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Gabapentin 300 mg, Actavis Elizabeth LLC, R 2666 R 2666 Pill – brown & yellow capsule/oblong, 19mm

Pill with imprint R 2666 R 2666 is Brown & Yellow, Capsule/Oblong and has been identified as Gabapentin 300 mg. It is supplied by Actavis Elizabeth LLC.

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 300 mg is not a controlled substance under the Controlled Substances Act (CSA).

Gabapentin

Imprint
R 2666 R 2666
Strength
300 mg
Color
Brown & Yellow
Size
19.00 mm
Shape
Capsule/Oblong
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
Actavis Elizabeth LLC
Inactive Ingredients
ferrosoferric oxide, corn starch, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, gelatin, mannitol, propylene glycol, ferric oxide red, silicon dioxide, sodium lauryl sulfate, magnesium silicate, titanium dioxide, ferric oxide yellow, shellac

Note: Inactive ingredients may vary.

Labelers / Repackagers

NDC Code Labeler / Repackager
14550-0512 (Discontinued) Actavis Pharma, Inc.
68084-0563 (Discontinued) Amerisource Health Services
45963-0556 Actavis Pharma, Inc.
68084-0762 (Discontinued) Amerisource Health Services

What is Gabapentin ?

Gabapentin capsules, tablets, and oral solution are used along with other medications to help control certain types of seizures in people who have epilepsy. Gabapentin capsules, tablets, and oral solution are also used to relieve the pain of postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Gabapentin extended-release tablets (Horizant) are used to treat restless legs syndrome (RLS; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down). Gabapentin is in a class of medications called anticonvulsants. Gabapentin treats seizures by decreasing abnormal excitement in the brain. Gabapentin relieves the pain of PHN by changing the way the body senses pain. It is not known exactly how gabapentin works to treat restless legs syndrome.

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.

Conclusion

Gabapentin works primarily by binding to the α2δ subunit of voltage-gated calcium channels, which leads to a reduction in calcium influx and a subsequent decrease in the release of excitatory neurotransmitters. This action helps to stabilize neuronal activity and reduce symptoms of seizures and neuropathic pain. Although its exact mechanism is not fully understood, gabapentin’s effects on neurotransmission and neuronal excitability make it a valuable medication for a variety of neurological and pain-related conditions.

Actavis Elizabeth LLC

Actavis Elizabeth LLC is a subsidiary of Actavis, which is now part of Teva Pharmaceuticals. Actavis was a prominent global pharmaceutical company known for manufacturing generic and branded pharmaceuticals. The specific branch, Actavis Elizabeth LLC, is located in Elizabeth, New Jersey, and has been involved in the development, manufacturing, and distribution of various pharmaceutical products. Here is an overview of Actavis Elizabeth LLC:

Company Overview

  1. Parent Company:
    • Actavis: Originally an independent pharmaceutical company, Actavis was acquired by Teva Pharmaceuticals in 2016.
    • Teva Pharmaceuticals: Teva is one of the world’s largest pharmaceutical companies, specializing in generic drugs, with a broad portfolio of products across many therapeutic areas.
  2. Headquarters:
    • Location: Actavis Elizabeth LLC is based in Elizabeth, New Jersey, USA.

Operations and Facilities

  1. Manufacturing:
    • Actavis Elizabeth LLC operates a manufacturing facility in Elizabeth, NJ, which is involved in the production of a wide range of generic pharmaceuticals.
    • The facility adheres to Good Manufacturing Practices (GMP) and meets the regulatory standards set by the U.S. Food and Drug Administration (FDA) and other international regulatory bodies.
  2. Research and Development:
    • The Elizabeth facility also focuses on research and development activities, aiming to develop new generic formulations and improve existing ones.

Product Portfolio

  1. Generics:
    • Actavis Elizabeth LLC produces a variety of generic medications across multiple therapeutic categories, including but not limited to cardiovascular, central nervous system, anti-infective, gastrointestinal, and pain management drugs.
    • The company is known for developing cost-effective generic alternatives to brand-name medications, making them accessible to a broader patient population.

Regulatory Compliance

  1. Quality Assurance:
    • The company ensures rigorous quality control and quality assurance processes to comply with FDA regulations and other global regulatory standards.
    • Regular inspections and audits are conducted to maintain compliance and ensure the highest standards of product safety, efficacy, and quality.

Strategic Importance

  1. Integration with Teva Pharmaceuticals:
    • Since its acquisition by Teva, Actavis Elizabeth LLC has been integrated into Teva’s extensive global operations, benefiting from Teva’s resources, expertise, and market reach.
    • The integration has enhanced Teva’s portfolio of generic medications and expanded its manufacturing capabilities in the United States.

Corporate Responsibility

  1. Sustainability:
    • The company is committed to sustainable manufacturing practices, focusing on minimizing environmental impact through efficient resource use and waste management.
  2. Community Engagement:
    • Actavis Elizabeth LLC, as part of Teva, participates in various corporate social responsibility (CSR) initiatives aimed at improving healthcare access, supporting education, and contributing to community development.

Conclusion

Actavis Elizabeth LLC, now part of Teva Pharmaceuticals, plays a significant role in the development and manufacturing of generic pharmaceuticals in the United States. With a strong focus on quality, regulatory compliance, and innovation, the company continues to contribute to making high-quality, affordable medications accessible to patients. The facility in Elizabeth, New Jersey, is a key component of Teva’s global manufacturing and R&D network, supporting the company’s mission to improve health and make healthcare more accessible.

 

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