Pregabalin 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 excitatory neurotransmitters, including glutamate, norepinephrine, and substance P, which may contribute to its analgesic, anxiolytic, 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 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 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 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, which can increase the risk of bleeding. If you experience unexplained bruising or bleeding, contact your doctor immediately.

Other Side Effects

Most medications can cause side effects, but many people may not experience any or may only have mild side effects. 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

These are not all the possible side effects that may occur. 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 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.
Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so. This medication may interact with other drugs or health conditions, and your doctor needs to be aware of all relevant information to provide the best possible care.

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.

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

A severe and potentially life-threatening reaction called angioedema has been associated with this medication. Recognizable symptoms 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.

This medication has been linked to severe breathing 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, exercise caution when taking this medication, as you may be more susceptible to side effects.

Men planning 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 unclear 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.

• CNS depressants (e.g., opioids, benzodiazepines, alcohol, barbiturates, other sedatives/hypnotics, tricyclic antidepressants, antihistamines with sedative properties): Increased risk of additive CNS depression (drowsiness, dizziness, respiratory depression, coma).
• Angiotensin-converting enzyme (ACE) inhibitors: May increase risk of angioedema when co-administered with pregabalin.

• Thiazolidinediones (e.g., rosiglitazone, pioglitazone): May increase risk of weight gain and peripheral edema.
• Gabapentin: Additive CNS effects, though not typically co-administered.

• Dizziness
• Somnolence
• Peripheral edema (swelling of hands/feet)
• Weight gain
• Blurred vision or other visual disturbances
• Difficulty concentrating
• Dry mouth
• Suicidal thoughts or behavior
• Unusual changes in mood or behavior (e.g., agitation, depression, anxiety, panic attacks, irritability, aggression, insomnia)
• Hypersensitivity reactions (e.g., angioedema, rash, hives, difficulty breathing)
• Muscle pain, tenderness, or weakness (especially if accompanied by fever or malaise)
• Signs of respiratory depression (shallow breathing, confusion, extreme drowsiness)

Pregabalin is 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. Patients should be enrolled in a pregnancy registry if exposed during pregnancy.

Pregabalin is excreted into human milk. The amount 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 the drug or from the underlying maternal condition.

Safety and efficacy have not been established in pediatric patients for most indications. For adjunctive therapy of partial onset seizures, limited data support use in children 4 years and older, with weight-based dosing and careful monitoring for adverse effects, particularly behavioral changes and weight gain.

Elderly patients (≥65 years) may experience increased incidence of adverse effects such as dizziness, somnolence, and peripheral edema. Renal function declines with age, so dose adjustments based on creatinine clearance are often necessary in this population. Start with lower doses and titrate slowly.

• Pregabalin should be tapered gradually over at least 1 week when discontinuing to minimize withdrawal symptoms.
• Patients should be advised about the potential for weight gain and peripheral edema, especially when co-administered with thiazolidinediones.
• Monitor for signs of angioedema, particularly in patients with a history of angioedema with ACE inhibitors.
• Due to its potential for abuse and dependence, especially in patients with a history of substance abuse, careful prescribing and monitoring are warranted.
• Patients should be educated on the importance of reporting any suicidal thoughts or behavioral changes immediately.

• For Neuropathic Pain: Gabapentin, Duloxetine, Venlafaxine, Amitriptyline, Nortriptyline, Carbamazepine (for trigeminal neuralgia), Topical Lidocaine.
• For Fibromyalgia: Duloxetine, Milnacipran, Amitriptyline, Cyclobenzaprine.
• For Partial Onset Seizures: Levetiracetam, Lamotrigine, Carbamazepine, Oxcarbazepine, Valproic acid, Phenytoin, Topiramate, Lacosamide, Brivaracetam.

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, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or 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.