Description

Indication & Scope

Roxithromycin Tablets are a prescription macrolide antibacterial indicated for the treatment of susceptible bacterial infections, including pharyngitis, tonsillitis, sinusitis, otitis media, acute bronchitis, acute exacerbations of chronic bronchitis, community-acquired pneumonia caused by atypical pathogens, skin and soft tissue infections, and non-gonococcal urethritis or cervicitis caused by Chlamydia trachomatis.

Mechanism: Roxithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby suppressing bacterial growth.
Drug class: Second-generation macrolide antibiotic.
Clinical use: Treatment of susceptible respiratory tract infections, skin and soft tissue infections, and Chlamydia trachomatis urogenital infections, particularly in patients requiring an oral macrolide.

Specification

Generic Name	Roxithromycin Tablets
Brand Name	OuYi Pharma®
Ingredient	Roxithromycin
Dosage Form	Tablet
Package	0.15 g/tablet, 24 tablets/box
Conditions Treated	Respiratory tract infections, skin and soft tissue infections, and non-gonococcal urethritis/cervicitis caused by susceptible organisms
Taboos	Hypersensitivity to roxithromycin, erythromycin or other macrolides; concomitant use with ergot alkaloids
Place of origin	China
Prescription type	Prescription Drug (Rx)
Storage Conditions	Store below 25°C in a dry place, protected from moisture and light.
Manufacturer	CSPC Ouyi Pharmaceutical Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA), China
Approval Number	H20056309
Approval Date	June 25, 2024
Shelf Life	24 months

How to use ?

Recommended Dose: Adults: 150 mg twice daily or 300 mg once daily, preferably taken on an empty stomach.

Time: Usually administered for 5–12 days. Streptococcal infections should be treated for at least 10 days.

Instructions for use: Swallow the tablets whole with water before meals. Complete the full prescribed treatment course even if symptoms improve.

Interaction: Avoid concomitant use with ergot alkaloids. Use cautiously with digoxin, warfarin, cyclosporine, and other QT-prolonging medicines.

Side effects: Common adverse reactions include nausea, abdominal discomfort, diarrhea, vomiting, headache, dizziness, rash, transient liver enzyme elevation, and rarely severe allergic reactions or QT prolongation.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What infections can Roxithromycin Tablets treat?

They are indicated for susceptible respiratory tract infections, skin and soft tissue infections, and Chlamydia trachomatis non-gonococcal urethritis or cervicitis.

Should the tablets be taken before or after meals?

They are generally recommended to be taken on an empty stomach, about 15–30 minutes before meals, for optimal absorption.

Can patients allergic to penicillin use roxithromycin?

Roxithromycin is commonly used as an alternative for certain susceptible infections in patients with penicillin allergy, provided there is no macrolide allergy.

Can treatment be stopped once symptoms improve?

No. Patients should complete the entire prescribed course to reduce the risk of treatment failure and bacterial resistance.