Gabapentin 600mg Tablets

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 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 loss of consciousness

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

Suicidal Thoughts or Actions

Like other medications used to treat seizures, this drug may increase the risk of suicidal thoughts or actions, particularly in people 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 affect other organs and 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 do not resolve:

Dizziness
Drowsiness
Fatigue
Weakness
Diarrhea
Upset stomach
Nausea or vomiting
Dry mouth

These are not all the possible side effects of this medication. 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.

Important Warnings and Cautions

General Precautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until you know how this drug affects you, avoid driving and other activities that require alertness.

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. 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). Do not substitute one for the other without consulting your doctor.

Stopping the Medication

Do not abruptly stop taking this medication without consulting your doctor, as this may increase the risk of side effects. If you need to discontinue the medication, your doctor will instruct you on how to gradually taper off the dose.

Respiratory Risks

Severe breathing problems have been reported in people taking this medication, especially when combined with other medications like opioid pain drugs. This risk is also higher in individuals with pre-existing lung or breathing problems and in those over 65 years old. In some cases, breathing problems have been fatal. If you have concerns, discuss them with your doctor.

Age-Related Precautions

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

For children between 3 and 12 years old, use this medication with caution, as the risk of mood or behavioral problems may be higher in this age group.

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 both you and your baby.

Seizure-Specific Precautions

If your seizures change or worsen after starting this medication, consult with your doctor.

• Opioids (e.g., Morphine, Hydrocodone, Oxycodone): Increased risk of respiratory depression, sedation, and coma. Co-prescription should be avoided unless benefits outweigh risks, and patients should be monitored closely.
• CNS Depressants (e.g., Benzodiazepines, Barbiturates, Alcohol): Additive CNS depressant effects, leading to increased sedation, dizziness, and 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 (AUC) by 12-15%. Clinical significance is usually minor but monitor for increased side effects.

• Dizziness
• Somnolence
• Ataxia
• Fatigue
• Peripheral edema
• Weight gain
• Blurred vision
• Tremor
• Mood changes (e.g., depression, anxiety, agitation)
• Suicidal thoughts or behaviors
• Unusual skin rashes or allergic reactions (e.g., DRESS syndrome)

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.

Gabapentin is excreted into human milk. The amount ingested by a breastfed infant is relatively small. Generally considered compatible with breastfeeding, but monitor the infant for sedation, poor feeding, or developmental milestones. Use with caution, especially in preterm infants or those with underlying medical conditions.

Approved for adjunctive treatment of partial seizures in children 3 years and older. Dosing is weight-based. Monitor for behavioral changes, including aggression and hyperactivity, which may be more pronounced in children.

Elderly patients are more likely to have decreased renal function, requiring dose adjustment. They may also be more sensitive to the CNS depressant effects (dizziness, somnolence, ataxia), increasing the risk of falls. Start with lower doses and titrate slowly.

• Gabapentin's absorption is saturable; higher doses do not proportionally increase plasma concentrations. This is why it's often given in divided doses.
• Abrupt discontinuation can lead to withdrawal symptoms (anxiety, insomnia, nausea, pain, sweating), especially in patients on high doses or long-term therapy. Taper slowly over at least 1 week.
• Despite its structural similarity to GABA, gabapentin does not directly affect GABA receptors or metabolism. Its primary mechanism is binding to the α2δ subunit of voltage-gated calcium channels.
• Off-label uses are common, including for restless legs syndrome, fibromyalgia, anxiety disorders, and alcohol withdrawal, though evidence varies.
• Be vigilant for signs of respiratory depression, especially when co-administered with opioids or other CNS depressants, even in patients without pre-existing respiratory compromise.
• Monitor for drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, a rare but serious hypersensitivity reaction, which can present with fever, rash, lymphadenopathy, and multi-organ involvement.

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

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, don't hesitate to consult 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 reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.