Gabapentin 250mg/5ml Sol No Xylitol

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, but 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, thereby reducing neuronal excitability and pain transmission.

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
+ Trouble 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, get medical help right away.

Suicidal Thoughts or Actions

Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or actions, especially in people with a history of suicidal behavior. Monitor your mood and behavior, and contact your doctor immediately if you experience:

New or worsening symptoms of depression
Anxiety, restlessness, or irritability
Panic attacks or other changes in mood or behavior
Suicidal thoughts or actions

Severe Skin Reactions

This medication may cause severe skin reactions, which can be life-threatening and affect other organs. Seek medical help immediately if you experience:

Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or skin
Fever, chills, or sore throat
Body aches or muscle pain
Shortness of breath or difficulty breathing
Unexplained bruising or bleeding
Fatigue or weakness
Dark urine or yellow skin and eyes
Trouble urinating or swollen glands

Other Side Effects

Most people do not experience severe 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 do not go away:

Dizziness, drowsiness, tiredness, or weakness
Diarrhea, nausea, or vomiting
* Dry mouth

This is not a comprehensive list of all possible 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 if it is safe to take this medication with your other medications and health issues.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor.

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 provide guidance on how to gradually taper off the dose.

There is a risk of severe breathing problems associated with this medication, particularly when used in conjunction with certain other medications (such as opioid pain medications) or in individuals with pre-existing lung or breathing problems. This risk may be higher in people over 65 years of age. In some cases, breathing problems have been fatal. If you have concerns, discuss them with your doctor.

If you are 65 years of age or older, use this medication with caution, as you may be more susceptible to side effects.

For children between 3 and 12 years of age, 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, inform your doctor, as you will need to discuss the potential benefits and risks to you and your baby.

Specific Considerations for Seizure Treatment

If you experience changes in your seizure pattern or worsening of seizures after starting this medication, consult with your doctor.

• Opioids (e.g., morphine, hydrocodone, oxycodone): Increased risk of respiratory depression, profound sedation, coma, and death.
• Other CNS depressants (e.g., benzodiazepines, alcohol, sedatives, hypnotics, tricyclic antidepressants): Additive CNS depression, including somnolence and respiratory depression.

• Antacids containing aluminum and magnesium (e.g., Maalox, Mylanta): Decrease gabapentin bioavailability by up to 24%. Separate administration by at least 2 hours.
• Naproxen: May increase gabapentin exposure (AUC).

• Dizziness
• Somnolence
• Ataxia
• Fatigue
• Peripheral edema
• Tremor
• Nystagmus
• Diplopia
• Weight gain
• Mood changes (depression, anxiety, agitation)
• Suicidal thoughts or behavior
• Unusual bruising or bleeding (rare, but possible blood dyscrasias)
• Signs of hypersensitivity reaction (rash, fever, lymphadenopathy, facial swelling, eosinophilia)

Gabapentin is 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. Data from pregnancy registries suggest no major increase in birth defects, but some studies suggest a possible increased risk of major congenital malformations, particularly cardiac defects, and lower birth weight.

Gabapentin is excreted into human breast milk. The amount transferred to the infant is relatively low. Monitor breastfed infants for sedation, poor feeding, and weight gain. Use with caution, weighing benefits of breastfeeding against potential risks to the infant.

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. Pediatric patients may experience behavioral problems (e.g., hyperactivity, hostility) more frequently than adults.

Elderly patients are more likely to experience dose-related adverse effects (e.g., dizziness, somnolence, ataxia) due to age-related decrease in renal function. Dose adjustment based on creatinine clearance is often necessary. Increased risk of respiratory depression, especially with co-administration of CNS depressants.

• Gabapentin's absorption is saturable; therefore, higher doses do not lead to proportionally higher plasma concentrations. Dosing should be divided into three times daily to optimize absorption and maintain therapeutic levels.
• Do not abruptly discontinue gabapentin, especially in patients with epilepsy, as this can precipitate status epilepticus. Taper gradually over at least 1 week.
• The 'No Xylitol' formulation is important for patients with xylitol sensitivity or for veterinary use (xylitol is toxic to dogs).
• Gabapentin is not metabolized by the liver, making it a good option for patients with hepatic impairment.
• Be vigilant for signs of respiratory depression, especially in patients receiving opioids or other CNS depressants, or those with underlying respiratory conditions.
• Monitor for signs of drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, a rare but serious hypersensitivity reaction.

• For Epilepsy: Levetiracetam, Lamotrigine, Topiramate, Valproic Acid, Carbamazepine, Phenytoin.
• For Neuropathic Pain: Pregabalin, Duloxetine, Venlafaxine, Amitriptyline, Nortriptyline, Carbamazepine (for trigeminal neuralgia).

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 your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, seek immediate medical attention or call your local poison control center. 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. This information will help healthcare professionals provide you with the most appropriate care and treatment.