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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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

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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:
  • u2022Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
  • Gabapentin is indicated for: u00b7u00a0 u00a0u00a0Adjunctive 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
  • u00b7u00a0u00a0u00a0 Epilepsy with Partial Onset Seizuresu00a0n
  • ou00a0u00a0 Patients 12 years of age and older: starting dose is 300 mg three times daily; may be titrated up to 600 mg three times daily
  • ou00a0u00a0 Patients 3 to 11 years of age: starting dose range is 10 to 15 mg/kg/day, given in three divided doses; recommended dose in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses; the recommended dose in patients 5 to 11 years of age is 25 to 35 mg/kg/day, given in three divided doses. The recommended dose is reached by upward titration over a period of approximately 3 days
  • u00b7u00a0u00a0u00a0u00a0 Dose should be adjusted in patients with reduced renal function (, )
  • Capsules:
  • u00b7u00a0u00a0u00a0 100 mg: White hard gelatin capsules imprinted u201c216u201d on body with blue ink.
  • u00b7u00a0u00a0u00a0 300 mg: Yellow hard gelatin capsules imprinted u201c215u201d on body with blue ink.
  • u00b7u00a0 u00a0u00a0400 mg: Orange hard gelatin capsules imprinted u201c214u201d on body with blue ink.
  • u00b7u00a0u00a0u00a0u00a0 Capsules: 100 mg, 300 mg, and 400 mg
  • Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
  • Known hypersensitivity to gabapentin or its ingredients
  • u00b7u00a0u00a0u00a0u00a0 Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): Discontinue if alternative etiology is not established n
  • u00b7u00a0u00a0u00a0u00a0 Anaphylaxis and Angioedema: Discontinue and evaluate patient immediately n
  • u00b7u00a0u00a0u00a0u00a0 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 (, ) u00a0
  • u00b7u00a0u00a0u00a0u00a0 Increased seizure frequency may occur in patients with seizure disorders if gabapentin is abruptly discontinuedu00a0()u00a0
  • u00b7u00a0u00a0u00a0u00a0 Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior n
  • u00b7u00a0u00a0u00a0u00a0 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:
  • u00b7u00a0u00a0u00a0 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see )]n n
  • u00b7u00a0u00a0u00a0 Anaphylaxis and Angioedema n
  • u00b7u00a0u00a0u00a0 Somnolence/Sedation and Dizziness [see)] n n
  • u00b7u00a0u00a0u00a0 Withdrawal Precipitated Seizure, Status Epilepticus [see )] n n
  • u00b7u00a0u00a0u00a0 Suicidal Behavior and Ideation [see )] n n
  • u00b7u00a0u00a0u00a0 Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) [see ]n n
  • u00b7u00a0 u00a0u00a0Sudden and Unexplained Death in Patients with Epilepsy [see )]
  • Most common adverse reactions (incidence u22658% and at least twice that for placebo) were:
  • u00b7u00a0u00a0u00a0u00a0 Epilepsy in patients >12 years of age: Somnolence, dizziness, ataxia, fatigue, and nystagmus ()
  • u00b7u00a0u00a0u00a0u00a0 Epilepsy in patients 3 to 12 years of age: Viral infection, fever, nausea and/or vomiting, somnolence, and hostility n n n
  • No data
  • Concentrations increased by morphine; may need dose adjustmentu00a0 (, )
  • u00b7u00a0u00a0u00a0u00a0 Pregnancy: Based on animal data, may cause fetal harmu00a0n
  • 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 patients clinical state or in patients with significant renal impairment. n n
  • If overexposure occurs, call your poison control center at 1-800-222-1222.
  • The active ingredient in gabapentin capsules is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is:n n
  • 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 capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: anhydrous lactose, cornstarch, and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate, and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propyl glycol, strong ammonia solution, and titanium dioxide.
  • No data
  • No data
  • The effectiveness of gabapentin as adjunctive therapy (added to other antiepileptic drugs) was established in multicenter placebo-controlled, double-blind, parallel-group clinical trials in adult and pediatric patients (3 years and older) with refractory partial seizures.
  • Evidence of effectiveness was obtained in three trials conducted in 705 patients (age 12 years and above) and one trial conducted in 247 pediatric patients (3 to 12 years of age). The patients enrolled had a history of at least 4 partial seizures per month in spite of receiving one or more antiepileptic drugs at therapeutic levels and were observed on their established antiepileptic drug regimen during a 12-week baseline period (6 weeks in the study of pediatric patients). In patients continuing to have at least 2 (or 4 in some studies) seizures per month, gabapentin or placebo was then added on to the existing therapy during a 12-week treatment period. Effectiveness was assessed primarily on the basis of the percent of patients with a 50% or greater reduction in seizure frequency from baseline to treatment (the u201cresponder rateu201d) and a derived measure called response ratio, a measure of change defined as (T - B)/(T + B), in which B is the patientu2019s baseline seizure frequency and T is the patientu2019s seizure frequency during treatment. Response ratio is distributed within the range -1 to +1. A zero value indicates no change while complete elimination of seizures would give a value of -1; increased seizure rates would give positive values. A response ratio of -0.33 corresponds to a 50% reduction in seizure frequency. The results given below are for all partial seizures in the intent-to-treat (all patients who received any doses of treatment) population in each study, unless otherwise indicated.
  • One study compared gabapentin 1200 mg/day, in three divided doses with placebo. Responder rate was 23% (14/61) in the gabapentin group and 9% (6/66) in the placebo group; the difference between groups was statistically significant. Response ratio was also better in the gabapentin group (-0.199) than in the placebo group (-0.044), a difference that also achieved statistical significance.
  • A second study compared primarily gabapentin 1200 mg/day, in three divided doses (N=101), with placebo (N=98). Additional smaller gabapentin dosage groups (600 mg/day, N=53; 1800 mg/day, N=54) were also studied for information regarding dose response. Responder rate was higher in the gabapentin 1200 mg/day group (16%) than in the placebo group (8%), but the difference was not statistically significant. The responder rate at 600 mg (17%) was also not significantly higher than in the placebo, but the responder rate in the 1800 mg group (26%) was statistically significantly superior to the placebo rate. Response ratio was better in the gabapentin 1200 mg/day group (-0.103) than in the placebo group (-0.022); but this difference was also not statistically significant (p = 0.224). A better response was seen in the gabapentin 600 mg/day group (-0.105) and 1800 mg/day group (-0.222) than in the 1200 mg/day group, with the 1800 mg/day group achieving statistical significance compared to the placebo group.
  • u00a0u00a0
  • A third study compared gabapentin 900 mg/day, in three divided doses (N=111), and placebo (N=109). An additional gabapentin 1200 mg/day dosage group (N=52) provided dose-response data. A statistically significant difference in responder rate was seen in the gabapentin 900 mg/day group (22%) compared to that in the placebo group (10%). Response ratio was also statistically significantly superior in the gabapentin 900 mg/day group (-0.119) compared to that in the placebo group (-0.027), as was response ratio in 1200 mg/day gabapentin (-0.184) compared to placebo.
  • Analyses were also performed in each study to examine the effect of gabapentin on preventing secondarily generalized tonic-clonic seizures. Patients who experienced a secondarily generalized tonic-clonic seizure in either the baseline or in the treatment period in all three placebo-controlled studies were included in these analyses. There were several response ratio comparisons that showed a statistically significant advantage for gabapentin compared to placebo and favorable trends for almost all comparisons.
  • Analysis of responder rate using combined data from all three studies and all doses (N=162, gabapentin; N=89, placebo) also showed a significant advantage for gabapentin over placebo in reducing the frequency of secondarily generalized tonic-clonic seizures.
  • In two of the three controlled studies, more than one dose of gabapentin was used. Within each study, the results did not show a consistently increased response to dose. However, looking across studies, a trend toward increasing efficacy with increasing dose is evident (see Figure 4).u00a0
  • Figure 4. Responder Rate in Patients Receiving gabapentin Expressed as a Difference from Placebo by Dose and Study: Adjunctive Therapy Studies in Patients u2265 12 Years of Age with Partial Seizures
  • In the figure, treatment effect magnitude, measured on the Y axis in terms of the difference in the proportion of gabapentin and placebo-assigned patients attaining a 50% or greater reduction in seizure frequency from baseline, is plotted against the daily dose of gabapentin administered (X axis).
  • u00a0u00a0
  • Although no formal analysis by gender has been performed, estimates of response (Response Ratio) derived from clinical trials (398 men, 307 women) indicate no important gender differences exist. There was no consistent pattern indicating that age had any effect on the response to gabapentin. There were insufficient numbers of patients of races other than Caucasian to permit a comparison of efficacy among racial groups.
  • A fourth study in pediatric patients age 3 to 12 years compared 25 u2013 35 mg/kg/day gabapentin (N=118) with placebo (N=127). For all partial seizures in the intent-to-treat population, the response ratio was statistically significantly better for the gabapentin group (-0.146) than for the placebo group (-0.079). For the same population, the responder rate for gabapentin (21%) was not significantly different from placebo (18%).
  • A study in pediatric patients age 1 month to 3 years compared 40 mg/kg/day gabapentin (N=38) with placebo (N=38) in patients who were receiving at least one marketed antiepileptic drug and had at least one partial seizure during the screening period (within 2 weeks prior to baseline). Patients had up to 48 hours of baseline and up to 72 hours of double-blind video EEG monitoring to record and count the occurrence of seizures. There were no statistically significant differences between treatments in either the response ratio or responder rate.u00a0
  • Product: 71335-1269
  • NDC: 71335-1269-1 90 CAPSULE in a BOTTLE
  • NDC: 71335-1269-2 28 CAPSULE in a BOTTLE
  • NDC: 71335-1269-3 58 CAPSULE in a BOTTLE
  • NDC: 71335-1269-4 30 CAPSULE in a BOTTLE
  • NDC: 71335-1269-5 60 CAPSULE in a BOTTLE
  • NDC: 71335-1269-6 120 CAPSULE in a BOTTLE
  • NDC: 71335-1269-7 180 CAPSULE in a BOTTLE
  • Product: 71335-1496
  • NDC: 71335-1496-1 90 CAPSULE in a BOTTLE
  • NDC: 71335-1496-2 28 CAPSULE in a BOTTLE
  • NDC: 71335-1496-3 120 CAPSULE in a BOTTLE
  • NDC: 71335-1496-4 30 CAPSULE in a BOTTLE
  • NDC: 71335-1496-5 60 CAPSULE in a BOTTLE
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • 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
  • Advise patients to discontinue gabapentin and seek medical care if they develop signs or symptoms of anaphylaxis or angioedema [n
  • Dizziness and Somnolence and n- Effects on Driving and Operating Heavy Machineryn- u00a0
  • 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 .
  • 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 .
  • u00a0
  • 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 .
  • 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 n
  • Trademarks are the property of their respective owners.
  • Manufactured by:
  • Alkem Laboratories Limited
  • ALKEM HOUSE, Lower Parel,
  • Mumbai u2013 400 013, INDIA
  • Distributed by:
  • Ascend Laboratories, LCC
  • Parsippany, NJ 07054n Revised: August,2019
  • PT 3365
  • Gabapentin Capsules USP
  • (GA ba PEN tin)n- Array
  • What is the most important information I should know about gabapentin?
  • Do not stop taking gabapentin without first talking to your healthcare provider.u00a0
  • Stopping gabapentin suddenly can cause serious problems.u00a0
  • Gabapentin can cause serious side effects including:
  • u00a0
  • 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:
  • u00b7u00a0u00a0u00a0 thoughts about suicide or dying
  • u00b7u00a0u00a0u00a0 attempts to commit suicide
  • u00b7u00a0u00a0u00a0 new or worse depression
  • u00b7u00a0u00a0u00a0 new or worse anxiety
  • u00b7u00a0u00a0u00a0 feeling agitated or restless
  • u00b7u00a0u00a0u00a0 panic attacks
  • u00b7u00a0u00a0u00a0 trouble sleeping (insomnia)
  • u00b7u00a0u00a0u00a0 new or worse irritability
  • u00b7u00a0u00a0u00a0 acting aggressive, being angry, or violent
  • u00b7u00a0u00a0u00a0 acting on dangerous impulses
  • u00b7u00a0u00a0u00a0 an extreme increase in activity and talking (mania)
  • u00b7u00a0u00a0u00a0 other unusual changes in behavior or mood
  • u00a0
  • How can I watch for early symptoms of suicidal thoughts and actions?
  • u00b7u00a0u00a0u00a0 Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • u00b7u00a0u00a0u00a0 Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
  • u00a0
  • Do not stop taking gabapentin without first talking to a healthcare provider.
  • u00b7u00a0u00a0u00a0 Stopping gabapentin suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
  • u00b7u00a0u00a0u00a0 Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
  • 2. Changes in behavior and thinking -
  • 3. Gabapentin may cause a serious or life-threatening allergic reactions
  • u00b7u00a0u00a0u00a0 skin rash
  • u00b7u00a0u00a0u00a0 hives
  • u00b7u00a0u00a0u00a0 difficulty breathing
  • u00b7u00a0u00a0u00a0 fever
  • u00b7u00a0u00a0u00a0 swollen glands that do not go away
  • u00b7u00a0u00a0u00a0 swelling of your face, lips, throat, or tongue
  • u00b7u00a0u00a0u00a0 yellowing of your skin or of the whites of the eyes
  • u00b7u00a0u00a0u00a0 unusual bruising or bleeding
  • u00b7u00a0u00a0u00a0 severe fatigue or weakness
  • u00b7u00a0u00a0u00a0 unexpected muscle pain
  • u00b7u00a0u00a0u00a0 frequent infections
  • 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.u00a0
  • What is gabapentin?
  • Gabapentin is a prescription medicine used to treat:
  • u00b7u00a0u00a0u00a0 Partial seizures when taken together with other medicines in adults and children 3 years of age and older with seizures.
  • u00a0
  • 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?
  • u00a0
  • Before taking gabapentin, tell your healthcare provider if you
  • u00b7u00a0u00a0u00a0 have or have had kidney problems or are on hemodialysis
  • u00b7u00a0u00a0u00a0 have or have had depression, mood problems, or suicidal thoughts or behavior
  • u00b7u00a0u00a0u00a0 have diabetes
  • u00b7u00a0u00a0u00a0 are pregnant or plan to become pregnant. It is not known if gabapentin can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking gabapentin. You and your healthcare provider will decide if you should take gabapentin while you are pregnant.
  • ou00a0 If you become pregnant while taking gabapentin, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
  • u00b7u00a0u00a0u00a0 are breast-feeding or plan to breast-feed. Gabapentin can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take gabapentin.
  • u00a0
  • 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.
  • u00a0
  • How should I take gabapentin?
  • u00b7u00a0u00a0u00a0 Take gabapentin exactly as prescribed. Your healthcare provider will tell you how much gabapentin to take.
  • ou00a0 Do not change your dose of gabapentin without talking to your healthcare provider.
  • ou00a0 Take gabapentin capsules with water.
  • If you take too much gabapentin, call your healthcare provider or your local Poison Control Center right away at 1-800-222-1222.u00a0
  • What should I avoid while taking gabapentin?
  • u00b7u00a0u00a0u00a0 Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin without first talking with your healthcare provider. Taking gabapentin with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
  • u00b7u00a0u00a0u00a0 Do not drive, operate heavy machinery, or do other dangerous activities until you know how gabapentin affects you. Gabapentin can slow your thinking and motor skills.
  • 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
  • u00b7u00a0u00a0u00a0 problems driving while using gabapentin. See u201cWhat I should avoid while taking gabapentin?u201d
  • u00b7u00a0u00a0u00a0 sleepiness u00a0and dizziness, which could increase the occurrence of accidental injury, including falls
  • u00b7u00a0u00a0u00a0 n
  • u00b7u00a0u00a0u00a0u00a0u00a0 lack of coordination
  • u00b7u00a0u00a0u00a0u00a0u00a0 feeling tired
  • u00b7u00a0u00a0u00a0u00a0u00a0 viral infection
  • u00b7u00a0u00a0u00a0u00a0u00a0 fever
  • u00b7u00a0u00a0u00a0u00a0u00a0 feeling drowsy
  • u00b7u00a0u00a0u00a0u00a0u00a0 jerky movements
  • u00b7u00a0u00a0u00a0u00a0u00a0 nausea and vomiting
  • u00b7u00a0u00a0u00a0u00a0u00a0 difficulty with coordination
  • u00b7u00a0u00a0u00a0u00a0u00a0 difficulty with speaking
  • u00b7u00a0u00a0u00a0u00a0u00a0 double vision
  • u00b7u00a0u00a0u00a0u00a0u00a0 tremor
  • u00b7u00a0u00a0u00a0u00a0u00a0 unusual eye movement
  • u00b7u00a0u00a0u00a0u00a0u00a0 swelling, usually of legs and feet
  • 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.u00a0
  • 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?
  • u00b7u00a0u00a0u00a0 Store gabapentin Capsules between 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); [see USP Controlled Room Temperature].n
  • Array
  • 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.
  • What are the ingredients in gabapentin?
  • Active ingredient:
  • Inactive ingredients in the capsules:
  • The 300-mg capsule shell also contains: gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide.
  • The 400-mg capsule shell also contains: gelatin, sodium lauryl sulfate, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propyl glycol, strong ammonia solution, and titanium dioxide.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0
  • Manufactured by:
  • Alkem Laboratories Limited
  • ALKEM HOUSE, Lower Parel,
  • Mumbai u2013 400 013, INDIA
  • Distributed by:
  • Ascend Laboratories, LCC
  • Parsippany, NJ 07054
  • u00a0
  • Revised : August, 2019
  • No data
  • No data

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Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

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Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

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Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

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Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

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General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

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