Pregabalin ER 82.5mg Tablets

Pregabalin binds with high affinity to the alpha2-delta (α2-δ) subunit of voltage-gated calcium channels in the central nervous system. While the precise mechanism of action in neuropathic pain and fibromyalgia is unknown, binding to the α2-δ subunit is thought to modulate the release of several neurotransmitters, including glutamate, norepinephrine, and substance P, which are involved in pain signaling.

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 immediate medical attention:

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 any of the following, seek medical help immediately:

Feeling extremely sleepy, dizzy, or passing out
Unresponsiveness, uncharacteristic behavior, or inability to wake up (caregivers, please seek help if you notice these symptoms in the patient)

Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal ideation. 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 suicidal thoughts or actions occur, seek help immediately.

Additionally, this medication may rarely cause low platelet counts, which can increase the risk of bleeding. If you experience any unexplained bruising or bleeding, contact your doctor right away.

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not resolve:

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 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 https://www.fda.gov/medwatch.

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. Be sure to describe the allergic reaction and its symptoms.
If you have kidney disease, as this may affect the medication's safety and efficacy.
If you are breastfeeding, as you should not breastfeed while taking this medication.

Additionally, to ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor, as some conditions may interact with this medication.
Verify that it is safe to take this medication with all your other medications and health conditions before starting, stopping, or changing the dose of any drug. Always consult your doctor before making any changes to your medication regimen.

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 to minimize potential risks.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, before using marijuana, other forms of cannabis, or prescription and over-the-counter drugs that may impair your actions, discuss the potential risks 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. If you experience any of these symptoms, seek immediate medical attention.

There is a risk of severe breathing problems when taking this medication, particularly in individuals who are also taking certain other medications, such as opioid pain drugs, or those with pre-existing lung or breathing issues. This risk may be higher in people over 65 years old, and in some cases, breathing problems have been fatal. If you have concerns, consult your doctor.

If you are 65 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 this 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 not known if these effects occur in humans, it is crucial to weigh the potential risks and benefits.

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.

• Opioids (e.g., oxycodone, hydrocodone): Increased risk of CNS depression, respiratory depression, sedation.
• Benzodiazepines (e.g., lorazepam, alprazolam): Increased risk of CNS depression, sedation.
• Other CNS depressants (e.g., alcohol, barbiturates, muscle relaxants): Additive CNS depressant effects.

• ACE inhibitors (e.g., captopril, enalapril): May increase risk of angioedema when co-administered with pregabalin.
• Thiazolidinediones (e.g., rosiglitazone, pioglitazone): May exacerbate weight gain and peripheral edema.

• Dizziness
• Somnolence
• Peripheral edema
• Weight gain
• Blurred vision
• Difficulty concentrating
• Dry mouth
• Suicidal thoughts or behavior
• Unusual changes in mood or behavior
• Signs of hypersensitivity (e.g., rash, hives, angioedema, swelling of face, mouth, or neck)
• Muscle pain, tenderness, or weakness (rare, but consider rhabdomyolysis)

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. There are no adequate and well-controlled studies in pregnant women.

Pregabalin is excreted into human milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother. Monitor breastfed infants for sedation and poor feeding.

Safety and effectiveness of Pregabalin ER in pediatric patients have not been established. Not recommended for use in children and adolescents.

Elderly patients may be more susceptible to dose-related adverse effects (e.g., dizziness, somnolence, peripheral edema) due to age-related decrease in renal function. Dose adjustments are often necessary based on creatinine clearance.

• Pregabalin ER is designed for once-daily dosing, typically with the evening meal, to improve adherence and provide sustained symptom control.
• Patients should be advised to swallow the tablet whole and not to crush, chew, or split it, as this will disrupt the extended-release mechanism.
• Titration is crucial to minimize side effects, especially dizziness and somnolence. Start low and go slow.
• Renal function must be assessed before initiating therapy and monitored periodically, as dose adjustments are critical in renal impairment.
• Patients should be warned about the potential for angioedema, especially if they are also taking ACE inhibitors.
• Withdrawal symptoms (insomnia, nausea, headache, anxiety, hyperhidrosis) can occur if discontinued abruptly, especially after long-term use. Taper gradually over at least 1 week.
• Monitor for signs of suicidal ideation or behavior, as with all AEDs.

• Gabapentin (for neuropathic pain)
• Duloxetine (for DPN, PHN, Fibromyalgia)
• Venlafaxine (for neuropathic pain)
• Tricyclic antidepressants (e.g., amitriptyline, nortriptyline for neuropathic pain)
• Tapentadol (for DPN)
• Carbamazepine (for trigeminal neuralgia, not general neuropathic pain)
• Topical lidocaine (for PHN)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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, don't hesitate to consult with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact 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.