Drug: Alinia

Alinia (nitazoxanide) Tablets and Alinia (nitazoxanide) for Oral Suspension contain the active ingredient, nitazoxanide, a synthetic antiprotozoal agent for oral administration. Nitazoxanide is a 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 C12H9N3O5S and the molecular weight is 307.3. The structural formula is: 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, talc, FD&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, and FD&C Blue No. 2 Aluminum Lake. Alinia (nitazoxanide) for Oral Suspension, after reconstitution, contains 100 mg nitazoxanide per 5 mL and the following inactive ingredients: sodium benzoate, sucrose, xanthan gum, microcrystalline cellulose and carboxymethylcellulose sodium, anhydrous citric acid, sodium citrate dihydrate, acacia gum, sugar syrup, FD&C Red #40 and natural strawberry flavoring.

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Alinia (nitazoxanide) Tablets: In controlled and uncontrolled clinical studies of 1,628 HIV-uninfected patients age 12 years and older who received various dosage regimens of Alinia (nitazoxanide) Tablets, the most common adverse events reported regardless of causality assessment were: abdominal pain (6.7%), diarrhea (4.3%), headache (3.1%) and nausea (3.1%). In placebo-controlled clinical trials using the recommended dose, the rates of occurrence of these events did not differ significantly from those of the placebo. In placebo-controlled trials of HIV-uninfected patients age 12 years and older who received Alinia (nitazoxanide) Tablets for the treatment of diarrhea caused by Giardia lamblia, approximately 1% of patients discontinued therapy because of an adverse event. Adverse events occurring in less than 1% of the patients age 12 years and older participating in clinical trials of Alinia (nitazoxanide) Tablets are listed below: 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. Alinia (nitazoxanide) for Oral Suspension: In controlled and uncontrolled clinical studies of 613 HIV-uninfected pediatric patients who received Alinia (nitazoxanide) for Oral Suspension, the most frequent adverse events reported regardless of causality assessment were: abdominal pain (7.8%), diarrhea (2.1%), vomiting (1.1%) and headache (1.1%). These were typically mild and transient in nature. In placebo-controlled clinical trials, the rates of occurrence of these events did not differ significantly from those of the placebo. None of the 613 pediatric patients discontinued therapy because of adverse events. Adverse events occurring in less than 1% of the pediatric patients participating in clinical trials of Alinia (nitazoxanide) for Oral Suspension are listed below: Digestive System: nausea, anorexia, flatulence, appetite increase, enlarged salivary glands.
Body as a Whole: fever, infection, malaise.
Metabolic & Nutrition: increased creatinine, increased SGPT. Skin: pruritus, sweat.
Special Senses: eye discoloration (pale yellow).
Respiratory System: rhinitis.
Nervous System: dizziness.
Urogenital System: discolored urine. The adverse events seen in adult patients treated with Alinia (nitazoxanide) for Oral Suspension were similar to those observed in adult patients treated with Alinia (nitazoxanide) Tablets. Read the Alinia (nitazoxanide) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

Indication Age Dosage Duration Treatment of diarrhea caused by Giardia lamblia 1-3 years 5 mL of Alinia for Oral Suspension (100 mg nitazoxanide) every 12 hours with food 3 days 4-11 years 10 mL of Alinia for Oral Suspension (200 mg nitazoxanide) every 12 hours with food ≥ 12 years 1 Alinia Tablet (500 mg nitazoxanide) every 12 hours with food or 25 mL of Alinia for Oral Suspension (500 mg nitazoxanide) every 12 hours with food Treatment of diarrhea caused by Cryptosporidium parvum 1-3 years 5 mL of Alinia for Oral Suspension (100 mg nitazoxanide) every 12 hours with food 3 days 4-11 years 10 mL of Alinia for Oral Suspension (200 mg nitazoxanide) every 12 hours with food Safety and effectiveness of Alinia (nitazoxanide) for Oral Suspension and Alinia (nitazoxanide) Tablets for the treatment of diarrhea caused by Cryptosporidium parvum in patients 12 years and older have not been established. A single Alinia tablet contains a greater amount of nitazoxanide than is recommended for pediatric dosing and should therefore not be used in pediatric patients 11 years or younger. Alinia (nitazoxanide) Tablets and Alinia (nitazoxanide) for Oral Suspension have not been studied for the treatment of Giardia lamblia in HIV-infected or immunodeficient patients. Alinia (nitazoxanide) Tablets and Alinia (nitazoxanide) for Oral Suspension have not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients (see Clinical Studies ). Directions For Mixing Alinia (nitazoxanide) For Oral Suspension Prepare a suspension at time of dispensing as follows: The amount of water required for preparation of the suspension is 48 mL. Tap bottle until all powder flows freely. Add approximately one-half of the total amount of water required for reconstitution and shake vigorously to suspend powder. Add remainder of water and again shake vigorously. The container should be kept tightly closed, and the suspension should be shaken well before each administration. The suspension may be stored for 7 days, after which any unused portion must be discarded.

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Tizoxanide is highly bound to plasma protein (>99.9%). Therefore, caution should be used when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g., warfarin). In vitro metabolism studies have demonstrated that tizoxanide 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. Last reviewed on RxList: 4/10/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Diarrhea caused by Giardia lamblia Alinia (nitazoxanide) for Oral Suspension (patients 1 year of age and older) and Alinia (nitazoxanide) Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia. Diarrhea caused by Cryptosporidium parvum Alinia (nitazoxanide) for Oral Suspension is indicated for patients 1 through 11 years of age for the treatment of diarrhea caused by Cryptosporidium parvum. Alinia (nitazoxanide) for Oral Suspension and Alinia (nitazoxanide) Tablets have not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients (see Clinical Studies). The safety and effectiveness of Alinia (nitazoxanide) for Oral Suspension or Alinia (nitazoxanide) Tablets for the treatment of diarrhea caused by Cryptosporidium parvum in patients 12 years of age and older have not been established.

Source: http://www.rxlist.com

Alinia (nitazoxanide) Tablets and Alinia (nitazoxanide) for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.Last reviewed on RxList: 4/10/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Information on nitazoxanide overdosage is not available. In acute studies in rodents and dogs, the oral LD50 was higher than 10,000 mg/kg. Single oral doses of up to 4000 mg nitazoxanide have been administered to healthy adult volunteers without significant adverse effects. In the event of overdose, gastric lavage may be appropriate soon after oral administration. Patients should be carefully observed and given symptomatic and supportive treatment.

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Alinia (nitazoxanide) Tablets are round, yellow, film-coated tablets debossed with ALINIA (nitazoxanide) on one side and 500 on the other side. Each tablet contains 500 mg of nitazoxanide. The tablets are packaged in HDPE bottles of 60 tablets and blister cards of 6 tablets. Bottles of 60                            NDC 67546-111-11
Boxes of 3 blister cards          NDC 67546-111-32
(Alinia (nitazoxanide) 3-Day Therapy Packs™) Alinia (nitazoxanide) for Oral Suspension is a pink-colored powder formulation that, when reconstituted as directed, contains 100 mg nitazoxanide/5 mL. The reconstituted suspension has a pink color and strawberry flavor. Alinia (nitazoxanide) for Oral Suspension is available as: Bottles of 60 mL                       NDC 67546-212-21 Storage and Stability: Store the tablets, unsuspended powder, and the reconstituted oral suspension at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature] ROMARK PHARMACEUTICALS, A division of Romark Laboratories, L.C. 3000 Bayport Drive, Suite 200, Tampa FL 33607. Telephone: 813-282-8544, Fax: 813-282-4910 E-mail: [email protected] Web site: www.romark.com. FDA revision date: 7/21/2004 Last reviewed on RxList: 4/10/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General: The pharmacokinetics of nitazoxanide in patients with compromised renal or hepatic function have not been studied. Therefore, nitazoxanide must be administered with caution to patients with hepatic and biliary disease, to patients with renal disease and to patients with combined renal and hepatic disease. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have not been conducted. Nitazoxanide was not genotoxic in the Chinese hamster ovary (CHO) cell chromosomal aberration assay or the mouse micronucleus assay. Nitazoxanide was genotoxic in one tester strain (TA 100) in the Ames bacterial mutation assay. Nitazoxanide did not adversely affect male or female fertility in the rat at 2400 mg/kg/day (approximately 20 times the clinical adult dose adjusted for body surface area). Pregnancy: Teratogenic Effects Pregnancy Category B: Reproduction studies have been performed at doses up to 3200 mg/kg/day in rats (approximately 26 times the clinical adult dose adjusted for body surface area) and 100 mg/kg/day in rabbits (approximately 2 times the clinical adult dose adjusted for surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to nitazoxanide. There are, however, no adequate and well-controlled studies in pregnant women. Nursing Mothers It is not known whether nitazoxanide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitazoxanide is administered to a nursing woman. Pediatric Use A single Alinia Tablet contains a greater amount of nitazoxanide than is recommended for pediatric dosing and should therefore not be used in pediatric patients 11 years or younger. Alinia for Oral Suspension should be used for dosing nitazoxanide in pediatric patients. (See DOSAGE AND ADMINISTRATION) Safety and effectiveness of Alinia (nitazoxanide) for Oral Suspension in pediatric patients less than one year of age have not been studied. Geriatrics Clinical studies of Alinia (nitazoxanide) Tablets and Alinia (nitazoxanide) for Oral Suspensiondid not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing Alinia (nitazoxanide) Tablets and Alinia (nitazoxanide) for Oral Suspension. As stated in the PRECAUTIONS section, this therapy must be administered with caution to patients with renal and or hepatic impairment. HIV-Infected or Immunodeficient Patients Alinia (nitazoxanide) Tablets and Alinia (nitazoxanide) for Oral Suspension have not been studied for the treatment of diarrhea caused by Giardia lamblia in HIV-infected or immunodeficient patients. Alinia (nitazoxanide) Tablets and Alinia (nitazoxanide) for Oral Suspension have not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients (see Clinical Studies). Last reviewed on RxList: 4/10/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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