Auro-Gabapentin Tablets

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Auro-Gabapentin Tablets are a generic form of Gabapentin, a medication commonly used to treat:

  1. Nerve Pain: Often prescribed for conditions like peripheral neuropathy or postherpetic neuralgia (nerve pain after shingles).
  2. Seizures: Used as an adjunctive therapy for partial seizures in adults and children.
  3. Restless Leg Syndrome (RLS): Occasionally used to manage symptoms of RLS.

SUMMARY PRODUCT INFORMATION

Dosage Form Strength:

oral Tablets/ 600 mg and 800 mg

All Nonmedicinal Ingredients:

  • Maize Starch (Extra White Maize Starch),
  • Crospovidone (Type A), Copovidone (VA 64),
  • Microcrystalline Cellulose (KG-1000),
  • Microcrystalline Cellulose (PH-102),
  • Magnesium Stearate,
  • Hydroxypropyl Cellulose
  • Talc.

Key Information:

  • Dosage Forms: Tablets, capsules, or oral solutions, with doses typically ranging from 100 mg to 800 mg.
  • How It Works: Gabapentin affects calcium channels in the nervous system, modulating nerve signaling to reduce pain and seizure activity.
  • Common Side Effects:
    • Drowsiness or dizziness
    • Fatigue
    • Coordination issues
    • Nausea or vomiting

Precautions:

  • Do not stop taking Gabapentin suddenly, as it may cause withdrawal symptoms or worsen seizures.
  • Use with caution if you have kidney problems, as the drug is excreted through the kidneys.
  • May interact with other medications or substances, including alcohol, increasing sedative effects.

Discontinuation of Treatment with Gabapentin

As with other anticonvulsant agents, abrupt withdrawal is not recommended because of the possibility of increased seizure frequency. There have been post-marketing reports of adverse
events such as anxiety, insomnia, nausea, pain and sweating following abrupt discontinuation of treatment. (See ADVERSE REACTIONS, Post-Market Adverse Drug Reactions). When in the judgement of the clinician there is a need for dose reduction, discontinuation or substitution with an alternative medication, this should be done gradually over a minimum of 1 week (a
longer period may be needed at the discretion of the prescriber).

Suicidal ideation and behaviour

Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. All patients treated with antiepileptic drugs, irrespective of indication, should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered.

Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.

An FDA meta-analysis of randomized placebo controlled trials, in which antiepileptic drugs were used for various indications, has shown a small increased risk of suicidal ideation and
behaviour in patients treated with these drugs. The mechanism of this risk is not known.

There were 43,892 patients treated in the placebo controlled clinical trials that were included in the meta-analysis. Approximately 75% of patients in these clinical trials were treated for
indications other than epilepsy and, for the majority of non-epilepsy indications the treatment (antiepileptic drug or placebo) was administered as monotherapy. Patients with epilepsy
represented approximately 25% of the total number of patients treated in the placebo controlled clinical trials and, for the majority of epilepsy patients, treatment (antiepileptic drug or placebo) was administered as adjunct to other antiepileptic agents (i.e., patients in both treatment arms were being treated with one or more antiepileptic drug). Therefore, the small increased risk of suicidal ideation and behaviour reported from the meta-analysis (0.43% for patients on antiepileptic drugs compared to 0.24% for patients on placebo) is based largely on patients that received monotherapy treatment (antiepileptic drug or placebo) for non-epilepsy indications.

The study design does not allow an estimation of the risk of suicidal ideation and behaviour for patients with epilepsy that are taking antiepileptic drugs, due both to this population being the minority in the study, and the drug-placebo comparison in this population being confounded by the presence of adjunct antiepileptic drug treatment in both arms.

 

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