Product Information
Registration Status: ActiveAPO-NITROFURANTOIN TABLET 100mg is approved to be sold in Singapore with effective from 1988-04-21. It is marketed by PHARMAFORTE SINGAPORE PTE LTD, with the registration number of SIN00290P.
This product contains Nitrofurantoin 100mg in the form of TABLET. It is approved for ORAL use.
This product is manufactured by APOTEX INC in CANADA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
A bacteriostatic or bactericidal agent depending on the concentration and susceptibility of the infecting organism. Nitrofurantoin is active against some gram positive organisms such as S. aureus, S. epidermidis, S. saprophyticus, Enterococcus faecalis, S. agalactiae, group D streptococci, viridians streptococci and Corynebacterium. Its spectrum of activity against gram negative organisms includes E. coli, Enterobacter, Neisseria, Salmonella and Shigella. It may be used as an alternative to trimethoprim/sulfamethoxazole for treating urinary tract infections though it may be less effective at eradicating vaginal bacteria. May also be used in females as prophylaxis against recurrent cystitis related to coitus. Nitrofurantoin is highly stable to the development of bacterial resistance, a property thought to be due to its multiplicity of mechanisms of action.
Indication
May be used as an alternative in the treatment of urinary tract infections. May be used by females pericoitally for prophylaxis against recurrent cystitis related to coitus.
Mechanism of Action
Nitrofurantoin is activated by bacterial flavoproteins (nitrofuran reductase) to active reduced reactive intermediates that are thought to modulate and damage ribosomal proteins or other macromolecules, especially DNA, causing inhibition of DNA, RNA, protein, and cell wall synthesis. The overall effect is inhibition of bacterial growth or cell death.
Pharmacokinetics
- Absorption
- Readily absorbed in GI tract primarily in small intestine. Enhanced by food or delayed gastric emptying via enhanced dissolution rate of the drug.
- Distribution
- Metabolism
- Partially metabolized in liver to aminofurantoin.
- Elimination
Toxicity
Acute toxicity may cause vomiting. Adverse effects include nausea and urine discolouration. Rare hepatotoxic and hypersensitivity reactions have occurred. Hemolytic anemia is a risk in patients with G6PD deficiency. Ascending polyneuropathy may occur with prolonged therapy or in patients with low creatinine clearance.
Active Ingredient/Synonyms
1-((5-nitro-2-furanyl)methylene)amino-2,4-imidazolidenedione | 1-((5-nitrofurfurylidene)amino)hydantoin | 5-Nitrofurantoin | N-(5-Nitrofurfurylidene)-1-aminohydantoin | Nitrofurantoin anhydrous | Nitrofurantoin macrocrystal | Nitrofurantoin macrocrystalline | Nitrofurantoin, macrocrystalline | Nitrofurantoin, macrocrystals | nitrofurantoina | nitrofurantoine | nitrofurantoinum | Nitrofurantoinum anhydrous | Nitrofurantoin |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.