Drugplain

Nitrofurantoin (monohydrate/macrocrystals) 25 mg/1

Nitrofurantoin (monohydrate/macrocrystals) · CAPSULE · NorthStar RxLLC

3 Recalls on RecordCurrently in Shortage
Plain English

Nitrofurantoin (monohydrate/macrocrystals) is a capsule containing nitrofurantoin (monohydrate/macrocrystals) at 25 mg/1, taken oral. Manufactured by NorthStar RxLLC.

Key Facts

Brand Name
Nitrofurantoin (monohydrate/macrocrystals)
Generic Name
Nitrofurantoin (monohydrate/macrocrystals)
NDC Code (Product)
72603-196
Manufacturer
NorthStar RxLLC
Strength
25 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA217357
Drug Class
Nitrofuran Antibacterial [EPC]
Marketing Start
12/01/2023

Recall History

3 Recalls on Record
Class II04/21/2015

Alvogen, Inc

Failed Dissolution Specification; 6 month time point

TerminatedVoluntary: Firm initiated
Class III11/07/2018

RemedyRepack Inc.

Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup; NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg may be potentially mislabeled as MINOCYCLINE HCL, Capsule, 50 mg, NDC 00591569401, Pedigree: AD52778_46, EXP: 5/20/2014.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea27 reports
nausea26 reports
pyrexia23 reports
chills21 reports
headache19 reports
cough18 reports
vomiting17 reports
asthenia16 reports
diarrhoea15 reports
myalgia15 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Nitrofurantoin (monohydrate/macrocrystals) is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin (monohydrate/macrocrystals) 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin (monohydrate/macrocrystals) are predisposed to persistence or reappearance of ba…

Dosage & Administration

DOSAGE AND ADMINISTRATION Nitrofurantoin capsules (monohydrate/macrocrystals) should be taken with food. Adults and Pediatric Patients Over 12 Years One 100 mg capsule every 12 hours for seven days.

Warnings

WARNINGS Pulmonary Reactions ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) SHOULD BE DISCONTINUED AND APPROPRIATE MEASURES TAKEN. REPORTS HAVE CITED PULMONARY REACTIONS AS A CONTRIBUTING CAUSE OF DEATH. CHRONIC PULMONARY REACTIONS (DIFFUSE INTERSTITIAL PNEUMONITIS OR PULMONARY FIBROSIS, OR BOTH) CAN DEVELOP INSIDIOUSLY. THESE REACTIONS OCCUR RARELY AND GENERALLY IN PATIENTS RECEIVING THERAPY FOR SIX MONTHS OR LONGER. CLOSE MONITORING OF THE PULMONARY CONDITION OF PATIENTS RECEIVING LONG-TERM THERAPY IS WARRANTED AND REQUIRES THAT THE BENEFITS OF THERAPY BE WEIGHED AGAINST POTENTIAL RISKS (SEE RESPIRATORY REACTIONS). Hepatotoxicity Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, occur rarely. Fatalities have been reported. The onset of chronic active hepatitis may be insidious, and patients should be monitored periodically for changes in biochemical tests that would indicate liver injury. If hepatitis occurs, the drug should be withdrawn immediately and appropriate measures should be taken. Ne…

Contraindications

CONTRAINDICATIONS Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug. Because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability), the drug is contraindicated in pregnant patients at term (38 to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent. For the same reason, the drug is contraindicated in neonates under one month of age. Nitrofurantoin (monohydrate/macrocrystals) is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin (monohydrate/macrocrystals) is also contraindicated in those patients with known hypersensitivity to nitrofurantoin.

Drug Interactions

Drug Interactions 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. 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.

Adverse Reactions

ADVERSE REACTIONS In clinical trials of nitrofurantoin (monohydrate/macrocrystals), the most frequent clinical adverse events that were reported as possibly or probably drug-related were nausea (8%), headache (6%), and flatulence (1.5%). Additional clinical adverse events reported as possibly or probably drug-related occurred in less than 1% of patients studied and are listed below within each body system in order of decreasing frequency: Gastrointestinal: Diarrhea, dyspepsia, abdominal pain, constipation, emesis Neurologic : Dizziness, drowsiness, amblyopia Respiratory: Acute pulmonary hypersensitivity reaction (see WARNINGS ) Allergic: Pruritus, urticaria Dermatologic: Alopecia Miscellaneous: Fever, chills, malaise The following additional clinical adverse events have been reported with the use of nitrofurantoin: Gastrointestinal: Sialadenitis, pancreatitis. There have been sporadic reports of pseudomembranous colitis with the use of nitrofurantoin. The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment (see WARNINGS ). Neurologic: Peripheral neuropathy, which may become severe or irreversible, has occurred. Fatalities have been reported.…

Frequently Asked Questions

What is Nitrofurantoin (monohydrate/macrocrystals) used for?

Nitrofurantoin (monohydrate/macrocrystals) contains Nitrofurantoin (monohydrate/macrocrystals). It is a capsule taken oral. Consult your doctor for specific uses.

Is Nitrofurantoin (monohydrate/macrocrystals) a controlled substance?

Nitrofurantoin (monohydrate/macrocrystals) is not classified as a controlled substance by the DEA.

What is the generic name for Nitrofurantoin (monohydrate/macrocrystals)?

The generic name for Nitrofurantoin (monohydrate/macrocrystals) is Nitrofurantoin (monohydrate/macrocrystals). There are 3 other brand versions of Nitrofurantoin (monohydrate/macrocrystals).

What is the NDC code for Nitrofurantoin (monohydrate/macrocrystals) 25 mg/1?

The NDC (National Drug Code) for Nitrofurantoin (monohydrate/macrocrystals) 25 mg/1 is 72603-196, listed by NorthStar RxLLC.

Product NDC

72603-196

Package NDC

72603-196-01

Other Nitrofurantoin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)