Clinical Information
Gen. Code and Des.
29984 nitazoxanide ORAL TABLET 500 MG
Strength
500 mg
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
8309200 ANTIPROTOZOALS, MISCELLANEOUS
Active Ingredients
6303 nitazoxanide 55981094
Inactive Ingredients
10138 blue dye
10143 yellow dye
13405 soy
2598 sucrose 57501
ALINIA- nitazoxanide tablet
ALINIA- nitazoxanide powder, for suspension
Romark Laboratories, LC
DESCRIPTION
Alinia Tablets and Alinia for Oral Suspension contain the active ingredient, nitazoxanide, synthetic antiprotozoal agent for oral administration. Nitazoxanide is light yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-N -(5-nitro-2-thiazolyl)benzamide. The molecular formula is C12 H9 N3 O5 and the molecular weight is 307.3
Alinia Tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, pregelatinized corn starch, hydroxypropyl methylcellulose, sucrose, sodium starch glycollate, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, FD&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. Aluminum Lake, and FD&C Blue No. Aluminum Lake.
Alinia for Oral Suspension, when reconstituted with 48 mL of water, produces 60 mL of homogeneous suspension with pink color that contains 100 mg nitazoxanide per mL and the following inactive ingredients: sodium benzoate, sucrose, xanthan gum, microcrystalline cellulose and carboxymethylcellulose sodium, anhydrous citric acid, sodium citrate dihydrate, maltodextrin, modified food starch, triacetin, FD&C Red #40 and artificial strawberry flavoring.
MICROBIOLOGY
Mechanism of Action
The antiprotozoal activity of nitazoxanide is believed to be due to interference with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction which is essential to anaerobic energy metabolism.
INDICATIONS AND USAGE
Diarrhea caused by Giardia lamblia or Cryptosporidium parvum:
Alinia for Oral Suspension (patients year of age and older) and Alinia Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
info. for Patients
Alinia Tablets and Alinia for Oral Suspension should be taken with food.
Diabetic patients and caregivers should be aware that the oral suspension contains 1.48 grams of sucrose per mL.
Body as Whole: asthenia, fever, pain, allergic reaction, pelvic pain, back 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.