19 . September , 2018 - Wednesday
Check todays hot topics or new products

Find a Drug: Advanced

Please Sign in or Register

All about: Nitazoxanide

Big Image Pronouncation: (nye-tah-ZOX-ah-nide)
Class: Antiprotozoal

Trade Names:
Alinia
- Tablets 500 mg
- Oral suspension 100 mg per 5 mL

Mechanism of Action

Pharmacology

Interferes with pyruvate:ferredoxin oxidoreductase enzyme-dependent electron transfer reaction, which is essential to anaerobic energy metabolism.

Pharmacokinetics

Absorption

After ingestion, nitazoxanide is converted to the active metabolites tizoxanide and tizoxanide glucuronide. Bioavailability of the suspension is 70% compared with the tablet. Pharmacokinetics of tizoxanide following administration of nitazoxanide 500 mg tablet with food in adults or children 12 yr of age and older is: C max 10.6 and 9.1 mcg/mL, respectively; T max is 3 and 4 hr, respectively; AUC is 41.9 and 39.5 mcg•hr/mL. For tizoxanide glucuronide, corresponding values are: C max 10.5 and 7.3 mcg/mL, respectively; T max of 4.5 and 4 hr, respectively; AUC of 63 and 46.5 mcg•hr/mL, respectively. Absorption of tizoxanide following administration of the oral suspension with food to children 4 to 11 yr of age or 1 to 3 yr of age is: C max 3 and 3.11 mcg/mL, respectively; T max 2 and 3.5 hr, respectively; AUC 13.5 and 11.7 mcg•hr/mL, respectively. For tizoxanide glucuronide, corresponding values are: C max 2.84 and 3.64 mcg/mL, respectively; T max 4 hr in both age groups; and AUC 16.9 and 19 mcg•hr/mL, respectively.

Distribution

Tizoxanide is more than 99% protein bound.

Metabolism

Nitazoxanide is rapidly hydrolyzed to an active metabolite, tizoxanide, which then undergoes conjugation, primarily by glucuronidation, to an active metabolite.

Elimination

Approximately 67% of the oral dose of nitazoxanide is excreted in the feces and 33% in the urine. Tizoxanide is excreted in the urine, bile, and feces, while tizoxanide glucuronide is excreted in the urine and bile.

Indications and Usage

Treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum .

Contraindications

Standard considerations.

Dosage and Administration

Diarrhea caused by G. lamblia
Adults and Children 12 yr of age and older

PO 500 mg q 12 hr with food.

Children 4 to 11 yr of age

PO 10 mL (200 mg) q 12 hr with food.

Children 1 to 3 yr of age

PO 5 mL (100 mg) q 12 hr with food.

Diarrhea caused by C. parvum
Children 4 to 11 yr of age

PO 10 mL (200 mg) q 12 hr with food.

Children 1 to 3 yr of age

PO 5 mL (100 mg) q 12 hr with food.

General Advice

  • Nitazoxanide tablets and oral suspension are not bioequivalent. The relative bioavailability of the suspension compared to tablet is 70%.
  • Administer with food to minimize GI side effects and increase absorption.
  • Shake suspension well before measuring dose.

Storage/Stability

Store tablets, unsuspended powder, and reconstituted oral suspension at controlled room temperature (59° to 86°F). Discard any unused suspension after 7 days.

Drug Interactions

Highly protein-bound drugs (eg, warfarin)

May compete for binding sites, transiently increasing the effects of the displaced drug.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache (3%).

GI

Abdominal pain (8%); diarrhea (4%); nausea (3%); vomiting (1%).

Precautions

Pregnancy

Category B .

Lactation

Not established.

Children

Safety and efficacy not established for treatment of C. parvum in patients 12 yr of age and older.

Oral suspension

Safety and efficacy not established in children younger than 1 yr of age.

Tablet

Not for use in children 11 yr of age or younger.

Elderly

Use with caution because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Special Risk Patients

Because nitazoxanide was not studied in patients with impaired hepatic or renal function, use with caution in patients with hepatic, biliary, or renal disease.

Tablet administration

A single tablet contains a greater amount of nitazoxanide than recommended for pediatric dosing and should not be used in patients 11 yr of age or younger.

Patient Information

  • Explain name, dose, action, and potential side effects of drug.
  • Instruct patient to take exactly as prescribed and not to change the dose or discontinue therapy unless advised by health care provider.
  • Advise patient to take prescribed dose with food to minimize GI side effects and increase absorption.
  • Advise patient or caregiver using oral suspension to: shake suspension well before measuring dose; measure and administer prescribed dose using dosing syringe, dosing spoon, or dosing cup; discard any remaining suspension after 7 days.
  • Instruct patient or caregiver to notify health care provider if diarrhea does not improve or worsens.
  • Advise patient to report any other bothersome side effects to health care provider.
  • Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
  • Instruct patient not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.
  • Advise patient that follow-up visits may be required to monitor therapy and to keep appointments.

Recent Drug Updates at DrugIndexOnline:





Adacel (adolescent and adult) Adacel (adolescent and adult)
Generic Name: diphtheria, pertussis acellular, and tetanus vaccine (Tdap, adult) (dif THEER ee a, per TUS iss ay SEL yoo ler, and TET a nus ) Brand Names: Adacel (adolescent and adult) What is diphtheria, pertussis acellular, and tetanus vaccine? Diphtheria, tetanus, and pertussis ar more...

Allegra -D 24 Hour Allegra -D 24 Hour
Generic Name: fexofenadine and pseudoephedrine (fex oh FEN a deen and soo doe e FED rin) Brand Names: Allegra -D 24 Hour, Allegra-D What is Allegra -D 24 Hour (fexofenadine and pseudoephedrine)? Fexofenadine is an antihistamine that reduces the natural chemical histamine in the body. H more...

Atripla Atripla
Generic Name: efavirenz, emtricitabine and tenofovir disoproxil fumarate Dosage Form: Tablets Rx Only Warning LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGS ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS more...

Brovex Suspension Brovex Suspension
Generic Name: Brompheniramine Oral Suspension (brome-fen-EER-a-meen) Brand Name: Examples include Brovex and J-TanBrovex Suspension is used for:Temporarily relieving runny nose, watery eyes, sneezing, and itchy nose, eyes, and throat associated with hay fever or other allergies. It may also be more...

Cardizem LA Cardizem LA
Generic Name: diltiazem (dil TYE a zem) Brand Names: Cardizem, Cardizem CD, Cardizem LA, Cardizem SR, Cartia XT, Dilacor XR, Diltia XT, Tiazac What is Cardizem LA (diltiazem)? Diltiazem is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your hear more...

Compro Suppositories Compro Suppositories
Generic Name: Prochlorperazine Suppositories (pro-klor-PURR-uh-zeen) Brand Name: Examples include Compazine and ComproCompro Suppositories is used for:Controlling severe nausea and vomiting and treating schizophrenia. It is also used for the short-term (4 weeks) treatment of generalized nonpsyc more...

Dr. Caldwell Senna Laxative Dr. Caldwell Senna Laxative
Some commonly used brand names are: In the U.S.— Agoral 35 Alophen 25 Alphamul 30 Alramucil Orange 7 Alramucil Regular 7 Bisac-Evac 25 Black-Draught 26 Black-Draught Lax-Senna 32 Carter's Little Pills 25 Cholac 14 Citroma 16 Citrucel Orange Flavor 3 Citrucel Sugar-Free Orange Flavor 3 Col more...

Ezide Ezide
Generic Name: hydrochlorothiazide (hy dro klor o THY a zide) Brand Names: Carozide, Diaqua, Esidrix, Ezide, Hydro Par, HydroDIURIL, Loqua, Microzide, Oretic What is Ezide (hydrochlorothiazide)? Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from abs more...