NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE 25 mg/1

NITROFURANTOIN MONOHYDRATE · CAPSULE · Direct_Rx

No Recall HistoryCurrently in Shortage

Plain English

NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE is a capsule containing nitrofurantoin monohydrate at 25 mg/1, taken oral. Manufactured by Direct_Rx.

Key Facts

Brand Name: NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE
Generic Name: NITROFURANTOIN MONOHYDRATE
NDC Code (Product): 61919-021
Manufacturer: Direct_Rx
Strength: 25 mg/1
Dosage Form: CAPSULE
Route: ORAL
Marketing Status
Application #: NDA020064
Drug Class: Nitrofuran Antibacterial [EPC]
Marketing Start: 07/08/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

bradycardia1 reports

chills1 reports

complex regional pain syndrome1 reports

dyspnoea1 reports

erythema nodosum1 reports

headache1 reports

oedema mouth1 reports

pain in extremity1 reports

pyrexia1 reports

swollen tongue1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Nitrofurantoin capsules (monohydrate/macrocrystals) are 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 capsules (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (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 capsules (monohydrate/macrocrystals) are predispose…

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 CAPSULES (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…

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 capsules (monohydrate/macrocrystals) are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin capsules (monohydrate/macrocrystals) are 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 capsules (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 b…

Frequently Asked Questions

What is NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE used for?

NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE contains NITROFURANTOIN MONOHYDRATE. It is a capsule taken oral. Consult your doctor for specific uses.

Is NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE a controlled substance?

NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE is not classified as a controlled substance by the DEA.

What is the generic name for NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE?

The generic name for NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE is NITROFURANTOIN MONOHYDRATE. There are 8 other brand versions of NITROFURANTOIN MONOHYDRATE.

What is the NDC code for NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE 25 mg/1?

The NDC (National Drug Code) for NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE 25 mg/1 is 61919-021, listed by Direct_Rx.

Product NDC

61919-021

Package NDC

61919-021-02

Other Nitrofurantoin Brands

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

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