Parecoxib Sodium Injection 40mg Technical Specification:
Product Name: | Parecoxib Sodium Injection 40mg |
Brand Name: | Generic |
Strength: | 40mg/2ml |
Dosage Form: | Lyophilized Dry Powder Solution |
Packing: | 1 Vial + 1 Ampule |
Route of Administration: | For IV/IM 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: | COX-2 inhibitor & NSAID |
Indication: | Parecoxib is used for the short-term treatment of pain in adults after an operation. |
Storage: | Store below 25°C. Protect from light. Keep out reach of children. |
Parecoxib sodium powder for solution for injection 40mg/2ml Manufacturers, Suppliers in India:
Taj Pharmaceuticals is of the prominent Parecoxib sodium powder for solution for injection 40mg/2ml Manufacturers in India that brings the best quality products. Our company Taj Pharma has rich experience in the niche manufacturing of Parecoxib sodium powder for solution for injection 40mg/2ml.
Parecoxib is a non-steroidal anti-inflammatory drug (NSAID) called COX-2 inhibitors. It works by blocking the release of certain chemical messengers that are responsible for pain and inflammation (redness and swelling).
Parecoxib sodium is rapidly converted to valdecoxib (the in vivo pharmacology of parecoxib). The mechanism of action of valdecoxib is by inhibition of cyclooxygenase-2(COX-2) mediated prostaglandin synthesis. When given at the recommended doses for the management of acute pain, the onset of analgesia is 7-14 min and reaches a peak effect within 2 hours. After a single dose, the duration for analgesia ranges from 6 to greater than 24 hours.
Taj Pharmaceuticals is a reputed manufacturer and Parecoxib sodium powder for solution for injection 40mg/2ml Suppliers in India prefer Taj Pharma is best known for the topmost standards and consistent quality of its products.
Taj Pharma is a well-known Parecoxib sodium powder solution for injection 40mg/2ml Manufacturer in India that assures high- quality and high standards. Strict quality control ensures that every batch of medicine brings a harmonious standard.
Parecoxib sodium powder for solution for injection 40mg/2ml manufactured at Taj Pharma follows ISH; i.e. the product is manufactured to comply with Good quality standards which are considered the Best in the world. Further, Taj Pharma uses Parecoxib sodium powder as a solution for injection 40mg/2ml grade best active ingredient to manufacture its Injections to comply with international standards of European products.
GENERIC NAME OF MEDICINAL PRODUCT:
- Parecoxib sodium powder for solution for injection (40mg/2ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Parecoxib sodium powder for solution for injection (40mg/2ml)
Composition:
Each vial contains:
Parecoxib……………..40mg
Equivalent to
Parecoxib sodium……42.36mg
Excipients…………….q.s.
Also contains Dibasic sodium phosphate heptahydrate, Phosphoric acid and/or sodium hydroxide.
2ml solvent ampule contains sodium chloride, hydrochloride acid, sodium hydroxide and water for injections.
THERAPEUTIC INDICATIONS:
Parecoxib is used for the short-term treatment of pain in adults after an operation. It is one of a family of medicines called COX-2 inhibitors (this is short for cyclo-oxygenase-2 inhibitors). Pain and swelling are sometimes caused by substances in the body called prostaglandins.
DIRECTION OF USE:
When reconstituted with 2ml solvent provides 40mg/ml of parecoxib.
After reconstitution, the product should be used immediately.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible in the vial after reconstitution, please do not use the solution.
Please do not use the solution and return the vial for free replacement.
THE LYOPHILLIZED CAKE MAY REDUCE TO A POWDER DURING SHIPING.
For single use only. After reconstitution the product should be use immediately.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store below 25°C. Protect from light.
Keep all medicines out of reach of children.
Purified vial sealed in vacuum.
Dosage: As directed by the Physician.
Why Taj Pharmaceuticals?
Taj Pharmaceuticals is a preferred choice for Parecoxib Sodium Powder for Injection for several compelling reasons. Firstly, the company is renowned for its steadfast commitment to maintaining the highest standards of quality in pharmaceutical production. This commitment is particularly crucial in the case of injectable medications like Parecoxib Sodium, which are administered directly into the bloodstream. The emphasis on quality assurance instills confidence among healthcare providers and patients, ensuring the effectiveness and safety of the medication. With a wealth of experience in the pharmaceutical industry, Taj Pharmaceuticals has garnered valuable expertise in the manufacturing and distribution of a diverse range of pharmaceutical products. This extensive experience contributes to the consistency and reliability of their pharmaceutical offerings, reinforcing their reputation as a trusted supplier. Taj Pharmaceuticals places a strong emphasis on compliance with rigorous regulatory standards and quality control procedures. This dedication to compliance ensures that Parecoxib Sodium Powder for Injection meets the stringent quality and safety requirements set by regulatory authorities. Healthcare providers can trust that the medication complies with all necessary regulations, further enhancing patient safety. Global reach and distribution are other notable strengths of Taj Pharmaceuticals. With a widespread presence and a well-established distribution network, they ensure the availability of Parecoxib Sodium and other pharmaceutical products to healthcare providers and patients across various regions. This global reach enhances accessibility and patient care on an international scale, making critical medications readily available when needed. Additionally, Taj Pharmaceuticals demonstrates a commitment to research and development (R&D). Investment in R&D is essential for ongoing improvement and innovation in pharmaceutical products. This commitment may result in the development of more effective and advanced formulations of Parecoxib Sodium, enhancing its therapeutic benefits.
Reliability in supply is paramount to ensure that healthcare institutions and patients have consistent access to essential medications. Taj Pharmaceuticals’ commitment to supply chain management contributes to the dependable availability of Parecoxib Sodium, ensuring that it remains accessible when required. Furthermore, affordability is a key consideration. Taj Pharmaceuticals may offer competitive pricing options, making Parecoxib Sodium more affordable and accessible to healthcare institutions and patients. Access to essential medications should not be restricted by prohibitive costs, and Taj Pharmaceuticals recognizes this imperative. Taj Pharmaceuticals’ patient-centric approach aligns with the importance of Parecoxib Sodium, which is used to manage postoperative pain and inflammation. Their strong emphasis on patient well-being and safety reinforces the trust placed in their products by healthcare providers and patients alike. Lastly, Taj Pharmaceuticals provides valuable educational resources and support to healthcare providers. This is especially important when dealing with injectable medications like Parecoxib Sodium, where proper administration and monitoring are critical for patient safety and efficacy. Taj Pharmaceuticals’ commitment to providing information and support enhances the safe and effective use of their products, ultimately benefiting patient care and outcomes. In conclusion, Taj Pharmaceuticals’ dedication to quality, compliance, research, affordability, and patient support makes it an attractive choice for healthcare providers seeking a reliable supplier for Parecoxib Sodium Powder for Injection and other pharmaceutical requirements. Their unwavering focus on patient safety aligns seamlessly with the significance of this medication in postoperative pain management and inflammation control.
What is Parecoxib Sodium Powder for Injection and its uses?
Parecoxib Sodium Powder for Injection is a medication that belongs to the class of nonsteroidal anti-inflammatory drugs (NSAIDs). It is primarily used to manage pain and inflammation in specific clinical settings. Here are its key uses:
- Postoperative Pain Management: Parecoxib Sodium Powder for Injection is commonly employed to manage pain in the immediate postoperative period, particularly following surgical procedures. It is effective in providing relief from moderate to severe pain, helping patients recover more comfortably after surgery.
- Acute Pain Management: In addition to postoperative pain, Parecoxib Sodium may be used in the management of other types of acute pain, such as pain due to injury, trauma, or medical conditions. It can be administered when oral NSAIDs are not appropriate or when rapid pain relief is needed.
- Inflammation Control: Parecoxib Sodium has anti-inflammatory properties, making it useful in controlling inflammation associated with surgical procedures or acute painful conditions. By reducing inflammation, it can help alleviate discomfort and improve patient outcomes.
- Preemptive Analgesia: In some cases, Parecoxib Sodium Powder for Injection may be administered prior to surgery as part of a preemptive analgesia strategy. This involves providing pain relief before the surgical procedure to enhance postoperative pain control and reduce the overall need for pain medications.
- Avoidance of Opioid Overuse: Parecoxib Sodium can be a valuable addition to pain management protocols, as it allows healthcare providers to reduce the reliance on opioids for pain relief. This is particularly important in light of the opioid epidemic and the desire to minimize opioid-related side effects and dependency.
- Hospital and Clinical Settings: Parecoxib Sodium is typically administered by healthcare professionals in hospital or clinical settings. It is available in injectable form, allowing for rapid onset of action, which is beneficial in managing acute pain and inflammation.
It’s important to note that the use of Parecoxib Sodium Powder for Injection should be under the supervision and guidance of a qualified healthcare provider. The dosage and administration of this medication depend on the specific type and severity of pain, the patient’s medical history, and other individual factors. Healthcare providers will determine the most appropriate use of Parecoxib Sodium to ensure optimal pain management and patient comfort.
How Does Parecoxib Sodium Powder for Injection Work?
Parecoxib Sodium Powder for Injection is a medication that works by inhibiting enzymes known as cyclooxygenases (COX), particularly the COX-2 enzyme. Here’s how it works:
- Inflammation and Pain: When tissues are damaged or injured, the body’s response includes the production of chemicals called prostaglandins. Prostaglandins play a key role in mediating pain, inflammation, and fever. They are produced in higher quantities at the site of injury or inflammation.
- COX Enzymes: There are two main types of cyclooxygenase enzymes in the body: COX-1 and COX-2. COX-1 is involved in the normal functioning of tissues, including protecting the stomach lining. COX-2, on the other hand, is induced during inflammation and is primarily responsible for generating prostaglandins associated with pain and inflammation.
- COX-2 Inhibition: Parecoxib Sodium specifically inhibits the COX-2 enzyme. By blocking COX-2, it reduces the production of prostaglandins that cause pain and inflammation. This leads to a decrease in the intensity of pain and a reduction in swelling and redness at the site of injury or inflammation.
- Pain Relief: By inhibiting COX-2 and reducing prostaglandin levels, Parecoxib Sodium provides effective pain relief. It is particularly valuable in managing postoperative pain, acute injuries, or conditions where pain and inflammation need to be controlled.
- Preservation of COX-1 Function: One advantage of Parecoxib Sodium over some other NSAIDs is that it has a relatively selective action on COX-2, sparing COX-1 to some extent. This selectivity may help reduce the risk of certain gastrointestinal side effects that can be associated with non-selective NSAIDs.
It’s important to note that Parecoxib Sodium Powder for Injection is typically administered by healthcare professionals in a clinical setting, as it is available in injectable form for rapid onset of action. The dosage and administration of Parecoxib Sodium should be determined by a qualified healthcare provider based on the patient’s specific needs and medical condition to ensure effective pain relief and inflammation control.
Benefits of Parecoxib Sodium Powder for Injection:
- Effective Pain Relief: Parecoxib Sodium is highly effective in providing pain relief, particularly in the postoperative period. It helps manage moderate to severe pain, improving patient comfort and promoting a smoother recovery process after surgery.
- Inflammation Control: This medication has anti-inflammatory properties, making it beneficial in reducing inflammation associated with surgical procedures or acute painful conditions. By addressing inflammation, it can alleviate discomfort and improve patient outcomes.
- Rapid Onset of Action: Parecoxib Sodium is available in injectable form, allowing for a rapid onset of action. This makes it especially useful when quick pain relief is needed in clinical settings.
- Avoidance of Opioid Overuse: Parecoxib Sodium can be used as part of a multimodal pain management approach, which aims to minimize the use of opioids for pain relief. This is important for reducing the potential side effects and risks associated with opioids, including addiction and respiratory depression.
- Preemptive Analgesia: In some cases, Parecoxib Sodium may be administered preemptively before surgery. This strategy can improve postoperative pain control and reduce the overall need for pain medications, enhancing patient comfort.
Side Effects of Parecoxib Sodium Powder for Injection:
- Gastrointestinal Effects: Parecoxib Sodium, like other NSAIDs, can cause gastrointestinal side effects such as stomach pain, nausea, indigestion, and in some cases, ulcers or bleeding. Using this medication in combination with gastroprotective agents may reduce the risk of these side effects.
- Cardiovascular Risks: There may be an increased risk of cardiovascular events, including heart attack and stroke, with the use of NSAIDs, including Parecoxib Sodium. This risk may be higher in individuals with pre-existing cardiovascular conditions.
- Kidney Function: NSAIDs, including Parecoxib Sodium, can affect kidney function, leading to reduced urine output or kidney damage in some cases. Patients with kidney problems or those taking other medications that affect the kidneys should be monitored closely.
- Allergic Reactions: While rare, allergic reactions to Parecoxib Sodium can occur and may manifest as skin rash, itching, swelling, or more severe allergic responses. Immediate medical attention is necessary if a severe allergic reaction occurs.
- Bleeding: Parecoxib Sodium can inhibit platelet function, potentially leading to an increased risk of bleeding, especially in patients undergoing surgical procedures.
- Liver Function: Some patients may experience changes in liver enzyme levels, although severe liver toxicity is rare. Liver function should be monitored in individuals with pre-existing liver conditions.
- Other Side Effects: Parecoxib Sodium may also cause less common side effects, including headache, dizziness, and changes in blood pressure.
It’s essential for healthcare providers to carefully assess the potential benefits and risks when prescribing Parecoxib Sodium Powder for Injection. The choice of medication and dosage should be tailored to the individual patient’s needs and medical history to achieve effective pain relief while minimizing potential side effects and risks.
Frequently Asked Questions About Parecoxib Sodium Powder for Injection:
Certainly, here are some frequently asked questions (FAQs) about Parecoxib Sodium Powder for Injection:
- What is Parecoxib Sodium Powder for Injection used for?
Parecoxib Sodium Powder for Injection is primarily used to manage pain, particularly in the postoperative period. It is effective in providing relief from moderate to severe pain and can also help control inflammation.
- How does Parecoxib Sodium work?
Parecoxib Sodium inhibits the enzyme COX2, which is involved in the production of prostaglandins associated with pain and inflammation. By blocking COX2, it reduces the production of these prostaglandins, leading to pain relief and inflammation control.
- Is Parecoxib Sodium similar to other NSAIDs like ibuprofen or naproxen?
Yes, Parecoxib Sodium belongs to the class of nonsteroidal anti-inflammatory drugs (NSAIDs), similar to ibuprofen and naproxen. However, it is administered as an injection and is often used in clinical settings for more severe pain.
- How is Parecoxib Sodium Powder for Injection administered?
Parecoxib Sodium is typically administered by healthcare professionals as an intravenous or intramuscular injection. The choice of administration route depends on the clinical situation and healthcare provider’s preference.
- Can Parecoxib Sodium be used for chronic pain conditions?
Parecoxib Sodium is primarily indicated for acute pain management, particularly in the postoperative setting. It is not typically used for chronic pain conditions.
- What are the common side effects of Parecoxib Sodium Powder for Injection?
Common side effects may include gastrointestinal symptoms (e.g., stomach pain, nausea), cardiovascular risks, kidney function changes, bleeding risk, and allergic reactions. It’s important to discuss potential side effects with your healthcare provider.
- Who should avoid using Parecoxib Sodium?
Individuals with a history of hypersensitivity to Parecoxib Sodium or other NSAIDs, a history of peptic ulcers, bleeding disorders, severe heart failure, or those taking anticoagulant medications should avoid its use. Pregnant women in the third trimester and individuals with impaired kidney or liver function should also use it with caution.
- Can Parecoxib Sodium be used in combination with other pain medications?
Parecoxib Sodium is often used as part of a multimodal pain management approach, which may include other pain medications. The choice of combination therapy depends on the specific patient and clinical situation.
- How quickly does Parecoxib Sodium provide pain relief?
Parecoxib Sodium has a rapid onset of action when administered intravenously or intramuscularly, providing relatively quick pain relief, which is beneficial in acute pain management.
- Is Parecoxib Sodium addictive?
Parecoxib Sodium is not considered an addictive medication. It does not have the same potential for addiction as opioids. However, it should be used only as prescribed by a healthcare provider.
These FAQs offer insight into the use and considerations surrounding Parecoxib Sodium Powder for Injection. Individual patient needs and medical history should always be considered when using this medication.
As Parecoxib Sodium Powder for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Parecoxib Sodium Powder for 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
Parecoxib Sodium Powder for 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 Parecoxib Sodium Powder for 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
GENERIC NAME OF MEDICINAL PRODUCT:
Parecoxib sodium powder for solution for injection (40mg/2ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Parecoxib sodium powder for solution for injection (40mg/2ml) Composition:
Each vial contains:
Parecoxib……………..40mg
Equivalent to Parecoxib sodium……42.36mg
Excipients…………….q.s.
Also contains Dibasic sodium phosphate heptahydrate, Phosphoric acid and/or sodium hydroxide.
2ml solvent ampule contains sodium chloride, hydrochloride acid, sodium hydroxide and water for injections.
Each vial contains:
Parecoxib……………..40mg
Equivalent to Parecoxib sodium……42.36mg
Excipients…………….q.s.
Also contains Dibasic sodium phosphate heptahydrate, Phosphoric acid and/or sodium hydroxide.
2ml solvent ampule contains sodium chloride, hydrochloride acid, sodium hydroxide and water for injections.
THERAPEUTIC INDICATIONS:
Parecoxib is now increasingly used in ambulatory or day-case surgery because it reduces opioid consumption, improves pain scores, and results in earlier hospital discharge and return to normal function.
DIRECTION OF USE:
When reconstituted with 2ml solvent provides 40mg/ml of parecoxib.
After reconstitution, the product should be used immediately.
After reconstitution, the product should be used immediately.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible in the vial after reconstitution, please do not use the solution. Please do not use the solution and return the vial for free replacement.
For single use only. After reconstitution the product should be use immediately.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
For single use only. After reconstitution the product should be use immediately.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store below 25°C. Protect from light.
Keep all medicines out of reach of children.
Purified vial sealed in vacuum.
Dosage: As directed by the Physician.
Keep all medicines out of reach of children.
Purified vial sealed in vacuum.
Dosage: As directed by the Physician.