GENERIC NAME OF MEDICINAL PRODUCT:

(A) Imipenem and Cilastatin Injection USP 1gm
(B) Imipenem and Cilastatin Injection USP 2gm
(C) Imipenem and Cilastatin Injection USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Imipenem and Cilastatin Injection USP 1gm
a) Each vial contains:
(Sterile) Imipenem IP
Eq. to Anhydrous Imipenem…………… 500mg
(Sterile) Cilastatin sodium IP
Eq. to Cilastatin ……………………….…….500mg
(Sterile) Sodium Bicarbonate IP
Added as a Buffer
b) Sterile Water for Injection IP…………10ml


2. Imipenem and Cilastatin Injection USP 2gm
a) Each vial contains:
(Sterile) Imipenem IP
Eq. to Anhydrous Imipenem…………… 1gm
(Sterile) Cilastatin sodium IP
Eq. to Cilastatin ……………………….…….1gm
(Sterile) Sodium Bicarbonate IP
Added as a Buffer
b) Sterile Water for Injection IP…………20ml

3. Imipenem and Cilastatin Injection USP 500mg
a) Each vial contains:
(Sterile) Imipenem IP
Eq. to Anhydrous Imipenem…………… 250mg
(Sterile) Cilastatin sodium IP
Eq. to Cilastatin ……………………….…….250mg
(Sterile) Sodium Bicarbonate IP
Added as a Buffer
b) Sterile Water for Injection IP…………10ml

THERAPEUTIC INDICATION:

Imipenem and cilastatin injection are used to treat certain serious infections that are caused by bacteria, including endocarditis and respiratory tract, urinary tract, abdominal, gynecological, blood, skin, bone, and joint infections.

DIRECTION OF USE:

Reconstitute with 10ml sterile water for Injection IP. Reconstituted should be used immediately after the preparation.
Read the enclosed leaflet before reconstitution & use.

CAUTION & SCHEDULE:

CAUTION: If any particle is visible in the vial after dissolving the contents, please do not use the solution & return the vial for replacement.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE H1 PRESCRIPTION DRUG: It is dangerous to take this preparation except in accordance with the medical advice.
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.
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.

Imipenem & Cilastatin Injection USP 1gm Technical Specification:

Product Name:Imipenem & Cilastatin Injection USP 1gm
Brand Name:(PIPRANEM)
Strength:1gm, 2gm, 500mg
Dosage Form:Dry Powder Injection (Sterile)
Packing:Vial + WFI in Tray
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:β-lactam Antibiotic, Anti-bacterial & Carbapenem.
Indication: Endocarditis, respiratory tract, urinary tract, abdominal, gynecological, blood, skin, bone, and joint infections
Storage:Store below 25°C. Protect from light & moisture.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Imipenem & Cilastatin Injection USP 1gm (PIPRANEM)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Imipenem & Cilastatin Injection USP 1gm
    Each vial contains:
    (Sterile) Imipenem IP
    Eq. to Anhydrous Imipenem…………… 500mg
    (Sterile) Cilastatin sodium IP
    Eq. to Cilastatin ……………………….…….500mg
    (Sterile) Sodium Bicarbonate IP
    Added as a Buffer
    Sterile Water for Injection IP…………10ml

THERAPEUTIC INDICATION:

Imipenem and cilastatin injections are used to treat certain serious infections that are caused by bacteria, including endocarditis and respiratory tract, urinary tract, abdominal, gynecological, blood, skin, bone, and joint infections.

DIRECTION OF USE:

Reconstitute with 10ml sterile water for Injection IP. Reconstituted should be used immediately after the preparation. Read the enclosed leaflet before reconstitution & use.

CAUTION & SCHEDULE:

CAUTION: If any particle is visible in the vial after dissolving the contents, please do not use the solution & return the vial for replacement.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

SCHEDULE H1 PRESCRIPTION DRUG: It is dangerous to take this preparation except in accordance with medical advice.
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.
KEEP OUT OF REACH OF CHILDREN.

DOSAGE: As directed by the Physician.

Why Taj Pharmaceuticals?

When considering a pharmaceutical company for medications like Imipenem and Cilastatin Injection, several crucial factors should guide the decision-making process. Taj Pharmaceuticals, an Indian-based pharmaceutical company, is one potential option, but the selection should be based on a thorough evaluation of various key considerations. First and foremost, the quality and regulatory compliance of the pharmaceutical company are paramount. Ensuring that Taj Pharmaceuticals maintains stringent manufacturing standards and adheres to regulatory guidelines is essential, especially for medications like Imipenem and Cilastatin Injection, which are used to treat serious bacterial infections. High-quality manufacturing is vital for the effectiveness and safety of the medication. Imipenem and Cilastatin Injection are prescription medications typically used to treat severe bacterial infections. Consequently, the choice of manufacturer should align with the recommendations and prescription provided by your healthcare provider. Given the seriousness of the conditions these medications treat, it is imperative to trust the quality and reliability of the manufacturer. Affordability and accessibility are significant considerations when evaluating pharmaceutical companies. Medication costs can vary, and understanding your budget and insurance coverage is essential in determining the most cost-effective option for obtaining Imipenem and Cilastatin Injection. Reliability in medication supply is crucial, particularly for individuals with bacterial infections requiring prompt treatment. Ensuring that the chosen pharmaceutical company, such as Taj Pharmaceuticals, maintains a dependable supply chain is essential for timely access to Imipenem and Cilastatin Injection when needed most. While patient reviews and feedback may not always be readily available for medications like Imipenem and Cilastatin, they can provide valuable insights into the experiences of individuals who have used a specific brand or manufacturer’s product. However, it’s essential to consider these insights in conjunction with guidance from healthcare providers. Ultimately, the decision regarding which pharmaceutical company to choose for Imipenem and Cilastatin Injection should be made in consultation with your healthcare provider. They can consider your unique medical history, the specific bacterial infection being treated, and your response to the medication when recommending a particular brand or manufacturer. In conclusion, when selecting a pharmaceutical company for Imipenem and Cilastatin Injection, it’s crucial to weigh factors such as quality, prescription guidance, cost, accessibility, and consultation with healthcare providers. This comprehensive approach ensures that you receive the most appropriate and effective treatment for your specific bacterial infection while prioritizing safety and efficacy.

What is Imipenem and Cilastatin Injection and its uses?

Imipenem and Cilastatin Injection is a combination medication used to treat serious bacterial infections. It consists of two active ingredients: imipenem and cilastatin, which are administered together to enhance the therapeutic effect of imipenem. Here’s an overview of Imipenem and Cilastatin Injection and its uses:

Imipenem and Cilastatin Injection: Imipenem is a carbapenem antibiotic that is effective against a broad spectrum of bacteria, including both gram-positive and gram-negative bacteria. It works by inhibiting the synthesis of bacterial cell walls, ultimately leading to the death of the bacteria. Cilastatin is a medication that is often combined with imipenem. It does not have antibacterial properties itself but serves to prevent the breakdown of imipenem in the kidneys, allowing imipenem to remain effective in the body for a longer duration.

Uses of Imipenem and Cilastatin Injection:

Imipenem and Cilastatin Injection is primarily used to treat severe bacterial infections in hospital settings. It is reserved for situations where other antibiotics may not be effective, and the infections are potentially life-threatening. Common uses include:

  • Intra-Abdominal Infections: Imipenem and Cilastatin Injection can be used to treat intra-abdominal infections, including peritonitis (inflammation of the lining of the abdomen) and infections of the abdominal organs.
  • Lower Respiratory Tract Infections: It is effective against severe lower respiratory tract infections, such as pneumonia, especially when caused by multidrug-resistant bacteria.
  • Skin and Soft Tissue Infections: Imipenem and Cilastatin Injection may be used for serious skin and soft tissue infections, including cellulitis and necrotizing fasciitis.
  • Urinary Tract Infections: In some cases, it may be employed to treat complicated urinary tract infections, particularly when caused by antibiotic-resistant bacteria.
  • Bacterial Septicemia: Imipenem and Cilastatin Injection can be used in the treatment of septicemia, a bloodstream infection often associated with severe illness.
  • Gynecological Infections: It may also be utilized for serious gynecological infections, such as pelvic inflammatory disease (PID).

It’s important to note that Imipenem and Cilastatin Injection is typically administered in a healthcare setting, such as a hospital, under the supervision of a healthcare provider. The choice of antibiotic, including this combination medication, is determined by the specific bacterial infection, its severity, and the results of culture and sensitivity tests. This medication is considered a last resort or reserved for situations where other antibiotics have failed or are inappropriate due to drug resistance. The dosage and duration of treatment are carefully determined by healthcare providers based on individual patient factors and the nature of the infection. Imipenem and Cilastatin Injection is not suitable for treating viral infections, such as the common cold or flu. It should only be used for bacterial infections as prescribed by a healthcare provider.

How do Imipenem and Cilastatin Injection work?

Imipenem and Cilastatin Injection work together to combat bacterial infections effectively. Here’s how they work:

Imipenem: Imipenem is a carbapenem antibiotic with a broad spectrum of activity against various bacteria, both gram-positive and gram-negative. It works by disrupting the formation of bacterial cell walls, which are essential for the structural integrity and protection of bacteria.

  • Inhibition of Cell Wall Synthesis: Bacterial cell walls are made up of a substance called peptidoglycan. Imipenem interferes with the synthesis of peptidoglycan, a critical component of the bacterial cell wall.
  • Weakening the Cell Wall: As imipenem disrupts cell wall formation, it weakens the structural integrity of the bacterial cell wall. This weakening causes the bacterial cell to become more susceptible to the internal pressure and eventually leads to cell lysis (bursting).
  • Bacterial Death: The weakening of the cell wall, along with the loss of osmotic stability, ultimately results in the death of the bacterial cell. This is a bactericidal (killing) effect, making imipenem highly effective against a wide range of bacterial species.

Cilastatin: Cilastatin is an inhibitor of the renal (kidney) enzyme dehydropeptidase I. While cilastatin does not possess antibacterial properties itself, it plays a crucial role in combination with imipenem.

  • Protection of Imipenem: Imipenem is susceptible to degradation by the enzyme dehydropeptidase I, which is present in the kidneys. Cilastatin inhibits this enzyme, preventing the breakdown of imipenem in the kidneys.
  • Prolonged Imipenem Activity: By protecting imipenem from renal degradation, cilastatin helps maintain therapeutic levels of imipenem in the bloodstream and throughout the body for an extended period. This allows imipenem to remain effective in combating bacterial infections.

The combination of imipenem and cilastatin enhances the antibacterial activity of imipenem and ensures its prolonged presence in the body, allowing it to effectively target and eliminate a wide range of bacterial infections. This combination medication is especially valuable for treating severe bacterial infections in hospital settings, particularly those caused by multidrug-resistant bacteria. Imipenem and Cilastatin Injection is administered intravenously by healthcare providers and is reserved for situations where other antibiotics may not be effective or where rapid and potent treatment is required. The choice of this medication is based on the specific bacterial infection, its severity, and the results of laboratory tests. It should be used as prescribed by a healthcare provider to ensure optimal therapeutic outcomes and minimize the development of antibiotic resistance.

Benefits of Imipenem & Cilastatin Injection:

  • Broad-Spectrum Antibiotic: Imipenem and Cilastatin Injection is effective against a wide range of bacteria, both gram-positive and gram-negative. This broad spectrum makes it valuable in treating various types of severe bacterial infections.
  • Treatment of Multidrug-Resistant Infections: It is particularly useful in cases where bacteria have developed resistance to other antibiotics. Imipenem can be effective against many drug-resistant strains of bacteria.
  • Rapid Onset of Action: Imipenem begins to exert its antibacterial effects quickly, making it suitable for treating serious infections that require prompt intervention.
  • Effective in Hospital-Acquired Infections: It is commonly used to treat hospital-acquired infections, where bacteria may be more resistant to standard antibiotics.
  • Combination with Cilastatin: Cilastatin, when combined with imipenem, protects the imipenem from degradation in the kidneys, allowing for a longer duration of action and improved effectiveness.
  • Versatile Uses: Imipenem and Cilastatin Injection can be used to treat various types of infections, including intra-abdominal infections, lower respiratory tract infections, skin and soft tissue infections, and more.

Common Side Effects of Imipenem & Cilastatin Injection:

  • Gastrointestinal Disturbances: Nausea, vomiting, diarrhea, and abdominal pain are common side effects. Taking the medication with food can help alleviate these symptoms.
  • Skin Reactions: Skin rash and itching may occur, although severe allergic reactions are rare.
  • Injection Site Reactions: Pain, redness, and swelling at the injection site are possible side effects.
  • Central Nervous System Effects: Headache, confusion, and seizures have been reported in some cases, especially when high doses are administered or in individuals with predisposing factors.
  • Changes in Blood Tests: Imipenem and Cilastatin Injection can affect blood test results, including liver and kidney function tests. Regular monitoring is often necessary during treatment.
  • Hypersensitivity Reactions: While uncommon, severe allergic reactions to imipenem and cilastatin can occur. These may include skin rash, swelling, difficulty breathing, and anaphylaxis. If any signs of an allergic reaction occur, immediate medical attention is required.

It’s important to note that the benefits of Imipenem & Cilastatin Injection often outweigh the risks of side effects, especially when used to treat serious bacterial infections that are unresponsive to other antibiotics. The medication should only be administered under the supervision of healthcare providers in a hospital setting. Individual responses to medications can vary, and not everyone will experience these side effects. Healthcare providers carefully consider the potential risks and benefits of using Imipenem & Cilastatin Injection and monitor patients for adverse reactions during treatment. Patients should report any unusual or severe side effects to their healthcare provider, and it’s crucial to follow the prescribed treatment plan and complete the full course of medication to ensure the most effective treatment and minimize the development of antibiotic resistance.

Frequently Asked Questions About Imipenem & Cilastatin Injection?

Certainly, here are some frequently asked questions (FAQs) about Imipenem & Cilastatin Injection:

  1. What is Imipenem & Cilastatin Injection, and what is it used for?

Imipenem & Cilastatin Injection is a combination medication used to treat severe bacterial infections. It consists of imipenem, an antibiotic, and cilastatin, which enhances the effectiveness of imipenem.

  1. How does Imipenem & Cilastatin Injection work?

Imipenem works by disrupting the formation of bacterial cell walls, leading to bacterial cell death. Cilastatin helps protect imipenem from degradation in the kidneys, allowing it to remain effective in the body for a longer duration.

  1. What types of bacterial infections can be treated with Imipenem & Cilastatin Injection?

Imipenem & Cilastatin Injection is used to treat a wide range of bacterial infections, including intraabdominal infections, lower respiratory tract infections, skin and soft tissue infections, and hospital acquired infections caused by multidrug resistant bacteria.

  1. Is Imipenem & Cilastatin Injection effective against antibiotic resistant bacteria?

Yes, Imipenem & Cilastatin Injection is often effective against multidrug resistant bacterial strains, making it valuable in cases where other antibiotics may not work.

  1. How is Imipenem & Cilastatin Injection administered?

Imipenem & Cilastatin Injection is administered intravenously (IV) by healthcare providers in a hospital or clinical setting. The dosage and duration of treatment are determined by the specific infection and individual patient factors.

  1. What are the common side effects of Imipenem & Cilastatin Injection?

Common side effects may include gastrointestinal symptoms (nausea, vomiting, diarrhea), skin rash, injection site reactions, and changes in blood test results. Central nervous system effects, such as headache or confusion, can also occur.

  1. Is it safe to use Imipenem & Cilastatin Injection during pregnancy or while breastfeeding?

The use of Imipenem & Cilastatin Injection during pregnancy or breastfeeding should be discussed with a healthcare provider, weighing the potential benefits and risks.

  1. Are there any drug interactions with Imipenem & Cilastatin Injection?

Imipenem & Cilastatin Injection may interact with other medications, so it’s important to inform your healthcare provider about all medications and supplements you are taking.

  1. Can I stop taking Imipenem & Cilastatin Injection once I start feeling better?

No, it’s essential to complete the full course of treatment as prescribed by your healthcare provider, even if your symptoms improve. Stopping early could result in the infection not being fully treated or lead to antibiotic resistance.

  1. Is Imipenem & Cilastatin Injection effective against viral infections?

No, Imipenem & Cilastatin Injection is specifically designed to treat bacterial infections and is not effective against viral infections like the common cold or flu.

These FAQs provide general information about Imipenem & Cilastatin Injection, but individual responses to medications can vary. Patients should consult with their healthcare provider for personalized guidance and information based on their specific medical condition and treatment plan.

As Imipenem & Cilastatin Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Imipenem & Cilastatin 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

Imipenem & Cilastatin 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 Imipenem & Cilastatin 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