ALINIA- nitazoxanide powder, for suspension ALINIA- nitazoxanide tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

NITAZOXANIDE (UNII: SOA12P041N) (NITAZOXANIDE - UNII:SOA12P041N)

可用日期:

Romark Laboratories, L.C.

INN（国际名称）:

NITAZOXANIDE

组成:

NITAZOXANIDE 500 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: ALINIA for Oral Suspension (patients 1 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 . Limitations of Use ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [ see Clinical Studies (14.2)] ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations. Risk Summary There are no data with ALINIA in pregnant women to inform a drug-associated risk. No teratogenicity or fetotoxicity was observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposure 30 and 2 times, respectively, the exposure at the maximum recommended human dose of 500 mg twice daily based on body surface area (BSA). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Nitazoxanide was administered orally to pregnant rats at doses of 0, 200, 800 or 3200 mg/kg/day on gestation days 6 to 15. Nitazoxanide produced no evidence of systemic maternal toxicity when administer once daily via oral gavage to pregnant female rats at levels up to 3200 mg/kg/day during the period of organogenesis . In rabbits, nitazoxanide was administered at doses of 0, 25, 50, or 100 mg/kg/day on gestation days 7 to 20. Oral treatment of pregnant rabbits with nitazoxanide during organogenesis resulted in minimal maternal toxicity and no external fetal anomalies. Risk Summary No information regarding the presence of nitazoxanide in human milk, the effects on the breastfed infant, or the effects on milk production is available. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for ALINIA and any potential adverse effects on the breastfed infant from ALINIA or from the underlying maternal condition. The safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 1 to 11 years of age has been established based on three (3) randomized, controlled studies with 104 pediatric subjects treated with ALINIA for Oral Suspension 100 mg/5 mL. Furthermore, the safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on two (2) randomized controlled studies with 44 pediatric subjects treated with ALINIA for Oral Suspension 100 mg/5 mL. [ see Clinical Studies (14.1)] The safety and efficacy of ALINIA Tablets for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on three (3) randomized controlled studies with 47 pediatric subjects treated with ALINIA Tablets 500 mg. A single ALINIA Tablet contains a greater amount of nitazoxanide than is recommended for use in pediatric patients 11 years or younger. [ see Dosage and Administration (2.1)]. Safety and efficacy of ALINIA for Oral Suspension in pediatric patients less than one year of age has not been studied. Clinical studies of ALINIA Tablets and ALINIA for Oral Suspension did 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 Tablets and ALINIA for Oral Suspension. The pharmacokinetics of nitzoxanide in patients with compromised renal or hepatic function has not been studied. ALINIA Tablets and ALINIA for Oral Suspension have not been studied for the treatment of diarrhea caused by G. lamblia in HIV-infected or immunodeficient patients. ALINIA Tablets and ALINIA for Oral Suspension have not been shown to be superior to placebo for the treatment of diarrhea caused by C. parvum in HIV-infected or immunodeficient patients [ see Clinical Studies (14)]

產品總結:

ALINIA tablets are round, yellow, film-coated tablets debossed with ALINIA on one side and 500 on the other side. Each tablet contains 500 mg of nitazoxanide. The tablets are packaged in HDPE bottles of 12 and 30 tablets. Bottles of 12 tablets NDC 67546-111-14 Bottles of 30 tablets NDC 67546-111-12 Store the tablets at 25 o C (77 o F); excursions permitted to 15 o C-30 o C (59 o F-86 o F). [See USP Controlled Room Temperature] ALINIA 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 for oral suspension is available as: Bottles of 60 mL NDC 67546-212-21 Store the unsuspended powder at 25 o C (77 o F); excursions permitted to 15 o C-30 o C (59 o F-86 o F). [See USP Controlled Room Temperature] The reconstituted suspension may be stored for 7 days at room temperature, after which any unused portion must be discarded [see Dosage and Administration (2.2)]

授权状态:

New Drug Application

产品特点

ALINIA- NITAZOXANIDE POWDER, FOR SUSPENSION
ALINIA- NITAZOXANIDE TABLET
ROMARK LABORATORIES, L.C.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALINIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALINIA.
ALINIA® (NITAZOXANIDE) TABLETS, FOR ORAL USE
ALINIA® (NITAZOXANIDE) FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
ALINIA is an antiprotozoal indicated for the treatment of diarrhea
caused by _Giardia lamblia_ or
_Cryptosporidium parvum_(1).
Limitations of Use:
ALINIA has not been shown to be effective for the treatment of
diarrhea caused by _C. parvum_ in HIV-
infected or immunodeficient patients (1).
DOSAGE AND ADMINISTRATION
ALINIA Tablets should not be administered to pediatric patient 11
years of age or younger ( 2.1)
Dosage for treatment of diarrhea caused by _G. lamblia_ or _C. parvum_
( 2.1):
AGE
DOSAGE
DURATION
1-3 years 5 mL of ALINIA for Oral Suspension (100 mg nitazoxanide)
every 12 hours with food
4-11
years
10 mL of ALINIA for Oral Suspension (200 mg nitazoxanide) every 12
hours with food 3 days
12 years
and older
One 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
DOSAGE FORMS AND STRENGTHS
ALINIA Tablets: 500 mg ( 3.1)
ALINIA for Oral Suspension: 100 mg/5 mL ( 3.2)
CONTRAINDICATIONS
Hypersensitivity ( 4.1)
ADVERSE REACTIONS
The most common adverse reactions in ≥2% of patients were abdominal
pain, headache, chromaturia,
and nausea ( 6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ROMARK AT 813-282-8544
OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Competition for binding sites may occur when administered concurrently
with other highly plasma protein-
bound drugs with narrow therapeutic indices. Monitor for adverse
reactions ( 7).
USE IN SPECIFIC POPULATIONS
Pediatric Patients: Safety and efficacy of ALINIA for Oral Suspension
in pediatric patients less than one
ye