Pregabalin 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 neurotransmitters, including glutamate, norepinephrine, and substance P, which are involved in pain and seizure activity. This modulation is believed to reduce neuronal excitability.

Serious 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 high (excessive laughter and euphoria)
Twitching

If you experience extreme drowsiness, 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.

Suicidal Thoughts or Actions

Like other medications used to treat seizures, this drug may 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
Anxiety, restlessness, or irritability
Panic attacks
Mood or behavioral changes

contact your doctor right away. If suicidal thoughts or actions occur, seek medical help immediately.

Low Platelet Counts

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 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 resolve, contact your doctor:

Dizziness, drowsiness, tiredness, or weakness
Weight gain
Difficulty concentrating
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, such as foods or drugs. Be sure to describe the symptoms you experienced.
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 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 the frequency or severity of seizures 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 taper off the dosage.

While taking this medication, 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.

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, which can be fatal, 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. 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 reduce fertility and cause sperm changes in animal studies, 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 weigh the benefits and risks.

If you are pregnant or plan to become pregnant, inform your doctor 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, dizziness, 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 and angioedema risk.
• Thiazolidinediones (e.g., pioglitazone, rosiglitazone): May enhance peripheral edema and weight gain.

• Dizziness
• Somnolence
• Peripheral edema (swelling of hands/feet)
• Weight gain
• Blurred vision or other visual disturbances
• Difficulty concentrating
• Mood changes (depression, anxiety, agitation)
• Suicidal thoughts or behavior
• Unexplained muscle pain, tenderness, or weakness (rhabdomyolysis)
• Signs of angioedema (swelling of face, lips, tongue, throat)
• Signs of hypersensitivity reaction (rash, hives)

Pregabalin is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are limited human data, but animal studies have shown developmental toxicity.

Pregabalin is excreted into human milk. The amount ingested by a breastfed infant is relatively low, but effects on the infant are possible. Use with caution, monitoring the infant for sedation or poor feeding. The American Academy of Pediatrics considers it compatible with breastfeeding.

Approved for adjunctive treatment of partial onset seizures in patients 4 years of age and older. Dosing is weight-based. Safety and efficacy for other indications (neuropathic pain, fibromyalgia) not established in most pediatric age groups.

Dose adjustment is required for 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. Increased risk of falls.

• Pregabalin is a Schedule V controlled substance due to potential for abuse and dependence, though lower than Schedule IV or III. Patients should be monitored for signs of abuse.
• Withdrawal symptoms (insomnia, nausea, headache, anxiety, diarrhea, flu-like symptoms, nervousness, depression, pain, seizures) can occur if discontinued abruptly, especially after long-term use. Taper gradually over at least 1 week.
• Peripheral edema and weight gain are common side effects. Monitor patients, especially those with pre-existing cardiovascular conditions.
• Can cause blurred vision or other visual disturbances; these are usually transient and resolve with continued use or dose reduction.
• Not significantly metabolized by the liver, making it a good option for patients with hepatic impairment.
• The 300mg capsule is a high single dose; ensure it aligns with the patient's titrated maintenance dose and renal function.

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

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.