Pregabalin 200mg Capsules

Pregabalin binds with high affinity to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system. This binding modulates calcium influx at nerve terminals, thereby reducing the release of several excitatory neurotransmitters, including glutamate, norepinephrine, and substance P. This action is thought to contribute to its antinociceptive, anticonvulsant, and anxiolytic 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
Changes in balance
Feeling confused
Shakiness
Trouble breathing, slow breathing, 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
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 sleepiness, 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 increase the risk of suicidal thoughts or actions, particularly in people 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 suicidal thoughts or actions occur, seek immediate medical attention.

Low Platelet Counts and Bleeding Risk

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

Other 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 or seek medical attention if they bother you or persist:

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 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 your safety, it is crucial to discuss all of your:

Prescription and over-the-counter 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 activities that require 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 you need to stop taking this medication, your doctor will guide you on how to gradually taper off the dosage.

Avoid consuming alcohol while taking this medication.

Before using marijuana, cannabis products, or prescription and over-the-counter medications that may impair your physical or mental abilities, 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. Seek immediate medical attention if you experience any of these symptoms.

Severe respiratory problems have occurred in individuals taking this medication, particularly when combined with opioid pain medications or in those with pre-existing lung or breathing issues. The risk is 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 planning 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 male animals, and birth defects have occurred in the offspring of male animals treated with this medication. Although it is unknown whether these effects occur in humans, it is crucial to have this conversation.

If you are pregnant or plan to become pregnant, inform your doctor to discuss the benefits and risks of using this medication during pregnancy.

• CNS depressants (e.g., opioids, benzodiazepines, alcohol): Increased risk of additive CNS depression, somnolence, respiratory depression, and sedation. Concomitant use should be approached with caution, and dose reduction of one or both agents may be necessary.
• Thiazolidinediones (e.g., pioglitazone, rosiglitazone): Increased risk of peripheral edema and weight gain when co-administered with pregabalin.

• Angiotensin-converting enzyme (ACE) inhibitors: May increase risk of angioedema when co-administered with pregabalin.

• Dizziness
• Somnolence
• Peripheral edema (swelling of hands, feet, ankles)
• Weight gain
• Blurred vision or other visual disturbances
• Suicidal thoughts or behavior (new or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania)
• Signs of hypersensitivity reactions (e.g., angioedema, rash, hives)
• Muscle pain, tenderness, or weakness (rare, but could indicate rhabdomyolysis)
• Respiratory depression (especially with concomitant opioid use)

Pregabalin is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown developmental toxicity (e.g., skeletal abnormalities, growth retardation) at doses higher than human therapeutic doses. Pregabalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patients should be enrolled in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

Pregabalin is excreted into human milk. The relative infant dose is estimated to be low (around 7% of the maternal weight-adjusted dose). Monitor breastfed infants for sedation, poor feeding, and adequate weight gain. Use with caution, weighing the benefits of breastfeeding against potential infant exposure.

Safety and efficacy have not been established for all indications in pediatric patients. Approved for partial-onset seizures in children 1 month of age and older, with weight-based dosing. The 200mg capsule strength is generally not suitable for initial pediatric dosing. Increased risk of suicidal thoughts/behavior in children and adolescents.

Dose adjustment is often necessary in elderly patients due to age-related decline in renal function. Elderly patients may be more susceptible to adverse effects such as dizziness, somnolence, and peripheral edema, increasing the risk of falls. Start with lower doses and titrate slowly.

• Pregabalin is a Schedule V controlled substance due to potential for abuse and dependence. Prescribers should assess patients for a history of drug abuse and observe for signs of pregabalin misuse or abuse.
• Withdrawal symptoms can occur if pregabalin is discontinued abruptly, especially after long-term use. Taper the dose gradually over at least 1 week.
• Patients should be advised about the potential for dizziness, somnolence, and blurred vision, and cautioned against driving or operating machinery until they know how the drug affects them.
• Peripheral edema and weight gain are common side effects, particularly when co-administered with thiazolidinediones.
• Monitor for signs of angioedema, especially in patients taking ACE inhibitors concurrently.
• Counsel patients and caregivers about the risk of suicidal thoughts and behaviors and the need for immediate reporting of any new or worsening symptoms.

• For Neuropathic Pain: Gabapentin, Duloxetine, Venlafaxine, Amitriptyline, Nortriptyline, Carbamazepine (for trigeminal neuralgia)
• For Fibromyalgia: Duloxetine, Milnacipran
• For Partial-Onset Seizures: Levetiracetam, Lamotrigine, Carbamazepine, Oxcarbazepine, Topiramate, Valproic acid

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 provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this 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.