Roxithromycin

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Sinusitis, tonsillitis, otitis media and pharyngitis caused by Group A beta-haemolytic Streptococci and Streptococcus pneumoniae
• Acute bronchitis and pneumonia caused by Streptococcus pneumoniae
• Atypical pneumonia caused by Mycoplasma pneumoniae
• Erysipelas and pyoderma caused by Staphylcoccus aureus and Group A beta-heamolytic Streptococci
• Non-gonococcal urethritis in males, due to Chlamydia trachomatis and Ureaplasma urealyticum

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to other macrolides
• Breastfeeding
• Severe hepatic impairment
• Coadministration with vasoconstrictive ergot derivatives

Cautions

• Pregnancy
• Renal impairment
• Elderly
• Children
• History of arrhythmias
• History of prolonged QT interval  

Forms avail. in SA and covered in this monograph: tab

Infections caused by Gram-positive aerobic cocci (excluding Staphylococcus spp.); Most Gram-negative aerobic organisms (excluding Klebsiella); Others, including Mycoplasma, Chlamydia spp., Gardnerella vaginalis

• Oral (tab): 150mg, 12hrly

To be taken before meals

Paed. forms avail. in SA and covered in this monograph: tab

Infections caused by Gram-positive aerobic cocci (excluding Staphylococcus spp.); Most Gram-negative aerobic organisms (excluding Klebsiella); Others, including Mycoplasma, Chlamydia spp., Gardnerella vaginalis

• Oral (tab): 5-8mg/kg, 12hrly; Max: 150mg, 12hrly

To be taken before meals

Pregnancy

• Caution; Not recommended
• The safety of roxithromycin for the human fetus has not been established
• Reproductive studies in rats, mice, and rabbits at doses of 100, 400 and 135 mg/kg/day, respectively, did not demonstrate evidence of developmental abnormalities. In rats, at doses above 180 mg/kg/day, there was evidence of embryotoxicity and maternotoxicity

Breastfeeding

• Contraindicated
• Small amounts of roxithromycin are excreted in the breast milk
• Breastfeeding or treatment of the mother should be discontinued as necessary

Fertility

• There was no effect on the fertility of rats treated with roxithromycin at oral doses up to 180 mg/kg/day

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Mild (Child-Pugh Class A): No dose adjustment recommended
• Moderate (Child-Pugh Class B): Dose adjustment recommeded                                                             
  Limit daily dose to 150mg, once per day
• Severe (Child-Pugh Class C): Contraindicated

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably porphyrinogenic (PRP)

Central Nervous System Disorders

• Dizziness
• Headache
• Paraesthesia

Cardiovascular Disorders

• Arrhythmias
• QT interval prolongation

Respiratory Disorders

• Bronchospasm

Gastrointestinal Disorders

• Gastric pain
• Nausea and vomiting
• Diarrhoea
• Taste disturbances

Hepatobiliary Disorders

• Acute pancreatitis
• Increased hepatic enzymes
• Hepatitis

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Rash
• Urticaria
• Purpura

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Angioedema
• Anaphylactic shock
• Eosinophilia
• Agranulocytosis
  

Sensory Disorders

• Smell disturbances

• Vasoconstrictive ergot alkaloids
• Astemizole
• Terfenadine
• Pimozide
• Cisapride
• Warfarin
• Midazolam
• Digoxin
• Theophylline
• Disopyramide
• Ciclosporin
• Cimetidine

Monitoring
ECG
Liver function test

• Roxithromycin should be taken at least 15 minutes before food or on an empty stomach (i.e. more than three hours after a meal)
• The film-coated tablets must be swallowed whole with a drink

Roxithromycin is a semi-synthetic macrolide antibiotic. It derives its antibacterial effect from its inhibition of protein synthesis. Roxithromycin inhibits the translocation of peptides by binding to the subunit 50S of the bacterial ribosome. 

Spectrum of activity: Gram-positive aerobic cocci (excluding Staphylococcus spp.); Most Gram-negative aerobic organisms (excluding Klebsiella); Others, including Mycoplasma, Chlamydia spp., Gardnerella vaginalis

Tablet 150mg

• Roxithromycin-Hexal (Sandoz)
• Roxxibid (Cipla Medpro)
• Throsyn (Pharmacare)