NITROFURANTOIN MONO-MCR 100 MG

USES: This medication is an antibiotic used to treat bladder infections (acute cystitis). It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. This medication should not be used in infants younger than 1 month old (see also Precautions section). This drug should not be used to treat infections outside the bladder (including kidney infections such as pyelonephritis or perinephric abscesses).

Indications : Enterobacter cystitis, prevention of bacterial urinary tract infection, Enterococcus urinary tract infection, E. coli urinary tract infection, Klebsiella urinary tract infection, Staphylococcus aureus urinary tract infection, Staphylococcus saprophyticus urinary tract infection, bacterial urinary tract infection, bacterial infection

SIDE EFFECTS: Nausea, headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. 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 cause your urine to turn dark yellow or brown in color. This is usually a harmless, temporary effect and will disappear when the medication is stopped. However, dark brown urine can also be a sign of rare side effects (liver problems or anemia). Get medical help right away if you notice dark urine along with any of the following symptoms: persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, tiredness, fast/pounding heartbeat. Tell your doctor right away if you have any serious side effects, including: eye pain, vision changes, mental/mood changes, persistent/severe headaches, new signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding. Get medical help right away if you have any very serious side effects, including: numbness/tingling of the hands/feet, unusual muscle weakness. 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: persistent cough, chest pain, shortness of breath/trouble breathing, joint/muscle pain, bluish/purplish skin. 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 nitrofurantoin for prolonged or repeated periods may result in oral thrush or a new vaginal yeast 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.

HOW TO USE: Take this medication by mouth with food as directed by your doctor, usually twice daily (every 12 hours). Swallow the medication whole for best results. Do not use magnesium trisilicate-containing antacids while taking this medication. These antacids can bind with nitrofurantoin, preventing its full absorption into your system. 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. 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 allow bacteria to continue to grow, which may result in a return of the infection. Inform your doctor if your condition persists or worsens.

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), lung disease, numbness/tingling of the arms/legs, vitamin B deficiency, mineral imbalance, blood disorders (e.g., anemia), diabetes, persistent weakness due to long-term disease, certain eye disorders (e.g., optic neuritis). Kidney function declines as you grow older. This medication is removed by the kidneys. Older adults may be at a greater risk for side effects while using this drug, especially nerve, liver or lung problems (see Side Effects section). This medication may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to. During pregnancy, this medication should be used only when clearly needed. It must not be used if you are near the end of your pregnancy (38-42 weeks), or at the time of labor and delivery. Doing so may cause a certain blood disorder (hemolytic anemia) in your baby. Discuss the risks and benefits with your doctor. This medication passes into breast milk and may have undesirable effects on nursing infants younger than 1 month old or those with a certain genetic condition (G-6-PD deficiency). Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also 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. Some products that may interact with this drug are: certain drugs to treat gout (uricosuric drugs such as sulfinpyrazone). This medication may interfere with certain laboratory tests (certain urine glucose tests), possibly causing false test results. Make sure laboratory 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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