Lacoset Inj.

LACOSET INJ. by SUN - SIRIUS Product Description

• Name: LACOSET INJ.

• Common Name: Lacosamide

• Brand Name: LACOSET INJ. (by Sun Pharmaceutical Industries Ltd.)

• Composition: LACOSET INJ. contains the active ingredient Lacosamide, typically at a concentration of 10mg/mL.

• Uses: LACOSET INJ. is an anticonvulsant medication used to treat and prevent seizures. It is prescribed for:

  • Partial-onset seizures in adults and children aged 1 month and older.
  • Adjunctive therapy for primary generalized tonic-clonic seizures (grand mal seizures) in adults and children aged 4 years and older when used with other medications. It is particularly valuable when oral administration is not feasible, such as during emergencies or when patients cannot swallow. Lacosamide works by decreasing disorganised electrical activity in the brain.

• Dosage and Administration: LACOSET INJ. is administered intravenously (via infusion into a vein) by a healthcare professional in a clinical setting. It is not for self-administration. The recommended infusion duration is typically 15 to 60 minutes. Dosage varies based on age, weight, and kidney function.

• Side Effects:

  • Common: Dizziness, headache, nausea, vomiting, diarrhea, dry mouth, blurred vision, double vision (diplopia), sleepiness, injection site reactions (redness, swelling), difficulties coordinating movements.
  • Serious: Allergic reactions (rash, swelling, difficulty breathing), suicidal thoughts or behavior, changes in mood, cardiac rhythm and conduction abnormalities (e.g., bradycardia, AV block), syncope (fainting), worsening seizures.

• Precautions:

  • Do not discontinue LACOSET INJ. abruptly, as this can increase seizure frequency.
  • Caution is advised in patients with heart conditions (e.g., AV block, cardiac conduction abnormalities); an ECG may be recommended before and during treatment.
  • Use with caution in patients with liver or kidney impairment, as dose adjustments may be necessary.
  • May cause reduced mental awareness, dizziness, or blurred vision; avoid driving or operating heavy machinery until you know how it affects you.
  • Patients should be monitored for suicidal thoughts or behaviors, especially those with a history of depression.
  • Avoid alcohol consumption.
  • Consult a doctor if pregnant or breastfeeding.

• Storage: Store in a cool and dry place, away from sunlight, typically below 30°C. Keep out of sight and reach of children. Once opened or diluted, the solution should be used within 4 hours at room temperature or 24 hours if refrigerated. Do not freeze.

Here are some frequently asked questions about Lacoset Injection (Lacosamide).

What is Lacoset Injection used for?

Lacoset Injection, containing Lacosamide, is an anticonvulsant medication primarily used in the treatment and prevention of epilepsy, a neurological condition characterized by seizures. It is used to control partial-onset seizures and can also be used in combination with other similar medicines for this purpose. In some cases, it may be used for primary generalized tonic-clonic seizures.

How does Lacoset Injection work?

Lacoset Injection works by decreasing abnormal and excessive electrical activity of nerve cells in the brain. It does this by selectively slowing the inactivation of voltage-gated sodium channels, which reduces the nerve impulses that cause seizures.

What is the usual dosage of Lacoset Injection?

The dosage of Lacoset Injection varies based on age, weight, and whether it's used alone (monotherapy) or with other medications (adjunctive therapy). For adults, initial doses typically start at 50 mg twice daily, increasing weekly by 50 mg twice daily up to a maintenance dose of 100-200 mg twice daily (200-400 mg/day). A loading dose of 200 mg given as a single dose, followed by maintenance dosing, may also be used. Pediatric dosages are weight-based and are increased weekly based on response and tolerability. It's crucial to follow the healthcare provider's specific instructions for dosing and titration.

What are the possible side effects of Lacoset Injection?

Common side effects can include dizziness, sleepiness, blurred vision, clumsiness, and unsteadiness. More serious side effects, though less common, can include cardiac rhythm and conduction abnormalities such as bradycardia (slow heart rate), AV block, and atrial fibrillation or flutter, especially in patients with underlying heart conditions or those taking other medications that affect heart rhythm. There is also an increased risk of suicidal thoughts or behavior, and a severe allergic reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) can occur. Pain, redness, or swelling at the injection site may also be experienced.

Is Lacoset Injection safe during pregnancy or breastfeeding?

There are pregnancy exposure registries that monitor outcomes in women exposed to antiepileptic drugs. While some limited case series suggest the relative safety of lacosamide monotherapy during pregnancy and breastfeeding, with no major congenital malformations observed, available data are still insufficient to definitively confirm a drug-associated risk. The manufacturer generally advises against its use during pregnancy and breastfeeding. If used while breastfeeding, infants should be carefully monitored for drowsiness and adequate weight gain. It is important to discuss the risks and benefits with your doctor.

Can Lacoset Injection be taken with other medications?

Lacoset Injection can be used alone or in combination with other antiepileptic drugs. However, caution is advised when taking it with medications that affect cardiac conduction or prolong the PR interval, such as sodium channel blockers, beta-blockers, and calcium channel blockers, as this can increase the risk of heart rhythm disturbances. It's important to inform your doctor about all other medications, supplements, and herbal products you are taking to avoid potential drug interactions and ensure proper monitoring.

What precautions should be taken with Lacoset Injection?

Lacoset Injection should not be stopped suddenly, as this can increase seizure frequency; withdrawal should be gradual, typically over a minimum of one week. It should not be self-administered. Patients should be monitored for new or worsening depression, suicidal thoughts or behavior. An electrocardiogram (ECG) is recommended before starting treatment and after reaching a stable maintenance dose, particularly for those with existing heart conditions or taking medications that affect cardiac conduction. Caution is also advised for patients with renal or hepatic impairment, and dose adjustments may be necessary.

What happens if a dose of Lacoset Injection is missed?

If a dose of Lacoset Injection is missed, it is important to take it as soon as possible. Missing a dose can be life-threatening in some cases and may trigger seizures. You should follow your doctor's specific instructions on how to manage a missed dose.

How should Lacoset Injection be stored?

Lacoset Injection vials should be stored at controlled room temperature, typically between 20°C and 25°C (68°F and 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Do not freeze the medication. Once diluted, the solution should not be stored for more than 4 hours at room temperature, and any unused portion must be discarded, as it is preservative-free.