Adult Dosing

Treatment of bacterial infections

• 300 mg PO qd or 150 mg PO bid x 5-10 days; atypical pneumonia: 150 mg PO bid

• The usual duration of treatment is 5-10 days; should be taken empty stomach or at least 15 minutes before food
• Streptococcal throat infections require at least 10 days of therapy
• Nongonococcal genital infections may require upto 20 days for complete cure

Pediatric Dosing

Treatment of bacterial infections

• > 40 kgs: 150 mg PO bid (equivalent to 5-8 mg/kg/day) x 5-10 days. [Max: 10 days]
• < 40 kgs: Tablets for suspension as follows (Rulide D)
• 6-11 kg: 25 mg (1/2 tablet) PO bid. [Max: 10 days]
• 12-23 kg: 50 mg (1 tablet ) PO bid. [Max: 10 days]
• 24-40 kg: 100 mg (2 tablets ) PO bid. [Max: 10 days]

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of the following mild to moderately severe infections in adults, caused by susceptible microorganisms
• Community-acquired pneumonia
• Acute exacerbation of chronic bronchitis
• Acute maxillary sinusitis
• Pharyngitis and tonsillitis
• Skin and skin structure infections
• Nongonococcal urethritis

• Treatment of the following mild to moderately severe infections in children, caused by susceptible microorganisms
• Acute pharyngitis
• Tonsillitis
• Impetigo

• Hypersensitivity to macrolides, including erythromycin
• Severe hepatic impairment
• Concomitant therapy with vasoconstrictive ergot alkaloids

• N/A

Renal Dose Adjustment

• Renal impairment: Caution advised; dose adjustments not defined

Hepatic Dose Adjustment

• Mild to Moderate hepatic impairment: Caution advised; dose adjustments not defined
• Severe hepatic impairment: Contraindicated

• Obtain culture and susceptibility tests before starting therapy
• Prolonged use increases risk of fungal or bacterial superinfection, including Clostridium difficile-associated diarrhea (CDAD), with severity ranging from mild diarrhea to fatal colitis
• Monitor for signs of hypersensitivity to roxithromycin; development of superinfection or antibiotic-associated diarrhea
• Concomitant therapy with drugs delaying peristalsis, e.g. opiates and diphenoxylate with atropine, may worsen the condition and is not recommended
• Concentration dependent lengthening in cardiac action potential duration has occurred at supratherapeutic concentrations; do not exceed recommended dosage
• Disturbances in taste and/or smell have been reported
• Symptoms of pancreatitis have been observed
• Monitor periodic WBC, chest X-ray if pneumonia, cultures, temperature

Cautions: Use cautiously

• Renal impairment (refer dose adjustment section)
• Hepatic impairment (refer dose adjustment section)
• Long term use (superinfection may occur)
• Surgical procedures
• Concomitant use of drugs that delay peristalsis
• Congenital prolongation of the QT interval
• Myasthenia gravis

Pregnancy Category:NR. U.S. Pregnancy Category yet to be determined.

Breastfeeding: Excreted in small amounts in breast milk, manufacturer recommends discontinuation of breastfeeding, or postponing of treatment (taking into account the importance of the drug to the mother)

• GI: Abdominal discomfort and cramps, epigastric pain, nausea, vomiting, diarrhea, anorexia, flatulence, pancreatitis
• HEPA: Elevated LFTs, hepatotoxicity, acute cholestatic hepatitis, acute hepatocellular injury
• HEMAT: Eosinophilia, thrombocytosis, lymphopenia
• RESP: Bronchospasm, asthma
• CNS: Headache, dizziness, fatigue
• EENT: Tinnitus
• DERM: Rash, urticaria, pruritus, purpura, Stevens-Johnson syndrome, exfoliative dermatitis, erythema multiforme
• MISC: Angioedema, anaphylactic shock, anaphylactic-like reactions, malaise, moniliasis, disorders of taste/or smell, angioedema, glottic oedema, generalised edema

• Macrolide antibiotic; inhibits protein synthesis; impairs elongation cycle of the peptidyl chain by specifically binding to the 50 S subunit of the ribosome
• Bioavailability: 50%
• Limited metabolism in liver; descladinose roxithromycin is the major metabolite
• Renally excreted: 7%, lungs: 13%, feces: 53%
• Half-life:
• Adults: 12 hrs
• Child: 20 hrs
• Elderly: 27 hrs
• Renal impairment: 18 hrs
• Hepatic impairment: 25 hrs

US Trade Name(s)

• N/A

US Availability

• N/A

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• Biaxsig
• Roxar
• Roxide
• Roximycin
• Rulide
• Rulide D

Australian Availability

roxithromycin (generic)

• TABS: 150, 300 mg

Biaxsig, Roxar, Roxide, Roximycin, Rulide

• TABS: 150, 300 mg

Rulide D

• TABS: 50 mg

[Outline]

Antimicrobials

Antibiotics

Macrolides

Infectious Disease

Antibiotics

Macrolides