ZStop

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ZStop uses


1 INDICATIONS AND USAGE

Diarrhea caused by Giardia lamblia or Cryptosporidium parvum:

ZStop for Oral Suspension (patients 1 year of age and older) and ZStop Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.

Limitations of Use

ZStop for Oral Suspension and ZStop 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)]

ZStop is an antiprotozoal indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum (1).

Limitations of Use:

ZStop has not been shown to be effective for the treatment of diarrhea caused by C. parvum in HIV-infected or immunodeficient patients (1).

2 DOSAGE & ADMINISTRATION

Age Dosage Duration
1-3 years 5 mL of ZStop for Oral Suspension (100 mg ZStop) every 12 hours with food
4-11 years 10 mL of ZStop for Oral Suspension (200 mg ZStop) every 12 hours with food 3 days
12 years and older One ZStop Tablet (500 mg ZStop) every 12 hours with food or 25 mL of ZStop for Oral Suspension (500 mg ZStop) every 12 hours with food

2.1 Recommended Dosage and Important Administration Instructions

Important Administration Instructions for Pediatric Patients 11 years of Age or Younger:

ZStop tablets should not be administered to pediatric patients 11 years of age or younger because a single tablet contains a greater amount of ZStop than the recommended dosing in this pediatric age group.

Table 1. Recommended Dosage

Age Dosage Duration
1-3 years

5 mL of ZStop for Oral suspension

(100 mg ZStop) taken orally every 12 hours with food

4-11 years

10 mL of ZStop for Oral Suspension

(200 mg ZStop) taken orally every 12 hours with food

3 Days
12 years and older One ZStop Tablet (500 mg ZStop) taken orally every 12 hours with food or 25 mL of ZStop for Oral Suspension (500 mg ZStop) taken orally every 12 hours with food

2.2 Directions for Mixing ZStop for Oral Suspension

Reconstitute ZStop for Oral Suspension as follows:


Keep container tightly closed, and shake the suspension well before each administration. The reconstituted suspension may be stored for 7 days at room temperature, after which any unused portion must be discarded.

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3 DOSAGE FORMS AND STRENGTHS

3.1 ZStop Tablets (500 mg)

Round, yellow, film-coated tablets debossed with ZStop on one side and 500 on the other side. Each tablet contains 500 mg of ZStop.

3.2 ZStop for Oral Suspension

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.

4 CONTRAINDICATIONS

Hypersensitivity

4.1 Hypersensitivity

ZStop Tablets and ZStop for Oral Suspension are contraindicated in patients with a prior hypersensitivity to ZStop or any other ingredient in the formulations.

6 ADVERSE REACTIONS

The most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia, and nausea.

To report SUSPECTED ADVERSE REACTIONS, contact Romark at 813-282-8544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ZStop was evaluated in 2177 HIV-uninfected subjects 12 months of age and older who received ZStop Tablets or ZStop for Oral Suspension at the recommended dose for at least three days. In pooled controlled clinical trials involving 536 HIV-uninfected subjects treated with ZStop Tablets or ZStop for Oral Suspension, the most common adverse reactions were abdominal pain, headache, chromaturia and nausea (≥2%).

Safety data were analyzed separately for 280 HIV-uninfected subjects ≥12 years of age receiving ZStop at the recommended dose for at least three days in 5 placebo-controlled clinical trials and for 256 HIV-uninfected subjects 1 through 11 years of age in 7 controlled clinical trials. There were no differences between the adverse reactions reported for ALINIA-treated subjects based upon age.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of ZStop. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following is a list of adverse reactions spontaneously reported with ZStop Tablets which were not included in clinical trial listings:

Gastrointestinal disorders: diarrhea, gastroesophageal reflux disease

Nervous System disorders: dizziness

Respiratory, thoracic and mediastinal disorders: dyspnea

Skin and subcutaneous tissue disorders: rash, urticaria

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7 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.

7.1 Highly Protein Bound Drugs with Narrow Therapeutic Indices

Tizoxanide (the active metabolite of ZStop) is highly bound to plasma protein (>99.9%). Therefore, monitor for adverse reactions when administering ZStop concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g., warfarin).

8 USE IN SPECIFIC POPULATIONS

Pediatric Patients: Safety and efficacy of ZStop for Oral Suspension in pediatric patients less than one year of age has not been studied.

8.1 Pregnancy

Risk Summary

There are no data with ZStop in pregnant women to inform a drug-associated risk. No teratogenicity or fetotoxicity was observed in animal reproduction studies with administration of ZStop 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

ZStop was administered orally to pregnant rats at doses of 0, 200, 800 or 3200 mg/kg/day on gestation days 6 to 15. ZStop 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, ZStop 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 ZStop during organogenesis resulted in minimal maternal toxicity and no external fetal anomalies.

8.2 Lactation

Risk Summary

No information regarding the presence of ZStop 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 ZStop and any potential adverse effects on the breastfed infant from ZStop or from the underlying maternal condition.

8.4 Pediatric Use

The safety and efficacy of ZStop 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 randomized, controlled studies with 104 pediatric subjects treated with ZStop for Oral Suspension 100 mg/5 mL. Furthermore, the safety and efficacy of ZStop 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 ZStop for Oral Suspension 100 mg/5 mL. [ see Clinical Studies (14.1)]

The safety and efficacy of ZStop 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 ZStop Tablets 500 mg.

A single ZStop Tablet contains a greater amount of ZStop than is recommended for use in pediatric patients 11 years or younger. [ see Dosage and Administration (2.1)].

Safety and efficacy of ZStop for Oral Suspension in pediatric patients less than one year of age has not been studied.

8.5 Geriatric Use

Clinical studies of ZStop Tablets and ZStop 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 ZStop Tablets and ZStop for Oral Suspension.

8.6 Renal and Hepatic Impairment

The pharmacokinetics of nitzoxanide in patients with compromised renal or hepatic function has not been studied.

8.7 HIV-Infected or Immunodeficient Patients

ZStop Tablets and ZStop for Oral Suspension have not been studied for the treatment of diarrhea caused by G. lamblia in HIV-infected or immunodeficient patients. ZStop Tablets and ZStop 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)]

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10 OVERDOSAGE

Limited information on ZStop overdosage is available. Single oral doses of up to 4000 mg ZStop 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 observed and given symptomatic and supportive treatment. There is no specific antidote for overdose with ZStop. Because tizoxanide is highly protein bound (>99.9%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.

11 DESCRIPTION

ZStop Tablets and ZStop for Oral Suspension contain the active ingredient, ZStop, a synthetic antiprotozoal for oral administration. ZStop is a light yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, ZStop is 2-acetyloxy- N-(5-nitro-2-thiazolyl)benzamide. The molecular formula is C 12H 9N 3O 5S and the molecular weight is 307.3. The structural formula is:

ZStop Tablets contain 500 mg of ZStop 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. 6 Aluminum Lake, and FD&C Blue No. 2 Aluminum Lake.

ZStop for Oral Suspension, when reconstituted with 48 mL of water, produces 60 mL of a homogeneous suspension with a pink color that contains 100 mg ZStop per 5 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 No. 40 and artificial strawberry flavoring.

structure

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

ZStop is an antiprotozoal [ see Microbiology )].

12.3 Pharmacokinetics

Absorption

Single Dosing:

Following oral administration of ZStop Tablets or Oral Suspension, the parent drug, ZStop, is not detected in plasma. The pharmacokinetic parameners of the metabolites, tizoxanide and tizoxanide glucuronide are shown in Tables 2 and 3 below.

Table 2. Mean (+/- SD) plasma pharmacokinetic parameters of tizoxanide and tizoxanide glucuronide following administration of a single dose of one 500 mg ZStop Tablet with food to subjects ≥12 years of age

Tizoxanide Tizoxanide Glucuronide
Age C max (µg/mL) T max (hr) AUC t (µg-hr/mL) C max (µg/mL) T max (hr) AUC t (µg-hr/mL)
12 - 17 years 9.1 (6.1) 4.0 (1-4) 39.5 (24.2) 7.3 (1.9) 4.0 (2-8) 46.5 (18.2)
>18 years 10.6 (2.0) 3.0 (2-4) 41.9 (6.0) 10.5 (1.4) 4.5 (4-6) 63.0 (12.3)

*T max is given as a Mean (Range)

Table 3. Mean (+/-SD) plasma pharmacokinetic of tizoxanide and tizoxanide glucuronide parameter values following administration of single dose of ZStop for Oral Suspension with food to subjects ≥1year of age

Tizoxanide Tizoxanide Glucuronide
Age Dose C max (µg/mL) *T max (hr) AUC t (µg-hr/mL) C max (µg/mL) *T max (hr) AUC inf (µg-hr/mL)
1-3 years 100 mg 3.11 (2.0) 3.5 (2-4) 11.7 (4.46) 3.64 (1.16) 4.0 (3-4) 19.0 (5.03)
4-11 years 200 mg 3.00 (0.99) 2.0 (1-4) 13.5 (3.3) 2.84 (0.97) 4.0 (2-4) 16.9 (5.00)
>18 years 500 mg 5.49 (2.06) 2.5 (1-5) 30.2 (12.3) 3.21 (1.05) 4.0 (2.5-6) 22.8 (6.49)

*T max is given as a Mean (Range)

Multiple dosing:

Following oral administration of a single ZStop Tablet every 12 hours for 7 consecutive days, there was no significant accumulation of ZStop metabolites tizoxanide or tizoxanide glucuronide detected in plasma.

Bioavailability:

ZStop for Oral Suspension is not bioequivalent to ZStop Tablets. The relative bioavailability of the suspension compared to the tablet was 70%.

When ZStop Tablets are administered with food, the AUC t of tizoxanide and tizoxanide glucuronide in plasma is increased almost two-fold and the C max is increased by almost 50%.

When ZStop for Oral Suspension was administered with food, the AUC t of tizoxanide and tizoxanide glucuronide increased by about 45-50% and the C max increased by ≤10%.

ZStop Tablets and ZStop for Oral Suspension were administered with food in clinical trials and hence they are recomended to be administered with food

Distribution

In plasma, more than 99% of tizoxanide is bound to proteins.

Elimination

Metabolism

Following oral administration in humans, ZStop is rapidly hydrolyzed to an active metabolite, tizoxanide (desacetyl-nitazoxanide). Tizoxanide then undergoes conjugation, primarily by glucuronidation.

Excretion

Tizoxanide is excreted in the urine, bile and feces, and tizoxanide glucuronide is excreted in urine and bile. Approximately two-thirds of the oral dose of ZStop is excreted in the feces and one-third in the urine.

Specific Populations

Pediatric Patients

The pharmacokinetics of tizoxanide and tizoxanide glucuronide following administration of ZStop Tablets in pediatric patients 12-17 years of age are provided above in Table 2. The pharmacokinetics of tizoxanide and tizoxanide glucuronide following administration of ZStop for Oral Suspension in pediatric patients 1-11 years of age are provided above in Table 3.

Drug Interaction Studies

In vitro studies have demonstrated that tizoxanide has no significant inhibitory effect on cytochrome P450 enzymes.

12.4 MICROBIOLOGY

Mechanism of Action

The antiprotozoal activity of ZStop 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. Studies have shown that the PFOR enzyme from G. lamblia directly reduces ZStop by transfer of electrons in the absence of ferredoxin. The DNA-derived PFOR protein sequence of C. parvum appears to be similar to that of G. lamblia. Interference with the PFOR enzyme-dependent electron transfer reaction may not be the only pathway by which ZStop exhibits antiprotozoal activity.

Resistance

A potential for development of resistance by C. parvum or G. lamblia to ZStop has not been examined.

Antimicrobial Activity

ZStop and its metabolite, tizoxanide, are active in vitro in inhibiting the growth of (i) sporozoites and oocysts of C. parvum and (ii) trophozoites of G. lamblia.

Susceptibility Test Methods

For protozoa such as C. parvum and G. lamblia, standardized tests for use in clinical microbiology laboratories are not available.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term carcinogenicity studies have not been conducted.

Mutagenesis

ZStop was not genotoxic in the Chinese hamster ovary (CHO) cell chromosomal aberration assay or the mouse micronucleus assay. ZStop was genotoxic in one tester strain (TA100) in the Ames bacterial mutation assay.

Impairment of Fertility

ZStop 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).

14 CLINICAL STUDIES

14.1 Diarrhea Caused by G. lamblia

Diarrhea caused by G. lamblia in adults and adolescents 12 years of age or older:

In a double-blind, controlled trial conducted in Peru and Egypt in adults and adolescents with diarrhea and with one or more enteric symptoms (e.g., abdominal pain, nausea, vomiting, fever, abdominal distention, loss of appetite, flatulence) caused by G. lamblia, a three-day course of treatment with ZStop Tablets administered 500 mg BID was compared with a placebo tablet for 3 days. A third group of patients received open-label ZStop for Oral Suspension administered 500 mg/25 mL of suspension BID for 3 days. A second double-blind, controlled trial (Study 2) conducted in Egypt in adults and adolescents with diarrhea and with or without enteric symptoms (e.g., abdominal colic, abdominal tenderness, abdominal cramps, abdominal distention, fever, bloody stool) caused by G. lamblia compared ZStop Tablets administered 500 mg BID for 3 days to a placebo tablet. For both of these studies, clinical response was evaluated 4 to 7 days following the end of treatment. A clinical response of ‘well’ was defined as ‘no symptoms, no watery stools and no more than 2 soft stools with no hematochezia within the past 24 hours’ or ‘no symptoms and no unformed stools within the past 48 hours.’ The following clinical response rates were obtained:

Table 4. Adult and Adolescent Patients with Diarrhea Caused by G. lamblia

Clinical Response Rates* 4 to 7 Days Post-therapy

% (Number of Successes/Total)


ZStop Tablets


ZStop for Oral Suspension


Placebo Tablets


Study 1


85% (46/54) ¶ §


83% (45/54) ¶ §


44% (12/27)


Study 2


100% (8/8)


-


30% (3/10)


* Includes all patients randomized with G. lamblia as the sole pathogen. Patients failing to complete the studies were treated as failures.

Clinical response rates statistically significantly higher when compared to placebo.

§ The 95% confidence interval of the difference in response rates for the tablet and suspension is (-14%, 17%).

Some patients with ‘well’ clinical responses had G. lamblia cysts in their stool samples 4 to 7 days following the end of treatment. The relevance of stool examination results in these patients is unknown. Patients should be managed based upon clinical response to treatment.

Diarrhea caused by G. lamblia in pediatric patients 1 through 11 years of age:

In a randomized, controlled trial conducted in Peru in 110 pediatric patients with diarrhea and with or without enteric symptoms (e.g., abdominal distention, right iliac fossa tenderness) caused by G. lamblia, a three-day course of treatment with ZStop (100 mg BID in pediatric patients ages 24-47 months, 200 mg BID in pediatric patients ages 4 through 11 years) was compared to a five-day course of treatment with metronidazole (125 mg BID in pediatric patients ages 2 through 5 years, 250 mg BID in pediatric patients ages 6 through 11 years). Clinical response was evaluated 7 to 10 days following initiation of treatment with a ‘well’ response defined as ‘no symptoms, no watery stools and no more than 2 soft stools with no hematochezia within the past 24 hours’ or ‘no symptoms and no unformed stools within the past 48 hours.’ The following clinical cure rates were obtained:

Table 5. Clinical Response Rates in Pediatric Patients 7 to 10 Days Following Initiation of Therapy

Intent-to-Treat and Per Protocol Analyses

% (Number of Successes/Total), [95% Confidence Interval]


Population


ZStop (3 days)


Metronidazole (5 days)


95% CI Diff §


Intent-to-treat analysis


85% (47/55)


80% (44/55 )


[-9%, 20%]


Per protocol analysis


90% (43/48)


83% (39/47 )


[-8%, 21%]


Intent-to-treat analysis includes all patients randomized with patients not completing the study treated as failures.

Per protocol analysis includes only patients who took all of their medication and completed the study. Seven patients in each treatment group missed at least one dose of medication and one in the metronidazole treatment group was lost to follow-up.

§ 95% Confidence Interval on the difference in response rates (nitazoxanide-metronidazole).

Some patients with ‘well’ clinical responses had G. lamblia cysts in their stool samples 4 to 7 days following the end of treatment. The relevance of stool examination results in these patients is unknown. Patients should be managed based upon clinical response to treatment.

14.2 Diarrhea Caused by C. parvum

Diarrhea caused by C. parvum in adults and adolescents 12 years of age or older:

In a double-blind, controlled trial conducted in Egypt in adults and adolescents with diarrhea and with or without enteric symptoms (e.g., abdominal pain/cramps, nausea, vomiting) caused by C. parvum, a three-day course of treatment with ZStop Tablets administered 500 mg BID was compared with a placebo tablet for 3 days. A third group of patients received open-label ZStop for Oral Suspension administered 500 mg/25 mL of suspension BID for 3 days. Clinical response was evaluated 4 to 7 days following the end of treatment. A clinical response of ‘well’ was defined as ‘no symptoms, no watery stools and no more than 2 soft stools within the past 24 hours’ or ‘no symptoms and no unformed stools within the past 48 hours.’ The following clinical response rates were obtained:

Table 6. Clinical Response Rates in Adult and Adolescent Patients 4 to 7 Days Post-therapy

% (Number of Successes/Total)


ZStop Tablets


ZStop Suspension


Placebo Tablets


Intent-to-treat analysis*


96% (27/28) ¶ §


87% (27/31) ¶ §


41% (11/27)


* Includes all patients randomized with C. parvum as the sole pathogen. Patients failing to complete the study were treated as failures.

Clinical response rates statistically significantly higher when compared to placebo.

§ The 95% confidence interval of the difference in response rates for the tablet and suspension is (-10%, 28%).

In a second double-blind, placebo-controlled study of ZStop tablets conducted in Egypt in adults and adolescents with diarrhea and with or without enteric symptoms (e.g., abdominal colic, abdominal cramps, epigastric pain) caused by C. parvum as the sole pathogen, clinical and parasitological response rates showed a similar trend to the first study. Clinical response rates, evaluated 2 to 6 days following the end of treatment, were 71% (15/21) in the ZStop group and 42.9% (9/21) in the placebo group.

Some patients with ‘well’ clinical responses had C. parvum oocysts in their stool samples 4 to 7 days following the end of treatment. The relevance of stool examination results in these patients is unknown. Patients should be managed based upon clinical response to treatment.

Diarrhea caused by C. parvum in pediatric patients 1 through 11 years of age :

In two double-blind, controlled trials in pediatric patients with diarrhea and with or without enteric symptoms (e.g., abdominal distention, colic, left iliac fossa tenderness) caused by C. parvum, a three-day course of treatment with ZStop (100 mg BID in pediatric patients ages 12-47 months, 200 mg BID in pediatric patients ages 4 through 11 years) was compared with a placebo. One study was conducted in Egypt in outpatients ages 1 through 11 years with diarrhea caused by C. parvum. Another study was conducted in Zambia in malnourished pediatric patients admitted to the hospital with diarrhea caused by C. parvum. Clinical response was evaluated 3 to 7 days post-therapy with a ‘well’ response defined as ‘no symptoms, no watery stools and no more than 2 soft stools within the past 24 hours’ or ‘no symptoms and no unformed stools within the past 48 hours.’ The following clinical response rates were obtained:

Table 7. Clinical Response Rates in Pediatric Patients 3 to 7 Days Post-therapy Intent-to-Treat Analyses

% (Number of Successes/Total)


Population


Nitazoxanide*


Placebo


Outpatient Study, age 1 - 11 years


88% (21/24)


38% (9/24)


Inpatient Study, Malnourished , age 12-35 months


56% (14/25)


23% (5/22 )


* Clinical response rates statistically significantly higher compared to placebo.

60% considered severely underweight, 19% moderately underweight, 17% mild underweight.

Some patients with ‘well’ clinical responses had C. parvum oocysts in their stool samples 3 to 7 days following the end of treatment. The relevance of stool examination results in these patients is unknown. Patients should be managed based upon clinical response to treatment.

Diarrhea caused by C. parvum in Acquired Immune Deficiency Syndrome (AIDS) patients :

A double-blind, placebo-controlled trial did not produce clinical cure rates that were significantly different from the placebo control when conducted in hospitalized, severely malnourished pediatric patients with acquired immune deficiency syndrome (AIDS) in Zambia. In this study, the pediatric patients received a three day course of ZStop suspension (100 mg BID in pediatric patients ages 12-47 months, 200 mg BID in pediatric patients ages 4 through 11 years) and were evaluated for response four days after the end of treatment.

16 HOW SUPPLIED

16.1 ZStop Tablets

ZStop tablets are round, yellow, film-coated tablets debossed with ZStop on one side and 500 on the other side. Each tablet contains 500 mg of ZStop. 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 oC (77 oF); excursions permitted to 15 oC-30 oC (59 oF-86 oF).

16.2 ZStop for Oral Suspension

ZStop 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. ZStop for oral suspension is available as:

Bottles of 60 mL NDC 27437-106-01

Store the unsuspended powder at 25 oC (77 oF); excursions permitted to 15 oC-30 oC (59 oF-86 oF).

The reconstituted suspension may be stored for 7 days at room temperature, after which any unused portion must be discarded

17 PATIENT COUNSELING INFORMATION

Advise patients and parents/caregivers of pediatric patients taking ZStop Tablets or ZStop for Oral Suspension of the following information:

Dosage and Administration:

ZStop Tablets and ZStop for Oral Suspension should be taken with food.

ZStop for Oral Suspension: The container should be kept tightly closed, and the suspension should be shaken well before each administration. The suspension may be stored at room temperature for 7 days, after which any unused portion must be discarded.

Drug-drug Interactions:

Avoid concurrent warfarin use.

MANUFACTURER INFORMATION

Romark, L.C.

3000 Bayport Drive, Suite 200, Tampa, FL 33607

Telephone: 813-282-8544, Fax: 813-282-1162

E-mail: customer.serviceZStopromark.com

Web site: www.romark.com

ZStop for Oral Suspension is distributed by Lupin Pharmaceuticals, Inc. under license from Romark.

Lupin Pharma

Baltimore, Maryland 21202 United States

US Patents No. 5,578,621; 6,020,353; 5,968,961; 5,387,598; 6,117,894; 5,965,590.

ZStop is a registered trademark of Romark.

PI-111/106-04 R.07/16

Romark Logo Lupin Logo

ZStop pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


ZStop available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


ZStop destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


ZStop Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


ZStop pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."ALINIA (NITAZOXANIDE) TABLET [AVERA MCKENNAN HOSPITAL]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."NITAZOXANIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "NITAZOXANIDE". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming ZStop?

Depending on the reaction of the ZStop after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider ZStop not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is ZStop addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on ZStop, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of ZStop consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

Visitor reported doses

No survey data has been collected yet

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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