Lyrica 150mg Capsules

Manufacturer PFIZER U.S. Active Ingredient Pregabalin Capsules(pre GAB a lin) Pronunciation pre-GAB-a-lin
It is used to help control certain kinds of seizures.It is used to treat painful nerve diseases.It is used to treat fibromyalgia.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Anticonvulsant, Analgesic (Neuropathic), Anxiolytic
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Pharmacologic Class
Alpha2-delta ligand
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Pregnancy Category
Not available (FDA removed categories; animal data suggest fetal harm)
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FDA Approved
Dec 2004
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DEA Schedule
Schedule V

Overview

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What is this medicine?

Pregabalin is a medication that helps to calm overactive nerves in your body. It's used to treat certain types of nerve pain (like from diabetes or shingles), a condition called fibromyalgia, and certain types of seizures. It can also help with generalized anxiety disorder.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, unless your doctor or healthcare provider tells you to stop.

Storing and Disposing of Your Medication

Store your medication in its original container at room temperature in a dry place, away from the bathroom. Keep it out of reach of children and pets, and store it in a secure location where others cannot access it, such as a locked box or area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Do not stop taking this medication suddenly, as it can cause withdrawal symptoms. Your doctor will tell you how to slowly reduce your dose.
  • Avoid alcohol while taking pregabalin, as it can increase dizziness and drowsiness.
  • Be careful when driving or operating machinery until you know how this medication affects you, as it can cause dizziness and sleepiness.
  • Report any unusual changes in mood or behavior, including thoughts of self-harm, to your doctor immediately.
  • This medication may cause weight gain and swelling in your hands or feet.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication: For neuropathic pain (DPN, PHN), initial 75 mg BID or 50 mg TID (150 mg/day), titrate to 300 mg/day, max 600 mg/day. For fibromyalgia, initial 75 mg BID (150 mg/day), titrate to 300-450 mg/day. For partial-onset seizures, initial 75 mg BID or 50 mg TID (150 mg/day), titrate to 150-600 mg/day. For GAD, initial 150 mg/day, titrate to 300-600 mg/day.
Dose Range: 150 - 600 mg

Condition-Specific Dosing:

Diabetic Peripheral Neuropathy: Initial 50 mg TID or 75 mg BID (150 mg/day), titrate to 300 mg/day within 1 week, max 600 mg/day.
Postherpetic Neuralgia: Initial 75 mg BID or 50 mg TID (150 mg/day), titrate to 300 mg/day within 1 week, max 600 mg/day.
Fibromyalgia: Initial 75 mg BID (150 mg/day), titrate to 300-450 mg/day. Max 450 mg/day.
Partial-Onset Seizures (adjunctive): Initial 75 mg BID or 50 mg TID (150 mg/day), titrate to 150-600 mg/day.
Generalized Anxiety Disorder (GAD): Initial 150 mg/day, titrate to 300-600 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (approved for partial-onset seizures in patients 1 month to <4 years, weight-based dosing)
Child: Not established (approved for partial-onset seizures in patients 4 to <17 years, weight-based dosing)
Adolescent: Not established (approved for partial-onset seizures in patients 4 to <17 years, weight-based dosing)
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Dose Adjustments

Renal Impairment:

Mild: CrCl 30-60 mL/min: 75-300 mg/day (divided BID or TID)
Moderate: CrCl 15-30 mL/min: 25-150 mg/day (divided QD or BID)
Severe: CrCl <15 mL/min: 25-75 mg/day (single dose or divided)
Dialysis: Supplemental dose of 25-100 mg immediately following a 4-hour hemodialysis session.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Pregabalin binds with high affinity to the alpha2-delta subunit of voltage-gated calcium channels (VGCCs) in the central nervous system. This binding is thought to modulate the release of several excitatory neurotransmitters, including glutamate, norepinephrine, and substance P, which are involved in pain, seizure activity, and anxiety.
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Pharmacokinetics

Absorption:

Bioavailability: >90%
Tmax: Approximately 1.5 hours
FoodEffect: Food slightly delays Tmax but does not significantly affect the extent of absorption.

Distribution:

Vd: Approximately 0.56 L/kg
ProteinBinding: <1%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 6.3 hours
Clearance: Primarily renal clearance
ExcretionRoute: Renal
Unchanged: Approximately 98%
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Pharmacodynamics

OnsetOfAction: Within 1 week for pain/anxiety, variable for seizures
PeakEffect: Variable, often within 2-4 weeks of reaching target dose
DurationOfAction: Approximately 8-12 hours (based on BID/TID dosing)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you or your caregiver notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight
Muscle pain or weakness
Changes in balance
Feeling confused
Shakiness
Trouble breathing, slow breathing, or shallow breathing
Blue or gray color of the skin, lips, nail beds, fingers, or toes
Memory problems or loss
Shortness of breath, significant weight gain, or swelling in the arms or legs
Fast or abnormal heartbeat
Fever, chills, or sore throat
Skin sores or any skin changes
Trouble speaking
Trouble sleeping
Trouble walking
Feeling unusually euphoric (easy laughing and feeling good)
Twitching

If you experience extreme drowsiness, dizziness, or loss of consciousness, seek medical help immediately. Caregivers should seek medical help right away if the patient is unresponsive, uncommunicative, or unable to wake up.

Suicidal Thoughts or Actions

Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal behavior. If you or your caregiver notice any new or worsening symptoms, such as:

Depression
Feeling nervous, restless, or irritable
Panic attacks
Changes in mood or behavior

contact your doctor right away. If you experience suicidal thoughts or actions, seek medical help immediately.

Low Platelet Counts

This medication may rarely cause low platelet counts, which can increase the risk of bleeding. If you notice any unexplained bruising or bleeding, contact your doctor right away.

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Feeling dizzy, sleepy, tired, or weak
Weight gain
Difficulty focusing
Headache
Dry mouth
Constipation
Increased appetite
Upset stomach
Joint pain
Nose or throat irritation

Reporting Side Effects

If you have questions about side effects or want to report any side effects, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or extreme sleepiness
  • Swelling of your face, lips, tongue, or throat (signs of a severe allergic reaction or angioedema)
  • Difficulty breathing
  • New or worsening depression, anxiety, or other mood changes
  • Thoughts about suicide or harming yourself
  • Unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or feeling unwell (could be signs of rhabdomyolysis)
  • Significant weight gain or swelling in your extremities
  • Blurred vision or other changes in eyesight
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have kidney disease, as this may affect the medication's safety and efficacy.
If you are breastfeeding, as you should not breastfeed while taking this medication.

Additionally, to ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor, as some may interact with this medication.
Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so. This medication may interact with other drugs or health conditions, and your doctor needs to be aware of all relevant information to provide proper guidance.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before engaging in activities that require alertness or clear vision, such as driving, wait until you understand how this medication affects you.

If you experience changes in your seizures or if they worsen after starting this medication, consult your doctor promptly.

Do not abruptly stop taking this medication without first consulting your doctor, as this may increase your risk of side effects. If you need to discontinue this medication, your doctor will instruct you on how to gradually stop taking it to minimize potential risks.

Avoid consuming alcohol while taking this medication.

Before using marijuana, cannabis products, or prescription and over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.

A severe and potentially life-threatening reaction called angioedema has been associated with this medication. Symptoms may include swelling of the hands, face, lips, eyes, tongue, or throat, difficulty breathing, swallowing problems, or unusual hoarseness. Seek immediate medical attention if you experience any of these symptoms.

This medication has been linked to severe respiratory problems, particularly in individuals taking certain other medications (such as opioid pain medications) or those with pre-existing lung or breathing issues. The risk may be higher in people over 65 years old, and in some cases, these breathing problems have been fatal. If you have concerns, consult your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Men planning to father a child should discuss this medication with their doctor, as it has been shown to reduce fertility and cause sperm changes in male animals, as well as increase the risk of birth defects in their offspring. Although it is unclear whether these effects occur in humans, it is crucial to weigh the potential risks and benefits.

If you are pregnant or plan to become pregnant, inform your doctor, as you will need to discuss the benefits and risks of using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Somnolence (extreme drowsiness)
  • Confusion
  • Agitation
  • Restlessness
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive and may include gastric lavage or emesis. Hemodialysis can effectively remove pregabalin from the plasma.

Drug Interactions

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Major Interactions

  • CNS depressants (e.g., opioids, benzodiazepines, alcohol, barbiturates): Increased risk of additive CNS depression (somnolence, dizziness, respiratory depression, coma, death).
  • ACE inhibitors (e.g., captopril, enalapril): May enhance the risk of peripheral edema and angioedema.
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Moderate Interactions

  • Thiazolidinediones (e.g., pioglitazone, rosiglitazone): Increased risk of weight gain and peripheral edema when co-administered with pregabalin.

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: Pregabalin is primarily renally excreted; dose adjustment is necessary in renal impairment.

Timing: Prior to initiation

Mental health assessment (history of depression, suicidal ideation, substance abuse)

Rationale: To assess baseline risk for suicidal thoughts/behavior and potential for abuse/misuse.

Timing: Prior to initiation

Baseline weight

Rationale: Pregabalin can cause weight gain.

Timing: Prior to initiation

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Routine Monitoring

Efficacy (pain scores, seizure frequency, anxiety symptoms)

Frequency: Regularly during titration and maintenance

Target: Individualized based on therapeutic goals

Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.

Adverse effects (dizziness, somnolence, peripheral edema, weight gain, blurred vision)

Frequency: Regularly during titration and maintenance

Target: Minimize occurrence

Action Threshold: Persistent or severe adverse effects may require dose reduction or discontinuation.

Renal function (CrCl)

Frequency: Periodically, especially in elderly or those with known renal impairment

Target: Maintain appropriate dose for CrCl

Action Threshold: Significant decline in CrCl requires dose adjustment.

Mental status (mood, behavior, suicidal ideation)

Frequency: Regularly, especially during initial therapy and dose changes

Target: Stable mood, absence of suicidal thoughts

Action Threshold: New or worsening depression, suicidal thoughts, or unusual behavioral changes require immediate evaluation.

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Symptom Monitoring

  • Dizziness
  • Somnolence
  • Peripheral edema (swelling of hands, feet, ankles)
  • Weight gain
  • Blurred vision or other visual disturbances
  • Muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise)
  • Unusual changes in mood or behavior (e.g., agitation, irritability, depression)
  • Thoughts of self-harm or suicide
  • Signs of hypersensitivity reaction (e.g., rash, hives, swelling of face, lips, tongue, throat, difficulty breathing)
  • Signs of angioedema (swelling of face, mouth, or neck)

Special Patient Groups

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Pregnancy

Based on animal studies, pregabalin may cause fetal harm. Human data are limited but suggest potential risks. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy exposure registry is available.

Trimester-Specific Risks:

First Trimester: Potential for major congenital malformations based on some human observational data and animal studies.
Second Trimester: Animal studies show developmental toxicity (skeletal and visceral malformations, growth retardation).
Third Trimester: Animal studies show developmental toxicity (skeletal and visceral malformations, growth retardation).
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Lactation

Pregabalin is excreted into human milk. The amount ingested by a breastfed infant is low. Monitor breastfed infants for sedation and poor feeding. Considered L3 (Moderately Safe) by LactMed.

Infant Risk: Low; monitor for sedation, poor feeding, and developmental milestones.
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Pediatric Use

Safety and efficacy have not been established for most indications in pediatric patients. Approved for adjunctive treatment of partial-onset seizures in patients 1 month to <4 years and 4 to <17 years, with weight-based dosing. Increased risk of suicidal thoughts/behavior in patients 4 years and older.

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Geriatric Use

Increased risk of adverse effects such as dizziness, somnolence, and falls. Dose adjustment is often necessary due to age-related decline in renal function. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Pregabalin should be tapered slowly over at least 1 week to avoid withdrawal symptoms such as insomnia, nausea, headache, anxiety, and diarrhea.
  • There is a potential for abuse and misuse, particularly in patients with a history of substance abuse. Prescribe with caution in this population.
  • Common side effects include dizziness, somnolence, peripheral edema, and weight gain. Counsel patients on these effects.
  • Not indicated for acute pain; primarily used for chronic neuropathic pain.
  • Patients should be advised to report any new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior immediately.
  • Can cause blurred vision or other visual disturbances; advise patients to report these symptoms.
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Alternative Therapies

  • Gabapentin (for neuropathic pain, seizures)
  • Duloxetine (for neuropathic pain, fibromyalgia, GAD)
  • Venlafaxine (for neuropathic pain, GAD)
  • Tricyclic antidepressants (e.g., amitriptyline, nortriptyline for neuropathic pain)
  • Other anticonvulsants (e.g., carbamazepine, oxcarbazepine, lamotrigine for seizures)
  • SSRIs/SNRIs (for GAD)
  • Benzodiazepines (for GAD, short-term)
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Cost & Coverage

Average Cost: Varies widely, check current pharmacy pricing per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 for generic; Tier 3 or 4 for brand
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial resource for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.