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Levetiracetam (Levetiracetam)

Trade Name : Levetiracetam

West-Ward Pharmaceuticals Corp

INJECTION

Strength 100 mg/mL

LEVETIRACETAM Decreased Central Nervous System Disorganized Electrical Activity [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Levetiracetam (Levetiracetam) which is also known as Levetiracetam and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 100 mg/mL per ml. Read more

Levetiracetam (Levetiracetam) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Contraindications ()u00a0u00a0u00a04/2017Warnings and Precautions, Anaphylaxis and Angioedema ()u00a0u00a0u00a0u00a0u00a04/2017
  • Levetiracetam injection is indicated for adjunctive therapy, as an alternative when oral administration is temporarily not feasible, in the treatment of:
  • Partial onset seizures in patients 1 month of age and older with epilepsy ()
  • Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ()
  • Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ()
  • Levetiracetam injection is for intravenous use only ()
  • Partial Onset Seizures
  • Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older
  • Primary Generalized Tonic-Clonic Seizures
  • Switching From or To Oral Levetiracetam
  • When switching from oral levetiracetam, the initial total daily dosage/frequency of levetiracetam injection should be equivalent to those of oral levetiracetam. At the end of the intravenous treatment period, the patient may be switched to levetiracetam oral administration at the equivalent daily dosage and frequency (, )
  • See full prescribing information for preparation and administration instructions (2.6) and dosage adjustment in adult patients with renal impairment ()
  • One vialu00a0of levetiracetamu00a0injection contains 500 mg levetiracetam (500 mg/5 mL).
  • Injection: 500 mg/5 mL single-dose vial ()
  • Levetiracetam Injection is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see ].
  • Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred ()
  • No data
  • Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms ()
  • Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam ()
  • Withdrawal Seizures: Levetiracetam must be gradually withdrawn. ()
  • The following adverse reactions are discussed in more details in other sections of labeling:
  • u00a0
  • Most common adverse reactions (incidence u22655% more thanu00a0placebo) include:
  • Adults: somnolence, asthenia, infection, and dizziness ()
  • Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability ()
  • Pregnancy: Plasma levels of levetiracetam may be decreased and therefore need to be monitored closely during pregnancy. Based on animal data, may cause fetal harm (, )
  • No data
  • Levetiracetamu00a0injection is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration.
  • The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-u03b1-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is CHNO and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:
  • Levetiracetam, USPu00a0is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)
  • Levetiracetamu00a0injection contains 100 mg of levetiracetam per mL. It is supplied in single-dose 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate.u00a0Levetiracetam injection must be diluted prior to intravenous infusion [see].
  • No data
  • Carcinogenesisn
  • in vitro
  • in vitro
  • in vivo
  • in vitro
  • Impairment of Fertilityn
  • All clinical studies supporting the efficacy of levetiracetam utilized oral formulations.
  • The finding of efficacy of levetiracetam injection is based on the results of studies using an oral formulation of levetiracetam, and on the demonstration of comparable bioavailability of the oral and parenteral formulations [see ].
  • No data
  • Psychiatric Reactions and Changes in Behavior n n- Array
  • Effects on Driving or Operating Machinery n n- Array
  • Anaphylaxis and Angioedeman n- Array
  • Dermatological Adverse Reactions n n- Array
  • Pregnancyn n- Array
  • Manufactured by:
  • Distributed by:
  • PIN291-WES/8Revised:u00a0May 2017
  • NDC 0143-9673-01n n INJECTIONn n n n FOR IV USE ONLYRx ONLY5 mL Single Dose Vialn See package insert.n n Store at 25u00baC (77u00baF); excursions permittedto 15u00ba to 30u00baC (59u00ba to 86u00baF) [See USPControlled Room Temperature].
  • NDC 0143-9673-10n n 10 x 5 mL Single Dose VialsEach 5 mL vial contains 500 mglevetiracetam, 8.2 mg sodium acetatetrihydrate, 45 mg sodium chloride,glacial acetic acid for pH adjustmentto 6.n u00a0See package insert.n n
  • NDC 0143-9673-25n n 25u00a0x 5 mL Single Dose VialsEach 5 mL vial contains 500 mg levetiracetam, 8.2 mg sodium acetate trihydrate, 45 mg sodium chloride, glacial acetic acid for pH adjustment to 6.n See package insert.n u00a0
  • No data

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