01 Roxithromycin Ambroxol Hydrochloride Tablets English InstructionsROXISARA AM Composition Each tablet of Roxisara AM contains roxithromycin 150 mg and ambroxol hydrochloride 30mg Description Roxit

rtussis, and Chlamydia trachomatis. Roxithromycin acts by binding to the 50S ribosomal subunit of susceptible bacteria and inhibiting protein synthesis. Ambroxol hydrochloride facilitates the penetration of roxithromycin into the respiratory tract fluids by reducing the viscosity of the mucus and enhancing its clearance from the airways. Indications : Roxisara AM is indicated for the treatment of respiratory tract infections, including acute and chronic bronchitis, community-acquired pneumonia, and infections caused by atypical pathogens like Mycoplasma pneumoniae and Chlamydia pneumoniae. It can also be used for the treatment of pharyngitis, tonsillitis, sinusitis, and skin and soft tissue infections caused by susceptible organisms. Dosage and Administration : The recommended dose of Roxisara AM is one tablet (150 mg roxithromycin and 30 mg ambroxol hydrochloride) taken orally, twice daily, after meals. The duration of treatment varies according to the severity and type of infection but usually ranges from 5 to 10 days. The tablets should be swallowed whole with a glass of water and should not be crushed or chewed. Contraindications : Roxisara AM is contraindicated in patients with known hypersensitivity to roxithromycin, ambroxol, or any macrolide antibiotics. It should not be used in patients with severe liver dysfunction or history of cholestatic jaundice or hepatic impairment. It is also contraindicated in patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Precautions and Warnings : Roxisara AM should be used with caution in patients with moderate or severe renal impairment and in those with a history of gastrointestinal diseases. It should be avoided in pregnant and lactating women and in children under 6 years of age. Patients should be advised to complete the full course of treatment even if symptoms improve earlier to prevent the development of antibiotic resistance. Adverse Effects : The most common adverse effects of Roxisara AM are gastrointestinal disturbances, including nausea, vomiting, diarrhea, and abdominal pain. Other adverse effects include headache, dizziness, skin rash, and allergic reactions. Rarely, severe adverse effects like liver dysfunction, Stevens-Johnson syndrome, and anaphylaxis have been reported. Drug Interactions : Roxisara AM may interact with other drugs like theophylline, warfarin, digoxin, and cyclosporine, leading to increased or decreased serum levels and altered pharmacokinetics. It should not be co-administered with other macrolide antibiotics or drugs that prolong the QT interval of the electrocardiogram. Storage : Roxisara AM tablets should be stored in a cool, dry place below 25°C, protected from light and moisture. Keep out of reach of children. Presentation : Roxisara AM tablets are available in blister packs of 10 tablets. Manufacturer : Roxisara AM is manufactured by Sarabhai Chemicals, India