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Furadantin
Overview
What is Furadantin?
Furadantin
Furadantin
Inactive Ingredients
What does Furadantin look like?
What are the available doses of Furadantin?
Sorry No records found.
What should I talk to my health care provider before I take Furadantin?
Sorry No records found
How should I use Furadantin?
Furadantin
Escherichiacoli
Staphylococcusaureus
Klebsiella
Enterobacter
Nitrofurantoin isnot indicated for the treatment of pyelonephritis or perinephric abscesses.
Nitrofurantoinslack the broader tissue distribution of other therapeutic agents approved forurinary tract infections. Consequently, many patients who are treated withFuradantin are predisposed to persistence or reappearance of bacteriuria. Urinespecimens for culture and susceptibility testing should be obtained before andafter completion of therapy. If persistence or reappearance of bacteriuriaoccurs after treatment with ,other therapeutic agents with broader tissue distribution should be selected.In considering the use of ,lower eradication rates should be balanced against the increased potential forsystemic toxicity and for the development of antimicrobial resistance whenagents with broader tissue distribution are utilized.
Furadantin
Adults
Pediatric Patients
Furadantin
Table 3: Pediatric Dosing Table
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 50-100 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. .
What interacts with Furadantin?
Anuria, oliguria,or significant impairment of renal function (creatinine clearance under 60 mLper minute or clinically significant elevated serum creatinine) arecontraindications. Treatment of this type of patient carries an increased riskof toxicity because of impaired excretion of the drug.
Because of thepossibility of hemolytic anemia due to immature erythrocyte enzyme systems(glutathione instability), the drug is contraindicated in pregnant patients atterm (38-42 weeks gestation), during labor and delivery, or when the onset oflabor is imminent. For the same reason, the drug is contraindicated in neonatesunder one month of age.
Furadantin
Furadantin
What are the warnings of Furadantin?
Pulmonary reactions
ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, FURADANTIN 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.)
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 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.
Hemolytic anemia
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 hemolysis ceases when the drug is withdrawn.
Clostridium difficile-associated diarrhea
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
What are the precautions of Furadantin?
INFORMATION FOR PATIENTS
Patients should beadvised to take with foodto further enhance tolerance and improve drug absorption. Patients should beinstructed to complete the full course of therapy; however, they should beadvised to contact their physician if any unusual symptoms should occur duringtherapy.
Diarrhea is acommon problem caused by antibiotics which usually ends when the antibiotic isdiscontinued. Sometimes after starting treatment with antibiotics, patients candevelop watery and bloody stools (with or without stomach cramps and fever)even as late as two or more months after having taken the last dose of theantibiotic. If this occurs, patients should contact their physician as soon aspossible.
Patients should beadvised not to use antacid preparations containing magnesium trisilicate whiletaking .
DRUG INTERACTIONS
Antacidscontaining magnesium trisilicate, when administered concomitantly withnitrofurantoin, reduce both the rate and extent of absorption. The mechanismfor this interaction probably is adsorption of nitrofurantoin onto the surfaceof magnesium trisilicate.
Uricosuric drugs,such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion ofnitrofurantoin. The resulting increase in nitrofurantoin serum levels mayincrease toxicity, and the decreased urinary levels could lessen its efficacyas a urinary tract antibacterial.
DRUG & OR LABORATORY TEST INTERACTIONS
As a result of thepresence of nitrofurantoin, a false-positive reaction for glucose in the urinemay occur. This has been observed with Benedict's and Fehling's solutions butnot with the glucose enzymatic test.
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Nitrofurantoin wasnot carcinogenic when fed to female Holtzman rats for 44.5 weeks or to femaleSprague-Dawley rats for 75 weeks. Two chronic rodent bioassays utilizing maleand female Sprague-Dawley rats and two chronic bioassays in Swiss mice and inBDF mice revealed no evidence of carcinogenicity.
Nitrofurantoinpresented evidence of carcinogenic activity in female B6C3F mice asshown by increased incidences of tubular adenomas, benign mixed tumors, andgranulosa cell tumors of the ovary. In male F344/N rats, there were increasedincidences of uncommon kidney tubular cell neoplasms, osteosarcomas of thebone, and neoplasms of the subcutaneous tissue. In one study involvingsubcutaneous administration of 75 mg/kg nitrofurantoin to pregnant female mice,lung papillary adenomas of unknown significance were observed in the F1generation.
Nitrofurantoin hasbeen shown to induce point mutations in certain strains of and forward mutations on L5178Y mouselymphoma cells. Nitrofurantoin induced increased numbers of sister chromatidexchanges and chromosomal aberrations in Chinese hamster ovary cells but not inhuman cells in culture. Results of the sex-linked recessive lethal assay inDrosophila were negative after administration of nitrofurantoin by feeding orby injection. Nitrofurantoin did not induce heritable mutation in the rodentmodels examined.
The significanceof carcinogenicity and mutagenicity findings relative to the therapeutic use ofnitrofurantoin in humans is unknown.
The administrationof high doses of nitrofurantoin to rats causes temporary spermatogenic arrest;this is reversible on discontinuing the drug. Doses of 10 mg/kg/day or greaterin healthy human males may, in certain unpredictable instances, produce aslight to moderate spermatogenic arrest with a decrease in sperm count.
PREGNANCY
Teratogenic effects
Pregnancy CategoryB. Several reproduction studies have been performed in rabbits and rats atdoses up to six times the human dose and have revealed no evidence of impairedfertility or harm to the fetus due to nitrofurantoin. In a single publishedstudy conducted in mice at 68 times the human dose (based on mg/kg administeredto the dam), growth retardation and a low incidence of minor and commonmalformations were observed. However at 25 times the human dose, fetalmalformations were not observed; the relevance of these findings to humans isuncertain. There are, however, no adequate and well-controlled studies inpregnant women. Because animal reproduction studies are not always predictiveof human response, this drug should be used during pregnancy only if clearlyneeded.
Non-teratogeniceffects
Nitrofurantoin hasbeen shown in one published transplacental carcinogenicity study to induce lungpapillary adenomas in the F1 generation mice at doses 19 times the human doseon a mg/kg basis. The relationship of this finding to potential humancarcinogenesis is presently unknown. Because of the uncertainty regarding thehuman implications of these animal data, this drug should be used duringpregnancy only if clearly needed.
LABOR & DELIVERY
See
NURSING MOTHERS
Nitrofurantoin hasbeen detected in human breast milk in trace amounts. Because of the potentialfor serious adverse reactions from nitrofurantoin in nursing infants under onemonth of age, a decision should be made whether to discontinue nursing or todiscontinue the drug, taking into account the importance of the drug to themother. (see )
PEDIATRIC USE
Safety andeffectiveness of inneonates below the age of one month have not been established. (see )
What are the side effects of Furadantin?
Respiratory
CHRONIC, SUBACUTE, OR ACUTE PULMONARY HYPERSENSITIVITY REACTIONS MAY OCCUR.
CHRONIC PULMONARY REACTIONS MAY 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 DEGREES 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 manifested by fever, chills, cough, chest pain, dyspnea, pulmonary infiltration with consolidation of pleural effusion on x-ray, and eosinophilia. Acute reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Resolution often is dramatic. (see )
Changes in EKG (e.g., non-specific ST/T wave changes, bundle branch block) have been reported in association with pulmonary reactions.
Cyanosis has been reported rarely.
Hepatic
Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic neurosis, occur rarely. (see )
Neurologic
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 diseases may increase the possibility of peripheral neuropathy (see )
Asthenia, vertigo, nystagmus, dizziness, headache, and drowsiness have also been reported with the use of nitrofurantoin.
Benign intracranial hypertension (pseudotumor cerebri), confusion, depression, optic neuritis, and psychotic reactions have been reported rarely. Bulging fontanels, as a sign of benign intracranial hypertension in infants, have been reported rarely.
Dermatologic
Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson syndrome) have been reported rarely. Transient alopecia also has been reported.
Allergic
A lupus-like syndrome associated with pulmonary reactions to nitrofurantoin has been reported. Also, angioedema; maculopapular, erythematous, or eczematous eruptions; pruritus; urticaria; anaphylaxis; arthralgia; myalgia; drug fever; and vasculitis (sometimes associated with pulmonary reactions) have been reported. Hypersensitivity reactions present the most frequent spontaneously-reported adverse events in world-wide postmarketing experience with nitrofurantoin formulations.
Gastrointestinal
Nausea, emesis, and anorexia occur most often. Abdominal pain and diarrhea are less common gastrointestinal reactions. These dose-related reactions can be minimized by reduction of dosage. Sialadenitis and pancreatitis have been reported. 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 )
Hematologic
Cyanosis secondary to methemoglobinemia has been reported rarely.
Miscellaneous
As with other antimicrobial agents, superinfections caused by resistant organisms, e.g., species or species, can occur. There are sporadic reports of C superinfections, or pseudomembranous colitis, with the use of nitrofurantoin.
Laboratory Adverse Events
The following laboratory adverse events have been reported with the use of nitrofurantoin; increased AST (SGOT), increased ALT (SGPT), decreased hemoglobin, increased serum phosphorus, eosinophilia, glucose-6-phosphate dehydrogenase deficiency anemia (see ), agranulocytosis, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia, megaloblastic anemia. In most cases, these hematologic abnormalities resolved following cessation of therapy. Aplastic anemia has been reported rarely.
To report SUSPECTED ADVERSE REACTIONS, contact Casper Pharma LLC. at 1-844–5–CASPER (1-844-522-7737) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using Furadantin?
Anuria, oliguria,or significant impairment of renal function (creatinine clearance under 60 mLper minute or clinically significant elevated serum creatinine) arecontraindications. Treatment of this type of patient carries an increased riskof toxicity because of impaired excretion of the drug.
Because of thepossibility of hemolytic anemia due to immature erythrocyte enzyme systems(glutathione instability), the drug is contraindicated in pregnant patients atterm (38-42 weeks gestation), during labor and delivery, or when the onset oflabor is imminent. For the same reason, the drug is contraindicated in neonatesunder one month of age.
Furadantin
Furadantin
Pulmonary reactions
ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, FURADANTIN 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.)
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 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.
Hemolytic anemia
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 hemolysis ceases when the drug is withdrawn.
Clostridium difficile-associated diarrhea
Clostridium difficile
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
What might happen if I take too much Furadantin?
Occasionalincidents of acute overdosage of have not resulted in any specific symptoms other than vomiting. Induction ofemesis is recommended. There is no specific antidote, but a high fluid intakeshould be maintained to promote urinary excretion of the drug. It isdialyzable.
How should I store and handle Furadantin?
JEVTANA is a cytotoxic anticancer drug. Follow applicable special handling and disposable procedures FuradantinNDCAvoid exposure to strong light which may darken the drug. It is stable when stored between 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days.Keep out of reach of children.Rx only Halo Pharmaceutical Canada IncCasper Pharma LLCPICN02182016 Issued: 02/2016FuradantinNDCAvoid exposure to strong light which may darken the drug. It is stable when stored between 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days.Keep out of reach of children.Rx only Halo Pharmaceutical Canada IncCasper Pharma LLCPICN02182016 Issued: 02/2016FuradantinNDCAvoid exposure to strong light which may darken the drug. It is stable when stored between 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days.Keep out of reach of children.Rx only Halo Pharmaceutical Canada IncCasper Pharma LLCPICN02182016 Issued: 02/2016FuradantinNDCAvoid exposure to strong light which may darken the drug. It is stable when stored between 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days.Keep out of reach of children.Rx only Halo Pharmaceutical Canada IncCasper Pharma LLCPICN02182016 Issued: 02/2016FuradantinNDCAvoid exposure to strong light which may darken the drug. It is stable when stored between 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days.Keep out of reach of children.Rx only Halo Pharmaceutical Canada IncCasper Pharma LLCPICN02182016 Issued: 02/2016FuradantinNDCAvoid exposure to strong light which may darken the drug. It is stable when stored between 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days.Keep out of reach of children.Rx only Halo Pharmaceutical Canada IncCasper Pharma LLCPICN02182016 Issued: 02/2016FuradantinNDCAvoid exposure to strong light which may darken the drug. It is stable when stored between 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days.Keep out of reach of children.Rx only Halo Pharmaceutical Canada IncCasper Pharma LLCPICN02182016 Issued: 02/2016FuradantinNDCAvoid exposure to strong light which may darken the drug. It is stable when stored between 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days.Keep out of reach of children.Rx only Halo Pharmaceutical Canada IncCasper Pharma LLCPICN02182016 Issued: 02/2016FuradantinNDCAvoid exposure to strong light which may darken the drug. It is stable when stored between 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days.Keep out of reach of children.Rx only Halo Pharmaceutical Canada IncCasper Pharma LLCPICN02182016 Issued: 02/2016FuradantinNDCAvoid exposure to strong light which may darken the drug. It is stable when stored between 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days.Keep out of reach of children.Rx only Halo Pharmaceutical Canada IncCasper Pharma LLCPICN02182016 Issued: 02/2016
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Orally administered Furadantin is readily absorbed and rapidly excreted in urine. Blood concentrations at therapeutic dosage are usually low. It is highly soluble in urine, to which it may impart a brown color.
Following a dose regimen of 100 mg q.i.d. for 7 days, average urinary drug recoveries (0-24 hours) on day 1 and day 7 were 42.7% and 43.6%.
Unlike many drugs, the presence of food or agents delaying gastric emptying can increase the bioavailability of , presumably by allowing better dissolution in gastric juices.
Nitrofurantoin is reduced by a wide range of enzymes including bacterial flavoproteins to reactive intermediates which are damaging to macromolecules such as DNA and proteins.
Although cross-resistance with other antimicrobials may occur, cross resistance with sulfonamides has not been observed.
Antagonism has been demonstrated in vitro between nitrofurantoin and quinolone antimicrobial agents. Nitrofurantoin, in the form of nitrofurantoin oral suspension, has been shown to be active against most of the following bacteria both in vitro and in clinical infections: (See ).
NOTE: Some strains of species and species are resistant to nitrofurantoin. The following data are available, but their clinical significance is unknown. Nitrofurantoin exhibits in vitro activity against the following bacteria; however, the safety and effectiveness of nitrofurantoin in treating clinical infections due to these bacteria have not been established in adequate and well controlled clinical trials.
Coagulase-negative staphylococci (including and )
Viridans group streptococci
Nitrofurantoin is not active against most strains of species or species. It has no activity against species.
When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug product for treatment.
Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method (broth or agar). The MIC values should be interpreted according to the criteria in Table 1.
Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized method. This procedure uses paper disks impregnated with 300 mcg of nitrofurantoin to test the susceptibility of bacteria to nitrofurantoin. The disk diffusion interpretive criteria are provided in Table 1.
Table 1: Susceptibility interpretive Criteria for Nitrofurantoin
S= susceptible, I= intermediate, R= resistant
A report of “Susceptible” indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentration at the infection site necessary to inhibit growth of the pathogen. A report of Intermediate indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body site where the drug is physiologically concentrated. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site; other therapy should be selected.
Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test. Standard nitrofurantoin powder should provide the following MIC values provided in Table 2. For the diffusion technique using the 300-mcg nitrofurantoin disk the criteria provided in Table 2 should be achieved.
Table 2: Acceptable Quality Control Ranges for Susceptibility Testing
Non-Clinical Toxicology
Anuria, oliguria,or significant impairment of renal function (creatinine clearance under 60 mLper minute or clinically significant elevated serum creatinine) arecontraindications. Treatment of this type of patient carries an increased riskof toxicity because of impaired excretion of the drug.Because of thepossibility of hemolytic anemia due to immature erythrocyte enzyme systems(glutathione instability), the drug is contraindicated in pregnant patients atterm (38-42 weeks gestation), during labor and delivery, or when the onset oflabor is imminent. For the same reason, the drug is contraindicated in neonatesunder one month of age.
Furadantin
Furadantin
Pulmonary reactions
ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, FURADANTIN 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.)
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 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.
Hemolytic anemia
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 hemolysis ceases when the drug is withdrawn.
Clostridium difficile-associated diarrhea
Clostridium difficile
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Antacidscontaining magnesium trisilicate, when administered concomitantly withnitrofurantoin, reduce both the rate and extent of absorption. The mechanismfor this interaction probably is adsorption of nitrofurantoin onto the surfaceof magnesium trisilicate.
Uricosuric drugs,such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion ofnitrofurantoin. The resulting increase in nitrofurantoin serum levels mayincrease toxicity, and the decreased urinary levels could lessen its efficacyas a urinary tract antibacterial.
Patients should beadvised to take with foodto further enhance tolerance and improve drug absorption. Patients should beinstructed to complete the full course of therapy; however, they should beadvised to contact their physician if any unusual symptoms should occur duringtherapy.
Diarrhea is acommon problem caused by antibiotics which usually ends when the antibiotic isdiscontinued. Sometimes after starting treatment with antibiotics, patients candevelop watery and bloody stools (with or without stomach cramps and fever)even as late as two or more months after having taken the last dose of theantibiotic. If this occurs, patients should contact their physician as soon aspossible.
Patients should beadvised not to use antacid preparations containing magnesium trisilicate whiletaking .
Respiratory
CHRONIC, SUBACUTE, OR ACUTE PULMONARY HYPERSENSITIVITY REACTIONS MAY OCCUR.
CHRONIC PULMONARY REACTIONS MAY 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 DEGREES 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 manifested by fever, chills, cough, chest pain, dyspnea, pulmonary infiltration with consolidation of pleural effusion on x-ray, and eosinophilia. Acute reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Resolution often is dramatic. (see )
Changes in EKG (e.g., non-specific ST/T wave changes, bundle branch block) have been reported in association with pulmonary reactions.
Cyanosis has been reported rarely.
Hepatic
Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic neurosis, occur rarely. (see )
Neurologic
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 diseases may increase the possibility of peripheral neuropathy (see )
Asthenia, vertigo, nystagmus, dizziness, headache, and drowsiness have also been reported with the use of nitrofurantoin.
Benign intracranial hypertension (pseudotumor cerebri), confusion, depression, optic neuritis, and psychotic reactions have been reported rarely. Bulging fontanels, as a sign of benign intracranial hypertension in infants, have been reported rarely.
Dermatologic
Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson syndrome) have been reported rarely. Transient alopecia also has been reported.
Allergic
A lupus-like syndrome associated with pulmonary reactions to nitrofurantoin has been reported. Also, angioedema; maculopapular, erythematous, or eczematous eruptions; pruritus; urticaria; anaphylaxis; arthralgia; myalgia; drug fever; and vasculitis (sometimes associated with pulmonary reactions) have been reported. Hypersensitivity reactions present the most frequent spontaneously-reported adverse events in world-wide postmarketing experience with nitrofurantoin formulations.
Gastrointestinal
Nausea, emesis, and anorexia occur most often. Abdominal pain and diarrhea are less common gastrointestinal reactions. These dose-related reactions can be minimized by reduction of dosage. Sialadenitis and pancreatitis have been reported. 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 )
Hematologic
Cyanosis secondary to methemoglobinemia has been reported rarely.
Miscellaneous
As with other antimicrobial agents, superinfections caused by resistant organisms, e.g., species or species, can occur. There are sporadic reports of C superinfections, or pseudomembranous colitis, with the use of nitrofurantoin.
Laboratory Adverse Events
The following laboratory adverse events have been reported with the use of nitrofurantoin; increased AST (SGOT), increased ALT (SGPT), decreased hemoglobin, increased serum phosphorus, eosinophilia, glucose-6-phosphate dehydrogenase deficiency anemia (see ), agranulocytosis, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia, megaloblastic anemia. In most cases, these hematologic abnormalities resolved following cessation of therapy. Aplastic anemia has been reported rarely. To report SUSPECTED ADVERSE REACTIONS, contact Casper Pharma LLC. at 1-844–5–CASPER (1-844-522-7737) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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