Nitrofurantoin

Storage

Oral

15–30°C.b Protect from light.a

20–25°C in tight, light-resistant containers.e Dispense in glass amber bottle; exposure to strong light may darken drug.e Protect from freezing.e

Avoid use; alternative agents preferred. Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling. Contraindicated in patients with a previous history of cholestatic jaundice or hepatic dysfunction associated with nitrofurantoin.

Capsules: Store at controlled room temperature, 15°C to 30°C (59°F to 86°F). Dispense in a tight container using a child-resistant closure.

Oral suspension: Avoid exposure to strong light, which may darken the drug. It is stable when stored between 20°C and 25°C (68°F and 77°F). Protect from freezing. Dispense in glass amber bottles.

False-positive urine glucose (Benedict's and Fehling's methods); no false positives with enzymatic tests

Frequency not defined.

Cardiovascular: ECG changes (nonspecific ST/T wave changes, bundle branch block)

Central nervous system: Bulging fontanel (infants), chills, confusion, depression, dizziness, drowsiness, headache, malaise, numbness, paresthesia, peripheral neuropathy, pseudotumor cerebri, psychotic reaction, vertigo

Dermatologic: Alopecia, erythema multiforme, exfoliative dermatitis, pruritus, skin rash (eczematous, erythematous, maculopapular), Stevens-Johnson syndrome, urticaria

Endocrine & metabolic: Hyperphosphatemia

Gastrointestinal: Abdominal pain, anorexia, Clostridium difficile associated diarrhea, constipation, diarrhea, dyspepsia, flatulence, nausea, pancreatitis, pseudomembranous colitis, sialadenitis, vomiting

Genitourinary: Urine discoloration (brown)

Hematologic & oncologic: Agranulocytosis, aplastic anemia, eosinophilia, glucose-6-phosphate dehydrogenase deficiency anemia, granulocytopenia, hemoglobin decreased, hemolytic anemia, leukopenia, megaloblastic anemia, thrombocytopenia

Hepatic: Cholestatic jaundice, hepatitis, hepatic necrosis, increased serum transaminases

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity (including acute pulmonary hypersensitivity)

Infection: Superinfection (eg, Pseudomonas or Candida)

Neuromuscular & skeletal: Arthralgia, lupus-like syndrome, myalgia, weakness

Ophthalmic: Amblyopia, nystagmus, optic neuritis

Respiratory: Acute pulmonary reaction (symptoms include chills, chest pain, cough, dyspnea, fever, and eosinophilia), cough, cyanosis, dyspnea, pneumonitis, pulmonary fibrosis (with long-term use), pulmonary infiltration

Miscellaneous: Fever

Postmarketing and/or case reports (Limited to important or life-threatening): Hepatotoxicty (idiosyncratic) (Chalasani, 2014)

Signs of pulmonary reaction; signs of numbness or tingling of the extremities; CBC, periodic liver function tests, periodic renal function tests with long-term use

Consult your pharmacist.

How to use Nitrofurantoin Powder

Consult your pharmacist.

Usual Adult Dose for Cystitis:

Regular release: 50 to 100 mg orally 4 times a day for 1 week or for at least 3 days after urine sterility is obtained
Dual release: 100 mg orally twice a day for 7 days

Usual Adult Dose for Cystitis Prophylaxis:

Regular release: 50 to 100 mg orally once a day at bedtime

Usual Pediatric Dose for Cystitis:

Regular release:
1 month or older: 5 to 7 mg/kg/day (up to 400 mg/day) orally in 4 divided doses

Dual release:
Greater than 12 years: 100 mg orally twice a day for 7 days

Usual Pediatric Dose for Cystitis Prophylaxis:

Regular release:
1 month or older: 1 to 2 mg/kg/day (up to 100 mg/day) orally in 1 to 2 divided doses

Applies to nitrofurantoin: oral capsule, oral suspension, oral tablet

Along with its needed effects, nitrofurantoin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nitrofurantoin:

• Changes in facial skin color
• chest pain
• chills
• cough
• fever
• general feeling of discomfort or illness
• hives
• hoarseness
• itching
• joint or muscle pain
• shortness of breath
• skin rash
• sudden trouble in swallowing or breathing
• swelling of the face, mouth, hands, or feet
• troubled breathing

• Black, tarry stools
• blood in the urine or stools
• burning, numbness, tingling, or painful sensations
• dizziness
• drowsiness
• headache
• pinpoint red spots on the skin
• sore throat
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness in the arms, hands, legs, or feet

• Abdominal or stomach pain
• blindness
• blistering, peeling, or loosening of the skin and mucous membranes
• blue-yellow color blindness
• bluish color of the fingernails, lips, skin, palms, or nail beds
• blurred vision or loss of vision, with or without eye pain
• bulging soft spot on the head of an infant
• change in the ability to see colors, especially blue or yellow
• confusion
• cracks in the skin
• darkening of the urine
• decreased vision
• diarrhea
• diarrhea, watery and severe, which may also be bloody
• eye pain
• general tiredness and weakness
• light-colored stools
• loss of appetite
• loss of heat from the body
• mental depression
• mood or mental changes
• nausea or vomiting
• pale skin
• pale stools
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• red, thickened, or scaly skin
• skin rash
• sores, ulcers, or white spots on the lips or in the mouth
• swollen or painful glands
• tenderness of salivary glands
• unpleasant breath odor
• upper right abdominal pain
• visual changes
• vomiting of blood
• wheezing or tightness in the chest
• yellow eyes or skin

Some side effects of nitrofurantoin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• gas

• Dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• lack or loss of strength
• loss of hair, temporary
• sensation of spinning
• uncontrolled eye movements

Regular release:
1 month or older: Doses as low as 1 mg/kg/day (up to 100 mg/day) orally in 1 to 2 divided doses may be adequate

Comments:
-This drug should be given with food to improve drug absorption and, in some patients, tolerance.
-Patients receiving long-term therapy should be monitored periodically for changes in renal function.

Use: Cystitis prophylaxis

Administration advice:
-This drug should be given with food to improve drug absorption and, in some patients, tolerance.

Monitoring parameters:
-Renal, liver, and pulmonary function (especially if on long term therapy)

General:
-The lowest effective dose should be used for prophylactic or for long-term suppressive therapy.

Patient advice:
-This drug may cause dizziness and drowsiness; avoid driving or operating machinery if you feel drowsy or dizzy.
-Take this drug with food or milk, avoid missing doses, and complete the entire course of therapy.
-Do not use antacid preparations containing magnesium trisilicate while taking this drug.
-This drug may cause a brownish discoloration of the urine.
-Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibiotic; if this occurs, contact your physician as soon as possible.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Nausea or vomiting, changes in facial skin color, dark colored urine, flatulence, headache and weight loss are the most common side effects. Other side effects, such as abdominal pain, constipation, diarrhea, skin reactions, cardiovascular effects are uncommon or relatively rare.
• Nitrofurantoin has been associated with potentially fatal lung conditions such as interstitial pneumonitis and pulmonary fibrosis. If these develop, nitrofurantoin should be discontinued. Risk is greater in people receiving nitrofurantoin for longer than six months.
• Not suitable for people with significantly impaired kidney function.
• Should not be used in pregnant patients near term (38 to 42 weeks gestation) or when labor is imminent, or in newborns aged less than one month, because of the risk of hemolytic anemia.
• Because the distribution of nitrofurantoin to other tissues is limited, there is a higher chance that the bacterial infection being treated may persist or recur. Urine samples should be taken both before and after treatment.
• Should not be taken again by people who have had liver problems or reactions to nitrofurantoin in the past.
• May cause liver problems, particularly with long-term use. Periodic liver enzyme monitoring may be needed.
• Long-term use has also been associated with peripheral neuropathy (nerve disease or damage particularly confined to the feet or hands). Risk is greater in people with kidney disease, anemia, diabetes, electrolyte imbalance, vitamin B deficiency or with chronic debilitating diseases. Rarely, optic neuritis (inflammation of the optic nerve) may develop.
• May also cause other serious side effects such as hemolytic anemia (risk is greater in people with glucose-6-phosphate deficiency) and clostridium difficile infection (symptoms include persistent diarrhea).

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.