Nitrofurantoin 25mg/5ml Oral Susp

Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermediates that inactivate or damage bacterial ribosomal proteins, DNA, RNA, and other macromolecules. This leads to inhibition of bacterial protein synthesis, aerobic energy metabolism, DNA synthesis, RNA synthesis, and cell wall synthesis. The broad spectrum of activity is due to the multiple targets of these reactive intermediates.

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Inability to control eye movements
Diarrhea, especially if it is severe or accompanied by:
+ Stomach pain
+ Cramps
+ Loose, watery, or bloody stools
+ Note: Diarrhea is common with antibiotics, but a severe form called C. diff-associated diarrhea (CDAD) can occur, which may lead to a life-threatening bowel problem.
Liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
+ Note: Liver problems can be fatal.
Nerve problems, such as:
+ Burning, numbness, or tingling sensations that are not normal
+ Note: The risk of nerve problems may be higher in people with kidney problems, anemia, diabetes, electrolyte problems, or low vitamin B levels.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:

Headache
Upset stomach or vomiting
Decreased appetite
Stomach pain or diarrhea
Dizziness, drowsiness, tiredness, or weakness
Hair loss (which may return to normal after stopping the medication)
* Urine color change to brown (which is normal and harmless)

Reporting Side Effects

This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
Kidney disease, as it may affect how your body processes the medication.
Difficulty urinating, as this may be a sign of an underlying condition that could interact with the medication.
Previous liver problems caused by this medication, as this may increase the risk of further liver damage.
Pregnancy, particularly if you are 38 weeks or more pregnant, as the medication may affect the fetus.

Special Considerations for Children:

If the patient is a child under 1 month of age, do not administer this medication, as it is not suitable for infants at this age.

Additional Precautions:

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist.
To ensure safe treatment, verify that it is safe to take this medication with all your other medications and health conditions.
* Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you may be at risk of developing anemia. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low G6PD levels.

If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable testing methods for you. Do not take this medication for a longer duration than prescribed, as this may increase the risk of a secondary infection.

Although rare, this medication has been associated with severe and potentially life-threatening lung problems, particularly in patients who have taken it for 6 months or longer. These lung problems can occur without warning signs. If you are taking this medication long-term, your doctor will monitor your lung function. Immediately contact your doctor if you experience symptoms such as fever, chills, chest pain, an abnormal cough, difficulty breathing, or other respiratory problems.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the potential benefits and risks of this medication with their doctor to make an informed decision.

• Probenecid
• Sulfinpyrazone

• Magnesium trisilicate-containing antacids
• Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin)

• Live bacterial vaccines (e.g., typhoid vaccine)

• Signs of pulmonary toxicity (e.g., cough, dyspnea, chest pain, fever, chills)
• Signs of peripheral neuropathy (e.g., tingling, numbness, weakness in extremities)
• Signs of hepatotoxicity (e.g., dark urine, pale stools, jaundice, persistent nausea/vomiting, abdominal pain)
• Signs of C. difficile-associated diarrhea (e.g., severe diarrhea, abdominal cramps, fever)
• Signs of hemolytic anemia (e.g., fatigue, pallor, dark urine, jaundice)

Generally considered safe for acute uncomplicated UTIs during the first and second trimesters. However, it is contraindicated at term (38-42 weeks gestation) and during labor and delivery due to the risk of hemolytic anemia in the neonate, especially in infants with immature enzyme systems (e.g., G6PD deficiency).

Considered compatible with breastfeeding. Nitrofurantoin is excreted into breast milk in very small amounts. However, caution is advised in infants with G6PD deficiency or those younger than 1 month due to the theoretical risk of hemolytic anemia.

Contraindicated in infants younger than 1 month of age. Use with caution in children due to potential for adverse effects, especially pulmonary reactions and peripheral neuropathy. Dosing is weight-based.

Use with caution due to increased likelihood of impaired renal function (CrCl < 60 mL/min), which is a contraindication. Elderly patients may also be at increased risk for pulmonary toxicity, hepatotoxicity, and peripheral neuropathy. Assess renal function prior to and during therapy.

• Always take nitrofurantoin with food or milk to enhance absorption and reduce gastrointestinal side effects.
• Contraindicated in patients with a creatinine clearance (CrCl) less than 60 mL/min due to reduced efficacy and increased risk of serious adverse effects (pulmonary, hepatic, neurologic).
• Monitor for signs of pulmonary toxicity (e.g., cough, dyspnea), hepatotoxicity (e.g., jaundice), and peripheral neuropathy (e.g., tingling, numbness), especially with long-term use.
• Urine may turn brown or dark yellow, which is a harmless side effect.
• Avoid use at term pregnancy (38-42 weeks) due to risk of neonatal hemolytic anemia.

• Trimethoprim/sulfamethoxazole (Bactrim)
• Fosfomycin
• Cephalexin
• Ciprofloxacin (for complicated UTIs, generally avoided for uncomplicated due to resistance concerns)
• Levofloxacin (for complicated UTIs, generally avoided for uncomplicated due to resistance concerns)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.