ROXID 50MG/5ML ORAL SUSPENSION

Indications

• Respiratory tract infections
• Skin infections
• Chlamydia infections
• Mycoplasma infections
• Bacterial infections caused by susceptible strains

Dosage

Children: Refer to BNF for Children for dosing guidance.

Adults: Refer to BNF for dosing guidance.

Mechanism of action

Roxithromycin prevents bacterial growth by interfering with their protein synthesis. It binds to the 50S subunit of bacterial ribosomes and inhibits the translocation of peptides.

Pharmacodynamics

Roxithromycin has a broad antibacterial spectrum in vitro, effective against bacteria such as Streptococcus agalactiae, Streptococcus pneumoniae, Neisseria meningitides, Listeria monocytogenes, Mycoplasma pneumoniae, Chlamydia trachomatis, Ureaplasma urealyticum, Legionella pneumophila, Helicobacter, Gardnerella vaginalis, Bordetella pertussis, Moraxella catarrhalis, and Haemophilus ducreyi. It is highly concentrated in polymorphonuclear leukocytes and macrophages, achieving intracellular concentrations that are significantly higher than those found extracellularly. This intracellular action enhances the adhesive and chemotactic functions of these immune cells, facilitating phagocytosis and bacterial lysis, which contributes to its bactericidal activity.

Pharmacokinetics

Roxithromycin is well-absorbed after oral administration, with good tissue penetration, particularly in lung and soft tissue. It has a long half-life, allowing for once-daily dosing in many cases. The drug is metabolized in the liver and eliminated primarily via the bile, with a small percentage excreted in urine. Its pharmacokinetic profile supports its use for both acute and chronic infections.

Contra-indications

• Hypersensitivity to roxithromycin or any of its components
• Severe hepatic impairment
• Concomitant use with certain drugs that prolong the QT interval

Adverse effects

• Gastrointestinal disturbances (nausea, vomiting, diarrhea)
• Abdominal pain
• Headache
• Dizziness
• Hypersensitivity reactions (skin rash, itching)
• Liver enzyme abnormalities

Interactions

• May interact with drugs that affect hepatic enzymes (e.g., macrolides, warfarin)
• Caution with other QT-prolonging agents
• Increased plasma concentrations of certain drugs metabolized by cytochrome P450

Precautions

• Use with caution in patients with hepatic impairment
• Monitor for signs of allergic reactions
• Evaluate renal function in patients with renal impairment

Pregnancy

Roxithromycin should only be used in pregnancy if the potential benefit justifies the potential risk to the fetus. Limited data is available on its safety in pregnancy.

Breast-feeding

Use with caution during breastfeeding. Roxithromycin is excreted in breast milk; therefore, a decision should be made whether to discontinue nursing or the drug.

Storage

Store in a cool, dry place, away from light. Keep out of reach of children.

Formulations

• Tablets (150 mg)
• Suspension (50 mg/5 mL)

Mechanism of action

Roxithromycin prevents bacterial growth by interfering with their protein synthesis. It binds to the 50S subunit of bacterial ribosomes and inhibits the translocation of peptides.

Pharmacodynamics

Roxithromycin has the following antibacterial spectrum <i>in vitro</i>: <i>Streptococcus agalactiae</i>, <i>Streptococcus pneumoniae</i> (Pneumococcus), <i>Neisseria meningitides</i> (Meningococcus), <i>Listeria monocytogenes</i>, <i>Mycoplasma pneumoniae</i>, <i>Chlamydia trachomatis</i>, <i>Ureaplasma urealyticum</i>, <i>Legionella pneumophila</i>, <i>Helicobacter</i> (Campylobacter), <i>Gardnerella vaginalis</i>, <i>Bordetella pertussis</i>, <i>Moraxella catarrhalis</i> (<i>Branhamella Catarrhalis</i>), and <i>Haemophilus ducreyi</i>. Roxithromycin is highly concentrated in polymorphonuclear leukocytes and macrophages, achieving intracellular concentrations greater than those outside the cell. Roxithromycin enhances the adhesive and chemotactic functions of these cells which in the presence of infection produce phagocytosis and bacterial lysis. Roxithromycin also possesses intracellular bactericidal activity.