Pregabalin 150mg 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 calcium influx at nerve terminals, thereby reducing the release of several excitatory neurotransmitters, including glutamate, norepinephrine, and substance P. This action is believed to contribute to its analgesic, anxiolytic, and anticonvulsant effects.

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 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 drowsiness, 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.

Like other medications used to treat seizures, this drug may rarely 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, irritability, panic attacks, or mood changes, contact your doctor right away. If suicidal thoughts or actions occur, seek medical help immediately.

In rare cases, this medication may cause low platelet counts, which can increase the risk of bleeding. If you experience unexplained bruising or bleeding, contact your doctor right away.

Other Possible Side Effects

Most medications can cause side effects, but many people may not experience any or may only have mild side effects. If you experience any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor or seek medical attention:

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 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 the medication's safety and efficacy.
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, it is recommended that you 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 known as 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.

There is a risk of severe breathing problems when taking this medication, particularly in individuals who are also taking opioid pain medications or have pre-existing lung or breathing issues. This risk may be higher in people over 65 years old, and in some cases, 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 their offspring. 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 taking this medication during pregnancy.

• CNS depressants (e.g., opioids, benzodiazepines, alcohol, other sedatives): Increased risk of respiratory depression, profound sedation, coma, and death. Concomitant use should be reserved for patients for whom alternative treatment options are inadequate.
• Angiotensin-converting enzyme (ACE) inhibitors: Potential for increased risk of angioedema when co-administered with pregabalin.

• Thiazolidinedione antidiabetic agents (e.g., rosiglitazone, pioglitazone): Increased risk of weight gain and peripheral edema.
• Other drugs causing dizziness/somnolence: Additive effects.

• Dizziness
• Somnolence
• Ataxia
• Peripheral edema
• Weight gain
• Blurred vision
• Diplopia
• Difficulty concentrating
• Dry mouth
• Suicidal thoughts or behavior
• Mood changes
• Signs of hypersensitivity (rash, hives, swelling of face/lips/tongue/throat)
• Signs of respiratory depression (slow, shallow breathing)

Pregabalin is classified as Pregnancy Category C. Studies in animals have shown developmental toxicity (skeletal abnormalities, growth retardation, increased mortality) at doses higher than human therapeutic doses. 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 of pregabalin ingested by a breastfed infant is estimated to be 7% of the maternal weight-adjusted dose. Monitor breastfed infants for sedation, poor feeding, and weight gain. Use with caution, weighing the benefits of breastfeeding against the potential risks.

Approved for adjunctive therapy of partial onset seizures in patients 4 years of age and older. Safety and efficacy for other indications (neuropathic pain, fibromyalgia) have not been established in pediatric patients. Dose adjustments are based on weight and renal function.

Dose adjustments are necessary for elderly patients due to age-related decreases in renal function. Elderly patients may be more susceptible to adverse effects such as dizziness, somnolence, and peripheral edema. Start with lower doses and titrate slowly.

• Pregabalin should be tapered gradually over at least 1 week when discontinuing to minimize withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety, diarrhea, flu-like symptoms, seizures).
• Patients should be advised about the potential for dizziness and somnolence, especially at the initiation of therapy and with dose increases.
• Weight gain and peripheral edema are common side effects; monitor patients, especially those with pre-existing cardiovascular conditions.
• Due to its abuse potential, prescribers should assess patients for a history of drug abuse and observe for signs of misuse or abuse.
• Pregabalin is not significantly metabolized by the liver, making it a good option for patients with hepatic impairment without dose adjustment.
• The 150mg capsule is a common strength for maintenance dosing across various indications, often taken once or twice daily depending on the total daily dose and patient tolerance.

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

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 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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.