Gabapentin 100mg 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. 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 involved in nociception and seizure activity.

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, including:
+ 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 right away:
Unresponsiveness
Unusual behavior or lack of reaction
Failure to wake up

Like other seizure medications, 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 immediately. If you have suicidal thoughts or actions, seek help right away.

Severe Skin Reactions

This medication may cause severe skin reactions, which can be life-threatening and affect internal organs. Seek medical attention 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
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, 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 concerns or questions, 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, about your treatment. This will help ensure your safety and prevent potential interactions with other medications or medical procedures.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require alertness. This will help prevent accidents and ensure your safety.

Lab Tests and Medical Procedures
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab personnel about your treatment, and follow your doctor's instructions for regular blood work and other lab tests.

Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor. These substances may interact with your medication and increase the risk of adverse effects.

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

Stopping Treatment
Do not stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to discontinue treatment, your doctor will guide you on how to gradually stop the medication to minimize potential risks.

Respiratory Risks
Severe breathing problems have been reported in people taking this medication, especially when combined with opioid pain medications or in those with pre-existing lung or breathing problems. Older adults (65 years and above) may be at higher risk. In some cases, breathing problems have been fatal. If you have concerns, discuss them with your doctor.

Age-Related Precautions
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Additionally, children between 3 and 12 years old may have a higher risk of mood or behavior problems when taking this medication.

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

Seizure Management
If you experience changes in your seizure pattern or worsening of seizures after starting this medication, consult your doctor to adjust your treatment plan as needed.

• Opioids (e.g., Morphine, Hydrocodone, Oxycodone): Increased risk of respiratory depression, sedation, and death. Use lowest effective doses and monitor closely.
• CNS Depressants (e.g., Benzodiazepines, Alcohol, Barbiturates): Increased risk of profound sedation, respiratory depression, and hypotension.

• Antacids (containing aluminum and magnesium): Decrease gabapentin bioavailability by up to 20%. Administer gabapentin at least 2 hours after antacid administration.
• Naproxen: May increase gabapentin exposure (AUC and Cmax) by 12-15%. Clinical significance is usually minor but monitor for increased gabapentin effects.

• Dizziness
• Somnolence
• Ataxia
• Fatigue
• Peripheral edema
• Weight gain
• Blurred vision
• Diplopia
• Tremor
• Nystagmus
• Behavioral changes (agitation, aggression, hostility)
• Mood changes (depression, anxiety, suicidal ideation)
• Signs of hypersensitivity (rash, fever, lymphadenopathy, facial swelling)
• Signs of respiratory depression (shallow breathing, confusion, extreme drowsiness)

Gabapentin is classified as Pregnancy Category C. Animal studies have shown adverse effects on fetal development, but 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. Discuss risks and benefits with a healthcare provider.

Gabapentin is excreted into human breast milk. The amount ingested by the infant is relatively low. Generally considered compatible with breastfeeding, but monitor the infant for sedation, poor feeding, or weight gain.

Approved for adjunctive treatment of partial seizures in children 3 years and older. Dosing is weight-based. Monitor for behavioral changes (e.g., aggression, hostility, hyperactivity) which may be more common in children.

Elderly patients may be more sensitive to the side effects of gabapentin (e.g., dizziness, somnolence, ataxia) and are more likely to have impaired renal function, requiring dose adjustments. Start with lower doses and titrate slowly.

• Gabapentin's absorption is saturable, meaning bioavailability decreases with increasing doses. This is why it's often dosed multiple times a day and titrated slowly.
• Despite its name, gabapentin does not directly act on GABA receptors. Its primary mechanism is thought to involve binding to the alpha-2-delta subunit of voltage-gated calcium channels.
• Gabapentin is not metabolized by the liver, making it a good option for patients with hepatic impairment. However, it is exclusively renally cleared, necessitating significant dose adjustments in renal dysfunction.
• Abrupt discontinuation of gabapentin, especially in patients on high doses or those with epilepsy, can precipitate withdrawal symptoms (anxiety, insomnia, nausea, pain, sweating) or status epilepticus. Taper slowly over at least 1 week.
• Be aware of the potential for misuse and abuse, particularly in patients with a history of substance abuse, due to its euphoric effects at high doses. Some states have scheduled gabapentin as a controlled substance.
• The 2019 FDA warning regarding serious breathing problems with CNS depressants or in patients with respiratory risk factors is crucial for patient safety.

• For Neuropathic Pain: Pregabalin, Duloxetine, Venlafaxine, Amitriptyline, Nortriptyline, 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 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, a patient fact sheet that 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, we encourage you 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.