Pregabalin ER 330mg 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 for its analgesic and anticonvulsant effects is not fully understood, 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 transmission 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 excessively euphoric (easy laughing and feeling good)
Twitching

If you experience extreme sleepiness, dizziness, or loss of consciousness, seek medical help immediately. Caregivers should also seek medical help right away 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 right away. If you experience suicidal thoughts or actions, seek medical help immediately.

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 right away.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

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 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, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes:

All your current health problems, as they may interact with this medication.
* Any potential interactions between this medication and your other medications or health conditions.

Remember, this is not an exhaustive list of all possible interactions. To ensure your safety, always consult your doctor before starting, stopping, or changing the dose of any medication.

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.

To minimize the risk of side effects, do not abruptly stop taking this medication without first consulting your doctor. If you need to discontinue use, your doctor will guide you on how to gradually taper off the medication.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, before using marijuana, cannabis products, or prescription and over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.

Be aware that 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.

There is a risk of severe breathing problems when taking this medication, particularly in individuals who are also taking opioid pain medications or have 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 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, and has also been linked to birth defects in the offspring of treated male animals. Although it is unclear if these effects occur in humans, it is crucial to have this conversation.

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, antihistamines): May potentiate CNS depression (drowsiness, dizziness, respiratory depression).
• Thiazolidinediones (e.g., pioglitazone, rosiglitazone): 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
• Ataxia (loss of coordination)
• Suicidal thoughts or behavior
• Mood changes (depression, anxiety, agitation)
• Signs of hypersensitivity reactions (e.g., angioedema, rash, hives, difficulty breathing)
• Muscle pain or weakness (rhabdomyolysis symptoms)

Pregabalin is not recommended during pregnancy unless the potential benefit outweighs the potential risk to the fetus. Based on animal data, pregabalin may cause fetal harm. A pregnancy exposure registry is available.

Pregabalin is excreted into human milk. 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. Monitor infants for sedation and poor feeding.

Safety and effectiveness of pregabalin extended-release tablets have not been established in pediatric patients. Not indicated for pediatric use.

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is required for elderly patients with impaired renal function.

• Pregabalin ER is designed for once-daily dosing, typically taken with food in the evening to minimize initial dizziness/somnolence.
• Do not substitute pregabalin ER with immediate-release pregabalin on a mg-per-mg basis, as the pharmacokinetic profiles are different.
• Patients should be advised not to abruptly discontinue pregabalin due to potential for withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety, diarrhea, seizures). Taper gradually over at least 1 week.
• Monitor for signs of angioedema (swelling of face, lips, tongue, throat) which can be life-threatening.
• Counsel patients on the risk of suicidal thoughts or behavior, and to report any mood changes immediately.
• Weight gain and peripheral edema are common side effects; monitor patients, especially those with pre-existing cardiovascular conditions.

• Gabapentin (for neuropathic pain, postherpetic neuralgia)
• Duloxetine (for neuropathic pain, fibromyalgia)
• Venlafaxine (for neuropathic pain)
• Amitriptyline (for neuropathic pain)
• Nortriptyline (for neuropathic pain)
• Carbamazepine (for trigeminal neuralgia)
• Topiramate (for neuropathic pain, fibromyalgia)
• Milnacipran (for fibromyalgia)

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 refill your prescription. 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, and the time it occurred, as this information is crucial for proper treatment.