Gabapentin 300mg Tablet(once Daily)

The exact mechanism of action of gabapentin is unknown. It 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. Gabapentin binds with high affinity to the alpha-2-delta (α2δ) subunit of voltage-gated calcium channels, which is thought to modulate the release of excitatory neurotransmitters involved in neuropathic pain.

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 problems, such as:
+ Trouble controlling body movements
+ Twitching
+ Change in balance
+ Trouble swallowing or speaking
Cognitive issues, such as:
+ Memory problems or loss
+ Change in eyesight
Ocular problems, such as:
+ Inability to control eye movements
Behavioral changes, such as:
+ Feeling confused
+ Difficulty focusing
+ Changes in behavior
Motor problems, such as:
+ Shakiness
Respiratory issues, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
Cardiovascular problems, such as:
+ Blue or gray color of the skin, lips, nail beds, fingers, or toes
Swelling in the arms or legs
Severe dizziness or passing out

If you experience extreme sleepiness, dizziness, or pass out, seek medical help right away. Caregivers should seek medical help immediately 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 or actions, particularly in individuals 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 medical help immediately.

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 or 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:

Dizziness
Sleepiness
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 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 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 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.

This medication may interfere with certain laboratory tests, so it is crucial to 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 laboratory tests.

Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor. Be aware that this medication is not interchangeable with gabapentin enacarbil (Horizant), and you should not use them as substitutes for each other. If you have any questions or concerns, discuss them 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 how to gradually taper 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. This risk is also higher in individuals with pre-existing lung or breathing problems and in those over 65 years old. In some cases, these 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.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You and your doctor 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 risk of respiratory depression, sedation, coma, and death. Use lowest effective doses and monitor closely.
• CNS Depressants (e.g., Benzodiazepines, Barbiturates, Alcohol, Antihistamines, Muscle Relaxants): Increased risk of additive CNS depression.

• Antacids (containing aluminum and magnesium): May decrease gabapentin bioavailability (for immediate-release gabapentin; less relevant for Gralise due to its formulation and food requirement, but separation by 2 hours is generally recommended for IR forms).
• Naproxen: May increase gabapentin exposure (for immediate-release gabapentin; clinical significance for Gralise is unknown).

• Dizziness
• Somnolence
• Ataxia
• Fatigue
• Peripheral edema
• Weight gain
• Blurred vision
• Tremor
• Unusual changes in mood or behavior (e.g., agitation, depression, anxiety, suicidal thoughts)
• Signs of hypersensitivity reaction (rash, fever, swollen lymph nodes)

Category C. Studies in animals have shown adverse effects on fetal development. 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.

Gabapentin is excreted into human milk. The effect on breastfed infants is unknown. Caution should be exercised when gabapentin is administered to a nursing woman. Monitor infant for sedation and poor feeding.

Gralise (extended-release gabapentin) is not indicated for use in pediatric patients. Safety and effectiveness have not been established in pediatric patients.

Elderly patients are more likely to have decreased renal function, which may require dose adjustments for immediate-release gabapentin. Gralise is not recommended for patients with CrCl <60 mL/min. Elderly patients may also be more sensitive to the CNS depressant effects (dizziness, somnolence, ataxia). Start with lower doses and titrate carefully.

• Gralise is an extended-release formulation of gabapentin specifically approved for once-daily dosing for Postherpetic Neuralgia (PHN). It is NOT interchangeable with immediate-release gabapentin (Neurontin) on a milligram-for-milligram basis.
• Gralise must be taken with the evening meal to ensure proper absorption and efficacy.
• Titration is crucial for Gralise to minimize side effects and achieve therapeutic levels.
• Gabapentin is renally cleared; monitor renal function, especially in elderly patients. Gralise is not recommended for moderate to severe renal impairment.
• Warn patients about CNS depressant effects (dizziness, somnolence, ataxia) and the risk of suicidal thoughts or behavior.
• Do not discontinue gabapentin abruptly, as this can lead to withdrawal symptoms or status epilepticus (if used for seizures, though Gralise is not indicated for seizures).

• Pregabalin (Lyrica) - another alpha-2-delta ligand for neuropathic pain
• Tricyclic antidepressants (e.g., Amitriptyline, Nortriptyline) - for neuropathic pain
• SNRIs (e.g., Duloxetine, Venlafaxine) - for neuropathic pain
• Topical Lidocaine patches - for localized neuropathic pain (e.g., PHN)
• Capsaicin topical - for localized neuropathic pain (e.g., PHN)

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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.