Lyrica 25mg 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 (like from diabetes or shingles), fibromyalgia, and certain types of seizures. It works by calming overactive nerves in the body and brain.
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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 the reach of children and pets, and inaccessible to others. Consider using a locked box or area to store your medication. Keep all medications away from pets.

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 machinery until you know how pregabalin affects you, as it can cause dizziness and drowsiness.
  • Avoid alcohol and other medications that cause drowsiness, as this can worsen side effects.
  • Do not stop taking pregabalin suddenly, as this can lead to withdrawal symptoms (e.g., seizures, insomnia, nausea, headache, anxiety). Your doctor will help you slowly reduce the dose if needed.
  • Report any unusual changes in mood, behavior, or thoughts of self-harm to your doctor immediately.
  • Report any swelling of the face, lips, tongue, or throat, or difficulty breathing, as these could be signs of a serious allergic reaction.

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 effect.
Dose Range: 150 - 600 mg

Condition-Specific Dosing:

Neuropathic Pain (Diabetic Peripheral Neuropathy): Initial 50 mg TID (150 mg/day), may increase to 100 mg TID (300 mg/day) within 1 week. Max 300 mg TID (600 mg/day).
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).
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 Therapy): 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 for all indications. For partial onset seizures (adjunctive): â‰Ĩ1 month, weight-based dosing (e.g., 3.5 mg/kg/day divided TID for 4 to <30 kg).
Child: For partial onset seizures (adjunctive): â‰Ĩ1 month, weight-based dosing (e.g., 3.5 mg/kg/day divided TID for 4 to <30 kg; 2.5 mg/kg/day divided TID for â‰Ĩ30 kg). Max 10 mg/kg/day or 600 mg/day.
Adolescent: For partial onset seizures (adjunctive): Dosing similar to adults (150-600 mg/day divided BID/TID).
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Dose Adjustments

Renal Impairment:

Mild: CrCl 60-90 mL/min: Max 400 mg/day (divided BID/TID)
Moderate: CrCl 30-60 mL/min: Max 300 mg/day (divided BID/TID)
Severe: CrCl 15-30 mL/min: Max 150 mg/day (divided QD/BID)
Dialysis: CrCl <15 mL/min: Max 75 mg/day (single dose or divided BID). Supplemental dose (25-50 mg) after 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. While the precise mechanism of action is unknown, binding to the ι2-δ subunit is thought to modulate the release of several excitatory neurotransmitters, including glutamate, norepinephrine, and substance P, which are involved in pain and seizure activity.
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Pharmacokinetics

Absorption:

Bioavailability: >90%
Tmax: Approximately 1.5 hours (fasted)
FoodEffect: Food delays Tmax by approximately 2.5 hours and decreases Cmax by 25-30%, but does not significantly affect the extent of absorption (AUC).

Distribution:

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

Elimination:

HalfLife: Approximately 6.3 hours
Clearance: Renal clearance is directly proportional to creatinine clearance.
ExcretionRoute: Renal (primarily as unchanged drug)
Unchanged: >98%
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Pharmacodynamics

OnsetOfAction: Varies by indication; pain relief may be seen within 1 week, full effect may take several weeks. Seizure control within days.
PeakEffect: Not precisely defined for all indications, generally correlates with steady-state plasma concentrations (achieved within 24-48 hours with multiple dosing).
DurationOfAction: Approximately 12 hours (requires BID or TID dosing)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 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 extremely happy or euphoric (easy laughing and feeling good)
Twitching

If you experience any of the following, seek medical help immediately:

Feeling extremely sleepy, dizzy, or passing out
Not responding, not answering, or not reacting normally
Not waking up

Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, especially in people with a history of suicidal thoughts or actions. Contact your doctor right away if you notice any new or worsening symptoms, such as:

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

Low platelet counts have been reported with this medication, which may increase the risk of bleeding. Contact your doctor right away if you experience any unexplained bruising or bleeding.

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

This is not an exhaustive list of possible 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
  • Swelling of hands, feet, or ankles (peripheral edema)
  • Significant weight gain
  • Muscle pain, tenderness, or weakness (especially with fever or unusual tiredness)
  • New or worsening depression, anxiety, or agitation
  • Thoughts of harming yourself
  • Any signs of allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
  • Unexplained bruising or bleeding
  • Signs of respiratory depression (slow, shallow breathing)
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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 you experienced, including any symptoms that occurred.
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, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes:

All prescription medications you are currently taking
Over-the-counter medications, such as pain relievers or antihistamines
Natural products, including herbal supplements or vitamins
* Any health problems you have, as they may interact with this medication

Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure it is safe to do so. This will help prevent potential interactions or adverse effects.
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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 guide you on how to gradually stop taking it.

Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter drugs that may impair your reactions, discuss the potential risks with your doctor.

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, difficulty breathing, swallowing problems, 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 certain other drugs, such as opioid pain medications, or those with pre-existing lung or breathing problems. 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 or older, use this medication with caution, as you may be more susceptible to side effects. Men who plan to father a child should consult their doctor, as this medication has been shown to reduce fertility and cause sperm changes in animal studies, and has also been associated with birth defects in the offspring of male animals treated with this drug. However, it is not known whether these effects occur in humans.

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

Overdose Symptoms:

  • Somnolence
  • Confusion
  • Agitation
  • Restlessness
  • Seizures (rare)
  • Coma
  • Respiratory depression

What to Do:

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

Drug Interactions

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Major Interactions

  • Opioids (e.g., oxycodone, hydrocodone, morphine): Increased risk of respiratory depression, sedation, coma, and death.
  • Benzodiazepines (e.g., lorazepam, alprazolam, diazepam): Increased risk of CNS depression (sedation, dizziness, respiratory depression).
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Moderate Interactions

  • Alcohol: Additive CNS depressant effects.
  • Other CNS depressants (e.g., barbiturates, hypnotics, anxiolytics, tricyclic antidepressants): Additive CNS depressant effects.
  • Thiazolidinediones (e.g., rosiglitazone, pioglitazone): May exacerbate weight gain and peripheral edema.

Monitoring

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Baseline Monitoring

Renal function (CrCl)

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

Timing: Prior to initiation

Mental health history (depression, suicidal ideation)

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

Timing: Prior to initiation

History of angioedema or hypersensitivity reactions

Rationale: Pregabalin can cause angioedema and hypersensitivity reactions.

Timing: Prior to initiation

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Routine Monitoring

Clinical assessment for suicidal ideation/behavior

Frequency: Regularly, especially during initial therapy and dose changes

Target: Absence of new or worsening suicidal thoughts/behavior

Action Threshold: Any new or worsening suicidal thoughts/behavior, depression, or unusual changes in mood/behavior warrant immediate evaluation.

Signs/symptoms of angioedema (swelling of face, mouth, neck)

Frequency: Regularly, especially during initial therapy

Target: Absence of swelling

Action Threshold: Any signs of angioedema require immediate discontinuation and medical attention.

CNS adverse effects (dizziness, somnolence, ataxia)

Frequency: Regularly, especially during initial therapy and dose changes

Target: Tolerable level of side effects

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

Weight

Frequency: Periodically

Target: Stable weight or acceptable gain

Action Threshold: Significant or rapid weight gain may warrant intervention or dose adjustment.

Peripheral edema

Frequency: Periodically

Target: Absence or mild, stable edema

Action Threshold: Significant or worsening edema may require evaluation for underlying conditions or dose adjustment.

Respiratory status (especially with concomitant CNS depressants)

Frequency: Monitor closely

Target: Normal respiratory rate and effort

Action Threshold: Signs of respiratory depression (slow, shallow breathing) require immediate medical attention.

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Symptom Monitoring

  • Dizziness
  • Somnolence
  • Ataxia
  • Peripheral edema
  • Weight gain
  • Blurred vision
  • Dry mouth
  • Difficulty concentrating
  • Suicidal thoughts or behavior
  • Changes in mood or behavior
  • Signs of angioedema (swelling of face, lips, tongue, throat)
  • Signs of hypersensitivity (rash, hives)
  • Muscle pain, tenderness, or weakness (rare, but consider rhabdomyolysis)

Special Patient Groups

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Pregnancy

Pregabalin is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown developmental toxicity. A pregnancy registry is available.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of major congenital malformations, particularly neural tube defects, based on some observational studies, though data are conflicting and require further research.
Second Trimester: Limited data, but generally considered lower risk than first trimester for structural malformations.
Third Trimester: Potential for neonatal withdrawal symptoms if discontinued abruptly. Risk of respiratory depression in neonate if mother used pregabalin near delivery, especially with opioids.
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Lactation

Pregabalin is excreted into breast milk. The amount is relatively low, and infant exposure is generally low. Monitor breastfed infants for sedation, poor feeding, and weight gain. Use with caution, or consider alternatives, especially in neonates or preterm infants.

Infant Risk: Low to moderate risk (L3). Monitor for sedation, poor feeding, and developmental milestones.
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Pediatric Use

Approved for adjunctive treatment of partial onset seizures in patients â‰Ĩ1 month of age. Dosing is weight-based. Safety and efficacy for other indications (e.g., neuropathic pain, fibromyalgia) have not been established in pediatric patients.

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Geriatric Use

Dose adjustment is required for elderly patients with impaired renal function. Elderly patients may be more susceptible to dizziness, somnolence, and peripheral edema. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Titration is crucial: Start low and increase dose gradually to minimize CNS side effects (dizziness, somnolence).
  • Do not discontinue abruptly: Taper dose over at least 1 week to avoid withdrawal symptoms (insomnia, nausea, headache, anxiety, hyperhidrosis, seizures).
  • Abuse potential: Pregabalin is a Schedule V controlled substance due to potential for abuse and physical dependence. Prescribe with caution in patients with a history of substance abuse.
  • Weight gain and edema: Common side effects; monitor patients, especially those with pre-existing cardiovascular conditions.
  • Respiratory depression: Increased risk when co-administered with opioids or other CNS depressants; monitor closely.
  • Off-label uses: Sometimes used for restless legs syndrome, chronic cough, or alcohol withdrawal, though not FDA-approved for these indications.
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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, Carbamazepine, Oxcarbazepine, Valproic Acid, Phenytoin, Topiramate, Lacosamide, Gabapentin.
  • 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: Varies widely, typically $10-$50 per 30 capsules (generic 25mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic); Tier 3 or higher (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 the poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.