Lyrica 50mg Capsules
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.
Drug Class
Anticonvulsant, Analgesic
Pharmacologic Class
Gamma-aminobutyric acid (GABA) analogue
Pregnancy Category
Category C
FDA Approved
Dec 2004
DEA Schedule
Schedule V
Overview
What is this medicine?
Pregabalin is a medication used to treat certain types of nerve pain (like from diabetes, shingles, or spinal cord injury), fibromyalgia, and partial seizures. It works by calming overactive nerve signals in the brain and body.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food. It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it in its original container at room temperature. Keep it in a dry place, away from the bathroom. Store 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 keep your medication safe. Remember to keep all medications out of reach of 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 to make up for the missed one.
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food. It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it in its original container at room temperature. Keep it in a dry place, away from the bathroom. Store 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 keep your medication safe. Remember to keep all medications out of reach of 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 to make up for the missed one.
Lifestyle & Tips
- Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- Avoid alcohol and other medications that cause drowsiness (e.g., opioids, benzodiazepines) as they can worsen side effects.
- Do not stop taking pregabalin suddenly, as this can lead to withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety, diarrhea). Your doctor will guide you on how to slowly reduce the dose.
- Report any unusual swelling (especially of the face, lips, tongue, or throat) or difficulty breathing immediately.
- Monitor your weight regularly, as weight gain can occur.
- Report any changes in mood, behavior, or thoughts of self-harm to your doctor immediately.
Available Forms & Alternatives
Available Strengths:
- Lyrica 25mg Capsules
- Lyrica 75mg Capsules
- Lyrica 50mg Capsules
- Lyrica 100mg Capsules
- Lyrica 150mg Capsules
- Lyrica 200mg Capsules
- Lyrica 225mg** Capsules
- Lyrica 300mg Capsules
- Lyrica 20mg/ml Solution
- Lyrica 100mg Capsules
- Lyrica CR 165mg Tablets
- Lyrica CR 330mg Tablets
- Lyrica CR 82.5mg Tablets
- Lyrica CR 82.5mg Tablets
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For neuropathic pain (e.g., DPN, PHN), initial 50 mg three times daily (TID) or 75 mg twice daily (BID).
Dose Range:
150 - 600 mg
Condition-Specific Dosing:
Diabetic Peripheral Neuropathy (DPN):
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 (PHN):
Initial 75 mg BID or 50 mg TID (150 mg/day); may increase to 150 mg BID or 100 mg TID (300 mg/day) within 1 week. Max 300 mg BID or 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).
Adjunctive Therapy for Partial Onset Seizures:
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).
Neuropathic Pain associated with Spinal Cord Injury:
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).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for most indications. For partial onset seizures: β₯1 month to <4 years, 3.5 mg/kg/day divided TID; β₯4 years to <17 years, 10-15 mg/kg/day divided TID (max 600 mg/day).
Child:
Not established for most indications. For partial onset seizures: β₯1 month to <4 years, 3.5 mg/kg/day divided TID; β₯4 years to <17 years, 10-15 mg/kg/day divided TID (max 600 mg/day).
Adolescent:
Not established for most indications. For partial onset seizures: β₯1 month to <4 years, 3.5 mg/kg/day divided TID; β₯4 years to <17 years, 10-15 mg/kg/day divided TID (max 600 mg/day).
Dose Adjustments
Renal Impairment:
Mild:
CrCl 30-60 mL/min: Initial 75 mg/day (divided BID or TID); Max 300 mg/day.
Moderate:
CrCl 15-30 mL/min: Initial 25-50 mg/day (divided QD or BID); Max 150 mg/day.
Severe:
CrCl <15 mL/min: Initial 25 mg/day (single dose or divided); Max 75 mg/day.
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
Mechanism of Action
Pregabalin binds with high affinity to the alpha2-delta (Ξ±2-Ξ΄) subunit of voltage-gated calcium channels in the central nervous system. While the precise mechanism of action is unknown, binding to the Ξ±2-Ξ΄ subunit is thought to modulate the release of several excitatory neurotransmitters, including glutamate, norepinephrine, and substance P, which may contribute to its analgesic and anticonvulsant effects.
Pharmacokinetics
Absorption:
Bioavailability:
>90%
Tmax:
1.5 hours (fasted state)
FoodEffect:
Food decreases Cmax by approximately 25-30% and delays Tmax by approximately 2.5-3 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:
Approximately 67 mL/min (renal clearance)
ExcretionRoute:
Renal (primarily unchanged drug)
Unchanged:
>90%
Pharmacodynamics
OnsetOfAction:
Within 1 week for some indications (e.g., neuropathic pain), but full effect may take longer.
PeakEffect:
Varies by indication and individual response. Steady state concentrations are achieved within 24-48 hours with multiple dosing.
DurationOfAction:
Approximately 8-12 hours, consistent with its half-life and dosing frequency (BID or TID).
Safety & Warnings
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 unusual skin changes
Speech difficulties
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 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 behaviors, particularly in individuals with a history of suicidal ideation. 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 immediately. If you experience suicidal thoughts or actions, seek medical help right away.
Low Platelet Counts
This medication may rarely cause low platelet counts, increasing the risk of bleeding. If you notice any unexplained bruising or bleeding, contact your doctor immediately.
Other Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
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.
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 unusual skin changes
Speech difficulties
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 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 behaviors, particularly in individuals with a history of suicidal ideation. 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 immediately. If you experience suicidal thoughts or actions, seek medical help right away.
Low Platelet Counts
This medication may rarely cause low platelet counts, increasing the risk of bleeding. If you notice any unexplained bruising or bleeding, contact your doctor immediately.
Other Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
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.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or somnolence
- Blurred vision or other vision changes
- Significant weight gain or swelling (edema)
- Muscle pain or weakness (signs of rhabdomyolysis)
- Signs of allergic reaction: rash, hives, swelling of face, lips, tongue, or throat, difficulty breathing or swallowing
- New or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, severe restlessness, or thoughts about suicide or harming yourself.
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 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 will help ensure that it is safe to take this medication with your other medications and health conditions.
Remember, this is not an exhaustive list of potential interactions. Therefore, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
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 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 will help ensure that it is safe to take this medication with your other medications and health conditions.
Remember, this is not an exhaustive list of potential interactions. Therefore, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
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 the frequency or severity of seizures after starting this medication, consult your doctor promptly.
Do not abruptly discontinue this medication without first consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dosage.
While taking this medication, avoid consuming alcohol. Additionally, consult your doctor before using marijuana, cannabis products, or prescription and over-the-counter medications that may cause drowsiness or impair your reactions.
A rare but 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 in combination with certain other medications, such as opioid pain relievers. This risk is also higher in people with pre-existing lung or breathing problems and in those over 65 years old. 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 animal studies have shown that this medication can reduce fertility and cause sperm abnormalities, as well as increase the risk of birth defects in 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.
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 the frequency or severity of seizures after starting this medication, consult your doctor promptly.
Do not abruptly discontinue this medication without first consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dosage.
While taking this medication, avoid consuming alcohol. Additionally, consult your doctor before using marijuana, cannabis products, or prescription and over-the-counter medications that may cause drowsiness or impair your reactions.
A rare but 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 in combination with certain other medications, such as opioid pain relievers. This risk is also higher in people with pre-existing lung or breathing problems and in those over 65 years old. 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 animal studies have shown that this medication can reduce fertility and cause sperm abnormalities, as well as increase the risk of birth defects in 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.
Overdose Information
Overdose Symptoms:
- Somnolence
- Confusion
- Agitation
- Restlessness
- Seizures
- Coma
What to Do:
Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is generally supportive and may include gastric lavage or emesis if recent ingestion. Hemodialysis can remove pregabalin from the system.
Drug Interactions
Major Interactions
- Opioids (e.g., oxycodone, hydrocodone): Increased risk of respiratory depression, sedation, coma, and death.
- Benzodiazepines (e.g., lorazepam, alprazolam): Increased risk of CNS depression, sedation, and respiratory depression.
- Other CNS depressants (e.g., alcohol, barbiturates, muscle relaxants): Additive CNS depressant effects.
Moderate Interactions
- Thiazolidinediones (e.g., pioglitazone, rosiglitazone): May increase risk of weight gain and peripheral edema when co-administered with pregabalin.
- ACE inhibitors (e.g., enalapril, lisinopril): May increase risk of angioedema when co-administered with pregabalin.
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: Pregabalin is primarily renally excreted; dose adjustment is required in patients with impaired renal function.
Timing: Prior to initiation of therapy.
Weight
Rationale: Pregabalin can cause weight gain.
Timing: Prior to initiation of therapy.
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 of therapy.
Routine Monitoring
Clinical symptoms of CNS depression (dizziness, somnolence)
Frequency: Regularly, especially during dose titration and with co-administration of other CNS depressants.
Target: Minimize symptoms while achieving therapeutic effect.
Action Threshold: Significant or debilitating symptoms may require dose reduction or discontinuation.
Weight
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated).
Target: Maintain healthy weight.
Action Threshold: Significant or rapid weight gain may warrant intervention or dose adjustment.
Signs/symptoms of peripheral edema
Frequency: Regularly.
Target: Absence of edema.
Action Threshold: Development of significant edema may require evaluation and dose adjustment.
Mood and behavior changes (e.g., suicidal ideation, depression, agitation)
Frequency: Regularly, especially during the initial weeks of therapy or with dose changes.
Target: Stable mood and behavior.
Action Threshold: New or worsening symptoms require immediate medical attention.
Vision changes
Frequency: If patient reports symptoms.
Target: Normal vision.
Action Threshold: Blurred vision or other visual disturbances should be evaluated.
Symptom Monitoring
- Dizziness
- Somnolence
- Blurred vision
- Weight gain
- Peripheral edema
- Difficulty concentrating
- Dry mouth
- Suicidal thoughts or behavior
- Mood changes (e.g., depression, agitation)
- Hypersensitivity reactions (e.g., angioedema, rash)
- Respiratory depression (especially with concomitant CNS depressants)
- Muscle pain or weakness (rhabdomyolysis)
Special Patient Groups
Pregnancy
Pregabalin is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy registry is available.
Trimester-Specific Risks:
First Trimester:
Animal studies show developmental toxicity (skeletal abnormalities, growth retardation) at doses higher than human therapeutic doses. Human data are limited but suggest a possible increased risk of major congenital malformations, particularly neural tube defects, when exposed during the first trimester, though more data are needed.
Second Trimester:
Limited human data. Animal studies suggest continued risk of developmental effects.
Third Trimester:
Limited human data. Potential for neonatal withdrawal symptoms if discontinued abruptly near term.
Lactation
Pregabalin is excreted into human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the motherβs clinical need for pregabalin, and any potential adverse effects on the breastfed infant from pregabalin or from the underlying maternal condition. Monitor infants for sedation.
Infant Risk:
L3 (Moderately Safe). Low levels in breast milk. Monitor for sedation, poor feeding, or developmental delay.
Pediatric Use
Safety and efficacy have not been established for all indications in pediatric patients. Approved for partial onset seizures in children β₯1 month of age. Dosing is weight-based. Increased risk of suicidal thoughts/behavior in children and adolescents.
Geriatric Use
Dose adjustment is required for elderly patients with impaired renal function. Elderly patients may be more susceptible to adverse effects such as dizziness, somnolence, and falls. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Pregabalin should be tapered gradually over at least 1 week when discontinuing to minimize the risk of withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety, diarrhea, seizures).
- Patients should be advised about the potential for weight gain and peripheral edema, especially when co-administered with thiazolidinediones.
- Due to its potential for abuse and dependence, particularly in patients with a history of substance abuse, careful assessment and monitoring are warranted.
- Patients should be monitored for signs of angioedema, especially if they have a history of angioedema or are taking ACE inhibitors.
- Respiratory depression can occur, especially when co-administered with CNS depressants like opioids. Patients should be educated on this risk.
Alternative Therapies
- For Neuropathic Pain: Gabapentin, Duloxetine (SNRI), Venlafaxine (SNRI), Amitriptyline (TCA), Nortriptyline (TCA), Carbamazepine (for trigeminal neuralgia).
- For Fibromyalgia: Duloxetine (SNRI), Milnacipran (SNRI), Amitriptyline (TCA).
- For Partial Onset Seizures: Levetiracetam, Lamotrigine, Carbamazepine, Oxcarbazepine, Valproic Acid, Topiramate, Phenytoin, Gabapentin.
Cost & Coverage
Average Cost:
Varies widely by pharmacy and formulation (brand vs. generic). For Lyrica 50mg capsules, typically $300-$600+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or Tier 3 for brand, Tier 1 for generic. Coverage varies by insurance plan and formulary.
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 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 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.