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ROLIZITH 500

Product Packing: 10X3

Product Composition: Azithromycin 500 mg

Product Price: MRP : 742.13

ROLIZITH 500 Tablets

Azithromycin 500 mg Tablets

ROLIZITH 500 is a prescription antibacterial formulation containing Azithromycin 500 mg. Azithromycin is a macrolide antibacterial medicine used for selected susceptible bacterial infections according to approved indications and clinical assessment.

Azithromycin binds to the 50S subunit of the bacterial ribosome and inhibits protein synthesis in susceptible organisms. Antibiotic treatment should be based on an appropriate diagnosis and follow approved prescribing information, local susceptibility patterns and antimicrobial-stewardship principles.

Composition

Each tablet contains:

· Azithromycin - 250 mg

· Excipients - q.s.

Dosage form: Tablet

Pack size: 3 x 10 tablets

Uses of ROLIZITH 500

ROLIZITH 500 may be prescribed for selected bacterial infections caused by susceptible organisms where Azithromycin therapy is approved and clinically appropriate.

· Treatment of selected respiratory-tract bacterial infections according to approved prescribing information

· Treatment of selected ear, throat or sinus bacterial infections where Azithromycin is appropriate

· Treatment of selected skin, soft-tissue or other approved susceptible bacterial infections

· Other approved bacterial indications as determined by the treating clinician

Azithromycin does not treat viral infections such as the common cold or influenza. Unnecessary or inappropriate antibiotic use contributes to antimicrobial resistance.

How ROLIZITH 500 Works

ROLIZITH 500 contains Azithromycin, a macrolide antibacterial medicine:

Ribosomal binding: Azithromycin binds to the 23S rRNA of the 50S bacterial ribosomal subunit.

Protein-synthesis inhibition: This interferes with bacterial protein synthesis and limits growth of susceptible organisms.

Antibacterial activity: Effectiveness depends on the bacterial species and local susceptibility or resistance patterns.

Clinical response depends on the infection site, organism susceptibility, dose, treatment duration and individual patient factors.

Dose selection and treatment duration must follow the approved product label and prescribing clinician's advice.

Dosage and Direction for Use

Use ROLIZITH 500 exactly as prescribed. Dose, frequency and duration depend on the diagnosed infection, age, clinical setting and other patient factors.

Swallow the tablet with water and follow the approved product instructions regarding administration with or without food.

Complete the prescribed course unless the treating healthcare professional advises otherwise. Do not skip doses, repeat treatment without advice or share antibiotics.

Patients with significant liver disease, relevant cardiac risk or complex concomitant therapy require individualized professional assessment.

Possible Side Effects

Possible unwanted effects may include:

· Diarrhoea, nausea, abdominal pain, vomiting or indigestion

· Headache or dizziness in some individuals

· Skin rash, itching or other hypersensitivity reactions can occur

· Rare but serious reactions can include severe allergy, significant liver injury, serious skin reactions, hearing-related effects or cardiac rhythm disturbances including QT prolongation

· Seek urgent medical attention for breathing difficulty, facial swelling, severe rash, jaundice, fainting, significant palpitations or persistent or bloody diarrhoea.

Persistent or troublesome adverse effects should be discussed with the treating healthcare professional.

Precautions and Contraindications

Before using ROLIZITH 500, the prescriber should review macrolide allergy, liver history, cardiac rhythm risk and all concomitant medicines. Important precautions include:

· Do not use in patients with known hypersensitivity to Azithromycin, erythromycin, other macrolide or ketolide antibiotics, or formulation ingredients according to approved prescribing information.

· Use caution in patients with liver disease; clinically significant hepatic reactions can occur.

· Azithromycin can prolong the QT interval. Particular caution is required in patients with known QT prolongation, certain arrhythmias, electrolyte abnormalities or concomitant QT-prolonging medicines.

· Antibiotic-associated diarrhoea, including C. difficile-associated disease, can occur during or after antibacterial treatment.

· Use caution in patients with myasthenia gravis because macrolides may worsen symptoms in susceptible individuals.

· Pregnancy, breastfeeding, children, older adults and patients with significant chronic conditions require individualized professional guidance.

· Keep out of reach of children and store according to the approved pack instructions.

· Drug Interaction Considerations

· Azithromycin can have clinically relevant interactions with certain medicines, including drugs that prolong the QT interval, anticoagulants and some other therapies. Aluminium- or magnesium-containing antacids can affect peak concentrations when taken at the same time, depending on formulation and regimen.

· Patients should provide the prescriber with a complete list of prescription medicines, OTC products and supplements before starting antibiotic therapy.

Business Growth Opportunity with ROLIZITH 500

ROLIZITH 500 offers pharmaceutical distributors and healthcare entrepreneurs an opportunity to add an Azithromycin 500 mg prescription antibiotic tablet to their anti-infective product portfolio.

Antibacterial therapy is an established prescription healthcare segment. Promotion and use should support antimicrobial stewardship and remain strictly consistent with approved product information and applicable pharmaceutical regulations.

Key Business Advantages

· Single-ingredient macrolide antibacterial formulation

· Azithromycin 500 mg

· Established macrolide antibacterial molecule

· Convenient tablet dosage form

· Suitable addition to anti-infective and general prescription portfolios

· Opportunity for ethical, stewardship-conscious promotion through appropriate healthcare channels

PCD Pharma Franchise Opportunity for ROLIZITH 500

Ethics Medinova Private Limited offers PCD Pharma Franchise opportunities for ROLIZITH 500 in selected territories across India, subject to availability, applicable regulations and mutually agreed business terms.

Franchise partners may benefit from the company's product portfolio, promotional support, supply coordination and business assistance.

Franchise Support May Include

· Monopoly-based territory opportunities, subject to availability

· Promotional materials and visual aids

· Product information and marketing support

· Reliable supply coordination

· Access to a growing pharmaceutical product portfolio

· Professional partner assistance

Partner with Ethics Medinova to explore PCD Pharma Franchise opportunities for ROLIZITH 500 and other quality-focused healthcare products.

Third-Party Manufacturing Support for Azithromycin 500 mg Tablets

Ethics Medinova also supports eligible businesses exploring third-party manufacturing of formulations similar to ROLIZITH 500 under their own brand, subject to applicable licensing, prescription-drug, regulatory and manufacturing requirements.

Our third-party manufacturing support may include:

· Customized product and pack requirements, subject to regulatory feasibility

· Private-label manufacturing opportunities

· Customized packaging and branding support

· Product label and pack configuration assistance

· Manufacturing coordination through suitable licensed facilities

· Support for documentation and applicable regulatory requirements

This service may be suitable for eligible pharmaceutical companies and healthcare brands seeking to expand an anti-infective prescription product portfolio.

Frequently Asked Questions About ROLIZITH 500

1. What is ROLIZITH 500?

ROLIZITH 500 is a tablet formulation containing Azithromycin 500 mg.

2. What is ROLIZITH 500 used for?

It may be prescribed for selected susceptible bacterial infections where Azithromycin therapy is approved and clinically appropriate.

3. How should ROLIZITH 500 be taken?

Take ROLIZITH 500 exactly as prescribed by a qualified healthcare professional and complete the prescribed course unless advised otherwise.

4. Can ROLIZITH 500 be used for a common cold or flu?

No. Azithromycin is an antibiotic for susceptible bacterial infections and does not treat viral infections such as the common cold or influenza.

5. Can Azithromycin affect heart rhythm?

Yes. Azithromycin can prolong the QT interval in susceptible patients. Relevant cardiac history and interacting medicines should be reviewed by the prescriber.

6. Can Azithromycin cause diarrhoea?

Yes. Diarrhoea can occur. Severe, persistent or bloody diarrhoea requires prompt medical assessment because antibiotic-associated colitis is possible.

7. Is a PCD Pharma Franchise available for ROLIZITH 500?

Yes. Ethics Medinova offers PCD Pharma Franchise opportunities for selected products and territories, subject to availability, applicable regulations and mutually agreed terms.

8. Can this formulation be manufactured under my own brand?

Eligible businesses interested in a similar Azithromycin 500 mg tablet may explore third-party manufacturing and private-label support with Ethics Medinova, subject to applicable licensing and regulatory requirements.

Disclaimer

ROLIZITH 500 product information in this document is for general professional and business information. Exact approved indications, dosage, contraindications, warnings, interactions, susceptibility considerations, administration instructions, monitoring requirements, duration of use, excipients and regulatory status must be verified against the current approved product label and applicable prescribing information before prescribing, dispensing, use or promotion. Antibiotics should be used responsibly to support antimicrobial stewardship. This document is not a substitute for professional medical advice.

Dosage Form

Therapy Wise

ROLIZITH 500

ROLIZITH 500 Tablets

Azithromycin 500 mg Tablets

Composition

Pack size: 3 x 10 tablets

Azithromycin does not treat viral infections such as the common cold or influenza. Unnecessary or inappropriate antibiotic use contributes to antimicrobial resistance.

Antibacterial activity: Effectiveness depends on the bacterial species and local susceptibility or resistance patterns.

Complete the prescribed course unless the treating healthcare professional advises otherwise. Do not skip doses, repeat treatment without advice or share antibiotics.

· Seek urgent medical attention for breathing difficulty, facial swelling, severe rash, jaundice, fainting, significant palpitations or persistent or bloody diarrhoea.

· Keep out of reach of children and store according to the approved pack instructions.

· Patients should provide the prescriber with a complete list of prescription medicines, OTC products and supplements before starting antibiotic therapy.

Antibacterial therapy is an established prescription healthcare segment. Promotion and use should support antimicrobial stewardship and remain strictly consistent with approved product information and applicable pharmaceutical regulations.

· Opportunity for ethical, stewardship-conscious promotion through appropriate healthcare channels

Franchise partners may benefit from the company's product portfolio, promotional support, supply coordination and business assistance.

Partner with Ethics Medinova to explore PCD Pharma Franchise opportunities for ROLIZITH 500 and other quality-focused healthcare products.

This service may be suitable for eligible pharmaceutical companies and healthcare brands seeking to expand an anti-infective prescription product portfolio.

Frequently Asked Questions About ROLIZITH 500

ROLIZITH 500 is a tablet formulation containing Azithromycin 500 mg.

It may be prescribed for selected susceptible bacterial infections where Azithromycin therapy is approved and clinically appropriate.

Take ROLIZITH 500 exactly as prescribed by a qualified healthcare professional and complete the prescribed course unless advised otherwise.

No. Azithromycin is an antibiotic for susceptible bacterial infections and does not treat viral infections such as the common cold or influenza.

Yes. Azithromycin can prolong the QT interval in susceptible patients. Relevant cardiac history and interacting medicines should be reviewed by the prescriber.

Yes. Diarrhoea can occur. Severe, persistent or bloody diarrhoea requires prompt medical assessment because antibiotic-associated colitis is possible.

Yes. Ethics Medinova offers PCD Pharma Franchise opportunities for selected products and territories, subject to availability, applicable regulations and mutually agreed terms.

Eligible businesses interested in a similar Azithromycin 500 mg tablet may explore third-party manufacturing and private-label support with Ethics Medinova, subject to applicable licensing and regulatory requirements.

Dosage Form

Therapy Wise

ROLIZITH 500

ROLIZITH 500 Tablets

Azithromycin 500 mg Tablets

Composition

Pack size: 3 x 10 tablets

Azithromycin does not treat viral infections such as the common cold or influenza. Unnecessary or inappropriate antibiotic use contributes to antimicrobial resistance.

Antibacterial activity: Effectiveness depends on the bacterial species and local susceptibility or resistance patterns.

Complete the prescribed course unless the treating healthcare professional advises otherwise. Do not skip doses, repeat treatment without advice or share antibiotics.

· Seek urgent medical attention for breathing difficulty, facial swelling, severe rash, jaundice, fainting, significant palpitations or persistent or bloody diarrhoea.

· Keep out of reach of children and store according to the approved pack instructions.

· Patients should provide the prescriber with a complete list of prescription medicines, OTC products and supplements before starting antibiotic therapy.

Antibacterial therapy is an established prescription healthcare segment. Promotion and use should support antimicrobial stewardship and remain strictly consistent with approved product information and applicable pharmaceutical regulations.

· Opportunity for ethical, stewardship-conscious promotion through appropriate healthcare channels

Franchise partners may benefit from the company's product portfolio, promotional support, supply coordination and business assistance.

Partner with Ethics Medinova to explore PCD Pharma Franchise opportunities for ROLIZITH 500 and other quality-focused healthcare products.

This service may be suitable for eligible pharmaceutical companies and healthcare brands seeking to expand an anti-infective prescription product portfolio.

Frequently Asked Questions About ROLIZITH 500

ROLIZITH 500 is a tablet formulation containing Azithromycin 500 mg.

It may be prescribed for selected susceptible bacterial infections where Azithromycin therapy is approved and clinically appropriate.

Take ROLIZITH 500 exactly as prescribed by a qualified healthcare professional and complete the prescribed course unless advised otherwise.

No. Azithromycin is an antibiotic for susceptible bacterial infections and does not treat viral infections such as the common cold or influenza.

Yes. Azithromycin can prolong the QT interval in susceptible patients. Relevant cardiac history and interacting medicines should be reviewed by the prescriber.

Yes. Diarrhoea can occur. Severe, persistent or bloody diarrhoea requires prompt medical assessment because antibiotic-associated colitis is possible.

Yes. Ethics Medinova offers PCD Pharma Franchise opportunities for selected products and territories, subject to availability, applicable regulations and mutually agreed terms.

Eligible businesses interested in a similar Azithromycin 500 mg tablet may explore third-party manufacturing and private-label support with Ethics Medinova, subject to applicable licensing and regulatory requirements.

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