Nidor contains the active ingredient Nitazoxanide, a synthetic antiprotozoal agent. Nitazoxanide is well absorbed from GI tract. It interferes with Pyruvate Ferredoxin Oxidoreductase (PFOR) enzyme dependent electron transfer reaction which is important for anaerobic glucose energy metabolism. This results in cell swelling, membrane damage resulting in dysfunction of the parasite. When Nitazoxanide is administered with food, the AUC in plasma is increased almost two-fold and the Cmax is increased by almost 50%.
The most common adverse events reported regardless of causality assessment were: abdominal pain, diarrhea, headache and nausea. Other side effects include, Body as a Whole: asthenia, fever, pain, allergic reaction, pelvic pain, chills, chills and fever, flu syndrome. Nervous System: dizziness, somnolence, insomnia, tremor, hypesthesia. Digestive System: vomiting, dyspepsia, anorexia, flatulence, constipation, dry mouth, thirst. Urogenital System: discolored urine, dysuria, amenorrhea, metrorrhagia, kidney pain, edema labia. Metabolic & Nutrition: increased SGPT. Hemic & Lymphatic Systems: anemia, leukocytosis. Skin: rash, pruritus. Special Senses: eye discoloration, ear ache. Respiratory System: epistaxis, lung disease, pharyngitis. Cardiovascular System: tachycardia, syncope, hypertension. Muscular System: myalgia, leg cramps, spontaneous bone fracture.
Nitazoxanide is highly bound to plasma protein (>99.9%). Therefore, caution should be taken when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index, as competition for binding sites may occur (e.g., warfarin). In vitro metabolism studies have demonstrated that Nitazoxanide has no significant inhibitory effect on cytochrome P450 enzymes. Although no drug-drug interaction studies have been conducted in vivo, it is expected that no significant interaction would occur when Nitazoxanide is co-administered with drugs that either are metabolized by or inhibit cytochrome P450 enzymes.
Pregnancy Category B: This drug should be used during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether Nitazoxanide is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Nitazoxanide is administered to a nursing woman.
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