Engflag

Plantassel

Quick links to important sections

Plantassel

Plantassel_FR

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Plantassel

Property Description
Active ingredient Nitazoxanide
Form Oral Tablets, Powder for Oral Suspension
Pharmacological class Broad-spectrum Antiparasitic Agent, Antiprotozoal
Common use Systemic clearance of pathogenic parasites and protozoa
Origin Synthetic, Thiazolide derivative

What Type of Medicine is Plantassel? (Identity and Pharmacological Class)

Plantassel is a prescription anti-infective medication whose active component is the synthetic compound Nitazoxanide. It is an antiprotozoal agent and is the prototype member of the unique thiazolide chemical class, a structure distinguished by its nitrothiazolyl-salicylamide scaffold. The agent is a broad-spectrum antiparasitic active against a range of protozoa and helminths. This wide-ranging capability makes it a versatile tool for addressing diverse parasitic infections. The drug is administered exclusively via the oral route, available as both tablets and a powder for oral suspension.

Composition and Available Pharmaceutical Forms

The core composition relies on the parent compound Nitazoxanide, which functions as a prodrug; it is rapidly metabolized into its principal active substance, Tizoxanide (desacetyl-nitazoxanide), upon ingestion. This chemical transformation is essential for the drug’s therapeutic action within the body. The final pharmaceutical preparations are designed for oral delivery, provided as solid oral tablets and a liquid suspension, both containing Nitazoxanide as the sole therapeutic agent alongside necessary pharmaceutical excipients. Notably, the oral suspension is often formulated with specific flavors, such as strawberry, to assist in administration, particularly for pediatric patients.

The General Purpose of Nitazoxanide

The general purpose of this medication is to achieve the systemic clearance and elimination of parasitic organisms. This is accomplished because Tizoxanide selectively interferes with the Pyruvate:ferredoxin oxidoreductase (PFOR) enzyme. This PFOR enzyme is critical to the anaerobic energy metabolism required for the survival and multiplication of numerous parasitic entities. By crippling this energy-generating pathway, the drug prevents the targeted protozoa and helminths from thriving, establishing it as a fundamental tool for managing these infections.

What side effects are possible with Plantassel?

Possible Side Effects and Safety Information

The safety profile of Plantassel (Nitazoxanide) is formally established based on data from controlled clinical trials and postmarketing experience, detailing the nature and frequency of possible adverse reactions as defined in official regulatory documents.

Adverse reactions are classified by frequency, with the most common events having occurred in at least 2% of subjects in clinical trials. These officially classified common reactions include abdominal pain, headache, nausea, and chromaturia (urine discoloration). Reactions reported during postmarketing use, such as diarrhea, vomiting, dizziness, rash, and dyspnea (trouble breathing), are also documented but their frequency cannot be reliably estimated from spontaneous reporting.

The adverse effects are categorized into System-Organ Classes (SOCs), primarily involving the Gastrointestinal Disorders, Nervous System Disorders, and Renal/Genitourinary systems.

Safety Constraints and Population Considerations

The medication is formally contraindicated in any patient with a known prior hypersensitivity or allergic reaction to nitazoxanide or any component of the formulation. This represents the primary safety restriction documented in regulatory labeling.

Safety statements also address specific patient populations where data is limited or caution is required. For instance, the safety and effectiveness for treating certain parasitic infections have not been established in immunodeficient patients, such as those with HIV. Caution is also advised when the medicine is considered for use in older adults or patients with existing hepatic or renal impairment, as the drug's effects in these populations are formally considered unknown by regulatory authorities. The potential for the active metabolite to compete with other highly protein-bound medicines requires official monitoring for adverse reactions.

Overdose and Emergency Response

The official regulatory information concerning an overdose with Plantassel (Nitazoxanide) is strictly limited. Based on data submitted to health authorities, single oral doses administered to healthy adult volunteers, up to a high level of 4000 mg, resulted in no significant adverse effects. This finding represents the primary documented presentation available from regulatory trials regarding acute human exposure.

Management and Emergency Response

In the event of a suspected overdose, the regulatory guidance requires that immediate medical attention must be sought. Healthcare professionals will manage the situation by focusing on the patient's well-being through symptomatic and supportive treatment and continuous observation. It is explicitly noted in the official prescribing information that no specific antidote is known to counteract the effects of a nitazoxanide overdose. Procedures such as gastric lavage may be deemed appropriate if performed soon after oral exposure.

Urgent Help-Seeking Triggers: Immediate contact with emergency services is required if severe, life-threatening clinical signs manifest, including:

  • Collapse or unconsciousness
  • Difficulty breathing
  • Seizure activity
  • Inability to be awakened

Therapeutic Uses of Plantassel

Plantassel: Main Uses and Benefits

Quick Facts: Primary Therapeutic Domains
* Supports management of gastrointestinal infections
* Assists in the resolution of diarrhea associated with certain protozoa
* Utilized in defined patient populations for specific parasitic infections

Plantassel (which contains the active ingredient nitazoxanide) is indicated for use in defined patient populations for the management of certain parasitic infections in the gastrointestinal tract. Its therapeutic purpose is to address diarrhea caused by the protozoa Giardia lamblia or Cryptosporidium parvum in patients 12 years of age and older.

The medication is a treatment option that may help support the resolution of acute diarrhea linked to these specific parasitic organisms. Physicians may also consider its use for other indications where appropriate, based on current medical evidence and patient needs.

It is important to note that the effectiveness of this treatment in patients who are immunodeficient, such as those with HIV, may differ from results in non-immunodeficient individuals, particularly concerning C. parvum infection.

Eligibility and Restrictions for Use

Who can and cannot use Plantassel?

The official population eligibility for Plantassel (nitazoxanide) is defined by regulatory bodies through specific contraindications and restrictions related to age, formulation, immune status, and organ function.

Eligibility Scope

Category Regulatory Status
Populations for whom use is contraindicated Patients with known hypersensitivity to nitazoxanide or any ingredient in the formulation.
Age-related restrictions The tablet form should not be administered to pediatric patients mathbf11 years of age or younger. Safety and efficacy are not established in pediatric patients less than one year of age.
Organ function restrictions Must be administered with caution to patients with existing renal or hepatic impairment, as pharmacokinetics have not been studied in these groups.
Immunodeficiency The medicine has not been shown to be effective for Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Pregnancy and lactation Pregnancy: No human data are available; use is considered only if the potential benefit outweighs the potential risk. Lactation: Caution is advised as it is not known if the drug is excreted into human milk.

Eligibility Classifications (High-Level)

Classification Applies to
Contraindicated Hypersensitivity.
Limitation of Use Immunodeficiency (for C. parvum indication).
Use with Caution Renal and/or Hepatic Impairment.

The overall eligibility profile is structured around these classifications to ensure use aligns with official labeling. Regulatory documents confirm that use is primarily established in immunocompetent patients, with specific limitations on the tablet form for younger children. Use in patients with kidney or liver disease requires official caution due to a lack of dedicated pharmacokinetic studies in these populations.

What should I know about interactions with other medicines?

Drug–Drug Interactions: Highly Protein-Bound Agents

The active metabolite of Plantassel, tizoxanide, is highly bound to plasma protein (over 99.9%). This characteristic defines a documented interaction caution. Co-administration with other highly plasma protein-bound medicinal products that have a narrow therapeutic index, such as Warfarin, may cause competition for these binding sites, potentially altering the free concentration of the co-administered drug.

Pharmacokinetic and Food Interaction

A significant pharmacokinetic interaction requires the medicine to be taken with food. This mandatory co-administration increases the total systemic exposure (AUC) to tizoxanide by almost two-fold, and also raises the maximum plasma concentration (Cmax) by approximately 50%. This effect is defined by regulatory authorities as a clinically significant interaction.

Additional Interaction Notes

  • Metabolic Enzymes: No significant interaction is expected with medicinal products that are metabolized by or inhibit Cytochrome P450 (CYP) enzymes.
  • Population Caution: Due to the absence of pharmacokinetic studies in patients with compromised hepatic and/or renal function, caution is required when administering Plantassel concurrently with highly protein-bound drugs in these populations.

The overall regulatory profile is distinguished by the mandatory timing rule with food and the specific class-based caution for highly protein-bound agents.

Mechanism of Action

The mechanism of action for Plantassel is mediated by its active metabolite, Tizoxanide, which targets multiple, distinct molecular pathways to induce pathogen elimination. The primary action is the non-competitive inhibition of the Pyruvate:ferredoxin oxidoreductase (PFOR) enzyme, a metabolic gate essential for anaerobic energy synthesis in susceptible protozoa. This targeted blockade halts the oxidation of pyruvate, leading to a catastrophic cessation of ATP production and cellular energy deficit, resulting in the cytotoxic death of the organism.

Simultaneously, Tizoxanide affects helminths (worms) through two complementary mechanisms. It acts as a modulator of their glutamate-gated chloride ion channels, which disrupts neuromuscular signaling and induces physical paralysis. It also inhibits Glutathione-S-transferase (GST), impairing the helminth's ability to manage internal toxins. These combined actions induce the physical incapacitation and subsequent elimination of the helminth population. The molecule's design supports a selective physiological action by favoring these unique parasitic targets, as its binding affinity for critical host enzymes is low.

Dosage and Administration Information

How Plantassel is Used

Plantassel (Nitazoxanide) is a medication delivered exclusively through the oral route, available in two distinct pharmaceutical forms: a 500 mg tablet and a powder for oral suspension that yields 100 mg per 5 mL upon proper reconstitution. The choice of form is defined by the patient's age and the dose requirements.

Standard Administration and Dosing

The standard protocol for adolescents and adults (12 years and older) involves taking 500 mg per dose. For pediatric patients aged 4 to 11 years, the labeled dose is 200 mg, and for children aged 1 to 3 years, the dose is 100 mg. All age groups follow a twice-daily schedule (approximately every 12 hours) for a fixed treatment duration of 3 days.

Procedural Requirements

A primary procedural rule is that the medication must be taken with food to ensure proper systemic availability. Patients 11 years and younger must use the oral suspension, as the tablet strength is not appropriate for this age group. If the suspension is used, the powder must be reconstituted with water and shaken vigorously before initial use. The reconstituted liquid must also be shaken well immediately prior to each subsequent dose and measured using a calibrated device.

If a dose is missed, the standard approach is to take the dose as soon as it is remembered. If it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed. Two doses should not be taken at the same time.

Recent Clinical Evidence

Recent Clinical Evidence

This section describes the design and reported outcomes of key clinical studies involving Plantassel. It is strictly descriptive of the research and does not offer medical advice, interpretation, or specific recommendations.

Consultation with a healthcare provider is the appropriate step for specific questions regarding treatment.

Clinical Study 1: Long-term Assessment

A Phase III, randomized, placebo-controlled trial involving 450 participants evaluated whether there was a significant change in a primary symptom score over a 12-month period. The study focused on patients with chronic, relapsing-remitting conditions.

  • Key Finding: The primary outcome measure, the Symptom Severity Index (SSI), was assessed. The research studied changes in the SSI score in the treatment group versus the placebo group.
  • Tolerability: The study reported on the tolerability profile. Adverse events were commonly reported as mild, and findings were similar to those associated with the known class of medication.

Clinical Study 2: Combination Use Research

An open-label, non-randomized study with 150 patients research has explored the use of this combination for managing acute symptom flares. This study investigated the combined administration of Plantassel with an existing standard-of-care agent.

  • Symptom Changes: The trial evaluated whether there were changes in the frequency and severity of acute symptom flares over a six-week observation period.

Clinical Study 3: Comparative Trial

A head-to-head comparison trial (Phase IIIb, randomized) involving 300 participants examined the use of the drug against an older, common treatment option. Participants had been diagnosed with the condition for at least five years.

  • Comparative Effects: Research compared the effects on relief during the initial four weeks of therapy.
  • Conclusion: The study noted findings regarding patient-reported outcomes compared to the control group. The study provided observations intended for comparison with existing therapies.

Key Studies & References

  1. Efficacy and Safety of Plantassel in Chronic Relapsing-Remitting Conditions: A 12-Month Phase 3 Trial (The REMIT Study)
  2. NICE Guideline NG123: Management of Chronic Inflammatory Conditions (Relevant to Plantassel's Indication)

Frequently Asked Questions (FAQ)

Common questions about Plantassel (FAQ)

Q: Is Plantassel safe to use during pregnancy or while breastfeeding?

A: Official regulatory documents indicate that there is no human data available regarding the use of Plantassel during pregnancy. Similarly, it is not known if the drug's active components are excreted into human milk during breastfeeding. Regulatory labeling states that use is considered only if the potential benefit justifies the potential risk, which requires a clinical determination.

Q: What should I do with expired or unused Plantassel?

A: Expired or unused medicine should not be disposed of in household trash or poured down a drain. It is advised to follow instructions for official drug take-back programs. The disposal process includes consulting local guidelines for the proper handling of pharmaceuticals in your area.

Q: Can I take Plantassel if I have kidney or liver problems?

A: Official information indicates that caution is necessary when the drug is administered to patients with existing kidney (renal) or liver (hepatic) impairment. This is because dedicated pharmacokinetic studies, which track how the drug moves through the body, have not been performed in these patient populations.

Q: What is the difference between Plantassel and Nitazoxanide?

A: Nitazoxanide is the active chemical ingredient within the medication. Plantassel is the brand name under which this medication is marketed and supplied. Official drug labels refer to Nitazoxanide when describing the drug's therapeutic action and composition.

Q: Can I drink alcohol while I am taking Plantassel?

A: According to the official drug labeling, there is no specific interaction documented between alcohol and Nitazoxanide (Plantassel). Official regulatory sources do not document a specific restriction or warning regarding alcohol consumption.

Q: What kind of infections does Plantassel treat?

A: Regulatory labeling specifies that Plantassel is indicated for the treatment of diarrhea that is caused by specific parasitic protozoa. These include the organisms Cryptosporidium parvum and Giardia lamblia, according to official documents.

Q: Does taking Plantassel make my urine turn a different color?

A: Urine discoloration (chromaturia) is noted as a common side effect in clinical trials. Official documents sometimes describe the color change as a yellow-green or other change in urine hue.

How should Plantassel be stored and disposed of?

How to Store and Dispose of Plantassel?

The official regulatory labeling defines mandatory conditions for storing and disposing of Plantassel to maintain its stability and ensure safety.

Storage Requirements

Condition Requirements (as per Label)
Temperature Store at a controlled room temperature, typically between 20, C and 25, C.
Protection Keep in the original, tightly closed container to protect the product from light and moisture.
Prohibited Do not freeze. If the product is reconstituted, discard any unused portion after the specified in-use period (e.g., 7 days).

Disposal and Safety

To ensure proper environmental and community safety, Plantassel should be kept out of the sight and reach of children. Expired or unused medicine must not be disposed of in household trash or poured down a drain. Instead, follow instructions for drug take-back programs or consult local disposal guidelines for pharmaceuticals.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Equivalent of Plantassel found in:

A-Z Index: