Gabapentin 600mg Tablet(once Daily)

The exact mechanism of action is unknown, but gabapentin is structurally related to the neurotransmitter GABA. It does not bind to GABA-A or GABA-B receptors, nor does it inhibit GABA uptake or degradation. Its primary mechanism is thought to involve binding to the alpha-2-delta (α2δ) subunit of voltage-gated calcium channels in the central nervous system, which may modulate the release of excitatory neurotransmitters involved in 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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Neurological problems, such as:
+ Trouble controlling body movements or twitching
+ Changes in balance or coordination
+ Difficulty swallowing or speaking
+ Memory problems or loss
+ Changes in eyesight or inability to control eye movements
Confusion, difficulty focusing, or changes in behavior
Shakiness or tremors
Respiratory problems, such as:
+ 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 fainting
Excessive sleepiness, dizziness, or loss of consciousness

If you or your caregiver notice any of these symptoms, seek medical help immediately. If the patient is unresponsive, does not answer or react normally, or cannot be awakened, call for emergency medical assistance.

Important Warning: Suicidal Thoughts and Behaviors

Like other medications used to treat seizures, this drug may increase the risk of suicidal thoughts or behaviors, particularly in people with a history of suicidal ideation or attempts. Monitor your mood and behavior, and contact your doctor right away if you experience any new or worsening symptoms, such as:
Depression
Anxiety, restlessness, or irritability
Panic attacks
Changes in mood or behavior
Suicidal thoughts or actions

Severe Skin Reactions

This medication may cause severe skin reactions, which can be life-threatening. Seek medical help immediately if you experience any of the following symptoms:
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 or muscle pain
Shortness of breath
Unexplained bruising or bleeding
Fatigue or weakness
Dark urine or yellow skin and eyes
Difficulty 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 do not resolve:
Dizziness, drowsiness, fatigue, or weakness
Diarrhea, nausea, or vomiting
* Dry mouth

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 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 whether 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.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before operating a vehicle or engaging in activities that require alertness, wait until you understand how this drug affects you.

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

Before consuming alcohol, marijuana, or other forms of cannabis, or using prescription or over-the-counter medications that may impair your reactions, consult with your doctor. Note that this medication is not interchangeable with gabapentin enacarbil (Horizant), and you should not use them interchangeably; discuss any concerns with your doctor.

To minimize the risk of side effects, do not abruptly discontinue this medication without consulting your doctor. If you need to stop taking this drug, your doctor will provide guidance on gradually tapering off the medication.

There is a risk of severe respiratory problems associated with this medication, particularly when used in conjunction with other drugs like opioid pain medications, or in individuals with 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, discuss them with your doctor.

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

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.

• Opioids (e.g., Morphine, Hydrocodone, Oxycodone): Increased CNS depression (somnolence, respiratory depression).
• CNS Depressants (e.g., Alcohol, Benzodiazepines, Antihistamines, Sedatives): Additive CNS depressant effects.
• Antacids (containing aluminum and magnesium): May decrease gabapentin bioavailability (for IR gabapentin, separate administration by at least 2 hours; less relevant for Gralise due to different absorption profile, but still a consideration).

• Dizziness
• Somnolence
• Ataxia
• Peripheral edema
• Fatigue
• Nausea
• Vomiting
• Diarrhea
• Constipation
• Weight gain
• Mood changes (depression, anxiety, agitation)
• Suicidal thoughts or behavior
• Signs of hypersensitivity reaction (rash, fever, lymphadenopathy, facial swelling)

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. Consider enrolling patients in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

Gabapentin is excreted into human milk. The amount ingested by a breastfed infant is small. Generally considered compatible with breastfeeding, but monitor infant for sedation, poor feeding, or weight gain.

Safety and effectiveness of Gralise in pediatric patients (under 18 years of age) have not been established. Gralise is not indicated for pediatric use.

Renal function declines with age, and gabapentin is renally excreted. Dose adjustments are necessary based on creatinine clearance. Elderly patients may be more sensitive to the adverse effects of gabapentin, particularly dizziness and somnolence, increasing the risk of falls.

• Gralise is an extended-release formulation of gabapentin specifically designed for once-daily dosing with the evening meal for Postherpetic Neuralgia (PHN). It is NOT interchangeable with immediate-release gabapentin.
• Always take Gralise with the evening meal to ensure proper absorption and efficacy.
• Titration is crucial to minimize side effects and achieve therapeutic benefit. Do not start at a high dose.
• Renal dose adjustments are critical for Gralise, and the specific adjustments differ from immediate-release gabapentin.
• Monitor for CNS depression (dizziness, somnolence) and mood changes, especially suicidal ideation, as these are common side effects.

• Pregabalin (Lyrica)
• Tricyclic antidepressants (e.g., Amitriptyline, Nortriptyline)
• SNRIs (e.g., Duloxetine, Venlafaxine)
• Topical Lidocaine patch
• Capsaicin topical

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. 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, a patient fact sheet that provides crucial information about its use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider for clarification.

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 detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.