Lyrica 225mg** Capsules

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 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 and seizure activity.

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
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 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 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 immediately. If you experience suicidal thoughts or actions, 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 notice any unexplained bruising or bleeding, contact your doctor immediately.

Other Possible Side Effects

Most people taking this medication 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:

Dizziness
Drowsiness
Fatigue
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.

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 medication. 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 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 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, 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 problems. This risk may be higher in individuals over 65 years old, and in some cases, has been fatal. 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 who plan to father a child should discuss the potential risks with their doctor, as this medication has been shown to decrease fertility and cause sperm changes in animal studies, and has also been associated with birth defects in the offspring of treated male animals. It is unknown whether these effects occur in humans.

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.

• CNS depressants (e.g., opioids, benzodiazepines, alcohol, anxiolytics, hypnotics, tricyclic antidepressants): May cause additive CNS depression (somnolence, dizziness, respiratory depression).
• Thiazolidinediones (e.g., rosiglitazone, pioglitazone): May increase risk of weight gain and peripheral edema.

• Dizziness
• Somnolence
• Peripheral edema (swelling of hands/feet)
• Weight gain
• Blurred vision or other visual disturbances
• Difficulty concentrating
• Dry mouth
• Suicidal thoughts or behavior
• Changes in mood or behavior (e.g., agitation, depression, anxiety)
• Signs of hypersensitivity reaction (e.g., rash, hives, swelling of face/lips/tongue/throat)
• Muscle pain, tenderness, or weakness (rare, but consider rhabdomyolysis)

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. A pregnancy exposure registry is available. Animal studies have shown developmental toxicity (skeletal abnormalities, growth retardation, functional deficits).

Pregabalin is excreted into human milk. The amount of pregabalin in breast milk is low, and adverse effects in breastfed infants are generally not expected, but somnolence or poor feeding could occur. Monitor the infant for sedation and feeding difficulties.

Safety and efficacy have not been established in pediatric patients for neuropathic pain or fibromyalgia. For adjunctive treatment of partial-onset seizures, efficacy has been established in patients 1 month to <4 years and 4 to <17 years of age, but dosing is weight-based and requires careful titration. Increased risk of accidental injury and weight gain in pediatric patients.

Elderly patients may be more susceptible to dose-related adverse effects (dizziness, somnolence, peripheral edema) due to age-related decline in renal function. Dose adjustment is often necessary based on creatinine clearance. Start with lower doses and titrate slowly.

• Pregabalin should be tapered gradually over at least 1 week when discontinuing to minimize withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety, diarrhea, flu-like syndrome, nervousness, depression, pain, convulsions).
• Patients should be advised about the potential for angioedema (swelling of the face, mouth, or neck) and to seek immediate medical attention if it occurs.
• Monitor for signs of suicidal ideation and behavior, especially at the beginning of treatment or after dose changes.
• Pregabalin can cause weight gain and peripheral edema, particularly when co-administered with thiazolidinediones.
• Due to its Schedule V classification, prescribers should be aware of the potential for abuse and dependence, although the risk is generally considered lower than for Schedule II-IV substances.

• Gabapentin (Neurontin)
• Duloxetine (Cymbalta)
• Venlafaxine (Effexor XR)
• Amitriptyline
• Nortriptyline
• Carbamazepine (Tegretol)
• Oxcarbazepine (Trileptal)
• Lamotrigine (Lamictal)
• Topiramate (Topamax)

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 your prescription is refilled. If you have any questions or concerns about this medication, consult 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 amount, and the time it occurred.