Gabapentin 800mg Tablets

Gabapentin is structurally related to the neurotransmitter GABA but does not bind to GABA-A or GABA-B receptors, nor does it affect 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 subunit of voltage-gated calcium channels in the central nervous system. This binding is believed to modulate the release of excitatory neurotransmitters involved in epileptogenesis and nociception.

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
Neurological problems, such as:
+ Trouble controlling body movements
+ Twitching
+ Change in balance
+ Trouble swallowing or speaking
+ Memory problems or loss
+ Change in eyesight
+ Inability to control eye movements
Confusion, difficulty focusing, or changes in behavior
Shakiness
Respiratory problems, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Swelling in the arms or legs
Severe dizziness or fainting
Excessive sleepiness, dizziness, or fainting

If you or your caregiver notice any of the following, seek medical help immediately:
Unresponsiveness
Unusual behavior
Failure to wake up

Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal ideation. If you experience any new or worsening symptoms, such as:
Depression
Anxiety
Restlessness
Irritability
Panic attacks
Mood or behavioral changes

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

Severe Skin Reactions

This medication may cause severe skin reactions, which can be life-threatening. If you experience any of the following symptoms, seek medical help right away:
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
Fatigue or weakness
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 attention if they bother you or persist:
Dizziness
Drowsiness
Fatigue
Weakness
Diarrhea
Upset stomach
Nausea 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 allergic reaction you experienced, including any symptoms that occurred.
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 medications and health issues.

Remember, do not start, stop, or modify 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 guide you on how to gradually taper off the dosage.

There is a risk of severe breathing problems associated with this medication, particularly when used with other medications like opioid pain drugs 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, consult with your doctor to discuss the potential benefits and risks to you and your baby.

Specific Guidance for Seizure Treatment

If you experience changes in your seizures or if they worsen after starting this medication, consult with your doctor.

• Opioids (e.g., Morphine, Hydrocodone, Oxycodone): Increased risk of respiratory depression, profound sedation, coma, and death. Use lowest effective doses and shortest duration possible. Monitor for signs of respiratory depression and sedation.
• Other CNS Depressants (e.g., Benzodiazepines, Alcohol, Antihistamines, Tricyclic Antidepressants): Increased risk of additive CNS depression, including sedation and somnolence.

• Antacids (containing aluminum and magnesium): May decrease gabapentin bioavailability by up to 24%. Administer gabapentin at least 2 hours after antacid administration.
• Naproxen: May increase gabapentin exposure (AUC) by 12-15%. Clinical significance is generally minor but monitor for increased gabapentin effects.

• Dizziness
• Somnolence
• Ataxia
• Peripheral edema
• Fatigue
• Unusual changes in mood or behavior (e.g., agitation, depression, suicidal thoughts)
• New or worsening seizures
• Difficulty breathing or shallow breathing
• Severe skin rash, fever, swollen lymph nodes (signs of DRESS)

Gabapentin 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. Animal studies have shown developmental toxicity.

Gabapentin is excreted into human breast milk. The decision to breastfeed should consider the potential for infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Monitor breastfed infants for drowsiness, poor feeding, and weight gain.

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 established in pediatric patients. Behavioral problems (e.g., emotional lability, hostility, hyperkinesia) have been reported more frequently in children 3-12 years of age.

Elderly patients are more likely to have decreased renal function, requiring dose adjustment. They may also be more susceptible to the central nervous system side effects (e.g., dizziness, somnolence, ataxia). Start with lower doses and titrate slowly, monitoring closely for adverse effects.

• Gabapentin should be titrated slowly to minimize CNS side effects like dizziness and somnolence. Abrupt discontinuation can precipitate withdrawal seizures in epileptic patients.
• Bioavailability is dose-dependent and saturable; higher doses do not proportionally increase absorption. This is why it's often given in divided doses.
• Renal dose adjustment is critical as gabapentin is almost exclusively renally excreted. Always check renal function before initiating and periodically during therapy.
• While not a controlled substance federally, some states have classified gabapentin as a Schedule V controlled substance due to abuse potential.
• Counsel patients on the risk of respiratory depression, especially if they are also taking opioids or other CNS depressants, and to avoid alcohol.
• Gabapentin is not effective for acute pain and is primarily used for neuropathic pain or as an adjunctive therapy for partial seizures.

• For Neuropathic Pain: Pregabalin, Duloxetine, Venlafaxine, Tricyclic Antidepressants (e.g., Amitriptyline), Carbamazepine (for trigeminal neuralgia).
• For Epilepsy (Partial Seizures): Levetiracetam, Lamotrigine, Carbamazepine, Oxcarbazepine, Valproic Acid, Phenytoin, Topiramate.

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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. This information will help healthcare professionals provide you with the most effective treatment.