Levetiracetam Injection

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Levetiracetam injection (brand name Keppra) is a sterile, clear, colourless solution used for intravenous administration when oral dosing is not feasible.

Description

Levetiracetam Injection

Healthy Inc is a specialized global supplier and exporter of advanced anti-epileptic therapies. We provide high-purity Levetiracetam Injection (500 mg / 5 ml), manufactured in WHO–GMP certified sterile injectable facilities. This “Next-Generation” anticonvulsant is a top export to neurology wards, intensive care units (ICU), and government health ministries in Africa, LATAM, and Southeast Asia, serving as a critical alternative for the rapid stabilization of seizures when oral administration is not feasible.


Product Overview

This formulation contains Levetiracetam, a S-enantiomer of etiracetam, which belongs to the pyrrolidine class of anti-epileptics.

The “SV2A” Specialist:

  • Mechanism (Synaptic Vesicle Modulation): Unlike traditional anti-epileptics that target sodium or calcium channels, Levetiracetam binds to the synaptic vesicle protein SV2A. This unique action modulates the release of neurotransmitters, effectively reducing neuronal excitability without interfering with normal nerve conduction.
  • Drug-Interaction Safety: It is not extensively metabolized by the liver (CYP450 system) and has low protein binding. This results in minimal drug-to-drug interactions, making it the safest choice for polypharmacy patients in the ICU or those on chemotherapy/antiretrovirals.
  • Rapid Stabilization: IV administration provides immediate therapeutic plasma concentrations, essential for preventing the progression of seizure clusters.

Product Composition & Strength

We supply this product as a Sterile, Clear, Colorless Solution in glass vials.

Active Ingredient Strength Concentration
Levetiracetam USP/BP 500 mg 100 mg/ml (in 5 ml Vial)
Excipients Sodium Acetate / Glacial Acetic Acid Buffer / pH Adjuster (5.5)

*Pack Sizes: Tray of 5 Vials, 10 Vials, or Single Vial packs.


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

HS Code 3004.90.99 (Medicaments containing other active substances)
CAS Number 102767-28-2
Dosage Form Injection (Concentrate for Infusion)
Packaging Type I Glass Vial with Bromobutyl rubber stopper.
Storage Store below 25°C. Do Not Freeze.
Certificates WHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • Chiral Purity: As the (S)-enantiomer is the active form, our manufacturing process utilizes validated chiral HPLC testing to ensure 100% optical purity, ensuring maximum efficacy and minimal side effects.
  • Sterile Integrity: Our 5ml vials are produced in Class 100 sterile zones using automated filling lines to ensure zero particulate contamination, essential for intravenous neurological medications.

Therapeutic Indications (Human Use)

Indicated for adjunctive therapy in the treatment of:

  • Partial Onset Seizures: With or without secondary generalization.
  • Myoclonic Seizures: In patients with Juvenile Myoclonic Epilepsy.
  • Primary Generalized Tonic-Clonic Seizures: In patients with Idiopathic Generalized Epilepsy.
  • Seizure Prophylaxis: In neurosurgery or post-traumatic brain injury.

Dosage & Administration

Recommended Dosage (Strictly as per Neurologist):

  • Route: Intravenous (IV) Infusion ONLY. (Must be diluted).
  • Adults: Initial dose of 500 mg twice daily. Can be increased up to 1500 mg twice daily.
  • Dilution Protocol: Dilute in 100 ml of 0.9% Sodium Chloride, Lactated Ringer’s, or 5% Dextrose.
  • Infusion Time: Administer over 15 minutes.
  • Renal Adjustment: Dose must be reduced in patients with impaired renal function (CrCl < 80 ml/min).

Safety Warnings (CRITICAL):

  • Neuropsychiatric Events: Monitor patients for behavioral changes, including irritability, aggression, or suicidal ideation.
  • Somnolence & Fatigue: Patients should be warned about dizziness and sleepiness, especially during the start of therapy.
  • Withdrawal: Avoid abrupt discontinuation; taper the dose to prevent rebound seizures.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Neuro-Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.

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