Gabapentin 800mg – D 25 Pill – White oval, Aurobindo Pharma USA, Inc.

Pill with imprint D 25 is White, Oval and has been identified as Gabapentin 800 mg. It is supplied by Aurobindo Pharma USA, Inc.

Gabapentin is used in the treatment of Back Pain; Postherpetic Neuralgia; Epilepsy; Chronic Pain; Seizures and belongs to the drug class gamma-aminobutyric acid analogs. Risk cannot be ruled out during pregnancy. Gabapentin 800 mg is not a controlled substance under the Controlled Substances Act (CSA).

 

Gabapentin

Imprint

D 25

Strength

800 mg

Color

White

Size

19.00 mm

Shape

Oval

Availability

Prescription only

Drug Class

Gamma-aminobutyric acid analogs

Pregnancy Category

C – Risk cannot be ruled out

CSA Schedule

Not a controlled drug

Labeler / Supplier

Aurobindo Pharma USA, Inc.

Inactive Ingredients

copovidone, corn starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, magnesium silicate

Note: Inactive ingredients may vary.

Labelers / Repackagers

NDC Code	Labeler / Repackager
65862-0524	Aurobindo Pharma Limited
16714-0332	NorthStar Rx LLC

Submitted by: Drugs.com

What is Gabapentin and How to Use it ?

Therapeutic Uses

1. Epilepsy:
   • Gabapentin is used as an adjunctive therapy in the treatment of partial seizures with or without secondary generalization in adults and children over the age of 3.
2. Neuropathic Pain:
   • Effective in managing pain from conditions such as diabetic neuropathy, postherpetic neuralgia (pain following shingles), and other forms of nerve pain.
3. Restless Legs Syndrome (RLS):
   • Gabapentin can help reduce the symptoms of RLS, improving sleep quality and reducing leg discomfort.
4. Anxiety Disorders:
   • Sometimes used off-label for the treatment of anxiety disorders, including generalized anxiety disorder (GAD) and social anxiety disorder (SAD).
5. Fibromyalgia:
   • Can be used to manage the chronic pain associated with fibromyalgia.

Pharmacokinetics

1. Absorption:
   • Gabapentin is absorbed from the gastrointestinal tract, with peak plasma concentrations occurring within 2 to 3 hours after oral administration. Its bioavailability decreases as the dose increases.
2. Distribution:
   • Widely distributed throughout the body but does not significantly bind to plasma proteins.
3. Metabolism:
   • Unlike many other medications, gabapentin is not significantly metabolized in the liver.
4. Elimination:
   • Excreted unchanged by the kidneys. The half-life of gabapentin is about 5 to 7 hours in individuals with normal renal function.

Gabapentin is a medication primarily used to treat seizures (epilepsy) and nerve pain (neuropathic pain). It belongs to a class of medications known as anticonvulsants or antiepileptic drugs. Gabapentin works by affecting certain chemicals and neurotransmitters in the brain involved in seizures and nerve pain.

Side Effects of Gabapentin

Common side effects of gabapentin include:

• Dizziness
• Drowsiness
• Peripheral edema (swelling of the extremities)
• Fatigue
• Ataxia (lack of coordination)
• Nystagmus (involuntary eye movement)

Less common but more serious side effects can include:

• Mood changes such as depression or anxiety
• Suicidal thoughts or behaviors
• Severe allergic reactions (rare)

Dosage

Gabapentin is available in various forms, including capsules, tablets, and an oral solution. Dosage depends on the condition being treated and individual patient factors, but it typically starts at a low dose and is gradually increased. Common dosing regimens include:

• Epilepsy: Starting at 300 mg once daily and increasing based on response.
• Neuropathic Pain: Starting at 100-300 mg once daily and titrating up as needed.
• RLS: Typically 600 mg once daily in the evening.

Drug Interactions

Gabapentin has relatively few drug interactions compared to many other medications, but it can interact with:

• Antacids (reduce gabapentin’s absorption)
• CNS depressants (increased risk of sedation and respiratory depression)

Here’s how gabapentin is typically used:

1. Seizures (Epilepsy): Gabapentin is commonly prescribed as an adjunctive treatment for partial seizures in adults and children aged 3 years and older. It is often used in combination with other antiepileptic medications to help control seizures.
2. Nerve Pain (Neuropathic Pain): Gabapentin is also frequently used to treat various types of nerve pain, including diabetic neuropathy, postherpetic neuralgia (nerve pain following shingles), and peripheral neuropathy. It is effective in relieving shooting or burning sensations, tingling, or numbness associated with nerve damage.

Gabapentin is usually taken orally in the form of capsules, tablets, or an oral solution. Here are some general guidelines for using gabapentin:

1. Dosage: The dosage of gabapentin varies depending on the individual’s medical condition, age, and response to treatment. It’s essential to follow your doctor’s instructions and the dosage prescribed on the medication label carefully.
2. Administration: Gabapentin is typically taken by mouth with or without food. Swallow the capsule or tablet whole with a full glass of water. Do not crush, chew, or break the tablet or capsule unless directed to do so by your doctor.
3. Timing: Take gabapentin exactly as prescribed by your doctor. It’s important to take it regularly and at the same times each day to maintain a consistent level of the medication in your body.
4. Gradual Dosing: If you are starting gabapentin treatment or increasing the dosage, your doctor may recommend starting with a low dose and gradually increasing it over time to minimize side effects.
5. Duration of Treatment: Continue taking gabapentin for the full duration of treatment prescribed by your doctor, even if you start to feel better. Stopping gabapentin suddenly can increase the risk of seizures or other withdrawal symptoms.
6. Monitor Side Effects: Pay attention to any side effects you may experience while taking gabapentin and report them to your doctor. Common side effects may include dizziness, drowsiness, fatigue, and weight gain.
7. Storage: Store gabapentin at room temperature away from moisture and heat. Keep it out of reach of children and pets.

It’s important to note that gabapentin can interact with other medications, so it’s essential to inform your doctor about all the medications you are taking, including prescription drugs, over-the-counter medications, and supplements. Additionally, never adjust your gabapentin dosage or stop taking it without consulting your doctor first, as sudden changes can lead to serious complications.

Mechanism of Action of Gabapentin

Gabapentin is a medication that is primarily used to treat epilepsy and neuropathic pain. Its exact mechanism of action is not fully understood, but it is known to interact with certain components of the nervous system. Here is a detailed explanation of the proposed mechanisms by which gabapentin exerts its therapeutic effects:

Mechanism of Action

1. Binding to the α2δ Subunit of Voltage-Gated Calcium Channels:
   • Gabapentin binds with high affinity to the α2δ subunit of voltage-gated calcium channels in the central nervous system.
   • This binding inhibits the influx of calcium ions into neurons, which in turn reduces the release of excitatory neurotransmitters such as glutamate, norepinephrine, and substance P.
   • By decreasing the release of these neurotransmitters, gabapentin helps to stabilize neuronal activity and reduce the hyperexcitability that contributes to seizures and neuropathic pain.
2. Reduction of Excitatory Neurotransmission:
   • The inhibition of calcium influx and subsequent reduction in neurotransmitter release results in decreased excitatory synaptic transmission.
   • This reduction in excitatory signaling is believed to contribute to the anticonvulsant and analgesic effects of gabapentin.
3. Modulation of GABAergic Neurotransmission:
   • Although gabapentin is structurally similar to the neurotransmitter gamma-aminobutyric acid (GABA), it does not directly bind to GABA receptors or influence GABA synthesis or uptake.
   • However, gabapentin may enhance the synthesis of GABA and increase its release in certain brain regions, which could contribute to its overall calming effect on neuronal activity.
4. Inhibition of Central Sensitization:
   • In conditions like neuropathic pain, there is often a phenomenon known as central sensitization, where the nervous system becomes sensitized to pain stimuli.
   • By inhibiting calcium influx and reducing excitatory neurotransmitter release, gabapentin helps to diminish central sensitization and alleviate chronic pain symptoms.

Therapeutic Effects

1. Anticonvulsant:
   • Gabapentin’s ability to decrease neuronal excitability and stabilize electrical activity in the brain makes it effective in controlling seizures, particularly partial seizures.
2. Analgesic:
   • The reduction in neurotransmitter release and inhibition of central sensitization make gabapentin effective in treating various forms of neuropathic pain, such as diabetic neuropathy and postherpetic neuralgia.
3. Other Uses:
   • Gabapentin is also used off-label for other conditions like restless legs syndrome (RLS) and certain anxiety disorders, where its modulatory effects on the nervous system can provide symptomatic relief.

Aurobindo Pharma USA

Aurobindo Pharma USA is the U.S. subsidiary of Aurobindo Pharma Ltd., a major Indian multinational pharmaceutical company. Aurobindo Pharma USA plays a critical role in the company’s global operations, focusing on the development, manufacturing, and distribution of generic pharmaceuticals in the United States. Here’s an overview of Aurobindo Pharma USA:

Company Overview

1. Establishment and Headquarters:
   • Founded: Aurobindo Pharma USA was established to cater to the U.S. pharmaceutical market.
   • Headquarters: East Windsor, New Jersey, USA.
2. Operations and Facilities:
   • Manufacturing: Aurobindo Pharma USA operates several manufacturing facilities in the United States, including sites in Dayton, New Jersey, and East Windsor, New Jersey.
   • Research and Development: The U.S. subsidiary has a strong focus on R&D, with facilities dedicated to developing generic formulations and ensuring compliance with U.S. regulatory standards.
3. Product Portfolio:
   • Generics: Aurobindo Pharma USA offers a wide range of generic medications, covering various therapeutic areas such as antibiotics, antiretrovirals, cardiovascular, central nervous system, gastroenterology, and anti-diabetics.
   • Over-the-Counter (OTC) Products: The company also provides a variety of OTC medications to the U.S. market.

Key Areas of Operation

1. Regulatory Compliance:
   • FDA Approval: Aurobindo Pharma USA ensures that all its products meet the stringent requirements of the U.S. Food and Drug Administration (FDA).
   • Quality Assurance: The company maintains high standards of quality control and assurance to comply with Good Manufacturing Practices (GMP).
2. Research and Development:
   • Innovation: The R&D efforts in the U.S. focus on developing complex generics and novel drug delivery systems.
   • Pipeline: Aurobindo Pharma USA has a robust pipeline of products in various stages of development, aimed at expanding its market presence and addressing unmet medical needs.
3. Manufacturing Excellence:
   • Advanced Facilities: The manufacturing facilities are equipped with state-of-the-art technology to produce high-quality pharmaceuticals efficiently.
   • Supply Chain Management: Aurobindo Pharma USA’s vertically integrated supply chain ensures the consistent availability of products and cost efficiencies.
4. Market Strategy:
   • Product Launches: The company is known for its timely launches of generic drugs, often being among the first to file for generic versions of brand-name drugs.
   • Competitive Pricing: Aurobindo Pharma USA offers competitively priced medications, making healthcare more affordable for patients.

Strategic Growth

1. Acquisitions and Partnerships:
   • Expansion: Aurobindo Pharma USA has grown through strategic acquisitions and partnerships, enhancing its product portfolio and market reach. Notable acquisitions include Sandoz’s U.S. dermatology and oral solids businesses.
   • Collaborations: The company collaborates with other pharmaceutical companies and research institutions to bolster its R&D efforts and market presence.
2. Corporate Responsibility:
   • Sustainability: Aurobindo Pharma USA is committed to sustainable practices, focusing on reducing its environmental impact and promoting efficient use of resources.
   • Community Engagement: The company engages in various corporate social responsibility (CSR) activities, including healthcare initiatives, educational programs, and community development projects.

Conclusion

Aurobindo Pharma USA is a key subsidiary of Aurobindo Pharma Ltd., focusing on the U.S. market. With a broad product portfolio, strong R&D capabilities, and commitment to regulatory compliance, Aurobindo Pharma USA plays a crucial role in making high-quality, affordable medications available to patients in the United States. The company’s strategic growth through acquisitions and partnerships, along with its dedication to sustainability and corporate responsibility, positions it as a significant player in the U.S. pharmaceutical industry.