Pregabalin 25mg Capsules

Pregabalin binds with high affinity to the alpha-2-delta (α2-δ) 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 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 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
Balance problems
Confusion
Shakiness
Breathing difficulties, including slow or shallow breathing
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Memory problems or loss
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Abnormal or rapid heartbeat
Fever, chills, or sore throat
Skin sores or any unusual skin changes
Speech difficulties
Sleep disturbances
Walking difficulties
Feeling excessively euphoric (easily laughing and feeling good)
Twitching

If you experience extreme drowsiness, dizziness, or loss of consciousness, seek medical help immediately. Caregivers should also seek medical attention right away if the patient is unresponsive, uncommunicative, or unable to wake up.

Suicidal Thoughts and Behaviors

Like other medications used to treat seizures, this drug may increase the risk of suicidal thoughts and behaviors, particularly in individuals with a history of such tendencies. 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 immediately. If suicidal thoughts or behaviors occur, seek medical help right away.

Low Platelet Counts and Bleeding Risks

This medication may rarely cause low platelet counts, increasing 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 symptoms. If you or your caregiver notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Dizziness, drowsiness, tiredness, or weakness
Weight gain
Difficulty concentrating
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, 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.

Avoid consuming alcohol while taking this medication.

Before using marijuana, cannabis, or any prescription or over-the-counter medications that may impair your actions, discuss this with your doctor.

Be aware that a severe reaction called angioedema has been associated with this medication, which can be life-threatening in some cases. 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 breathing problems have occurred in individuals taking this medication, particularly when combined with other medications like opioid pain drugs, or in 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, use this medication with caution, as you may be more susceptible to side effects.

Men who plan to father a child should discuss this with their doctor, as this medication 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.

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): Increased risk of additive CNS depression (somnolence, dizziness, respiratory depression).
• Thiazolidinedione antidiabetic agents (e.g., rosiglitazone, pioglitazone): Increased risk of peripheral edema and weight gain.

• ACE inhibitors (e.g., captopril, enalapril): Potential for increased risk of angioedema.
• Other sedating medications (e.g., antihistamines, muscle relaxants): Additive sedative effects.

• Dizziness
• Somnolence
• Blurred vision
• Weight gain
• Peripheral edema
• Suicidal thoughts or behavior
• Mood changes
• Hypersensitivity reactions (e.g., angioedema, rash)
• Muscle pain, tenderness, or weakness (rare, rhabdomyolysis)
• Respiratory depression (especially with concomitant CNS depressants)

Category C. Studies in animals have shown reproductive toxicity. 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 amount ingested by a breastfed infant is low. Monitor infants for sedation (e.g., drowsiness, poor feeding). Use with caution.

Safety and efficacy have not been established in pediatric patients for most indications. Not recommended for use in children.

Dose adjustment is necessary in elderly patients with impaired renal function. Elderly patients may be more susceptible to dizziness, somnolence, and falls. Start with lower doses and titrate slowly.

• Pregabalin is a Schedule V controlled substance due to potential for abuse and dependence, though lower than Schedule IV. Prescribers should be aware of this potential.
• Abrupt discontinuation can lead to withdrawal symptoms; taper dose gradually over at least 1 week.
• Patients should be advised about the potential for dizziness, somnolence, and blurred vision, especially at the start of therapy or with dose increases.
• Weight gain and peripheral edema are common side effects; monitor patients, especially those with pre-existing cardiovascular conditions.
• No significant drug-drug interactions via CYP450 enzymes, making it a favorable option for patients on multiple medications.
• The 25mg capsule is particularly useful for initiating therapy, especially in patients with renal impairment or those who are sensitive to medication side effects, allowing for very gradual titration.

• For Neuropathic Pain: Gabapentin, Duloxetine, Venlafaxine, Tricyclic Antidepressants (e.g., Amitriptyline), Carbamazepine.
• For Fibromyalgia: Duloxetine, Milnacipran, Amitriptyline.
• For Partial-Onset Seizures: Other antiepileptic drugs (e.g., Levetiracetam, Lamotrigine, Carbamazepine, Valproate).
• For Generalized Anxiety Disorder: SSRIs (e.g., Escitalopram, Sertraline), SNRIs (e.g., Venlafaxine, Duloxetine), Benzodiazepines (short-term).

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, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. 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 amount, and the time it occurred.