Lyrica 100mg Capsules

Manufacturer PFIZER 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
GABA analogue, Alpha2-delta ligand
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Pregnancy Category
Not available
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FDA Approved
Dec 2004
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DEA Schedule
Schedule V

Overview

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What is this medicine?

Pregabalin is a medication that works in the brain to calm overactive nerve signals. It's used to treat certain types of nerve pain (like from diabetes or shingles), a condition called fibromyalgia, and certain types of seizures. It helps reduce pain, improve sleep, and control seizures by affecting how certain chemicals are released in your 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 secure location where children cannot see or access it, and where others cannot get to it. Consider using a locked box or area to keep your medication safe. Remember to keep all medications out of reach of 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

  • Do not stop taking pregabalin suddenly without talking to your doctor, as this can cause withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety, diarrhea).
  • Avoid alcohol and other medications that cause drowsiness (e.g., opioids, benzodiazepines) as they can increase dizziness and sleepiness.
  • Be cautious when driving or operating machinery until you know how pregabalin affects you, as it can cause dizziness and blurred vision.
  • Report any unusual mood changes, thoughts of self-harm, or worsening depression to your doctor immediately.
  • Report any swelling in your hands, feet, or face, or unexplained weight gain to your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication: Neuropathic pain (DPN, PHN) 50 mg TID (150 mg/day) initially, up to 300 mg BID or TID (600 mg/day) max. Fibromyalgia 75 mg BID (150 mg/day) initially, up to 225 mg BID (450 mg/day) max. Partial-onset seizures 75 mg BID (150 mg/day) initially, up to 300 mg BID or TID (600 mg/day) max.
Dose Range: 150 - 600 mg

Condition-Specific Dosing:

Diabetic Peripheral Neuropathy: Initial 50 mg TID, may increase to 100 mg TID within 1 week, max 300 mg TID (600 mg/day).
Postherpetic Neuralgia: Initial 75 mg BID or 50 mg TID, may increase to 150 mg BID or 100 mg TID within 1 week, max 300 mg BID or 200 mg TID (600 mg/day).
Fibromyalgia: Initial 75 mg BID, may increase to 150 mg BID within 1 week, max 225 mg BID (450 mg/day).
Partial-Onset Seizures (adjunctive): Initial 75 mg BID, may increase to 150 mg BID within 1 week, max 300 mg BID or TID (600 mg/day).
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Pediatric Dosing

Neonatal: Not established
Infant: Partial-onset seizures (1 month to <4 years): Initial 3.5 mg/kg/day in 3 divided doses, max 14 mg/kg/day. Dosing based on weight and CrCl.
Child: Partial-onset seizures (4 to <17 years): Initial 3.5 mg/kg/day in 2-3 divided doses, max 14 mg/kg/day. Dosing based on weight and CrCl.
Adolescent: Partial-onset seizures (17 years): Same as adult dosing for partial-onset seizures.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 60 mL/min: Max 300 mg/day in 2-3 divided doses.
Moderate: CrCl 30-60 mL/min: Max 150 mg/day in 2-3 divided doses.
Severe: CrCl 15-30 mL/min: Max 75 mg/day in 1-2 divided doses.
Dialysis: CrCl <15 mL/min: Max 25-50 mg/day in 1 dose. Supplemental dose of 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. This binding modulates the influx of calcium into nerve terminals, thereby reducing the release of several excitatory neurotransmitters, including glutamate, norepinephrine, and substance P. This action is thought to contribute to its analgesic, anxiolytic, and anticonvulsant effects.
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Pharmacokinetics

Absorption:

Bioavailability: >=90%
Tmax: Approximately 1.5 hours
FoodEffect: Food reduces Cmax by approximately 25-30% and prolongs Tmax to approximately 2.5-3 hours, but does not affect the extent of absorption (AUC).

Distribution:

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

Elimination:

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

OnsetOfAction: Within 1 week for neuropathic pain, within 1-2 weeks for fibromyalgia, within 1 week for seizures.
PeakEffect: Not precisely defined for chronic conditions, typically within 2-4 weeks for full therapeutic effect.
DurationOfAction: Approximately 12 hours (based on BID dosing)

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
Balance problems
Confusion
Shakiness
Breathing difficulties, including 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 changes in skin condition
Difficulty speaking
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 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 increase the risk of suicidal thoughts or behaviors, particularly in individuals with a history of such thoughts or actions. 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 encounter any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

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, 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 somnolence
  • Significant swelling of hands, feet, or face (angioedema)
  • Difficulty breathing or swallowing
  • Rash or hives
  • Blurred vision or other changes in eyesight
  • Unexplained muscle pain, tenderness, or weakness (especially if accompanied by fever or dark urine)
  • New or worsening depression, anxiety, agitation, or suicidal thoughts/behavior
  • Unusual bruising or bleeding
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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 your ability to take this 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 in combination 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 dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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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 operating a vehicle or engaging in any activity that requires alertness and clear vision, wait until you understand how this medication affects you.

If you experience a change 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 experiencing side effects. If it is necessary to stop taking this medication, your doctor will provide guidance on how to gradually taper off the dosage.

While taking this medication, it is recommended that you avoid consuming alcohol.

Before using marijuana, other cannabis products, or prescription or over-the-counter medications that may cause drowsiness, discuss the potential risks with your doctor.

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. 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 such as opioid pain relievers, or in those with pre-existing lung or breathing difficulties. The risk may be higher in individuals over 65 years of age, and in some cases, these respiratory problems have been fatal. If you have concerns, consult your doctor.

If you are 65 years of age or older, use this medication with caution, as you may be more susceptible to side effects.

Men who are planning to father a child should discuss the potential risks with their doctor, as this medication has been shown to reduce fertility and cause sperm abnormalities in animal studies, and has also been linked to birth defects in the offspring of male animals treated with this medication. However, it is not known whether these effects occur in humans.

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

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management is supportive and may include gastric lavage or emesis if recent ingestion. Hemodialysis can remove pregabalin from the system.

Drug Interactions

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Major Interactions

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

  • Ethanol (alcohol): Additive CNS depressant effects.
  • Other CNS depressants (e.g., barbiturates, sedating antihistamines, muscle relaxants): Additive CNS depressant effects.
  • Thiazolidinediones (e.g., pioglitazone, rosiglitazone): May exacerbate peripheral edema and weight gain.

Monitoring

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Baseline Monitoring

Renal function (Creatinine Clearance)

Rationale: Pregabalin is primarily renally excreted; dose adjustment is necessary in patients with impaired renal function.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (pain scores, seizure frequency, fibromyalgia symptoms)

Frequency: Regularly during dose titration and periodically thereafter.

Target: Individualized based on patient response and tolerability.

Action Threshold: Lack of adequate response or intolerable side effects may warrant dose adjustment or discontinuation.

Adverse effects (dizziness, somnolence, peripheral edema, weight gain, blurred vision, suicidal ideation)

Frequency: Regularly, especially during dose titration and initial weeks of therapy.

Target: Absence or minimal severity of adverse effects.

Action Threshold: Significant or persistent adverse effects may require dose reduction or discontinuation.

Renal function (Creatinine Clearance)

Frequency: Periodically, especially in elderly patients or those with pre-existing renal impairment, or if renal function changes are suspected.

Target: Not applicable (used for dose adjustment).

Action Threshold: Decline in CrCl requires dose adjustment.

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Symptom Monitoring

  • Dizziness
  • Somnolence
  • Peripheral edema (swelling of hands/feet)
  • Weight gain
  • Blurred vision or other visual disturbances
  • Difficulty concentrating
  • Mood changes (e.g., depression, anxiety, agitation)
  • Suicidal thoughts or behavior
  • Unusual bruising or bleeding (rare, but possible blood dyscrasias)
  • Muscle pain or weakness (rhabdomyolysis, rare)
  • Signs of hypersensitivity reaction (e.g., rash, hives, angioedema, difficulty breathing)

Special Patient Groups

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Pregnancy

Pregabalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data from pregnancy registries and observational studies have not identified a clear association with major birth defects, but animal studies have shown developmental toxicity. A pregnancy exposure registry is available.

Trimester-Specific Risks:

First Trimester: Limited human data, animal studies show developmental toxicity (skeletal abnormalities, growth retardation).
Second Trimester: Limited human data.
Third Trimester: Limited human data. Potential for neonatal withdrawal symptoms if used late in pregnancy.
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Lactation

Pregabalin is excreted into human milk. The amount of pregabalin ingested by a breastfed infant is low. Monitor breastfed infants for sedation and poor feeding. Use with caution.

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

Approved for adjunctive treatment of partial-onset seizures in patients 1 month to <17 years of age. Dosing is weight-based and adjusted for renal function. Safety and efficacy for other indications (neuropathic pain, fibromyalgia) have not been established in pediatric patients.

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Geriatric Use

Dose adjustment is necessary in elderly patients due to age-related decline in renal function. Elderly patients may be more susceptible to adverse effects such as dizziness, somnolence, and peripheral edema. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Pregabalin is a Schedule V controlled substance due to potential for abuse and dependence, though lower than Schedule IV.
  • Withdrawal symptoms can occur if discontinued abruptly, especially after long-term use or high doses. Taper slowly over at least 1 week.
  • Significant dose adjustments are required for renal impairment; always check CrCl before initiating and during therapy.
  • Patients should be warned about potential for dizziness, somnolence, and blurred vision, especially at initiation and with dose increases.
  • Monitor for signs of angioedema (swelling of face, mouth, throat) which can be life-threatening.
  • Weight gain and peripheral edema are common side effects; monitor patients, especially those with pre-existing cardiovascular conditions.
  • Co-administration with opioids or other CNS depressants significantly increases the risk of respiratory depression and sedation.
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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, Topiramate, Lacosamide.
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Cost & Coverage

Average Cost: Varies widely, typically $50-$300 per 30 capsules (100mg)
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'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 about its use. 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 discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.