GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Pregabalin Capsules USP 25mg
B) Pregabalin Capsules USP 50mg
C) Pregabalin Capsules USP 75mg
D) Pregabalin Capsules USP 100mg
E) Pregabalin Capsules USP 150mg
F) Pregabalin Capsules USP 200mg
G) Pregabalin Capsules USP 300mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Pregabalin Capsules USP 25mg
Each hard gelatin capsule contains:
Pregabalin USP………………….25mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.

B) Pregabalin Capsules USP 50mg
Each hard gelatin capsule contains:
Pregabalin USP………………….50mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.

C) Pregabalin Capsules USP 75mg
Each hard gelatin capsule contains:
Pregabalin USP………………….75mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.

D) Pregabalin Capsules USP 100mg
Each hard gelatin capsule contains:
Pregabalin USP………………….100mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.

E) Pregabalin Capsules USP 150mg
Each hard gelatin capsule contains:
Pregabalin USP………………….150mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.

F) Pregabalin Capsules USP 200mg
Each hard gelatin capsule contains:
Pregabalin USP………………….200mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.

G) Pregabalin Capsules USP 300mg
Each hard gelatin capsule contains:
Pregabalin USP………………….300mg
Excipients………………………….q.s.
Approved colours used in hard gelatin capsule shells.

THERAPEUTIC INDICATIONS:

Pregabalin is an anticonvulsant, analgesic and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, opioid withdrawal and generalized anxiety disorder. Its use in epilepsy is as an add-on therapy for partial seizures.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Pregabalin Capsules USP 75mg Technical Specification

Product Name:Pregabalin Capsules USP
Brand Name:Generic
Strength:25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 300mg
Dosage Form:Capsules (Hard Gelatin)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anticonvulsant, Anti-Epileptic, Anti anxiety
Indication: Pregabalin is used to treat epilepsy and anxiety. It’s also taken to treat nerve pain. Nerve pain can be caused by different conditions including diabetes and shingles, or an injury.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Pregabalin Capsules USP 25mg
  • Pregabalin Capsules USP 50mg
  • Pregabalin Capsules USP 75mg
  • Pregabalin Capsules USP 100mg
  • Pregabalin Capsules USP 150mg
  • Pregabalin Capsules USP 200mg
  • Pregabalin Capsules USP 300mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Pregabalin Capsules USP 25mg
    Each hard gelatin capsule contains:
    Pregabalin USP………………….25mg
    Excipients………………………….q.s.
    Approved colours used in hard gelatin capsule shells.
  • Pregabalin Capsules USP 50mg
    Each hard gelatin capsule contains:
    Pregabalin USP………………….50mg
    Excipients………………………….q.s.
    Approved colours used in hard gelatin capsule shells.
  • Pregabalin Capsules USP 75mg
    Each hard gelatin capsule contains:
    Pregabalin USP………………….75mg
    Excipients………………………….q.s.
    Approved colours used in hard gelatin capsule shells.
  • Pregabalin Capsules USP 100mg
    Each hard gelatin capsule contains:
    Pregabalin USP………………….100mg
    Excipients………………………….q.s.
    Approved colours used in hard gelatin capsule shells.
  • Pregabalin Capsules USP 150mg
    Each hard gelatin capsule contains:
    Pregabalin USP………………….150mg
    Excipients………………………….q.s.
    Approved colours used in hard gelatin capsule shells.
  • Pregabalin Capsules USP 200mg
    Each hard gelatin capsule contains:
    Pregabalin USP………………….200mg
    Excipients………………………….q.s.
    Approved colours used in hard gelatin capsule shells.
  • Pregabalin Capsules USP 300mg
    Each hard gelatin capsule contains:
    Pregabalin USP………………….300mg
    Excipients………………………….q.s.
    Approved colours used in hard gelatin capsule shells.

THERAPEUTIC INDICATIONS:

Pregabalin is an anticonvulsant, analgesic and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, opioid withdrawal and generalized anxiety disorder. Its use in epilepsy is as an add-on therapy for partial seizures.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Why Taj Pharmaceuticals? 

Taj Pharmaceuticals stands out as a highly reputable choice for Pregabalin Capsules, offering a multitude of compelling reasons for consideration. Central to its reputation is a steadfast commitment to maintaining the highest standards of quality in the pharmaceutical industry. Taj Pharmaceuticals rigorously adheres to strict quality control processes, ensuring that their Pregabalin Capsules consistently meet and exceed industry benchmarks. This unwavering commitment to quality provides both healthcare providers and patients with the assurance of safe and effective medications. With a robust presence in the pharmaceutical sector, Taj Pharmaceuticals brings a wealth of experience and expertise to the forefront. Over the years, the company has consistently delivered dependable and effective medications, earning the trust of healthcare professionals and patients worldwide. Their legacy of excellence in healthcare is a testament to their unwavering commitment to providing the best in the industry.

Taj Pharmaceuticals doesn’t rest on its laurels; it continues to invest in research and development. This forward-looking approach ensures that their medications, including Pregabalin Capsules, remain at the cutting edge of therapeutic efficacy. By continually optimizing their treatments, they can effectively address the ever-evolving healthcare needs of patients. Global accessibility is another hallmark of Taj Pharmaceuticals. With a widespread presence, they make essential medications accessible to patients worldwide. Their extensive distribution network ensures that life-saving treatments are readily available, regardless of geographical location, helping bridge healthcare gaps on a global scale. Affordability is a central tenet of Taj Pharmaceuticals’ approach. They recognize the importance of making healthcare accessible to all. Consequently, they offer cost-effective solutions, ensuring that essential medications such as Pregabalin Capsules remain affordable without compromising on quality. This affordability makes critical treatments accessible to a broader spectrum of patients.

Taj Pharmaceuticals adopts a customer-centric approach that places patient satisfaction at the core of its mission. They prioritize delivering exceptional service and support, creating a positive healthcare experience for both healthcare professionals and patients. Patient needs and concerns are handled with care and responsiveness, fostering trust and confidence. Environmental responsibility is another key facet of Taj Pharmaceuticals’ operations. They actively implement eco-friendly manufacturing practices to minimize their ecological footprint, aligning with contemporary environmental concerns and demonstrating their commitment to sustainability. Taj Pharmaceuticals is a trusted healthcare partner for Pregabalin Capsules. Their unwavering dedication to quality, safety, affordability, and customer satisfaction underscores their mission to prioritize the health and well-being of patients. By choosing Taj Pharmaceuticals, individuals and healthcare providers alike opt for a reliable partner with a global presence and a legacy of excellence in healthcare.

What are Pregabalin Capsules and their uses:

Pregabalin Capsules contain the active ingredient pregabalin, which is a medication used to treat various medical conditions, primarily those related to nerve pain and certain types of seizures. Here are the main uses of Pregabalin Capsules:

  • Neuropathic Pain: Pregabalin is often prescribed to manage neuropathic pain, which is caused by damage or dysfunction of the nervous system. This type of pain can be associated with conditions such as diabetic neuropathy (nerve pain in diabetes), postherpetic neuralgia (nerve pain following shingles), and peripheral neuropathy.
  • Fibromyalgia: Pregabalin is approved for the treatment of fibromyalgia, a chronic condition characterized by widespread musculoskeletal pain, fatigue, and other symptoms. It can help reduce pain and improve sleep in individuals with fibromyalgia.
  • Epilepsy: Pregabalin is used as an adjunctive therapy (used in addition to other antiepileptic medications) to treat certain types of seizures in individuals with epilepsy. It can help reduce the frequency and severity of seizures.
  • Generalized Anxiety Disorder (GAD): In some cases, Pregabalin may be prescribed to manage the symptoms of generalized anxiety disorder. It can help alleviate excessive worry, restlessness, and other anxiety-related symptoms.
  • Off-Label Uses: Pregabalin is sometimes used off-label to manage other conditions, such as social anxiety disorder, neuropathic pain associated with spinal cord injury, and certain types of chronic pain.

Pregabalin belongs to a class of medications known as anticonvulsants or antiepileptics. Its exact mechanism of action in treating these conditions is not fully understood, but it is believed to work by reducing abnormal electrical activity in the brain and nervous system, which can help alleviate pain and control seizures.

How Does Pregabalin Capsules Work?

Pregabalin Capsules work by affecting the nervous system, particularly the activity of certain neurotransmitters in the brain and spinal cord. While the exact mechanism of action is not fully understood, pregabalin is believed to primarily target the following processes:

  • Reduction of Nerve Excitability: Pregabalin is classified as an anticonvulsant or antiepileptic medication. It binds to specific sites on calcium channels in nerve cells. By doing so, it reduces the release of certain neurotransmitters, including glutamate, which play a role in transmitting pain signals. This action results in a decreased excitability of nerve cells, making them less likely to transmit pain signals or abnormal electrical impulses.
  • Inhibition of Abnormal Electrical Activity: In the context of epilepsy, pregabalin helps stabilize electrical activity in the brain. It reduces the likelihood of rapid and excessive firing of nerve cells, which can lead to seizures. By doing this, pregabalin helps control and prevent seizures associated with epilepsy.
  • Pain Management: Pregabalin is particularly effective in managing neuropathic pain. Neuropathic pain arises from damage or dysfunction in the nervous system and is characterized by abnormal pain sensations, such as burning or shooting pain. Pregabalin’s ability to reduce neurotransmitter release and nerve excitability helps dampen these abnormal pain signals, providing relief to individuals with conditions like diabetic neuropathy and fibromyalgia.
  • Anxiolytic Effect: Pregabalin may also have anxiolytic (anxiety-reducing) properties. While the exact mechanism for its anxiolytic effects is not fully understood, it is thought to involve the modulation of neurotransmitters in the brain, such as gamma-aminobutyric acid (GABA), which has calming effects.

Pregabalin Capsules help to regulate abnormal nerve signalling, which is crucial in managing conditions characterized by nerve-related pain and seizures. By reducing the overactivity of nerves and the transmission of pain signals, pregabalin can provide relief and improve the quality of life for individuals affected by these conditions. However, it’s important for patients to use pregabalin as prescribed by their healthcare provider, as its effectiveness and safety depend on proper dosage and monitoring.

Benefits of Pregabalin Capsules:

  • Effective Pain Management: Pregabalin Capsules are highly effective in managing neuropathic pain, making them valuable for conditions such as diabetic neuropathy, postherpetic neuralgia (shingles-related nerve pain), and peripheral neuropathy. They help alleviate discomfort and improve the quality of life for individuals suffering from these conditions.
  • Fibromyalgia Relief: Pregabalin is an approved treatment for fibromyalgia, providing relief from the widespread musculoskeletal pain, fatigue, and sleep disturbances associated with this chronic condition.
  • Seizure Control: Pregabalin serves as an adjunctive therapy for certain types of seizures, helping reduce their frequency and severity in individuals with epilepsy. It can contribute to better seizure control and an improved overall quality of life for those affected by this neurological disorder.
  • Anxiety Management: Pregabalin may have anxiolytic (anxiety-reducing) effects, which can be beneficial for individuals with generalized anxiety disorder (GAD). It can help reduce excessive worrying and anxiety-related symptoms.

Common Side Effects of Pregabalin Capsules:

  • Dizziness: Dizziness is a common side effect of pregabalin and can make activities requiring concentration, such as driving, challenging. It often subsides with continued use.
  • Drowsiness: Some individuals may experience drowsiness or sedation when taking pregabalin, which can affect their ability to stay alert and focused.
  • Weight Gain: Weight gain is a potential side effect of pregabalin, which can be concerning for some patients. It’s important to maintain a healthy lifestyle and diet while on this medication.
  • Peripheral Edema: Swelling of the extremities, known as peripheral edema, can occur in some individuals taking pregabalin. It’s important to monitor and report any significant swelling to a healthcare provider.
  • Dry Mouth: Dry mouth is a relatively common side effect and can lead to discomfort. Staying hydrated and practicing good oral hygiene can help alleviate this symptom.
  • Blurred Vision: Blurred vision is another potential side effect, which may require temporary adjustments in activities that require clear vision.
  • Constipation: Some individuals may experience constipation while taking pregabalin. Adequate fluid intake and dietary fiber can help mitigate this side effect.
  • Increased Appetite: Pregabalin may lead to an increase in appetite, potentially contributing to weight gain.
  • Mood Changes: Mood changes, including mood swings and irritability, have been reported by some individuals.
  • Coordination Issues: Pregabalin may affect coordination in some people, making tasks that require fine motor skills more challenging.

It’s important to note that not everyone will experience these side effects, and many individuals tolerate pregabalin well. Patients should discuss potential side effects and any concerns with their healthcare provider. The benefits of pregabalin in managing pain, seizures, and anxiety often outweigh the side effects for individuals who require this medication.

Frequently Asked Questions About Pregabalin Capsules:

Certainly, here are some frequently asked questions (FAQs) about Pregabalin Capsules:

  • What are Pregabalin Capsules?

Pregabalin Capsules are a medication that contains the active ingredient pregabalin. They are used to treat various medical conditions, including neuropathic pain, fibromyalgia, epilepsy, and anxiety disorders.

  • How does Pregabalin work?

Pregabalin works by affecting the nervous system, specifically by reducing the release of certain neurotransmitters in the brain and spinal cord. This action helps alleviate pain, control seizures, and reduce anxiety.

  • What conditions are Pregabalin Capsules used to treat?

Pregabalin is prescribed for neuropathic pain, fibromyalgia, epilepsy (as an adjunctive therapy), and generalized anxiety disorder (GAD).

  • How should I take Pregabalin Capsules?

Pregabalin should be taken exactly as prescribed by your healthcare provider. The dosage and frequency will depend on your specific medical condition. It is usually taken orally with or without food.

  • Are there any common side effects of Pregabalin Capsules?

Common side effects of Pregabalin Capsules may include dizziness, drowsiness, weight gain, peripheral edema (swelling of the extremities), dry mouth, blurred vision, constipation, increased appetite, mood changes, and coordination issues.

  • Can I drink alcohol while taking Pregabalin?

It’s advisable to limit or avoid alcohol consumption while taking Pregabalin, as it can increase the risk of dizziness and drowsiness.

  • Is Pregabalin addictive?

Pregabalin has a low potential for abuse and addiction. However, it should still be taken as prescribed by a healthcare provider.

  • How long does it take for Pregabalin to work?

The time it takes for Pregabalin to provide relief varies depending on the condition being treated. Some individuals may experience an improvement in symptoms within a few days, while others may require several weeks of treatment.

  • Can I stop taking Pregabalin abruptly?

It’s important not to stop taking Pregabalin suddenly without consulting your healthcare provider. A gradual reduction in dosage is typically recommended to avoid withdrawal symptoms.

  • Can Pregabalin interact with other medications?

Pregabalin may interact with certain medications or supplements. It’s crucial to inform your healthcare provider about all the medications and supplements you are taking to prevent potential drug interactions.

Patients should always consult their healthcare provider for personalized information and guidance regarding the use of Pregabalin Capsules, including dosage, potential side effects, and any specific concerns or questions they may have.

As Pregabalin Capsules Exporters; We can cater to export business queries from the following geographies. We are exporting our Pregabalin Capsules product to the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Pregabalin Capsules Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Pregabalin Capsules, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274