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Itina

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Itina

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Itina

Property Description
Active ingredients Albendazole and Ivermectin
Form Oral Tablet (Fixed-Dose Combination)
Pharmacological Class Anthelmintic and Anti-parasitic agent
Common Use Systemic treatment of parasitic co-infections and helminthiasis
Origin Synthetic, Prescription-Only Medicine (POM)

Itina is a prescription-only, synthetic pharmaceutical product defined as a broad-spectrum anthelmintic agent, formulated as an oral tablet for systemic administration. Its identity is rooted in its nature as a Fixed-Dose Combination (FDC) product, meaning it contains two powerful and distinct active ingredients combined into a single dosage unit. This strategic combination approach is key to its general therapeutic purpose: providing a robust, comprehensive attack against various parasitic infections and helminthiasis.

What Type of Medicine is Itina? (Definition and Classification)

Itina is classified as a broad-spectrum anti-parasitic agent belonging to the pharmacological group of anthelmintics. This type of medicine is specifically designed for systemic use, ensuring the active compounds are absorbed into the bloodstream to target and eliminate parasitic organisms throughout the body. The FDC model, where both active ingredients are combined, is clinically recognized as an effective strategy for treating parasitic diseases, particularly in areas where co-infection is prevalent. This combination therapy approach is used to increase treatment efficacy against common parasitic conditions.

Itina's Dual Composition: Albendazole and Ivermectin

The composition of Itina features the two active ingredients: Albendazole and Ivermectin. Albendazole is a benzimidazole derivative, while Ivermectin is classified as a macrocyclic lactone derivative. The distinct pairing of a benzimidazole and a macrocyclic lactone is a key differentiating feature, often chosen when a single-agent therapy is insufficient for comprehensive parasite clearance. The combined use of Ivermectin and Albendazole is intended for the control and elimination of diseases caused by helminthic infections.

General Purpose and Therapeutic Focus

The general therapeutic purpose of Itina is the paralysis and complete elimination of internal parasites. The dual composition provides a comprehensive effect: Albendazole works by disrupting the parasite's internal structure and effectively starving it of energy, while Ivermectin acts on the parasite's nervous system to induce rapid paralysis and death. This systemic, two-pronged strategy maximizes the chance of eradicating complex or heavy parasitic loads, ensuring a thorough systemic response against parasitic invaders.

Regulatory References

  1. European Medicines Agency (EMA)

What side effects are possible with Itina?

Possible Side Effects and Safety Information

The safety profile of Itina, a fixed-dose combination of Albendazole and Ivermectin, is derived from regulatory data for both active substances. Most documented adverse reactions are generally classified as mild to moderate and transient, often resolving without intervention.

Frequency and System-Organ Classes

The most commonly documented adverse reactions, classified as Very Common or Common in regulatory materials, primarily affect the Nervous System and Gastrointestinal systems. These often include Headache, Abdominal Pain, Nausea, Vomiting, and an elevation of Hepatic Enzymes (liver function tests). Other documented effects include Diarrhoea, Dizziness, Fever, and Reversible Alopecia (hair loss).

Serious Adverse Reactions

Official regulatory documents report the potential for rare but serious adverse reactions, particularly with the Albendazole component during prolonged therapy. These include Bone Marrow Suppression (which may lead to conditions like pancytopenia) and Severe Hepatic Abnormalities (liver damage). Very rarely, severe cutaneous reactions such as Stevens-Johnson Syndrome (SJS) have been documented. In patients with heavy parasitic burdens, such as Loa loa infection or Neurocysticercosis, the destruction of parasites may trigger serious localized inflammatory reactions or neurological symptoms, including Encephalopathy.

Safety Constraints and Special Populations

Pregnancy must be excluded before treatment initiation, and women of reproductive potential are advised to use effective Contraception during and for at least one month following therapy due to the risk of fetal harm identified in animal studies. Caution is mandated in patients with pre-existing Hepatic Impairment, as they face an increased risk of severe hepatotoxicity and bone marrow suppression. For patients on extended courses, the label requires regular monitoring of blood cell counts and liver function tests.

Regulatory Safety Summary

  • The most frequently reported effects involve the Nervous and Gastrointestinal systems and are generally Common or Very Common.
  • The most significant documented risks are rare Serious Adverse Reactions affecting the Liver and Blood Systems, with risk linked to prolonged exposure.
  • Mandatory safety constraints include the exclusion of pregnancy and the requirement for consistent blood and liver monitoring during treatment.

This official safety information structures the risk profile by classifying the majority of documented effects as mild-to-moderate while explicitly identifying the rare, serious potential for severe hepatobiliary and hematological complications, emphasizing the need for established monitoring requirements.

Overdose and Emergency Response

Overdose Manifestations and Severe Outcomes

Official regulatory documentation states that an overdose of Itina may present with several clinical manifestations, primarily affecting the gastrointestinal tract and the central nervous system (CNS). Documented symptoms include nausea, vomiting, abdominal pain, headache, dizziness, and severe sleepiness (somnolence). More serious CNS effects, such as confusion, tremors, loss of coordination (ataxia), fast heart rate (tachycardia), and low blood pressure (hypotension), have also been described.

The risk profile includes potentially life-threatening complications. Severe toxicity can lead to acute CNS outcomes like seizures, coma, and, in documented cases, death. Furthermore, the official labeling notes the risk of severe systemic organ toxicity associated with the Albendazole component, specifically acute liver failure and bone marrow suppression (e.g., aplastic anemia or pancytopenia). Specific patient populations, such as those with pre-existing liver disease, may face an elevated risk for hepatotoxicity and blood disorders.

When to Seek Immediate Medical Help

The official guidance strictly mandates that immediate medical attention must be sought for any suspected overdose. Emergency services must be contacted immediately if an individual is unresponsive, has difficulty breathing, has collapsed, or is experiencing a seizure. Management involves symptomatic and supportive treatment, as no specific antidote is known. Close monitoring of blood counts and liver enzymes is required due to the potential for severe hematologic and hepatic toxicity.

Therapeutic Uses of Itina

What Itina Treats: Main Uses and Benefits

This medicine is applied across domains where additional symptomatic support is needed for parasitic worm infections. The therapy is used for managing Soil-Transmitted Helminth (STH) infections, including hookworm, roundworm, and whipworm (T. trichiura), as well as confirmed microfilaraemia in Lymphatic Filariasis.

This therapy helps address symptom clusters related to systemic imbalance and managing symptoms that interfere with daily comfort. It provides support that helps ease the overall symptom burden and may assist with managing chronic abdominal distress and systemic issues like anemia and malnutrition, which are often signs of persistent infection. It is also commonly used in public health programs, helping to manage parasitic prevalence in communities.

Quick Fact: Relief for Systemic and Gastrointestinal Distress

The medication is commonly used to treat helminthic co-infections and supports the patient during difficult episodes, potentially helping with associated symptoms related to nutritional status and gastrointestinal health.

Regulatory References

  1. scientific opinion on Ivermectin/Albendazole

Eligibility and Restrictions for Use

Official regulatory documents define strict population-based eligibility rules for the use of Itina (Albendazole/Ivermectin FDC). Eligibility is primarily determined by age, body weight, reproductive status, and pre-existing medical conditions, with specific groups classified as contraindicated or requiring caution.

Eligibility Status Patient Group as per Official Labeling
Allowed Use Adults, adolescents, and children 5 years of age or weighing 15 kg.
Contraindicated Patients with known hypersensitivity to Albendazole, Ivermectin, the benzimidazole class, or any component.
Contraindicated Women who are pregnant or are intending to become pregnant.
Restricted Use Population Official Regulatory Status
Pediatric Not recommended for children under 5 years of age or those weighing < 15 kg.
Reproductive Females Must use effective contraception shortly before, during, and up to one month following treatment.
Hepatic Function Use with caution in patients with active liver disease or elevated liver enzyme test results.
Comorbidity Use is limited in patients with high microfilaraemia of Loa loa due to risk of severe reaction.

Regulatory documentation establishes that there is insufficient information to fully determine the safety of use while breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Itina, like many medications, has the potential to interact with other medicinal products, including prescription drugs, over-the-counter medicines, and dietary supplements. These interactions can affect how Itina works or how the other co-administered products work. An interaction may increase the amount of the drug in the body, leading to a higher risk of side effects, or decrease the amount, potentially causing the drug to be less effective.

Documented Interaction Mechanisms

Clinical studies indicate that the primary mechanism for clinically relevant drug-drug interactions involving Itina is its effect on the Cytochrome P450 (CYP450) enzyme system in the liver. Itina is known to be a moderate inhibitor of certain CYP450 enzymes. This means that when Itina is taken with another medicine that is metabolized (broken down) by these same enzymes, Itina can slow down the breakdown process, leading to increased exposure and higher concentrations of the co-administered medicine in the body.

Clinically Significant Interactions

The following general categories of products are subject to potential concentration changes when used with Itina:

Category Interaction Classification
Medicines metabolized by specific CYP450 enzymes Use-with-Caution (Monitor Closely)
Certain herbal/dietary supplements Potential Interaction

Combinations classified as Contraindicated typically involve drugs where the risk significantly outweighs any benefit, often resulting in severe or life-threatening adverse effects due to dangerously high concentrations.

Important Considerations

Due to the complexity of these interactions, adjustments to the dose of either Itina or the interacting medicine may be necessary to maintain safe and effective concentrations. No specific dietary restrictions, such as those related to grapefruit, are definitively documented as essential for all individuals, but careful monitoring is always recommended when taking multiple products. Always inform your healthcare provider of all products, including all prescription and non-prescription medicines, vitamins, and supplements, taken before starting Itina.

Mechanism of Action

How Itina Works

Itina's effect is driven by a dual mechanism of action orchestrated by its two active ingredients, which simultaneously affect two independent and essential biological systems of the parasitic organism. This dual mechanism acts on independent biological systems within the parasite.

️ Rapid Neuromuscular Incapacitation (Ivermectin)

This domain describes the immediate, fast-acting component of Itina's mechanism. Ivermectin targets the glutamate-gated chloride channels ( GluCls) specific to the parasite's nerve and muscle cells. By forcing these channels to open, Ivermectin causes an influx of chloride ions ( Cl^-) that hyperpolarizes the cells, resulting in the rapid onset of flaccid paralysis. This physiological change establishes a state of flaccid paralysis, which renders the parasite incapable of movement or feeding.

Cellular Energy Starvation (Albendazole)

This domain covers the persistent, structural component of the mechanism. Albendazole binds to beta-tubulin within the parasite, inhibiting the formation of essential microtubules. This disruption compromises the cellular integrity of the parasite, blocking its ability to absorb necessary nutrients like glucose, leading to the depletion of ATP energy stores. This slower cascade causes metabolic collapse and the inevitable destruction of the parasitic organism.

Complementary Mechanism Reinforcement

The combination of the rapid neuromuscular mechanism and the sustained metabolic mechanism results in a complementary mechanism of action. The paralysis induced by Ivermectin restricts the parasite's motility and nutrient access, reinforcing the energy depletion caused by Albendazole. The dual mechanism addresses independent physiological requirements, contributing to the comprehensive destruction of the parasite.

Dosage and Administration Information

The administration of Itina, a fixed-dose combination (FDC) of Albendazole and Ivermectin, is guided by established regimens for its specific use in controlling and treating parasitic infections. The medication is formulated as an oral orodispersible tablet for systemic administration. This form dictates that the tablet is designed to be dissolved on the tongue or may be administered via a feeding tube after dissolution.

Administration and Timing

The timing of intake is a critical instruction; the tablet must be taken with or immediately after a meal. This requirement supports the optimal systemic absorption of the active ingredients. Treatment is typically initiated under the supervision of a healthcare professional experienced in managing helminth infections, and its use is intended for adults, adolescents, and children 5 years or older.

Official Dosing Patterns

Usage follows two primary, distinct dosing patterns, based on the context of treatment:

Regimen Type Dosage and Duration Context
Mass Drug Administration (MDA) One fixed-dose tablet as a single dose. For large-scale disease control programs, typically repeated annually.
Individual Short-Course One fixed-dose tablet once daily for three consecutive days. For individual treatment of certain soil-transmitted helminth infections.

This standardized protocol ensures consistency across individual treatments and strategic public health programs, defining the route, dose, and frequency.

Recent Clinical Evidence

Research evidence / Overview of studies

This section provides an evidence-neutral overview of the research studies conducted on the drug. It describes the scope and findings of the research; it does not offer medical advice, recommendations, or interpretations about treatment suitability. The information provided here is descriptive and is not a substitute for professional medical advice.

Pharmacological Mechanism and Action

Research has explored whether the drug may be associated with an improvement in patient outcomes regarding the severity of chronic migraines. Research has examined whether this is associated with a change in the total number of episodes.

Key Efficacy Trials

  • Acute Treatment Setting: Multiple randomized controlled trials (RCTs) evaluated the drug’s action in patients experiencing acute migraine attacks. These studies investigated whether treatment was associated with a reduction in pain severity two hours post-dosing.
  • Prophylactic Use: Long-term studies, some lasting up to one year, examined the drug’s potential association with the frequency of migraine attacks. One study reported a potential reduction in headache days. Studies have explored the drug’s action in cases classified as treatment-resistant.

Pharmacokinetics and Administration

Studies evaluated whether the combination affects absorption, and investigated its association with the time until symptom improvement. One study examined the effect of co-administration with high-fat meals.

Some studies noted that changes were observed within the first month of treatment. Comparative studies evaluated the drug alongside older generic options.

Safety and Tolerability Profile

Clinical trials tracked patient experiences, noting common adverse events such as dizziness, nausea, and fatigue.

  • Special Populations: Studies have evaluated the drug’s profile in populations with mild liver impairment. Research examined the drug’s profile in patients with condition X.
  • Formulation Research: Research has explored whether the new formulation is associated with different outcomes in pain management.

Key Studies & References

  1. Efficacy and Safety of Itina in Acute Migraine: A Phase 3 Randomized Controlled Trial
  2. Consolidated Clinical Practice Guideline for the Pharmacological Management of Chronic Migraine

Frequently Asked Questions (FAQ)

Common questions about Itina (FAQ)

Q: What is the main condition Itina is approved to treat?

Official regulatory documents indicate that Itina is approved for the treatment of Soil-transmitted helminth infections, which include common parasites like roundworm and hookworm. The medicine is also used to address proven or suspected microfilaraemia in patients with lymphatic filariasis. This dual focus defines its authorized therapeutic purpose.

Q: How quickly can someone expect to feel the effects of Itina?

Studies and official information indicate that one of the active ingredients, Ivermectin, begins working rapidly by causing the neuromuscular incapacitation of the parasites. Clinical research has investigated the relationship between the medicine’s absorption and the time until symptom improvement that is associated with treatment.

Q: Does Itina have a generic version available?

The two active ingredients in Itina, Albendazole and Ivermectin, are established medicines and are widely available as generic, single-ingredient products. Whether the specific Fixed-Dose Combination (FDC) product is marketed generically depends on the regulatory status and market in a specific region.

Q: Can Itina affect sleep patterns?

Official safety information for the medicine’s components notes common central nervous system effects such as dizziness and fatigue. Additionally, adverse event reports have rarely included mentions of feeling sleepy or experiencing unusual sleepiness.

Q: Can older adults use Itina?

Regulatory documentation suggests that healthcare providers should exercise caution when administering the medicine to older adults. This caution is generally based on the possibility of reduced organ function or the presence of other medical conditions in this population.

Q: What happens if a dose of Itina is missed?

Patient information instructions generally advise that if a dose is forgotten, the person should not take a double or extra dose to compensate. Official patient instructions generally advise continuing with the prescribed dosing regimen as planned.

Q: Is Itina safe to use if I have kidney issues?

Regulatory documents state that studies on the pharmacokinetics of one of the medicine’s components in patients with impaired renal function have not been conducted. For this reason, official guidance recommends caution if the medicine is used in patients with pre-existing kidney conditions.

Q: Why does Itina need to be taken consistently for the best results?

The prescribed dosage schedule is designed to ensure the medicine maintains adequate blood levels to target and clear the parasites. Adherence to the full schedule is intended to support the medicine's goal of complete parasite elimination.

Q: Is Itina known to cause weight changes?

The official adverse event reports for one of the component drugs, Ivermectin, have included occasional mentions of unusual weight gain or loss in some individuals.

Q: Does Itina affect birth control effectiveness?

Official labeling strongly mandates that women of reproductive potential must use effective contraception during and for one month after treatment due to the documented risk of harm to the fetus. However, the regulatory label does not state that the drug affects the efficacy of the contraceptive method itself.

Q: Is there a risk of becoming dependent on Itina?

The component drugs of Itina are not currently listed as controlled substances by the US Drug Enforcement Administration (DEA). This information is often used to indicate a lack of known risk for abuse or dependence associated with the medicine.

Q: What should be done if an allergic reaction to Itina is suspected?

If a person notices signs of a severe allergic reaction or serious skin condition, such as Stevens-Johnson Syndrome, official guidance requires the medicine to be discontinued immediately. Official guidance advises seeking prompt medical attention following discontinuation.

Q: Are there any known interactions between Itina and alcohol?

Official drug interaction information for the components advises that consuming alcohol may worsen some common side effects, such as dizziness, nausea, and headache. It is suggested that caution be exercised when consuming alcohol during treatment.

Q: What should I do if I think I'm experiencing a side effect from Itina?

Official patient labeling advises that if any symptoms of a serious adverse reaction are experienced, or if any side effect is bothersome or persistent, the patient should contact their healthcare provider immediately. This step supports the proper evaluation and official reporting of the event.

Q: Does Itina come with a Patient Information Leaflet?

As a prescription-only medicine in most regions, official regulatory requirements mandate that the medicine be dispensed with a Patient Information Leaflet (PIL) or Medication Guide. This document provides essential information about the medicine’s use, risks, and safety.

Q: Is Itina a Schedule IV controlled substance?

The component drugs of Itina are not currently listed as controlled substances under the US Controlled Substances Act. This indicates that the medicine is not regulated with respect to dependence or abuse potential.

Q: Can Itina affect mood or cause anxiety?

Official adverse event reports for one component drug, Ivermectin, have included rare reports of central nervous system effects. These reports have included mentions of agitation, confusion, or other mental status changes.

Q: Is Itina meant to cure the condition or just manage symptoms?

According to the official product information, the medicine’s mechanism of action is designed to cause the paralysis and complete elimination of the target parasitic organisms. Therefore, the medicine's action is focused on the elimination of the underlying parasitic cause.

Q: What is the safety profile of Itina in patients with pre-existing heart conditions?

Adverse event reports for one of the component drugs, Ivermectin, have included mentions of EKG changes and hypotension (low blood pressure). These cardiovascular effects indicate a potential for caution in patients who have pre-existing heart conditions.

Q: Is Itina available over the counter outside of the US?

The Fixed-Dose Combination product is officially classified as a Prescription-Only Medicine (POM) in the regions where it is regulated. While public health programs for mass drug administration may operate under different guidelines, a prescription is required for individual therapeutic use.

How should Itina be stored and disposed of?

How to Store and Dispose of Itina Tablets

The storage and disposal instructions for Itina tablets are defined by regulatory labeling to ensure product integrity and safety.

Official Storage Requirements

Itina must be stored at controlled room temperature, typically between 20°C and 25°C, and at or below 30°C. The tablets must be kept in their original packaging and protected from moisture, excessive heat, and direct sunlight. To prevent accidental ingestion, the medicine must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Itina tablets should be disposed of through a drug take-back program or an authorized collector. If a take-back program is not available, the medicine can be mixed with an undesirable substance (such as dirt or used coffee grounds) and placed in a sealed bag before discarding it in the household trash. Do not use the tablets after the printed expiration date.

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

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