Lyrica 300mg 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 excitatory neurotransmitters, including glutamate, norepinephrine, and substance P, which may contribute to its analgesic and anticonvulsant 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 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
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 unusual skin changes
Speech difficulties
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 help right away if the patient is unresponsive, uncommunicative, or unable to wake up.

Important Warning: Suicidal Thoughts and Behaviors

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 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 emergency medical help.

Low Platelet Count Warning

This medication may rarely cause a decrease in platelet count, increasing the risk of bleeding. If you experience unexplained bruising or bleeding, contact your doctor right away.

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 persist:

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 possible side effects. If you have questions or concerns about side effects, consult 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 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 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 changes in your seizure patterns or if they worsen 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 instruct you on how to gradually taper off the dosage to minimize potential side effects.

Refrain from consuming alcohol while taking this medication.

Prior to using marijuana, cannabis products, or prescription and over-the-counter medications that may impair your reactions, 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. 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, 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 this medication with their doctor, as it 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 unknown whether 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, morphine): Increased risk of respiratory depression, sedation, and death.
• Benzodiazepines (e.g., lorazepam, alprazolam, diazepam): Increased risk of CNS depression, sedation, and respiratory depression.
• Other CNS depressants (e.g., alcohol, barbiturates, muscle relaxants, sedatives/hypnotics): Additive CNS depressant effects.

• ACE inhibitors (e.g., captopril, enalapril): May enhance peripheral edema risk.
• Thiazolidinediones (e.g., pioglitazone, rosiglitazone): May enhance peripheral edema and weight gain risk.

• Dizziness
• Somnolence
• Peripheral edema (swelling of hands, feet, ankles)
• Weight gain
• Blurred vision or other visual disturbances
• Difficulty concentrating
• Ataxia (loss of coordination)
• Suicidal thoughts or behavior (new or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, severe restlessness, hypomania, mania)
• Signs of hypersensitivity reaction (e.g., angioedema, rash, hives, difficulty breathing)
• Muscle pain, tenderness, or weakness (rare, but consider rhabdomyolysis)

Pregabalin is classified as Pregnancy Category C. Studies in animals have shown developmental toxicity (skeletal abnormalities, growth retardation, increased mortality) at doses higher than human therapeutic doses. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pregabalin is excreted into human milk. The amount of pregabalin ingested by a breastfed infant is estimated to be low (approximately 7% of the maternal weight-adjusted dose). Monitor breastfed infants for sedation, poor feeding, and weight gain. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for pregabalin, and any potential adverse effects on the breastfed infant from pregabalin or from the underlying maternal condition.

Safety and efficacy for most indications (neuropathic pain, fibromyalgia, GAD) have not been established in pediatric patients. Approved for adjunctive treatment of partial onset seizures in patients 1 month of age and older. Dosing is weight-based. Pediatric patients may be more susceptible to certain side effects like somnolence and weight gain. Monitor for behavioral changes and suicidal ideation.

Elderly patients (≥65 years) may experience a higher incidence of dizziness, somnolence, and peripheral edema. Renal function declines with age, so dose adjustments based on creatinine clearance are often necessary. Start with lower doses and titrate slowly. Increased risk of falls due to dizziness and somnolence.

• 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 symptoms, nervousness, depression, pain, convulsions).
• Patients should be advised about the potential for dizziness and somnolence, especially at the initiation of therapy and with dose increases. These effects are often dose-related.
• Monitor for signs of angioedema (swelling of face, mouth, or neck) which can be life-threatening. Discontinue immediately if this occurs.
• Pregabalin has a potential for abuse and dependence, particularly in patients with a history of substance abuse. Prescribe with caution and monitor for signs of misuse.
• Weight gain and peripheral edema are common side effects. Counsel patients on lifestyle modifications and monitor weight regularly.
• While not a controlled substance in all countries, it is Schedule V in the US, indicating a lower potential for abuse than Schedule II-IV drugs, but still present.

• Gabapentin (for neuropathic pain, seizures)
• Duloxetine (for neuropathic pain, fibromyalgia, GAD)
• Venlafaxine (for neuropathic pain, GAD)
• Amitriptyline (for neuropathic pain)
• Nortriptyline (for neuropathic pain)
• Carbamazepine (for neuropathic pain, seizures)
• Lamotrigine (for seizures)
• Topiramate (for seizures)
• Milnacipran (for fibromyalgia)
• SSRIs/SNRIs (for GAD)

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, 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 quantity, and the time it occurred.