Lyrica 75mg 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, Neuropathic Pain Agent, Fibromyalgia Agent
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Pharmacologic Class
Gamma-aminobutyric acid (GABA) analogue
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Pregnancy Category
Not available
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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 pain from shingles or diabetes, and pain from fibromyalgia. It's also used to treat partial seizures and generalized anxiety disorder. It works by calming overactive nerves in the 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 with or without food, as directed. It's essential to continue taking this medication as prescribed by your doctor or healthcare provider, even if you're feeling well.

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 safe and secure location, out of sight and reach of children and pets, and inaccessible to others. Consider using a locked box or area to store your medication.

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 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 to make up for a missed one.
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Lifestyle & Tips

  • Avoid driving or operating heavy machinery until you know how pregabalin affects you, as it can cause dizziness and drowsiness.
  • Avoid alcohol and other CNS depressants, as they can increase side effects like drowsiness and dizziness.
  • Do not stop taking pregabalin suddenly, as this can cause withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety, diarrhea, flu-like symptoms, seizures). Your doctor will tell you how to slowly reduce your dose.
  • Report any unusual mood changes, thoughts of self-harm, or worsening depression to your doctor immediately.
  • Monitor for swelling in your hands, feet, or ankles, and report it to your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication, typically initiated at 75 mg BID or 50 mg TID, titrated up to 300-600 mg/day in divided doses.
Dose Range: 150 - 600 mg

Condition-Specific Dosing:

Postherpetic Neuralgia: Initial 75 mg BID (150 mg/day), may increase to 150 mg BID (300 mg/day) within 1 week. Max 300 mg BID (600 mg/day).
Diabetic Peripheral Neuropathy: Initial 50 mg TID (150 mg/day), may increase to 100 mg TID (300 mg/day) within 1 week. Max 200 mg TID (600 mg/day).
Fibromyalgia: Initial 75 mg BID (150 mg/day), may increase to 150 mg BID (300 mg/day) within 1 week. Max 225 mg BID (450 mg/day).
Partial Onset Seizures (adjunctive): Initial 75 mg BID (150 mg/day), may increase to 150 mg BID (300 mg/day) within 1 week. Max 300 mg BID (600 mg/day).
Generalized Anxiety Disorder (GAD): Initial 150 mg/day, 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
Child: Not established for most indications. For partial onset seizures (adjunctive, 4 years and older): Dosing is weight-based, typically 3.5-10 mg/kg/day in 3 divided doses, max 14 mg/kg/day.
Adolescent: Similar to adult dosing for partial onset seizures, but generally not established for other indications.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 60 mL/min or greater: No adjustment needed. CrCl 30-60 mL/min: Max 300 mg/day in 2-3 divided doses.
Moderate: CrCl 15-30 mL/min: Max 150 mg/day in 1-2 divided doses.
Severe: CrCl less than 15 mL/min: Max 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, thereby reducing neuronal excitability and pain signaling.
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Pharmacokinetics

Absorption:

Bioavailability: >90%
Tmax: 1 hour (fasted)
FoodEffect: Food delays Tmax by approximately 2.5 hours and decreases Cmax by 25-30%, but does not affect the extent of absorption (AUC).

Distribution:

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

Elimination:

HalfLife: 6.3 hours
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal (unchanged drug)
Unchanged: >98%
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Pharmacodynamics

OnsetOfAction: Varies by indication; generally within days to weeks for full therapeutic effect.
PeakEffect: Not precisely defined, as it's a chronic treatment. Clinical effect builds over time.
DurationOfAction: Approximately 12 hours (consistent with BID dosing)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

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 high (excessive laughter and euphoria)
Twitching

If you feel extremely sleepy, dizzy, or pass out, seek medical help immediately. Caregivers or others should seek medical help right away if the patient is unresponsive, uncommunicative, or unable to wake up.

Suicidal Thoughts or Actions

Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. If you experience any new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor right away. If you have suicidal thoughts or actions, seek medical help immediately.

Low Platelet Counts

This medication may rarely cause low platelet counts, increasing the risk of bleeding. If you experience 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 and they bother you or do not go away, contact your doctor:

Feeling dizzy, sleepy, tired, or weak
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 drowsiness
  • Blurred or double vision
  • Significant weight gain or swelling (edema)
  • Muscle pain or weakness (especially if accompanied by fever or dark urine)
  • New or worsening depression, anxiety, or panic attacks
  • Thoughts of self-harm or suicide
  • Unusual changes in behavior or mood
  • Signs of an allergic reaction (e.g., rash, hives, swelling of face, lips, tongue, throat, difficulty breathing)
  • Chest pain or shortness of breath
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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 your safety, 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 medications 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 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 taper off the dose.

Avoid consuming alcohol while taking this medication.

Before using marijuana, cannabis products, or prescription and over-the-counter medications that may cause drowsiness, 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.

Severe respiratory problems, which can be fatal, have occurred in individuals taking this medication, particularly when combined with opioid pain medications or in those with pre-existing lung or breathing issues. The risk may be higher in people over 65 years old. If you have concerns, consult 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 the potential risks with their doctor, as this medication has been shown to decrease fertility and cause sperm changes in male animals, and birth defects have occurred in the offspring of male animals treated with this medication. Although it is unknown whether these effects occur in humans, it is crucial to have this conversation.

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
  • Confusion
  • Agitation
  • Restlessness
  • Seizures
  • Coma

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, other sedatives): Increased risk of additive CNS depression (dizziness, somnolence, respiratory depression, coma, death).
  • Thiazolidinediones (e.g., pioglitazone, rosiglitazone): Increased risk of peripheral edema and weight gain.
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Moderate Interactions

  • ACE inhibitors (e.g., captopril, enalapril): May increase risk of angioedema.
  • Other drugs causing dizziness/somnolence: Additive effects.

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 of therapy

History of suicidal thoughts or behavior, depression, or other psychiatric disorders

Rationale: Antiepileptic drugs (AEDs), including pregabalin, may increase the risk of suicidal thoughts or behavior.

Timing: Prior to initiation of therapy

History of substance abuse

Rationale: Pregabalin has potential for abuse and dependence.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in pain, seizure frequency, anxiety symptoms)

Frequency: Regularly during 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, dry mouth)

Frequency: Regularly, especially during dose titration

Target: Tolerable level

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

Mood changes, emergence or worsening of depression, suicidal thoughts or behavior

Frequency: Regularly, especially during initial therapy and dose changes

Target: Absence of these symptoms

Action Threshold: Any new or worsening psychiatric symptoms require immediate evaluation.

Signs of angioedema (swelling of face, mouth, throat)

Frequency: Regularly, especially with concomitant ACE inhibitors

Target: Absence of swelling

Action Threshold: Immediate medical attention required if angioedema occurs.

Signs of hypersensitivity reactions (e.g., rash, hives)

Frequency: Regularly

Target: Absence of reactions

Action Threshold: Discontinue pregabalin immediately if severe hypersensitivity occurs.

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Symptom Monitoring

  • Dizziness
  • Somnolence
  • Blurred vision
  • Weight gain
  • Peripheral edema (swelling of hands/feet)
  • Dry mouth
  • Difficulty concentrating
  • Mood changes
  • Thoughts of self-harm or suicide
  • Unexplained muscle pain or weakness
  • Signs of angioedema (swelling of face, lips, tongue, throat)

Special Patient Groups

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Pregnancy

Pregabalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are reports of major birth defects and miscarriage in human observational studies, but a causal relationship has not been definitively established. A pregnancy exposure registry is available.

Trimester-Specific Risks:

First Trimester: Potential increased risk of major congenital malformations, particularly neural tube defects, cardiac defects, and oral clefts, based on some observational studies. Data are conflicting and limited.
Second Trimester: Limited data, but continued exposure may carry risks similar to first trimester.
Third Trimester: Limited data. Potential for neonatal withdrawal symptoms if discontinued abruptly near term.
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Lactation

Pregabalin is excreted into breast milk. The amount transferred to the infant is low, and adverse effects in breastfed infants are generally not expected. Monitor infants for sedation or poor feeding.

Infant Risk: Low
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Pediatric Use

Safety and efficacy have not been established for all indications in pediatric patients. For partial onset seizures, dosing is weight-based for children 4 years and older. Use with caution and close monitoring for adverse effects.

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Geriatric Use

Elderly patients may be more susceptible to adverse effects such as dizziness, somnolence, and falls. Dose adjustments are required based on renal function, which often declines with age. 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 when discontinuing to avoid withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety, diarrhea, flu-like symptoms, seizures).
  • Patients should be advised of the potential for dizziness and somnolence, and to avoid activities requiring mental alertness until they know how the drug affects them.
  • There is a potential for misuse and dependence, particularly in patients with a history of substance abuse. Prescribe with caution in this population.
  • Angioedema (swelling of the face, mouth, neck) has been reported, sometimes after the first dose. Patients should be advised to seek immediate medical attention if this occurs.
  • Peripheral edema and weight gain are common side effects, especially when co-administered with thiazolidinediones.
  • Creatine kinase elevations and rhabdomyolysis have been reported rarely; advise patients to report unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever.
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Alternative Therapies

  • Other anticonvulsants (e.g., gabapentin, carbamazepine, oxcarbazepine, lamotrigine) for neuropathic pain or seizures.
  • Tricyclic antidepressants (e.g., amitriptyline, nortriptyline) for neuropathic pain or fibromyalgia.
  • SNRIs (e.g., duloxetine, venlafaxine) for neuropathic pain, fibromyalgia, or GAD.
  • Topical analgesics (e.g., lidocaine patches, capsaicin cream) for localized neuropathic pain.
  • NSAIDs or acetaminophen for general pain management (less effective for neuropathic pain).
  • Physical therapy, occupational therapy, psychological counseling (e.g., CBT) for chronic pain conditions.
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Cost & Coverage

Average Cost: Varies widely per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 for generic, Tier 3 or higher 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 promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information 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, 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 reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.