GENERIC NAME OF MEDICINAL PRODUCT:

A. Azithromycin for Injection 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Azithromycin for Injection 500mg
a) Each vial contains:
Azithromycin IP
Eq to Anhydroyus Azithromycin ……..500mg
Excipients………………………………………q.s
b) This pack is also contains:
Sterile Water for Injection IP…….5ml

THERAPEUTIC INDICATION:

Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV). Azithromycin belongs to the class of drugs known as macrolide antibiotics.

DIRECTION OF USE:

Reconstitute with 4.8ml of Sterile Water for Injection IP. Reconstituted the contents with prior diluent and reconstituted solution should be used immediately. Not to be stored.
For details of sterile water for Injection I.P. refer ampule label.

CAUTION AND SCHEDULE:

CAUTION:
• If any particles are visible in the vial after dissolving the contents, please do not use the solution and ask for replacement.
• Must be further diluted before use.
• Even visible damage to vial caused during transit, storage or handling may result into contamination.
• Reconstituted solution should be use immediately after preparation.
• KEEP OUT OF REACH AND SIGHT OF CHILDREN.
• FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE 'H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

Storage: Store below 25℃.
Store in a cool, dry and dark place.
Protect from light and moisture.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Azithromycin for Injection 500mg Technical Specification:

Product Name:Azithromycin for Injection
Brand Name:Generic
Strength:500mg/Vial
Dosage Form:Lyophilized Powder for Injection
Packing:1 Sterile Single Dose Vial + WFI Tray
Route of Administration:For I.V. Infusion only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Antibacterials, Anti-Infectives, Antibiotic (macrolide)
Indication: Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV). Azithromycin belongs to the class of drugs known as macrolide antibiotics.
Storage:Store below 25℃. Store in a cool, dry and dark place. Protect from light and moisture.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Azithromycin for Injection 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Azithromycin for Injection 500mg
    a. Each vial contains:
    Azithromycin IP
    Eq to Anhydroyus Azithromycin ……..500mg
    Excipients………………………………………q.s
    b. This pack is also contains:
    Sterile Water for Injection IP…….5ml

THERAPEUTIC INDICATION:

Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV). Azithromycin belongs to the class of drugs known as macrolide antibiotics.

DIRECTION OF USE:

Reconstitute with 4.8ml of Sterile Water for Injection IP. Reconstituted the contents with prior diluent and reconstituted solution should be used immediately. Not to be stored.
For details of sterile water for Injection I.P. refer ampule label.

CAUTION AND SCHEDULE:

CAUTION:

  • If any particles are visible in the vial after dissolving the contents, please do not use the solution and ask for replacement.
  • Must be further diluted before use.
  • Even visible damage to vial caused during transit, storage or handling may result into contamination.
  • Reconstituted solution should be use immediately after preparation.
  • KEEP OUT OF REACH AND SIGHT OF CHILDREN.
  • FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

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

STORAGE AND DOSAGE:

STORAGE: Store below 25℃.
Store in a cool, dry and dark place.
Protect from light and moisture.
Keep all medicines out of reach of children.

DOSAGE: As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharma is a leading provider of Azithromycin for Injection, known for its unwavering commitment to quality and global accessibility. With a strong reputation in the pharmaceutical industry, Taj Pharma ensures consistent and reliable production of this vital antibiotic. Beyond product quality, they offer support services and cost-effective solutions, making Azithromycin for Injection accessible to healthcare professionals and patients worldwide. Taj Pharma is the trusted choice for addressing bacterial infections effectively and efficiently. Discover why Taj Pharma is the preferred choice for Azithromycin for Injection. Explore their commitment to quality, accessibility, and reputation in providing this essential antibiotic medication for a wide range of bacterial infections, backed by rigorous manufacturing standards and global availability.

What is Azithromycin for Injection and its uses?

Azithromycin for Injection is a medication that contains the active ingredient Azithromycin, which is a broad-spectrum antibiotic belonging to the macrolide class. It is used for the treatment of various bacterial infections when oral administration may not be suitable or when a more immediate and higher concentration of the drug is required. Here are its primary uses:

Uses of Azithromycin for Injection:

  • Respiratory Tract Infections: Azithromycin for Injection is often used to treat respiratory tract infections, including pneumonia, bronchitis, and sinusitis, caused by susceptible bacteria.
  • Skin and Soft Tissue Infections: It can be used to treat skin and soft tissue infections like cellulitis, impetigo, and erysipelas.
  • Genital and Urinary Tract Infections: Azithromycin is effective against certain sexually transmitted infections (STIs), such as chlamydia and gonorrhea, as well as urinary tract infections (UTIs).
  • Ear Infections: It may be prescribed for ear infections, particularly in cases where the infection has not responded to other antibiotics.
  • Community-Acquired Pneumonia: Azithromycin is sometimes used as a treatment option for community-acquired pneumonia, especially in cases where atypical pathogens are suspected.
  • Preventive Measures: In some cases, Azithromycin for Injection is used as a preventive measure against certain bacterial infections in individuals at risk, such as those with weakened immune systems or undergoing certain surgical procedures.
  • Other Infections: This antibiotic may also be considered for the treatment of other bacterial infections when appropriate, as determined by a healthcare provider.

Azithromycin works by inhibiting the growth of bacteria and interfering with their ability to replicate and spread within the body. It is available in various forms, including oral tablets, oral suspensions, and intravenous (IV) or intramuscular (IM) injections. The choice of administration route depends on the specific infection being treated and the patient’s condition. It’s essential to take Azithromycin as prescribed by a healthcare provider and to complete the full course of treatment, even if symptoms improve before the medication is finished, to ensure the infection is fully eradicated.

How do Azithromycin for Injection work?

Azithromycin for Injection contains the active ingredient Azithromycin, which is a macrolide antibiotic. It works by interfering with the growth and reproduction of bacteria, ultimately leading to their elimination. Here’s how Azithromycin for Injection works:

  • Inhibition of Protein Synthesis: Azithromycin primarily targets bacterial protein synthesis. Within bacterial cells, there are structures called ribosomes responsible for building proteins essential for the bacteria’s survival and replication. Azithromycin binds to the ribosomes and inhibits their function, preventing the bacteria from producing essential proteins.
  • Bacteriostatic or Bactericidal Action: Azithromycin’s effect on protein synthesis can be either bacteriostatic or bactericidal, depending on the concentration of the drug and the susceptibility of the bacteria. In lower concentrations, it inhibits bacterial growth (bacteriostatic), while in higher concentrations or with more susceptible bacteria, it can lead to bacterial cell death (bactericidal).
  • Interference with Replication: By disrupting protein synthesis, Azithromycin also interferes with the bacteria’s ability to replicate and reproduce. This halts the spread of the infection and reduces the bacterial load in the body.
  • Anti-Inflammatory Properties: Azithromycin has been found to possess anti-inflammatory properties beyond its antibiotic action. This can be particularly useful in the treatment of certain respiratory infections, where it can help reduce inflammation in addition to targeting the underlying bacterial infection.
  • Duration of Action: One of the unique features of Azithromycin is its extended duration of action. A single dose or a short course of treatment can be effective for several days due to Azithromycin’s long half-life. This convenience is advantageous for patients with certain infections.

It’s important to note that Azithromycin is effective against a wide range of bacteria, including some atypical pathogens that other antibiotics may not target effectively. However, like all antibiotics, it should be used only as prescribed by a healthcare provider, and the full course of treatment should be completed to ensure the infection is completely eradicated. Overuse or misuse of antibiotics can lead to antibiotic resistance, where bacteria become less responsive to treatment.

Benefits of Azithromycin for Injection:

  • Broad-Spectrum Antibacterial Action: Azithromycin for Injection is effective against a wide range of bacterial infections, making it a versatile antibiotic for treating various conditions.
  • Convenient Dosage Form: The injectable form of Azithromycin allows for rapid delivery of the medication, making it suitable for patients who cannot take oral antibiotics or when immediate treatment is required.
  • Extended Duration of Action: Azithromycin has a long half-life, which means that a single dose or a short course of treatment can remain effective for several days. This can improve treatment adherence and convenience.
  • Effectiveness Against Atypical Pathogens: Azithromycin is known for its efficacy against atypical bacteria that may cause respiratory and other infections. This makes it valuable in treating certain cases where other antibiotics may not be as effective.
  • Reduced Inflammation: In addition to its antibacterial properties, Azithromycin has anti-inflammatory effects. This can be beneficial in conditions where inflammation plays a significant role, such as certain respiratory infections.

Side Effects of Azithromycin for Injection:

  • Gastrointestinal Distress: Common side effects can include stomach upset, nausea, vomiting, diarrhea, and abdominal pain. These symptoms are generally mild and transient.
  • Allergic Reactions: In rare cases, individuals may experience allergic reactions to Azithromycin, which can manifest as skin rash, itching, swelling, or difficulty breathing. Seek immediate medical attention if these symptoms occur.
  • Cardiovascular Risks: There have been reports of rare but serious cardiovascular side effects, including irregular heart rhythms (arrhythmias) and QT interval prolongation, especially in patients with certain pre-existing conditions or those taking medications that can interact with Azithromycin.
  • Liver Function: Azithromycin may cause transient increases in liver enzyme levels, but severe liver problems are rare. Individuals with liver disease should use this medication with caution and under medical supervision.
  • Kidney Function: There have been reports of kidney issues, including acute kidney injury, associated with Azithromycin use, particularly in high doses or with prolonged treatment.
  • Antibiotic Resistance: Overuse or misuse of Azithromycin and other antibiotics can contribute to antibiotic resistance, where bacteria become less responsive to treatment.
  • Other Side Effects: Some patients may experience headaches, dizziness, changes in taste, and hearing disturbances, although these are less common.

It’s important to use Azithromycin for Injection only as prescribed by a healthcare provider and to inform your healthcare provider of any existing medical conditions or medications you are taking to minimize the risk of side effects or interactions. If you experience severe or unusual side effects, seek prompt medical attention.

Frequently Asked Questions About Azithromycin for Injection?

Certainly, here are some frequently asked questions (FAQs) about Azithromycin for Injection:

  1. What is Azithromycin for Injection, and what conditions does it treat?

Azithromycin for Injection is a medication containing the antibiotic Azithromycin. It is used to treat a wide range of bacterial infections, including respiratory tract infections, skin and soft tissue infections, sexually transmitted infections, and more.

  1. How is Azithromycin for Injection administered?

Azithromycin for Injection is administered via intravenous (IV) or intramuscular (IM) injection by a healthcare professional. The choice of administration route depends on the specific infection and the patient’s condition.

  1. Is Azithromycin for Injection suitable for children?

Azithromycin for Injection can be used in pediatric patients, but the dosage and administration should be determined by a healthcare provider based on the child’s age, weight, and the nature of the infection.

  1. How quickly does Azithromycin for Injection work?

The onset of action varies depending on the infection being treated. Azithromycin for Injection starts to work shortly after administration, but it may take a day or more to experience symptom relief.

  1. Can Azithromycin for Injection be used during pregnancy or while breastfeeding?

Pregnant or breastfeeding individuals should consult their healthcare provider before using Azithromycin for Injection to assess the potential benefits and risks and determine the most appropriate treatment options.

  1. What are the common side effects of Azithromycin for Injection?

Common side effects can include gastrointestinal symptoms like nausea, vomiting, diarrhea, and abdominal pain. Other potential side effects may include headaches and dizziness.

  1. Are there any serious side effects associated with Azithromycin for Injection?

Yes, Azithromycin for Injection may have rare but serious side effects, including cardiovascular effects like irregular heart rhythms, liver and kidney issues, and allergic reactions. Any severe or unusual symptoms should be reported to a healthcare provider.

  1. Can Azithromycin for Injection interact with other medications?

Azithromycin can interact with certain medications, so it’s essential to inform your healthcare provider about all medications and supplements you are taking to avoid potential interactions.

  1. Is Azithromycin for Injection effective against all types of infections?

Azithromycin is effective against a wide range of bacterial infections, but it may not be suitable for all cases. The choice of antibiotic depends on the type of bacteria causing the infection and its susceptibility to Azithromycin.

  1. Is it necessary to complete the full course of Azithromycin for Injection, even if symptoms improve?

Yes, it is crucial to complete the full course of Azithromycin for Injection as prescribed by your healthcare provider to ensure that the infection is fully treated and to reduce the risk of antibiotic resistance.

These FAQs provide general information about Azithromycin for Injection, but individual recommendations and usage may vary. Always consult with a healthcare provider for personalized advice and guidance on the use of this antibiotic and its potential benefits and risks.

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

Azithromycin 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 Azithromycin 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