Pregabalin 100mg 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 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 and seizure activity. This modulation leads to a reduction in 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 extremely happy or euphoric (easy laughing and feeling good)
Twitching

If you experience any of the following, seek medical help right away:
Feeling extremely sleepy, dizzy, or passing out
Not responding, not answering, or not reacting normally
Not waking up

Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or actions, especially in people who have had suicidal thoughts or actions in the past. Contact your doctor immediately if you notice any new or worsening symptoms, such as:
Depression
Feeling nervous, restless, or irritable
Panic attacks
Other changes in mood or behavior
Suicidal thoughts or actions

Low platelet counts have been reported with this medication, which may increase the risk of bleeding. Contact your doctor right away if you experience any unexplained bruising or bleeding.

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 go away:
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 a comprehensive list of all 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, 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 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.

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.

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 may be 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 this medication with their doctor, as it has been shown to reduce 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 weigh the potential risks.

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, tricyclic antidepressants): Increased risk of additive CNS depression (somnolence, dizziness, respiratory depression).
• Thiazolidinediones (e.g., pioglitazone, rosiglitazone): Increased risk of weight gain and peripheral edema when co-administered with pregabalin.

• Dizziness
• Somnolence
• Peripheral edema (swelling of hands, feet, ankles)
• 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 (rash, hives, swelling of face/lips/tongue/throat)
• Muscle pain or weakness (rare, but can indicate rhabdomyolysis)

Pregabalin is classified as Pregnancy Category C. 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. A pregnancy registry is available.

Pregabalin is excreted into human milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother. Monitor breastfed infants for sedation, poor feeding, and weight gain.

Safety and efficacy have not been established in pediatric patients under 18 years of age for any indication. Use is generally not recommended.

Elderly patients may be more susceptible to dose-related adverse effects (dizziness, somnolence, peripheral edema) due to age-related decline in renal function. Dose adjustments are often necessary based on creatinine clearance. Start with lower doses and titrate slowly.

• Pregabalin should be tapered gradually over at least 1 week when discontinuing to minimize withdrawal symptoms.
• It is not metabolized by the liver, making it a good option for patients with hepatic impairment.
• Dose adjustments are crucial in patients with renal impairment; failure to adjust can lead to increased side effects and toxicity.
• Patients should be warned about potential for weight gain and peripheral edema, especially if co-administered with thiazolidinediones.
• While not a controlled substance in all countries, it is Schedule V in the US due to potential for abuse and dependence, particularly at higher doses or in individuals with a history of substance abuse.

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

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, which is a valuable resource that provides important information about its use. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it was taken.