Lyrica CR 82.5mg Tablets
It is used to treat painful nerve diseases.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
Aug 2017
DEA Schedule
Schedule V
Overview
What is this medicine?
Lyrica CR is an extended-release medication used to treat certain types of nerve pain, such as pain from diabetes or shingles, and a condition called fibromyalgia. It works by affecting certain chemicals in your brain that send pain signals.
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 dose after the evening meal if you are taking it once daily. Swallow the tablet whole - do not chew, break, or crush it. Continue taking this medication as directed by your doctor or healthcare provider, even if you start 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 the medication out of reach of children and pets, and store it in a secure location where others cannot access it. Consider using a locked box or area to keep your medication safe.
Missing a Dose
If you miss a dose, take it just before bedtime after eating a snack, or after the next day's morning meal. If you miss taking the missed dose after the next day's morning meal, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose after the evening meal if you are taking it once daily. Swallow the tablet whole - do not chew, break, or crush it. Continue taking this medication as directed by your doctor or healthcare provider, even if you start 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 the medication out of reach of children and pets, and store it in a secure location where others cannot access it. Consider using a locked box or area to keep your medication safe.
Missing a Dose
If you miss a dose, take it just before bedtime after eating a snack, or after the next day's morning meal. If you miss taking the missed dose after the next day's morning meal, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take Lyrica CR once daily with food, preferably with the evening meal, to reduce stomach upset and improve absorption.
- Swallow the tablet whole; do not crush, chew, or split it.
- Avoid alcohol and other medications that cause drowsiness, as Lyrica CR can increase these effects.
- Do not stop taking Lyrica CR suddenly, as this can cause withdrawal symptoms. Your doctor will help you slowly reduce the dose if needed.
- Be aware that this medication may cause dizziness, sleepiness, or blurred vision, especially when you first start taking it or when the dose is changed. Avoid driving or operating machinery until you know how it affects you.
- Monitor for weight gain and swelling in your hands or feet (edema). Report these to your doctor.
- 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:
Initial dose for neuropathic pain associated with diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN) is 165 mg once daily. Initial dose for fibromyalgia is 82.5 mg once daily.
Dose Range:
82.5 - 330 mg
Condition-Specific Dosing:
Diabetic Peripheral Neuropathy (DPN):
Initial: 165 mg once daily. May increase to 330 mg once daily based on response and tolerability after 1 week.
Postherpetic Neuralgia (PHN):
Initial: 165 mg once daily. May increase to 330 mg once daily based on response and tolerability after 1 week.
Fibromyalgia:
Initial: 82.5 mg once daily. May increase to 165 mg once daily after 1 week based on response and tolerability. Maximum 330 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
CrCl 60-90 mL/min: No dose adjustment needed for Lyrica CR.
Moderate:
CrCl 30-60 mL/min: Reduce dose by 50%. Max dose 165 mg once daily.
Severe:
CrCl <30 mL/min: Not recommended for Lyrica CR due to lack of studies and difficulty in dose adjustment with extended-release formulation. Immediate-release pregabalin is recommended with significant dose reduction.
Dialysis:
Not recommended for Lyrica CR. Immediate-release pregabalin requires supplemental dose after dialysis.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose 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, thereby reducing neuronal excitability and pain signaling.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
Approximately 3 hours (fasting) to 4 hours (with food) for Lyrica CR.
FoodEffect:
Food delays Tmax by approximately 3 hours and reduces Cmax by approximately 25-30% for Lyrica CR, but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 0.56 L/kg
ProteinBinding:
<1%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 6.3 hours (for immediate release; Lyrica CR provides sustained release)
Clearance:
Primarily renal clearance
ExcretionRoute:
Renal (urine)
Unchanged:
>90%
Pharmacodynamics
OnsetOfAction:
Within 1 week for pain relief (based on clinical trials for immediate release, CR formulation provides sustained levels)
PeakEffect:
Steady-state concentrations are achieved within 1-2 days of once-daily dosing for Lyrica CR.
DurationOfAction:
24 hours (due to extended-release formulation)
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
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 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 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 right away. If you experience 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 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 or seek medical attention if they bother you or persist:
Dizziness, drowsiness, tiredness, or weakness
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 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
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 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 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 right away. If you experience 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 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 or seek medical attention if they bother you or persist:
Dizziness, drowsiness, tiredness, or weakness
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 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
- Significant swelling of hands, feet, or ankles
- Unexplained weight gain
- Blurred vision or other vision changes
- Muscle pain, tenderness, or weakness (rare, but can indicate rhabdomyolysis)
- Signs of allergic reaction: rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing
- 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, such as foods or drugs. 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, 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.
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 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, 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.
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 dosage.
While taking this medication, it is recommended that you avoid consuming alcohol.
Before using marijuana, other forms of cannabis, or prescription or 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. If you experience any of these symptoms, seek immediate medical attention.
Severe respiratory problems have occurred in individuals taking this medication, particularly when combined with other medications like opioid pain relievers, or in those with pre-existing lung or breathing issues. The risk may be higher in individuals 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 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 reduce fertility and cause sperm changes in male animals, and has also been associated with birth defects in the offspring of treated male animals. Although it is unclear if these effects occur in humans, it is crucial to weigh the benefits and risks.
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 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 dosage.
While taking this medication, it is recommended that you avoid consuming alcohol.
Before using marijuana, other forms of cannabis, or prescription or 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. If you experience any of these symptoms, seek immediate medical attention.
Severe respiratory problems have occurred in individuals taking this medication, particularly when combined with other medications like opioid pain relievers, or in those with pre-existing lung or breathing issues. The risk may be higher in individuals 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 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 reduce fertility and cause sperm changes in male animals, and has also been associated with birth defects in the offspring of treated male animals. Although it is unclear if these effects occur in humans, it is crucial to weigh the benefits and risks.
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 (rare)
- Coma (rare)
What to Do:
Seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US). There is no specific antidote. Treatment is supportive and may include gastric lavage or emesis if recent ingestion, and monitoring of vital signs.
Drug Interactions
Major Interactions
Moderate Interactions
- Angiotensin-converting enzyme (ACE) inhibitors: 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 necessary in renal impairment.
Timing: Prior to initiation of therapy.
Baseline weight
Rationale: Pregabalin can cause weight gain.
Timing: Prior to initiation of therapy.
History of angioedema or hypersensitivity reactions
Rationale: Risk of angioedema and hypersensitivity reactions.
Timing: Prior to initiation of therapy.
History of substance abuse
Rationale: Pregabalin is a Schedule V controlled substance with potential for abuse.
Timing: Prior to initiation of therapy.
Routine Monitoring
Renal function (CrCl)
Frequency: Periodically, especially in elderly or those with changing renal status.
Target: Maintain appropriate CrCl for dosing.
Action Threshold: Adjust dose if CrCl declines.
Weight
Frequency: Periodically
Target: Maintain stable weight or manage weight gain.
Action Threshold: Counsel on diet/exercise if significant weight gain occurs.
Signs/symptoms of peripheral edema
Frequency: Regularly
Target: Absence of significant edema.
Action Threshold: Evaluate for underlying cardiac issues or consider dose reduction/discontinuation if severe.
Mental status (mood, behavior, suicidal ideation)
Frequency: Regularly, especially during initial therapy or dose changes.
Target: Stable mood and behavior.
Action Threshold: Promptly assess and intervene if new or worsening suicidal thoughts/behaviors, depression, or unusual changes in mood/behavior occur.
Symptom Monitoring
- Dizziness
- Somnolence
- Peripheral edema
- Weight gain
- Blurred vision
- Difficulty concentrating
- Dry mouth
- Suicidal thoughts or behavior
- Unusual changes in mood or behavior
- Signs of angioedema (swelling of face, lips, tongue, throat)
- Signs of hypersensitivity (rash, hives, difficulty breathing)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown developmental toxicity (skeletal abnormalities, growth retardation) at clinically relevant exposures. There is a pregnancy registry for women exposed to pregabalin during pregnancy.
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 limited.
Second Trimester:
Limited data, but generally considered lower risk than first trimester for major malformations.
Third Trimester:
Potential for neonatal withdrawal symptoms if discontinued abruptly near term. Risk of respiratory depression in neonates if used close to delivery.
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 Lyrica CR, and any potential adverse effects on the breastfed infant from Lyrica CR or from the underlying maternal condition. Monitor infants for sedation and poor feeding.
Infant Risk:
L3 (Moderately safe) - Monitor for sedation, poor feeding, and weight gain.
Pediatric Use
Safety and effectiveness of Lyrica CR in pediatric patients have not been established. Immediate-release pregabalin is approved for partial-onset seizures in pediatric patients 1 month and older, but not for neuropathic pain or fibromyalgia in this population.
Geriatric Use
Elderly patients (β₯65 years) may have reduced renal function, requiring dose adjustment based on creatinine clearance. They may also be more susceptible to dizziness, somnolence, and peripheral edema. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Lyrica CR is an extended-release formulation designed for once-daily dosing, typically taken with the evening meal.
- It is crucial to adjust the dose in patients with renal impairment; Lyrica CR is not recommended for severe renal impairment (CrCl <30 mL/min) or dialysis patients due to the difficulty in dose adjustment with the extended-release formulation.
- Patients should be counseled on the risk of dizziness, somnolence, and peripheral edema, especially during initiation and dose titration.
- Abrupt discontinuation can lead to withdrawal symptoms (insomnia, nausea, headache, anxiety, diarrhea), so taper slowly over at least 1 week.
- Monitor for signs of suicidal ideation and behavior, particularly in patients with a history of depression or psychiatric disorders.
- Be aware of the potential for abuse and dependence, especially in patients with a history of substance abuse. Pregabalin is a Schedule V controlled substance.
- Lyrica CR is specifically indicated for DPN, PHN, and fibromyalgia. It is not interchangeable with immediate-release Lyrica on a mg-per-mg basis.
Alternative Therapies
- Gabapentin (immediate-release or extended-release formulations like Gralise, Horizant)
- Duloxetine (Cymbalta)
- Venlafaxine (Effexor XR)
- Tricyclic antidepressants (e.g., amitriptyline, nortriptyline)
- Topical analgesics (e.g., lidocaine patches, capsaicin cream)
- Opioid analgesics (generally not first-line for chronic neuropathic pain)
- Non-pharmacological therapies (e.g., physical therapy, exercise, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
$300 - $600 per 30 tablets (Lyrica CR 82.5mg)
Insurance Coverage:
Tier 2 or Tier 3 (Brand-name drug, may require prior authorization)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.