GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Azithromycin Tablets USP 250mg
B) Azithromycin Tablets USP 500mg
C) Azithromycin Tablets USP 600mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Azithromycin Tablets USP 250mg
Each Film-coated tablet contains:
Azithromycin Dihydrate USP
Eq. to Anhydrous Azithromycin USP ……250mg
Excipients ………………………………….…….……q. s
Colour: Titanium Dioxide USP

B) Azithromycin Tablets USP 500mg
Each Film-coated tablet contains:
Azithromycin Dihydrate USP
Eq. to Anhydrous Azithromycin USP ……500mg
Excipients ………………………………….…….……q. s
Colour: Iron oxide red


C) Azithromycin Tablets USP 600mg
Each Film-coated tablet contains:
Azithromycin Dihydrate USP
Eq. to Anhydrous Azithromycin USP ……600mg
Excipients ………………………………….…….……q. s
Colour: Iron oxide black

THERAPEUTIC INDICATIONS:

Azithromycin is used to treat certain bacterial infections, such as bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Take whole tablet with water.
Preserve in tight container.
A full course of antibiotic therapy in just 5 doses.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Azithromycin Tablets USP 500mg Technical Specification:

Product Name:Azithromycin Tablets USP 500mg
Brand Name:Zithromin
Strength:250mg, 500mg, 600mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 20s, 30s, 50s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-biotics
Indication: Azithromycin is used to treat certain bacterial infections, such as bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs
Storage:Store at 20° to 25°C (68° to 77°F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Azithromycin Tablets USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Azithromycin Tablets USP 500mg
    Each Film-coated tablet contains:
    Azithromycin Dihydrate USP
    Eq. to Anhydrous Azithromycin USP ……500mg
    Excipients ………………………………….…….……q. s
    Colour: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Azithromycin is used to treat certain bacterial infections, such as bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Take whole tablet with water.
Preserve in tight container.
A full course of antibiotic therapy in just 5 doses.
Read enclosed leaflet before use.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Why Taj Pharmaceuticals?

Taj Pharma emerges as the ideal choice for Azithromycin Tablets USP, driven by its unwavering commitment to quality and patient well-being. The company’s pharmaceuticals, including Azithromycin Tablets USP, are produced with cutting-edge technology and adhere to stringent quality standards, ensuring the safety and effectiveness of treatments. With proven formulations and a track record of success in treating various bacterial infections, Taj Pharma delivers reliability and consistency. Their global recognition and dedication to innovation have solidified their position as a trusted name in the healthcare industry. Taj Pharma’s patient-centric approach ensures exceptional customer service and a seamless experience, prioritizing the health and satisfaction of their customers. Choose Taj Pharma for your antibiotic needs, and experience pharmaceutical excellence and a commitment to your well-being. Taj Pharma’s commitment to excellence extends beyond the confines of the laboratory, encompassing affordability and accessibility. They believe that essential medications should be within reach for all individuals. Taj Pharma offers competitive pricing for Azithromycin Tablets USP without compromising on the quality, making it a cost-effective choice for those in need of effective antibiotic therapy.

Furthermore, Taj Pharma’s dedication to research and development ensures that their Azithromycin formulations stay at the forefront of medical advancements. Their focus on innovation leads to improved treatment outcomes and enhanced patient experiences. This commitment to continuous improvement sets Taj Pharma apart in the pharmaceutical industry. Taj Pharma’s Azithromycin Tablets USP embody a fusion of quality, reliability, affordability, and innovation. Their global reputation and patient-centric approach make them a trusted partner in healthcare, providing not just effective treatments but also a promise of well-being for those they serve. When it comes to antibiotic therapy, Taj Pharma’s legacy of pharmaceutical excellence shines through, making them a preferred choice for healthcare professionals and patients alike.

What is Azithromycin Tablets USP and its use?

Azithromycin Tablets USP refer to a medication containing the active ingredient Azithromycin that conforms to the United States Pharmacopeia (USP) standards. Azithromycin is an antibiotic used to treat a variety of bacterial infections. Here’s more information about Azithromycin Tablets USP and their common uses:

  • Antibiotic Medication: Azithromycin is classified as a macrolide antibiotic. It works by inhibiting the growth of or killing certain bacteria responsible for causing infections in the body.
  • Respiratory Tract Infections: Azithromycin is used to treat respiratory infections such as bronchitis, pneumonia, and sinusitis.
  • Ear and Throat Infections: It is effective in treating ear infections (otitis media) and throat infections (pharyngitis or strep throat).
  • Skin and Soft Tissue Infections: Azithromycin can be used for certain skin and soft tissue infections.
  • Sexually Transmitted Infections (STIs): It is often prescribed to treat STIs like chlamydia and gonorrhea.
  • Traveler’s Diarrhea: In some cases, Azithromycin is used to prevent or treat traveller’s diarrhea.
  • Mechanism of Action: Azithromycin works by interfering with the protein synthesis processes of bacteria. It binds to the bacterial ribosomes, preventing them from making essential proteins that are necessary for the bacteria’s survival and reproduction. This action ultimately leads to the inhibition of bacterial growth and the eradication of the infection.
  • Dosage and Administration: The dosage and duration of Azithromycin treatment can vary depending on the type and severity of the infection. It is usually taken orally as tablets, often with or without food. It’s essential to follow the prescribed dosage and complete the full course of treatment, even if symptoms improve before it’s finished.
  • Precautions and Side Effects: Azithromycin is generally well tolerated, but it can cause side effects in some individuals. Common side effects may include nausea, diarrhea, abdominal pain, and headache. It’s important to inform your healthcare provider of any allergies or medical conditions you have and any other medications you are taking, as interactions or contraindications can occur.

Azithromycin Tablets USP are a valuable tool in the fight against bacterial infections, but they should only be used under the guidance of a healthcare professional to ensure appropriate treatment and minimize the risk of antibiotic resistance. It’s crucial to complete the full prescribed course of antibiotics as directed to effectively treat the infection.

How does Azithromycin Tablets USP work?

Azithromycin Tablets USP work by interfering with the ability of bacteria to grow and multiply. Azithromycin, the active ingredient in these tablets, belongs to a class of antibiotics called macrolides. Here’s how Azithromycin works:

  • Inhibition of Protein Synthesis: Bacteria require proteins to grow and replicate. Azithromycin disrupts the bacterial protein synthesis process by binding to the ribosomes within the bacterial cells. Ribosomes are the cellular structures responsible for assembling proteins. When Azithromycin attaches to the ribosomes, it prevents them from effectively creating new proteins.
  • Inhibition of Bacterial Growth: By interfering with protein synthesis, Azithromycin effectively inhibits the growth and multiplication of bacteria. This means that bacteria are unable to produce the essential proteins they need to sustain themselves and reproduce.
  • Bacterial Death: As the bacterial cells are unable to function properly without the necessary proteins, they become weakened and eventually die. This action of Azithromycin leads to the elimination of the bacterial infection.
  • Specificity for Bacteria: Importantly, Azithromycin has a high degree of specificity for bacterial ribosomes and protein synthesis processes. It does not have the same inhibitory effect on human cells, which means it can selectively target and treat bacterial infections while sparing human cells.

Azithromycin Tablets USP are effective against a wide range of bacterial infections, making them a valuable tool in the treatment of conditions such as respiratory infections, ear and throat infections, skin infections, and sexually transmitted infections (STIs), among others. It’s important to use Azithromycin as directed by a healthcare professional, complete the full prescribed course of treatment, and follow any specific instructions provided to ensure effective treatment and minimize the risk of antibiotic resistance.

Benefits and Side effects of Azithromycin Tablets USP:

Azithromycin Tablets USP offer benefits in the treatment of bacterial infections, but like all medications, they can have potential side effects. Here’s an overview of the benefits and common side effects associated with Azithromycin Tablets USP:

Benefits:

  • Effective Against Various Infections: Azithromycin is effective in treating a wide range of bacterial infections, including respiratory tract infections (e.g., bronchitis, pneumonia), ear and throat infections, skin and soft tissue infections, and sexually transmitted infections (e.g., chlamydia and gonorrhea).
  • Convenience: Azithromycin is typically taken as a once-daily oral tablet for a relatively short duration, which can enhance patient compliance and convenience.
  • Broad Spectrum: Azithromycin has a broad spectrum of activity, which means it can target a variety of different bacteria, making it a versatile choice for treating infections.
  • Reduced Risk of Antibiotic Resistance: Azithromycin’s mechanism of action makes it less likely to induce antibiotic resistance compared to some other antibiotics.

Side Effects:

  • Gastrointestinal Disturbances: The most common side effects of Azithromycin Tablets USP involve the gastrointestinal system. These may include nausea, vomiting, diarrhea, and abdominal pain. Taking the medication with food can help reduce these side effects.
  • Headache: Some individuals may experience mild to moderate headaches while taking Azithromycin.
  • Allergic Reactions: Although rare, some people may develop allergic reactions to Azithromycin, which can include rash, itching, swelling, severe dizziness, and difficulty breathing. Seek immediate medical attention if you experience these symptoms.
  • Liver Function: In rare cases, Azithromycin can affect liver function, leading to elevated liver enzymes. Your healthcare provider may monitor your liver function during treatment.
  • Cardiovascular Effects: There have been reports of Azithromycin potentially affecting the electrical activity of the heart, leading to abnormal heart rhythms. This risk is higher in individuals with certain pre-existing heart conditions.

It’s essential to take Azithromycin as prescribed by your healthcare provider and to complete the full course of treatment, even if your symptoms improve before finishing the medication. This helps ensure that the infection is completely eradicated and reduces the risk of antibiotic resistance.

Before taking Azithromycin Tablets USP, inform your healthcare provider about any allergies, medical conditions, or medications you are currently taking. They can assess the potential benefits and risks and determine whether Azithromycin is the appropriate treatment for your specific condition. If you experience severe or persistent side effects, contact your healthcare provider promptly.

Frequently asked questions (FAQs) about Azithromycin Tablets USP:

  1. What is Azithromycin Tablets USP used for?

Azithromycin Tablets USP are used to treat a wide range of bacterial infections, including respiratory tract infections, ear and throat infections, skin and soft tissue infections, and certain sexually transmitted infections.

  1. How does Azithromycin work to treat infections?

Azithromycin works by inhibiting bacterial protein synthesis, which is essential for bacterial growth and reproduction. By disrupting this process, Azithromycin effectively kills or inhibits the growth of bacteria.

  1. Is Azithromycin effective against viral infections, like the common cold or flu?

No, Azithromycin is an antibiotic and is only effective against bacterial infections. It will not treat viral infections like the common cold or flu.

  1. Can I take Azithromycin if I’m allergic to other antibiotics?

It’s crucial to inform your healthcare provider about any allergies you have, especially to antibiotics. They can determine if Azithromycin is a suitable option or if an alternative medication is needed.

  1. How should I take Azithromycin Tablets USP?

Azithromycin is typically taken orally with or without food, as directed by your healthcare provider. Follow the prescribed dosage and complete the full course of treatment, even if you start feeling better before finishing the medication.

  1. Are there any interactions with other medications or substances?

Yes, Azithromycin can interact with certain medications. Inform your healthcare provider about all the medications, supplements, and herbal products you are taking to avoid potential interactions.

  1. What should I do if I miss a dose of Azithromycin?

If you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

  1. Are there any specific side effects to watch for?

While generally welltolerated, common side effects of Azithromycin may include gastrointestinal symptoms like nausea, diarrhea, and abdominal pain. Contact your healthcare provider if you experience severe or persistent side effects.

  1. Can I drink alcohol while taking Azithromycin?

It’s generally recommended to avoid alcohol while taking any medication, including Azithromycin. Alcohol can potentially interact with the medication and may exacerbate side effects.

  1. Can I use Azithromycin if I’m pregnant or breastfeeding?

It’s important to consult with your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding before using Azithromycin. They can assess the potential benefits and risks for your specific situation.

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

Azithromycin Tablets 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 Azithromycin Tablets 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