Nitrofurantoin Macrocrystals
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Questions & Answers
Side Effects & Adverse Reactions
ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, NITROFURANTOIN 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 ADVERSE REACTIONS, Respiratory).
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 If hepatitis occurs, the drug should be withdrawn immediately and appropriate measures should be taken.
Peripheral neuropathy, which may become severe or irreversible, has occurred. Fatalities have been reported. Conditions such as renal impairment (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating disease may enhance the occurrence of peripheral neuropathy. Patients receiving long-term therapy should be monitored periodically for changes in renal function.
Optic neuritis has been reported rarely in postmarketing experience with nitrofurantoin formulations.
Cases of hemolytic anemia of the primaquine-sensitivity type have been induced by nitrofurantoin. Hemolysis appears to be linked to a glucose-6-phosphate dehydrogenase deficiency in the red blood cells of the affected patients. This deficiency is found in 10 percent of Blacks and a small percentage of ethnic groups of Mediterranean and Near-Eastern origin. Hemolysis is an indication for discontinuing nitrofurantoin macrocrystals; hemolysis ceases when the drug is withdrawn.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including nitrofurantoin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Nitrofurantoin Capsules USP (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 USP (Macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules USP (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 USP (Macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Capsules USP (Macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules USP (Macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
History
There is currently no drug history available for this drug.
Other Information
Nitrofurantoin Capsules USP (Macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin Capsules USP (Macrocrystals) are an antibacterial agent for specific urinary tract infections.
Nitrofurantoin, USP (macrocrystals) is chemically designated as 2,4-Imidazolidinedione, 1-[[(5-nitro-2-furanyl)methylene]amino]- and has the following structural formula:
C8H6N4O5 (anhydrous) M.W. 238.16
Each capsule, for oral administration, contains 50 mg or 100 mg of nitrofurantoin, USP (macrocrystals). In addition, each capsule contains the following inactive ingredients: corn starch, edible black ink (black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol, shellac glaze), gelatin, lactose monohydrate, talc, titanium dioxide and colorant D&C Red No. 33.
Sources
Nitrofurantoin Macrocrystals Manufacturers
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A-s Medication Solutions Llc
![Nitrofurantoin Macrocrystals Capsule [A-s Medication Solutions Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Nitrofurantoin Macrocrystals | A-s Medication Solutions Llc
Nitrofurantoin capsules (macrocrystals) should be given with food to improve drug absorption and, in some patients, tolerance.
Adults50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.
Pediatric Patients5 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 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. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
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Stat Rx Usa Llc
Nitrofurantoin Macrocrystals | Stat Rx Usa Llc
Nitrofurantoin macrocrystals should be given with food to improve drug absorption and, in some patients, tolerance.
Adults50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.
Pediatric Patients5 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 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. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
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Blenheim Pharmacal, Inc.
Nitrofurantoin Macrocrystals | Blenheim Pharmacal, Inc.
Nitrofurantoin macrocrystals should be given with food to improve drug absorption and, in some patients, tolerance.
Adults50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.
Pediatric Patients5 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 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. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
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Redpharm Drug Inc.
Nitrofurantoin Macrocrystals | Redpharm Drug Inc.
Nitrofurantoin macrocrystals should be given with food to improve drug absorption and, in some patients, tolerance.
Adults50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.
Pediatric Patients5 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 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. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
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Pd-rx Pharmaceuticals, Inc.
Nitrofurantoin Macrocrystals | Pd-rx Pharmaceuticals, Inc.
Nitrofurantoin capsules (macrocrystals) should be given with food to improve drug absorption and, in some patients, tolerance.
Adults50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.
Pediatric Patients5 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 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. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Nitrofurantoin Macrocrystals | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Nitrofurantoin macrocrystals should be given with food to improve drug absorption and, in some patients, tolerance.
Adults50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.
Pediatric Patients5 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 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. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
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Physicians Total Care, Inc.
Nitrofurantoin Macrocrystals | Physicians Total Care, Inc.
Nitrofurantoin macrocrystals should be given with food to improve drug absorption and, in some patients, tolerance.
Adults50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.
Pediatric Patients5 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 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. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
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Rebel Distributors Corp
Nitrofurantoin Macrocrystals | Rebel Distributors Corp
Nitrofurantoin macrocrystals should be given with food to improve drug absorption and, in some patients, tolerance.
Adults50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.
Pediatric Patients5 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 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. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
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Bluepoint Laboratories
Nitrofurantoin Macrocrystals | 3m Health Care
Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.
Supervise children in the use of this product. -
Teva Pharmaceuticals Usa Inc
Nitrofurantoin Macrocrystals | Teva Pharmaceuticals Usa Inc
Nitrofurantoin capsules (macrocrystals) should be given with food to improve drug absorption and, in some patients, tolerance.
Adults50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.
Pediatric Patients5 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 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. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
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American Health Packaging
Nitrofurantoin Macrocrystals | American Health Packaging
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Unit Dose Services
Nitrofurantoin Macrocrystals | Unit Dose Services
Nitrofurantoin capsules (macrocrystals) should be given with food to improve drug absorption and, in some patients, tolerance.
Adults50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.
Pediatric Patients5 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 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. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
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Liberty Pharmaceuticals, Inc.
Nitrofurantoin Macrocrystals | Liberty Pharmaceuticals, Inc.
Nitrofurantoin macrocrystals should be given with food to improve drug absorption and, in some patients, tolerance.
Adults50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.
Pediatric Patients5 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 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. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
-
Liberty Pharmaceuticals, Inc.
Nitrofurantoin Macrocrystals | Liberty Pharmaceuticals, Inc.
Nitrofurantoin capsules (macrocrystals) should be given with food to improve drug absorption and, in some patients, tolerance.
Adults50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.
Pediatric Patients5 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 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. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
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Bryant Ranch Prepack
Nitrofurantoin Macrocrystals | Bryant Ranch Prepack
Nitrofurantoin macrocrystals should be given with food to improve drug absorption and, in some patients, tolerance.
Adults50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.
Pediatric Patients5 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 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. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.
![Nitrofurantoin Macrocrystals Capsule [Stat Rx Usa Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fb4c9c55-63c4-4d8a-b89e-36e921b39e81&name=NITROFURANTOIN100MG380.jpg)
![Nitrofurantoin Macrocrystals Capsule [Blenheim Pharmacal, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=013433a1-c27c-4712-a03b-0949b2969fbb&name=10544-601-20-0093-2131-01.jpg)
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![Nitrofurantoin Macrocrystals Capsule [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=602aeac6-9e4e-4e05-8a67-b9df4d804382&name=Nitrofurantoin100mgTeva.jpg)
![Nitrofurantoin Macrocrystals Capsule [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6acc17e8-20e2-403c-b1c5-6512201fe6a8&name=0107.jpg)
![Nitrofurantoin Macrocrystals Capsule [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=407a8f85-11c4-4404-8678-1c5e68860c8f&name=407a8f85-11c4-4404-8678-1c5e68860c8f-03.jpg)
![Nitrofurantoin Macrocrystals Capsule [Bluepoint Laboratories]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a8c72bcf-9e60-4702-b666-72639b0505b6&name=3mx01-0006-02.jpg)
![Nitrofurantoin Macrocrystals Capsule [Teva Pharmaceuticals Usa Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=09d16de0-e11e-4ca1-8073-cc0bb0677aa9&name=0370b5b3-aebd-4fa7-b8ad-39bf6b60d750-04.jpg)
![Nitrofurantoin Macrocrystals Capsule [American Health Packaging]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b15533c-61e8-4d76-8323-012c2e922bbe&name=9b15533c-61e8-4d76-8323-012c2e922bbe-02.jpg)
![Nitrofurantoin Macrocrystals Capsule [Unit Dose Services]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=be0fcd76-a1f2-4d5b-8714-30abcbfab627&name=50436-6591.jpg)
![Nitrofurantoin Macrocrystals Capsule [Liberty Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=41b65a12-25d4-4e29-ae00-010df78b73ed&name=nitrofurantoin-for-teva-3.jpg)
![Nitrofurantoin Macrocrystals Capsule [Liberty Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=81fd4f9a-594f-444f-a0d4-d33dc4818a8a&name=nitrofurantoin-100-mg--for-teva-14-caps-3.jpg)
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