Nitrofurantoin


Generic Medicine Info
Indications and Dosage
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: >3 months 3 mg/kg daily in 4 divided doses for 7 days. As dual-release preparation: >12 years Same as adult dose.

Oral
Prophylaxis of surgical infections
Adult: As immediate-release preparation: 50-100 mg once daily.
Child: As immediate-release preparation: >3 months 1 mg/kg at bedtime

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
 60 Contraindicated.
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.
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.
PO: B (contraindicated at 38-42 weeks gestation)
Patient Counseling Information
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
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.
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
Description: 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.
Pharmacokinetics:
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
Chemical Structure

Chemical Structure Image
Nitrofurantoin

Source: National Center for Biotechnology Information. PubChem Database. Nitrofurantoin, CID=6604200, https://pubchem.ncbi.nlm.nih.gov/compound/Nitrofurantoin (accessed on Jan. 22, 2020)

Storage
Cap: Store between 15-30°C. Suspension: Store between 20-25°C. Protect from light and moisture.
MIMS Class
ATC Classification
J01XE01 - nitrofurantoin ; Belongs to the class of nitrofuran derivative antibacterials. Used in the systemic treatment of infections.
References
Anon. Nitrofurantoin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/02/2019.

Buckingham R (ed). Nitrofurantoin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/02/2019.

Joint Formulary Committee. Nitrofurantoin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/02/2019.

Nitrofurantoin Monohydrate/Macrocrystalline Capsule (BluePoint Laboratories). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 04/02/2019.

Nitrofurantoin Suspension (Actavis Pharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 04/02/2019.

Nitrofurantoin. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com/. Accessed 04/02/2019.

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