Full Prescribing Info
Each tablet contains nitrofurantoin 50 mg or 100 mg, respectively.
The treatment of pyelonephritis, pyelitis, and cystitis when due to susceptible organisms. Not indicated for the treatment of associated renal cortical or perinephric absecesses, nor in prostatitis.
Dosage/Direction for Use
To minimize gastric upset, administer the drug with food or milk. Adults: 50 to 100 mg 4 times a day. Continue therapy for at least 1 week and for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for revaluation.
If the drug is to be used for long-term suppressive therapy, consider a dosage reduction.
Symptoms: Occasional incidents of acute overdosage of nitrofurantoin have not resulted in any specific symptomatology other than vomiting.
Treatment: In cases 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, but only in case of overdosage.
Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 40 ml/min.) are contraindications to nitrofurantoin therapy. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug. For the same reason, the drug is much less effective under these circumstances.
Nitrofurantoin is contraindicated in pregnant patients at term as well as in infants under 1 month of age, because of the possibility of hemolytic anemia due to immature enzyme systems (glutathione instability).
Known hypersensitivity to nitrofurantoin.
Special Precautions
Hemolytic anemia of the primaquine-sensitivity type has been induced by nitrofurantoin. The hemolysis appears to be linked to a glucose-6-phosphate dehydrogenase deficiency in the affected patients' red blood cells. This deficiency is found in 10% of Negroes and in 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 Hemolysis ceases when the drug is withdrawn.
Predisposing conditions such as renal impairment, anemia, diabetes, electrolyte imbalance, vitamin B deficiency, and debilating disease may enhance the occurrence of peripheral neuropathy.
Peripheral neuropathy may occur with nitrofuratoin therapy, this may become severe or irreversible, a fatality has been reported. If numbness or tingling occurs, discontinue the drug.
Use In Pregnancy & Lactation
Pregnancy: Nitrofurantoin is contraindicated in pregnant patients at term.
Nitrofurantoin's safety during pregnancy and lactation has not been established. It should not be used in women of childbearing potential unless the expected benefits outweight the possible hazards.
Adverse Reactions
Gastrointestinal: Anorexia, nausea, emesis are the most frequent reactions; less frequently, abdominal pain and diarrhea: rarely, hepatitis. This dose-related toxicity reaction can be minimized by reduction of dosage, especially in the female patient.
Hypersensitivity: Pulmonary sensitivity reactions, which can be acute, subacute, or chronic. Acute reaction is commonly manifested by fever, chills, cough, chest pain, dyspnea, pulmonary infiltration with consolidation or pleural effusion on X-ray, and eosinophilia. The acute reactions usually occur within the first week of treatment and resolve with cessation of the drug therapy.
Subacute or chronic pulmonary reaction is associated with prolonged therapy. Insidious onset of malaise, dyspnea on exertion, cough, altered pulmonary function, and roentgenographic and histologic findings of diffuse interstitial pneumonitis or fibrosis or both are common manifestations. Impaired pulmonary function may result even after cessation of the drug therapy.
Dermatologic: Maculopapular, erythematous, or eczematous eruption, pruritus, urticaria, angioedema.
Other sensitivity reaction: anaphylaxis, asthmatic attack in patients with history of asthma, cholestatic jaundice, drug fever, arthralgia.
Hematologic: Hemolytic anemia, granulocytopenia, eosinophilia, megaloblastic anemia. Return of the blood picture to normal has followed cessation of therapy.
Peripheral neuropathy, headache, dizziness, nystagmus and drowsiness.
Miscellaneous: Transient alopecia. As with other antimicrobial agents, superinfections by resistant organisms may occur: With nitrofurantoin, however, these are limited to the genitourinary tract because suppression of normal bacterial flora elsewhere in the body does not occur.
Pseudomonas is the organism most commonly implicated in superinfections in patients with nitrofurantoin.
Drug Interactions
Do not administer nitrofurantoin concomitantly with drugs which may produce impaired renal function.
Caution For Usage
Incompatibilities: Nitrofurantoin was "physically incompatible" with tetracycline in dextrose solution. There was a loss of clarity when intravenous solutions of nitrofurantoin is mixed with a variety of drugs. Check before mixing. Nitrofurantoin sodium is incompatible with amikacin sulphate in a variety of diluents.
Store in a cool place, protect from light.
ATC Classification
J01XE01 - nitrofurantoin ; Belongs to the class of nitrofuran derivative antibacterials. Used in the systemic treatment of infections.
Tab 50 mg (scored) x 100's. 100 mg (scored) x 100's.
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