GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Bupivacaine Hydrochloride Injection USP 0.25%
B. Bupivacaine Hydrochloride Injection USP 0.50%
C. Bupivacaine Hydrochloride Injection USP 0.75%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Bupivacaine Hydrochloride Injection USP 0.25%
Each ml contains:
Bupivacaine Hydrochloride USP…………..2.5mg
Sodium Chloride USP (for isotonicity)….8.0mg
Water for Injection USP……………………....q.s

B. Bupivacaine Hydrochloride Injection USP 0.50%
Each ml contains:
Bupivacaine Hydrochloride USP………….5mg
Sodium Chloride USP (for isotonicity)….8.0mg
Water for Injection USP…………………….…q.s


C. Bupivacaine Hydrochloride Injection USP 0.75%
Each ml contains:
Bupivacaine Hydrochloride USP….………7.5mg
Sodium Chloride USP (for isotonicity)….8.0mg
Water for Injection USP……………………….q.s

THERAPEUTIC INDICATIONS:

Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work. This medicine is also used to numb your shoulder after surgery for up to 72 hours.

PACKING:

(A) 0.25% (2.5mg/ml)
25mg/10ml (10ml Single Dose Vial)
50mg/20ml (20ml Single Dose Vial)
75mg/30ml (30ml Single Dose Vial)
125mg/50ml (50ml Multiple Dose Vial)

(B) 0.5% (5mg/ml)
50mg/10ml (10ml Single Dose Vial)
100mg/20ml (20ml Single Dose Vial)
150mg/30ml (30ml Single Dose Vial)
250mg/50ml (50ml Multiple Dose Vial)


(C) 0.75% (7.5mg/ml)
75mg/10ml (10ml Single Dose Vial)
225mg/30ml (30ml Single Dose Vial)

DIRECTION OF USE:

• Bupivacaine Hydrochloride Injection0.25% is for INFILTATION, NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.
Bupivacaine Hydrochloride Injection0.5% is for NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.
• Bupivacaine Hydrochloride Injection0.75% is for EPIDURAL AND RETROBULBAR ANESTHESIA and not for Obstetric anesthesia.
• A healthcare professional will administer the Bupivacaine Hydrochloride Injection, do not self-administer.
• Refer package insert for full prescribing information.

CAUTION & WARNING:

CAUTION: Do not use if any foreign particulate matter is visible.
Not for spinal anesthesia.
Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia.
Do not dispose of container causing pollution of the environment.
Arrange for collection of controlled waste.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20 to 25°C (68°F to 77°F).
The expiry date refers to the product properly stored, in its package.
Keep all medicines out of reach of children.
Dosage: Refer package insert for full prescribing information.

Bupivacaine Hydrochloride Injection USP 0.50% Technical Specification:

Product Name:Bupivacaine Hydrochloride Injection USP
Brand Name:Generic
Strength:0.25%,   0.50%,   0.75%
Dosage Form:Liquid Injection
Packing:Single Dose and Multi Dose Vials
Route of Administration:0.25%-is for INFILTATION, NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.
0.50%-is for NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.
0.75% is for EPIDURAL AND RETROBULBAR ANESTHESIA.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Local Anaesthetic
Indication: Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work. This medicine is also used to numb your shoulder after surgery for up to 72 hours.
Storage:Store at 20°C to 25°C (68°F to 77°F)

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Bupivacaine Hydrochloride Injection USP 0.50%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Bupivacaine Hydrochloride Injection USP 0.50%
    Each ml contains:
    Bupivacaine Hydrochloride USP…………..5mg
    Sodium Chloride USP (for isotonicity)…….8.0mg
    Water for Injection USP…………………….q.s

THERAPEUTIC INDICATIONS:

Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work. This medicine is also used to numb your shoulder after surgery for up to 72 hours.

PACKING:

  • 0.50% (5mg/ml)
    50mg/10ml (10ml Single Dose Vial)
    100mg/20ml (20ml Single Dose Vial)
    150mg/30ml (30ml Single Dose Vial)
    250mg/50ml (50ml Multiple Dose Vial)

DIRECTION OF USE:

Bupivacaine Hydrochloride Injection0.25% is for INFILTATION, NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.
Bupivacaine Hydrochloride Injection0.5% is for NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.
Bupivacaine Hydrochloride Injection0.75% is for EPIDURAL AND RETROBULBAR ANESTHESIA and not for Obstetric anesthesia.
A healthcare professional will administer the Bupivacaine Hydrochloride Injection, do not self-administer.
Refer package insert for full prescribing information.

CAUTION & WARNING:

CAUTION:

Do not use if any foreign particulate matter is visible.
Not for spinal anesthesia.
Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia.
Do not dispose of container causing pollution of the environment.
Arrange for collection of controlled waste.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20 to 25°C (68°F to 77°F).
The expiry date refers to the product properly stored, in its package.
Keep all medicines out of reach of children.
Dosage: Refer package insert for full prescribing information.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals can offer several compelling reasons for being a top choice when it comes to Bupivacaine Hydrochloride Injection USP. Firstly, they prioritize the assurance of product quality, ensuring that each injection meets rigorous quality control standards, thereby guaranteeing its effectiveness and safety. This dedication to quality extends to their consistent supply chain, ensuring that healthcare professionals have dependable access to this critical medication for various medical procedures and surgeries. Drawing from their extensive experience in the pharmaceutical industry, Taj Pharmaceuticals has cultivated expertise in producing and delivering effective medications. Their seasoned background instills confidence in healthcare providers, assuring them of the reliability and quality of their pharmaceutical products. Taj Pharmaceuticals maintains a strong focus on patient well-being, aligning with their mission to enhance patients’ health and overall experience, particularly in pain management and medical procedures.

Additionally, Taj Pharmaceuticals may offer competitive pricing, making essential medications such as Bupivacaine Hydrochloride Injection more economically accessible for both patients and healthcare institutions. Their unwavering commitment to regulatory compliance ensures that their products meet stringent safety and efficacy standards, providing assurance to healthcare professionals and patients alike. Furthermore, Taj Pharmaceuticals recognizes the value of support and education. They provide healthcare providers and patients with valuable information about Bupivacaine Hydrochloride Injection USP, its uses, and proper administration, contributing to a well-informed medical community. With a global presence and an extensive distribution network, Taj Pharmaceuticals can facilitate the availability of Bupivacaine Hydrochloride Injection USP in various regions, ensuring that it reaches healthcare providers and patients worldwide. Ultimately, the decision of pharmaceutical supplier should align with the healthcare provider’s commitment to patient safety and effective pain management during medical procedures. Taj Pharmaceuticals offers a comprehensive package of quality, reliability, affordability, compliance, and support in the realm of pharmaceuticals, making it a compelling choice for Bupivacaine Hydrochloride Injection USP and other medications.

What is Bupivacaine Hydrochloride Injection USP and its use:

Bupivacaine Hydrochloride Injection USP is a medication commonly used as a local anesthetic. It contains the active ingredient bupivacaine, which belongs to a class of drugs known as amide-type local anesthetics. This injection is used for various medical purposes to provide temporary numbing or pain relief in specific areas of the body. Here’s an overview of Bupivacaine Hydrochloride Injection USP and its uses:

Bupivacaine Hydrochloride Injection USP:

Bupivacaine is a local anesthetic that works by blocking the transmission of pain signals from nerves to the brain. The “USP” in the name indicates that it complies with the United States Pharmacopeia, ensuring its quality and purity.

Uses:

  • Surgical Anesthesia: Bupivacaine Hydrochloride Injection is commonly used by healthcare providers to provide anesthesia during various surgical procedures. It can be administered as a local anesthetic to numb a specific area of the body or as a regional anesthetic to block sensation in a larger region, such as an entire limb.
  • Obstetrical Anesthesia: Bupivacaine may be used during childbirth to provide epidural anesthesia. This involves injecting the medication into the epidural space in the spine to numb the lower half of the body, offering pain relief during labor and delivery.
  • Postoperative Pain Management: Bupivacaine can also be used to provide postoperative pain relief. It may be administered through catheters or injections at surgical sites to reduce pain and discomfort after surgery.
  • Nerve Blocks: Healthcare providers may use Bupivacaine Injection to perform nerve blocks, which involve injecting the medication near specific nerves to provide pain relief for conditions like chronic pain, neuropathic pain, or certain nerve-related disorders.
  • Dental Procedures: Bupivacaine may be used by dentists for local anesthesia during dental procedures to numb the mouth or surrounding tissues, making dental work more comfortable for patients.
  • Chronic Pain Management: In some cases, Bupivacaine injections are used for the management of chronic pain conditions, such as back pain, joint pain, or neuropathic pain. This provides localized pain relief without affecting the entire body.

It’s important to note that Bupivacaine Hydrochloride Injection should be administered by trained healthcare professionals, and the dosage and administration method will vary depending on the specific medical condition and patient needs. While it is effective for providing localized pain relief, it is not suitable for all situations, and potential risks and benefits should be carefully considered by healthcare providers.

How Does Bupivacaine Hydrochloride Injection USP Work?

Bupivacaine Hydrochloride Injection USP is a local anesthetic, and its mechanism of action involves blocking the transmission of pain signals in nerves. Here’s how it works:

  • Inhibition of Sodium Channels: Bupivacaine belongs to a class of drugs known as amide-type local anesthetics. It works by inhibiting sodium channels in nerve cell membranes. These sodium channels are responsible for the initiation and propagation of action potentials, which are electrical signals that allow nerves to transmit pain signals to the brain.
  • Blockade of Nerve Impulses: When Bupivacaine is injected into the target area, it diffuses into the nerve fibers in that region. Once inside the nerve cells, it binds to sodium channels and prevents them from opening in response to electrical stimuli. This blockade of sodium channels effectively inhibits the influx of sodium ions into the nerve cells, which is necessary for the generation and conduction of action potentials.
  • Numbness and Loss of Sensation: By blocking nerve impulses and the transmission of pain signals, Bupivacaine causes a temporary loss of sensation in the area where it is applied. This results in numbness and pain relief, allowing medical procedures to be performed with reduced discomfort or for postoperative pain to be managed effectively.
  • Duration of Action: Bupivacaine Hydrochloride is known for its relatively long duration of action compared to some other local anesthetics. This means that the numbness and pain relief it provides can last for an extended period, making it suitable for various surgical and medical purposes.
  • Metabolism and Clearance: Over time, Bupivacaine is metabolized and cleared from the body, allowing normal nerve function to gradually return to the treated area. The duration of anesthesia depends on the specific formulation (e.g., standard or extended-release) and the dosage used.

It’s important to emphasize that Bupivacaine Hydrochloride Injection USP is administered by trained healthcare professionals who carefully consider the dosage and administration technique to achieve the desired level of anesthesia while minimizing potential side effects or complications. Local anesthesia with Bupivacaine provides effective pain relief for a variety of medical procedures and is a valuable tool in pain management.

Benefits of Bupivacaine Hydrochloride Injection USP:

  • Effective Localized Pain Relief: Bupivacaine Hydrochloride Injection is highly effective at providing localized pain relief. It is commonly used for various medical procedures and surgeries to ensure patients remain comfortable and pain-free during and after the intervention.
  • Extended Duration of Action: Bupivacaine is known for its relatively prolonged duration of action compared to some other local anesthetics. This means that a single injection can offer pain relief for an extended period, reducing the need for frequent re-administration.
  • Precision in Pain Management: By targeting specific areas, Bupivacaine allows healthcare providers to achieve precise pain management. This precision is particularly valuable in surgical settings, where it helps maintain patient stability and allows for more accurate procedures.
  • Minimized Systemic Effects: Bupivacaine primarily acts locally at the site of injection, limiting its systemic absorption. This reduces the risk of widespread side effects that can occur with systemic pain medications, leading to a more favorable safety profile.
  • Customizable Dosage: Healthcare providers can tailor the dosage of Bupivacaine Hydrochloride Injection to meet the individual needs of patients. This versatility ensures that pain management is optimized for each specific case.
  • Enhanced Patient Comfort: The pain relief provided by Bupivacaine helps patients remain comfortable during medical procedures, promoting a more positive patient experience and reducing anxiety associated with pain.
  • Improved Surgical Precision: By eliminating pain in the target area, Bupivacaine enables surgeons and medical professionals to perform procedures with greater precision, ensuring the best possible outcomes.
  • Reduced Postoperative Pain: Bupivacaine is often used for postoperative pain management. It helps minimize discomfort during the recovery period, allowing patients to heal more comfortably and potentially reducing the need for systemic pain medications.

These benefits make Bupivacaine Hydrochloride Injection USP a valuable tool in various medical and surgical settings, providing effective pain relief with a focus on patient safety and comfort.

Side Effects of Bupivacaine Hydrochloride Injection USP:

While Bupivacaine Hydrochloride Injection is generally safe when administered by trained healthcare professionals, it can have some potential side effects, including:

  • Local Anesthetic Toxicity: If too much Bupivacaine is administered or if it is inadvertently injected into a blood vessel, it can lead to local anesthetic toxicity. This can result in symptoms such as dizziness, confusion, seizures, irregular heart rate, and cardiac arrest in severe cases.
  • Nerve Damage: In rare instances, local anesthetics like Bupivacaine can cause nerve damage at the injection site. This can result in numbness, weakness, or prolonged loss of sensation in the affected area.
  • Allergic Reactions: While uncommon, some individuals may experience allergic reactions to Bupivacaine, which can manifest as skin rashes, itching, or more severe allergic responses.
  • Injection Site Reactions: Pain, redness, or swelling at the injection site can occur, but these side effects are generally mild and transient.
  • Systemic Effects: Although Bupivacaine is primarily localized, it can still be absorbed systemically in small amounts. This can lead to mild side effects such as dizziness, headache, or nausea.
  • Cardiovascular Effects: High doses of Bupivacaine or systemic absorption can affect the cardiovascular system, potentially causing changes in heart rate and blood pressure.

It’s important for healthcare providers to carefully consider the dosage and administration technique to minimize the risk of side effects. Patients should also be monitored during and after administration to ensure their safety. The benefits of Bupivacaine Hydrochloride Injection, including effective pain relief and reduced systemic effects, make it a valuable tool in various medical procedures and pain management contexts when used appropriately.

Frequently Asked Questions About Bupivacaine Hydrochloride Injection USP:

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

  1. What is Bupivacaine Hydrochloride Injection USP used for?

Bupivacaine Hydrochloride Injection USP is used as a local anesthetic to provide temporary pain relief and numbness in specific areas of the body. It is commonly used during medical procedures and surgeries.

  1. How does Bupivacaine Hydrochloride Injection USP work?

Bupivacaine works by blocking the transmission of pain signals in nerves. It inhibits sodium channels in nerve cell membranes, preventing the initiation and propagation of pain signals to the brain.

  1. Is Bupivacaine Hydrochloride Injection USP safe for use during surgery?

When administered by trained healthcare professionals, Bupivacaine Hydrochloride Injection is generally considered safe for surgical anesthesia. However, its safety depends on proper dosage and administration techniques.

  1. How long does the pain relief from Bupivacaine Hydrochloride Injection last?

The duration of pain relief varies depending on the specific formulation and dosage used. Bupivacaine is known for its relatively extended duration of action compared to some other local anesthetics, and it can provide pain relief for several hours to several days.

  1. What are the potential side effects of Bupivacaine Hydrochloride Injection USP?

Common side effects include pain or discomfort at the injection site, numbness, and temporary loss of sensation. Rare but serious side effects can include local anesthetic toxicity, nerve damage, and allergic reactions.

  1. Can Bupivacaine Hydrochloride Injection USP be used during childbirth?

Yes, Bupivacaine Hydrochloride Injection is commonly used as an epidural anesthetic during labor and delivery to provide pain relief to the lower half of the body.

  1. How is Bupivacaine Hydrochloride Injection USP administered?

Bupivacaine is typically administered by injection directly into the target area by a healthcare provider. The dosage and administration technique vary depending on the specific medical procedure and patient needs.

  1. Is Bupivacaine Hydrochloride Injection USP suitable for dental procedures?

Yes, Bupivacaine Hydrochloride Injection can be used for local anesthesia during dental procedures to numb the mouth or surrounding tissues.

  1. Can Bupivacaine Hydrochloride Injection USP cause allergies?

While allergic reactions to Bupivacaine are rare, they can occur. Patients should inform their healthcare provider of any known allergies before receiving the injection.

  1. Is Bupivacaine Hydrochloride Injection USP safe for children and elderly patients?

Bupivacaine can be used in pediatric and elderly populations, but the dosage and administration must be adjusted based on age and individual factors. Healthcare providers carefully consider the patient’s specific needs and medical history.

Patients should consult with their healthcare providers for personalized information and guidance regarding the use of Bupivacaine Hydrochloride Injection USP in their specific medical situations.

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

Bupivacaine Hydrochloride Injection USP 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 Bupivacaine Hydrochloride Injection USP, 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