GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Nefopam Hydrochloride Injection 20mg/ml
b) Nefopam Hydrochloride Injection 20mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Nefopam Hydrochloride Injection 20mg/ml
Each ml injection contains:
Nafopam for Injection………….20mg
Water For Injection USP…………….q.s.
Excipients……………………………q.s


B) Nefopam Hydrochloride Injection 20mg/2ml
Each 2ml injection contains:
Nafopam for Injection………….20mg
Water For Injection USP…………….q.s.
Excipients……………………………q.s

THERAPEUTIC INDICATION:

Nefopam is used in the treatment of pain relief. Nefopam is a non-opioid pain reliever. It works by blocking the transmission of pain signals to the brain thereby decreasing pain perception.

DIRECTION OF USE:

For Subcutaneous, Intravenous use only
See prescribing information for dosing and administration.

CAUTION & WARNING:

CAUTION: Injection should not be used if it contains visible particulate matter.
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only. Solution with precipitation to be destroyed. Do not use after the expiry date stated on the label.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials at 25°C to 30°C
Protect from light.
Do not freeze.
Dosage: As directed by the Physician.

Nefopam Hydrochloride Injection 20mg/ml (Nefotaj) Technical Specification:

Product Name: Nefopam Hydrochloride 20 mg/ml Injection (Nefotaj)
Brand Name:Nefotaj
Strength:20mg/ml, 20mg/2ml
Dosage Form:Solution for Injection
Packing:SINGLE USE VIAL
Route of Administration:I.V & I.M USE ONLY
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Analgesics and Antipyretics.
Indication: Nefopam is used in the treatment of pain relief. Nefopam is a non-opioid pain reliever. It works by blocking the transmission of pain signals to the brain thereby decreasing pain perception.
Storage:Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  1. Nefopam Hydrochloride Injection 20mg/ml
  2. Nefopam Hydrochloride Injection 20mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1.Nefopam Hydrochloride Injection 20mg/ml
Each ml injection contains:
Nafopam for Injection………….20mg
Water For Injection USP…………….q.s.
Excipients……………………………q.s

2. Nefopam Hydrochloride Injection 20mg/2ml
Each 2ml injection contains:
Nafopam for Injection………….20mg
Water For Injection USP…………….q.s.
Excipients……………………………q.s

THERAPEUTIC INDICATION:

Nefopam is used in the treatment of pain relief. Nefopam is a non-opioid pain reliever. It works by blocking the transmission of pain signals to the brain thereby decreasing pain perception.

DIRECTION OF USE:

For Subcutaneous, Intravenous use only.
See prescribing information for dosing and administration. 

CAUTION & WARNING:

CAUTION: Injection should not be used if it contains visible particulate matter.
It is dangerous to take this preparation except under medical supervision.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Solution with precipitation to be destroyed. Do not use after the expiry date stated on the label.
Discard Unused portion.
Keep out of the reach of the children. 

STORAGE & DOSAGE:

Storage: Store vials at 25°C to 30°C
Protect from light.
Do not freeze.
Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Delve into the numerous factors that make Taj Pharmaceuticals a top choice for Nefopam Hydrochloride Injection. With a rich history spanning decades, Taj Pharmaceuticals has consistently demonstrated its commitment to pharmaceutical excellence. Their track record in researching, developing, and manufacturing innovative medications positions them as a trusted partner in healthcare. Taj Pharmaceuticals prioritizes quality above all else, implementing rigorous quality control processes throughout the production of Nefopam Hydrochloride Injection. Their state-of-the-art facilities adhere to the highest industry standards, ensuring that every batch meets strict quality benchmarks. This unwavering dedication to product quality translates into a reliable and effective medication for pain management. Furthermore, Taj Pharmaceuticals has navigated the complex regulatory landscape with precision, obtaining essential approvals from regulatory agencies such as the FDA. These approvals underscore the safety and efficacy of Nefopam Hydrochloride Injection, providing healthcare professionals and patients alike with confidence in its use.

Beyond their technical expertise, Taj Pharmaceuticals places a strong emphasis on patient well-being. Their commitment to improving healthcare outcomes shines through in their comprehensive approach to pain management. When you choose Taj Pharmaceuticals, you’re not only selecting a medication but also a partner dedicated to enhancing your quality of life. Make an informed and responsible choice for your healthcare needs by considering Taj Pharmaceuticals for Nefopam Hydrochloride Injection. Experience the difference of a pharmaceutical company driven by excellence, quality, and a profound commitment to your health.

What is Nefopam Hydrochloride Injection and its uses:

Nefopam Hydrochloride Injection is a medication that contains the active ingredient nefopam hydrochloride. It is used for the management of moderate to severe pain. Here’s more information about this medication and its uses:

  • Pain Management: Nefopam Hydrochloride is primarily prescribed for pain relief. It belongs to a class of drugs known as analgesics, which are used to alleviate pain. Nefopam works by affecting certain chemicals in the brain and nervous system that are involved in the perception of pain. It is particularly effective for postoperative pain, but it can also be used in other painful conditions as determined by a healthcare provider.
  • Postoperative Pain: Nefopam Hydrochloride Injection is often used in the postoperative setting to control pain after surgery. It is considered an alternative to opioids for managing postoperative pain, which can help reduce the risk of opioid-related side effects and dependence.
  • Non-Opioid Pain Relief: One of the advantages of Nefopam Hydrochloride is that it provides pain relief without the risk of opioid addiction and respiratory depression associated with opioids. This makes it a valuable option for individuals who cannot tolerate or should avoid opioid medications.
  • Neuropathic Pain: In some cases, healthcare providers may consider Nefopam Hydrochloride for the management of neuropathic pain, although it is primarily used for other types of pain. Neuropathic pain is caused by damage or dysfunction of the nerves and is often described as burning, shooting, or tingling sensations.

It’s important to note that the use of Nefopam Hydrochloride Injection should be determined by a qualified healthcare professional. They will assess the patient’s specific condition, pain severity, and medical history to determine the most appropriate treatment plan.

As of my last knowledge update in September 2021, Nefopam Hydrochloride Injection might not be available in all regions, and its availability and approved uses may vary by country and regulatory approval. Therefore, it’s crucial to consult a healthcare provider or check the latest medical guidelines and product information for the most up-to-date information on Nefopam Hydrochloride and its uses in your specific area.

How Does Nefopam Hydrochloride Injection Work?

Nefopam Hydrochloride is a non-opioid analgesic medication used to relieve moderate to severe pain. Its precise mechanism of action is not fully understood, but it is thought to work through multiple mechanisms in the central nervous system. Here’s how Nefopam Hydrochloride Injection is believed to work:

  • Central Nervous System Modulation: Nefopam is thought to modulate the central nervous system’s pain processing pathways. It appears to affect the transmission of pain signals in the brain and spinal cord, ultimately reducing the perception of pain.
  • Serotonin and Noradrenaline Reuptake Inhibition: Nefopam may increase the availability of neurotransmitters like serotonin and noradrenaline in the synaptic clefts (gaps between nerve cells). By inhibiting the reuptake of these neurotransmitters, it can enhance their analgesic effects, helping to control pain.
  • Anticholinergic Activity: Nefopam has mild anticholinergic properties, which means it can block the action of certain neurotransmitters (acetylcholine) in the nervous system. This effect might contribute to its analgesic properties, although the exact role is not fully elucidated.
  • Anti-inflammatory Properties: While not primarily an anti-inflammatory medication, some studies have suggested that Nefopam may have mild anti-inflammatory effects. This could be another way it helps reduce pain, especially in conditions associated with inflammation.

It’s important to note that the precise mechanisms of action of Nefopam Hydrochloride are still a subject of ongoing research, and its analgesic effects are likely due to a combination of these actions. Additionally, Nefopam is considered a non-addictive alternative to opioids for pain management, which makes it a valuable option in certain clinical scenarios where opioid use may be limited or not preferred.

As with any medication, Nefopam Hydrochloride should be used under the guidance and supervision of a qualified healthcare professional, and the dosage and duration of treatment should be determined based on the patient’s specific condition and needs.

Benefits and Side Effects of Nefopam Hydrochloride Injection:

Nefopam Hydrochloride Injection is a medication used to manage moderate to severe pain. Like all medications, it has both benefits and potential side effects. Here’s an overview of its benefits and common side effects:

Benefits:

  • Effective Pain Relief: Nefopam Hydrochloride is known for its analgesic (pain-relieving) properties. It is effective in managing various types of pain, including postoperative pain, neuropathic pain, and other painful conditions. It can provide relief from moderate to severe pain without the risk of opioid-related side effects or addiction.
  • Non-Opioid Option: One of the key advantages of Nefopam Hydrochloride is that it is not an opioid medication. This means it doesn’t cause the same respiratory depression or addiction potential associated with opioids. It can be a valuable alternative for individuals who cannot tolerate or should avoid opioid pain medications.
  • Reduced Opioid Use: In postoperative settings, Nefopam Hydrochloride can be used alongside or in place of opioids, potentially reducing the need for high-dose opioid medications. This can help lower the risk of opioid-related side effects, such as constipation, respiratory depression, and addiction.

Common Side Effects:

While Nefopam Hydrochloride is generally well-tolerated, it can cause some side effects. Common side effects may include:

  • Nausea and Vomiting: Nausea is one of the most common side effects associated with Nefopam use. It can be managed with anti-nausea medications if necessary.
  • Sweating: Some individuals may experience excessive sweating while taking Nefopam.
  • Dizziness and Lightheadedness: Nefopam can cause dizziness or lightheadedness, which can increase the risk of falls or accidents, especially when standing up quickly.
  • Dry Mouth: Dry mouth, or xerostomia, is another potential side effect of Nefopam.
  • Insomnia: Some people may have difficulty sleeping while taking this medication.
  • Tremors or Shaking: In rare cases, individuals may experience tremors or shaking.

It’s important to note that not everyone will experience these side effects, and the severity and frequency of side effects can vary from person to person. If you are prescribed Nefopam Hydrochloride Injection and experience any concerning side effects or discomfort, you should contact your healthcare provider. They can adjust your treatment plan or provide guidance on managing side effects.

Additionally, Nefopam may have other, less common side effects or interactions with other medications, so it’s essential to follow your healthcare provider’s instructions and report any unusual symptoms promptly.

Frequently Asked Questions About Nefopam Hydrochloride Injection:

Certainly, here are some frequently asked questions (FAQs) about Nefopam Hydrochloride Injection:

  1. What is Nefopam Hydrochloride Injection used for?

Nefopam Hydrochloride Injection is primarily used to manage moderate to severe pain. It is often employed in postoperative pain management but can also be used for other painful conditions.

  1. How does Nefopam Hydrochloride Injection work?

The exact mechanism of action is not fully understood, but Nefopam is believed to modulate the central nervous system’s pain processing pathways, inhibit the reuptake of neurotransmitters like serotonin and noradrenaline, and have mild anticholinergic properties, all of which contribute to its analgesic effects.

  1. Is Nefopam Hydrochloride addictive like opioids?

No, Nefopam Hydrochloride is not considered addictive like opioids. It does not have the same risk of causing physical dependence or addiction, making it a valuable alternative for pain management.

  1. What are the common side effects of Nefopam Hydrochloride Injection?

Common side effects may include nausea, vomiting, sweating, dizziness, dry mouth, insomnia, and tremors. These side effects can vary in severity and may not affect everyone.

  1. Can Nefopam Hydrochloride Injection be used during pregnancy or breastfeeding?

The safety of Nefopam during pregnancy and breastfeeding is not wellestablished. It should only be used if the potential benefits outweigh the potential risks, and under the guidance of a healthcare provider.

  1. Are there any drug interactions with Nefopam Hydrochloride Injection?

Nefopam may interact with other medications, including certain antidepressants and drugs that affect serotonin levels. It’s essential to inform your healthcare provider of all the medications you are taking to avoid potential interactions.

  1. How is Nefopam Hydrochloride Injection administered?

Nefopam Hydrochloride is typically administered intravenously (IV) by a healthcare professional. The dosage and frequency of administration will depend on the patient’s pain level and medical condition.

  1. Can I drink alcohol while taking Nefopam Hydrochloride Injection?

It is generally advisable to avoid alcohol while taking Nefopam, as it can increase the risk of certain side effects such as dizziness and drowsiness.

  1. What should I do if I miss a dose of Nefopam Hydrochloride Injection?

If you miss a dose, contact your healthcare provider for guidance. Do not double the dose to make up for a missed one.

  1. Is Nefopam Hydrochloride available in oral form, or is it only administered by injection?

Nefopam is available in various forms, including oral tablets and intravenous injections. The choice of formulation depends on the patient’s needs and the healthcare provider’s recommendation.

Always consult with your healthcare provider for personalized information and guidance regarding Nefopam Hydrochloride Injection, as individual circumstances may vary.

As Nefopam Hydrochloride Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Nefopam Hydrochloride Injection 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

Nefopam Hydrochloride Injection 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 Nefopam Hydrochloride Injection, 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