LYRICA (PREGABALIN) - NEW GABAPENTINOID WITH WIDE CLINICAL APPLICATION



Developed by Pfizer, pregabalin, marketed under the brand name Lyrica, is a 3-substituted analogue of gamma-amino butyric acid (GABA) and a compound related to Pfizer's hugely successful antiepileptic drug gabapentin (Neurontin).
In July 2004, Pfizer secured Europe-wide approval for Lyrica (pregabalin) for use in the management of peripheral neuropathic pain as well as an adjunctive therapy in the treatment of partial epileptic seizures. Subsequently in December 2004 the company gained FDA approval for use of Lyrica (pregabalin) in neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia; making it the first FDA-approved treatment for both of these neuropathic pain states. Lyrica (pregabalin) is also being reviewed by the FDA as an adjunctive treatment for partial epileptic seizures in adults.
A SUCCESSOR TO GABAPENTIN

First marketed in 1983, gabapentin (Neurontin) has been one of Pfizer's top performing drugs. Lyrica (pregabalin) is seen as an important successor now that gabapentin is facing the threat of generic competition.

Both drugs share a similar mechanism of action: binding to calcium channels and modulating calcium influx as well as influencing GABergic neurotransmission. This mode of action translates into anti-epileptic, analgesic and anxiolytic effects. Because it is more potent than gabapentin, Lyrica (pregabalin) achieves efficacy at lower doses. This increases its therapeutic index with respect to gabapentin and should lead to fewer dose-related side effects. Clinical studies with Lyrica (pregabalin) have been carried out on over 10,000 patients worldwide.
CLINICAL STUDIES WITH LYRICA (PREGABALIN) IN EPILEPSY

Gabapentin is approved worldwide for adjunctive treatment of patients with partial epilepsy. Because it is not metabolised (and so does not alter the pharmacokinetics of co-administrated drugs) it is a good candidate for use in combination with other antiepileptic medications. Clinical studies with oral Lyrica (pregabalin) suggest it is at least as effective as gabapentin as adjunctive therapy in patients refractory to one or more conventional antiepileptic drugs. In large-scale, placebo-controlled studies of 12 weeks' duration, add-on therapy with oral Lyrica (pregabalin) reduced seizure frequency by up to 75%. In these studies doses of Lyrica (pregabalin) ranged from 150mg to 600mg daily.
CLINICAL STUDIES WITH LYRICA (PREGABALIN) IN NEUROPATHIC PAIN AND ANXIETY DISORDER

Neuropathic pain is chronic pain that arises from damage to sensory nerves. It can include:

* Pain arising from trapped or compressed nerves
* Drug-induced nerve damage
* Diabetic neuropathy
* Post-herpetic pain
* Phantom limb syndrome following limb amputation
* Peripheral neuropathy
* Fibromyalgia

Neuropathic pain generally does not respond to treatment with opioid or non-steroidal anti-inflammatory drugs (NSAIDs). At high doses gabapentin has proven effective against neuropathic pain induced by diabetic neuropathy and postherpetic neuralgia. Data from clinical studies show that Lyrica (pregabalin) shares this analgesic effectiveness. Efficacy has been demonstrated in a number of clinical studies, including those in patients with diabetic neuropathy and fibromyalgia. Treatment of neuropathic pain is seen as the drug's leading indication.

A double-blind, placebo-controlled monotherapy study in 529 patients with fibromyalgia, for example, showed that eight weeks' treatment with Lyrica (pregabalin) 150mg to 450mg per day produced significantly greater reductions in pain compared with placebo as well as improving sleep quality and fatigue. Pain, sleep disturbances and fatigue are core symptoms of fibromyalgia, which has proved an extremely difficult condition to treat.

Data from a series of phase II and III placebo-controlled clinical studies in over 1,200 patients with generalised anxiety disorder suggest that Lyrica (pregabalin) will be effective for this disabling disorder. In comparison with venlafaxine, pregabalin provided more rapid relief of psychic and somatic symptoms. In comparison with alprazolam (a benzodiazepine), Lyrica (pregabalin) appeared equally effective in reducing somatic symptoms. Overall, these findings show that Lyrica (pregabalin) combines the benefits of both antidepressants and benzodiazepines. It appears at least as rapid as benzodiazepines against somatic symptoms, while providing more rapid control of psychic symptoms than antidepressants.

MARKETING COMMENTARY

Once generic manufacture of gabapentin is approved, sales of Pfizer's Neurontin are likely to fall dramatically. Encouraging physicians to switch patients from Neurontin to Lyrica (pregabalin), if approved, will be an important strategy in minimising the impact of generic competition. Lyrica (pregabalin) is as effective as Neurontin, but at lower doses, which translates to fewer side effects. Thus, it is well placed to capture Neurontin's market share. Through the successful launch of follow-on products, Pfizer has maintained leadership in other CNS areas, such as the market for antidepressants.

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More information about Lyrica Oral:


Important Note: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

PREGABALIN - ORAL
Pronunciation: (pree-GAH-ba-lin)


USAGE:
This medication is used to treat pain caused by nerve damage due to diabetes and shingles (herpes zoster) infection. It is also used with other medications to treat certain types of seizures (partial onset seizures).

HOW TO USE
Read 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, usually twice or three times a day, or as directed by your doctor. You may take it with or without food. When you start this medication, your dosage will probably need to be increased slowly by your doctor to reduce side effects, especially dizziness or drowsiness. Your dosage is based on your medical condition and response to therapy.

Use this medication regularly in order to get the most benefit from it. 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 drug suddenly without your doctor's approval since seizures may come back, or you may have a withdrawal reaction.

This medication may cause dependence, especially if it has been used regularly for an extended period of time, or if it has been used in high doses. In such cases, if you suddenly stop this drug, withdrawal reactions may occur. Such reactions can include difficulty sleeping, nausea, headache and diarrhea. Report to your doctor immediately any such reactions. When stopping extended, regular treatment with this drug, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.

Though it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit-forming). Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.

Inform your doctor if your condition persists or worsens.
Learn more

SIDE EFFECTS:
Drowsiness, dizziness, confusion, difficulty concentrating, unsteadiness, fatigue, swollen arms/legs, increased appetite, weight gain, nausea, dry mouth or constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because 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 immediately if any of these unlikely but serious side effects occur: change in amount of urine, difficulty speaking, loss of coordination, mental/mood changes, muscle pain/tenderness/weakness (especially if your are tired or have a fever), stomach/abdominal pain, uncontrolled movements (e.g., tremor, twitching), unusual tiredness, vision changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: unusual bleeding/bruising, slow or irregular heartbeat.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

If you notice other effects not listed above, contact your doctor or pharmacist.
Learn more

PRECAUTIONS:
Before taking pregabalin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (e.g., heart failure), kidney disease.

This drug may make you dizzy or drowsy or cause blurred vision; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages because they may increase the risk of this drug's side effects.

Kidney function declines as you grow older. This medication is removed by the kidneys. Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially drowsiness.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS:
Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: certain diabetic medications (glitazones such as rosiglitazone).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., carbamazepine), medicine for sleep (e.g., sedatives), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), tranquilizers.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

OVERDOSE:
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

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 at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 - 86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

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Frequently Asked Questions (FAQ)


LYRICA

1. What is nerve pain?

Nerve pain is different from other types of pain you may feel, such as pain from a sprained ankle or muscle ache. Nerve pain often feels like a numbness, tingling, pins and needles, or a burning, sharp, stabbing, or shooting pain. This type of pain may keep you up at night or stop you from doing daily tasks. Even the lightest touch, such as from your clothes and bedsheets, can cause severe pain.

Common pain medicines that you can get without a prescription have not been clinically proven to work very well for nerve pain. Thankfully, there is a new drug approved to treat two of the most common types of nerve pain—nerve pain associated with diabetes and shingles.
2. What is LYRICA?

LYRICA is the first medication approved by the US Food and Drug Administration (FDA) to treat the pain that occurs with both diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN)—two of the most common forms of nerve pain. LYRICA is also approved as adjunctive treatment for partial onset seizures in adults.
3. How does LYRICA work?

The central nervous system is made up of millions of nerve cells. In people with nerve pain, some cells are over-excited because they are damaged. This causes the cells to fire too many signals throughout the body, resulting in pain.

LYRICA works by attaching to part of the over-firing nerve cells. This is thought to help to reduce the pain signals that cause the symptoms of diabetic nerve pain.

LYRICA may reduce the nerve pain that can prevent the enjoyment of everyday activities.

Watch a video that shows how LYRICA works.

Some people taking LYRICA start to have relief by the first week.

4. Can I take LYRICA with other medicines?

Tell your doctor about all the medicines you take including prescription or non-prescription medicines, vitamins or herbal supplements. LYRICA and other medicines may affect each other.

Especially tell your doctor if you take:

* rosiglitazone (Avandia®) or pioglitazone (Actos®) for diabetes. You may have a higher chance of weight gain or swelling if these medicines are taken with LYRICA
* any narcotic pain medicine (such as oxycodone), tranquilizers or medicines for anxiety (such as lorazepam). You may have a higher chance for dizziness and sleepiness if these medicines are taken with LYRICA
* any medicines that make you sleepy


Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

5. What are the most common side effects with LYRICA?

In clinical trials, the most common side effects were:

* dizziness
* sleepiness
* dry mouth
* swelling of hands and feet
* blurry vision
* weight gain
* trouble concentrating

These side effects were often mild to moderate, and few people in clinical trials stopped taking LYRICA because of the side effects.

Some side effects went away after a few weeks of treatment. Tell your doctor about any side effect that bothers you or that does not go away.

When you first start taking LYRICA, do not drive a car, work with machines, or do other dangerous activities until you know how LYRICA affects how alert you are.

For a complete list of side effects, see the Patient Prescribing Information for LYRICA.
6. My doctor just prescribed LYRICA. But I’m not sure what to expect when I start taking LYRICA. Is there information that can help me?

Yes. Now that you are ready to begin treatment with LYRICA, click here for important information about getting started on LYRICA.
7. How do I take LYRICA?

LYRICA comes in 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsules. Your doctor will tell you how much you need to take and when to take it.

* Take LYRICA 2 or 3 times a day, depending on what your doctor tells you
* You can take LYRICA with or without food
* Keep taking LYRICA, even after you start feeling relief from your pain
* Do not suddenly stop taking LYRICA. Talk to your doctor first
* Plan ahead to have a refill so you don’t run out

8. What do I do if I miss a dose?

If you miss a dose by a few hours, take it as soon as you remember. If it is too close to your next dose, do NOT take the missed capsule. Just take LYRICA at your next regular time. Do NOT take 2 doses of LYRICA at the same time.

9. Who should not take LYRICA?

Do not take LYRICA if you are allergic to pregabalin or any other ingredient in LYRICA. Pregabalin is the main ingredient in LYRICA.

Ask your doctor or pharmacist for a list of ingredients.

10. What do I have to let my doctor know before I start taking LYRICA?

Be sure to tell your doctor if you:

* Are pregnant, plan to become pregnant, or are breast feeding
* Are planning to father a child
* Are taking Avandia®* or Actos®† or other prescription medications
* Are taking nonprescription medicines or natural/herbal remedies
* Have ever had itching, wheezing, hives, or swelling of the throat or face after taking any medication
* Have any kidney problems



*Avandia is a registered trademark of GlaxoSmithKline.

†Actos is a registered trademark of Takeda Chemical Industries, Ltd. and used under license by Takeda Pharmaceuticals America, Inc. and Eli Lilly and Co.

Source:- Pfizer Inc.
________________

US Brand Names

* Lyrica

Canadian Brand Names

* Lyrica

Description

Pregabalin (pre-GAB-a-lin) is used to help control some types of seizures in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

This medicine is also used to manage a condition called post-herpetic neuralgia (pain after “shingles”). It is also used for pain caused by nerve damage associated with diabetes.

Pregabalin is available only with your doctor's prescription, in the following dosage form:

Oral
*

Capsules (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pregabalin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pregabalin. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy

Pregabalin has not been studied in pregnant women. However, studies in pregnant animals have shown that pregabalin may cause unwanted effects in offspring when given to the mother in doses larger than the largest human dose. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding

It is not known whether pregabalin passes into breast milk. However, pregabalin is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of pregabalin in children with use in other age groups.

Older adults

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, elderly patients are more likely to be more sensitive to pregabalin than younger adults and may require a lower dose.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking pregabalin, it is especially important that your doctor and pharmacist know if you are taking any of the following:

*

Antidiabetic drugs (e.g., Thiazolidinedione [ciglitazone])—May cause weight gain and/or fluid retention, and may increase your risk of serious side effects

Other medical problems

The presence of other medical problems may affect the use of pregabalin. Make sure you tell your doctor if you have any other medical problems, especially:

*

Diabetes mellitus—May increase your weight and may increase your risk for skin ulcerations

*

Heart disease—May increase your chance of side effects

*

Kidney disease—Your doctor may lower your dose of pregabalin

Proper Use of This Medicine

Take this medicine only as directed by your doctor , to help your condition as much as possible. Do not take more or less of it, and do not take it more or less often than your doctor ordered.

Pregabalin may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

Read the patient information leaflet prior to beginning pregabalin therapy

Dosing

The dose of pregabalin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pregabalin. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking pregabalin.

*

For oral dosage form (capsules):
o

For diabetic nerve pain:
+

Adults—Oral, 150 milligrams per day, divided (50 mg three times a day).
+

Children—Dose must be determined by your doctor.
o

For epilepsy:
+

Adults—Oral, 150 to 600 milligrams per day. The total daily dose should be divided and given two or three times a day.
+

Children—Dose must be determined by your doctor.
o

For post-herpetic neuralgia:
+

Adults—Oral, 150 to 300 milligrams per day. The total daily dose should be divided and given two or three times a day.
+

Children—Dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

To store this medicine:

*

Keep out of the reach of children.
*

Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
*

Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits , especially for the first few months you take pregabalin. This is necessary to allow dose adjustments and to reduce any unwanted effects.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; other medicines for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking pregabalin .

Pregabalin may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, drowsiness, or trouble in thinking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well. If these reactions are especially bothersome, check with your doctor.

This medicine may cause you to keep extra fluid in your body or cause you to gain weight. If this side effect is bothersome, check with your doctor.

Do not suddenly stop taking your pregabalin . If you have been instructed to stop taking pregabalin, ask your healthcare professional how to slowly decrease the dose. This is to decrease the chance of having discontinuation symptoms such as dizziness, nausea, headache, vomiting, irritability, nightmares, P**kling or tingling feelings.

Report any unexplained muscle pain, tenderness, or weakness particularly if accompanied by a fever.

For patients with diabetes, check with your doctor if you notice changes to your skin or skin sores while taking pregabalin.

Notify your doctor if you become pregnant, if you plan to become pregnant, or if you father a child while taking pregabalin.
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Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
Difficult or labored breathing; shortness of breath; tightness in chest; wheezing.

Rare
Blistering, peeling, loosening of skin; chills; cough; difficulty swallowing; diarrhea; dizziness; fast heartbeat; hives; itching; joint or muscle pain; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; red irritated eyes; red skin lesions, often with a purple center; skin rash; sore throat; sores, ulcers, or white spots in mouth or on lips; unusual tiredness or weakness.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

More Common
Accidental injury; bloating or swelling of face, arms, hands, lower legs, or feet; blurry vision; burning, tingling, numbness or pain in the hands, arms, feet, or legs; change in walking and balance; clumsiness; confusion; delusions; dementia; difficulty having a bowel movement (stool); difficulty in speaking; double vision; dry mouth; fever; headache; hoarseness; increased appetite; lack of coordination; loss of memory; lower back or side pain; mood or mental changes; painful or difficult urination; problems with memory; rapid weight gain; seeing double; shakiness and unsteady walk; sensation of pins and needles; sleepiness or unusual drowsiness; stabbing pain; swelling; tingling of hands or feet; trembling, or other problems with muscle control or coordination; trembling or shaking of hands or feet; shakiness in legs, arms, hands, feet; unusual weight gain or loss.

Less common
Anxiety; bloated full feeling; burning, crawling, itching, numbness, P**kling, "pins and needles" , or tingling feelings; changes in vision; chest pain; cold sweats; coma; cool pale skin; cough producing mucus; decrease or change in vision; depression; eye disorder; excess air or gas in stomach or intestines; false or unusual sense of well-being; general feeling of discomfort or illness; increased hunger; joint pain; loss of appetite; loss of bladder control; loss of strength or energy; muscle aches and pains; muscle weakness; muscle twitching or jerking; nausea; nervousness; nightmares; noisy breathing; pain; passing gas; rhythmic movement of muscles; runny nose; seizures; shivering; slurred speech; sweating; trouble sleeping; twitching; uncontrolled eye movements; vomiting.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.


Nov 14, 2005

SOURCE:- mayoclinic.com

Article URL: http://www.medicalnewstoday.com/medicalnews.php?newsid=40404

Lyrica (from ePocrates)

pregabalin
Tell A FriendPrint this monograph
Entire Monograph


Adult Dosing

Dosage forms: 25,50,75,100,150,200,225,300
neuropathic pain, diabetic peripheral
100 mg PO tid
Start: 50 mg PO tid, incr. to 300 mg/day over 7 days; Max: 300 mg/day; Info: taper dose over 7 days to D/C
post-herpetic neuralgia
150-300 mg/day PO div bid-tid
Start: 50 mg PO tid or 75 mg PO bid, incr. to 300 mg/day over 7 days; Max: 600 mg/day; Info: may incr. to 600 mg/day PO div bid-tid if inadequate relief after 2-4wk on 300 mg/day; taper dose over 7 days to D/C
partial seizures, adjunct tx
150-600 mg/day PO div bid-tid
Start: 50 mg PO tid or 75 mg PO bid; Max: 600 mg/day; Info: taper dose over 7 days to D/C
fibromyalgia
150-225 mg PO bid
Start: 75 mg PO bid, incr. to 300 mg/day over 7 days; Max: 450 mg/day; Info: taper dose over 7 days to D/C
renal dosing
adjust dose amount, frequency
CrCl 30-60: 75-300 mg/day div bid-tid; CrCl 15-30: 25-150 mg/day div qd-bid; CrCl <15: 25-75 mg qd; HD: give 25-50 mg as supplement if on 25 mg/day; 50-75 mg if on 25-50 mg/day; 100-150 mg if on 75 mg/day
hepatic dosing
no adjustment

Peds Dosing

This information is currently unavailable or not applicable for this drug.


Contraindications/Cautions

hypersens. to drug/class/compon.
avoid abrupt withdrawal
caution in elderly pts
caution if impaired renal fxn
caution if CHF class III, IV NYHA
caution if angioedema hx or risk
caution if depression or hx

Drug Interactions

Monitor/Modify Tx

sevelamer
Caution Advised

acetaminophen/caffeine/CNS depressant combos
acetaminophen/opiate combos
acetaminophen/propoxyphene
acetaminophen/tramadol
antihist/decongest/DM combos
antihist/decongestant combos
antihistamines, sedating
antipsychotics
apomorphine
aspirin/caffeine/CNS depressant combos
aspirin/caffeine/orphenadrine
aspirin/opiate combos
azelastine nasal
barbiturates
BZDs, all
cannabinoids
central alpha 2 agonists
cetirizine
chlorpheniramine/hydrocodone
dantrolene
decongest/opiate combos
droperidol
ethanol
hydrocodone/ibuprofen
ibuprofen/oxycodone
levocetirizine
meperidine/promethazine
methadone
metoclopramide
muscle relaxants
olanzapine/fluoxetine
opiate agonist/antagonists
opiates
oxcarbazepine
phenothiazines
pramipexole
promethazine/codeine
propoxyphene
ropinirole
rotigotine transdermal
sedative/hypnotics
sodium oxybate
thalidomide
thiazolidinediones
tramadol
tricyclic antidepressants
valproic acid derivatives

Adverse Reactions

Serious Reactions
thrombocytopenia
hypersensitivity rxn
angioedema (rare)
anaphylactoid rxns (rare)
skin rxns, severe (rare)
rhabdomyolysis (rare)
suicidality
Common Reactions
dizziness
somnolence
ataxia
peripheral edema
weight gain
blurred vision
accidental injury
diplopia
abnormal thinking
dry mouth
tremor
infection
headache
asthenia
constipation
incr. appetite
amnesia
neuropathy
confusion
incoordination
pain
abnormal vision
abnormal gait
vertigo
muscle twitching
decreased platelets
arthralgia/myalgia

Safety Monitoring

Pregnancy:C
Lactation: Safety Unknown
Monitoring Parameters: Cr at baseline; s/sx depression, behavior changes, suicidality

Pharmacology

Metabolism: none; CYP450: none
Excretion: urine (90% unchanged); Half-life: 6.3h
Class: Other Neurologics Anti-Convulsants
Mechanism Of Action
exact mechanism of action unknown; binds alpha2-delta subunit of calcium channels reducing neurotransmitter release; produces antinociceptive and antiseizure effects

Manufacturer/Pricing

Manufacturer: Pfizer Inc.
DEA/FDA: Schedule V
Approximate Retail Price
from www.drugstore.com

capsule:
25 mg (30 ea): $63.99
50 mg (30 ea): $63.99
75 mg (30 ea): $63.99
100 mg (30 ea): $64.99
150 mg (30 ea): $64.99
200 mg (30 ea): $64.99
225 mg (30 ea): $63.59
300 mg (30 ea): $64.99

Patient Education - English

Show Spanish
Generic Name: pregabalin
Pronounced: pre GAB a lin
Brand Name: Lyrica
What is the most important information I should know about pregabalin?
If you are taking pregabalin to prevent seizures, keep taking the medication even if you feel fine. You may have an increase in seizures if you stop taking pregabalin. Follow your doctor's instructions.

Do not change your dose of pregabalin without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

If you stop taking pregabalin suddenly, your seizures may become worse or you may have withdrawal symptoms. Withdrawal symptoms include headache, sleep problems, nausea, and diarrhea. Do not stop using pregabalin suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Carry an ID card or wear a medical alert bracelet stating that you are taking pregabalin, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

What is pregabalin?
Pregabalin is an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Pregabalin also affects chemicals in the brain that send pain signals across the nervous system.

Pregabalin is used to control seizures and to treat fibromyalgia. It is also used to treat pain caused by nerve damage in people with diabetes (diabetic neuropathy) or herpes zoster (post-herpetic neuralgia).

Pregabalin may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking pregabalin?
You should not use this medication if you are allergic to pregabalin.

Before using pregabalin, tell your doctor if you are allergic to any drugs, or if you have:

congestive heart failure;
diabetes; or
kidney disease.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take pregabalin.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment.

It is not known whether pregabalin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 18 years old.

How should I take pregabalin?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

You may take pregabalin with or without food.

Do not change your dose of pregabalin without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

If you are taking pregabalin to prevent seizures, keep taking it even if you feel fine. You may have an increase in seizures if you stop taking pregabalin. Follow your doctor's instructions.

You may have withdrawal symptoms when you stop using pregabalin after using it over a long period of time. Withdrawal symptoms include headache, sleep problems, nausea, and diarrhea. Do not stop using pregabalin suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Carry an ID card or wear a medical alert bracelet stating that you are taking pregabalin, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

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

What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical treatment if you think you have used too much of this medicine.

Symptoms of a pregabalin overdose are not known.

What should I avoid while taking pregabalin?
Avoid drinking alcohol. It can increase some of the side effects of pregabalin.

Pregabalin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by pregabalin. Tell your doctor if you regularly use any of these other medicines.

What are the possible side effects of pregabalin?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

muscle pain, weakness, or tenderness (especially if you also have a fever and feel tired);
easy bruising or bleeding; or
swelling in your hands or feet, rapid weight gain.
Less serious side effects may include:

dizziness or drowsiness, anxiety;
blurred vision;
loss of balance or coordination;
problems with memory or concentration;
dry mouth;
skin rash or itching;
constipation, stomach pain;
increased appetite; or
joint or muscle pain.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect pregabalin?
There may be other drugs that can interact with pregabalin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?
Your pharmacist can provide more information about pregabalin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.

Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Pill Pictures


Lyrica (pregabalin) 75 mg

Lyrica (pregabalin) 100 mg

Lyrica (pregabalin) 150 mg

Lyrica (pregabalin) 200 mg

Lyrica (pregabalin) 25 mg

Lyrica (pregabalin) 300 mg

Lyrica (pregabalin) 50 mg

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of your healthcare professional. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you. You should consult your healthcare professional before taking any drug, changing your diet or commencing or discontinuing any course of treatment.

Tried it two years ago. 50 mg starting dose. Horrible stuff. It promptly switched off my anti-depressant ( Mirtazapine ) and put my head into another space. Really out of it for ten hours.
It may work for some people, but it does not work for me ...

Stuart.

Auckland,
New Zealand.


Never tought I flsued