NITROFURANTOIN (Systemic)

Some commonly used brand names are:

In the U.S.?

• Furadantin
• Macrobid
• Macrodantin

In Canada?

• Apo-Nitrofurantoin
• Macrobid
• Macrodantin
• Novo-Furantoin

Generic name product may be available in the U.S. and Canada.

Category

• Antibacterial, systemic

Description

Nitrofurantoin (nye-troe-fyoor-AN-toyn) belongs to thefamily of medicines called anti-infectives. It is used to treat infectionsof the urinary tract. It may also be used for other conditions as determinedby your doctor.

Nitrofurantoin is available only with your doctor's prescription, in thefollowing dosage forms:

Oral
• Capsules (U.S. and Canada)
• Extended-release Capsules (U.S. and Canada)
• Oral Suspension (U.S.)
• Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For nitrofurantoin,the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to nitrofurantoin or to any related medicines such as furazolidone(e.g., Furoxone) or nitrofurazone (e.g., Furacin). Also tell your health careprofessional if you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Nitrofurantoin should not be used if you are withina week or 2 of your delivery date or during labor and delivery. It may causeproblems in the infant. Studies in animals have shown some problems when givenin doses many times the human dose. Before taking this medicine, make sureyour doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?Nitrofurantoin passes into the breast milk in smallamounts and may cause problems in nursing babies, especially those with glucose-6-phosphatedehydrogenase (G6PD) deficiency. It may be necessary for you to take anothermedicine or to stop breast-feeding during treatment. Be sure you have discussedthe risks and benefits of the medicine with your doctor.

Children?This medicine has been tested in children 1 monthof age and older and, in effective doses, has not been shown to cause differentside effects or problems in children than it does in adults. However, infantsup to 1 month of age should not be given this medicine because they are especiallysensitive to the effects of nitrofurantoin.

Older adults?Elderly people may be more sensitive to the effectsof nitrofurantoin. This may increase the chance of side effects during treatment.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingnitrofurantoin, it is especially important that your health care professionalknow if you are taking any of the following:

• Acetohydroxamic acid (e.g., Lithostat) or
• Antidiabetics, oral (diabetes medicine you take by mouth) or
• Dapsone or
• Furazolidone (e.g., Furoxone) or
• Methyldopa (e.g., Aldomet) or
• Primaquine or
• Procainamide (e.g., Pronestyl) or
• Quinidine (e.g., Quinidex) or
• Sulfonamides (sulfa medicine) or
• Sulfoxone (e.g., Diasone) or
• Vitamin K (e.g., AquaMEPHYTON, Synkayvite)?Patients who takenitrofurantoin with any of these medicines may have an increase in side effectsaffecting the blood

• Carbamazepine (e.g., Tegretol) or
• Chloroquine (e.g., Aralen) or
• Cisplatin (e.g., Platinol) or
• Cytarabine (e.g., Cytosar-U) or
• Diphtheria, tetanus, and pertussis (DTP) vaccine or
• Disulfiram (e.g., Antabuse) or
• Ethotoin (e.g., Peganone) or
• Hydroxychloroquine (e.g., Plaquenil) or
• Lindane, topical (e.g., Kwell) or
• Lithium (e.g., Lithane) or
• Mephenytoin (e.g., Mesantoin) or
• Mexiletine (e.g., Mexitil) or
• Other anti-infectives by mouth or by injection (medicine for infection)or
• Pemoline (e.g., Cylert) or
• Phenytoin (e.g., Dilantin) or
• Pyridoxine (e.g., Hexa-Betalin) (with long-term, high-dose use) or
• Vincristine (e.g., Oncovin)?Patients who take nitrofurantoinwith any of these medicines, or who have received a DTP vaccine within thelast 30 days or are going to receive a DTP vaccine may have an increase inside effects affecting the nervous system

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)?Patients who take nitrofurantoinwith either of these medicines may have an increase in side effects

• Quinine (e.g., Quinamm)?Patients who take nitrofurantoin withquinine may have an increase in side effects affecting the blood and the nervoussystem

Other medical problems?The presence of other medicalproblems may affect the use of nitrofurantoin. Make sure you tell your doctorif you have any other medical problems, especially:

• Anemia or
• Diabetes mellitus or
• Lung disease or
• Nerve damage or
• Other serious illness or
• Vitamin B deficiency?These conditions may increase the chancefor side effects

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency?Nitrofurantoinmay cause anemia in patients with G6PD deficiency

• Kidney disease (other than infection)?The chance of side effectsof this medicine may be increased and the medicine may be less effective inpatients with kidney disease

Proper Use of This Medicine

Do not give this medicine to infants up to 1 month of age.

Nitrofurantoin is best taken with food or milk. This may lessen stomachupset and help your body to better absorb the medicine.

For patients taking the oral liquid form of this medicine:

• Shake the oral liquid forcefully before each dose to help make itpour more smoothly and to be sure the medicine is evenly mixed.
• Use a specially marked measuring spoon or other device to measureeach dose accurately. The average household teaspoon may not hold the rightamount of liquid.
• Nitrofurantoin may be mixed with water, milk, fruit juices, or infants'formulas. If it is mixed with any of these liquids, take the medicine immediatelyafter mixing. Be sure to drink all the liquid in order to get the full doseof medicine.

For patients taking the extended-release capsuleform of this medicine:

• Swallow the capsules whole.
• Do not open, crush, or chew the capsules before swallowing them.

To help clear up your infection completely, keep takingthis medicine for the full time of treatment, even if you begin tofeel better after a few days. Do not miss any doses.

Dosing?The dose of nitrofurantoin will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of nitrofurantoin. If your dose isdifferent, do not change it unless your doctor tells you to do so.

• For the capsule, oral suspension, and tablet dosage forms:
  • For the prevention of urinary tract infection:
    • Adults and adolescents?50 to 100 mg once a day at bedtime.
    • Children 1 month of age and older?Dose is based on body weightand must be determined by your doctor.
    • Children up to 1 month of age?Use is not recommended.
  • For the treatment of urinary tract infection:
    • Adults and adolescents?50 to 100 mg every six hours.
    • Children 1 month of age and older?Dose is based on body weightand must be determined by your doctor.
    • Children up to 1 month of age?Use is not recommended.
• For the extended-release capsule dosageform:
  • Adults and children 12 years of age and older: 100 mg every twelvehours for seven days.
  • Children up to 12 years of age: Dose must be determined by the doctor.

Missed dose?If you do miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule or tablet form of this medicine in the bathroom,near the kitchen sink, or in other damp places. Heat or moisture may causethe medicine to break down.
• Keep the oral liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It isimportant that your doctor check your progress at regular visits if you willbe taking this medicine for a long time.

If your symptoms do not improve within a few days, or if they become worse,check with your doctor.

For diabetic patients:

• This medicine may cause false test results withsome urine sugar tests. Check with your doctor before changing yourdiet or the dosage of your diabetes medicine.

Side Effects of This Medicine

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

Check with your doctor immediately if any ofthe following side effects occur:

More common

Changes in facial skin color; chestpain; chills; cough; fever; general feeling of discomfortor illness; hives; hoarseness; itching; joint or musclepain; shortness of breath; skin rash; sudden trouble in swallowing or breathing; swelling of face, mouth, hands, or feet; troubled breathing

Less common

Black, tarry stools; blood in urineor stools; burning, numbness, tingling, or painfulsensations; dizziness; drowsiness; headache; pinpointred spots on skin; sore throat; unusual bleeding or bruising; unusual tiredness orweakness; weakness in arms, hands, legs, or feet

Rare

Abdominal or stomach pain; blistering,peeling, or loosening of skin and mucous membranes; bluish color of skin; blurred vision or loss of vision,with or without eye pain; bulging fontanel in infants; confusion; darkening ofurine; diarrhea, watery and severe, which may alsobe bloody; loss of appetite; mental depression; mood or mental changes; nausea or vomiting; pale skin; pale stools; red skin lesions, oftenwith a purple center; red, thickened, or scaly skin; skin rash; sores, ulcers,or white spots on lips or in mouth; swollen or painfulglands; unpleasant breath odor; visual changes; vomiting of blood; wheezing or tightness in chest; yellow eyes or skin

Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

More common

Diarrhea; gas

After you stop using this medicine, your bodymay need time to adjust. The length of time this takes depends on the amountof medicine you were using and how long you used it. During this period oftime check with your doctor immediately if younotice any of the following side effects:

Abdominal or stomach cramps or pain,severe; diarrhea, watery and severe, which may alsobe bloody; fever

This medicine may cause the urine to become rust-yellowto brown. This side effect does not require medical attention.

Nitrofurantoin may cause a temporary loss of hair in some people.

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.