Lyrica CR 165mg Tablets

Pregabalin binds with high affinity to the alpha2-delta (α2-δ) subunit of voltage-gated calcium channels in the central nervous system. This binding is thought to modulate the release of several excitatory neurotransmitters, including glutamate, norepinephrine, and substance P, thereby reducing neuronal excitability and pain signaling.

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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 behaviors, 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 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 do not resolve:

Dizziness
Drowsiness
Fatigue
Weakness
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 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 how your body processes the medication.
If you are breastfeeding, as you should not breastfeed while taking this medication.

Additionally, to ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems you have

This information will help your doctor determine if it is safe for you 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 to confirm it is safe to do so.

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.

Avoid consuming alcohol while taking this medication.

Before 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 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.

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 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 reduce fertility and cause sperm changes in male animals, and has also been linked to birth defects in the offspring of treated male animals. However, it is unclear if 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, barbiturates, other sedatives/hypnotics): Increased risk of additive CNS depression, respiratory depression, and sedation. Use with caution and consider dose reduction of one or both agents.
• Angiotensin-converting enzyme (ACE) inhibitors: May increase risk of angioedema when co-administered with pregabalin.

• Thiazolidinedione antidiabetic agents (e.g., pioglitazone, rosiglitazone): May increase risk of weight gain and peripheral edema when co-administered with pregabalin.

• Dizziness
• Somnolence
• Peripheral edema
• Weight gain
• Blurred vision or other visual disturbances
• Difficulty concentrating
• Dry mouth
• Angioedema (swelling of face, lips, tongue, throat)
• Hypersensitivity reactions (rash, hives)
• Mood changes, agitation, depression, suicidal thoughts or behavior
• Muscle pain, tenderness, or weakness (rare, but consider rhabdomyolysis)

Pregabalin is classified as Pregnancy Category C. Studies in animals have shown developmental toxicity (e.g., skeletal abnormalities, growth retardation) 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 decision to breastfeed during pregabalin therapy should consider the potential for infant exposure, the benefits of breastfeeding, and the potential for adverse effects on the breastfed infant. Monitor breastfed infants for sedation, poor feeding, and weight gain.

Safety and efficacy of Lyrica CR have not been established in pediatric patients. Lyrica (immediate-release) is approved for certain indications in pediatric patients 1 month and older, but dosing and formulations differ.

Elderly patients (≥65 years) may experience a higher incidence of adverse events such as dizziness, somnolence, and falls. Renal function should be assessed in elderly patients, and dose adjustments made accordingly, as pregabalin is renally excreted. Start with lower doses and titrate slowly.

• Lyrica CR is an extended-release formulation designed for once-daily dosing, improving patient adherence compared to the immediate-release formulation.
• Always take Lyrica CR with food to ensure consistent absorption and minimize gastrointestinal upset.
• Emphasize the importance of not crushing, chewing, or splitting the tablets, as this will disrupt the extended-release mechanism.
• Counsel patients on the potential for dizziness, somnolence, and peripheral edema, especially during initiation and dose titration.
• Due to its renal excretion, careful dose adjustment based on creatinine clearance is crucial, particularly in elderly patients or those with impaired renal function.
• Patients should be warned about the risk of suicidal thoughts or behavior, and advised to report any mood changes immediately.
• Abrupt discontinuation can lead to withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety, diarrhea), so taper off gradually over at least 1 week.

• Gabapentin (Neurontin, Gralise, Horizant) - another GABA analogue, often used for similar indications.
• Duloxetine (Cymbalta) - SNRI, approved for DPN, PHN, and fibromyalgia.
• Venlafaxine (Effexor XR) - SNRI, used for neuropathic pain.
• Tricyclic antidepressants (e.g., Amitriptyline, Nortriptyline) - often used for neuropathic pain.
• Topical analgesics (e.g., Lidocaine patch, Capsaicin cream) - for localized neuropathic pain.
• Other anticonvulsants (e.g., Carbamazepine, Oxcarbazepine) - for neuropathic pain (e.g., trigeminal neuralgia).
• Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy).

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate 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 amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.