Dobutamine Hydrochloride Injection USP 250mg/vial Technical specification:

Product Name:Dobutamine Hydrochloride Injection USP
Brand Name:(GENERICS)
Strength:250mg/vial
Dosage Form:Dry Powder Injection (Lyophilized)
Packing:20ml vial
Route of Administration:For I.V. Infusion after dilution 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:Cardiovascular System, Cardiology
Indication: Dobutamine is a medication used in the treatment of cardiogenic shock (as a result of inadequate tissue perfusion) and severe heart failure. It may also be used in certain types of cardiac stress tests.
Storage:Store at 15°C to 30°C, See USP controlled room temperature. Protect from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Dobutamine Hydrochloride Injection USP 250mg/vial 

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Dobutamine Hydrochloride Injection USP 250mg/vial
    Each vial contains:
    Dobutamine Hydrochloride USP
    Equivalent to Anhydrous Dobutamine Hcl……….250mg
    Excipients………………………q.s.

THERAPEUTIC INDICATION:

Dobutamine is a medication used in the treatment of cardiogenic shock (as a result of inadequate tissue perfusion) and severe heart failure. It may also be used in certain types of cardiac stress tests.

DIRECTION OF USE:

For Intravenous Infusion only

Must be diluted prior to use

Use within 24 hrs. after dilution.

I.V. infusion after dilution, at least 50ml.

CAUTION & Warning:

CAUTION:

  • Do not use if any foreign particulate matter is visible.
  • Dobutamine is Oxygen sensitive. Do not use If the solution is discolored or contains precipitate, it must be discarded.
  • DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
  • KEEP OUT OF REACH AND SIGHT OF CHILDREN.
  • For I.V. infusion after dilution, at least 50ml.
  • Preservative not Added.

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

Avoid use with alkaline solution.

You should not self-Administer this medicine at home.

This Product is only for Hospital supplies.

STORAGE & DOSAGE:

Storage:  Store at 15°C to 30°C, See USP controlled room temperature. Protect from light.

Contains No Antimicrobial Preservatives.

Discard Unused Portion.  

Dosage:  As directed by Physician.

Why Taj Pharmaceuticals?

Elevate cardiac care with Taj Pharma’s Dobutamine Hydrochloride Injection USP. This specialized medication is designed to support patients with cardiac issues, helping to improve heart function and alleviate symptoms. Explore the uses, recommended dosage, and safety information to ensure optimal patient care. Taj Pharma is your reliable partner in delivering high-quality pharmaceutical solutions that prioritize patient well-being and recovery. Taj Pharma’s commitment to excellence and quality assurance ensures that Dobutamine Hydrochloride Injection USP meets the highest industry standards. With a focus on patient health and recovery, Taj Pharma continues to be a trusted name in the healthcare industry, delivering innovative solutions for cardiac support and overall well-being.

What is Dobutamine Hydrochloride Injection USP and its use?

Dobutamine Hydrochloride Injection USP is a medication used in the field of cardiology and critical care medicine. It is a sterile, clear, and colorless solution administered intravenously. The primary active ingredient in this medication is dobutamine hydrochloride.

Uses of Dobutamine Hydrochloride Injection USP:

  • Cardiac Support: Dobutamine Hydrochloride is primarily used to support and stimulate the heart in cases of acute heart failure or other conditions where the heart is not pumping blood effectively. It helps increase cardiac output and improve blood flow throughout the body.
  • Diagnostic Testing: In some cases, dobutamine is used during diagnostic testing, such as stress echocardiography, to evaluate the heart’s function and detect any abnormalities or blockages in the coronary arteries.
  • Short-Term Treatment: This medication is typically used for short-term treatment in a hospital or clinical setting, often in intensive care units or during surgery when cardiac support is needed.
  • Heart Surgery: Dobutamine may be used before or during heart surgery to help the heart function optimally and ensure adequate blood circulation.

It’s essential to note that the use of Dobutamine Hydrochloride Injection USP should be under the strict supervision of a qualified healthcare provider, such as a cardiologist or anesthesiologist. The dosage and administration of this medication are tailored to the individual patient’s needs and condition, and it should only be used in a clinical setting where the patient’s vital signs can be closely monitored.

How does Dobutamine Hydrochloride Injection USP work?

Dobutamine Hydrochloride Injection USP works as a medication to support and stimulate the heart. Its primary mechanism of action is through its effects on cardiac receptors, particularly the beta-1 adrenergic receptors in the heart muscle. Here’s how it works:

  • Beta-1 Adrenergic Receptor Agonist: Dobutamine is a synthetic catecholamine that acts as a selective agonist (activator) of the beta-1 adrenergic receptors in the heart. These receptors are part of the sympathetic nervous system, which plays a crucial role in regulating heart rate and contractility.
  • Increased Contractility: When Dobutamine is administered, it specifically binds to and activates beta-1 adrenergic receptors in the heart muscle. This activation results in increased contractility of the heart muscle fibers, leading to stronger and more efficient contractions of the heart.
  • Increased Heart Rate: Dobutamine also has a secondary effect of increasing the heart rate, although this effect is generally less pronounced compared to its positive inotropic (contractility-enhancing) effect. The increased heart rate can contribute to an increase in cardiac output.
  • Improved Cardiac Output: By increasing both the contractility and, to some extent, the heart rate, Dobutamine enhances the heart’s pumping ability. This results in an improved cardiac output, which means that more blood is ejected from the heart with each beat. Improved cardiac output can help increase blood flow to the body’s vital organs and tissues.

Dobutamine’s selective action on beta-1 adrenergic receptors in the heart makes it useful for situations where it’s necessary to support cardiac function, such as in cases of acute heart failure, cardiac surgery, or diagnostic stress testing. It helps the heart work more effectively, thereby improving blood circulation and oxygen delivery to the body’s tissues.

Benefits and Side Effects of Dobutamine Hydrochloride Injection USP

Dobutamine Hydrochloride Injection USP is a medication primarily used to support and stimulate the heart in cases of acute heart failure or during diagnostic testing. Like all medications, it has potential benefits and side effects. It’s important to note that Dobutamine should only be administered under the supervision of a qualified healthcare professional, who will assess the patient’s specific medical condition and determine whether the potential benefits outweigh the risks. Here are the benefits and potential side effects of Dobutamine Hydrochloride Injection USP:

Benefits:

  • Improved Cardiac Output: Dobutamine increases the strength of contractions of the heart muscle, leading to improved cardiac output. This means that the heart pumps a greater volume of blood with each beat, enhancing blood flow to the body’s organs and tissues.
  • Support for Acute Heart Failure: Dobutamine is often used in cases of acute heart failure, where the heart is not pumping blood effectively. It can provide temporary support to stabilize the patient’s condition until other interventions can be implemented.
  • Diagnostic Testing: In diagnostic settings, Dobutamine is used during stress echocardiography to evaluate the heart’s function and identify any abnormalities, such as reduced blood flow to certain areas of the heart muscle. This can help in the diagnosis of coronary artery disease.

Side Effects:

  • Increased Heart Rate: One of the common side effects of Dobutamine is an increase in heart rate (tachycardia). While this effect can be therapeutic in some cases, it may not be suitable for individuals with certain heart conditions or arrhythmias.
  • Arrhythmias: Dobutamine can sometimes cause irregular heart rhythms (arrhythmias), which can be potentially serious. Patients with preexisting heart rhythm disorders may be at higher risk.
  • Increased Blood Pressure: Dobutamine can raise blood pressure, which may not be suitable for patients with hypertension or certain vascular conditions.
  • Headache: Some individuals may experience headaches as a side effect of Dobutamine.
  • Nervousness or Anxiety: Dobutamine’s stimulatory effects can sometimes lead to feelings of nervousness or anxiety.
  • Nausea and Vomiting: These gastrointestinal symptoms can occur in some patients receiving Dobutamine.
  • Chest Pain: In rare cases, Dobutamine can cause chest pain (angina) due to increased cardiac workload.
  • Palpitations: Some individuals may experience sensations of palpitations or a racing heartbeat.

It’s crucial for healthcare professionals to carefully monitor patients receiving Dobutamine, adjusting the dosage as needed to achieve the desired therapeutic effect while minimizing side effects. Dobutamine should not be used in certain medical conditions, and its use should be avoided or approached with caution in individuals with a history of heart arrhythmias or other cardiac issues. Always consult with a healthcare provider for personalized information and guidance regarding Dobutamine therapy.

Frequently asked questions about Dobutamine Hydrochloride Injection USP:

Here are some frequently asked questions (FAQs) about Dobutamine Hydrochloride Injection USP:

  • What is Dobutamine Hydrochloride Injection USP?

Dobutamine Hydrochloride Injection USP is a medication administered intravenously used to support and stimulate the heart’s function in cases of acute heart failure or during diagnostic testing.

  • How does Dobutamine work?

Dobutamine works by stimulating beta1 adrenergic receptors in the heart, increasing the strength of heart contractions, and improving cardiac output.

  • What is the primary use of Dobutamine?

The primary use of Dobutamine is to provide temporary support for the heart in cases of acute heart failure, where the heart is not pumping blood effectively. It is also used during stress echocardiography for diagnostic purposes.

  • Is Dobutamine suitable for all patients with heart problems?

No, Dobutamine may not be suitable for all patients, especially those with certain heart rhythm disorders or other contraindications. Its use should be determined by a healthcare professional based on an individual’s medical history and condition.

  • What are the potential side effects of Dobutamine?

Common side effects can include increased heart rate, arrhythmias, increased blood pressure, headache, anxiety, nausea, vomiting, chest pain, and palpitations. Serious side effects are rare but can occur.

  • Can Dobutamine be administered at home?

No, Dobutamine is typically administered in a hospital or clinical setting under the supervision of healthcare professionals due to the need for close monitoring and intravenous administration.

  • How is the dosage of Dobutamine determined?

The dosage of Dobutamine is determined by a healthcare provider based on the patient’s specific medical condition, weight, and the desired therapeutic effect.

  • Is Dobutamine safe during pregnancy or breastfeeding?

The safety of Dobutamine during pregnancy and breastfeeding has not been well established, and its use should be carefully considered by healthcare professionals in such situations.

  • Can Dobutamine interact with other medications?

Yes, Dobutamine can interact with certain medications, so it’s important to inform your healthcare provider of all medications, supplements, and herbs you are taking to avoid potential drug interactions.

  • Is Dobutamine a long-term treatment?

No, Dobutamine is typically used as a short-term treatment to provide acute cardiac support. Long-term management of cardiac conditions may require other medications or interventions.

Always consult with a qualified healthcare professional for specific information and recommendations regarding the use of Dobutamine Hydrochloride Injection USP, as individual circumstances and medical conditions can vary.

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

Dobutamine 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 Dobutamine 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

GENERIC NAME OF MEDICINAL PRODUCT:

(A) Dobutamine Hydrochloride Injection USP 250mg/vial (12.5mg/ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

(A) Dobutamine Hydrochloride Injection USP 250mg/vial (12.5mg/ml)
Each vial contains:
Dobutamine Hydrochloride USP
Equivalent to Anhydrous Dobutamine Hcl……….250mg
Excipients………………………q.s.


THERAPEUTIC INDICATION:

Dobutamine is a medication used in the treatment of cardiogenic shock (as a result of inadequate tissue perfusion) and severe heart failure. It may also be used in certain types of cardiac stress tests.

DIRECTION OF USE:

For Intravenous Infusion only
Must be diluted prior to use
Use within 24 hrs. after dilution.
I.V. infusion after dilution, at least 50ml.

CAUTION & WARNING:

CAUTION: Do not use if any foreign particulate matter is visible.
• Dobutamine is Oxygen sensitive. Do not use If the solution is discolored or contains precipitate, it must be discarded.
• DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
• KEEP OUT OF REACH AND SIGHT OF CHILDREN.
• For I.V. infusion after dilution, at least 50ml.
• Preservative Not Added.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Avoid use with alkaline solution.
You should Not Self-Administer this medicine at home.
This Product is only for Hospital supplies.

STORAGE & DOSAGE:

Storage: Store at 15°C to 30°C, See USP controlled room temperature. Protect from light.
Contains no Antimicrobial Preservatives.
Discard unused portion.

Dosage: As directed by Physician.