Macrobid 25 mg/1
Nitrofurantoin Monohydrate/Macrocrystalline · CAPSULE · REMEDYREPACK INC.
Macrobid is an oral antibiotic capsule used to treat urinary tract infections. It contains nitrofurantoin, which works by killing bacteria in the urinary system.
Key Facts
- Brand Name
- Macrobid
- Generic Name
- Nitrofurantoin Monohydrate/Macrocrystalline
- NDC Code (Product)
70518-2531- Manufacturer
- REMEDYREPACK INC.
- Strength
- 25 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA020064
- Drug Class
- Nitrofuran Antibacterial [EPC]
- Marketing Start
- 01/08/2020
Recall History
Alvogen, Inc
Failed dissolution specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Macrobid 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 Macrobid and other antibacterial drugs, Macrobid 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 Macrobid are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completio…
Dosage & Administration
DOSAGE AND ADMINISTRATION Macrobid capsules 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, MACROBID 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. Neuropathy: Peripheral neuropath…
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. Macrobid is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Macrobid 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 Macrobid , 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. Conditions such as renal imp…
Frequently Asked Questions
What is Macrobid used for?
Macrobid is an oral antibiotic capsule used to treat urinary tract infections. It contains nitrofurantoin, which works by killing bacteria in the urinary system.
Is Macrobid a controlled substance?
Macrobid is not classified as a controlled substance by the DEA.
What is the generic name for Macrobid?
The generic name for Macrobid is Nitrofurantoin Monohydrate/Macrocrystalline. There are 4 other brand versions of Nitrofurantoin Monohydrate/Macrocrystalline.
What is the NDC code for Macrobid 25 mg/1?
The NDC (National Drug Code) for Macrobid 25 mg/1 is 70518-2531, listed by REMEDYREPACK INC..