Nitrofurantoin 50mg/5ml Susp 60ml

Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermediates that inactivate or damage bacterial ribosomal proteins, DNA, RNA, and cell wall synthesis. This broad-spectrum activity is due to the rapid and extensive damage to multiple bacterial macromolecules, leading to inhibition of vital metabolic processes. It is bacteriostatic at low concentrations and bactericidal at higher concentrations.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ 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 rarely, a severe form called C. diff-associated diarrhea (CDAD) can occur, which may lead to a life-threatening bowel problem.
Liver problems, which can be rare but potentially fatal, characterized by:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Nerve problems, which can be severe, permanent, or life-threatening, especially in people with:
+ Kidney problems
+ Anemia
+ Diabetes
+ Electrolyte problems
+ Low vitamin B levels
+ Symptoms may include:
- Burning sensation
- Numbness
- Tingling that is not normal

Other Possible Side Effects

Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention 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 (a harmless and normal effect)

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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, especially 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 your safety, verify that it is acceptable to take this medication with all your other medications and health conditions.
* Never start, stop, or adjust 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 a higher risk of developing anemia. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low levels of G6PD.

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. Prolonged use may increase the risk of a second infection.

Although rare, this medication can cause severe and potentially life-threatening lung problems, particularly in individuals who have been taking 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.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.

• Probenecid (in patients with renal impairment)
• Sulfinpyrazone (in patients with renal impairment)

• Probenecid (decreases renal excretion of nitrofurantoin, increasing serum levels and toxicity, and decreasing efficacy in urinary tract)
• Sulfinpyrazone (decreases renal excretion of nitrofurantoin, increasing serum levels and toxicity, and decreasing efficacy in urinary tract)
• Live bacterial vaccines (e.g., Typhoid vaccine, oral) - may reduce therapeutic effect of vaccine

• Antacids containing magnesium trisilicate (may decrease absorption of nitrofurantoin)
• Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin) - theoretical antagonism, though clinical significance is debated.

• Persistent cough
• Shortness of breath
• Chest pain
• Fever
• Chills
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Unusual fatigue
• Numbness or tingling in hands or feet
• Muscle weakness
• Severe diarrhea
• Rash

Generally considered safe for use during the first and second trimesters for uncomplicated UTIs. 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 or G6PD deficiency.

Excreted in small amounts into breast milk. Generally considered compatible with breastfeeding, but caution is advised for infants with G6PD deficiency or those less than 1 month of age due to the theoretical risk of hemolytic anemia.

Contraindicated in infants less than 1 month of age. Use with caution in infants older than 1 month, especially those with G6PD deficiency. Dosing is weight-based. Long-term use for prophylaxis should be carefully considered due to potential for chronic toxicities.

Use with caution, especially in elderly patients with impaired renal function (CrCl < 60 mL/min), as they are at increased risk for pulmonary, hepatic, and peripheral neuropathy toxicities. Avoid if CrCl < 60 mL/min. Monitor for adverse effects.

• Nitrofurantoin is effective only for lower urinary tract infections (cystitis) and does not achieve therapeutic concentrations in systemic tissues or the kidneys, making it unsuitable for pyelonephritis or other systemic infections.
• Always advise patients to take nitrofurantoin with food or milk to enhance absorption and minimize gastrointestinal upset.
• Counsel patients about the potential for urine discoloration (brown/orange), which is harmless.
• Emphasize the importance of completing the full course of therapy, even if symptoms improve, to prevent recurrence and resistance.
• Be vigilant for signs of pulmonary toxicity (cough, dyspnea, chest pain) and hepatotoxicity (jaundice, fatigue, dark urine), especially with long-term use. Discontinue immediately if suspected.
• Contraindicated in patients with a creatinine clearance (CrCl) less than 60 mL/min due to reduced efficacy and increased risk of systemic toxicity, particularly peripheral neuropathy.

• Trimethoprim/sulfamethoxazole (Bactrim)
• Fosfomycin
• Pivmecillinam (not available in US)
• Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) - generally reserved for more complicated UTIs or when other agents are not suitable due to resistance concerns.
• Beta-lactam antibiotics (e.g., amoxicillin/clavulanate, cephalexin) - for specific susceptible organisms.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 details about the medication taken, the amount, and the time it happened.