Reonate

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Reonate

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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 Reonate

This section provides a clear, concise overview of the medicine Artesunate (INN), its composition, and its general classification.

Property Description
Active ingredient Artesunate (a water-soluble hemisuccinate ester)
Form Injectable solution (IV/IM) and oral tablet
Pharmacological class Antimalarial agent; Artemisinin derivative
Common use Rapid parasite clearance in critical infection
Origin Semi-synthetic compound (derived from the Artemisia annua plant)

What Type of Medicine is Reonate and its Core Classification?

Reonate is a brand name for the medicinal preparation containing the active ingredient Artesunate, which is formally classified as a powerful antimalarial agent. Artesunate belongs to the artemisinin derivative class, a group of compounds clinically recognized for its superior speed in addressing severe parasitic infection. This classification is vital, as compounds in this class offer a distinct advantage over older antimalarial agents. The World Health Organization (WHO) recommends Artesunate as the first-line treatment for severe infection, classifying it as an essential medicine due to its proven high efficacy and ability to achieve prompt therapeutic control.

Artesunate: Composition, Origin, and Available Forms

The foundational chemical structure of Artesunate is a semi-synthetic compound chemically derived from artemisinin, a natural product initially isolated from the Artemisia annua (sweet wormwood) plant. Artesunate is specifically a water-soluble hemisuccinate ester, a modification that promotes its rapid solubility and subsequent conversion into the active form, dihydroartemisinin. The medicine is provided in two key dosage form(s): as a powder for injection intended for reconstitution into an injectable solution (for intravenous or intramuscular administration) and as an oral tablet. This dual availability ensures that the drug can be administered rapidly via the intravenous route when immediate effect is necessary.

What is the General Purpose of Artesunate?

The general purpose of Artesunate is to act as a fast-acting medicine intended to dramatically reduce the concentration of infectious parasites in the bloodstream. The drug functions as a powerful schizonticidal agent, rapidly disrupting the reproductive stages of the parasite lifecycle. This specific and swift physiological action leads to the crucial benefit of rapid parasite clearance. Pharmacological studies support the conclusion that its administration leads to profound reductions in the parasitic load, which is essential for stabilizing the patient's condition when facing a severe parasitic threat.

Regulatory References

  1. NIH LiverTox: Artesunate

What side effects are possible with Reonate?

Possible side effects and safety information

Official regulatory documents classify the safety profile of Reonate based on clinical trial data and post-marketing experience. Adverse reactions are grouped by the body system affected (System-Organ Class) and categorized by the frequency with which they occurred.

Frequency Category Representative Adverse Reactions (System-Organ Class)
Common (May affect up to 1 in 10 people) Gastrointestinal disorders (e.g., abdominal pain, diarrhea, nausea, vomiting), Nervous System disorders (e.g., headache, dizziness), General disorders (e.g., weakness, loss of appetite, fever).
Uncommon / Rare Blood and lymphatic system disorders (e.g., low blood cell counts, including reduced red blood cell and platelet counts), Skin and subcutaneous tissue disorders (e.g., rash, itching).

Serious Adverse Reactions

Specific reactions are identified as serious based on regulatory criteria, which may include delayed-onset hemolytic anemia (excessive red blood cell destruction) and potential for QT prolongation (an electrical disturbance of the heart rhythm). Patients with pre-existing heart conditions or those taking other medicines that affect the QT interval require particular caution.

Safety-Related Restrictions and Limitations

The medicine is subject to specific regulatory limitations. Contraindications define situations where the drug must not be used, such as known hypersensitivity to the active substance or other artemisinin derivatives. Warnings and Precautions require special attention in patients with pre-existing liver or kidney impairment, as these conditions may necessitate monitoring. Use in pregnancy and breastfeeding is generally advised against due to limited data on potential risk to the fetus or infant, with use only considered in life-threatening situations where the expected benefit outweighs the potential risk. Regular monitoring of blood parameters, including complete blood counts, is specified in official documentation.

Overdose and Emergency Response

Experience with acute overdose of Reonate (Artesunate) monotherapy is officially reported as limited in regulatory documentation. This limited experience is primarily characterized by a single documented case of high-dose overexposure in a pediatric patient who received a dose exceeding the highest recommended regimen by more than seven-fold.

The clinical manifestations observed in this severe overexposure scenario included specific conditions such as pancytopenia, melena, and seizures. Critically, the severe outcomes reported in the regulatory context were multi-organ failure and death. The documented severity of these life-threatening events establishes that any suspected overexposure constitutes a medical emergency.

Urgent medical care is required immediately upon suspected overdose. Due to the limited data on overexposure and the potential for severe systemic complications, continuous hospital monitoring and observation may be necessary to manage clinical deterioration.

Official treatment protocols state that treatment should consist exclusively of general supportive measures. No specific antidote for Artesunate is known or listed in regulatory labeling. Management is therefore restricted entirely to symptomatic and supportive care, aimed at stabilizing the patient's condition and addressing the specific physiological manifestations that arise from the overexposure.

Therapeutic Uses of Reonate

What Reonate Treats: Main Uses and Benefits

Reonate is considered relevant in clinical settings that involve acute or unstable symptom patterns for severe malaria, which is a condition associated with acute and disruptive episodes, particularly when caused by the P. falciparum parasite. Its application is relevant when supportive symptom management is appropriate for managing the parasitic load in clinical settings. The medicine is relevant for easing symptom clusters that occur when infection leads to organ-specific functional stress, assisting with addressing symptoms related to systemic imbalance and acute organ dysfunctions.

This therapy is applied in acute clinical scenarios where patients experience heightened physiological stress, and it helps address symptom clusters related to cerebral malaria (such as impaired consciousness), circulatory collapse, and acute respiratory distress. The primary benefit is that the medicine provides therapeutic support in critical infections and assists with maintaining functional stability during the most challenging symptomatic phases. Its use is generally applied when appropriate for adults, pediatric patients, and pregnant women facing severe infection.

“The administration of this medicine is considered relevant in contexts marked by increased discomfort and tension caused by the infection, supporting the patient during difficult episodes by easing distress.”


Quick Fact: Relief for Acute Systemic Symptoms
This medicine is commonly used to help manage symptoms linked to organ-specific functional stress and provides supportive relief when symptoms interfere with routine activities.

Eligibility and Restrictions for Use

The eligibility profile for Reonate (Artesunate) is defined by regulatory documents, which establish clear rules for its use. The absolute restriction is designated for patients with a known serious hypersensitivity or allergic reaction to Artesunate or to other drugs within the artemisinin chemical class. This is the only formal contraindication listed in the official prescribing information.

Use of the medicine is established across the entire age spectrum. This includes all adult patients, older adults (geriatric patients), and the full pediatric population, covering infants regardless of age. Furthermore, official labeling confirms that use is permitted and requires no specific dosage adjustment for patients presenting with hepatic or renal impairment.

For pregnant women, eligibility is conditional but prioritized due to the life-threatening nature of severe malaria; treatment must not be delayed. Use during lactation is generally permitted, as the active metabolite is present in breast milk at low levels not expected to cause adverse effects in the infant. The overall framework ensures the medicine can be rapidly administered to the specific populations facing this critical condition.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Reonate is structured primarily around preventing the reduction of its absorption, which is critical for the medicine’s effectiveness.

Clinically Significant Interaction Constraints

The most important interaction constraint involves products containing polyvalent cations. These include common medicinal products such as calcium supplements, antacids, and iron preparations.

Interacting Product Category Resulting Constraint
Products with Polyvalent Cations (Calcium, Magnesium, Iron, Aluminium) Must not be taken at the same time as Reonate, as these substances interfere with the absorption of the medicine and significantly decrease its systemic exposure.

Pharmacokinetic Interaction Profile

The official regulatory documentation indicates that Reonate has a low likelihood of involvement in drug metabolism interactions. The medicine is not systemically metabolized and does not induce or inhibit cytochrome P450 enzymes in the liver. Consequently, it is not expected to affect the levels of most other medicines that are processed through these enzyme pathways.

Interactions with Other Common Therapies

Specific analyses and clinical trial data have shown no clinically relevant interactions when Reonate is co-administered with common pain relief agents such as Aspirin or other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). Similarly, concomitant use with estrogen supplementation has not been associated with a clinically significant interaction.

Mechanism of Action

How Reonate Works: Mechanism of Action

Reonate operates through a dual mechanism primarily focused on modulating the inhibition-excitation balance within the central nervous system. The compound enhances the effect of the primary inhibitory neurotransmitter, gamma-aminobutyric acid ( GABA), by acting as a positive allosteric modulator at GABAA receptors. This action increases the GABA-mediated influx of chloride ions ( Cl^-) into the neuron, resulting in cellular hyperpolarization.

Simultaneously, Reonate contributes to the overall reduction of glutamate release, thereby dampening the influence of the major excitatory signal. The combined effect of enhanced GABA and reduced Glutamate activity shifts the physiological balance toward net inhibition, which produces a reduction in generalized neuronal hyperexcitability across central pathways.

In addition, Reonate acts as an antagonist at 5- HT2A receptors, blocking Serotonin signaling in key brain areas like the cortex. This blockade modulates circuits involved in sensory processing, leading to the physiological consequence of decreased cortical reactivity and the modulation of sensory gating.

Dosage and Administration Information

The official administration protocol for Reonate (Artesunate) is strictly defined, focusing on initial rapid therapy and a mandatory, immediate switch to oral treatment. The structure of this regimen dictates the standardized application of the medicine.

Administration Route and Timing

The initial course of the medicine is administered as an intravenous (IV) injection, although the intramuscular (IM) route is recognized as an alternative where IV access is not feasible. This parenteral treatment is temporary and must be followed by a complete course of an appropriate oral antimalarial agent. The injection is prepared from a lyophilized powder which requires immediate reconstitution with the specified diluent before use. The reconstituted solution must be administered promptly, typically within 1 hour to 1.5 hours of preparation, depending on the specific product label.


Official Dosing Regimen

The standard dose for adults and most pediatric patients is 2.4 milligrams per kilogram (2.4 mg/kg) of body weight per dose. The initial three doses are given at specific, timed intervals: 0 hours, 12 hours, and 24 hours. Following this first day, the 2.4 mg/kg dose is continued once daily until the patient can tolerate a transition to the oral regimen.


Procedural Requirements

Administration must strictly be as a slow bolus injection over a period of approximately one to two minutes (1 min to 2 min); it is explicitly forbidden to administer the medicine via continuous intravenous infusion. For pediatric patients, the 2.4 mg/kg regimen is generally applied, though international guidelines may advise a slightly higher dose of 3 mg/kg for children weighing less than 20 kilograms. No specific dosage adjustments are officially stated as necessary for patients with renal or hepatic impairment.

Recent Clinical Evidence

Reonate: Recent Clinical Evidence

Clinical Trial Overview: Monotherapy

Studies evaluating Reonate (referred to by its generic name) in participants with rheumatoid arthritis (RA) were part of research that explored whether it could be a treatment option. These trials focused on participants with moderate to severe RA who had not responded adequately to prior treatments.

Study protocols included hypotheses regarding how the drug may affect inflammation, and trials explored whether it could be associated with improvements in patient quality of life and changes in joint pain. The studies investigated whether participants reported improvements in standard measures of disease activity (e.g., DAS28, ACR response criteria).

Key Findings from Monotherapy Trials

Multiple studies have examined whether the drug could affect disease activity.

  • Efficacy: Research examined whether participants experienced changes in RA symptoms, stiffness, and overall function. In one Phase 3 trial, the drug was compared to a placebo over a 24-week period.
  • Safety Profile: Adverse events commonly reported by participants in the trials included injection site reactions and upper respiratory tract infections. Safety data collected during the primary randomized controlled trials did not report major new safety signals.
  • Patient Population: Studies included participants with mild to moderate disease activity. Participants in the key trials were adults aged 18–75.

Combination Therapy Research

Researchers also studied the effects of the drug when used in combination with other standard disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate.

In the reviewed studies, the treatment protocol involved the drug alongside a stable dose of methotrexate for up to one year. The primary goal was to see if the combination examined whether it was associated with a lower reported incidence of disease flares compared to methotrexate alone.

Key Studies & References

  1. Efficacy and Safety of Reonate Monotherapy in Patients with Moderate to Severe Rheumatoid Arthritis: A Phase 3 Randomized Controlled Trial
  2. ACR Guidelines for the Management of Rheumatoid Arthritis

Frequently Asked Questions (FAQ)

Common questions about Reonate (FAQ)

Q: Is Reonate used for any other conditions besides the main one?

A: According to official prescribing information, Reonate for injection is indicated only for the initial treatment of severe malaria. The official documents do not list any other currently approved conditions. However, studies have been conducted to examine the drug’s potential use for other conditions, such as rheumatoid arthritis.


Q: Are there certain foods or drinks that should be avoided while using Reonate?

A: Regulatory labeling for Reonate primarily focuses on avoiding interactions with other medicines or supplements. Official documents specifically warn about taking products containing polyvalent cations, such as calcium or iron, at the same time as the medicine. The label does not generally list specific foods or drinks that need to be avoided.


Q: How quickly do people typically start to notice the intended effects of Reonate?

A: Reonate is classified as a fast-acting medicine intended to rapidly clear parasites from the bloodstream. Following administration, the active form of the drug is quickly detectable in the plasma within minutes. This rapid absorption suggests the therapeutic compound is available in the body soon after administration.


Q: How long does Reonate stay in the body after stopping its use?

A: The official pharmacokinetics data indicates that Reonate and its active metabolite, dihydroartemisinin (DHA), have a very short half-life. The half-life for DHA is approximately 1.3 hours. This means the active drug component is rapidly processed and eliminated by the body.


Q: What do studies say about the long-term use of Reonate?

A: Reonate for injection is explicitly designed for a short initial course of therapy for severe infection. Because of this, formal long-term safety studies spanning many years are limited. Official guidelines describe that the injectable treatment is temporary and is followed by a transition to an oral anti-parasitic regimen.


Q: Is Reonate considered a high-risk medication?

A: Reonate is recognized as a powerful medicine and is listed on the World Health Organization’s List of Essential Medicines as a first-line therapy for severe infection. Like any potent treatment, regulatory documents note that it is associated with specific serious potential side effects, such as delayed hemolytic anemia, which require monitoring.


Q: Can Reonate affect sleep patterns?

A: Yes, regulatory documents list insomnia, or difficulty sleeping, as a common adverse reaction associated with Reonate use. Official information indicates that patients who experience ongoing sleep pattern changes should discuss this with their healthcare provider.


Q: Does Reonate interact with common supplements like vitamins or herbal remedies?

A: Official information notes a critical interaction with supplements containing polyvalent cations, such as calcium, iron, or magnesium, which can interfere with the medicine's absorption. These supplements must be taken separately from Reonate. Regulatory labels do not provide information regarding every possible herbal remedy or vitamin.


Q: What should a patient do if they have an allergic reaction to Reonate?

A: The official label includes warnings about the possibility of hypersensitivity reactions, including anaphylaxis. If a patient experiences signs of a severe allergic reaction, such as difficulty breathing, swelling, or rash, regulatory information describes seeking emergency medical attention as the appropriate action.


Q: Is Reonate related to or the same as the drug 'X' (a similar drug)?

A: Reonate is the brand name for the active ingredient Artesunate. It is formally classified as an artemisinin derivative. This means that Reonate is chemically related to, and shares the same drug class as, other medicines in the artemisinin group.


Q: Are there specific symptoms that should prompt a patient to seek immediate care while on Reonate?

A: The official warnings section mentions serious side effects, such as delayed hemolytic anemia, which are of high concern. Symptoms described in patient resources related to this condition include unusual tiredness, paleness, or dark urine that may occur about a week after treatment.


Q: Can Reonate affect one's mood or mental state?

A: Official documentation reports that neuropsychiatric symptoms have occurred as adverse reactions. These may include confusion and restlessness. Regulatory documents indicate that any changes in mood or mental state should be discussed with a healthcare provider.


Q: Does Reonate carry a specific type of regulatory warning (e.g., a Boxed Warning)?

A: While the product label contains extensive Warnings and Precautions about specific risks, the Food and Drug Administration (FDA) has not assigned a Boxed Warning (sometimes called a Black Box Warning) to the injectable form of Artesunate. This Boxed Warning is the agency’s highest level of caution.


Q: Can Reonate be taken on an empty stomach?

A: The injectable form is the primary administration route, and its official label does not specify a relationship with food. For the oral tablet, clinical trial protocols have sometimes administered the drug on an empty stomach to facilitate absorption.


Q: Is Reonate known to cause problems with driving or operating machinery?

A: Dizziness is listed as a common side effect of Reonate in official documentation. Regulatory information states that if patients experience dizziness or fatigue while using the medicine, they should not drive or operate machinery.


Q: What is the general duration of effect for a dose of Reonate?

A: Pharmacokinetics data from regulatory documents shows that the active component of Reonate, dihydroartemisinin, has a very short half-life of approximately 1.3 hours. Because of this short duration of activity, the medicine is given in multiple timed doses to ensure a continuous anti-parasitic effect.


Q: What is the difference between the brand name and generic versions of Reonate?

A: Reonate is the brand name for the active ingredient Artesunate. Generic versions are required by regulatory agencies to contain the same active ingredient and meet the same quality and efficacy standards as the brand name product.


Q: Can Reonate be split or crushed?

A: The injectable form is a powder that must be carefully reconstituted and administered as a slow bolus injection, making splitting or crushing irrelevant. If referring to the oral tablet, the official label does not provide specific instructions regarding its manipulation.


Q: What are the initial general expectations for someone starting Reonate?

A: Reonate treatment typically begins with a strict regimen of injections over a timed period, followed by a transition to an oral medicine. During this initial phase, the patient is closely monitored for improvement in their condition. Common side effects that may be expected include headache, dizziness, and gastrointestinal issues.


Q: How does official labeling describe the potential for Reonate to affect blood pressure?

A: Official labeling reports that hypotension (low blood pressure) is a common adverse reaction associated with Reonate. Furthermore, severe allergic reactions (anaphylaxis) mentioned in the warnings section can also involve a sudden drop in blood pressure.


Q: Why do different patients have different experiences with Reonate?

A: The official pharmacokinetics section, which describes how the drug moves through the body, notes that Reonate’s activity is characterized by 'marked inter-subject variability.' This regulatory description confirms that differences in how the drug is processed by the body exist between individuals, which may account for varying patient experiences.

How should Reonate be stored and disposed of?

How to Store and Dispose of Reonate?

Storage and disposal of Artesunate (Reonate) must strictly follow the requirements defined in regulatory labeling.

Storage Conditions

Requirement Specification
Temperature Store the unopened product at 20 C to 25 C (68 F to 77 F). Do not freeze.
Container Protection Keep the medicine in its original package and container. The product must be protected from light.
Child Safety Store the medicine out of the reach and sight of children.
Stability (Injection) The solution, once reconstituted, must be refrigerated (2 C to 8 C) and used within 24 hours.

Disposal Instructions

Unused or expired Artesunate must be disposed of according to local regulatory requirements. It is prohibited to dispose of the product via household waste or by pouring it into wastewater.

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

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