Gabapentin (Gabapentin)

Trade Name : Gabapentin

Bryant Ranch Prepack

CAPSULE

Strength 300 mg/1

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

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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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 300 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
  • ntttttttGabapentin Capsules, USP are indicated for:ntttttt
  • Gabapentin Capsules, USP are indicated for
  • Postherpetic neuralgia in adults 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
  • No data
  • nttttttttttttPostherpetic Neuralgia n n
  • nttttttttttttEpilepsy with Partial Onset Seizures n n
  • Dose should be adjusted in patients with reduced renal function (, )
  • Capsules:
  • Capsules: 100 mg, 300 mg, and 400 mg n
  • Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
  • Known hypersensitivity to gabapentin or its ingredients n
  • No data
  • Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): Discontinue if alternative etiology is not be established n
  • Anaphylaxis and Angioedema: Discontinue and evaluate patient immediately 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
  • Increased seizure frequency may occur in patients with seizure disorders if Gabapentin is abruptly discontinued n
  • Suicidal Behavior and Ideation: Monitor for suicidal thoughts / behaviorn
  • Neuropsychiatric Adverse Reactions in Children 3-12 Years of Age: Monitor for such events 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:
  • To report SUSPECTED ADVERSE REACTIONS, contact ACI HealthcareUSA, Inc. at 1-888-802-1213 or www.acihealthcareusa.com or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.
  • Postherpetic neuralgia: Dizziness, somnolence, and peripheral edema n
  • Epilepsy in patients >12 years of age: Somnolence, dizziness, ataxia, fatigue, and nystagmus n
  • Epilepsy in patients 3 to 12 years of age: Viral infection, fever, nausea and/or vomiting, somnolence, and hostility n
  • No data
  • Concentrations increased by morphine; may need dose adjustment n n
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm n
  • No data
  • A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8000 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 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 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 u20131.25.
  • Each Gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: Pregelatinized Maize starch, talc, gelatin, titanium dioxide, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (300 mg and 400 mg only), black iron oxide (300 mg and 400 mg only). Ingredients of Imprinting Ink( Black SW-9049) are Black Iron Oxide NF(E 172), Butyl Alcohol NF, Dehydrated Alcohol USP, Isopropyl Alcohol USP, Potassium Hydroxide NF, Propylene Glycol USP, Shellac NF, and Strong Ammonia Solution NF.
  • 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.
  • Mutagenesis
  • in vitro
  • in vivo
  • Impairment of Fertility
  • No data
  • Product: 71335-1348
  • NDC: 71335-1348-0 20 CAPSULE in a BOTTLE
  • NDC: 71335-1348-1 30 CAPSULE in a BOTTLE
  • NDC: 71335-1348-2 90 CAPSULE in a BOTTLE
  • NDC: 71335-1348-3 60 CAPSULE in a BOTTLE
  • NDC: 71335-1348-4 120 CAPSULE in a BOTTLE
  • NDC: 71335-1348-5 100 CAPSULE in a BOTTLE
  • NDC: 71335-1348-6 28 CAPSULE in a BOTTLE
  • NDC: 71335-1348-7 112 CAPSULE in a BOTTLE
  • NDC: 71335-1348-8 84 CAPSULE in a BOTTLE
  • NDC: 71335-1348-9 180 CAPSULE in a BOTTLE
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Administrative Information
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivityn- [see ]
  • Anaphylaxis and Angioedema n- [].
  • Dizziness and Somnolence and Effects on Driving and Operating Heavy Machineryn- [ and ].
  • Suicidal Thinking and Behaviorn- [see ]
  • Use in Pregnancyn- [see and ]
  • 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 .
  • This productu2019s label may have been updated. For full prescribing information, please visit www.acihealthcareusa.com.
  • Manufactured By
  • Strides Shasun Limited
  • Unit u2013 II, R.S.No.32, 33 & 34, PIMS Road,
  • Periyakalapet, Puducherry - 605 014, India.
  • Distributed by:
  • ACI Healthcare USA, Inc. 10100 W. Sample Road, Suite 406 Coral Springs, FL 33065
  • 72000400-00
  • 1036940
  • Revised: 06/2018
  • Arrayn- u00ae
  • Gabapentin Capsules, USP Rx Only
  • What is the most important information I should know about Gabapentin Capsules? Do not stop taking Gabapentin Capsules without first talking to your healthcare provider.
  • Stopping Gabapentin Capsules suddenly can cause serious problems.
  • Gabapentin Capsules can cause serious side effects including: 1.Suicidal Thoughts. Like other antiepileptic drugs, Gabapentin Capsules 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 Capsules without first talking to a healthcare provider.
  • 2. Changes in behavior and thinking -
  • 3. Gabapentin Capsules 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 Capsules.
  • What is Gabapentin Capsules?
  • Gabapentin Capsule is a prescription medicine used to treat:
  • Who should not take Gabapentin Capsules?
  • Do not take Gabapentin Capsules if you are allergic to gabapentin or any of the other ingredients in Gabapentin Capsules . See the end of this Medication Guide for a complete list of ingredients in Gabapentin Capsules .
  • What should I tell my healthcare provider before taking Gabapentin Capsules ? Before taking Gabapentin Capsules , tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take,
  • Taking Gabapentin Capsules 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 Capsules?
  • 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 Capsules?
  • What are the possible side effects of Gabapentin Capsules?
  • Gabapentin Capsules may cause serious side effects including:
  • See u201cWhat is the most important information I should know about Gabapentin Capsules?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 Capsules . 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 Capsules?
  • Keep Gabapentin Capsules and all medicines out of the reach of children.
  • General information about the safe and effective use of Gabapentin Capsules
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Gabapentin Capsules for a condition for which it was not prescribed. Do not give Gabapentin Capsules 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 Capsules . If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Gabapentin Capsules that was written for healthcare professionals.
  • For more information go to http://www.acihealthcareusa.com or call 1-754-702-5116
  • What are the ingredients in Gabapentin Capsules ?
  • Active ingredient:
  • Inactive ingredients in the capsules:
  • The 100-mg capsule shell also contains: gelatin and titanium dioxide.
  • The 300-mg capsule shell also contains: gelatin, titanium dioxide, black iron oxide, red iron oxide and yellow iron oxide.
  • The 400-mg capsule shell also contains: gelatin, titanium dioxide, black iron oxide, red iron oxide and yellow iron oxide.
  • Trademarks are the property of their respective owners.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • This productu2019s label may have been updated. For current full prescribing information, please visit www.acihealthcareusa.comu00a0u00a0
  • Manufactured By
  • Strides Shasun Limited
  • Unit u2013 II, R.S.No.32, 33 & 34, PIMS Road,
  • Periyakalapet, Puducherry - 605 014, India.
  • Distributed by:
  • ACI Healthcare USA, Inc. 10100 W. Sample Road, Suite 406 Coral Springs, FL 33065
  • 72000401-00
  • 1036940
  • Revised: 06/2018
  • Arrayn- u00ae
  • No data

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