Nitrofurantoin


Full Generic Medicine Info
Dosage/Direction for Use

Oral
Acute uncomplicated urinary tract infections
Adult: As immediate-release preparation: 50 mg 4 times daily for 7 days. As dual-release preparation: 100 mg bid for 7 days. Patient with severe chronic recurrent cases: As immediate-release preparation: 100 mg 4 times daily for 7 days.
Child: As immediate-release preparation:>3months 3 mg/kg daily in 4 divided doses for 7 days. As dual-release preparation: >12 years Same as adult dose.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<60Contraindicated.


Oral
Prophylaxis of uncomplicated urinary tract infections
Adult: As immediate-release preparation: 50-100 mg once daily.
Child: As immediate-release preparation: >3months 1 mg/kg at bedtime
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<60Contraindicated.


Oral
Prophylaxis of surgical infections
Adult: As immediate-release preparation: 50 mg 4 times daily. As dual-release preparation: 100 mg bid. All doses start on the day of the procedure and 3 days thereafter.
Child: As dual-release preparation: 12 years Same as adult dose.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<60Contraindicated.
Administration
Should be taken with food. Take w/ or immediately after meals.
Contraindications
Hypersensitivity. Acute porphyria, G6PD deficiency, infants <1 month. Pregnancy at term (during labour and delivery). Severe renal impairment, anuria, oliguria, significantly elevated serum creatinine, CrCl <60 ml/min or eGFR <45 mL/min, history of cholestatic jaundice or hepatic impairment associated with previous nitrofurantoin use. Concurrent vaccination with live polio vaccines.
Special Precautions
Patient with anaemia, diabetes mellitus, vitamin B deficiency, electrolyte imbalance, debilitating diseases, pre-existing pulmonary diseases, neurological disorders, or allergic diathesis. Lactation. Children and elderly. Patient Counselling This drug may cause dizziness and drowsiness, if affected, do not drive or operate machinery. This drug may cause yellow or brown discoloration of urine. Monitoring Parameters Monitor CBC; LFT and renal function periodically. Monitor for pulmonary reactions (e.g. malaise, dyspnoea, cough, fever, and radiologic evidence of diffuse interstitial pneumonitis or fibrosis), and signs of numbness or tingling of extremities.
Adverse Reactions
Significant: Optic neuritis, peripheral neuropathy, superinfection, C. difficile-associated diarrhoea, haemolytic anaemia. Blood and lymphatic system disorders: Agranulocytosis, aplastic anaemia. Cardiac disorders: Angina. Eye disorders: Amblyopia. Gastrointestinal disorders: Diarrhea, dyspepsia, abdominal pain, constipation, emesis. General disorders and administration site conditions: Fever, chills, malaise, asthenia. Immune system disorders: Anaphylactoid reactions, angioedema, urticaria. Metabolism and nutrition disorders: Anorexia. Musculoskeletal and connective tissue disorders: Arthralgia. Nervous system disorders: Dizziness, drowsiness. Respiratory, thoracic and mediastinal disorders: Acute pulmonary hypersensitivity reactions. Skin and subcutaneous tissue disorders: Pruritus, alopecia.
Potentially Fatal: Rarely, cholestatic jaundice, hepatitis, hepatic necrosis. Acute, subacute or chronic pulmonary toxicity, peripheral neuropathy.
B contraindicated at term (38-42 weeks gestation)
Overdosage
Symptoms: Gastric irritation, nausea, and vomiting. Management: Induce emesis or perform gastric lavage for recent ingestion. Haemodialysis may be performed. Maintain high fluid intake to promote urinary excretion.
Drug Interactions
Reduced rate and extent of absorption with antacids containing Mg trisilicate. Increased serum level and toxicity and decreased renal excretion with uricosuric drugs (e.g. probenecid, sulfinpyrazone). Antagonistic effects with quinolone antibacterials. Decreased antimicrobial effect with effects with carbonic anhydrase inhibitors (e.g. acetazolamide). May diminish the therapeutic effect of norfloxacin, and live polio vaccine.
Food Interaction
Food may increase bioavailability.
Lab Interference
May give false positive result for urine glucose test using Benedict's and Fehling's methods.
Action
Nitrofurantoin interferes with the organism's carbohydrate metabolism by inhibiting bacterial acetyl coenzyme-A. It also inhibits protein synthesis, aerobic energy metabolism, DNA, RNA, and bacterial cell wall synthesis. It is generally a bacteriostatic but can be bactericidal in high doses.
Absorption: Readily absorbed from the gastrointestinal tract.; macrocrystalline form absorbed more slowly. Bioavailability: Increases with food by approx. 40%
Distribution: Crosses placenta, enters breast milk. Volume of distribution: 0.8 L/kg. Plasma protein binding: 60-90%.
Metabolism: Metabolised in the liver; 60% in body tissues to inactive metabolites.
Excretion: As suspension: Via urine (approx 30-40%, as unchanged drug); faeces (small amount as metabolites and unchanged drug). As macrocrystals: Via urine (20-25% as unchanged drug). Elimination half-life: 20-60 minutes
Storage
Oral: Cap: Store betwee 15-30°C. Suspension: Store between 20-25°C. Protect from light and moisture.
CIMS Class
ATC Classification
J01XE01 - nitrofurantoin ; Belongs to the class of nitrofuran derivative antibacterials. Used in the systemic treatment of infections.
Disclaimer: This information is independently developed by CIMS based on nitrofurantoin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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