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JAMP NITROFURANTOIN BID is a brand name for Nitrofurantoin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
Adults and Children over 12 years:
One JAMP Nitrofurantoin BID 100 mg capsule twice a day for 7 days (maximum 200 mg/day). JAMP Nitrofurantoin BID should be taken every 12 hours with food or milk to minimize gastric upset. Therapy for acute urinary tract infections should be continued for 7 days or for at least 3 days after sterility of the urine is obtained.
Continued infection indicates the need for re-evaluation. 18 g/mol Description Nitrofurantoin is a yellow crystalline powder or yellow crystals; very slightly soluble in water and in ethanol (96 percent), soluble in dimethylformamide.
JAMP Nitrofurantoin BID (Nitrofurantoin Capsules) Product Monograph Page 11 of 20 Composition Each 100 mg JAMP Nitrofurantoin BID capsule contains the equivalent of 100 mg of nitrofurantoin in the form of nitrofurantoin macrocrystals and nitrofurantoin monohydrate and the following inactive ingredients: carbomer homopolymer type B, lactose monohydrate, magnesium stearate, starch – maize, povidone and talc.
The hard gelatin capsule shell contains the following inactive ingredients:
D&C yellow No. 10, FD&C blue No. 1, FD&C red No. 40, gelatin, sodium lauryl sulfate and titanium dioxide.
Dissolution:
In-house (by UV) Storage Store at controlled room temperature 15-30°C. Keep out of reach and sight of children. AVAILABILITY JAMP Nitrofurantoin BID 100 mg is available for oral administration as a hard gelatin capsule, size “1”, with black cap imprinted with “NIT” and yellow opaque body imprinted with “100” containing white to yellowish granular powder and yellow coloured tablets.
Available in HDPE bottles of 100 capsules. MICROBIOLOGY The in vitro antibacterial activity of nitrofurantoin against clinical isolates is given below. Minimal Inhibitory Concentration (mcg/mL) Organism (# strains tested) MIC50 MIC90 Range Citrobacter freundii (97) 32 32 16 - >128 Enterobacter aerogenes (75) 64 128 32 - 128 Enterobacter cloacae (135) 64 128 4 - 128 Escherichia coli (1792) 16 32 8 - 128 Klebsiella oxytoca (52) 32 64 ≤16 - >128 Klebsiella pneumoniae (410) 64 128 32 - >128 Staphylococcus aureus (84) 16 32 16 - 32 Staphylococcus epidermidis (25) 16 16 8 - 32 Staphylococcus saprophyticus (25) 16 16 8 - 32 Enterococcus faecalis (598) 16 16 8 - 64 Nitrofurantoin is not active against most strains of Proteus or Serratia species.
It has no activity against Pseudomonas species. Nitrofurantoin is bactericidal in urine at levels equal to one or two times the MIC. Nitrofurantoin monohydrate / macrocrystals exhibits concentration dependent killing of bacteria. Antagonism has been demonstrated in vitro between nitrofurantoin and quinolone antimicrobials.
The clinical significance of this finding is unknown. Development of resistance to nitrofurantoin has not been a significant problem since its JAMP Nitrofurantoin BID (Nitrofurantoin Capsules) Product Monograph Page 12 of 20 introduction in 1953.
d. d. 5%). The following additional clinical adverse events have been reported with the use of nitrofurantoin: Respiratory: Chronic, subacute or acute pulmonary hypersensitivity reactions may occur with the use of nitrofurantoin (SEE WARNINGS).
Chronic pulmonary reactions generally occur in patients who have received continuous treatment for 6 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 the degree of their 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 nitrofurantoin therapy. The risk is greater when 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 is not stopped, the symptoms may become more severe. Acute reactions are commonly manifested by fever, chills, cough, chest pain, dyspnea, pulmonary infiltration with consolidation or 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. Changes in ECG may occur associated with pulmonary reactions. Collapse and cyanosis have seldom been reported.
Gastrointestinal:
Diarrhea, dyspepsia, abdominal pain, constipation, emesis, sialadenitis, pancreatitis. Pseudomembranous colititis, including that due to an overgrowth by Colstridium difficile, have been reported rarely with the use of nitrofurantoin.
Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications to therapy with this drug. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug.
For the same reason, this drug is much less effective under these circumstances. The drug is contraindicated in pregnant patients during labour and delivery, or when the onset of labour is imminent, and in infants under one month of age because of the possibility of hemolytic anemia in the fetus or the newborn infant due to their immature erythrocyte enzyme systems (glutathione instability).
JAMP Nitrofurantoin BID capsule therapy is also contraindicated in those patients with known hypersensitivity to nitrofurantoin monohydrate / macrocrystals. WARNINGS Acute, subacute or chronic pulmonary reactions have been observed in patients treated with nitrofurantoin products (SEE ADVERSE REACTIONS).
If these reactions occur, the drug should be withdrawn 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).
Hepatic reactions, including hepatitis, hepatic necrosis, cholestatic jaundice and chronic active hepatitis, occur rarely. Fatalities have been reported. The onset of chronic active hepatitis may be insidious, and patients should be monitored periodically for changes in liver function.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Cross-resistance with antibiotics and sulfonamides has not been observed, and transferable resistance is, at most, a very rare phenomenon. Susceptibility Tests - Quantitative methods that require measurement of zone diameters give the most precise estimates of antimicrobial susceptibility.
One recommended procedure, (National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disc Susceptibility Tests, Approved Standard: M2-A4, Vol. 10, Number 7, 1990), uses a disc containing 300 mcg nitrofurantoin for testing susceptibility.
Reports from the laboratory should be interpreted according to the following criteria: Susceptible organisms produce zones of 17 mm or greater indicating that the tested organism is likely to respond to therapy. Organisms of intermediate susceptibility produce zones of 15 to 16 mm, indicating that the tested organism may or may not be susceptible.
Resistant organisms produce zones of 14 mm or less, indicating that other therapy should be selected. Alternatively, a bacterial isolate may be considered susceptible if the MIC value for nitrofurantoin is not more than 32 mcg/mL. A MIC of 64 mcg/mL indicates intermediate susceptibility.
Organisms are considered resistant if the MIC is equal to or greater than 128 mcg/mL. Dilution and diffusion susceptibility tests should give MICs and zone diameters within the ranges listed below for the following quality control organisms.
Organism MIC (mcg/mL) Zone Size Range (mm) E. coli (ATCC 25922) 4-16 20-25 S. aureus (ATCC 29213) 8-32 18-22 E. faecalis (ATCC 29212) 4-16 - - PHARMACOLOGY Human: Nitrofurantoin taken orally is rapidly absorbed from the gastrointestinal tract and appears to be widely distributed.
Based upon urine recovery levels its bioavailability may be increased by as much as 40% when administered with food. 8 hrs in plasma. 1 hrs. Plasma levels do not normally exceed 1 mcg/mL following therapeutic administration of nitrofurantoin monohydrate / macrocrystals capsules to subjects with normal kidney function.
Levels far exceeding those in plasma have been reported for human bile, seminal fluid and kidney. 5% of urine contents are metabolized. Little is known […]
Hepatic:
Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis occur rarely (SEE WARNINGS).
Neurologic:
Peripheral neuropathy, including optic neuritis (SEE WARNINGS). JAMP Nitrofurantoin BID (Nitrofurantoin Capsules) Product Monograph Page 8 of 20 Dizziness, drowsiness, amblyopia, asthenia, vertigo, and nystagmus also have been reported with the use of nitrofurantoin Benign intracranial hypertension has seldom been reported.
Confusion, depression, euphoria and psychotic reactions have been reported rarely.
Dermatologic:
Alopecia. Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson Syndrome) have been reported rarely.
Allergic Reactions:
Lupus-like syndrome associated with pulmonary reaction to nitrofurantoin has been reported. Also, angioedema; maculopapular, erythematous or eczematous eruptions; pruritis; urticaria; anaphylaxis; arthralgia; myalgia; drug fever; chills; and malaise have been reported.
Hematologic:
Glucose-6-phosphate dehydrogenase deficiency anemia (SEE WARNINGS), agranulocytosis, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia, megaloblastic anemia, and eosinophilia have occurred. In most cases, these hematologic abnormalities resolved following cessation of therapy.
Aplastic anemia has been reported rarely. , Pseudomonas species or Candida species, may occur with the use of nitrofurantoin. Superinfections have been limited to the genitourinary tract. Increased AST (SGOT), increased ALT (SGPT), decreased hemoglobin and increased serum phosphorus.
Nitrofurantoin monohydrate / macrocrystals may cause a rust yellow to brown discolouration of the urine. The clinical significance is unknown. SYMPTOMS AND TREATMENT OF OVERDOSAGE Occasional incidents of acute overdosage of nitrofurantoin have not resulted in any specific symptomatology other than vomiting.
In case vomiting does not occur soon after an excessive dose, induction of emesis is recommended. There is no specific antidote for nitrofurantoin but a high fluid intake should be maintained to promote urinary excretion of the drug.
It is dialyzable. For management of a suspected drug overdose, contact your regional poison control centre. JAMP Nitrofurantoin BID (Nitrofurantoin Capsules) Product Monograph Page 9 of 20 DOSAGE AND ADMINISTRATION Adults and Children over 12 years: One JAMP Nitrofurantoin BID 100 mg capsule twice a day for 7 days (maximum 200 mg/day).
JAMP Nitrofurantoin BID should be taken every 12 hours with food or milk to minimize gastric upset. Therapy for acute urinary tract infections should be continued for 7 days or for at least 3 days after sterility of the urine is obtained.
Continued infection indicates the need for re-evaluation. 18 g/mol Description Nitrofurantoin is a yellow crystalline powder or yellow crystals; very slightly soluble in water and in ethanol (96 percent), soluble in dimethylformamide.
JAMP Nitrofurantoin BID (Nitrofurantoin Capsules) Product Monograph Page 11 of 20 Composition Each 100 mg JAMP Nitrofurantoin BID capsule […]
If hepatitis occurs, the drug should be withdrawn immediately and appropriate measures taken. Peripheral neuropathy (including optic neuritis) may occur with nitrofurantoin therapy; this may become severe or irreversible. Fatalities have been reported.
Predisposing 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 such occurrence.
Patients receiving long-term therapy should be monitored periodically for changes in renal function. If numbness or tingling occurs, discontinue use. Cases of hemolytic anemia of the primaquine-sensitivity type have been induced by nitrofurantoin.
The 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.
Any sign of hemolysis is an indication to discontinue the drug. Hemolysis ceases when the drug is withdrawn. Pseudomonas is the organism most commonly implicated in superinfections in patients with nitrofurantoin preparations. JAMP Nitrofurantoin BID (Nitrofurantoin Capsules) Product Monograph Page 5 of 20 Carcinogenesis, Mutagenesis and Impairment of Fertility: Nitrofurantoin presented evidence of carcinogenic activity in female B6C3F1 mice as shown by increased incidences of tubular adenomas, benign mixed tumours, and granulosa cell tumours of the ovary.
In male F344/N rats, there were increased incidences of uncommon kidney tubular cell neoplasms, osteosarcomas of the bone, and neoplasms of the subcutaneous tissue. In one study involving three subcutaneous injections of 75 mg/kg nitrofurantoin to pregnant female mice, lung papillary adenomas were observed in the F1 generation.
5 weeks or to female Sprague-Dawley rats for 75 weeks. Two chronic rodent bioassays utilizing male and female Sprague-Dawley rats and two chronic bioassays in Swiss mice and BDF1 mice revealed no evidence of carcinogenicity. Nitrofurantoin has demonstrated mutagenic potential in a variety of laboratory assays conducted in vitro with mammalian and non-mammalian cells exposed to therapeutically attainable and higher concentrations.
Point and possibly other types of mutations were observed in bacteria, yeast and fungi. Damage to DNA or inhibition of DNA synthesis were produced in human fibroblasts and lymphocytes, and Chinese hamster ovaries and lung fibroblasts.
In vivo tests on rodents utilizing a wide range of doses demonstrated similar potential. DNA damage to liver, lung, spleen and kidney were observed in rat (alkaline elution test), immature red blood cells (rat micronucleus test) and sperm (H-test in mouse).
Some test results were negative such as the sex-linked recessive lethal assay in Drosophila where nitrofurantoin was administered by feeding or injection. The significance of the carcinogenicity and mutagenicity findings relative to the therapeutic use of nitrofurantoin in humans is unknown.
Because of the potential toxicity of nitrofurantoin when used for long-term therapy, the benefits of long-term therapy should be weighed against potential risks (See DOSAGE AND ADMINISTRATION section for prescribing information). The administration of high doses of nitrofurantoin to rats causes temporary spermatogenic arrest, which is reversible on discontinuing the drug.
Doses of 10 mg/kg/day or greater in healthy human males may, in certain unpredictable instances, produce slight to moderate spermatogenic arrest with a decrease in sperm count.
Susceptibility/Resistance:
Development of Drug Resistant Bacteria: Prescribing JAMP Nitrofurantoin BID in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
PRECAUTIONS Drug Interactions:
Antacids containing […]