Pregabalin Sustained Release Capsules 150mg Technical Specification:

Product Name:Pregabalin Sustained Release Capsules 150mg
Brand Name:Pregal
Strength:75mg, 150mg
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 Sustained Release Capsules 150mg (Pregal)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Pregabalin Sustained Release Capsules 150mg
    Each hard gelatin Capsule contains:
    Pregabalin……………….150mg
    Excipients………………….q.s
    Approved colour used in empty capsules.

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].
Protect from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

Why Taj Pharmaceuticals?

Meta Description: “Experience Superior Quality and Efficacy with Taj Pharma’s Pregabalin Sustained Release Capsules”

When it comes to managing neuropathic pain and seizures, trust Taj Pharma for Pregabalin Sustained Release Capsules. Our commitment to excellence in pharmaceuticals ensures that you receive a product of unparalleled quality and effectiveness.

Here’s why Taj Pharma is your ideal choice:

  • Proven Expertise: With a legacy of pharmaceutical excellence, Taj Pharma brings decades of experience in producing high-quality medications. You can rely on our expertise for safe and consistent results.
  • Sustained Relief: Our Pregabalin Sustained Release Capsules are designed to provide long-lasting relief. The sustained-release formula ensures a steady release of the medication over time, reducing the frequency of dosing and providing continuous symptom control.
  • Neuropathic Pain Management: Pregabalin is a recognized and effective treatment for neuropathic pain conditions such as diabetic neuropathy, post-herpetic neuralgia, and fibromyalgia. Taj Pharma’s formulation ensures that you can manage these conditions with confidence.
  • Seizure Control: Pregabalin is also widely used to control seizures in epilepsy. Our sustained-release capsules offer a reliable and convenient way to maintain seizure management and improve your quality of life.
  • Quality Assurance: Taj Pharma is committed to stringent quality control measures. Our products undergo rigorous testing and adhere to international quality standards, ensuring safety and efficacy with every dose.
  • Trusted Name: Taj Pharma is a globally recognized name in the pharmaceutical industry, known for its dedication to patient well-being. When you choose Taj Pharma, you’re choosing a brand that cares about your health.

Discover the difference with Taj Pharma’s Pregabalin Sustained Release Capsules. Experience sustained relief, superior quality, and peace of mind in managing neuropathic pain and seizures. Trust Taj Pharma for your healthcare needs.

What is Pregabalin Sustained Release Capsules and its use?

Pregabalin Sustained Release Capsules are a medication that contains the active ingredient pregabalin in a special formulation designed to release the drug gradually over an extended period. Pregabalin is a medication commonly used to treat various medical conditions, primarily those related to neuropathic pain and epilepsy. The sustained-release formulation of pregabalin offers several advantages, including a longer duration of action and reduced dosing frequency.

Uses of Pregabalin Sustained Release Capsules:

  • Neuropathic Pain: Pregabalin, in its sustained-release form, is frequently prescribed to manage neuropathic pain. This type of pain is caused by damage or dysfunction of the nervous system and is commonly associated with conditions such as diabetic neuropathy (nerve pain due to diabetes), post-herpetic neuralgia (pain following shingles), and fibromyalgia. Pregabalin helps alleviate neuropathic pain by modulating nerve signals.
  • Epilepsy: Pregabalin is also used in the treatment of epilepsy, a neurological disorder characterized by recurrent seizures. It is often prescribed as an adjunctive therapy, meaning it is used in combination with other antiepileptic medications to help control seizures more effectively.
  • Anxiety Disorders: In some cases, pregabalin may be prescribed off-label for the treatment of certain anxiety disorders, such as generalized anxiety disorder (GAD). It can help manage symptoms of anxiety by affecting neurotransmitters in the brain.

Pregabalin Sustained Release Capsules should be under the guidance and supervision of a healthcare professional. They will determine the appropriate dosage and treatment duration based on your specific condition and medical history. pregabalin may have potential side effects and interactions with other drugs. It’s crucial to follow your healthcare provider’s instructions closely, report any side effects promptly, and inform them of any other medications or health conditions you have to ensure safe and effective treatment.

How does Pregabalin Sustained Release Capsules Work?

Pregabalin Sustained Release Capsules work by affecting the nervous system to reduce pain, seizures, and, in some cases, anxiety. Pregabalin is the active ingredient in these capsules, and it exerts its therapeutic effects through the following mechanisms:

  • Modulation of Neurotransmitters: Pregabalin primarily works by binding to a specific type of calcium channel in the central nervous system. These calcium channels play a crucial role in transmitting pain signals and abnormal electrical activity in the brain (as seen in epilepsy). By binding to these channels, pregabalin reduces the release of certain neurotransmitters, such as glutamate. This modulation of neurotransmitter release helps to dampen excessive nerve signaling, which can lead to pain or seizures.
  • Pain Relief: In the context of neuropathic pain conditions like diabetic neuropathy, post-herpetic neuralgia, and fibromyalgia, pregabalin helps to reduce the abnormal pain signals sent by damaged nerves. It essentially “calms down” overactive nerve cells, making them less likely to transmit pain signals to the brain. The sustained-release formulation ensures that the drug is released slowly over time, providing extended pain relief.
  • Seizure Control: For epilepsy, pregabalin’s ability to reduce excessive nerve signaling is essential. Epileptic seizures result from abnormal electrical activity in the brain, and pregabalin helps to stabilize this activity, reducing the likelihood of seizures. When used as an adjunctive therapy with other antiepileptic drugs, it can enhance seizure control.
  • Anxiety Reduction (Off-label): While not its primary indication, pregabalin is sometimes prescribed off-label for anxiety disorders. It may work by affecting the release of neurotransmitters like gamma-aminobutyric acid (GABA), which has inhibitory effects on brain activity. By increasing GABA activity, pregabalin can have a calming and anxiety-reducing effect.

Pregabalin’s sustained-release formulation allows for a slower and more controlled release of the drug into the bloodstream. This has the advantage of maintaining a consistent therapeutic effect over an extended period, reducing the need for frequent dosing and potentially improving patient compliance.

It’s important to note that the precise mechanism of action of pregabalin may vary depending on the specific condition being treated. The use of pregabalin should always be directed and monitored by a healthcare professional to ensure safe and effective treatment.

Benefits of Pregabalin Sustained Release Capsules:

  • Effective Pain Relief: Pregabalin sustained release capsules are highly effective in managing neuropathic pain associated with conditions like diabetic neuropathy, post-herpetic neuralgia, and fibromyalgia. They can significantly reduce pain symptoms, improving the quality of life for individuals suffering from these conditions.
  • Seizure Control: Pregabalin, in its sustained-release form, is a valuable addition to the treatment of epilepsy. It helps control and prevent seizures when used as part of an overall antiepileptic drug regimen, enhancing the quality of life for individuals with epilepsy.
  • Extended Relief: The sustained-release formulation means that the medication is released slowly over time, resulting in a longer duration of action. This reduces the need for frequent dosing, making it more convenient for patients.
  • Anxiety Reduction (Off-label): While not its primary indication, pregabalin may also help reduce symptoms of anxiety disorders, such as generalized anxiety disorder (GAD). This off-label use can provide relief for individuals with anxiety-related conditions.

Common Side Effects of Pregabalin Sustained Release Capsules:

  • Dizziness: Dizziness is one of the most common side effects of pregabalin. It can make tasks like driving or operating heavy machinery unsafe. Patients are advised to use caution when engaging in activities that require mental alertness.
  • Drowsiness: Pregabalin can cause drowsiness or sedation, which may affect daily activities. It is often recommended to take the medication at bedtime to minimize this side effect.
  • Weight Gain: Some individuals may experience weight gain while taking pregabalin. Maintaining a healthy lifestyle and diet can help manage this side effect.
  • Edema (Swelling): Swelling, especially in the extremities, is a known side effect of pregabalin. Monitoring for edema and informing your healthcare provider if it occurs is important.
  • Blurred Vision: Blurred vision can occur as a side effect of pregabalin. It’s essential to report any changes in vision to your healthcare provider.
  • Dry Mouth: Dry mouth is another common side effect, which can be managed with good oral hygiene and staying hydrated.
  • Headache: Some individuals may experience headaches while taking pregabalin.
  • Nausea: Nausea is a less common side effect but can occur in some cases.
  • Constipation: Constipation may be experienced by some individuals.

Serious Side Effects (Less Common):

While less common, some individuals may experience more severe side effects, including mood changes (such as depression or suicidal thoughts), allergic reactions, or severe skin reactions. If you notice any unusual or severe symptoms, it’s crucial to contact your healthcare provider immediately.

It’s essential to remember that everyone’s response to medication is different, and not everyone will experience all of these side effects. Your healthcare provider will assess the potential benefits and risks of pregabalin in your specific case and monitor your progress during treatment. It’s important to follow their guidance closely and report any side effects promptly.

Frequently asked questions (FAQs) about Pregabalin Sustained Release Capsules:

  1. What is Pregabalin Sustained Release Capsules used for?

Pregabalin Sustained Release Capsules are primarily used to treat neuropathic pain associated with conditions like diabetic neuropathy, postherpetic neuralgia, and fibromyalgia. They are also used as an adjunctive treatment for epilepsy and, in some cases, for managing anxiety disorders.

  1. How does Pregabalin Sustained Release Capsules work?

Pregabalin affects the central nervous system by modulating certain neurotransmitters and reducing the release of pain signals. It stabilizes abnormal electrical activity in the brain, making it effective for pain relief and seizure control.

  1. What is the difference between regular Pregabalin and Pregabalin Sustained Release Capsules?

The sustained release capsules release the medication slowly over time, providing longer lasting relief compared to immediate release forms. This means less frequent dosing and consistent therapeutic effects.

  1. How should I take Pregabalin Sustained Release Capsules?

Follow your healthcare provider’s instructions regarding dosage and timing. Typically, it’s taken with or without food, but consistency in taking it with or without food is important. Swallow the capsules whole; do not crush or chew them.

  1. Are there any common side effects of Pregabalin Sustained Release Capsules?

Common side effects may include dizziness, drowsiness, weight gain, swelling, blurred vision, dry mouth, headache, and nausea. These side effects can vary in intensity among individuals.

  1. Is Pregabalin habit-forming or addictive?

Pregabalin is not considered habit-forming or addictive when used as prescribed. However, it’s essential to take it exactly as directed by your healthcare provider.

  1. Can I drink alcohol while taking Pregabalin Sustained Release Capsules?

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

  1. Can I stop taking Pregabalin abruptly?

It’s not recommended to stop taking pregabalin suddenly, especially if you’ve been using it for an extended period. Consult your healthcare provider for guidance on tapering the medication if you wish to discontinue it.

  1. Is Pregabalin safe during pregnancy and breastfeeding?

Pregabalin should be used during pregnancy or breastfeeding only if the potential benefits outweigh the potential risks. Discuss this with your healthcare provider.

  1. Can Pregabalin interact with other medications I’m taking?

Pregabalin may interact with certain medications, including opioids and drugs that cause dizziness or drowsiness. Inform your healthcare provider about all the medications you’re taking to prevent potential interactions.

  1. What should I do if I miss a dose of Pregabalin Sustained Release Capsules?

If you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses.

As Pregabalin Sustained Release Capsules Exporters; We can cater to export business queries from the following geographies. We are exporting our Pregabalin Sustained Release Capsules product in 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 Sustained Release 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 Sustained Release 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

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Pregabalin Sustained Release Capsules 75mg (Pregal)
B) Pregabalin Sustained Release Capsules 150mg (Pregal)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Pregabalin Sustained Release Capsules 75mg
Each hard gelatin Capsule contains:
Pregabalin……………….75mg
Excipients………………….q.s
Approved colour used in empty capsules.

B) Pregabalin Sustained Release Capsules 150mg
Each hard gelatin Capsule contains:
Pregabalin……………….150mg
Excipients………………….q.s
Approved colour used in empty capsules.


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].
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.