Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2017 Publisher: Teva Pharma (New Zealand) Limited, PO Box 128 244, Remuera, Auckland 1541, Telephone: 0800 800 097
Roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections caused by or likely to be caused by susceptible micro-organisms:
Roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible micro-organisms: acute pharyngitis, acute tonsillitis and impetigo.
Appropriate culture and sensitivity tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. Therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
This product may not be interchangeable with other products containing this ingredient in the New Zealand’s market. The bioequivalence with Rulide marketed in Australia has been demonstrated.
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.
The recommended dosage is 300 mg per day, which may be taken according to one of the following dosage regimens.
Usual dosage: Roxithromycin 300 mg tablets: one tablet daily. Roxithromycin 150 mg tablets: one tablet twice daily or two tablets once daily.
For atypical pneumonia, the recommended dosage is 150 mg twice daily. The usual duration of treatment is five to ten days depending on the indication and clinical response. Streptococcal throat infections require at least ten days of therapy. A small proportion of patients with non-gonococcal genital infections may require twenty days for complete cure.
Roxithromycin 300 mg tablets: one tablet daily.
Roxithromycin 150 mg tablets: one tablet twice daily or two tablets once daily.
Roxithromycin 300 mg tablets: one tablet daily.
Roxithromycin 150 mg tablets: one tablet twice daily or two tablets once daily.
One roxithromycin 150 mg tablet once daily for patients with documented cirrhotic liver disease.
Roxithromycin is administered twice daily at a dose of 5 to 8 mg/kg/day (see Special warnings and precautions for use).
One roxithromycin 150 mg tablet morning and evening.
The usual duration of treatment is five to ten days depending on the indication and clinical response. Streptococcal throat infections require ten days of therapy. The duration of treatment should not exceed ten days
In case of overdosage, gastric lavage may remove residual drug in the stomach. Clinical monitoring should be considered along with symptomatic and supportive treatment as required. There is no specific antidote.
LD50 dosage was high in mice and rats at 0.75 g/kg and 1-1.7 g/kg, respectively. In dogs, a dose of 2 g/kg did not result in toxicity.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
24 months.
Store in a cool, dry place where it stays below 25°C, and protect from light and moisture.
PVC/PVdC/Aluminium foil blister strips. Pack size of 10 tablets (150 mg) and 5 tablets (300 mg).
No special requirements for disposal.
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