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Levetiracetam (Levetiracetam)

Trade Name : Levetiracetam

Pharmaceutical Associates, Inc.

SOLUTION

Strength 100 mg/mL

LEVETIRACETAM Decreased Central Nervous System Disorganized Electrical Activity [PE]

Delivery Process

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Pharmaceutical Associates, Inc.. 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

Validated Cold Chain Shipment

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.

Read more
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  • Levetiracetam Oral Solution USP is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (n n n )n nn
  • Levetiracetam Oral Solution USP is indicated for adjunctive therapy for the treatment of:
  • Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (n n n )n n n
  • Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (n n n )n n n
  • Partial-Onset Seizures (monotherapy or adjunctive therapy)
  • Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older
  • Primary Generalized Tonic-Clonic Seizures
  • Adult Patients with Impaired Renal Function
  • Levetiracetam Oral Solution USP
  • 16 fl oz (473 mL) bottles - NDC 0121-0799-16
  • 5 mL Unit Dose Cups packaged in trays of 10 - NDC 0121-4799-05
  • 10 mL Unit Dose Cups packaged in trays of 10 - NDC 0121-1598-10
  • 15 mL Unit Dose Cups packaged in trays of 10 - NDC 0121-2397-15
  • 100 mg/mL solution (n n n )n n n
  • Levetiracetam Oral Solution USP is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [n n n n
  • Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred (n n n , n n n )n nn
  • No data
  • Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms (n n n )n n n
  • Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior (n n n )n n n
  • Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam (n n n )n n n
  • Serious Dermatological Reactions: Discontinue levetiracetam at the first sign of rash unless clearly not drug related. (n n n )n n n
  • Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination. Advise patients to not drive or operate machinery until they have gained experience on levetiracetam. (n n n )n n n
  • Withdrawal Seizures: Levetiracetam must be gradually withdrawn (n n n )n n n
  • The following adverse reactions are discussed in more details in other sections of labeling:
  • Most common adverse reactions (incidence u2265 5% more than placebo) include:
  • To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or n n n n
  • Adult patients: somnolence, asthenia, infection and dizziness (n n n )n n n
  • Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability (n n n )n n n
  • 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 (n n n , n n n )n nn
  • No data
  • Levetiracetam Oral Solution USP is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration.
  • The chemical name of levetiracetam, a single enantiomer, is (u2013)u2013(S)u2013u03b1u2013ethylu20132u2013oxou20131-pyrrolidine acetamide, its molecular formula is Cn n n Hn n n Nn n n On n n and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:n nn
  • Levetiracetam is 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 nu2013hexane. (Solubility limits are expressed as g/100 mL solvent.)
  • Levetiracetam Oral Solution USP contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, artificial grape flavor, citric acid, glycerin, maltitol solution, methylparaben, propylparaben, purified water, and sodium citrate.
  • No data
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  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • MANUFACTURED AND DISTRIBUTED BYn- Array
  • R10/19
  • No data
  • NDC 0121-0799-16
  • Levetiracetamu00a0n- Oral Solution USP
  • 100 mg/mL
  • PHARMACIST:
  • Rx ONLY
  • 16 fl oz (473 mL)
  • Pharmaceuticalu00a0n- Associates, Inc.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- Array
  • Dispense in a tight,n- Array
  • USUAL DOSAGE:
  • Warning:
  • R05/17
  • X0799160517
  • Delivers n n n n
  • NDC 0121-4799-05
  • Arrayn- Ln n n n On n n Sn n n , USPn n n
  • 500 mg/5 mL
  • Rx ONLY
  • FOR INSTITUTIONAL USE ONLY
  • PHARMACEUTICAL ASSOCIATES, INC. n n n Greenville, SC 29605n nn
  • SEE INSERT
  • A47990500
  • Delivers n n n n
  • NDC 0121-1598-10
  • Arrayn- Ln n n n On n n Sn n n , USPn n n
  • 1,000 mg/10 mL
  • Rx ONLY
  • FOR INSTITUTIONAL USE ONLY
  • PHARMACEUTICAL ASSOCIATES, INC.n n n Greenville, SC 29605n nn
  • SEE INSERT
  • A4799100917u00a0
  • Deliversu00a0n n n n
  • NDC 0121-2397-10
  • Arrayn- Array
  • 1,500 mg/15 mL
  • Rx ONLY
  • FOR INSTITUTIONAL USE ONLY
  • PHARMACEUTICAL ASSOCIATES, INC.n n n Greenville, SC 29605n nn
  • SEE INSERT
  • A4799150917u00a0

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

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Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

Clinical Trials Supply

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Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
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TEL: +1 704 557 0412

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