Макродантин инструкция по применению

AdultPediatric

Postmarketing Reports

Respiratory: Chronic, subacute, or acute pulmonary hypersensitivity reactions

Hepatic: Hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis

Neurologic: Peripheral neuropathy, asthenia, vertigo, nystagmus, dizziness, headache, drowsiness, benign intracranial hypertension (pseudotumor cerebri), confusion, depression, optic neuritis, and psychotic reactions

Dermatologic: Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson syndrome), alopecia

Allergic: Hypersensitivity reported most frequently; lupus-like syndrome associated with pulmonary reactions to nitrofurantoin reported; angioedema; maculopapular, erythematous, or eczematous eruptions; pruritus; urticaria; anaphylaxis; arthralgia; myalgia; drug fever; and vasculitis (sometimes associated with pulmonary reactions)

Gastrointestinal (GI): Nausea, emesis, and anorexia occur most often; abdominal pain and diarrhea are less common GI reactions (these dose-related reactions can be minimized by dose reduction); sialadenitis, pancreatitis, pseudomembranous colitis

Hematologic: Cyanosis secondary to methemoglobinemia

Miscellaneous: Superinfections caused by resistant organisms

Laboratory: Increased AST/ALT, decreased hemoglobin, increased serum phosphorus, eosinophilia, glucose-6-phosphate dehydrogenase deficiency anemia, agranulocytosis, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia, megaloblastic anemia

Contraindications

Renal failure (anuria, oliguria, or CrCl <60 mL/min)

Pregnancy at term (38-42 weeks of gestation), during labor and delivery, or when onset of labor is imminent

History of hepatic dysfunction/cholestatic jaundice associated with nitrofurantoin

Neonates (<28 days) owing to possible hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability)

Hypersensitivity

Cautions

Hypersensitivity reactions

• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported
• Immediately discontinue Immediately discontinue if hypersensitivity signs and symptoms occur and initiate appropriate medications and/or supportive care
• Contraindicated in patients with known hypersensitivity to nitrofurantoin

Pulmonary reactions

• Acute, subacute, or chronic pulmonary reactions reported; if these reactions occur, discontinue therapy and take appropriate measures
• Reports have cited pulmonary reactions as contributing cause of death
• Chronic pulmonary reactions (diffuse interstitial pneumonitis or pulmonary fibrosis, or both)can develop insidiously
• These reactions generally occur in patients receiving therapy for ≥6 months; closely monitor pulmonary condition of patients receiving long-term therapy
• Benefits of therapy should be weighed against potential risks
• Avoid long-term use in the elderly (may increase risk for pulmonary toxicity)

Hepatotoxicity

• Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, have occurred; fatalities reported
• Onset of chronic active hepatitis may be insidious
• Monitor patients periodically for changes in biochemical tests that would indicate liver injury
• Discontinue immediately if hepatitis occurs

Neuropathy

• Peripheral neuropathy, which may become severe or irreversible, reported; fatalities reported
• Conditions such as renal impairment (CrCl <60 mL/min or clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating disease may enhance occurrence of peripheral neuropathy
• Monitor patients receiving long-term therapy periodically for changes in renal function
• Optic neuritis reported with nitrofurantoin formulations

Hemolytic anemia

• Cases of hemolytic anemia of the primaquine-sensitivity type induced by nitrofurantoin; hemolysis appears to be linked to glucose-6-phosphate dehydrogenase (G6PD) deficiency in red blood cells of affected patients
• G6PD deficiency is found in 10% of Blacks and a small percentage of ethnic groups of Mediterranean and Near-Eastern origin
• Discontinued immediately if hemolysis occurs; hemolysis ceases when the drug is withdrawn

Clostridioides difficile-associated diarrhea

• Clostridioides difficile-associated diarrhea (CDAD) reported with use of nearly all antibacterial agents, including this drug, and may range in severity from mild diarrhea to fatal colitis
• Treatment with antibacterial agents alters normal flora of the colon leading to overgrowth of C difficile; C difficile produces toxins A and B, which contribute to development of CDAD
• Hypertoxin producing strains of C difficile cause increased morbidity and mortality, as these infections can be refractory to antibacterial therapy and may require colectomy
• CDAD must be considered in all patients who present with diarrhea following antibacterial use; careful medical history is necessary since CDAD has been reported to occur over two months after administration of antibacterial agents
• If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C difficile may need to be discontinued
• Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C difficile, and institute surgical evaluation as clinically indicated

Persistence or reappearance of bacteriuria

• Nitrofurantoin lacks broader tissue distribution of other therapeutic agents approved for UTIs; consequently, many patients who are treated with this drug are predisposed to persistence or reappearance of bacteriuria
• If persistence or reappearance of bacteriuria occurs with symptoms of UTI, after treatment, other therapeutic agents with broader tissue distribution should be selected
• When considering nittrofurantoin use, lower eradication rates should be balanced against increased potential for systemic toxicity and for development of antibacterial resistance when agents with broader tissue distribution are utilized

Drug interaction overview

• Antacids

  • Avoid coadministration with antacids containing magnesium trisilicate
  • Nitrofurantoin’s rate and extent of absorption is reduced when administered concomitantly with magnesium trisilicate antacids

• Uricosuric drugs

  • Monitor
  • Uricosuric drugs (eg, probenecid, sulfinpyrazone) can inhibit renal tubular secretion ofnitrofurantoin
  • This inhibition may increase nitrofurantoin serum levels may increase toxicity, and decreased nitrofurantoin urinary levels and lessen its efficacy as a urinary tract antibacterial

• False-positive urine glucose test

  • Use test s based on enzymatic glucose oxidase reactions to detect urinary glucose
  • Nitrofurantoin can cause a false-positive reaction for urinary glucose when using Benedict’s or Fehling’s copper reduction reaction tests

Pregnancy

Contraindicated in pregnant women at term (38 weeks to 42 weeks gestation), during labor and delivery, or when onset of labor is imminent because of possibility of hemolytic anemia in the infant due to immature erythrocyte enzyme systems (glutathione instability)

Published epidemiological studies, including cohort studies and case-control studies, have reported inconsistent findings related to use during first trimester and risk of major birth defects

These studies cannot definitively establish presence or absence of risk due to several methodological limitations

Limited number of epidemiological studies available have not identified drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

Animal data

• No fetal harm was observed when nitrofurantoin was administered orally to pregnant rats and rabbits, during organogenesis, at up to 6 times the recommended human dose

Infertility

• Based on findings from a fertility study conducted in 36 healthy male volunteers and an animal fertility study, this drug may reversibly decrease spermatogenesis
• Doses of ≥10 mg/kg/day in healthy human males may produce a slight to moderate spermatogenic arrest with decreased sperm count; effect on fertility is unknown

Lactation

Present in human breast milk following oral administration; there are insufficient data on effect of nitrofurantoin on milk production

Breastfeeding is not recommended in infants aged <1 month or who have glucose-6-phosphate dehydrogenase (G6PD) deficiency; these infants risk for hemolytic anemia from exposure to nitrofurantoin

In a breastfed infant aged ≥1 month and with normal G6PD, the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from this drug or from underlying maternal condition; monitor these infants for vomiting, diarrhea, and rash

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Inactivates or alters bacterial ribosomal proteins and other macromolecules that may interfere with metabolism and cell-wall synthesis

Absorption

Well absorbed; macrocrystalline form absorbed more slowly due to slower dissolution (causes less GI distress)

Blood concentrations at therapeutic dosage are usually low

Bioavailability: Increased with food

Distribution

Highly soluble in urine; lacks broader tissue distribution

Crosses placenta, but not well distributed

Protein bound: Approximately 60-90%

Vd: 0.8 L/kg

Metabolism

Reduced by bacterial flavoproteins to reactive intermediates

Body tissues (except plasma) metabolize 60% of drug to inactive metabolites

Elimination

Half-life: 20-60 min; prolonged with renal impairment

Excretion: Urine (40%); feces (small amounts)

Oral Administration

Administer with food to enhance tolerance and improve drug absorption

Oral suspension: Shake vigorously before measuring dose

Storage

Oral capsules/tablets

• Store at 20-25ºC (68-77ºF); excursion permitted to 15-30ºC (59-86ºF)

Oral suspension

• Store at 20-25ºC (68-77ºF); excursion permitted to 15-30ºC (59-86ºF)
• Protect from freezing
• Dispense in tight, light-resistant, plastic (PET) or glass container; use within 30 days of once bottle opened
• Protect from light

Copyright © 2010 First DataBank, Inc.

NITROFURANTOIN — ORAL

(NYE-troe-fure-AN-toyn)

COMMON BRAND NAME(S): Macrodantin

USES: This medication is used to treat or prevent certain urinary tract infections.This medication is an antibiotic that works by stopping the growth of bacteria. It will not work for viral infections (such as common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.Nitrofurantoin should not be used by children less than one month of age due to the risk of a certain blood problem (hemolytic anemia).

HOW TO USE: Take this medication by mouth with food or milk as directed by your doctor. This medication is usually taken four times daily to treat an infection or once daily at bedtime to prevent infections. Swallow the medication whole. Avoid using magnesium trisilicate-containing antacids while taking this medication. Magnesium trisilicate-containing antacids bind with nitrofurantoin, preventing its full absorption.The dosage and duration is based on your medical condition and response to treatment. Children’s dosage is also based on weight.For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time(s) every day.When taking this medication to prevent infection, take it exactly as directed by your doctor. Do not skip doses or stop taking it without your doctor’s approval. Inform your doctor if you notice signs of a new urinary tract infection (such as pain while you are urinating).If you are taking this medication to treat an infection, continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition lasts or gets worse.

SIDE EFFECTS: Nausea, vomiting, loss of appetite, headache, or diarrhea may occur. Take this medication with food to help minimize nausea. If any of these effects last or get worse, notify your doctor or pharmacist promptly.This medication may cause your urine to turn dark yellow or brown in color. This effect is harmless and will disappear when the medication is stopped.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may rarely cause very serious (possibly fatal) lung problems. Lung problems may occur within the first month of treatment or after long-term use of nitrofurantoin (generally for 6 months or longer). Get medical help right away if you develop symptoms of lung problems, including: cough that doesn’t go away, chest pain, shortness of breath/trouble breathing, joint/muscle pain, bluish/purplish skin.Tell your doctor right away if you have any serious side effects, including: headache that is severe or doesn’t go away, new signs of infection (such as sore throat that doesn’t go away, fever, chills), easy bruising/bleeding, mental/mood changes, vision changes.This drug may rarely cause serious (possibly fatal) liver disease, blood or nerve problems. Tell your doctor right away if you notice any of the following serious side effects: nausea/vomiting that doesn’t stop, unusual tiredness, dark urine, yellowing of eyes/skin, fast/pounding heartbeat, numbness/tingling of the arms/legs, muscle weakness.This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn’t stop, abdominal or stomach pain/cramping, blood/mucus in your stool.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (such as oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada — Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking nitrofurantoin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease (including liver problems caused by nitrofurantoin in the past), a certain genetic condition (G-6-PD deficiency), certain blood disorders (such as anemia), lung diseases, certain nerve problems (peripheral neuropathy), certain eye diseases (optic neuritis), diabetes, untreated mineral imbalance, vitamin B deficiency.Nitrofurantoin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using nitrofurantoin before having any immunizations/vaccinations.Older adults may be at a greater risk for side effects while using this drug, especially nerve, liver or lung problems.During pregnancy, this medication should be used only when clearly needed. This medication should not be used if you are near or at the time of delivery (weeks 38-42 of pregnancy) due to possible harm to the newborn, such as a certain blood problem (hemolytic anemia). Discuss the risks and benefits with your doctor.This medication passes into breast milk and may have undesirable effects on nursing infants less than one month old and infants with a certain genetic condition (G-6-PD deficiency). Consult your doctor before breastfeeding.

DRUG INTERACTIONS: See also the How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.This medication may interfere with certain lab tests (such as certain urine glucose tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.Lab and/or medical tests (such as complete blood counts, tests for kidney and liver function, urine cultures) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised April 2025. Copyright(c) 2025 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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