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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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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.

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  • No data
  • Rx only
  • Levetiracetam oral solution is an antiepileptic drug available as a clear, colorless to slightly yellowish, grape-flavored liquid (100 mg/mL) for oral administration.
  • The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-u03b1-ethyl-2-oxo-l-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 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 n-hexane. (Solubility limits are expressed as g/100 mL solvent.)
  • Levetiracetam oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: ammonium glycyrrhizinate, citric acid, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor.
  • No data
  • In the following studies, statistical significance versus placebo indicates a p value <0.05.
  • Levetiracetam oral solution is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
  • Levetiracetam oral solution is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
  • This product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in levetiracetam oral solution.
  • No data
  • No data
  • The prescriber should be aware that the adverse event incidence figures in the following tables, obtained when levetiracetam was added to concurrent AED therapy, cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.
  • The abuse and dependence potential of levetiracetam has not been evaluated in human studies.
  • No data
  • Levetiracetam oral solution is indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
  • Levetiracetam oral solution is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
  • Levetiracetam 100 mg/mL oral solution, is a clear, colorless to slightly yellowish, grape-flavored liquid. It is supplied in the following oral dosage forms:
  • 5 mL Unit Dose Cups packaged in trays of 10 u2013 NDC 0121-4802-05
  • 10 mL Unit Dose Cups packaged in trays of 10 u2013 NDC 0121-4802-10
  • 15 mL Unit Dose Cups packaged in trays of 10 u2013 NDC 0121-4802-15
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container with a child-resistant closure.
  • Manufactured by:Morton Grove Pharmaceuticals, Inc.Morton Grove, IL 60053
  • Packaged by:n n
  • R11/10
  • Levetiracetam Oral Solution, 100 mg/mL
  • Read this Medication Guide before you start taking Levetiracetam Oral Solution and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
  • What is the most important information I should know about Levetiracetam Oral Solution?
  • Like other antiepileptic drugs, Levetiracetam Oral Solution may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.
  • Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
  • Do not stop Levetiracetam Oral Solution without first talking to a healthcare provider.
  • How can I watch for early symptoms of suicidal thoughts and actions?
  • What is Levetiracetam Oral Solution?
  • Levetiracetam is a prescription medicine taken by mouth that is used with other medicines to treat:
  • It is not known if levetiracetam is safe or effective in children under 4 years of age.
  • Before taking your medicine, make sure you have received the correct medicine. Compare the name above with the name on your bottle and the appearance of your medicine with the description of levetiracetam provided below. Contact your pharmacist immediately if you believe a dispensing error may have occurred.
  • Levetiracetam oral solution is a clear, colorless to slightly yellowish, grape-flavored liquid.
  • What should I tell my healthcare provider before starting Levetiracetam Oral Solution?
  • Before taking levetiracetam, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your healthcare provider.
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
  • How should I take Levetiracetam Oral Solution?
  • Take levetiracetam exactly as prescribed.
  • What should I avoid while taking Levetiracetam Oral Solution?
  • Do not drive, operate machinery or do other dangerous activities until you know how levetiracetam affects you. Levetiracetam may make you dizzy or sleepy.
  • What are the possible side effects of Levetiracetam Oral Solution?
  • Levetiracetam can cause serious side effects.
  • Call your healthcare provider right away if you have any of these symptoms:
  • The most common side effects seen in people who take levetiracetam include:
  • The most common side effects seen in children who take levetiracetam include, in addition to those listed above:
  • These side effects can happen at any time but happen more often within the first 4 weeks of treatment except for infection.
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of levetiracetam. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store Levetiracetam Oral Solution?
  • General information about Levetiracetam Oral Solution.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use levetiracetam for a condition for which it was not prescribed. Do not give levetiracetam to other people, even if they have the same symptoms that you have. It may harm them.
  • This Medication Guide summarizes the most important information about levetiracetam. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about levetiracetam that is written for health professionals. You can also call 1-800-845-8210.
  • What are the ingredients of Levetiracetam Oral Solution?
  • Levetiracetam oral solution
  • Inactive ingredients: ammonium glycyrrhizinate, citric acid, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor.
  • Levetiracetam does not contain lactose or gluten. Levetiracetam oral solution does contain carbohydrates. The liquid is dye-free.
  • Rx Only
  • This Medication Guide has been approved by the US Food and Drug Administration.
  • Manufactured by:Morton Grove Pharmaceuticals, Inc.Morton Grove, IL 60053
  • Packaged by:Pharmaceutical Associates, Inc.Greenville, SC 29605
  • MGAE100R11/10
  • Deliversn NDC 0121-4802-05
  • Ln O Sn
  • 500 mg/5 mL
  • Rx ONLYFOR INSTITUTIONAL USE ONLYn- SEE INSERT
  • A48020501

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