Pregabalin 50mg Capsules
It is used to help control certain kinds of seizures.It is used to treat painful nerve diseases.It is used to treat fibromyalgia.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant; Neuropathic Pain Agent
Pharmacologic Class
Gamma-aminobutyric acid (GABA) analogue
Pregnancy Category
Category C
FDA Approved
Dec 2004
DEA Schedule
Schedule V
Overview
What is this medicine?
Pregabalin is a medication that works in the brain to help control seizures, reduce nerve pain (like from diabetes or shingles), and manage fibromyalgia. It's thought to work by calming overactive nerve 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 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.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Do not stop taking Pregabalin suddenly without consulting your doctor, as this can cause withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety, diarrhea).
- Avoid alcohol and other CNS depressants (e.g., opioids, benzodiazepines) while taking Pregabalin, as this can increase dizziness, drowsiness, and respiratory depression.
- Pregabalin may cause dizziness and drowsiness; avoid driving or operating heavy machinery until you know how it affects you.
- Report any unusual changes in mood or behavior, including thoughts of self-harm, to your doctor immediately.
- Report any swelling of the face, lips, tongue, or throat, or difficulty breathing, as these could be signs of a serious allergic reaction (angioedema).
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:
Initial dose typically 150 mg/day in 2-3 divided doses, titrated up to 300-600 mg/day depending on indication and tolerability.
Dose Range:
150 - 600 mg
Condition-Specific Dosing:
neuropathic_pain_diabetic:
Initial: 50 mg TID (150 mg/day); Max: 100 mg TID (300 mg/day)
postherpetic_neuralgia:
Initial: 75 mg BID or 50 mg TID (150 mg/day); Max: 300 mg BID or 200 mg TID (600 mg/day)
fibromyalgia:
Initial: 75 mg BID (150 mg/day); Max: 225 mg BID (450 mg/day)
partial_onset_seizures:
Initial: 75 mg BID or 50 mg TID (150 mg/day); Max: 300 mg BID or 200 mg TID (600 mg/day)
generalized_anxiety_disorder_europe:
Initial: 150 mg/day; Max: 600 mg/day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Partial-onset seizures (âĨ1 month to <4 years): Initial 3.5 mg/kg/day in 3 divided doses; Max 14 mg/kg/day. Partial-onset seizures (âĨ4 years to <17 years): Initial 3.5 mg/kg/day in 2-3 divided doses; Max 14 mg/kg/day (up to 600 mg/day).
Adolescent:
Partial-onset seizures (âĨ17 years): Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
CrCl 60-90 mL/min: Max 600 mg/day (divided doses)
Moderate:
CrCl 30-60 mL/min: Max 300 mg/day (divided doses)
Severe:
CrCl 15-30 mL/min: Max 150 mg/day (divided doses)
Dialysis:
CrCl <15 mL/min: Max 75 mg/day (single dose or divided). Supplemental dose of 25-50 mg after each 4-hour hemodialysis session.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
Pharmacology
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. While the precise mechanism of action is unknown, binding to the ι2-δ 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:
âĨ90%
Tmax:
1.5 hours (fasted)
FoodEffect:
Food decreases Cmax by 25-31% and delays Tmax by approximately 2.5-3 hours, but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
0.56 L/kg
ProteinBinding:
<1%
CnssPenetration:
Yes
Elimination:
HalfLife:
6.3 hours
Clearance:
Not available
ExcretionRoute:
Renal (primarily unchanged)
Unchanged:
>90%
Pharmacodynamics
OnsetOfAction:
Within 1 week for neuropathic pain, variable for other indications.
PeakEffect:
Variable, often after several weeks of titration.
DurationOfAction:
Approximately 12 hours (requires BID or TID dosing)
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 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 notice any 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 concentrating
Headache
Dry mouth
Constipation
Increased appetite
Upset stomach
Joint pain
Nose or throat irritation
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you or your caregiver notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight
Muscle pain or weakness
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 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 notice any 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 concentrating
Headache
Dry mouth
Constipation
Increased appetite
Upset stomach
Joint pain
Nose or throat irritation
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased seizures (if used for epilepsy)
- Worsening pain (if used for pain)
- New or worsening depression, anxiety, or panic attacks
- Thoughts about suicide or harming yourself
- Aggressive or irritable behavior
- Restlessness or agitation
- Difficulty sleeping (insomnia)
- Swelling of hands, feet, or ankles (peripheral edema)
- Blurred vision or other vision changes
- Unexplained muscle pain, tenderness, or weakness
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing
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 guide you on how to gradually stop taking it.
While taking this medication, it is recommended that you avoid consuming alcohol.
Before using marijuana, cannabis products, or prescription and over-the-counter medications that may impair your actions, 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.
Severe respiratory problems, which can be fatal, have occurred in individuals taking this medication, particularly when combined with opioid pain medications or in those with pre-existing lung or breathing issues. The risk may be higher in people over 65 years old. 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 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 changes in male animals, as well as increase the risk of birth defects in their offspring. It is unknown whether these effects occur in humans.
If you are pregnant or plan to become pregnant, inform your doctor 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, it is recommended that you avoid consuming alcohol.
Before using marijuana, cannabis products, or prescription and over-the-counter medications that may impair your actions, 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.
Severe respiratory problems, which can be fatal, have occurred in individuals taking this medication, particularly when combined with opioid pain medications or in those with pre-existing lung or breathing issues. The risk may be higher in people over 65 years old. 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 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 changes in male animals, as well as increase the risk of birth defects in their offspring. It is unknown whether these effects occur in humans.
If you are pregnant or plan to become pregnant, inform your doctor 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. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and may include gastric lavage or emesis if recent ingestion. Hemodialysis can remove pregabalin from the system.
Drug Interactions
Moderate Interactions
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: Pregabalin is primarily renally excreted; dose adjustment is necessary in renal impairment.
Timing: Prior to initiation
Mental status/mood
Rationale: To assess baseline for potential psychiatric adverse effects, including suicidal ideation.
Timing: Prior to initiation
Weight
Rationale: Pregabalin can cause weight gain.
Timing: Prior to initiation
Routine Monitoring
Efficacy (pain, seizure control, anxiety symptoms)
Frequency: Regularly during titration and maintenance
Target: Individualized based on patient response
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.
Adverse effects (dizziness, somnolence, peripheral edema, weight gain)
Frequency: Regularly, especially during titration
Target: Minimize side effects while maintaining efficacy
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Mental status/mood changes (e.g., suicidal ideation, depression, anxiety)
Frequency: Regularly, especially during initial therapy and dose changes
Target: Stable mood, absence of suicidal thoughts
Action Threshold: New or worsening psychiatric symptoms require immediate evaluation and intervention.
Renal function
Frequency: Periodically, especially in elderly or those with risk factors for renal impairment
Target: Stable CrCl
Action Threshold: Significant decline in CrCl requires dose adjustment.
Symptom Monitoring
- Dizziness
- Somnolence
- Peripheral edema
- Weight gain
- Blurred vision
- Difficulty concentrating
- Suicidal thoughts or behavior
- Unusual changes in mood or behavior
- Signs of hypersensitivity (e.g., angioedema, rash, hives)
- Muscle pain, tenderness, or weakness (rare, but consider rhabdomyolysis)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data from human pregnancies are limited, but animal studies show developmental toxicity.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show skeletal and visceral malformations at high doses.
Second Trimester:
Limited human data.
Third Trimester:
Limited human data; potential for neonatal withdrawal symptoms if discontinued abruptly.
Lactation
Pregabalin is excreted into human milk. The amount ingested by a breastfed infant is low. Monitor infants for sedation and poor feeding. Use with caution, weighing benefits vs. risks. L3 (Moderately safe).
Infant Risk:
Low risk of adverse effects, but monitor for sedation, poor feeding, and developmental milestones.
Pediatric Use
Approved for partial-onset seizures in patients âĨ1 month of age. Dosing is weight-based. Safety and efficacy for other indications (neuropathic pain, fibromyalgia) not established in pediatric patients.
Geriatric Use
Dose adjustment is often necessary due to age-related decline in renal function. Elderly patients may be more susceptible to dizziness, somnolence, and peripheral edema. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Pregabalin is a Schedule V controlled substance due to potential for abuse and dependence, though lower than Schedule IV or II drugs. Patients should be monitored for signs of abuse or dependence.
- Withdrawal symptoms (insomnia, nausea, headache, anxiety, diarrhea) can occur if discontinued abruptly, especially after long-term use. Taper gradually over at least 1 week.
- Weight gain and peripheral edema are common side effects. Monitor weight and assess for edema, especially in patients with cardiovascular risk factors.
- Patients should be advised about the risk of angioedema and to seek immediate medical attention if swelling of the face, lips, tongue, or throat occurs.
- Pregabalin has a linear pharmacokinetic profile, meaning dose increases result in proportional increases in plasma concentration, simplifying dose titration.
- Unlike many antiepileptic drugs, pregabalin does not induce or inhibit CYP450 enzymes, leading to fewer drug-drug interactions related to metabolism.
Alternative Therapies
- For Neuropathic Pain: Gabapentin, Duloxetine, Venlafaxine, Amitriptyline, Nortriptyline, Carbamazepine (for trigeminal neuralgia).
- For Fibromyalgia: Duloxetine, Milnacipran.
- For Partial-Onset Seizures: Levetiracetam, Lamotrigine, Carbamazepine, Oxcarbazepine, Topiramate, Valproic Acid, Lacosamide, Gabapentin.
Cost & Coverage
Average Cost:
Varies widely, e.g., $30-$200+ per 30 capsules (50mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 is a valuable resource that provides important information. 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 seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.