Gabapentin (Gabapentin)

Trade Name : Gabapentin

Bryant Ranch Prepack

TABLET, COATED

Strength 600 mg/1

GABAPENTIN Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

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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

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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 Gabapentin (Gabapentin) which is also known as Gabapentin and Manufactured by Bryant Ranch Prepack. It is available in strength of 600 mg/1 per ml. Read more

Gabapentin (Gabapentin) 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
  • No data
  • Gabapentin is indicated for:
  • Gabapentin is indicated for:
  • Postherpetic neuralgia in adults ()
  • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ()
  • No data
  • Postherpetic Neuralgia () tn
  • Epilepsy with Partial Onset Seizures () t n
  • Dose should be adjusted in patients with reduced renal function (, )
  • No data
  • Tablets: 600 mg, and 800 mg ()
  • Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
  • Known hypersensitivity to gabapentin or its ingredients ()
  • No data
  • Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): Discontinue if alternative etiology is not established ()
  • Anaphylaxis and Angioedema: Discontinue and evaluate patient immediately ()
  • Driving Impairment; Somnolence/Sedation and Dizziness: Warn patients not to drive until they have gained sufficient experience to assess whether their ability to drive or operate heavy machinery will be impaired (, )
  • Increased seizure frequency may occur in patients with seizure disorders if gabapentin is abruptly discontinued ()
  • Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior ()
  • Neuropsychiatric Adverse Reactions in Children 3 to 12 Years of Age: Monitor for such events ()
  • The following serious adverse reactions are discussed in greater detail in other sections:
  • Most common adverse reactions (incidence u2265 8% and at least twice that for placebo) were:
  • To report SUSPECTED ADVERSE REACTIONS, contact TAGI Pharma, Inc. at 1-855-225-8244 or FDA at 1-800-FDA-1088 or n
  • Postherpetic neuralgia: Dizziness, somnolence, and peripheral edema ()
  • Epilepsy in patients > 12 years of age: Somnolence, dizziness, ataxia, fatigue, and nystagmus ()
  • Epilepsy in patients 3 to 12 years of age: Viral infection, fever, nausea and/or vomiting, somnolence, and hostility ()
  • No data
  • Concentrations increased by morphine; may need dose adjustment (, )
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm ()
  • No data
  • A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8,000 mg/kg. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation. Acute oral overdoses of gabapentin up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy, and diarrhea were observed. All patients recovered with supportive care. Coma, resolving with dialysis, has been reported in patients with chronic renal failure who were treated with gabapentin. Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient's clinical state or in patients with significant renal impairment. If overexposure occurs, call your poison control center at 1-800-222-1222.
  • The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid.
  • The molecular formula of gabapentin is CHNO and the molecular weight is 171.24. The structural formula of gabapentin is:
  • Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is u20131.25.
  • Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: copovidone, corn starch, macrogol, magnesium stearate, polyvinyl alcohol, talc and titanium dioxide.
  • No data
  • No data
  • No data
  • Product: 71335-1287
  • NDC: 71335-1287-0 28 TABLET, COATED in a BOTTLE
  • NDC: 71335-1287-1 30 TABLET, COATED in a BOTTLE
  • NDC: 71335-1287-2 60 TABLET, COATED in a BOTTLE
  • NDC: 71335-1287-3 180 TABLET, COATED in a BOTTLE
  • NDC: 71335-1287-4 90 TABLET, COATED in a BOTTLE
  • NDC: 71335-1287-5 100 TABLET, COATED in a BOTTLE
  • NDC: 71335-1287-6 120 TABLET, COATED in a BOTTLE
  • NDC: 71335-1287-7 500 TABLET, COATED in a BOTTLE
  • NDC: 71335-1287-8 84 TABLET, COATED in a BOTTLE
  • NDC: 71335-1287-9 112 TABLET, COATED in a BOTTLE
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • The brands listed are the registered trademarks of their respective owners.
  • Manufactured by: n n Shijiazhuang, Hebei, China, 052160
  • Manufactured for: n n South Beloit, IL 61080
  • MEDICATION GUIDE
  • What is the most important information I should know about gabapentin tablets?
  • Do not stop taking gabapentin tablets without first talking to your healthcare provider.
  • Gabapentin tablets can cause serious side effects including:
  • Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
  • How can I watch for early symptoms of suicidal thoughts and actions?
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
  • Do not stop taking gabapentin tablets without first talking to a healthcare provider.
  • These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking gabapentin tablets.
  • What are gabapentin tablets?
  • Who should not take gabapentin tablets?
  • What should I tell my healthcare provider before taking gabapentin tablets? Before taking gabapentin tablets, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take
  • Taking gabapentin tablets with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
  • Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
  • How should I take gabapentin tablets?
  • If you take too much gabapentin tablets, call your healthcare provider or your local Poison Control Center right away at 1-800-222-1222.
  • What should I avoid while taking gabapentin tablets?
  • What are the possible side effects of gabapentin tablets? Gabapentin tablets may cause serious side effects including:
  • 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 gabapentin tablets. 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 gabapentin tablets?
  • Keep gabapentin tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of gabapentin tablets
  • This Medication Guide summarizes the most important information about gabapentin tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about gabapentin tablets that was written for healthcare professionals.
  • For more information contact TAGI Pharma, Inc. at 1-855-225-8244.
  • What are the ingredients in gabapentin tablets?n- Active ingredient:n- Inactive ingredients in the tablets:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • The brands listed are the registered trademarks of their respective owners.
  • Manufactured by: n n Shijiazhuang, Hebei, China, 052160
  • Manufactured for: n n South Beloit, IL 61080
  • Revised: 3/2019
  • No data

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