Lyrica CR 330mg Tablets

Manufacturer VIATRIS SPECIALTY Active Ingredient Pregabalin Extended-Release Tablets(pre GAB a lin) Pronunciation pre-GAB-a-lin
It is used to treat painful nerve diseases.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Anticonvulsant, Analgesic (Neuropathic Pain)
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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
Jun 2014
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DEA Schedule
Schedule V

Overview

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What is this medicine?

Lyrica CR is an extended-release medicine used to treat certain types of nerve pain, such as pain from diabetes (diabetic peripheral neuropathy) or shingles (postherpetic neuralgia). It works by calming overactive nerves in the body that cause pain signals.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. If you're taking this medication once daily, take it after your evening meal. Swallow the tablet whole - do not chew, break, or crush it. Continue taking your medication as directed by your doctor or healthcare provider, even if you're 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 in a dry place. Avoid storing it in a bathroom. Keep your medication out of reach of children and pets, and consider storing it in a locked box or secure area to prevent accidental ingestion or misuse.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as possible before bedtime after eating a snack, or wait until the next morning and take it with your morning meal. If you miss taking the missed dose by the next morning, 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 dose.
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Lifestyle & Tips

  • Take Lyrica CR once daily with or without food. Swallow the tablet whole; do not crush, chew, or split it.
  • Do not stop taking Lyrica CR suddenly, as this can cause withdrawal symptoms. Your doctor will tell you how to slowly reduce your dose.
  • Avoid alcohol and other medicines that can make you drowsy (like opioids or benzodiazepines) while taking Lyrica CR, as this can increase dizziness and sleepiness.
  • Do not drive or operate heavy machinery until you know how Lyrica CR affects you, as it can cause dizziness and drowsiness.
  • Report any new or worsening mood changes, depression, or suicidal thoughts to your doctor immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: 330 mg orally once daily
Dose Range: 165 - 330 mg

Condition-Specific Dosing:

Diabetic Peripheral Neuropathy (DPN): Initial dose 165 mg once daily, may increase to 330 mg once daily after 1 week based on tolerability and response. Max 330 mg/day.
Postherpetic Neuralgia (PHN): Initial dose 165 mg once daily, may increase to 330 mg once daily after 1 week based on tolerability and response. Max 330 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for CrCl â‰Ĩ60 mL/min.
Moderate: Not recommended for Lyrica CR due to lack of studies and difficulty with dose adjustment. Immediate-release pregabalin should be used with dose reduction (e.g., 75 mg once daily for CrCl 30-60 mL/min).
Severe: Contraindicated for Lyrica CR. Immediate-release pregabalin should be used with significant dose reduction (e.g., 25-50 mg once daily or every other day for CrCl <30 mL/min).
Dialysis: Not recommended for Lyrica CR. Immediate-release pregabalin requires supplemental dosing after dialysis.

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 modulates the release of several excitatory neurotransmitters, including glutamate, norepinephrine, and substance P, leading to reduced neuronal excitability and pain transmission. It does not bind directly to GABA-A or GABA-B receptors, nor does it affect GABA uptake or degradation.
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Pharmacokinetics

Absorption:

Bioavailability: >90%
Tmax: 3 hours (median) for Lyrica CR
FoodEffect: Food delays Tmax and reduces Cmax for Lyrica CR, but AUC is not significantly affected. Can be taken with or without food.

Distribution:

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

Elimination:

HalfLife: 11-12 hours (effective half-life for CR formulation)
Clearance: Primarily renal clearance
ExcretionRoute: Urine
Unchanged: >90%
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Pharmacodynamics

OnsetOfAction: Variable, typically within a few days to a week for pain relief
PeakEffect: Steady state typically reached within 24-48 hours with regular once-daily dosing
DurationOfAction: 24 hours (due to extended-release formulation)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you or your caregiver notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight
Muscle pain or weakness
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 experience extreme drowsiness, dizziness, or loss of consciousness, seek medical help immediately. Caregivers should also seek medical help 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 actions, particularly in individuals with a history of suicidal behavior. If you or your caregiver notice any new or worsening symptoms, such as:

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

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, which can increase the risk of bleeding. If you experience unexplained bruising or bleeding, contact your doctor right away.

Other Side Effects

Most medications can cause side effects, but many people experience no side effects or only mild ones. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

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 extreme sleepiness
  • Significant swelling of hands, feet, ankles, or face (peripheral edema)
  • Rapid or excessive weight gain
  • Blurred vision or other changes in eyesight
  • Unexplained muscle pain, tenderness, or weakness (especially with fever or dark urine)
  • Unusual bruising or bleeding
  • Signs of an allergic reaction: rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing
  • New or worsening depression, anxiety, agitation, or suicidal thoughts
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have kidney disease, as this may affect how your body processes the medication.
If you are breastfeeding, as you should not breastfeed while taking this medication.

Additionally, to ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:

All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
* Any health problems you have, as these may interact with the medication.

Remember, this is not an exhaustive list of potential interactions. Therefore, it is vital to verify that it is safe to take this medication with all 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 seizures, and they change or 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 guide you on how to gradually stop taking it.

While taking this medication, avoid consuming alcohol.

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.

This medication has been linked to severe breathing problems, particularly in individuals taking certain other medications (such as opioid pain medications) or those with pre-existing lung or breathing issues. The risk may be higher in people over 65 years old, and in some cases, these 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 decrease fertility and cause sperm changes in male animals, and has also been linked to birth defects in the offspring of treated male animals. Although it is unknown whether these effects occur in humans, it is crucial to discuss the potential 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.
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Overdose Information

Overdose Symptoms:

  • Somnolence (extreme drowsiness)
  • Confusion
  • Agitation
  • Restlessness
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive. Hemodialysis can remove pregabalin from the system.

Drug Interactions

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Major Interactions

  • CNS depressants (e.g., opioids, benzodiazepines, alcohol): Increased risk of additive CNS depression (dizziness, somnolence, respiratory depression, coma).
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Moderate Interactions

  • Thiazolidinediones (e.g., pioglitazone, rosiglitazone): Increased risk of weight gain and peripheral edema.
  • ACE inhibitors: Increased risk of angioedema.

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

Pain and symptom assessment

Rationale: To establish baseline severity and track treatment efficacy.

Timing: Prior to initiation

Baseline edema assessment

Rationale: Pregabalin can cause peripheral edema.

Timing: Prior to initiation

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Routine Monitoring

Pain and symptom assessment

Frequency: Regularly, as clinically indicated (e.g., weekly during titration, then monthly/quarterly)

Target: Reduction in pain score, improvement in quality of life

Action Threshold: Lack of efficacy, worsening symptoms

Renal function (CrCl)

Frequency: Periodically, especially in elderly or those with changing renal status

Target: Stable renal function

Action Threshold: Significant decline in CrCl requiring dose adjustment

Signs of peripheral edema and weight

Frequency: Regularly, as clinically indicated

Target: No significant edema or excessive weight gain

Action Threshold: Significant or bothersome edema, rapid or excessive weight gain

Mental status changes, suicidal ideation

Frequency: Regularly, especially during initial therapy or dose changes

Target: Stable mood and mental state

Action Threshold: New or worsening depression, suicidal thoughts, unusual behavior changes

Vision changes

Frequency: As reported by patient

Target: Normal vision

Action Threshold: Blurred vision, other visual disturbances

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data are available; animal studies have shown developmental toxicity.

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity observed in animal studies; human data limited.
Second Trimester: Human data limited; animal studies suggest potential risks.
Third Trimester: Human data limited; animal studies suggest potential risks.
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Lactation

Lactation Risk L3 (Moderately safe). Pregabalin is excreted into breast milk. Monitor breastfed infants for signs of sedation (e.g., lethargy, poor feeding) or other adverse effects. Weigh the benefits of breastfeeding against the potential risks to the infant.

Infant Risk: Low to moderate risk; monitor for sedation, poor feeding, or developmental milestones.
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Pediatric Use

Lyrica CR is not approved for pediatric use. The safety and effectiveness of Lyrica CR in pediatric patients have not been established.

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Geriatric Use

Use with caution in elderly patients due to increased risk of adverse effects (e.g., dizziness, somnolence, falls) and age-related decline in renal function. Start with lower doses and titrate slowly based on renal function and tolerability.

Clinical Information

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Clinical Pearls

  • Lyrica CR is an extended-release formulation designed for once-daily dosing, which may improve patient adherence compared to immediate-release pregabalin.
  • Tablets must be swallowed whole; crushing, chewing, or splitting will alter the extended-release properties and may lead to rapid drug release and increased side effects.
  • Abrupt discontinuation of pregabalin can lead to withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety, diarrhea, seizures). Taper the dose gradually over at least 1 week.
  • Patients should be advised about the potential for peripheral edema and weight gain.
  • There is an increased risk of angioedema when pregabalin is co-administered with ACE inhibitors.
  • Patients should be monitored for signs of suicidal thoughts or behavior, especially at the beginning of therapy or with dose changes.
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Alternative Therapies

  • Gabapentin (for neuropathic pain, seizures)
  • Duloxetine (for neuropathic pain, fibromyalgia)
  • Venlafaxine (for neuropathic pain)
  • Tricyclic antidepressants (e.g., amitriptyline, nortriptyline for neuropathic pain)
  • Carbamazepine (for trigeminal neuralgia)
  • Topical lidocaine (for localized neuropathic pain)
  • Other antiepileptic drugs (for seizure disorders, if applicable for IR pregabalin)
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Cost & Coverage

Average Cost: Highly variable, typically $300-$600+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand-name Lyrica CR); Tier 1 or Tier 2 (for generic pregabalin extended-release)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.