Gabapentin 400mg Capsules

Gabapentin is structurally related to the neurotransmitter GABA but does not bind to GABA-A or GABA-B receptors, nor does it inhibit GABA uptake or degradation. Its precise mechanism of action is unknown, but it is thought to exert its effects by binding with high affinity to the alpha-2-delta (α2δ) subunit of voltage-gated calcium channels in the central nervous system. This binding is believed to modulate the release of excitatory neurotransmitters, thereby reducing neuronal excitability and pain transmission.

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 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
Neurological symptoms, such as:
+ Trouble controlling body movements
+ Twitching
+ Change in balance
+ Trouble swallowing or speaking
Cognitive symptoms, such as:
+ Memory problems or loss
+ Change in eyesight
+ Inability to control eye movements
Behavioral changes, such as:
+ Feeling confused
+ Difficulty focusing
+ Changes in behavior
Physical symptoms, such as:
+ Shakiness
+ Trouble breathing, slow breathing, or shallow breathing
+ Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
+ Swelling in the arms or legs
+ Severe dizziness or passing out
If you feel extremely sleepy, dizzy, or pass out, seek medical help immediately. Caregivers should seek medical help if the patient is unresponsive, uncommunicative, or unable to wake up.

Suicidal Thoughts or Actions

Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. If you experience any new or worsening symptoms, such as:

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

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

Severe Skin Reactions

This medication may cause severe skin reactions, which can be life-threatening and affect internal organs. Seek medical help immediately if you experience:

Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever, chills, or sore throat
Body aches
Shortness of breath
Muscle pain or weakness
Unexplained bruising or bleeding
Feeling extremely tired or weak
Dark urine or yellow skin and eyes
Trouble urinating
Swollen glands

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 help if they bother you or persist:

Feeling dizzy, sleepy, tired, or weak
Diarrhea, upset stomach, or vomiting
* Dry mouth

This is not an exhaustive list of potential side effects. If you have questions or concerns, 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 or are undergoing dialysis.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health issues.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.

Important Warnings and Cautions

When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.

To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you.

This medication may interfere with certain laboratory tests. Be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug. Additionally, follow your doctor's instructions for regular blood work and other laboratory tests.

Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.

Note that this medication is not interchangeable with gabapentin enacarbil (Horizant). If you have any questions or concerns, discuss them with your doctor.

Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue this medication, your doctor will provide guidance on how to gradually taper off the drug.

There is a risk of severe breathing problems associated with this medication, particularly when taken with certain other medications (such as opioid pain medications) or in individuals with pre-existing lung or breathing problems. This risk may be higher in people over 65 years old. In some cases, breathing problems have been fatal. If you have concerns, discuss them with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

For children between 3 and 12 years old, use this medication with caution, as they may be at a higher risk of developing mood or behavioral problems.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to you and your baby.

Specific Considerations for Seizure Treatment

If you experience changes in your seizure patterns or worsening seizures after starting this medication, consult with your doctor.

• Opioids (e.g., morphine, hydrocodone, oxycodone): Increased risk of respiratory depression, profound sedation, coma, and death. Co-prescription should be avoided unless benefits outweigh risks, and patients should be monitored closely.
• Other CNS depressants (e.g., benzodiazepines, alcohol, sedating antihistamines, tricyclic antidepressants): Increased risk of CNS depression, somnolence, dizziness.

• Antacids (containing aluminum and magnesium): May decrease gabapentin bioavailability by up to 20%. Administer gabapentin at least 2 hours after antacid administration.
• Naproxen: May increase gabapentin exposure by 12-15%.

• Dizziness
• Somnolence
• Ataxia
• Fatigue
• Peripheral edema
• Blurred vision
• Tremor
• Weight gain
• Signs of respiratory depression (slow, shallow breathing, unusual sleepiness)
• Changes in mood or behavior (e.g., agitation, depression, suicidal thoughts)

Category C. Animal studies have shown developmental 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. Pregnancy registries are available.

Gabapentin is excreted into human milk. The amount ingested by a breastfed infant is small. Monitor infants for sedation and poor feeding. Use with caution, weighing benefits of breastfeeding against potential risks.

Approved for adjunctive treatment of partial seizures in children 3 years and older. Safety and efficacy for other indications (e.g., neuropathic pain) are not well-established in pediatric populations. Dose adjustments based on weight and age are necessary for epilepsy.

Elderly patients are more likely to have decreased renal function, requiring dose adjustment. They are also more susceptible to dose-related adverse effects such as somnolence, dizziness, and ataxia. Increased risk of respiratory depression when co-administered with opioids or other CNS depressants.

• Gabapentin's absorption is saturable; higher doses do not proportionally increase plasma concentrations. This is why it's often dosed TID and why very high single doses are not effective.
• Always titrate gabapentin slowly to minimize CNS side effects like dizziness and somnolence.
• Do not abruptly discontinue gabapentin, especially in patients with epilepsy, as this can precipitate seizures or withdrawal symptoms.
• Be vigilant for signs of respiratory depression, particularly when co-prescribing with opioids or in patients with respiratory compromise.
• Gabapentin is not metabolized by the liver, making it a good option for patients with hepatic impairment, but dose adjustment is crucial for renal impairment.

• Pregabalin (Lyrica) - another alpha-2-delta ligand, similar mechanism and uses.
• Carbamazepine (Tegretol) - for neuropathic pain (e.g., trigeminal neuralgia) and seizures.
• Oxcarbazepine (Trileptal) - for seizures.
• Lamotrigine (Lamictal) - for seizures and neuropathic pain.
• Duloxetine (Cymbalta) - for neuropathic pain (e.g., diabetic neuropathy, fibromyalgia).
• Venlafaxine (Effexor XR) - for neuropathic pain.
• Tricyclic antidepressants (e.g., amitriptyline, nortriptyline) - for neuropathic pain.
• Topiramate (Topamax) - for seizures and neuropathic pain.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.