Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: Innovata Pharmaceuticals (Pty) LTD, 100 Northern Parkway Rd, Crownwood Office, Block D, Ground Floor, Ormonde, 2091
DUROBAC and DUROBAC D/S is effective against a wide range of Gram-positive and Gram-negative organisms.
It is indicated for:
Two DUROBAC tablets or one DUROBAC DOUBLE STRENGTH tablet twice daily, morning and evening after meals.
Minimum dosage and dosage for long-term treatment (more than 14 days): one DUROBAC tablet twice daily or half a DUROBAC DOUBLE STRENGTH twice daily.
Maximum dosage (for particularly severe cases): Three DUROBAC tablets or one and a half DUROBAC DOUBLE STRENGTH tablets twice daily.
In acute infections, DUROBAC should be given for at least 5 days or until the patient has been symptom free for 2 days.
If DUROBAC is indicated for patients with renal impairment, the following dosage scheme, based on creatinine clearance is suggested:
Above 25 mL/min: Standard dosage
15–25 mL/min: Standard dosage for a maximum of 3 days followed by half the standard daily dosage.
Below 15 mL/min: Not to be administered unless haemodialysis facilities are available when half the standard daily dosage may be given. Measurements of plasma concentrations of sulfamethoxazole at intervals of 2 days are recommended in samples obtained 12 hours after administration of DUROBAC. If the concentration of total sulfamethoxazole exceeds 150 ug/mL then treatment should be interrupted until the value falls below 120 ug/mL.
No Information is available for children with renal failure.
The tablets must be taken by mouth, after food. The tablets must be swallowed with a drink of water.
Nausea, vomiting, dizziness and confusion are likely signs/symptoms of overdosage (see also section 4.8). Bone marrow depression has been reported in acute trimethoprim overdosage.
If vomiting has not occurred, induction of vomiting may be desirable. Dependent on the status of renal function, administration of fluids is recommended if urine output is low.
Both trimethoprim and active sulfamethoxazole are moderately dialysable by haemodialysis. Peritoneal dialysis is not effective.
DUROBAC: 36 months.
DUROBAC D/S: 24 months.
Store below 25°C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.
DUROBAC: 28 or 56 tablets packed in a L.D.P.E “ziploc” plastic patient ready packs and 100, 500 or 1000 tablets packed in HDPE containers.
DUROBAC DOUBLE STRENGTH: 30 or 100 tablets packed in white securitainers and 1000 tablets packed in HDPE containers.
No special requirements for disposal.
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