Product image of Nitrofurantoïne Prolepha (Nitrofurantoin) supplied by GNH India

Nitrofurantoïne Prolepha

Active Ingredient:
Nitrofurantoin
Origin:
EU

Nitrofurantoïne Prolepha (Nitrofurantoin)

Nitrofurantoin, the active ingredient in Nitrofurantoïne Prolepha, is a nitrofuran antibiotic presented as an oral dosage form for oral use. It treats uncomplicated urinary tract infections and is used for prophylaxis of recurrent infections in adults.
GNH India supplies Nitrofurantoïne Prolepha as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Prolepha Research B.V.

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Indications & Clinical Uses

Nitrofurantoïne Prolepha is a nitrofuran antibiotic indicated for infections of the urinary tract.

  • Uncomplicated urinary tract infection (cystitis): eliminates the causative bacteria and resolves urinary symptoms.
  • Prophylaxis of recurrent urinary tract infections: reduces the frequency of future infection episodes.
  • Acute uncomplicated cystitis in women: provides bactericidal activity directly within the urinary tract.

How It Works

  • Nitrofurantoin is bactericidal; it is reduced by bacterial flavoproteins to reactive intermediates that damage bacterial DNA, ribosomal proteins, and cell‑wall precursors. This interferes with carbohydrate metabolism and cell‑wall synthesis, leading to inhibition of bacterial growth primarily in the urinary tract where the drug is concentrated.

Side Effects

Nitrofurantoin may cause a range of adverse reactions.

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Diarrhea: loose stools occurring during therapy.
  • Loss of appetite: reduced desire to eat.
  • Headache: transient mild headache.

Serious or Rare Side Effects

  • Pulmonary toxicity: interstitial lung disease or acute respiratory distress.
  • Hepatic injury: elevated liver enzymes or hepatitis.
  • Severe allergic reactions: rash, Stevens‑Johnson syndrome, or anaphylaxis.

Precautions & Warnings

Before prescribing Nitrofurantoïne Prolepha, consider the following safety measures.

  • Renal function: assess creatinine clearance, as efficacy depends on urinary excretion.
  • Pregnancy: use only when benefit outweighs risk (Category B).
  • G6PD deficiency: avoid due to risk of hemolysis.
  • Drug interactions: review concomitant medications for absorption or toxicity concerns.
  • Store at ambient temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Nitrofurantoin can interact with several medicines; monitoring is essential.

Major Interactions (Avoid)

  • Antacids containing magnesium or aluminum: reduce nitrofurantoin absorption; separate dosing by at least 2 hours.
  • Warfarin: may potentiate anticoagulant effect; monitor INR closely.
  • Fluoroquinolones: antagonistic antibacterial activity; avoid co‑administration.

Moderate Interactions (Monitor Closely)

  • Diuretics: may increase nitrofurantoin concentration; watch renal function.
  • Probenecid: decreases renal excretion, potentially raising plasma levels; adjust dose if needed.

Frequently Asked Questions

Nitrofurantoïne Prolepha contains nitrofurantoin, an antibiotic used to treat uncomplicated urinary tract infections such as cystitis and to prevent recurrent infections in adults. It works by concentrating in the urine where it kills susceptible bacteria.

Nitrofurantoin is reduced by bacterial enzymes to reactive intermediates that damage bacterial DNA, ribosomal proteins, and cell‑wall precursors. This multi‑target attack interferes with carbohydrate metabolism and cell‑wall synthesis, resulting in bactericidal activity primarily within the urinary tract.

The dosage of Nitrofurantoïne Prolepha is determined by the prescribing clinician based on the infection severity, patient renal function, and local guidelines. Patients should follow the prescriber’s instructions and not alter the dose without medical advice.

Nitrofurantoïne is classified as pregnancy Category B, indicating that animal studies have not shown risk but there are no adequate human studies. It may be used during pregnancy only if the potential benefit justifies the risk. Limited data are available for breastfeeding; a prescriber should evaluate the risk‑benefit balance.

To order, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any required import documentation.

Nitrofurantoin is distinct from fluoroquinolones and trimethoprim‑sulfamethoxazole because it achieves high concentrations in urine and has a narrow spectrum focused on common uropathogens. It is often preferred for uncomplicated cystitis when resistance to other agents is a concern, but it requires adequate renal function for efficacy.

Store the product at ambient temperature, below 25 °C, in its original packaging. Protect it from moisture, excessive heat, and direct sunlight. Do not refrigerate or freeze the tablets, and keep them out of reach of children.

Nitrofurantoïne Prolepha is taken orally, usually with food or a full glass of water to improve absorption and reduce gastrointestinal irritation. The exact dosing schedule should be followed as prescribed by the healthcare professional.

Serious risks include pulmonary toxicity (interstitial lung disease or acute respiratory distress), hepatic injury, severe allergic reactions such as Stevens‑Johnson syndrome, and hemolytic anemia in patients with G6PD deficiency. Patients should seek immediate medical attention if they experience shortness of breath, jaundice, rash, or dark urine.

Nitrofurantoïne Prolepha is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min), known hypersensitivity to nitrofurantoin, or a history of G6PD deficiency. It should also be avoided in late‑term pregnancy (≥ 38 weeks) due to potential fetal hemolysis.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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