Nitrofurantoin Macro 50mg Capsules

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 nature of this damage makes development of resistance rare.

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, bloody, or accompanied by stomach pain or cramps (see below for more information on diarrhea)
Liver problems, which can be indicated by:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Nerve problems, which can cause:
+ Burning sensations
+ Numbness
+ Tingling
+ Abnormal feelings

Important Information About Diarrhea

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) can occur. This condition can lead to a life-threatening bowel problem. If you experience stomach pain, cramps, or very loose, watery, or bloody stools, contact your doctor immediately. Do not treat diarrhea without consulting your doctor first.

Other Possible Side Effects

Most people do not experience significant side effects or only have minor ones. However, if you notice any of the following side effects or if they bother you or do not go away, contact your doctor:

Headache
Upset stomach or vomiting
Decreased appetite
Stomach pain or diarrhea
Dizziness, drowsiness, tiredness, or weakness
Hair loss (this usually resolves when the medication is stopped)
* Urine color change to brown (this is a harmless side effect)

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 this may affect how your body processes the medication.
Difficulty urinating, as this could be a sign of an underlying condition that may 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 this 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. This will help ensure that it is safe to take this medication with your other treatments and health issues. Never start, stop, or change the dosage of any medication without consulting your doctor first.

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 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 antacids

• Live bacterial vaccines (e.g., Typhoid oral vaccine)
• Quinolone antibiotics (e.g., Nalidixic acid, Ciprofloxacin)

• Antacids (containing magnesium or aluminum)

• New or worsening cough
• Shortness of breath
• Chest pain
• Fever
• Numbness
• Tingling
• Weakness in extremities
• Jaundice (yellowing of skin/eyes)
• Dark urine
• Unusual fatigue
• Nausea
• Abdominal pain
• Pallor
• Signs of allergic reaction (rash, itching, swelling)

Generally considered Category B. However, it is contraindicated at term (38-42 weeks gestation) and during labor and delivery due to the potential for hemolytic anemia in the neonate, especially if the infant has G6PD deficiency.

Excreted in breast milk in small amounts. Generally considered compatible with breastfeeding (L2).

Contraindicated in infants younger than 1 month due to the immaturity of enzyme systems (e.g., G6PD) and the risk of hemolytic anemia. Use with caution in children with known or suspected G6PD deficiency.

Increased risk of pulmonary, hepatic, and neurological toxicities, especially with long-term use or impaired renal function. Renal function should be carefully monitored. Use the lowest effective dose for the shortest duration necessary.

• Nitrofurantoin is effective only for lower urinary tract infections (cystitis) and does not achieve therapeutic concentrations in systemic tissues or the kidneys (pyelonephritis).
• The macrocrystalline formulation (Macrodantin) is generally preferred over the microcrystalline form for better gastrointestinal tolerability and more sustained urinary levels.
• Long-term use (e.g., for UTI prophylaxis) significantly increases the risk of serious adverse effects such as irreversible pulmonary fibrosis, chronic active hepatitis, and peripheral neuropathy. Careful risk-benefit assessment and regular monitoring are crucial for long-term therapy.
• Patients should be advised that their urine may turn brown or dark yellow while taking nitrofurantoin; this is a common and harmless side effect.
• Nitrofurantoin is contraindicated in patients with a creatinine clearance (CrCl) less than 30 mL/min due to lack of efficacy in achieving adequate urinary concentrations and a significantly increased risk of systemic toxicity.

• Trimethoprim/sulfamethoxazole (Bactrim)
• Fosfomycin (Monurol)
• Ciprofloxacin (Cipro)
• Levofloxacin (Levaquin)
• Cephalexin (Keflex)
• Amoxicillin/clavulanate (Augmentin)

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.