GENERIC NAME OF MEDICINAL PRODUCT:

(A) Ampicillin Sodium Injection IP 1gm
(B) Ampicillin Sodium Injection IP 500mg
(C) Ampicillin Sodium Injection IP 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Ampicillin Sodium Injection IP 1gm
A. Each vial contains:
(Sterile) Ampicillin Sodium IP
Eq. to Anhydrous
Ampicillin IP…………1000mg
B. Sterile water for Injection IP.……… 10ml


2. Ampicillin Sodium Injection IP 500mg
A. Each vial contains:
(Sterile) Ampicillin Sodium IP
Eq. to Anhydrous
Ampicillin IP…………500mg
B. Sterile water for Injection IP ……….…… 5ml

3. Ampicillin Sodium Injection IP 250mg
A. Each vial contains:
(Sterile) Ampicillin Sodium IP
Eq. to Anhydrous
Ampicillin IP…………250mg
B. Sterile water for Injection IP ……….…… 5ml

THERAPEUTIC 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 penicillins

DIRECTION OF USE:

Reconstitute using 10ml of sterile water for injection IP.
Reconstituted solution should be use immediately after preparation Read enclosed leaflet before reconstitution and use.

CAUTION & SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE 'H' DRUG: Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store Below 25°C Protect from light & moisture.
Reconstituted solution should be use immediately after preparation.
Any unused reconstitution portion must be discarded.
KEEP OUT OF REACH OF CHILDREN.
DOSAGE: As directed by Physician.

Ampicillin Sodium Injection IP 1gm Technical Specification:

Product Name:Ampicillin Sodium Injection IP 1gm
Brand Name:AMP-TAJ
Strength:1gm, 500mg, 250mg
Dosage Form:Dry Powder Injection (Sterile)
Packing:Vial + WFI in Tray
Route of Administration:For I.M./I.V. use
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:β-lactam Antibiotic, Anti-bacterial & Penicillin.
Indication: Ampicillin injection is used to treat certain infections that are caused by bacteria such as meningitis and lung, blood, heart, urinary tract, and gastrointestinal tract infections.
Storage:Store Below 25°C. Protect from light & moisture.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ampicillin Sodium Injection IP 1gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ampicillin Sodium Injection IP 1gm
    Each vial contains:
    (Sterile) Ampicillin Sodium IP
    Eq. to Anhydrous
    Ampicillin IP…………1000mg
    Sterile water for Injection IP.……… 10ml

THERAPEUTIC 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 penicillins

DIRECTION OF USE:

Reconstitute using 10ml of sterile water for injection IP. The reconstituted solution should be used immediately after preparation Read the enclosed leaflet before reconstitution and use.

CAUTION & SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
KEEP OUT OF REACH OF CHILDREN.

SCHEDULE: SCHEDULE ‘H’ DRUG; Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store Below 25°C Protect from light & moisture.
The reconstituted solution should be used immediately after preparation.
Any unused reconstitution portion must be discarded.
DOSAGE: As directed by the Physician.

Why Taj Pharmaceuticals?

The compelling reasons why Taj Pharma is the foremost choice for Ampicillin Sodium Injection IP. With a rich heritage in pharmaceutical excellence spanning decades, Taj Pharma embodies a commitment to healthcare quality that goes beyond ordinary standards. Our Ampicillin Sodium Injections are a testament to our unwavering dedication to patient well-being, characterized by stringent quality control and rigorous manufacturing processes. When you choose Taj Pharma, you’re selecting a trusted partner in delivering antibiotics of unparalleled safety and efficacy. Join countless healthcare professionals and institutions who rely on Taj Pharma for their Ampicillin Sodium Injection IP needs, and experience the exceptional standard of care that defines us.

What is Ampicillin Sodium Injection IP and its use?

Ampicillin Sodium Injection IP is a medication that belongs to the penicillin group of antibiotics. It contains the active ingredient ampicillin sodium, which is a semi-synthetic derivative of penicillin. This injection is used to treat a variety of bacterial infections when oral administration of antibiotics may not be feasible or effective. Here’s more information about Ampicillin Sodium Injection IP and its uses:

Uses of Ampicillin Sodium Injection IP:

  • Bacterial Infections: Ampicillin Sodium Injection IP is prescribed to treat a wide range of bacterial infections caused by susceptible organisms. These infections can affect various parts of the body, including the respiratory tract, urinary tract, skin, soft tissues, bones, and joints.
  • Meningitis: It is effective against certain bacteria that can cause meningitis, a serious infection of the membranes covering the brain and spinal cord. Ampicillin may be used as part of the treatment regimen for bacterial meningitis.
  • Intra-Abdominal Infections: Intra-abdominal infections, such as peritonitis (inflammation of the abdominal lining) and abscesses, can be treated with Ampicillin Sodium Injection IP when caused by susceptible bacteria.
  • Endocarditis: This medication may also be used as part of the treatment for bacterial endocarditis, an infection of the heart’s inner lining and valves.
  • Neonatal Infections: In neonates (newborns), Ampicillin Sodium Injection IP is sometimes used to treat or prevent early-onset bacterial infections, particularly those affecting the respiratory and urinary systems.
  • Surgical Prophylaxis: It can be administered before certain surgical procedures to reduce the risk of postoperative infections.

Ampicillin works by interfering with the synthesis of bacterial cell walls, weakening them, and ultimately leading to bacterial cell death. It is effective against a range of gram-positive and some gram-negative bacteria.

As with any antibiotic, it is essential to use Ampicillin Sodium Injection IP only when prescribed by a healthcare provider and to complete the full course of treatment as directed, even if symptoms improve before the medication is finished. This helps prevent the development of antibiotic resistance and ensures the infection is completely eradicated.

How does Ampicillin Sodium Injection IP Work?

Ampicillin Sodium Injection IP works as an antibiotic by interfering with the synthesis of bacterial cell walls. This mechanism of action makes it effective against a wide range of bacteria, including some gram-positive and gram-negative strains. Here’s how Ampicillin Sodium Injection IP works:

  • Inhibition of Cell Wall Synthesis: Bacteria have a protective outer cell wall that gives them structural integrity and protection. This cell wall is primarily composed of peptidoglycan, a complex molecule. Ampicillin sodium interferes with the formation of peptidoglycan by inhibiting enzymes called penicillin-binding proteins (PBPs) that are involved in cross-linking the peptidoglycan strands.
  • Weakening of Cell Walls: As a result of Ampicillin’s action, the bacterial cell wall becomes weaker and more susceptible to damage. This weakening leads to structural instability in the bacterial cell.
  • Cell Lysis: The weakened cell wall can no longer withstand the internal pressure of the bacterial cell, causing the cell to take up excess water and swell. Eventually, the bacterial cell wall ruptures, leading to cell lysis (bursting). This destruction of the bacterial cell is fatal to the microorganism.
  • Bacterial Death: The disruption of the bacterial cell wall and the subsequent cell lysis result in the death of the bacteria. This prevents their ability to reproduce and multiply, effectively treating the bacterial infection.

Ampicillin Sodium Injection IP is particularly effective against a variety of gram-positive bacteria, such as Streptococcus and Enterococcus species, and some gram-negative bacteria, including Escherichia coli (E. coli) and Haemophilus influenzae. However, its effectiveness may vary depending on the specific strain of bacteria and their susceptibility to the antibiotic.

Benefits of Ampicillin Sodium Injection IP:

  • Effective Antibacterial Action: Ampicillin Sodium Injection IP is effective against a wide range of gram-positive and some gram-negative bacteria, making it valuable for treating various bacterial infections.
  • Treatment of Serious Infections: It can be used to treat serious bacterial infections such as meningitis, septicemia, endocarditis, and intra-abdominal infections.
  • Surgical Prophylaxis: Ampicillin Sodium Injection IP is used as prophylaxis to prevent postoperative infections in certain surgical procedures.
  • Neonatal Infections: It is used to treat or prevent bacterial infections in newborns, particularly respiratory and urinary tract infections.
  • High Susceptibility: Many bacteria are susceptible to ampicillin, and it is often effective even against strains that have not developed resistance to it.

Side Effects of Ampicillin Sodium Injection IP:

  • Allergic Reactions: Allergic reactions to ampicillin, such as skin rashes, itching, and hives, can occur. In rare cases, severe allergic reactions like anaphylaxis may occur, requiring immediate medical attention.
  • Gastrointestinal Disturbances: Common side effects include nausea, vomiting, diarrhea, and abdominal pain. These symptoms are usually mild and resolve with continued use or after treatment completion.
  • Superinfections: Ampicillin Sodium Injection IP can lead to the overgrowth of non-susceptible bacteria or fungi, causing superinfections such as oral or vaginal thrush (candidiasis).
  • Hypersensitivity Dermatitis: Some individuals may develop a skin condition known as maculopapular rash, often accompanied by fever, eosinophilia, and other systemic symptoms.
  • Liver Function Abnormalities: Elevated liver enzymes and, rarely, liver dysfunction have been reported in some cases.
  • Hematologic Changes: Rarely, ampicillin can lead to changes in blood cell counts, such as leukopenia (reduced white blood cell count) and thrombocytopenia (reduced platelet count).
  • Kidney Dysfunction: In rare instances, kidney function abnormalities, including interstitial nephritis, may occur.
  • Neurological Effects: High doses of ampicillin can rarely lead to neurological side effects, including confusion, seizures, and encephalopathy.
  • Clostridium difficile Infection: Prolonged use of ampicillin can disrupt the normal balance of gut bacteria and lead to the development of Clostridium difficile-associated diarrhea, which can be severe.

Frequently asked questions about Ampicillin Sodium Injection IP

  1. What is Ampicillin Sodium Injection IP used for?

Ampicillin Sodium Injection IP is used to treat a wide range of bacterial infections, including respiratory, urinary tract, skin, soft tissue, intraabdominal, and more severe infections like meningitis.

  1. How is Ampicillin Sodium Injection IP administered?

It is typically administered as an intravenous (IV) or intramuscular (IM) injection by a healthcare professional in a hospital or clinical setting.

  1. Can Ampicillin Sodium Injection IP be used for viral infections like the common cold or flu?

No, Ampicillin Sodium Injection IP is specifically used to treat bacterial infections and is not effective against viral infections.

  1. Are there any precautions or contraindications for using Ampicillin Sodium Injection IP?

Yes, individuals with a history of severe allergic reactions to penicillin or other betalactam antibiotics should not use Ampicillin Sodium Injection IP. It should also be used with caution in patients with kidney disease.

  1. How long should I take Ampicillin Sodium Injection IP?

The duration of treatment with Ampicillin Sodium Injection IP depends on the type and severity of the infection. It’s important to complete the full course of treatment as prescribed by your healthcare provider.

  1. What should I do if I miss a dose of Ampicillin Sodium Injection IP?

If you miss a dose, it’s important to inform your healthcare provider, who will determine the appropriate course of action. Do not double the dose to make up for a missed one.

  1. Are there any common side effects of Ampicillin Sodium Injection IP?

Common side effects may include nausea, vomiting, diarrhea, and skin rashes. These side effects are usually mild and temporary.

  1. Can Ampicillin Sodium Injection IP be used during pregnancy or while breastfeeding?

It should be used during pregnancy or breastfeeding only if the benefits outweigh the potential risks, and under the guidance of a healthcare provider.

  1. Can Ampicillin Sodium Injection IP be used in pediatric patients?

Yes, Ampicillin Sodium Injection IP can be used in pediatric patients, and the dosage is adjusted based on the child’s age, weight, and the severity of the infection.

  1. Can I drink alcohol while receiving treatment with Ampicillin Sodium Injection IP?

It is generally advisable to avoid alcohol while taking antibiotics, as alcohol can interact with certain medications and potentially decrease their effectiveness. Check with your healthcare provider for specific guidance.

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