Pregabalin 75mg 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 is believed to reduce neuronal excitability.

Serious Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 (easy laughing and feeling good)
Twitching

If you feel extremely sleepy, dizzy, or pass out, seek medical help immediately. Caregivers or others should seek medical help right away if the patient is unresponsive, does not answer or react normally, or cannot be awakened.

Suicidal Thoughts or Actions

Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal thoughts or actions. Contact your doctor immediately if you experience any new or worsening symptoms, such as:

Depression
Feeling nervous, restless, or irritable
Panic attacks
Changes in mood or behavior
Suicidal thoughts or actions

Low Platelet Counts

This medication may rarely cause low platelet counts, which can increase the risk of bleeding. Contact your doctor immediately if you experience any unexplained bruising or bleeding.

Other Side Effects

Most people 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 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

These are not all the possible side effects that may occur. If you have questions about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or 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 you experienced, including any symptoms that occurred.
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 provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
Any existing health problems you have

This information will help your doctor determine whether it is safe for you to take this medication in combination with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.

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 seizures, and they become different or 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 to minimize potential risks.

While taking this medication, it is recommended that you avoid consuming alcohol.

Before using marijuana, other forms of cannabis, or prescription and over-the-counter drugs 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. Symptoms may 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.

Severe breathing problems, which can be fatal, have occurred in individuals taking this medication, especially 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 the potential risks with their doctor, as this medication 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 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, barbiturates, muscle relaxants): Increased risk of additive CNS depression (somnolence, dizziness, respiratory depression).
• Thiazolidinediones (e.g., pioglitazone, rosiglitazone): Increased 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)
• Dry mouth
• Suicidal thoughts or behavior
• Changes in mood or behavior (e.g., agitation, depression, anxiety)
• Hypersensitivity reactions (e.g., angioedema, rash, hives)
• Muscle pain or weakness (rhabdomyolysis symptoms)
• Respiratory depression (especially with concomitant CNS depressants)

Pregabalin is classified as Pregnancy Category C. Studies in animals have shown developmental toxicity (skeletal abnormalities, growth retardation, increased fetal mortality) at doses greater than or equal to clinical exposure. 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.

Pregabalin is excreted into human milk. The amount ingested by a breastfed infant is estimated to be low. Monitor infants for sedation, poor feeding, and weight gain. The American Academy of Pediatrics considers pregabalin's effect on nursing infants as 'unknown, but may be of concern'. Weigh the benefits of breastfeeding against the potential risks to the infant.

Safety and efficacy have not been established for all indications in pediatric patients. For adjunctive treatment of partial onset seizures, dosing is weight-based for children 4 years and older. Younger children may be more susceptible to adverse effects like somnolence and dizziness. Long-term effects on growth and development are unknown.

Elderly patients are more likely to have decreased renal function, requiring dose adjustments. They may also be more susceptible to CNS adverse effects (dizziness, somnolence, ataxia), increasing the risk of falls. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

• Pregabalin should be tapered gradually over at least 1 week when discontinuing to minimize withdrawal symptoms.
• Patients should be advised about the potential for peripheral edema and weight gain, especially when co-administered with thiazolidinediones.
• Monitor for signs of angioedema (swelling of face, mouth, throat) which can be life-threatening.
• Patients with a history of substance abuse may be at higher risk for misuse or abuse, though pregabalin's abuse potential is generally considered low compared to opioids or benzodiazepines.
• The onset of pain relief may take several days to a week, and full therapeutic effect may take longer.

• Gabapentin (for neuropathic pain, seizures)
• Duloxetine (for neuropathic pain, fibromyalgia)
• Venlafaxine (for neuropathic pain)
• Amitriptyline (for neuropathic pain)
• Nortriptyline (for neuropathic pain)
• Carbamazepine (for neuropathic pain, seizures)
• Oxcarbazepine (for seizures)
• Topiramate (for seizures, neuropathic pain)
• Valproic acid (for seizures)

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 provides crucial information for patients. Please read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult 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 quantity, and the time it occurred.