Ampicillin Sodium Powder for Injection 500 mg

Ampicillin Sodium Powder for Injection 500mg Technical Specification:

Product Name:Ampicillin Sodium Powder for Injection
Brand Name:Generics
Strength:500mg, 1000mg, 2000mg
Dosage Form:Lyophilized Powder for Injection (Sterile)
Packing:1 Vial + WFI Tray
Route of Administration:For I.V./I.M. use
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antibacterial, Antibiotics(polymyxin)
Indication:Ampicillin injection is used to treat certain infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and lung, blood, heart, urinary tract, and gastrointestinal tract infections. Ampicillin injection is in a class of medications called penicillin’s.
Storage:Store dry powder at 20° to 25°C (68° to 77°F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Ampicillin Sodium Powder for Injection 2000 mg
B. Ampicillin Sodium Powder for Injection 1000 mg
C. Ampicillin Sodium Powder for Injection 500 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Ampicillin Sodium Powder for Injection 2000 mg
    Each vial contains:
    Ampicillin Sodium BP
    Equivalent to Ampicillin (Anhydrous)……………….2000mg
    Buffering Agent ……………………………………………q.s.
    Powder for solution for injection.
  2. Ampicillin Sodium Powder for Injection 1000 mg
    Each vial contains:
    Ampicillin Sodium BP
    Equivalent to Ampicillin (Anhydrous)……………….1000mg
    Buffering Agent ……………………………………………q.s.
    Powder for solution for injection.
  3. Ampicillin Sodium Powder for Injection 500 mg
    Each vial contains:
    Ampicillin Sodium BP
    Equivalent to Ampicillin (Anhydrous)……………….500mg
    Buffering Agent ……………………………………………q.s.
    Powder for solution for injection.

THERAPEUTIC INDICATIONS:

Ampicillin injection is used to treat certain infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and lung, blood, heart, urinary tract, and gastrointestinal tract infections. Ampicillin injection is in a class of medications called penicillins.

DIRECTION OF USE:

For I.V./I.M. use

Dissolve the contents in sterile Water for Injection USP 20ml.

For full prescribing information and direction on reconstitution, see enclosed package insert.

CAUTION & Warning:

CAUTION:  The injection should not be used It contains visible particulate matter after reconstitution.

Intravenous route over a period of at least 10-15 minutes.

More rapid administration may result in major seizures.

Contraindications: A history of a previous hypersensitivity reaction to any of the penicillin’s is a Contraindication.

MUST BE DILUTED BEFORE INFUSION.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

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

Keep well closed.

Single Dose Only.

STORAGE & DOSAGE:

Storage: Store between 20°C to 25°C (68°F to 77°F)

Protect from light and moisture. Do not freeze.

Keep all medicines out of reach of children.

Dosage:  As directed by the Physician.

Why Taj Pharmaceuticals?

Selecting a pharmaceutical manufacturer for medications like Ampicillin Sodium Powder for Injection involves various critical considerations. One primary factor is the assurance of product quality. It is essential that the medications meet stringent quality standards to ensure safety and efficacy. Manufacturers, such as Taj Pharma, are expected to adhere to Good Manufacturing Practices (GMP) and other regulatory standards to maintain high-quality products. Regulatory compliance is another crucial aspect. Pharmaceuticals must comply with regulations set by authorities like the FDA, EMA, or WHO. Choosing a manufacturer with a track record of compliance helps ensure that the medication meets these stringent requirements. Reputation within the pharmaceutical industry also matters. A manufacturer’s reputation can be indicative of its reliability and product quality. Opting for a company known for producing safe and effective medications can provide peace of mind. Cost considerations come into play as well. Different manufacturers offer varying pricing structures, so selecting one that aligns with your budget while maintaining quality is vital. Reliable availability and a robust supply chain are essential for consistent medication supply, especially for healthcare providers and institutions. Some manufacturers may have better distribution networks, ensuring a stable supply of medications. Packaging and presentation are factors too. The way medications are packaged and presented can affect convenience and suitability for specific needs. Customer support and assistance are critical. Factors like order processing, technical support, and responsiveness to inquiries can impact the overall experience. Geographic location may also be a consideration. Some may prefer manufacturers located closer to reduce shipping times and costs. Ultimately, the choice of a pharmaceutical manufacturer for a specific medication depends on a combination of these factors and the specific needs and priorities of healthcare providers or institutions. Due diligence, including assessing certifications, inspecting facilities, and reviewing product quality records, is crucial. Consulting regulatory agencies and seeking recommendations from trusted healthcare sources can aid in making an informed decision.

What is Ampicillin Sodium Powder for Injection and its uses?

Ampicillin Sodium Powder for Injection is a medication that contains the active ingredient ampicillin, which belongs to the class of antibiotics known as penicillins. It is used for the treatment of various bacterial infections. Here’s an overview of its uses and how it works:

Uses:

  • Bacterial Infections: Ampicillin Sodium Powder for Injection is primarily prescribed to treat a wide range of bacterial infections caused by susceptible organisms. This includes infections of the respiratory tract, urinary tract, skin and soft tissues, gastrointestinal tract, and more.
  • Meningitis: It can also be used to treat bacterial meningitis, a serious infection of the membranes covering the brain and spinal cord.
  • Intra-Abdominal Infections: Ampicillin may be used in combination with other antibiotics to treat intra-abdominal infections such as peritonitis.
  • Septicemia: In cases of septicemia (bloodstream infection), ampicillin may be administered to target the causative bacteria.
  • Prophylaxis: In some cases, ampicillin might be used prophylactically to prevent certain infections, particularly in healthcare settings or before certain medical procedures.

How Does Ampicillin Sodium Powder for Injection Work?

Ampicillin Sodium Powder for Injection works as an antibiotic by targeting and disrupting the structure of bacterial cell walls. Here’s a detailed explanation of how it works:

  • Bacterial Cell Walls: Bacterial cells are surrounded by a rigid outer layer called the cell wall. This cell wall is crucial for maintaining the shape and structural integrity of the bacterium. It also serves as a protective barrier against the external environment.
  • Peptidoglycan Structure: The cell wall of many bacteria, especially Gram-positive and some Gram-negative bacteria, consists of a complex molecule called peptidoglycan. Peptidoglycan is a mesh-like structure made up of long chains of sugars (glycans) cross-linked by short peptide chains.
  • Inhibition of Cell Wall Synthesis: Ampicillin, like other penicillin antibiotics, interferes with the synthesis of peptidoglycan in bacterial cell walls. It does this by targeting enzymes known as penicillin-binding proteins (PBPs) that are responsible for cross-linking the glycan strands.
  • Weakens and Lyses Bacterial Cells: When Ampicillin binds to PBPs, it inhibits their ability to cross-link peptidoglycan strands properly. As a result, the bacterial cell wall becomes structurally weak and unable to withstand the internal pressure of the bacterial cell. This weakened cell wall eventually leads to the rupture and lysis (breakdown) of the bacterial cell.
  • Bacterial Vulnerability: With the bacterial cell wall compromised, the bacterium becomes highly vulnerable to external factors, including the body’s immune system and osmotic pressure changes. Without an intact cell wall, the bacterium is unable to maintain its shape and protect its internal contents.
  • Bactericidal Effect: Ampicillin’s action is bactericidal, which means it kills the bacteria rather than merely inhibiting their growth. By disrupting the cell wall, directly leads to the death of susceptible bacteria.

It’s important to note that Ampicillin Sodium Powder for Injection is effective against a wide range of bacteria but is only active against those bacteria that are susceptible to it. Bacterial resistance to ampicillin has developed over time, and some bacteria have acquired mechanisms to evade the effects of this antibiotic. As with any antibiotic, it’s crucial to use Ampicillin as prescribed by a healthcare professional, complete the full course of treatment even if symptoms improve, and avoid using it for non-bacterial infections or without proper medical guidance. Additionally, antibiotic resistance is a growing concern, so antibiotics like ampicillin should be used judiciously to help prevent the development of antibiotic-resistant bacteria.

Benefits of Ampicillin Sodium Powder for Injection:

  • Treatment of Bacterial Infections: Ampicillin is effective against a wide range of bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, gastrointestinal infections, and more. It is considered a broad-spectrum antibiotic, which means it can target a variety of bacterial species.
  • Bactericidal Action: Ampicillin is bactericidal, which means it kills susceptible bacteria rather than just inhibiting their growth. This can lead to a more rapid resolution of the infection.
  • Prophylactic Use: In some cases, Ampicillin Sodium Powder for Injection may be used prophylactically to prevent certain infections, particularly in healthcare settings or before specific medical procedures where there is a risk of infection.
  • Effectiveness Against Gram-Positive and Some Gram-Negative Bacteria: Ampicillin is particularly effective against Gram-positive bacteria like Streptococcus and Enterococcus species. It also has activity against some Gram-negative bacteria.

Side Effects of Ampicillin Sodium Powder for Injection:

  • Allergic Reactions: Allergic reactions to ampicillin, including skin rash, itching, swelling, and, in severe cases, anaphylaxis (a life-threatening allergic reaction), can occur. Patients with a history of penicillin allergy are at higher risk.
  • Gastrointestinal Disturbances: Common side effects include nausea, vomiting, diarrhea, and abdominal pain. These symptoms are generally mild and resolve after treatment discontinuation.
  • Superinfections: Antibiotics like ampicillin can disrupt the natural balance of bacteria in the body, leading to the overgrowth of resistant bacteria or fungi. This can result in secondary infections, such as oral or vaginal yeast infections or Clostridium difficile-associated diarrhea (a severe intestinal infection).
  • Hypersensitivity Reactions: Some individuals may experience hypersensitivity reactions other than anaphylaxis, such as fever, joint pain, and eosinophilia.
  • Kidney Dysfunction: In rare cases, ampicillin can cause kidney dysfunction, especially when high doses are administered or in patients with pre-existing kidney issues.
  • Blood Disorders: Ampicillin can occasionally affect blood cell counts, leading to conditions like leukopenia (low white blood cell count) or thrombocytopenia (low platelet count).
  • Neurological Symptoms: High doses of ampicillin may rarely lead to neurological symptoms, such as seizures, especially in patients with kidney dysfunction.

It’s important to note that while Ampicillin Sodium Powder for Injection can be highly effective in treating bacterial infections, it should be used with caution and only as prescribed by a healthcare professional. It’s essential to complete the full course of treatment, even if symptoms improve, to ensure that the infection is completely eradicated and to minimize the risk of antibiotic resistance. If you experience any unusual or severe side effects while taking this medication, it’s crucial to contact your healthcare provider promptly. Additionally, inform your healthcare provider about any allergies or medical conditions you may have before starting ampicillin therapy.

Frequently Asked Questions About Ampicillin Sodium Powder for Injection:

Frequently asked questions (FAQs) about Ampicillin Sodium Powder for Injection can help individuals and healthcare providers better understand this medication and its usage. Here are some common questions and their answers:

  1. What is Ampicillin Sodium Powder for Injection used for?

Ampicillin Sodium Powder for Injection is an antibiotic medication used to treat a wide range of bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more.

  1. How does Ampicillin Sodium Powder for Injection work?

Ampicillin works by interfering with the formation of bacterial cell walls, weakening them and ultimately leading to the death of susceptible bacteria. It is considered a bactericidal antibiotic.

  1. Is Ampicillin Sodium Powder for Injection effective against all types of bacteria?

No, Ampicillin is effective against a broad spectrum of bacteria, but its effectiveness is limited to bacteria that are susceptible to it. Some bacteria have developed resistance to ampicillin.

  1. Can I use Ampicillin for viral infections like the common cold or flu?

No, Ampicillin is an antibiotic and is only effective against bacterial infections. It should not be used to treat viral infections like the common cold or flu.

  1. What are the common side effects of Ampicillin Sodium Powder for Injection?

Common side effects may include nausea, vomiting, diarrhea, abdominal pain, and skin rashes. Serious allergic reactions and other uncommon side effects can also occur.

  1. Who should not use Ampicillin Sodium Powder for Injection?

Individuals with a known allergy to penicillin or ampicillin should not use this medication. It’s essential to inform your healthcare provider of any allergies or medical conditions before starting treatment.

  1. How is Ampicillin Sodium Powder for Injection administered?

Ampicillin Sodium Powder for Injection is typically administered intravenously (IV) or intramuscularly (IM) by a healthcare professional in a clinical setting.

  1. Can I stop taking Ampicillin once my symptoms improve?

No, it’s crucial to complete the full course of treatment as prescribed by your healthcare provider, even if your symptoms improve before the medication is finished. Stopping prematurely can lead to incomplete eradication of the infection and antibiotic resistance.

  1. Are there any drug interactions with Ampicillin Sodium Powder for Injection?

Ampicillin may interact with certain medications, including oral contraceptives and drugs that reduce stomach acid. Inform your healthcare provider about all medications and supplements you are taking.

  1. How should Ampicillin Sodium Powder for Injection be stored?

Store the medication as directed on the label, typically at room temperature away from light and moisture. Follow any specific storage instructions provided by your healthcare provider or pharmacist.

As Ampicillin Sodium Powder for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Ampicillin 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

Ampicillin 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 Ampicillin 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 THE MEDICINAL PRODUCT:

A. Ampicillin Sodium Powder for Injection 2000 mg
B. Ampicillin Sodium Powder for Injection 1000 mg
C. Ampicillin Sodium Powder for Injection 500 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Ampicillin Sodium Powder for Injection 2000 mg
Each vial contains:
Ampicillin Sodium BP
Equivalent to Ampicillin (Anhydrous)……………….2000mg
Buffering Agent ……………………………………………q.s.
Powder for solution for injection.

b) Ampicillin Sodium Powder for Injection 1000 mg
Each vial contains:
Ampicillin Sodium BP Equivalent to Ampicillin (Anhydrous)……………….1000mg
Buffering Agent ……………………………………………q.s.
Powder for solution for injection.

c) Ampicillin Sodium Powder for Injection 500 mg
Each vial contains:
Ampicillin Sodium BP
Equivalent to Ampicillin (Anhydrous)……………….500mg
Buffering Agent ……………………………………………q.s.
Powder for solution for injection.

THERAPEUTIC INDICATIONS:

Ampicillin injection is used to treat certain infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and lung, blood, heart, urinary tract, and gastrointestinal tract infections. Ampicillin injection is in a class of medications called penicillins.

DIRECTION OF USE:

For I.V./I.M. use
Dissolve the contents in sterile Water for Injection USP 20ml.
For full prescribing information and direction on reconstitution, see enclosed package insert.

CAUTION & WARNING:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Intravenous route over a period of at least 10-15 minutes.
More rapid administration may result in major seizures.
Contraindications: A history of a previous hypersensitivity reaction to any of the penicillin’s is a Contraindication.
MUST BE DILUTED BEFORE INFUTION.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner. Keep well closed.
Single Dose Only.

STORAGE & DOSAGE:

Storage: Store between 20°C to 25°C (68°F to 77°F)
Protect from light and moisture. Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

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