Nitrofurantoin 25 mg/1
Nitrofurantoin · CAPSULE · Preferred Pharmaceuticals Inc.
Nitrofurantoin is a capsule containing nitrofurantoin at 25 mg/1, taken oral. Manufactured by Preferred Pharmaceuticals Inc..
Key Facts
- Brand Name
- Nitrofurantoin
- Generic Name
- Nitrofurantoin
- NDC Code (Product)
68788-8258- Manufacturer
- Preferred Pharmaceuticals Inc.
- Strength
- 25 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA208516
- Drug Class
- Nitrofuran Antibacterial [EPC]
- Marketing Start
- 09/16/2022
Recall History
American Health Packaging
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Alvogen, Inc
Failed dissolution specifications
Alvogen, Inc
Failed Dissolution Specification; 6 month time point
Sandoz Inc
Cross Contamination with Other Products
Sandoz Inc
Cross Contamination with Other Products
American Health Packaging
Failed Dissolution Specifications
RemedyRepack Inc.
Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Aidapak Services, LLC
Labeling: Label Mixup; NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg may be potentially mislabeled as PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: AD25452_1, EXP: 4/30/2014.
AvKARE
Failed Dissolution Specifications
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE Nitrofurantoin is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli , Enterococcus species, Staphylococcus aureus , Klebsiella species and Enterobacter species. Limitations of Use Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions (5.7)]. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin and other antibacterial drugs, nitrofurantoin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoin is a nitrofuran antibacterial indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections caused by susceptible bacteria. (1) Limitations of Use…
Dosage & Administration
2 DOSAGE & ADMINISTRATION Adult Patients: 50 mg to 100 mg four times a day -the lower dosage level is recommended for uncomplicated urinary tract infections. (2.2) Pediatric Patients: 5 mg/kg to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age). (2.3) 2.1 Recommended Dosage and Administration in Adult Patients The recommended dosage is 50 mg to 100 mg of nitrofurantoin four times a day. For long-term suppressive therapy in adults, a reduction of dosage to 50 mg to 100 mg at bedtime may be adequate . The benefits of long-term suppressive therapy should be balanced against the increased potential for systemic toxicity and for the development of antibacterial resistance [see Warnings and Precautions (5.2, 5.4, 5.6)]. Administer nitrofurantoin with food to improve drug absorption [see Clinical Pharmacology (12.3)] and, in some patients, tolerance. 2.2 Recommended Dosage and Administration in Pediatric Patients (1 month of age and older) The recommended dosage of nitrofurantoin is 5 mg/kg to 7 mg/kg of body weight per 24 hours, given in four divided doses in pediatric patients aged 1 month and older. Administer nitrofurantoin with …
Contraindications
4 CONTRAINDICATIONS Nitrofurantoin is contraindicated in: patients with known hypersensitivity to nitrofurantoin [see Warnings and Precautions (5.1)]. patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin [see Warnings and Precautions (5.3)]. patients who have anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) due to an increased risk of toxicity resulting from impaired excretion of the drug [see Warnings and Precautions (5.4)]. pregnant patients at term (38 weeks to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent and in pediatric patients younger than 1 month of age because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability) [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1 and 8.4)]. Known hypersensitivity to nitrofurantoin. (4) History of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. (4) Patients who have anuria, oliguria, or significant impairment of renal function (creatinin…
Drug Interactions
7 DRUG INTERACTIONS Antacids : Decreased absorption of nitrofurantoin. (7.1) Uricosuric drugs: Inhibit renal tubular secretion of nitrofurantoin. (7.2) 7.1 Antacids Antacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of nitrofurantoin onto the surface of magnesium trisilicate. If coadministration of nitrofurantoin with antacids containing magnesium trisilicate cannot be avoided, monitor for lack of efficacy [see Clinical Pharmacology (12.3)] . 7.2 Uricosuric Drugs Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin. The resulting increase in nitrofurantoin serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial. Therefore, monitor for nitrofurantoin adverse reactions when co-administering nitrofurantoin with uricosuric drugs. 7.3 Drug Interference with Laboratory Tests The presence of nitrofurantoin can cause a false-positive reaction for glucose in the urine when using Benedict's or Fehling's copper reduct…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Pulmonary Reactions [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.3)] Neuropathy [see Warnings and Precautions (5.4)] Hemolytic anemia [see Warnings and Precautions (5.5)] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.6)] Persistence or Reappearance of Bacteriuria [see Warnings and Precautions (5.7)] The following adverse reactions associated with the use of nitrofurantoin formulations, including nitrofurantoin oral suspension, were identified in clinical studies or post-marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Respiratory : chronic, subacute, or acute pulmonary hypersensitivity reactions have occurred. Chronic pulmonary reactions have occurred generally in patients who have received continuous treatment for six months or long…
Frequently Asked Questions
What is Nitrofurantoin used for?
Nitrofurantoin contains Nitrofurantoin. It is a capsule taken oral. Consult your doctor for specific uses.
Is Nitrofurantoin a controlled substance?
Nitrofurantoin is not classified as a controlled substance by the DEA.
What is the generic name for Nitrofurantoin?
The generic name for Nitrofurantoin is Nitrofurantoin. There are 10 other brand versions of Nitrofurantoin.
What is the NDC code for Nitrofurantoin 25 mg/1?
The NDC (National Drug Code) for Nitrofurantoin 25 mg/1 is 68788-8258, listed by Preferred Pharmaceuticals Inc..
Other Nitrofurantoin Dosages
Other Nitrofurantoin Brands
See all →- Nitrofurantoin Monohydrate/Macrocrystal25 mg/172189-395
- nitrofurantoin macrocrystals50 mg/172603-183
- Nitrofurantoin Macrocrystals100 mg/172789-270
- Nitrofurantoin (monohydrate/macrocrystals)25 mg/10904-7571
- NITROFURANTOIN25 mg/146708-389
- NITROFURANTOIN50 mg/146708-390
- nitrofurantoin macrocrystals50 mg/147781-307
- nitrofurantoin100 mg/150090-7217
- Nitrofurantoin Macrocrystals100 mg/150268-624
- Nitrofurantoin Macrocrystals100 mg/161919-842
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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