Gabapentin 250mg/5ml Solution

Gabapentin is structurally related to the neurotransmitter GABA but does not bind to GABA-A or GABA-B receptors, nor is it converted metabolically into GABA or a GABA agonist. Its precise mechanism of action is unknown, but it is thought to involve binding to the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system, which may modulate the release of excitatory neurotransmitters.

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
Confusion, difficulty focusing, or changes in behavior
Shakiness
Respiratory problems, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
Cyanosis (blue or gray discoloration of the skin, lips, nail beds, fingers, or toes)
Swelling in the arms or legs
Severe dizziness or fainting

If you experience excessive sleepiness, dizziness, or fainting, seek medical help immediately. Caregivers should seek medical attention if the patient is unresponsive, uncommunicative, or unable to wake up.

Suicidal Thoughts or Actions

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 behavior. If you or your caregiver notice any new or worsening symptoms, such as:

Depression
Anxiety
Restlessness
Irritability
Panic attacks
Mood or behavioral changes

contact your doctor immediately. If suicidal thoughts or actions occur, 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
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 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, 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 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.

To avoid accidents, do not drive or engage in activities that require your full attention until you understand how this medication affects you. Additionally, be aware that this drug may interfere with certain laboratory tests, so it is crucial to notify your healthcare providers and laboratory personnel about your treatment. Follow your doctor's instructions for regular blood work and 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 to discuss potential risks and interactions. It is also important to note that this medication is not interchangeable with gabapentin enacarbil (Horizant), and you should not use them as substitutes for each other without consulting your doctor.

To minimize the risk of side effects, do not stop taking this medication abruptly without consulting your doctor. If you need to discontinue treatment, your doctor will provide guidance on how to gradually taper off the medication. Be aware that severe breathing problems have occurred in people taking this medication, especially when combined with opioid pain medications or in those with pre-existing lung or breathing problems. This risk may be higher in individuals over 65 years old, and in some cases, breathing problems have been fatal. If you have concerns, discuss them with your doctor.

Older adults (65 years and older) should use this medication with caution, as they may be more susceptible to side effects. Similarly, children between 3 and 12 years old may have a higher risk of mood or behavioral problems, and this medication should be used with caution in this age group.

If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to discuss the potential benefits and risks of this medication to you and your baby.

Specific Considerations for Seizure Treatment

If you experience changes in your seizure patterns or worsening of seizures after starting this medication, notify your doctor promptly to discuss potential adjustments to your treatment plan.

• Opioids (e.g., Morphine, Hydrocodone, Oxycodone): Increased risk of respiratory depression, profound sedation, coma, and death. Co-prescribing should be avoided unless benefits outweigh risks, and patients should be monitored closely for CNS depression.
• CNS Depressants (e.g., Benzodiazepines, Barbiturates, Alcohol): Increased risk of additive CNS depression (drowsiness, dizziness, respiratory depression).

• 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
• Weight gain
• Blurred vision
• Tremor
• Behavioral changes (especially in children)
• Mood changes
• Suicidal thoughts or behavior
• Unexplained rash or fever (signs of DRESS or SJS/TEN)

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. Pregnancy registries are available for women exposed to antiepileptic drugs during pregnancy.

L2 (Likely Compatible). Gabapentin is excreted into breast milk. The amount ingested by the infant is generally low. Monitor breastfed infants for sedation, poor feeding, and weight gain. Use with caution, especially in preterm or neonates.

Approved for adjunctive treatment of partial seizures in children 3 years and older. Dosing is weight-based. Behavioral problems (e.g., hostility, emotional lability, 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 CNS side effects (dizziness, somnolence, ataxia, peripheral edema). Start with lower doses and titrate slowly.

• Gabapentin absorption is saturable, meaning bioavailability decreases with increasing dose. This is why it's often dosed three times a day and why higher single doses don't necessarily lead to proportionally higher plasma levels.
• Gabapentin is not metabolized by the liver and is excreted unchanged by the kidneys, making it a good option for patients with liver disease but requiring careful dose adjustment in renal impairment.
• Abrupt discontinuation can precipitate withdrawal symptoms (anxiety, insomnia, nausea, pain, sweating) and potentially seizures, especially in patients with epilepsy. Taper gradually over at least 1 week.
• Peripheral edema is a common side effect, especially in older adults, and can be significant.
• Despite its structural similarity to GABA, gabapentin does not directly interact with GABA receptors or affect GABA uptake/metabolism in the same way as benzodiazepines or other GABAergic drugs.
• Gabapentin is increasingly used off-label for various neuropathic pain conditions, restless legs syndrome, and anxiety disorders, though evidence varies for these uses.

• For Neuropathic Pain: Pregabalin, Duloxetine, Venlafaxine, Amitriptyline, Nortriptyline, Carbamazepine, Oxcarbazepine.
• For Epilepsy (Partial Seizures): Levetiracetam, Lamotrigine, Carbamazepine, Oxcarbazepine, Valproic Acid, Phenytoin, Topiramate, Lacosamide, Zonisamide.

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 provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance. 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.