Lacosamide 200mg/20ml Inj, 20ml

Lacosamide's precise mechanism of action is not fully understood. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, leading to stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. It does not affect fast inactivation of sodium channels. It also binds to the collapsin response mediator protein 2 (CRMP-2), a phosphoprotein expressed in the nervous system, though the functional consequence of this binding is unknown.

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 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
Change in balance
Memory problems or loss
Severe dizziness or passing out
Abnormal heartbeat (fast, slow, or irregular)
Shakiness
Double vision
Shortness of breath
Chest pain
Burning, numbness, or tingling sensations that are not normal
Inability to control eye movements

Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal behavior. If you experience any new or worsening symptoms, such as:

Depression
Feeling nervous, restless, or irritable
Panic attacks
Changes in mood or behavior

contact your doctor right away. If you have suicidal thoughts or actions, seek help immediately.

A rare but potentially deadly side effect has been reported in people taking seizure medications like this one. If you experience any of the following symptoms, contact your doctor right away:

Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following symptoms and they bother you or do not go away, contact your doctor:

Dizziness
Drowsiness
Fatigue
Weakness
Headache
Blurred vision
Diarrhea
Upset stomach
Vomiting
Dry mouth
* Excessive sweating

This is not an exhaustive list of 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 allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect the safety and efficacy of the medication.

This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. This includes:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Any health problems you have, as they may interact with this medication

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.

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 any activity that requires your full attention, wait until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.

Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor.

Prior to consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.

If you experience any changes in the frequency or severity of seizures after starting this medication, notify your doctor promptly.

Do not abruptly discontinue this medication without first consulting your doctor, as this may increase your risk of seizures. If it is necessary to stop taking this medication, your doctor will provide guidance on how to gradually taper off the dosage.

Be aware that this medication has been associated with abnormal heart rhythms, which can, in rare cases, lead to severe cardiac complications and even death. If you have any questions or 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. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.

• Drugs that prolong PR interval (e.g., beta-blockers, calcium channel blockers, digoxin, class I antiarrhythmics): Concomitant use may increase the risk of PR interval prolongation and associated cardiac adverse events. ECG monitoring is recommended.
• Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine): May lead to a modest increase in lacosamide exposure, but generally not clinically significant enough to require dose adjustment unless renal impairment is also present.

• Strong CYP2C19 inducers (e.g., rifampin, St. John's Wort): May lead to a modest decrease in lacosamide exposure, but generally not clinically significant enough to require dose adjustment.
• Alcohol: May cause additive CNS depression (dizziness, ataxia).

• Dizziness
• Headache
• Nausea
• Diplopia (double vision)
• Blurred vision
• Ataxia (lack of coordination)
• Tremor
• Fatigue
• Somnolence (sleepiness)
• Cardiac symptoms (palpitations, slow heart rate, fainting)
• Signs of hypersensitivity reaction (rash, fever, swollen lymph nodes)
• Mood changes, depression, suicidal thoughts or behavior

Lacosamide is classified as 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. Patients should be enrolled in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

Lacosamide is excreted into human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for lacosamide, and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition. Monitor breastfed infants for sedation, poor feeding, and weight gain.

Approved for partial-onset seizures in patients 4 years of age and older. Dosing is weight-based for children 4 to <17 years. Safety and efficacy in patients younger than 4 years have not been established.

No specific dose adjustment is required based on age alone, but dose adjustments may be necessary due to age-related decreases in renal function. Elderly patients may be more susceptible to adverse effects such as dizziness, ataxia, and falls. Monitor cardiac conduction more closely.

• Lacosamide IV can be used as an alternative to oral administration when oral intake is temporarily not feasible, with direct substitution at the same dose and frequency.
• The IV infusion should be administered slowly over 30-60 minutes to minimize infusion-related reactions and cardiac conduction effects.
• ECG monitoring is crucial, especially during titration and in patients with pre-existing cardiac conditions or those on other PR-prolonging medications, due to the risk of PR interval prolongation and AV block.
• Titration of the dose is important to minimize CNS adverse effects such as dizziness and ataxia.
• Patients should be advised not to discontinue lacosamide abruptly due to the risk of increased seizure frequency or status epilepticus.
• Lacosamide has a low potential for drug-drug interactions compared to many other AEDs, particularly regarding CYP enzyme induction/inhibition, making it a favorable option in polytherapy.

• Levetiracetam (IV, oral)
• Phenytoin (IV, oral)
• Fosphenytoin (IV, IM)
• Valproate (IV, oral)
• Carbamazepine (oral)
• Lamotrigine (oral)
• Topiramate (oral)
• Oxcarbazepine (oral)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which can be a safe and convenient way to dispose of unwanted medications.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information about its use. It is crucial to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will help healthcare professionals provide appropriate treatment.