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Gabapentin (Gabapentin)

Trade Name : Gabapentin

Actavis Pharma, Inc.

TABLET, FILM COATED

Strength 600 mg/1

GABAPENTIN Anti-epileptic Agent [EPC],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 Gabapentin (Gabapentin) which is also known as Gabapentin and Manufactured by Actavis Pharma, Inc.. 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

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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
  • Gabapentinu00a0tablets are indicated for:
  • Gabapentinu00a0tablets are 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
  • Tablets
  • u2022u00a0u00a0 600 mg: light green, capsule shaped, film coated tablet imprinted withu00a0u00a0u00a0and 636 on one side and bisected on the other side contains 600 mg of gabapentin, USP.
  • u2022u00a0 800 mg: light gray, capsule shaped, film coated tablet imprinted withu00a0u00a0u00a0and 637 on one side and bisected on the other side contains 800 mg of gabapentin, USP.
  • u00a0
  • Tablets: 600 mg and 800 mg ()
  • Gabapentinu00a0tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
  • u00a0
  • Known hypersensitivity to gabapentin or its ingredients ()
  • No data
  • The following serious adverse reactions are discussed in greater detail in other sections:
  • Most common adverse reactions (incidence greater than or equal to 8% and at least twice that for placebo) were:
  • To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.u00a0
  • Postherpetic neuralgia: Dizziness, somnolence, and peripheral edema ()
  • Epilepsy in patients greater than 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 patientu2019s 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, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid.
  • The molecular formula of gabapentin, USP is CHNO and the molecular weight is 171.24. The structural formula of gabapentin, USP is:
  • Gabapentin, USP is a white to off-white crystalline solid with a pK of 3.7 and a pK 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 -1.25.
  • Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide. The 600 mg tablet also contains FD&C blue #2 aluminum lake and synthetic yellow iron oxide. The 800 mg tablet also contains synthetic black iron oxide.
  • No data
  • Carcinogenesis
  • Studies designed to investigate the mechanism of gabapentin-induced pancreatic carcinogenesis in rats indicate that gabapentin stimulates DNA synthesis in rat pancreatic acinar cells and, thus, may be acting as a tumor promoter by enhancing mitogenic activity. It is not known whether gabapentin has the ability to increase cell proliferation in other cell types or in other species, including humans.
  • Mutagenesisn
  • in vitro
  • in vivo
  • Impairment of Fertilityn
  • No data
  • Gabapentin tablets, USP are supplied as follows:
  • 600 mg u2014 Each light green, capsule shaped, film coated tablet imprinted withu00a0u00a0u00a0u00a0and 636 on one side and bisected on the other side contains 600 mg of gabapentin, USP. Tablets are supplied in bottles of 100 (NDC 0228-2636-11) and bottles of 500 (NDC 0228-2636-50).
  • 800 mg u2014 Each light gray, capsule shaped, film coated tablet imprinted withu00a0u00a0u00a0u00a0u00a0and 637 on one side and bisected on the other side contains 800 mg of gabapentin, USP. Tablets are supplied in bottles of 100 (NDC 0228-2637-11) and bottles of 500 (NDC 0228-2637-50).
  • Dispense in a tight, light-resistant container as defined in the USP.
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [See USP Controlled Room Temperature].
  • Brands listed are the trademarks of their respective owners.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Administration Information
  • Inform patients that gabapentin is taken orally with or without food. Inform patients that, should they divide the scored 600 mg or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Advise patients to discard half-tablets not used within 28 days of dividing the scored tablet.
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity
  • Prior to initiation of treatment with gabapentin, instruct patients that a rash or other signs or symptoms of hypersensitivity (such as fever or lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately .
  • Anaphylaxis and Angioedema
  • Advise patients to discontinue gabapentin and seek medical care if they develop signs or symptoms of anaphylaxis or angioedema .
  • Dizziness and Somnolence and Effects on Driving and Operating Heavy Machinery
  • Advise patients that gabapentin may cause dizziness, somnolence, and other symptoms and signs of CNS depression. Other drugs with sedative properties may increase these symptoms. Accordingly, although patientsu2019 ability to determine their level of impairment can be unreliable, advise them neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on gabapentin to gauge whether or not it affects their mental and/or motor performance adversely. Inform patients that it is not known how long this effect lasts n
  • Suicidal Thinking and Behavior
  • Counsel the patient, their caregivers, and families that AEDs, including gabapentin, may increase the risk of suicidal thoughts and behavior. Advise patients 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 about self-harm. Instruct patients to report behaviors of concern immediately to healthcare providers .
  • Use in Pregnancy
  • Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy, and to notify their physician if they are breastfeeding or intend to breastfeed during therapy .
  • Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 .
  • Manufactured by:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIA
  • Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • 40-9257
  • Revised u2013 December 2017
  • GABAPENTIN () TABLETS, USP
  • What is the most important information I should know about gabapentin tablets?
  • Do not stop taking gabapentinu00a0tablets without first talking to your healthcare provider.
  • Stopping gabapentinu00a0tablets suddenly can cause serious problems.
  • Gabapentin can cause serious side effects including:
  • 1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
  • 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.
  • 2. Changes in behavior and thinking
  • 3.u00a0n- Gabapentin may cause a serious or life-threatening allergic reactions
  • 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?
  • Gabapentinu00a0tablets are a prescription medicine used to treat:
  • Who should not take gabapentin tablets?
  • Do not take gabapentinu00a0tablets if you are allergic to gabapentin or any of the other ingredients in gabapentin tablets. See the end of this Medication Guide for a complete list of ingredients in 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 gabapentinu00a0tablets 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 many 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?
  • Gabapentin may cause serious side effects including:
  • See u201cWhat is the most important information I should know about gabapentin tablets?u201d
  • 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. 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 gabapentinu00a0tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of gabapentin tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use gabapentin tablets for a condition for which it was not prescribed. Do not give gabapentinu00a0tablets 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 gabapentin tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about gabapentinu00a0tablets that was written for healthcare professionals.
  • For medical inquiries or to report side effects regarding gabapentin tablets, please call Actavis at 1-800-432-8534.
  • What are the ingredients in gabapentin tablets, USP?
  • Active ingredient:
  • Inactive ingredients in the tablets:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Brands listed are the trademarks of their respective owners.
  • Manufactured by:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIA
  • Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • 40-9257
  • (MG 41-1220/1217)u00a0
  • 0228-2636-11
  • Gabapentin Tablets, USP 600 mg
  • PHARMACIST: Dispense the Medication Guide provided separately to each patient.
  • 100 Tablets
  • Rx Only
  • Actavis
  • 0228-2637-11
  • Gabapentin Tablets, USP 800 mg
  • PHARMACIST: Dispense the Medication Guide provided separately to each patient.
  • 100 Tablets
  • Rx Only
  • Actavis

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