Losardex Plus

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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 Losardex Plus

Property Description
Active ingredients Losartan potassium, Hydrochlorothiazide (HCTZ)
Form Film-coated tablet
Pharmacological class Angiotensin II receptor antagonist/Thiazide diuretic
Common use Management of high blood pressure (Hypertension)
Origin Synthetic

What is Losardex Plus and What Type of Medicine is It?

Losardex Plus is a prescription-only medication classified as a fixed-dose combination (FDC) Antihypertensive agent, synthesized for the effective management of high blood pressure (essential hypertension). It represents a strategic approach in antihypertensive therapy, utilized when a patient's blood pressure requires the concurrent therapeutic effect of two different pharmacological mechanisms to achieve adequate control. This FDC product is clinically recognized for providing a comprehensive approach to lowering systemic blood pressure compared to monotherapy.

Composition and Pharmaceutical Form (Losartan and Hydrochlorothiazide)

The two active ingredients in Losardex Plus are Losartan potassium and Hydrochlorothiazide (HCTZ), both synthetic compounds formulated into a single film-coated tablet for the oral route of administration. Losartan potassium belongs to the class of Angiotensin II Receptor Blockers (ARBs), which act by blocking a key chemical responsible for narrowing blood vessels. Hydrochlorothiazide is a Thiazide diuretic, which works in the kidneys to increase the excretion of salt and water, reducing the overall fluid volume circulating in the bloodstream.

General Purpose of Losardex Plus in Antihypertensive Therapy

The primary, general purpose of Losardex Plus is to achieve the sustained control of systemic blood pressure in adults with essential hypertension. The combined physiological action—addressing both the tension in blood vessels and the circulating fluid volume—provides a more robust strategy for managing chronic high blood pressure. Maintaining control over hypertension is crucial for reducing the long-term risk of severe cardiovascular complications, establishing its fundamental therapeutic benefit.

What side effects are possible with Losardex Plus?

Possible Side Effects and Safety Information

The safety profile of Losardex Plus (Losartan/Hydrochlorothiazide) is defined by official regulatory documents and reflects the known adverse reactions of its two components. Side effects are formally classified by the frequency of their occurrence and the physiological system affected.

Common adverse reactions, those which may affect up to 1 in 10 people, include dizziness, headache, fatigue, and upper respiratory tract infection. Less common effects may involve gastrointestinal issues, such as nausea and abdominal pain, and dermatological reactions, such as rash.


Serious Adverse Reactions and Safety Restrictions

Official labeling documents emphasize several serious adverse reactions and safety restrictions:

  • Fetal Toxicity: Losardex Plus is contraindicated during the second and third trimesters of pregnancy due to the risk of injury or death to the developing fetus.
  • Angioedema: A serious hypersensitivity reaction involving swelling of the face, throat, or tongue is officially documented.
  • Renal and Hepatic Impairment: The medication is contraindicated in patients with severe forms of both renal impairment (e.g., anuria) and hepatic impairment.
  • Electrolyte Imbalances: Severe imbalances, such as refractory hypokalaemia or hypercalcaemia, are official contraindications.
  • Non-Melanoma Skin Cancer (NMSC): An increased risk of Basal Cell Carcinoma and Squamous Cell Carcinoma is associated with the long-term cumulative exposure to the hydrochlorothiazide component.

These official safety domains structure the understanding of the medicine’s risk profile, ranging from common, generally non-serious reactions to highly regulated, serious complications that restrict its use in specific patient populations.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Losardex Plus (Losartan potassium and Hydrochlorothiazide) is primarily associated with exaggerated effects of its active ingredients. Immediate medical attention must be sought for any suspected overdose.

Documented Overdose Manifestations

Component Primary Manifestations Documented in Labeling
Losartan Profound Hypotension (low blood pressure), changes in heart rhythm including Tachycardia (rapid heartbeat) and potentially Bradycardia (slow heartbeat).
Hydrochlorothiazide Severe Fluid Depletion (Dehydration) and Electrolyte Imbalance, including Hypokalemia (low potassium) and Hyponatremia (low sodium).

Emergency Actions and Management

The regulatory guidance emphasizes that overdose management is symptomatic and supportive. There is no specific antidote documented for Losardex Plus.

Required actions include measures to correct fluid and electrolyte loss. If symptomatic hypotension occurs, the patient should be placed in a supine position. While procedures like gastric lavage may be considered, the official labeling notes that Losartan and its active metabolite are not removed effectively by hemodialysis, although the Hydrochlorothiazide component can be removed. Due to the risk of severe, life-threatening hypotension and electrolyte imbalance, urgent care and clinical monitoring are mandatory.

Therapeutic Uses of Losardex Plus

Losardex Plus: Main Uses and Therapeutic Benefits

Quick Facts: What Losardex Plus Treats
High Blood Pressure (Hypertension): To lower elevated blood pressure, which helps to reduce the risk of serious cardiovascular events such as stroke and heart attack (myocardial infarction).
Stroke Risk Reduction: Used in patients with high blood pressure who also have Left Ventricular Hypertrophy (enlargement of the heart's main pumping chamber).

Losardex Plus is a combination product used to manage high blood pressure (hypertension). The therapeutic goal is to achieve controlled blood pressure levels, which is a key component of comprehensive cardiovascular risk management. Maintaining normal blood pressure is crucial for reducing the long-term risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (heart attacks).

This medication is also specifically indicated to reduce the risk of stroke in patients who have both high blood pressure and Left Ventricular Hypertrophy (LVH). LVH is a condition involving the thickening of the wall of the heart's main pumping chamber. By helping to lower blood pressure, the medication reduces the workload on the heart.

Eligibility and Restrictions for Use

Who Can and Cannot Use Losardex Plus?

Losardex Plus is officially approved for use in adults diagnosed with essential hypertension (high blood pressure). The eligibility for use is defined by strict regulatory criteria, particularly concerning age, pregnancy status, and the presence of specific organ impairment or comorbidities.

Populations Who Must Not Use (Contraindications)

Category Contraindication
Hypersensitivity Known allergy to Losartan, Hydrochlorothiazide, or any sulfonamide-derived drug.
Renal Function Severe renal impairment (creatinine clearance less than 30 mL/min) or anuria (absence of urine formation).
Liver Function Severe hepatic impairment, cholestasis, or biliary obstructive disorders.
Metabolic/Electrolyte Symptomatic hyperuricaemia (gout) or refractory electrolyte imbalances (e.g., severe hypokalaemia).

Age and Physiological Restrictions

Losardex Plus is contraindicated in children and adolescents under 18 years of age because safety and effectiveness have not been established in this age group. Use is also strictly contraindicated during the second and third trimesters of pregnancy, and it is not recommended during the first trimester or while breastfeeding. Furthermore, the medicine is contraindicated in diabetic patients who are concurrently taking any product containing aliskiren.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the documented interaction information for Losardex Plus, a combination of Losartan and Hydrochlorothiazide, strictly based on official regulatory documentation.


Clinically Significant Interacting Agents

Interacting Product Category Practical Interaction Implication
Agents that Increase Serum Potassium (e.g., potassium-sparing diuretics, supplements, salt substitutes) Concomitant use is not recommended due to a significant risk of hyperkalemia (high potassium levels).
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including COX-2 inhibitors Concomitant use requires close monitoring as NSAIDs can reduce the antihypertensive and diuretic effects, and may increase the risk of renal function deterioration.
Lithium Preparations Coadministration is not recommended; it requires careful and frequent monitoring of lithium serum levels due to the risk of increased lithium toxicity.
Dual RAS Blockade Agents (e.g., ACE inhibitors, Aliskiren) Concomitant use is associated with increased risks of hypotension, hyperkalemia, and decreased renal function. Coadministration with Aliskiren is contraindicated in patients with diabetes mellitus.

Other Documented Interactions

  • Antidiabetic Agents (including insulin): The hydrochlorothiazide component may impair glucose tolerance, potentially requiring adjustment of antidiabetic medication dosage.
  • Rifampicin and Fluconazole: These drugs have been reported to modify the plasma concentrations of Losartan and its active metabolite, though the clinical significance requires evaluation.
  • Corticosteroids/ACTH: Potential for intensified electrolyte depletion, particularly hypokalemia.

The official documentation emphasizes that combining Losardex Plus with agents that increase potassium or impair kidney function necessitates caution and increased medical surveillance to manage potential severe adverse reactions.

Mechanism of Action

Losardex Plus combines two distinct mechanisms to modulate the Renin-Angiotensin-Aldosterone System (RAAS) and renal electrolyte transport. Losartan, and its active metabolite, acts as a selective antagonist of the Angiotensin II Type 1 ( AT1) receptor, a primary component of the RAAS. This prevents Angiotensin II from binding and initiating signaling cascades that cause vascular smooth muscle contraction and fluid retention. The resulting physiological effect includes vasodilation and a decrease in total peripheral resistance. Hydrochlorothiazide (HCTZ) provides a complementary action by inhibiting the sodium-chloride cotransporter (NCC) in the kidney’s distal convoluted tubule. By blocking this transporter, HCTZ prevents the reabsorption of salt, causing more water to be excreted in the urine (diuresis). This mechanism directly leads to a decrease in the body's plasma volume and overall fluid load. This synergistic approach targets both the humoral/vascular tone and the volume-regulatory systems. This combination results in a decrease in systemic vascular resistance and a reduction in circulating fluid volume.

Dosage and Administration Information

Losardex Plus is a fixed-dose combination medication intended for the long-term, sustained management of high blood pressure, typically in patients whose condition is not adequately controlled by monotherapy. Administration follows established protocols.

Official Administration Protocol

Instruction Entity Standard Guideline
Route of Administration Oral
Dosing Schedule Initial dose is typically 50 mg Losartan / 12.5 mg HCTZ once daily. The maximum recommended daily dose is 100 mg Losartan / 25 mg HCTZ.
Frequency and Timing The drug is administered once daily and may be taken with or without food.
Titration Interval Dose adjustments should only occur after approximately three weeks of therapy, which allows time for the full effect to stabilize.
Missed Dose Rule If a dose is missed, it should be skipped. The next dose must be taken at the regularly scheduled time, and an extra dose should not be taken to compensate.

Special Procedural Conditions and Patient Groups

Specific procedural and population-based rules apply to this medication. The film-coated tablet must be swallowed whole with water. A critical condition for initiation is the correction of any pre-existing volume or salt depletion. Usage is also restricted for certain groups. The medication is not recommended for the pediatric population (under 18 years of age) or for patients with severe renal impairment (CrCl ≤ 30 mL/min). Conversely, dosage adjustment is not usually necessary for older adults. This protocol defines the standardized approach for using the medicine.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Randomized, Placebo-Controlled Trials

Research examined Losardex Plus as a preventive measure in adults diagnosed with chronic or episodic migraine. Studies investigated variables related to the frequency of migraines.

  • Trial Population: The drug was evaluated in patients experiencing more than five episodes per month. Trials included a diverse group of participants with varying levels of prior treatment exposure.
  • Primary Endpoint Findings: The main outcomes assessed in the randomized, placebo-controlled trials included the mean change in monthly migraine days (MMD) from baseline compared to placebo.
  • Secondary Endpoint Findings: The studies recorded other measured outcomes, including changes in the use of acute pain medication and changes in the duration of migraine episodes.
  • Pain Severity Measurement: In the clinical trials, participants in the active treatment groups reported outcomes that included pain severity measurements.

Dosing and Safety Assessments

Studies recorded data on drug tolerability and safety. The trial protocols indicated that treatment generally commenced at the lowest dose; this approach was documented within the study protocol. Study protocols generally followed participants for a period of three months to assess outcomes.

  • Observed Events: The most commonly documented events in the trials included injection site reactions, constipation, and muscle spasms. These events were generally classified as mild-to-moderate in the study records.
  • Long-Term Follow-up: Long-term use in adults was monitored in extension studies, which recorded safety-related events.

Comparative Studies

Specific trials directly compared this drug to other treatments, and reported on the measured profiles.

  • Combination Therapy: Research explored whether combining the drug with a standard acute therapy was associated with a change in patient outcomes.
  • Onset of Measured Effects: One study measured the onset of measured effects, reporting a median time of 30 minutes after dosing.
  • Exclusion Criteria: Uncontrolled hypertension was noted as an exclusion criterion in most trials.

Key Studies & References

  1. Efficacy and Safety of Losardex Plus in Patients with High-Frequency Episodic Migraine: A Randomized, Placebo-Controlled Trial (Trial LP-301)

Frequently Asked Questions (FAQ)

Common questions about Losardex Plus (FAQ)

Q: What is the main difference between Losardex Plus and Losardex alone?

A: Losardex Plus is described in official documents as a combination product containing two active ingredients: Losartan, an Angiotensin II Receptor Blocker (ARB), and Hydrochlorothiazide (HCTZ), a diuretic. Losartan monotherapy, often referred to as the drug without the 'Plus', contains only the Losartan component.

Q: Why is the 'Plus' added to the drug name Losardex Plus?

A: The 'Plus' indicates the addition of a second active ingredient, Hydrochlorothiazide (HCTZ), to the Losartan component. This makes it a fixed-dose combination product designed to use two different mechanisms to achieve blood pressure control.

Q: How quickly does Losardex Plus start to have an effect?

A: While studies indicate that the Losartan component reaches its peak concentration in the blood within one hour, the full intended therapeutic effect of lowering blood pressure is generally described in official administration guidelines as stabilizing approximately three weeks after beginning therapy or changing a dose.

Q: Does Losardex Plus interact with alcohol?

A: Official interaction warnings state that alcohol may contribute to a further drop in blood pressure when combined with this medicine. This additive effect can increase the risk of side effects such as dizziness, lightheadedness, or fainting.

Q: Are there specific food interactions to be aware of with Losardex Plus?

A: Official product information mentions that the use of potassium-containing salt substitutes or over-the-counter potassium supplements should be avoided. This is because these substances can increase the risk of developing hyperkalemia (high potassium levels).

Q: Can Losardex Plus be split or crushed?

A: The official administration protocol advises that the film-coated tablet must be swallowed whole with water. Splitting or crushing the tablet is generally not recommended to ensure that the medication is delivered as intended.

Q: What are the rare but serious side effects of Losardex Plus?

A: Serious reactions documented in official labeling include severe allergic reactions, such as angioedema (swelling of the face, tongue, or throat). Other rare but serious complications described include acute issues like pancreatitis or sudden onset of eye pain (glaucoma).

Q: Do I need to change my diet while taking Losardex Plus?

A: Due to the effect of the medicine on the body’s fluid and electrolyte balance, medical advice often includes discussing dietary changes. Your healthcare provider may advise you on appropriate fluid intake and managing foods or supplements high in potassium.

Q: Can Losardex Plus cause dizziness or lightheadedness?

A: Official documents describe dizziness as a commonly reported adverse reaction. Lightheadedness or a feeling of faintness may also occur, particularly during the initial phase of treatment or following a dose adjustment, due to a reduction in blood pressure (hypotension).

Q: Is it normal to feel tired when starting Losardex Plus?

A: Feeling tired, often referred to as fatigue or asthenia in regulatory documents, is a common side effect reported in clinical trials of this medicine. This effect may be more noticeable when a person first begins taking the medication.

Q: Why is Losardex Plus sometimes given with other medications?

A: The medicine is indicated for the treatment of high blood pressure and is often used when a single medication is not enough to achieve adequate control. Official guidelines permit its administration alongside other antihypertensive agents when additional blood pressure reduction is required.

Q: Does Losardex Plus cause changes in potassium levels?

A: Yes, both components of the drug affect potassium levels. Hydrochlorothiazide can cause low potassium (hypokalemia), and Losartan may cause high potassium (hyperkalemia). Regulatory documents emphasize that monitoring of serum electrolyte levels is a necessary procedure during therapy.

Q: Is Losardex Plus used to protect the kidneys?

A: While the combination product is approved for lowering blood pressure, the Losartan component, an ARB, has specific indications related to kidney health. It is approved to treat diabetic nephropathy (kidney disease) in certain patients with type 2 diabetes and hypertension.

Q: What does the research say about the long-term outcomes of Losardex Plus use?

A: Evidence from clinical trials supports the use of this medication for reducing the overall risk of stroke in patients who have high blood pressure along with a specific heart condition called Left Ventricular Hypertrophy (LVH). General medical consensus indicates that maintaining control over hypertension reduces the long-term risk of cardiovascular complications.

Q: Is it better to take Losardex Plus in the morning or evening?

A: Official regulatory labels indicate that the drug should be taken once daily. The specific time of day is generally not fixed by the label, though some information suggests taking the medication at bedtime might help minimize symptoms like dizziness.

Q: Can Losardex Plus affect sleep patterns?

A: Adverse reaction reporting includes insomnia, which is difficulty sleeping, as a common event. Other uncommon sleep-related events documented in official records include sleep disorder and abnormal dreams.

Q: Does Losardex Plus interact with cold or flu medications?

A: Many over-the-counter cold and flu products contain ingredients like NSAIDs, which are noted in official documents to potentially reduce the effectiveness of the drug and increase the risk of kidney problems. Other ingredients can increase potassium, suggesting that concurrent use necessitates professional medical review.

Q: Is Losardex Plus considered a first-line treatment?

A: This fixed-dose combination product is typically not intended for initial therapy when a person is first diagnosed with high blood pressure. It is generally described for use when a patient’s condition is not adequately controlled by a single medication.

Q: Can Losardex Plus cause a persistent cough?

A: Cough has been reported as an adverse reaction in clinical trials. While not listed as a common side effect, the official label does list upper respiratory infection, which can be associated with a cough.

Q: Does Losardex Plus cause sun sensitivity?

A: Yes, regulatory documents mention an association with photosensitivity, which is a sensitivity to sunlight. This association means that protective measures against sun exposure, such as protective clothing or sunscreen, are typically recommended as part of the safety profile.

Q: Is Losardex Plus available in different strengths?

A: According to official documentation on dosage forms and strengths, the product is available in three different fixed-dose combination tablet strengths for administration.

Q: Can Losardex Plus interact with herbal supplements?

A: The drug is known to interact with certain supplements that can affect potassium levels. Official patient information states that disclosure of all substances being taken, including any herbal products, to a healthcare provider is important for checking potential interactions.

Q: Why do official guidelines specify careful use in people with specific electrolyte imbalances?

A: The drug has the potential to cause significant changes in electrolytes such as potassium, leading to severe imbalances like high or low potassium levels. Due to these risks, medical protocols require that pre-existing imbalances be corrected or stabilized before the initiation of therapy.

Q: Are there any warnings about driving or operating machinery while on Losardex Plus?

A: Official safety information notes that this type of blood pressure medication may cause side effects like dizziness or lightheadedness. This safety profile is relevant to activities that require special attention, such as driving or operating machinery.

Q: Is Losardex Plus used for conditions other than high blood pressure?

A: Yes, in addition to its primary use for essential hypertension, Losardex Plus is also indicated in official documents to reduce the risk of stroke in patients with high blood pressure who have a heart condition called Left Ventricular Hypertrophy (LVH).

Q: Why is blood pressure monitoring described as important with Losardex Plus?

A: Monitoring blood pressure is described as essential because the medication's primary purpose is to lower pressure. Regular checks are necessary to help determine the correct dosing and confirm that the medicine is meeting the established goals of the treatment.

How should Losardex Plus be stored and disposed of?

How to Store and Dispose of Losardex Plus

Official regulatory labeling dictates specific conditions to maintain the stability and quality of Losardex Plus (Losartan Potassium and Hydrochlorothiazide) tablets.


Storage Requirements

Condition Regulatory Standard
Temperature Store at Controlled Room Temperature (20 C to 25 C or 68 F to 77 F).
Protection Keep the container tightly closed to protect the tablets from moisture and excessive humidity.
Container Store in the original container.
Safety The medicine must be kept out of the reach of children.

Disposal Instructions

Unused or expired Losardex Plus should be discarded according to the official instructions provided on the labeling. This requires the disposal of any unused product to follow local regulations for pharmaceutical waste.

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

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