Nitrofurantoin Macrocrystals 100 mg/1
Nitrofurantoin Macrocrystals · CAPSULE · Proficient Rx LP
Nitrofurantoin Macrocrystals is a capsule containing nitrofurantoin macrocrystals at 100 mg/1, taken oral. Manufactured by Proficient Rx LP.
Key Facts
- Brand Name
- Nitrofurantoin Macrocrystals
- Generic Name
- Nitrofurantoin Macrocrystals
- NDC Code (Product)
71205-297- Manufacturer
- Proficient Rx LP
- Strength
- 100 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA073652
- Drug Class
- Nitrofuran Antibacterial [EPC]
- Marketing Start
- 03/08/2007
Recall History
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.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli , enterococci, Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. 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 (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (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 (macrocrystals) are predispo…
Dosage & Administration
DOSAGE AND ADMINISTRATION Nitrofurantoin capsules, (macrocrystals) should be given with food to improve drug absorption and, in some patients, tolerance. Adults: 50 mg to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections. 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). Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation. For long-term suppressive therapy in adults, a reduction of dosage to 50 mg to 100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
Warnings
WARNINGS Pulmonary reactions: ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, NITROFURANTOIN CAPSULES (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. Neu…
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 (macrocrystals) are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin capsules (macrocrystals) are also contraindicated in those patients with known hypersensitivity to nitrofurantoin.
Adverse Reactions
ADVERSE REACTIONS Respiratory: CHRONIC, SUBACUTE, OR ACUTE PULMONARY HYPERSENSITIVITY REACTIONS MAY OCCUR. CHRONIC PULMONARY REACTIONS OCCUR GENERALLY IN PATIENTS WHO HAVE RECEIVED CONTINUOUS TREATMENT FOR SIX MONTHS OR LONGER. MALAISE, DYSPNEA ON EXERTION, COUGH, AND ALTERED PULMONARY FUNCTION ARE COMMON MANIFESTATIONS WHICH CAN OCCUR INSIDIOUSLY. RADIOLOGIC AND HISTOLOGIC FINDINGS OF DIFFUSE INTERSTITIAL PNEUMONITIS OR FIBROSIS, OR BOTH, ARE ALSO COMMON MANIFESTATIONS OF THE CHRONIC PULMONARY REACTION. FEVER IS RARELY PROMINENT. THE SEVERITY OF CHRONIC PULMONARY REACTIONS AND THEIR DEGREE OF RESOLUTION APPEAR TO BE RELATED TO THE DURATION OF THERAPY AFTER THE FIRST CLINICAL SIGNS APPEAR. PULMONARY FUNCTION MAY BE IMPAIRED PERMANENTLY, EVEN AFTER CESSATION OF THERAPY. THE RISK IS GREATER WHEN CHRONIC PULMONARY REACTIONS ARE NOT RECOGNIZED EARLY. In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form. Upon cessation of therapy, recovery may require several months. If the symptoms are not recognized as being drug-related and nitrofurantoin therapy is not stopped, the symptoms may become more severe. Acute pulmonary reactions are commonly mani…
Frequently Asked Questions
What is Nitrofurantoin Macrocrystals used for?
Nitrofurantoin Macrocrystals contains Nitrofurantoin Macrocrystals. It is a capsule taken oral. Consult your doctor for specific uses.
Is Nitrofurantoin Macrocrystals a controlled substance?
Nitrofurantoin Macrocrystals is not classified as a controlled substance by the DEA.
What is the generic name for Nitrofurantoin Macrocrystals?
The generic name for Nitrofurantoin Macrocrystals is Nitrofurantoin Macrocrystals. There are 8 other brand versions of Nitrofurantoin Macrocrystals.
What is the NDC code for Nitrofurantoin Macrocrystals 100 mg/1?
The NDC (National Drug Code) for Nitrofurantoin Macrocrystals 100 mg/1 is 71205-297, listed by Proficient Rx LP.
Other Nitrofurantoin Macrocrystals Dosages
Other Nitrofurantoin Brands
See all →- nitrofurantoin macrocrystals50 mg/172603-183
- nitrofurantoin macrocrystals50 mg/147781-307
- nitrofurantoin100 mg/150090-7217
- nitrofurantoin macrocrystals100 mg/168001-605
- nitrofurantoin macrocrystals100 mg/172789-340
- Nitrofurantoin macrocrystals100 mg/143386-642
- nitrofurantoin macrocrystals50 mg/168001-604
- nitrofurantoin macrocrystals50 mg/170771-1170
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)