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Vigabatrin (Vigadrone)

Trade Name : VIGADRONE

Upsher-Smith Laboratories, LLC

POWDER, FOR SOLUTION

Strength 50 mg/mL

VIGABATRIN Anti-epileptic Agent [EPC]

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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 Vigabatrin (Vigadrone) which is also known as VIGADRONE and Manufactured by Upsher-Smith Laboratories, LLC. It is available in strength of 50 mg/mL per ml. Read more

Vigabatrin (Vigadrone) 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

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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
  • Indications and Usage ()nttu00a0u00a0u00a0u00a0u00a0nt1/2020
  • Dosage and Administration (, , , )nttu00a0u00a0u00a0u00a0u00a0nt1/2020
  • Warnings and Precautions ()nttu00a0u00a0u00a0u00a0u00a0nt1/2020
  • Warnings and Precautions ()nttu00a0u00a0u00a0u00a0u00a0nt7/2019
  • WARNING: PERMANENT VISION LOSS
  • See full prescribing information for complete boxedu00a0warning.
  • VIGADRONE can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGADRONE may also decrease visual acuity (n- Arrayn- ).
  • Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure to VIGADRONE known to be free of risk of vision loss (n- Arrayn- ).
  • Risk of new and worsening vision loss continues as long as VIGADRONE is used, and possibly after discontinuing VIGADRONE (n- Arrayn- ).
  • Baseline and periodic vision assessment is recommended for patients on VIGADRONE. However, this assessment cannot always prevent vision damage (n- Arrayn- ).
  • VIGADRONE is available only through a restricted program called the Vigabatrin REMS Program (n- Arrayn- ).
  • VIGADRONEu00a0is indicated for the treatment of:
  • Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternativeu00a0treatments; VIGADRONE is not indicated as a first line agent ()n
  • Infantile Spasms u2013 monotherapy in infants 1u00a0month to 2u00a0years of age for whom the potential benefits outweigh the potential risk of vision loss ()
  • Refractory Complex Partial Seizures
  • Infantile Spasms
  • Renal Impairment
  • 500u00a0mg packets of a white to off-white granular powder.
  • Powder for Oral Solution: 500u00a0mg ()
  • None.
  • None ()
  • No data
  • Abnormalu00a0MRI signal changes and intramyelinic edema have been reported in some infants with Infantile Spasms receiving vigabatrinu00a0(, )n
  • Suicidal behavior and ideation: Antiepileptic drugs, including VIGADRONE, increase the risk of suicidal thoughts and behavior ()n
  • Withdrawal of AEDs: Taper dose to avoid withdrawal seizures ()n
  • Anemia: Monitor for symptoms of anemia ()n
  • Somnolence and fatigue: Advise patients not to drive or operate machinery until they have gained sufficient experience on VIGADRONE ()
  • The following serious and otherwise important adverse reactions are described elsewhere in labeling:
  • Refractory Complex Partial Seizures
  • Most common adverse reactions in controlled studies include (incidence u22655% over placebo):
  • Infantile Spasms (incidence u02c35% and greater than on placebo)
  • Decreased phenytoin plasma levels: dosage adjustment may be needed ()
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm ()n
  • Lactation: VIGADRONE is excreted in human milk ()
  • No data
  • No data
  • VIGADRONE (vigabatrin, USP) is an oral antiepileptic drug and is available as a white to off-white granular powder for oral solution in packets of 500u00a0mg.
  • The chemical name of vigabatrin, a racemate consisting of two enantiomers, is (u00b1)u00a04-amino-5-hexenoic acid. The molecular formula is CHNO and the molecular weight is 129.16. It has the following structural formula:
  • Vigabatrin, USP is a white to off-white powder which is freely soluble in water, slightly soluble in methyl alcohol, very slightly soluble in ethyl alcohol and chloroform, and insoluble in toluene and hexane. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin is about 0.011 (log -1.96) at physiologic pH. Vigabatrin melts with decomposition in a 3-degree range within the temperature interval of 171u00b0Cu00a0to 176u00b0C. The dissociation constants (pK) of vigabatrin are 4 and 9.7 at room temperature (25u00b0C).
  • VIGADRONEu00a0powder for oral solutionu00a0is available as white to off-white granular powder for oral administration. Each packet contains 500u00a0mg of vigabatrin.
  • No data
  • Vigabatrin showed no carcinogenic potential in mouse or rat when given in the diet at doses up to 150u00a0mg/kg/day for 18u00a0months (mouse) or at doses up to 150u00a0mg/kg/day for 2u00a0years (rat). These doses are less than the maximum recommended human dose (MRHD) for infantile spasms (150u00a0mg/kg/day) and for refractory complex partial seizures (3u00a0g/day) on a mg/m basis.
  • Vigabatrin was negative in n n (Ames, CHO/HGPRT mammalian cell forward gene mutation, chromosomal aberration in rat lymphocytes) and in n n o (mouse bone marrow micronucleus) assays.
  • No adverse effects on male or female fertility were observed in rats at oral doses up to 150u00a0mg/kg/day (approximately u00bd the MRHD of 3u00a0g/day on a mg/m basis for refractory complex partial seizures).
  • No data
  • No data
  • Advise patients and caregivers to read the FDA-approved patient labeling ( and ).
  • Administration Instructions for n- VIGADRONEn- u00a0n- Powder n- for Oral Solution
  • Physicians should confirm that caregiver(s) understand how to mix VIGADRONE for Oral Solution and to administer the correct dose to their infants and pediatric patientsu00a0n n n n
  • Permanent Vision Loss
  • Inform patients and caregivers of the risk of permanent vision loss, particularly loss of peripheral vision, from VIGADRONE, and the need for monitoring vision n n n n
  • Monitoring of vision, including assessment of visual fields and visual acuity, is recommended at baseline (no later than 4u00a0weeks after starting VIGADRONE), at least every 3u00a0months while on therapy, and about 3u00a0to 6 months after discontinuation of therapy. In patients for whom vision testing is not possible, treatment may continue without recommended testing according to clinical judgment with appropriate patient or caregiver counseling. Patients or caregivers should be informed that if baseline or subsequent vision is notu00a0normal, VIGADRONE should only be used if the benefits of VIGADRONE treatment clearly outweigh the risks of additional vision loss.
  • Advise patients and caregivers that vision testing may be insensitive and may not detect vision loss before it is severe. Also advise patients and caregivers that if vision loss is documented, such loss is irreversible. Ensure that both of these points are understood by patients and caregivers.
  • Patients and caregivers should be informed that if changes in vision are suspected, they should notify their physician immediately.
  • Vn- igabatrinn- REMS Program
  • VIGADRONEu00a0is available only through a restricted program called the Vigabatrin REMS Programu00a0n n n Inform patients/caregivers of the following:
  • MRI Abnormalities in Infants
  • Inform caregiver(s)u00a0of the possibility that infants may develop an abnormal MRI signal of unknown clinical significance n n n n
  • Suicidal Thinking and Behavior
  • Counsel patients, their caregiver(s), and families that AEDs, including VIGADRONE, may increase the risk of suicidal thoughts and behavior. Also advise patients and caregivers of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm. Behaviors of concern should be reported immediately to healthcare providers n n n
  • Pregnancy
  • Advise pregnant women and women of child-bearing potential that the use of VIGADRONE during pregnancy can cause fetal harm which may occur early in pregnancy before many women know they are pregnant. Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy.u00a0Advise patients that there is a pregnancy exposure registry that collects information about the safety of antiepileptic drugs during pregnancy n n .
  • Nursing
  • Counsel patients that VIGADRONE is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants from VIGADRONE, breastfeeding is not recommended. If a decision is made to breastfeed, nursing mothers should be counseled to observe their infants for signs of vision loss, sedation and poor sucking n n n
  • Withdrawal of n- VIGADRONEn- Therapy
  • Instruct patients and caregivers not to suddenly discontinue VIGADRONEu00a0therapy without consulting with their healthcare provider. As with all AEDs, withdrawal should normally be gradual n n n n
  • Manufactured forn n n Maple Grove, MN 55369
  • VIGADRONE is a registered trademark of Upsher-Smith Laboratories, LLC.
  • Made in Germany
  • PN0046
  • Revised 0220
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • PN0046nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntRevised 2/2020
  • INSTRUCTIONS FOR USE
  • VIGADRONEn- Arrayn- u00a0n- (vi-ga-dru014dne)
  • (n- vigabatrin)
  • Powder n- for n- on- ral n- sn- olution
  • Read this Instructions for Use before your child starts taking VIGADRONE and each time you get a refill.u00a0 There may be new information. This information does not take the place of talking with your healthcare provider about your childu2019s medical condition or treatment. Talk to your healthcare provider if you have any questions about the right dose of medicine to give your child or how to mix it.
  • Important Note:
  • Supplies you will need to mix 1n- u00a0n- dose of n- VIGADRONE
  • Stepn- u00a0n- 1n- 1
  • Stepn- u00a0n- 2
  • Stepn- u00a0n- 3
  • Step 4n- 1
  • u00a0n
  • Stepn- u00a0n- 5n- second
  • Do not
  • u00a0For example:
  • Stepn- u00a0n- 6n- tip
  • u00a0n
  • Stepn- u00a0n- 7
  • u00a0n
  • Stepn- u00a0n- 8
  • Stepn- u00a0n- 9
  • Stepn- u00a0n- 10: Slowly
  • u00a0n
  • Repeat sn- tepsn- u00a0n- 6n- u00a0n- through 10 until all of the water that is needed to mix 1n- u00a0n- dose of n- VIGADRONEn- has been added to the cup containing the powder.
  • Stepn- u00a0n- 11
  • u00a0n
  • Stepn- u00a0n- 12n- tip
  • u00a0n
  • u00a0u00a0n
  • Stepn- u00a0n- 13n- a small amount at a time
  • Stepn- u00a0n- 14n- Do not
  • Stepn- u00a0n- 15
  • For Instructions for Use, please visit www.upsher-smith.com or call 1-888-650-3789.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Manufactured forn n n Maple Grove, MN 55369
  • VIGADRONE is a registered trademark of Upsher-Smith Laboratories, LLC.
  • Made in Germany
  • PN0046nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntRevised 2/2020
  • NDC 0245-0556-50VIGADRONEu00a0(vigabatrin) for oral solution500 mg50 Single-Dose PacketsRx Only

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