seizures, somnolence was reported in 21% of drug treated patients and 14% of placebo patients. It occurred more frequently at higher doses.

• Very common (10% or more): Dizziness (up to 37%), somnolence (up to 25%)
• Common (1% to 10%): Neuropathy, ataxia, vertigo, incoordination, tremor, abnormal gait, headache, speech disorder, twitching
• Uncommon (0.1% to 1%): Syncope, stupor, myoclonus, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, hyporeflexia, hyperesthesia, burning sensation, ageusia, malaise
• Rare (less than 0.1%): Convulsions, parosmia, hypokinesia, dysgraphia, shock, circumoral paresthesia, dysarthria, hyperalgesia, hyperkinesia, hypokinesia, hypotonia, myoclonus, neuralgia cerebellar syndrome, cogwheel rigidity, coma, dysautonomia, dystonia, encephalopathy, extrapyramidal syndrome, Guillain-Barre syndrome, hypalgesia, intracranial hypertension, torticollis, trismus, peripheral neuritis

Cardiovascular

• Very common (10% or more): Peripheral edema (up to 12%)
• Common (1% to 10%): Chest pain
• Uncommon (0.1% to 1%): Hypotension, hypertension, hot flushes, flushing, peripheral coldness, heart failure, postural hypotension, syncope
• Rare (less than 0.1%): ST depressed, ventricular fibrillation
• Frequency not reported: PR interval prolongation

In controlled clinical trials in adult patients, peripheral edema was reported in 6% of patients receiving this drug compared with 2% in the placebo group; 0.5% and 0.2% of patients withdrew due to peripheral edema in the drug treated group and the placebo group, respectively.

Analyses of clinical trial ECG data has shown the mean PR interval increase was 3 to 6 msec at doses greater than or equal to 300 mg/day. Subgroup analyses did not identify an increased risk of PR prolongation in patients with baseline PR prolongation or those taking other PR prolonging medications, although the number of patients in the study was not sufficient to draw a definitive conclusion.

Psychiatric

• Common (1% to 10%): Confusion, euphoria, amnesia, nervousness, irritability, disorientation, insomnia, libido decreased, disturbance in attention, anxiety, depersonalization, stupor, abnormal thinking
• Uncommon (0.1% to 1%): Cognitive disorder, mental impairment, abnormal dreams, agitation, apathy, aphasia, hallucinations, hostility
• Rare (less than 0.1%): Delirium, delusions, manic reaction, paranoid reaction, personality disorder, psychotic depression, schizophrenic reaction, sleep disorder, disinhibition

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity
• Rare (0.01% to 0.1%): Allergic reaction, anaphylactic reaction

Dermatologic

Symptoms of angioedema have included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There have also been reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Therapy should be discontinued immediately in patients with these symptoms. Caution is recommended if this drug is used in patients who have had a previous episode of angioedema. Patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE inhibitors]) may be at increased risk of developing angioedema.

• Common (1% to 10%): Ecchymosis, pruritus
• Uncommon (0.1% to 1%): Angioedema, rash papular, urticaria, hyperhidrosis, abscess, cellulitis, alopecia, dry skin, eczema, hirsutism, skin ulcer, urticaria, vesiculobullous rash
• Rare (less than 0.1%): Stevens Johnson syndrome, cold sweat, angioedema, exfoliative dermatitis, lichenoid dermatitis, melanosis, nail disorder, petechial rash, purpuric rash, pustular rash, skin atrophy, skin necrosis, skin nodule, subcutaneous nodule

Gastrointestinal

• Common (1% to 10%): Dry mouth, constipation, nausea, vomiting, diarrhea, flatulence, abdominal distention, gastroenteritis
• Uncommon (0.1% to 1%): Gastroesophageal reflux disease, salivary hypersecretion, hypoesthesia oral, cholecystitis, cholelithiasis, colitis, dysphagia, esophagitis, gastritis, GI hemorrhage, melena, mouth ulceration, pancreatitis, rectal hemorrhage, tongue edema
• Rare (less than 0.1%): Ascites, granuloma

Genitourinary

• Common (1% to 10%): Urinary incontinence, erectile dysfunction, impotence, urinary frequency, urinary incontinence
• Uncommon (0.1% to 1%): Sexual dysfunction, ejaculation delayed, dysmenorrhea, breast pain, anorgasmia, albuminuria, dysuria, hematuria, kidney calculus, leukorrhea, menorrhagia, metrorrhagia, oliguria, urinary retention, urine abnormality, abnormal ejaculation, albuminuria, amenorrhea, dysmenorrhea, kidney calculus, menorrhagia, metrorrhagia, oliguria
• Rare (less than 0.1%): Breast discharge, breast enlargement, gynecomastia, pelvic pain, balanitis, bladder neoplasm, cervicitis, dyspareunia, epididymitis, glomerulitis, ovarian disorder

Hematologic

• Uncommon (0.1% to 1%): Neutropenia, blood creatine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased, blood creatinine increased, blood potassium decreased, deep thrombophlebitis
• Rare (less than 0.1%): White blood cell count decreased, anemia, eosinophilia, hypochromic anemia, leukocytosis, leukopenia, lymphadenopathy, thrombocytopenia
• Rare (0.01% to 0.1%): Myelofibrosis, polycythemia, prothrombin decreased, purpura

Immunologic

• Very common (10% or more): Infection (up to 14%)
• Common (1% to 10%): Influenza syndrome

Musculoskeletal

• Common (1% to 10%): Myasthenia, muscle cramp, arthralgia, back pain, pain in limb, cervical spasm, leg cramps
• Uncommon (0.1% to 1%): Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness, neck rigidity, arthrosis
• Rare (less than 0.1%): Rhabdomyolysis, chondrodystrophy, generalized spasm

Ocular

• Very common (10% or more): Visual field changes (13%)
• Common (1% to 10%): Blurry vision, abnormal vision, diplopia, conjunctivitis
• Uncommon (0.1% to 1%): Peripheral vision loss, visual disturbance, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, photopsia, photosensitivity reaction, dry eye, lacrimation increased, eye irritation, retinal vascular disorder, abnormality of accommodation, blepharitis, dry eyes, eye hemorrhage, hyperacusis, photophobia, retinal edema
• Rare (0.01% to 0.1%): Vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness, anisocoria, blindness, corneal ulcer, exophthalmos, extraocular palsy, iritis, keratitis, keratoconjunctivitis, miosis, mydriasis, night blindness, ophthalmoplegia, optic atrophy, papilledema, parosmia, ptosis, uveitis

Other

• Common (1% to 10%): Asthenia, accidental injury, face edema, pain, otitis media, tinnitus
• Uncommon (less than 0.1% to 1%): Generalized edema, pain, pyrexia, chills, thirst
• Rare (0.01% to 0.1%): Retroperitoneal fibrosis, retinal vascular disorder, taste loss, taste perversion
• Frequency not reported: Withdrawal effects following rapid discontinuation
• Some patients have reported withdrawal effects following abrupt/rapid discontinuation. These symptoms included insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea.

Respiratory

• Common (1% to 10%): Dyspnea, bronchitis, nasopharyngitis
• Uncommon (0.1% to 1%): Epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness
• Rare (less than 0.1%): Pulmonary edema, throat tightness, apnea, atelectasis, bronchiolitis, hiccup, laryngismus, lung fibrosis, yawn

Metabolic

• Common (1% to 10%): Weight gain, edema, hypoglycemia, increased appetite
• Uncommon (0.1% to 1%): Weight decreased, blood glucose increased
• Rare (0.01% to 0.1%): Glucose tolerance decreased, urate crystalluria

Hepatic

• Uncommon (0.1% to 1%): Nephritis
• Rare (0.01% to 0.1%): Acute kidney failure, pyelonephritis

Endocrine

• Postmarketing reports: Gynecomastia, breast enlargement

How to cope with side effects

What to do about:

• headaches – make sure you rest and drink plenty of fluids. Don’t drink too much alcohol. Ask your pharmacist to recommend a painkiller. Headaches should usually go away after the first week of taking Lyrica. Talk to your doctor if they last longer than a week or are severe.
• feeling sleepy, tired or dizzy – as your body gets used to Lyrica, these side effects should wear off. If they don’t wear off within a week or two, your doctor may reduce your dose or increase it more slowly. If that doesn’t work you may need to switch to a different medicine.
• feeling sick – take Lyrica with or after a meal or snack to ease feelings of sickness. It may also help if you don’t eat rich or spicy food.
• diarrhea – have small but frequent sips of water. It may also help to take oral rehydration solutions which you can buy from a pharmacy or supermarket to prevent dehydration. Don’t take any other medicines to treat diarrhoea without speaking to a pharmacist or doctor.
• blurred vision – don’t drive for a week.
• weight gain – Lyrica can make you hungrier so it can be quite a challenge to stop yourself putting on weight. Try to eat a healthy balanced diet without increasing your portion sizes. Don’t snack on foods that contain a lot of calories, such as crisps, cakes, biscuits and sweets. If you’re hungry between meals, eat fruit and vegetables and low-calorie foods. Regular exercise will also help to keep your weight stable.

Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation

As with all antiepileptic drugs (antiepileptic drugs), withdraw Lyrica gradually to minimize the potential of increased seizure frequency in patients with seizure disorders.

Following abrupt or rapid discontinuation of Lyrica, some patients reported symptoms including insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea.

If Lyrica is discontinued, taper the drug gradually over a minimum of 1 week rather than discontinue the drug abruptly.

Suicidal Behavior and Ideation

Antiepileptic drugs (antiepileptic drugs), including Lyrica, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor patients treated with any antiepileptic drug for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different antiepileptic drugs showed that patients randomized to one of the antiepileptic drugs had approximately twice the risk of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 antiepileptic drug-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with antiepileptic drugs was observed as early as one week after starting drug treatment with antiepileptic drugs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with antiepileptic drugs of varying mechanisms of action and across a range of indications suggests that the risk applies to all antiepileptic drugs used for any indication. The risk did not vary substantially by age (5–100 years) in the clinical trials analyzed.

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing Lyrica or any other antiepileptic drug must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which antiepileptic drugs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, your doctor needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Lyrica overdose

The highest reported accidental overdose of Lyrica (pregabalin) during the clinical development program was 8000 mg, and there were no notable clinical consequences ⁴.

There is no known antidote for Lyrica (pregabalin). Treatment is generally symptomatic and supportive. To enhance elimination- hemodialysis is indicated by the patients clinical state; patients with significant renal impairment may increase clearance of Lyrica (pregabalin) approximately 50% in 4 hours. Monitoring of vital signs and observation of clinical status of the patient. Supportive care- Contacting a certified poison control center for up-to-date information on management of overdose with Lyrica (pregabalin) ⁵.

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