Pregabalin 165mg ER 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, Neuropathic Pain Agent
Pharmacologic Class
GABA Analogue
Pregnancy Category
Category C
FDA Approved
Sep 2017
DEA Schedule
Schedule V
Overview
What is this medicine?
Pregabalin extended-release is a medication used to treat certain types of nerve pain, such as pain after shingles (postherpetic neuralgia), nerve pain from diabetes (diabetic peripheral neuropathy), and fibromyalgia. It works by affecting certain chemicals in your brain that send pain signals.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription 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
Store your medication in its original container at room temperature, in a dry place. Avoid storing it in a bathroom. Keep your medication out of sight and 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 as soon as you remember, either just before bedtime after eating a snack or with your next morning meal. If you miss taking the missed dose by the next morning, skip it 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.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription 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
Store your medication in its original container at room temperature, in a dry place. Avoid storing it in a bathroom. Keep your medication out of sight and 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 as soon as you remember, either just before bedtime after eating a snack or with your next morning meal. If you miss taking the missed dose by the next morning, skip it 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.
Lifestyle & Tips
- Take this medication exactly as prescribed, once daily, with food.
- Do not crush, chew, or break the extended-release tablet; swallow it whole.
- Avoid alcohol and other medications that cause drowsiness, as this can worsen side effects like dizziness and sleepiness.
- Be cautious when driving or operating machinery until you know how this medication affects you.
- Do not stop taking this medication suddenly without consulting your doctor, as it can lead to withdrawal symptoms or worsening of your condition.
- Report any new or worsening mood changes, depression, or thoughts of self-harm to your doctor immediately.
Available Forms & Alternatives
Available Strengths:
- Pregabalin 50mg Capsules
- Pregabalin 200mg Capsules
- Pregabalin 20mg/ml Solution
- Pregabalin 150mg Capsules
- Pregabalin 75mg Capsules
- Pregabalin 100mg Capsules
- Pregabalin 300mg Capsules
- Pregabalin 225mg Capsules
- Pregabalin 20mg/ml Solution
- Pregabalin 25mg Capsules
- Pregabalin ER 82.5mg Tablets
- Pregabalin 165mg ER Tablets
- Pregabalin ER 330mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
165 mg orally once daily, taken with food.
Dose Range:
165 - 330 mg
Condition-Specific Dosing:
Postherpetic Neuralgia (PHN):
Initial: 165 mg once daily. May increase to 330 mg once daily after 1 week based on response and tolerability.
Diabetic Peripheral Neuropathy (DPN):
Initial: 165 mg once daily. May increase to 330 mg once daily after 1 week based on response and tolerability.
Fibromyalgia:
Initial: 165 mg once daily. May increase to 330 mg once daily after 1 week based on response and tolerability.
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.
Moderate:
CrCl 30-60 mL/min: Reduce dose by 50% (e.g., 82.5 mg once daily or 165 mg every other day).
Severe:
CrCl <30 mL/min: Reduce dose by 75% (e.g., 41.25 mg once daily or 82.5 mg every other day).
Dialysis:
Administer a supplemental dose immediately following each 4-hour hemodialysis session (e.g., 25-100 mg immediate-release, or equivalent for ER formulation, consult specific guidelines).
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 in humans is unknown, binding to the Ξ±2-Ξ΄ subunit is thought to modulate the release of several neurotransmitters, including glutamate, norepinephrine, and substance P, which are involved in pain and seizure activity.
Pharmacokinetics
Absorption:
Bioavailability:
β₯90%
Tmax:
Approximately 3-4 hours (for immediate-release); for extended-release, Tmax is delayed to approximately 8 hours with food.
FoodEffect:
Food delays Tmax and reduces Cmax for extended-release formulation, but total absorption (AUC) is not significantly affected. Taking with food is recommended to improve tolerability.
Distribution:
Vd:
Approximately 0.5 L/kg
ProteinBinding:
<1%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 6.3 hours (for immediate-release); extended-release formulation provides once-daily dosing.
Clearance:
Primarily renal clearance.
ExcretionRoute:
Renal
Unchanged:
>90%
Pharmacodynamics
OnsetOfAction:
Within 1 week for pain relief, but full effect may take longer.
PeakEffect:
Variable, often within 1-2 weeks of stable dosing.
DurationOfAction:
24 hours (for extended-release formulation).
Safety & Warnings
Side Effects
Urgent 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 skin changes
Speech difficulties
Sleep disturbances
Walking difficulties
Feeling excessively euphoric (easy laughing and feeling good)
Twitching
If you experience extreme sleepiness, 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.
Important Warning: Suicidal Thoughts and 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 or attempts. 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 suicidal thoughts or actions occur, seek medical help right away.
Low Platelet Counts and Bleeding Risk
This medication may rarely cause low platelet counts, increasing the risk of bleeding. If you experience unexplained bruising or bleeding, contact your doctor immediately.
Other Possible Side Effects
Most medications can cause side effects, but many people may not experience any or may only have mild symptoms. If you or your caregiver notice any of the following side effects, contact your doctor if they bother you or persist:
Dizziness, sleepiness, tiredness, 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 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.
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 skin changes
Speech difficulties
Sleep disturbances
Walking difficulties
Feeling excessively euphoric (easy laughing and feeling good)
Twitching
If you experience extreme sleepiness, 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.
Important Warning: Suicidal Thoughts and 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 or attempts. 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 suicidal thoughts or actions occur, seek medical help right away.
Low Platelet Counts and Bleeding Risk
This medication may rarely cause low platelet counts, increasing the risk of bleeding. If you experience unexplained bruising or bleeding, contact your doctor immediately.
Other Possible Side Effects
Most medications can cause side effects, but many people may not experience any or may only have mild symptoms. If you or your caregiver notice any of the following side effects, contact your doctor if they bother you or persist:
Dizziness, sleepiness, tiredness, 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 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.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or somnolence
- Significant swelling of hands, feet, or ankles (peripheral edema)
- Unexplained weight gain
- Blurred vision or other changes in eyesight
- Muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise
- Signs of an 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 suicidal thoughts/behavior.
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 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 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 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 guide you on how to gradually stop taking it.
While taking this medication, avoid consuming alcohol. Additionally, before using marijuana, cannabis products, or prescription and over-the-counter medications that may impair your reactions, discuss this with your doctor.
A severe and potentially life-threatening reaction known as 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 respiratory 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 reduce 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 not known if these effects occur in humans, it is crucial to discuss this with your doctor.
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 guide you on how to gradually stop taking it.
While taking this medication, avoid consuming alcohol. Additionally, before using marijuana, cannabis products, or prescription and over-the-counter medications that may impair your reactions, discuss this with your doctor.
A severe and potentially life-threatening reaction known as 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 respiratory 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 reduce 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 not known if these effects occur in humans, it is crucial to discuss this with your doctor.
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. Management is generally supportive and may include gastric lavage or emesis if ingestion is recent. Hemodialysis can remove pregabalin from the system.
Drug Interactions
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.
Mental health history (depression, suicidal ideation)
Rationale: Antiepileptic drugs, including pregabalin, may increase the risk of suicidal thoughts or behavior.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (pain scores, symptom relief)
Frequency: Regularly during titration and periodically thereafter.
Target: Patient-specific improvement in symptoms.
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.
Adverse effects (dizziness, somnolence, peripheral edema, weight gain, blurred vision)
Frequency: Regularly during titration and periodically thereafter.
Target: Minimization of intolerable side effects.
Action Threshold: Persistent or severe side effects may require dose reduction or discontinuation.
Renal function (CrCl)
Frequency: Periodically, especially in elderly patients or those with changing renal status.
Target: Maintain appropriate dose for renal function.
Action Threshold: Significant decline in CrCl requires dose adjustment.
Mood and behavior changes (suicidal ideation, depression, anxiety)
Frequency: Regularly, especially during initial therapy and dose changes.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: Emergence or worsening of suicidal thoughts/behavior or other mood changes requires immediate evaluation and intervention.
Symptom Monitoring
- Dizziness
- Somnolence
- Peripheral edema (swelling of hands/feet)
- Weight gain
- Blurred vision or other visual disturbances
- Difficulty concentrating
- Dry mouth
- Suicidal thoughts or behavior
- Unusual changes in mood or behavior (e.g., agitation, depression, anxiety)
- Hypersensitivity reactions (e.g., angioedema, rash, hives, difficulty breathing)
Special Patient Groups
Pregnancy
Pregabalin is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown developmental toxicity.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations based on some observational studies, though data are conflicting and limited.
Second Trimester:
Limited data, but generally considered lower risk than first trimester for structural malformations.
Third Trimester:
Potential for neonatal withdrawal symptoms if discontinued abruptly 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 pregabalin, and any potential adverse effects on the breastfed infant from pregabalin 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. The amount transferred to milk is relatively low.
Pediatric Use
Safety and effectiveness of pregabalin extended-release tablets in pediatric patients have not been established. Use in pediatric populations is generally off-label for immediate-release formulations for specific conditions, but not for the ER formulation.
Geriatric Use
Use with caution in elderly patients due to increased likelihood of decreased renal function and increased susceptibility to adverse effects (e.g., dizziness, somnolence, falls). Dose adjustments are often necessary based on renal function. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Pregabalin ER should be taken once daily with food to improve tolerability and reduce gastrointestinal side effects.
- Do not crush, chew, or break the extended-release tablets; they must be swallowed whole.
- Patients should be advised about the potential for dizziness, somnolence, and blurred vision, and cautioned against driving or operating machinery until they know how the drug affects them.
- Monitor for signs of angioedema (swelling of face, lips, tongue, throat) and hypersensitivity reactions, which can be life-threatening.
- Patients should be educated on the risk of suicidal thoughts and behaviors and instructed to report any mood or behavioral changes immediately.
- Taper pregabalin gradually over at least 1 week when discontinuing to minimize withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety, diarrhea).
Alternative Therapies
- Gabapentin (for neuropathic pain, PHN)
- Duloxetine (for DPN, fibromyalgia)
- Venlafaxine (for DPN)
- Amitriptyline (for neuropathic pain, PHN, fibromyalgia)
- Nortriptyline (for neuropathic pain, PHN)
- Carbamazepine (for trigeminal neuralgia, not general neuropathic pain)
- Topical lidocaine (for PHN)
- Tapentadol (for DPN)
- Milnacipran (for fibromyalgia)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for brand), Tier 1 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you 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.