Pacific Pharmaceuticals Ltd.
Ofuran SR is indicated for Uncomplicated UTI
Precautions and warnings
Elderly. Monitor hepatic and pulmonary function during prolonged therapy. Pre-existing pulmonary, hepatic, neurological, or allergic disorders, predisposition to peripheral neuropathy e.g. renal impairment, anaemia, DM, electrolyte imbalance, debility, vitamin B deficiency. Withdraw if signs of peripheral neuropathy occur. Lactation.
Nausea, vomiting, anorexia, abdominal pain, diarrhoea; headache, drowsiness, vertigo, dizziness, nystagmus, benign intracranial hypertension; rash, urticaria, pruritus, fever, sialadenitis, angioedema, erythema multiforme, exfoliative dermatitis, pancreatitis, lupus-like syndrome, myalgia, arthralgia; acute pulmonary sensitivity reactions; megaloblastic anaemia, leucopenia, granulocytopenia or agranulocytosis, thrombocytopenia, aplastic anaemia, haemolytic anaemia (in G6PD-deficient patients); transient alopecia; brownish discolouration of urine.
Potentially Fatal: Peripheral polyneuropathy, hepatotoxicity, anaphylaxis, Stevens-Johnson syndrome, interstitial pneumonitis, pulmonary fibrosis.
Reduced excretion with probenecid or sulfinpyrazone. Absorption reduced by magnesium trisilicate. Antagonistic effects with quinolone antibacterials. Reduced effects with carbonic anhydrase inhibitors or urinary alkalinisers.
Severe renal impairment (anuria, oliguria, significantly elevated serum creatinine, CrCl
Mode of actions
Nitrofurantoin interferes with cell metabolism and cell wall synthesis by inhibiting several enzyme systems including acetyl coenzyme A. It is bactericidal to most gram-positive and gram-negative urinary tract pathogens.
Dosage & Administration
Acute uncomplicated urinary tract infections
Adult: 50-100 mg 4 times daily for 7 days. Dual-release preparation: 100 mg bid.
Child: >3 mth and older children: 3 mg/kg daily in 4 divided doses.
Prophylaxis of uncomplicated urinary tract infections
Adult: 50-100 mg at bedtime.
Child: >3 mth and older children: 1 mg/kg once daily.
Pregnancy & Lactation
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.