Lyrica 200mg 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 Pain), Anxiolytic
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Pharmacologic Class
Gamma-aminobutyric acid (GABA) analogue
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Pregnancy Category
Category C
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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 used to treat certain types of nerve pain, such as that caused by diabetes or shingles, and pain from fibromyalgia. It's also used to treat partial seizures and generalized anxiety disorder. It works by calming overactive nerves in the brain and body.
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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. It's essential to continue taking this medication even if you feel well, as instructed by your doctor or healthcare provider.

Storing and Disposing of Your Medication

Store your medication in its original container at room temperature, in a dry place. Avoid storing it in a bathroom. Keep your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to ensure safety. Remember to keep all medications away from pets.

What to Do If You Miss 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Avoid alcohol consumption while taking pregabalin, as it can increase dizziness and drowsiness.
  • Do not drive or operate heavy machinery until you know how pregabalin affects you, as it can cause dizziness, drowsiness, and blurred vision.
  • Do not stop taking pregabalin suddenly without consulting your doctor, as this can lead to withdrawal symptoms.
  • Report any unusual mood changes, thoughts of self-harm, or behavioral changes to your doctor immediately.
  • Be aware of potential weight gain and swelling in the hands or feet.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication: e.g., Neuropathic pain: 150-300 mg/day in 2-3 divided doses, max 600 mg/day. Fibromyalgia: 300-450 mg/day in 2 divided doses. Partial onset seizures: 150-600 mg/day in 2-3 divided doses.
Dose Range: 150 - 600 mg

Condition-Specific Dosing:

Neuropathic Pain (DPN, PHN): Initial 50 mg three times daily (150 mg/day); may increase to 100 mg three times daily (300 mg/day) within 1 week. Max 300 mg twice daily or three times daily (600 mg/day).
Fibromyalgia: Initial 75 mg twice daily (150 mg/day); may increase to 150 mg twice daily (300 mg/day) within 1 week. Max 225 mg twice daily (450 mg/day).
Partial Onset Seizures: Initial 75 mg twice daily or 50 mg three times daily (150 mg/day); may increase to 150 mg twice daily or 100 mg three times daily (300 mg/day) within 1 week. Max 300 mg twice daily or 200 mg three times daily (600 mg/day).
Generalized Anxiety Disorder (GAD): Initial 150 mg/day in 2-3 divided doses; may increase to 300 mg/day after 1 week. Max 600 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (except for partial onset seizures in children â‰Ĩ1 month, specific dosing required)
Child: Not established for most indications. For partial onset seizures (â‰Ĩ1 month to <4 years): 3.5 mg/kg/day in 3 divided doses, max 14 mg/kg/day. (â‰Ĩ4 years to <12 years): 3.5 mg/kg/day in 2-3 divided doses, max 14 mg/kg/day.
Adolescent: Not established for most indications. For partial onset seizures (â‰Ĩ12 years): Dosing similar to adults, starting at 150 mg/day, max 600 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 30-60 mL/min: 75-300 mg/day in 2-3 divided doses.
Moderate: CrCl 15-30 mL/min: 25-150 mg/day in 1-2 divided doses.
Severe: CrCl <15 mL/min: 25-75 mg/day in 1 divided dose.
Dialysis: Patients on hemodialysis should receive a supplemental dose (25-100 mg) immediately following each 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 (ι2-δ) subunit of voltage-gated calcium channels in the central nervous system. This binding is thought to modulate the release of several excitatory neurotransmitters, including glutamate, norepinephrine, and substance P, leading to antinociceptive, anxiolytic, and anticonvulsant effects.
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Pharmacokinetics

Absorption:

Bioavailability: >90%
Tmax: 1.5 hours (fasted)
FoodEffect: Food reduces Cmax by 25-30% and prolongs Tmax to ~3 hours, but does not affect the overall extent of absorption (AUC).

Distribution:

Vd: 0.5 L/kg
ProteinBinding: <1%
CnssPenetration: Yes

Elimination:

HalfLife: 6.3 hours
Clearance: Renal clearance is proportional to creatinine clearance.
ExcretionRoute: Renal (unchanged)
Unchanged: >90%
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Pharmacodynamics

OnsetOfAction: Varies by indication; generally within days to 1-2 weeks for therapeutic effect.
PeakEffect: Steady state concentrations are achieved within 24-48 hours with multiple dosing.
DurationOfAction: Requires twice or thrice daily dosing due to half-life.

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
Balance problems
Confusion
Shakiness
Breathing difficulties, such as slow or shallow breathing
Blue or gray discoloration 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
Abnormal or rapid heartbeat
Fever, chills, or sore throat
Skin sores or any changes in skin condition
Difficulty speaking
Sleep disturbances
Walking difficulties
Feeling excessively euphoric (easily laughing and feeling good)
Twitching

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

Suicidal Thoughts and Behaviors

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

Depression
Anxiety, restlessness, or irritability
Panic attacks
Mood or behavioral changes

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

Low Platelet Count

This medication may rarely cause a decrease in platelet count, increasing the risk of bleeding. If you notice any unexplained bruising or bleeding, contact your doctor right away.

Other Side Effects

Most people taking this medication do not experience significant side effects, but some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not resolve on their own:

Dizziness, drowsiness, fatigue, or weakness
Weight gain
Difficulty concentrating
Headache
Dry mouth
Constipation
Increased appetite
Upset stomach
Joint pain
Nose or throat irritation

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or extreme sleepiness
  • Significant swelling of hands, feet, or ankles (peripheral edema)
  • Blurred vision or other changes in eyesight
  • Unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine (signs of rhabdomyolysis)
  • Unusual bruising or bleeding
  • Signs of an allergic reaction: swelling of the face, lips, tongue, or throat; difficulty breathing; rash; hives
  • New or worsening depression, anxiety, panic attacks, insomnia, irritability, agitation, restlessness, aggression, or thoughts about suicide or harming yourself.
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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, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have kidney disease, as this may affect how your body processes the medication.
If you are breastfeeding, as you should not breastfeed while taking this medication.

Additionally, to ensure safe treatment, it is crucial to discuss all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

with your doctor and pharmacist. This will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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 drug affects you.

If you experience changes or worsening of seizures after starting this medication, consult your doctor promptly. Do not abruptly stop taking this drug 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.

While taking this medication, avoid consuming alcohol. Additionally, consult your doctor before using marijuana, cannabis, or prescription or over-the-counter (OTC) drugs that may cause drowsiness or impaired reaction times.

Be aware that 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, as well as difficulty breathing, swallowing, or unusual hoarseness. Seek immediate medical attention if you experience any of these symptoms.

There is a risk of severe breathing problems when taking this medication, particularly in individuals who are also taking opioid pain medications or have pre-existing lung or breathing issues. This risk may be higher in people over 65 years old, and in some cases, breathing problems have been fatal. If you have concerns, discuss them with your doctor.

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

Men who plan to father a child should discuss this with their doctor, as this medication 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 not known if 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:

  • Severe drowsiness
  • Confusion
  • Agitation
  • Restlessness
  • Seizures
  • Coma
  • Respiratory depression

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. There is no specific antidote; treatment is supportive.

Drug Interactions

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Major Interactions

  • CNS depressants (e.g., opioids, benzodiazepines, alcohol, barbiturates, other sedatives): Increased risk of additive CNS depression, including respiratory depression and sedation.
  • Gabapentin: Additive effects due to similar mechanism.
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Moderate Interactions

  • ACE inhibitors (e.g., captopril, enalapril): May enhance the risk of peripheral edema.
  • Thiazolidinediones (e.g., pioglitazone, rosiglitazone): May enhance the risk of weight gain and peripheral edema.

Monitoring

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Baseline Monitoring

Renal function (Creatinine Clearance)

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

Timing: Prior to initiation of therapy.

Baseline pain/seizure assessment

Rationale: To establish a baseline for efficacy monitoring.

Timing: Prior to initiation of therapy.

Mental status and mood assessment

Rationale: To screen for pre-existing psychiatric conditions and monitor for suicidal ideation or behavioral changes.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (pain reduction, seizure frequency)

Frequency: Regularly during dose titration and maintenance.

Target: Individualized based on patient response.

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, mood changes)

Frequency: Regularly, especially during dose titration.

Target: N/A

Action Threshold: Significant or intolerable side effects may require dose reduction or discontinuation.

Renal function (CrCl)

Frequency: Periodically, especially in elderly or those with risk factors for renal decline.

Target: N/A

Action Threshold: Decline in renal function requires dose adjustment.

Signs of hypersensitivity (e.g., angioedema)

Frequency: Regularly, especially early in therapy.

Target: N/A

Action Threshold: Immediate discontinuation if angioedema occurs.

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Symptom Monitoring

  • Dizziness
  • Somnolence
  • Peripheral edema (swelling of hands/feet)
  • Weight gain
  • Blurred vision or other visual disturbances
  • Difficulty concentrating
  • Unusual mood changes (e.g., agitation, depression, anxiety)
  • Suicidal thoughts or behavior
  • Muscle pain or weakness (rhabdomyolysis symptoms)
  • Unusual bruising or bleeding
  • Signs of hypersensitivity (e.g., rash, hives, swelling of face, lips, tongue, throat, difficulty breathing)
  • Respiratory depression (especially with concomitant CNS depressants)

Special Patient Groups

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Pregnancy

Pregabalin is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown developmental toxicity (skeletal malformations, growth retardation) at doses higher than human therapeutic doses. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of major congenital malformations based on some observational studies, though data are conflicting and limited.
Second Trimester: Limited data, but generally considered less critical for major organogenesis than first trimester.
Third Trimester: Potential for neonatal withdrawal symptoms if discontinued abruptly near term; risk of respiratory depression in neonate if used close to delivery.
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Lactation

Pregabalin is excreted into human milk. The effects on the breastfed infant are unknown. The decision to discontinue breastfeeding or discontinue the drug should take into account the importance of the drug to the mother and the potential risks to the infant.

Infant Risk: L3 (Moderately Safe) - Monitor infant for sedation, poor feeding, and developmental milestones. Potential for CNS depression in the infant.
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Pediatric Use

Safety and efficacy have not been established for most indications in pediatric patients. Approved for partial onset seizures in children â‰Ĩ1 month of age. Dose adjustments are weight-based. Children may be more susceptible to certain side effects.

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Geriatric Use

Dose adjustment is often necessary in elderly patients due to age-related decline in renal function. Elderly patients may be more susceptible to adverse effects such such as dizziness, somnolence, and peripheral edema. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Titrate pregabalin dose slowly to minimize CNS side effects like dizziness and somnolence.
  • Discontinuation should be gradual (over at least 1 week) to avoid withdrawal symptoms such as insomnia, nausea, headache, anxiety, and diarrhea.
  • Patients should be monitored for signs of angioedema (swelling of face, lips, tongue, throat) and hypersensitivity reactions, which require immediate discontinuation.
  • Pregabalin can cause weight gain and peripheral edema; monitor patients for these effects, especially those with pre-existing cardiovascular conditions.
  • There is a potential for abuse and misuse, particularly in patients with a history of substance abuse. Prescribe with caution in this population.
  • Patients should be advised to avoid alcohol and other CNS depressants due to additive effects.
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Alternative Therapies

  • For Neuropathic Pain: Gabapentin, Duloxetine, Venlafaxine, Amitriptyline, Nortriptyline, Carbamazepine (for trigeminal neuralgia).
  • For Fibromyalgia: Duloxetine, Milnacipran, Amitriptyline, Cyclobenzaprine.
  • For Partial Onset Seizures: Levetiracetam, Lamotrigine, Topiramate, Carbamazepine, Oxcarbazepine, Valproic Acid.
  • For Generalized Anxiety Disorder: SSRIs (e.g., Escitalopram, Sertraline), SNRIs (e.g., Venlafaxine, Duloxetine), Buspirone, Benzodiazepines (short-term).
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Cost & Coverage

Average Cost: Highly variable (e.g., $50-$500+) per 30 capsules (200mg)
Generic Available: Yes
Insurance Coverage: Generic pregabalin is typically covered as Tier 1 or Tier 2. Brand-name Lyrica may be Tier 3 or Tier 4, requiring prior authorization.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you to discuss them 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 reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.