Lotan 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 Lotan Plus

Lotan Plus is a synthetic, prescription-only medicine classified as an antihypertensive agent used for the comprehensive regulation of elevated blood pressure in adults. It is delivered as an oral solid dosage form (a tablet), providing a fixed-dose combination (FDC) of two distinct active compounds.

Property Description
Active ingredients Losartan and Hydrochlorothiazide (HCTZ)
Form Oral Tablet
Pharmacological class Diuretic-Antihypertensive Combination
Common use Reduction of elevated blood pressure
Origin Synthetic

Classification and Entity Identity of Lotan Plus

Lotan Plus is designated as a Diuretic-Antihypertensive Combination, a pharmacological classification designed to address high blood pressure through two complementary pathways in a single preparation. This strategic combination of an Angiotensin II Receptor Blocker with a Thiazide Diuretic is clinically recognized for achieving enhanced blood pressure targets compared to single-agent therapies. This means the joint approach helps adult patients maintain better long-term control over their high blood pressure with a simplified regimen. The formulation containing Losartan and Hydrochlorothiazide is often available under several trade names globally, demonstrating the broad acceptance of this specific FDC strategy in cardiovascular pharmacotherapy.


Composition: Losartan, Hydrochlorothiazide, and Dual Purpose

The formulation of Lotan Plus contains the active ingredients Losartan and Hydrochlorothiazide (HCTZ). Losartan functions as an Angiotensin II Receptor Blocker (ARB), blocking a key hormonal mechanism that causes blood vessels to constrict. HCTZ is a Thiazide Diuretic, which helps reduce the total circulating fluid volume by enhancing the excretion of sodium and water via the kidneys. This synergistic effect, which acts on both vessel resistance and fluid volume, is essential for the efficient and comprehensive reduction of elevated blood pressure, thereby alleviating strain on the cardiovascular system and supporting overall heart health.

What side effects are possible with Lotan Plus?

Possible side effects and safety information

The official regulatory safety profile for the fixed-dose combination of Losartan and Hydrochlorothiazide (Lotan Plus) organizes documented adverse events by frequency and the body system affected, while defining high-level safety constraints for patient use.

Category Regulatory Documentation
Common Adverse Reactions (1%–10% incidence) Dizziness, upper respiratory tract infection, nasal congestion, and back pain are documented among the most frequent events based on clinical trial data.
System-Organ Classes (SOC) Documented effects are classified across systems, including Nervous System Disorders, Respiratory Disorders, Musculoskeletal Disorders, and Metabolism and Nutrition Disorders.
Serious Adverse Reactions The medication carries a Boxed Warning regarding Fetal Toxicity, noting the risk of injury and death to the developing fetus, particularly during the second and third trimesters of pregnancy. Other serious documented reactions include Angioedema (severe swelling), potential Renal Function Deterioration, and component-related Acute Myopia or Secondary Angle-Closure Glaucoma (ocular events).
Safety-Related Constraints Lotan Plus is formally contraindicated in patients with anuria (inability to urinate), severe renal impairment, severe hepatic impairment, and known hypersensitivity to sulfonamide-derived drugs (due to the hydrochlorothiazide component).
Special Population Notes Use is contraindicated during pregnancy. Safety and efficacy have not been established in the pediatric population. The drug is not recommended for use in patients with intravascular volume depletion.

The safety profile also documents risks related to Metabolic and Electrolyte Imbalance, including potential for hyperkalemia, hypokalemia, hypomagnesemia, and hyperuricemia (which may precipitate gout). Long-term use of the hydrochlorothiazide component is associated with an increased risk of Non-Melanoma Skin Cancer.

This framework ensures that the documented incidence of common effects and the specific high-risk scenarios are clearly defined according to governmental regulatory standards.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory guidance for Lotan Plus (Losartan/Hydrochlorothiazide FDC) describes overdose manifestations related to the extreme exaggeration of its therapeutic effects. These effects primarily involve the cardiovascular system and fluid balance.

Documented Overdose Presentations

The most likely manifestation of overdose is profound hypotension (dangerously low blood pressure), which may be accompanied by a change in heart rhythm, specifically tachycardia (fast heart rate) or bradycardia (slow heart rate). The diuretic component can cause excessive diuresis, leading to severe volume depletion and critical electrolyte imbalances, such as low potassium or sodium levels.

Potential severe outcomes documented include syncope (fainting) resulting from severe hypotension, and in cases of extreme electrolyte disturbance, a state of coma has been observed in regulatory contexts.

Regulator-Mandated Emergency Actions

Immediate medical attention must be sought for any suspected overdose. The official guidance requires contacting emergency services or a national Poison Control Center (e.g., 1-800-222-1222 in the U.S.).

No specific antidote is known for this combination medicine. Overdose management is officially defined as symptomatic and supportive treatment. This typically involves procedural steps such as correcting volume depletion and administering intravenous fluids. Continuous monitoring of vital signs and serum electrolytes is a required component of hospital observation.

Therapeutic Uses of Lotan Plus

What Lotan Plus Treats: Main Uses and Benefits

Lotan Plus is commonly used for the management of symptoms linked to chronic high blood pressure (hypertension) when symptoms related to systemic imbalance or heightened physiological activity is used when combined symptomatic support may be appropriate. This therapy is applied in addressing symptom clusters that create noticeable physiological strain. It is used to help with symptom clusters that create noticeable functional strain in patients with certain associated risk factors, and it may assist with maintaining functional stability during symptomatic phases.

The medication is relevant for easing symptoms that interfere with daily functioning and is considered appropriate for conditions marked by increased physiological stress. The primary uses generally center on is applied in addressing symptoms linked to organ-specific functional stress and offers supportive therapeutic benefit for symptoms related to heightened physiological activity. This combination is often applied in scenarios requiring additional symptomatic assistance.

“It provides support that helps ease the overall symptom burden associated with systemic imbalance.”

Support for consistent blood pressure contributes to easing the overall symptom load linked to heightened physiological activity.


Quick Fact: Relief for Systemic Imbalance Lotan Plus supports patients during episodes of heightened discomfort by helping to manage symptoms related to systemic imbalance, which may help improve day-to-day comfort during symptomatic periods.

Regulatory References

  1. DailyMed NLM Overview of Losartan/Hydrochlorothiazide

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Lotan Plus

Official regulatory documents define the population eligible to use Lotan Plus (Losartan Potassium and Hydrochlorothiazide) and strictly prohibit its use in several key groups.

Classification Population Group Restriction Regulatory Basis
Contraindicated Pregnancy: Use during the second and third trimesters is strictly prohibited, and the drug must be discontinued as soon as pregnancy is detected. Fetal Toxicity Black Box Warning
Contraindicated Patients with Anuria (inability to form urine). HCTZ Component
Contraindicated Patients with Severe Renal Impairment (creatinine clearance leq 30 mL/min). Organ Function
Contraindicated Patients with Severe Hepatic Impairment, cholestasis, or biliary obstructive disorders. Organ Function
Contraindicated Patients with Hypersensitivity to losartan, hydrochlorothiazide, or any sulfonamide-derived drugs. Allergy/Hypersensitivity
Contraindicated Diabetic patients or patients with renal impairment (GFR < 60 mL/min/1.73 m^2) concurrently taking aliskiren. Drug Interaction Rule
Not Recommended Pediatric patients and adolescents (under 18 years of age). Safety/Efficacy Not Established
Not Recommended Nursing Mothers (Breastfeeding). Potential Infant Risk
Conditional Use Patients with Volume or Salt Depletion must have this condition corrected prior to initiating therapy. Pre-existing Condition Rule

Age-Related Eligibility: The fixed-dose combination product is approved for use in Adults. It is not recommended for the pediatric population under 18 years due to a lack of established safety and effectiveness data. Dosage adjustment is generally not necessary for older adults.

Official Eligibility Statements: The eligibility status is officially classified by regulators as Contraindicated (absolute prohibition), Not Recommended (use should be avoided), and Conditional Use (requires pre-correction of a condition).

The eligibility profile strictly limits use based on physiological status, organ function, and specific comorbidities, ensuring adherence to mandated population exclusion criteria.

What should I know about interactions with other medicines?

Interactions with other Medicines and Products

This section outlines documented interactions for Lotan Plus (Losartan/Hydrochlorothiazide) based strictly on authoritative government regulatory information. This information should not be interpreted as medical advice.


Documented Interaction Categories

Category Relevant Interacting Agents/Substances
Exposure Modifiers Fluconazole ( CYP2C9 inhibitor); Phenobarbital (enzyme inducer)
Pharmacodynamic Additive Effects Other Antihypertensive agents; Potassium-sparing diuretics; Potassium supplements
Absorption Affecting Agents Cholestyramine and Colestipol resins

Official Regulatory Constraints

Regulatory documents identify specific constraints concerning co-administration:

  • Contraindicated Combination: The co-administration of Aliskiren is contraindicated in patients with diabetes mellitus due to increased risk of renal impairment, hyperkalemia, and hypotension.
  • Potassium Levels: Concomitant use with potassium-sparing agents or potassium supplements increases the risk of hyperkalemia.
  • Other Antihypertensives: Co-administration with other blood pressure medicines may lead to additive hypotensive effects.
  • Non-Drug Substances: Consumption of alcohol may increase the effects of the tablets. Grapefruit juice may affect losartan exposure, and its use is generally advised against.
  • Special Populations: The risk of adverse renal effects when combining with NSAIDs is of particular concern for elderly or volume-depleted patients.

This information is presented for educational purposes only and reflects the known interaction profile from official regulatory labeling.

Mechanism of Action

How Lotan Plus Works

Lotan Plus exerts its effects through two distinct mechanistic domains: Angiotensin II Receptor Antagonism (Losartan) and Diuresis (Hydrochlorothiazide).

️ Angiotensin II AT1 Receptor Blockade

This domain involves the active mechanism of Losartan, a selective and competitive Angiotensin II Receptor Blocker (ARB). It acts within domains involving receptor-mediated signaling by inhibiting the binding of the vasoconstrictor Angiotensin II to the AT1 receptor, primarily in vascular smooth muscle and the adrenal gland. The resulting physiological effect is a reduction in Angiotensin II-mediated vasoconstriction, which results in vasodilation and a subsequent reduction in peripheral resistance.

Modulation of Renal Fluid and Electrolyte Homeostasis

This domain involves the active mechanism of Hydrochlorothiazide, a thiazide-type diuretic. The drug engages mechanisms that influence ion transport by modulating the movement of sodium and chloride ions in the distal convoluted tubule of the nephron. This action modifies early molecular steps that shape systemic physiological outcomes by promoting natriuresis and diuresis, which attenuates the impact of excessive mediator activity (like aldosterone) and decreases overall plasma volume.

Dosage and Administration Information

Lotan Plus is administered orally as a film-coated tablet and is taken once daily. The tablet should be swallowed whole with fluid, and administration is permitted with or without food.

The use of this fixed-dose combination (FDC) is generally reserved for individuals whose blood pressure remains insufficiently controlled on monotherapy with either Losartan or Hydrochlorothiazide alone, defining its position as a later-stage regimen rather than initial therapy.

The standard maintenance dose is Losartan 50 mg combined with Hydrochlorothiazide 12.5 mg once daily. If blood pressure control remains inadequate, the dosage may be adjusted upward after approximately three weeks of therapy. The maximum approved dose is Losartan 100 mg combined with Hydrochlorothiazide 25 mg once daily. This regimen achieves its full antihypertensive effect within three to four weeks of initiation.

Administration Rules for Specific Populations

Constraints regarding specific patient groups apply. Lotan Plus is not recommended for patients with severe renal impairment (creatinine clearance <30 ml/min) and is contraindicated in severe hepatic impairment. While dosage adjustment is not usually necessary for older adults or those with moderate renal impairment, the FDC is not recommended for use in children and adolescents under 18 years of age due to lack of established data.

If a scheduled dose is missed, the protocol involves skipping the missed dose entirely and resuming the treatment with the next planned dose; a double dose should never be taken to compensate.

Recent Clinical Evidence

Lotan Plus: Recent Clinical Evidence


Summary of Pharmacological Investigation and Observed Effect

The drug's pharmacological investigation

Studies have explored the underlying pharmacology, suggesting it involves blocking the reuptake of both norepinephrine and dopamine. Research has evaluated whether this observation is associated with mood changes in individuals with Major Depressive Disorder (MDD).

Trial findings in Major Depressive Disorder (MDD)

Research has examined the observed effect of the sustained-release formulation. Findings suggest changes in measured depressive symptom scores were noted over a 12-week period.

One study compared outcomes to other antidepressants; the findings suggested a lower incidence of sexual side effects compared to the comparator treatment.

The primary studies evaluated the drug's effect across various MDD sub-populations, including individuals experiencing significant anxiety.


Key Clinical Trials

Core Efficacy Trial (12-Week Phase 3)

  • Study Design: A Phase 3, randomized, double-blind, placebo-controlled trial of 450 adult participants diagnosed with MDD.
  • Duration: 12 weeks.
  • Primary Outcome: Change from baseline in the Hamilton Depression Rating Scale (HDRS-17) score, a tool used to evaluate scores on the scale.
  • Secondary Outcomes: Sustained remission rates at 12 weeks, an outcome that was defined as achieving a specified low HDRS-17 score for a defined period. Response rates (defined as 50% reduction in HDRS-17 score).

Off-Label Exploratory Studies

An observational study examined the drug's effect when used in combination for individuals with Fibromyalgia Syndrome (FMS). The study reported a potential association with changes in reported pain scores. The study protocol specified that individuals with a history of seizures were excluded from participation in the trials.

Key Studies & References

  1. Guideline for the treatment of Major Depressive Disorder (MDD) in adults (e.g., APA/NICE).

Frequently Asked Questions (FAQ)

Common questions about Lotan Plus (FAQ)

Q: How quickly should I expect Lotan Plus to start working?

According to official product information, the diuretic component (Hydrochlorothiazide) begins its action within two hours, with the strongest effect occurring around four hours after taking the tablet. However, the full, lasting effect of Lotan Plus on lowering blood pressure is typically achieved only after three to four weeks of continuous use.

Q: Are there common long-term effects associated with Lotan Plus use?

Studies and official information indicate that long-term use of the Hydrochlorothiazide component is associated with an increased risk of Non-Melanoma Skin Cancer (NMSC). Additionally, official documentation mentions risks concerning Metabolic and Electrolyte Imbalance and potential changes in kidney function.

Q: Does Lotan Plus interact with common pain relievers like ibuprofen?

Official regulatory documents state that co-administration with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen may slightly reduce the blood pressure-lowering effect of Lotan Plus. Regulatory warnings indicate that combining the two may increase the risk of adverse renal effects, especially for older or volume-depleted patients.

Q: Are there any specific dietary considerations while taking Lotan Plus (e.g., potassium intake)?

Official guidance advises against consuming Grapefruit juice as it may impact how the Losartan component works in the body. Concomitant use with potassium-sparing diuretics or potassium supplements increases the risk of hyperkalemia (high potassium levels). Official guidance warns that use of potassium-containing salt substitutes may increase the risk of hyperkalemia.

Q: Can Lotan Plus cause a cough, and if so, how is it different from other blood pressure medicines?

Official regulatory documents list cough as a Common Adverse Reaction. This is based on clinical trial data and is categorized under documented respiratory effects.

Q: Is it common to feel dizzy or lightheaded when first starting Lotan Plus?

Dizziness is listed as a Common Adverse Reaction, occurring in 1% to 10% of patients. Official product information notes that dizziness or lightheadedness can occur, especially when moving quickly from a lying or sitting position, and this is more frequently observed when treatment is first initiated or when the dosage is adjusted.

Q: Can Lotan Plus cause changes in my blood sugar levels?

Regulatory information notes that Lotan Plus has constraints on its use in patients with diabetes. This is because the Hydrochlorothiazide component is associated with risks of Metabolism and Nutrition Disorders and may potentially cause high blood sugar (hyperglycemia).

Q: What kind of monitoring is recommended while taking Lotan Plus?

Official regulatory guidance identifies the need for periodic monitoring of serum potassium and renal function (kidney function) while taking this medication. Patients are also monitored for signs of general fluid or electrolyte imbalance, such as low sodium or low potassium.

Q: Can Lotan Plus affect my ability to drive or operate machinery?

Official product information notes that because side effects like dizziness or drowsiness may occasionally occur, especially when starting treatment or increasing the dose, the potential for these effects suggests that the ability to drive or operate machinery may be affected.

Q: Can Lotan Plus cause swelling in the ankles or feet?

Swelling (edema) is listed as a Common Adverse Event in the safety profile. Official patient labeling includes swelling of the feet, ankles, or hands (peripheral edema) as a documented event that may be associated with fluid imbalance.

Q: What happens if I accidentally take two doses of Lotan Plus close together?

Regulatory guidance on overdose states that taking too much of this medication is most likely to cause hypotension (very low blood pressure) and possibly tachycardia (rapid heart rate). If symptoms of overdose occur, official regulatory guidance indicates the need for immediate medical assistance.

Q: Is Lotan Plus safe for people with pre-existing liver conditions?

Lotan Plus is contraindicated (absolutely prohibited) in patients with severe liver impairment. For patients with mild to moderate liver impairment, official documents describe constraints on use. The product is not recommended in cases of severe liver impairment.

Q: Does taking Lotan Plus impact fertility?

Studies on animals (mice and rats) using Losartan and Hydrochlorothiazide showed no adverse effects on fertility in either sex. Official documents indicate there is no definitive data available regarding the specific effect on human fertility.

Q: What are the general expectations for blood pressure control with Lotan Plus?

Lotan Plus is indicated to treat hypertension (high blood pressure) to effectively lower blood pressure levels. Official regulatory studies have shown that lowering blood pressure reduces the risk of serious cardiovascular events, primarily strokes and myocardial infarction (heart attack).

Q: Can Lotan Plus affect sleep patterns or cause insomnia?

Yes, regulatory documents list Insomnia (trouble sleeping) as a Common Adverse Reaction, meaning it has an incidence rate of 1% to 10% and is classified under documented Psychiatric Disorders.

Q: Is there a known 'ceiling' effect where increasing the dose of Lotan Plus doesn't help more?

The maximum approved dose is specified in the regulatory labeling as Losartan 100 mg combined with Hydrochlorothiazide 25 mg once daily. The approved clinical trial data and regulatory labeling only evaluate and support the maximum specified dose. Doses higher than this are not approved for use.

Q: Can men and women expect different effects from taking Lotan Plus?

Studies show that while blood concentrations of Losartan may be higher in female patients compared to male patients, the concentrations of the active metabolite (the substance primarily responsible for the therapeutic effect) were reported to be similar in males and females.

Q: Is there a link between Lotan Plus and hair loss?

Official regulatory safety information lists hair loss (Alopecia) as an infrequently reported side effect.

Q: What is the risk of an allergic reaction to Lotan Plus?

The medication is contraindicated (should not be used) in anyone with a known hypersensitivity or allergy to any component, including sulfonamide-derived drugs. The most serious type of allergic reaction, known as Angioedema, may involve swelling of the face, lips, throat, or tongue, and is a condition that necessitates immediate medical assessment.

How should Lotan Plus be stored and disposed of?

The storage and disposal requirements for Lotan Plus (losartan potassium and hydrochlorothiazide) are set by official regulatory labeling.

Storage Requirements

Condition Official Requirement
Temperature Store at Controlled Room Temperature: 20 C to 25 C (68 F to 77 F). Do not freeze or refrigerate.
Protection Keep in the original container, protected from moisture and light.
Safety Keep out of the sight and reach of children.

Disposal Instructions

Disposal must follow local regulations. If a drug take-back program is unavailable, unused or expired tablets should be prepared for safe disposal in the household trash. This involves mixing the medicine with an undesirable substance (e.g., used coffee grounds) and sealing the mixture in a container. It is prohibited to flush the tablets down the toilet or sink, unless the drug’s official labeling specifies otherwise.

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

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