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Gabapentin (Gabapentin)

Trade Name : Gabapentin

Golden State Medical Supply Inc.

CAPSULE

Strength 100 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 Golden State Medical Supply Inc.. It is available in strength of 100 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

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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
  • Gabapentin is indicated for:
  • Gabapentin is indicated for:
  • Postherpetic neuralgia in adults (n n n )n n n
  • 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 (n n n )n n n
  • No data
  • Postherpetic Neuralgia (n n n )n n n n n
  • Epilepsy with Partial Onset Seizures (n n n ) n n n n n
  • Dose should be adjusted in patients with reduced renal function (n n n , n n n )n n n
  • Capsules:
  • Tablets:
  • Capsules : 100 mg, 300 mg and 400 mg (n n n ) n n n
  • Tablets (functional scored): 600 mg, and 800 mg (n n n ) n n n
  • Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
  • Known hypersensitivity to gabapentin or its ingredients (n n n )n n n
  • No data
  • Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): Discontinue if alternative etiology is not established (n n n )n n n
  • Anaphylaxis and Angioedema: Discontinue and evaluate patient immediately (n n n )n n n
  • 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 (n n n , n n n )n n n
  • Increased seizure frequency may occur in patients with seizure disorders if gabapentin is abruptly discontinued (n n n )n n n
  • Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior (n n n )n n n
  • Neuropsychiatric Adverse Reactions in Children 3 to 12 Years of Age: Monitor for such events (n n n )n n n
  • The following serious adverse reactions are discussed in greater detail in other sections:
  • Most common adverse reactions (incidence u22658% and at least twice that for placebo) were:
  • Postherpetic neuralgia: Dizziness, somnolence, and peripheral edema (n n n )n n n
  • Epilepsy in patients >12 years of age: Somnolence, dizziness, ataxia, fatigue, and nystagmus (n n n )n n n
  • Epilepsy in patients 3 to 12 years of age: Viral infection, fever, nausea and/or vomiting, somnolence, and hostility (n n n )n n n
  • No data
  • Concentrations increased by morphine; may need dose adjustment (n n n , n n n )n n n
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm (n n n )n n n
  • 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 capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid.
  • The molecular formula of gabapentin is Cn n n Hn n n NOn n n and the molecular weight is 171.24. The structural formula of gabapentin is: n nn
  • Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 4.72u00b10.10 and a pKa2 of 10.27u00b10.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083u00b10.235 at 25u00b0C temperature.nn
  • Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.
  • Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc.n
  • No data
  • Gabapentin was administered orally to mice and rats in 2-year carcinogenicity studies. No evidence of drug-related carcinogenicity was observed in mice treated at doses up to 2,000 mg/kg/day. At 2,000 mg/kg, the plasma gabapentin exposure (AUC) in mice was approximately 2 times that in humans at the MRHD of 3,600 mg/day. In rats, increases in the incidence of pancreatic acinar cell adenoma and carcinoma were found in male rats receiving the highest dose (2,000 mg/kg), but not at doses of 250 or 1,000 mg/kg/day. At 1,000 mg/kg, the plasma gabapentin exposure (AUC) in rats was approximately 5 times that in humans at the MRHD.
  • Studies designed to investigate the mechanism of gabapentin-induced pancreatic carcinogenesis in rats indicate that gabapentin stimulates DNA synthesis in rat pancreatic acinar cells n n n 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. n nn
  • Mutagenesis
  • in vitro
  • in vivo
  • Impairment of Fertility
  • No data
  • Gabapentin capsules and tablets, USP are supplied as follows:
  • 100 mg capsules:
  • White to off-white powder filled in size u201c3u201d hard gelatin capsules with opaque white colored cap and opaque white colored body imprinted n on cap and n on body with black ink, available in:n
  • Bottles of 90: NDC 51407-047-90
  • Bottles of 180: NDC 51407-047-18
  • Bottles of 270: NDC 51407-047-27
  • Bottles of 1000: NDC 51407-047-10
  • 300 mg capsules:
  • White to off-white powder filled in size u201c1u201d hard gelatin capsules with opaque yellow colored cap and opaque yellow colored body imprinted n on cap and n on body with black ink, available in:n
  • Bottles of 30: NDC 51407-048-30
  • Bottles of 60: NDC 51407-048-60
  • Bottles of 90: NDC 51407-048-90
  • Bottles of 180: NDC 51407-048-18
  • Bottles of 270: NDC 51407-048-27
  • Bottles of 1000: NDC 51407-048-10
  • 400 mg capsules:
  • White to off-white powder filled in size u201c0u201d hard gelatin capsules with opaque orange colored cap and opaque orange colored body imprinted n on cap and n on body with black ink, available in:n
  • Bottles of 90: NDC 51407-049-90
  • Bottles of 270: NDC 51407-049-27
  • Bottles of 500: NDC 51407-049-05
  • Store gabapentin capsules at 25u00b0C (77u00b0F); excursions permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].
  • 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 n .n
  • Anaphylaxis and Angioedema n- [see n ] n
  • 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 .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 n .n
  • 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 breast feeding or intend to breast feed during therapy n .n
  • 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 n .n
  • Manufactured by:n n nScieGen Pharmaceuticals, Inc.n n nHauppauge, NY 11788 USAn
  • Rx Only
  • Rev: 08/18
  • Marketed/Packaged by:
  • GSMS, Inc
  • Camarillo, CA 93012 U.S.A.
  • Gabapentin Capsules, USPn n n Gabapentin Tablets, USPn n n n n (gab'' a pen' tin)n
  • What is the most important information I should know about gabapentin?
  • Do not stop taking gabapentin without first talking to your healthcare provider.
  • Stopping gabapentin suddenly can cause serious problems.
  • Gabapentin can cause serious side effects including:
  • What is gabapentin?
  • Gabapentin is a prescription medicine used to treat:
  • Who should not take gabapentin?
  • Do not take gabapentin if you are allergic to gabapentin or any of the other ingredients in gabapentin. See the end of this Medication Guide for a complete list of ingredients in gabapentin.
  • What should I tell my healthcare provider before taking gabapentin?
  • Before taking gabapentin, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take
  • Taking gabapentin 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?
  • If you take too much gabapentin, call your healthcare provider or your local Poison Control Center right away at 1-800-222-1222.
  • What should I avoid while taking gabapentin?
  • 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?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?
  • Store gabapentin capsules and tablets between 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).
  • Keep gabapentin and all medicines out of the reach of children.
  • General information about the safe and effective use of gabapentin
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use gabapentin for a condition for which it was not prescribed. Do not give gabapentin 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. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about gabapentin that was written for healthcare professionals.
  • For more information call ScieGen Pharmaceuticals, Inc. at 1-855-724-3436.
  • What are the ingredients in gabapentin capsules, USP and tablets, USP?
  • Active ingredient:
  • Inactive ingredients in the capsules:
  • The 100-mg capsule shell also contains: gelatin, sodium lauryl sulfate (SLS), titanium dioxide.
  • The 300-mg capsule shell also contains: gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS).
  • The 400-mg capsule shell also contains: gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40.
  • The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide.
  • Inactive ingredients in the tablets:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • All brands listed are the trademarks of their respective owners and are not trademarks of ScieGen Pharmaceuticals, Inc.
  • Manufactured by:n n nScieGen Pharmaceuticals, Inc.n n nHauppauge, NY 11788 USAn
  • Rev: 08/18
  • Marketed/Packaged by:
  • GSMS, Inc
  • Camarillo, CA 93012 U.S.A.
  • NDC 51407-047-90
  • Gabapentin
  • Capsules, USP
  • 100 mg
  • Rx Only 90 Capsules
  • GSMS, Inc.
  • NDC 51407-048-90
  • Gabapentin
  • Capsules, USP
  • 300 mg
  • Rx Only 90 Capsules
  • GSMS, Inc.
  • NDC 51407-049-90
  • Gabapentin
  • Capsules, USP
  • 400 mg
  • Rx Only 00 Capsules
  • GSMS, Inc.

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