Main therapeutic uses

Losartankalium Teva is a medication primarily used to manage conditions related to the cardiovascular system and renal function. It belongs to a group of medicines known as angiotensin II receptor antagonists.

Treatment of high blood pressure

The primary use of this medication is for the management of hypertension (high blood pressure) in adults, as well as in children and adolescents aged 6 to 18 years. By helping to relax the blood vessels, the medication facilitates smoother blood flow, which contributes to the reduction of elevated blood pressure levels.

Management of heart failure

In certain cases, this medication is used to treat patients with chronic heart failure. It is typically considered when treatment with specific other medications, such as Angiotensin-Converting Enzyme (ACE) inhibitors, is not deemed suitable by a healthcare professional.

Renal protection in diabetic patients

Losartankalium Teva is utilized for its protective effects on kidney function in adult patients with type 2 diabetes and hypertension. It is used in individuals who have laboratory evidence of impaired renal function and proteinuria (the presence of excess proteins in the urine).

Benefits and long-term goals

Reduction of cardiovascular risks

In hypertensive patients with a specific heart condition known as left ventricular hypertrophy (thickening of the heart muscle), this medication is used to reduce the risk of serious cardiovascular events, such as stroke.

Support for organ function

The goal of treatment is not only to lower blood pressure but also to provide long-term protection for vital organs. By managing pressure levels and blocking the effects of angiotensin II, the medication helps to:

• Decrease the workload on the heart muscle.
• Slow the progression of kidney damage in patients with type 2 diabetes.
• Improve the overall management of chronic cardiovascular conditions.

Regulatory References

1. Losartan: MedlinePlus Drug Information

Eligibility Map: Official Regulatory Information

Losartankalium Teva is an angiotensin II receptor blocker (ARB) with specific eligibility criteria and strict exclusions outlined in authoritative government regulatory documents.

Populations for whom use is Contraindicated

• Patients with hypersensitivity (allergy) to losartan or any component of the tablet.
• Women who are in the second or third trimesters of pregnancy due to risk of fetal injury, including death.
• Patients with diabetes mellitus when receiving concomitant treatment with Aliskiren (a direct renin inhibitor).
• Patients with severe hepatic impairment (severe liver disease).

Age-Related Eligibility and Restrictions

• Adults (18+ years): Generally eligible for treatment.
• Pediatric Patients: Use is generally restricted to children 6 years of age and older for the treatment of hypertension. It is not recommended for children under 6 years of age or in pediatric patients with severe kidney problems (glomerular filtration rate < 30 mL/min/1.73 m²).

Physiological Status Restrictions

Status	Regulatory Statement
Pregnancy	Contraindicated in the second and third trimesters; must be discontinued as soon as possible if pregnancy is detected.
Breastfeeding	Not recommended due to a lack of available data on excretion into human milk and the potential for adverse effects on the infant.
Hepatic Impairment	Contraindicated in severe impairment; a lower starting dose is required for patients with mild-to-moderate impairment.
Volume Depletion	Patients who are volume or salt depleted (e.g., those on high-dose diuretics) require a lower starting dose (conditional use).

Regulatory documentation clearly establishes the boundaries for who can safely use the medicine, defining mandatory exclusions based on reproductive status, specific co-medication status, and the presence of severe organ dysfunction.

Losartankalium Teva's interaction profile is strictly classified in regulatory documents based on potential changes to drug exposure and synergistic pharmacodynamic effects.

Officially Documented Restrictions

Co-administration of Losartankalium Teva is contraindicated with Aliskiren in patients diagnosed with diabetes mellitus or moderate-to-severe renal impairment (GFR <60 mL/min). This restriction is officially documented due to the increased risk of severe adverse outcomes, including hyperkalemia and renal impairment. Losartan is also contraindicated for use in patients with severe hepatic impairment, as significantly increased plasma concentrations are documented in this group.

Pharmacokinetic and Pharmacodynamic Interactions

The drug’s metabolism leads to documented pharmacokinetic interactions with enzyme-altering agents. The CYP2C9 inhibitor Fluconazole decreases the exposure of the active metabolite while increasing Losartan's own plasma levels. Conversely, Rifampin reduces the exposure of both Losartan and its active metabolite.

Pharmacodynamic interactions primarily involve systemic effects. Concomitant use with potassium-sparing diuretics or potassium supplements increases the officially documented risk of hyperkalemia. Additionally, NSAIDs may attenuate the antihypertensive effect and increase the risk of worsening renal function, particularly in elderly patients. Use with Lithium has been documented to increase serum concentrations of Lithium. Losartan may be administered with or without food.

How Losartankalium Teva Works

Losartankalium Teva primarily functions by modulating the Renin-Angiotensin-Aldosterone System (RAAS), a cascade central to fluid and pressure homeostasis.

Selective Angiotensin II Receptor Blockade

Losartan is a non-peptide, selective, and competitive antagonist of the Angiotensin II type 1 (AT1) receptor found in vascular smooth muscle, the heart, and renal structures. The compound prevents the binding of the hormone Angiotensin II to the AT1 receptor sites. This inhibition interrupts the Gq protein-coupled signaling sequence that is typically initiated by Angiotensin II, thereby modulating IP3 and DAG pathways and influencing Ca^2+ release. The result is the modulation of peripheral vascular resistance and vascular smooth muscle contraction.

Modulation of Volume and Electrolyte Processes

By blocking the AT1 receptor, Losartan attenuates the stimulatory effects of Angiotensin II on the adrenal cortex and renal tubules. This effect leads to a reduction in aldosterone synthesis and secretion, and it increases the urinary excretion of sodium and water (natriuresis and diuresis). The consequence of this activity is a modification of total plasma volume and the physiological processes that determine systemic arterial pressure.

Uric Acid Clearance

Beyond its core RAAS antagonism, Losartan and its active metabolite engage in a secondary mechanism: the inhibition of the urate transporter 1 (URAT1) in the proximal kidney tubule. This action reduces the tubular reabsorption of uric acid, resulting in increased renal clearance of uric acid.

How to Use Losartankalium Teva

Losartankalium Teva is an oral medication with standard administration protocols. The drug is supplied as film-coated tablets and is intended exclusively for the oral route of administration.

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Official Dosing and Frequency

The established regimen for adults with hypertension or diabetic nephropathy involves a standard starting dose of 50 mg taken once daily. The dose is adjusted according to the required blood pressure response, typically ranging from 50 mg to a maximum daily dose of 100 mg.

The primary frequency pattern is once daily, though the total daily dose may be divided and taken twice a day if needed to maintain optimal blood pressure control.

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Administration and Procedural Rules

Instruction	Detail
Timing in Relation to Meals	May be taken with or without food.
Preparation	Tablets should be swallowed whole with water.
Dose Adjustment Timeline	The maximal effect may take 3 to 6 weeks to achieve, and dose titration is typically based on assessment after this period.
Missed Dose Rule	If a dose is missed, take it as soon as remembered, but do not take a double dose to make up for the skipped one.

Population-Specific Adjustments

Specific procedural adjustments are applied for certain patient groups. A lower 25 mg starting dose is recommended for patients who have volume depletion (e.g., due to high-dose diuretics) or those with hepatic impairment. Pediatric dosing (ages 6-16) is weight-based, starting at 0.7 mg/kg once daily.

Research Evidence / Overview of Studies

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How the Drug Was Studied

Studies investigated the potential action of Losartankalium Teva. As an Angiotensin II Receptor Blocker (ARB), clinical trials have assessed its effects on multiple outcome measures related to blood pressure and subsequent risk factors in people with high blood pressure (hypertension).

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Key Clinical Trial Findings

Hypertension and End-Organ Protection

• Blood Pressure Reduction: Extensive randomized controlled trials (RCTs) have evaluated the drug's effect on systolic and diastolic blood pressure, noting observed mean decreases compared to placebo over periods of 8 to 12 weeks. Losartan-based regimens demonstrated sustained antihypertensive activity over 24-hour dosing intervals.
• Stroke Risk Reduction: In high-risk patients with hypertension and left ventricular hypertrophy (enlargement of the heart muscle), large-scale studies have explored the drug's association with a reduced rate of composite cardiovascular endpoints (e.g., cardiovascular death, heart attack, or stroke) when compared to an older class of blood pressure medicine (e.g., Atenolol).
• Kidney Function: Research has specifically examined the drug’s profile in patients with Type 2 diabetes and hypertension, noting the effect on markers related to diabetic kidney disease (nephropathy).

Other Research Context

• Combination Use: Studies have investigated the effects observed when Losartan is used in conjunction with other medicines, such as diuretics (e.g., hydrochlorothiazide), to achieve target blood pressure levels. Some research has also explored its potential use in combination with therapies for conditions outside of its approved indications, such as in oncology, though this research remains exploratory.

Key Studies & References

1. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol (LIFE Trial)
2. Losartan Monograph and Efficacy Data (Example: Texas Health and Human Services or FDA-equivalent Efficacy Section)

Common questions about Losartankalium Teva (FAQ)

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Q: What are the signs of a severe allergic reaction to Losartankalium Teva (like angioedema) and what should I do?

Losartan can, in rare cases, cause a serious allergic reaction known as angioedema, which is documented in official warnings. This involves swelling of the face, lips, throat, and/or tongue. If you suspect angioedema or another severe allergic reaction, official product information advises immediate discontinuation of the medicine and seeking emergency medical attention.

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Q: What is the recommended starting dose for a patient with normal kidney and liver function?

For most adult patients who are starting treatment for high blood pressure, the usual starting dose is often in the lower range, taken once daily. The healthcare provider determines the specific dose after evaluating the patient's condition and needs. This information is based on the official Dosage and Administration section of the drug's regulatory labeling.

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Q: Why do I need a lower dose if I have liver problems (hepatic impairment)?

Regulatory documents indicate that if you have mild to moderate liver impairment, the body processes Losartan more slowly. Due to this, the official labeling recommends that patients with liver impairment be started on a lower dose. This adjustment helps to prevent potential over-exposure to the medicine.

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Q: What is the risk of hyperkalemia with Losartankalium Teva, and what are the symptoms I should look out for?

Losartan is associated with a risk of hyperkalemia, or abnormally high potassium levels, especially when used with certain other medications. Reported signs associated with high potassium include muscle weakness, fatigue, or an irregular heart rhythm. These should be discussed with a healthcare provider.

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Q: Does Losartankalium Teva help with high uric acid/gout?

While the primary approved uses are for managing high blood pressure and diabetic kidney disease, official product information notes that Losartan's mechanism includes a secondary effect that increases the elimination of uric acid. This is a documented property of the medicine's activity.

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Q: Can I drink alcohol while taking Losartankalium Teva?

Regulatory documents note that alcohol may add to the blood pressure lowering effect of Losartan. This could increase the risk of experiencing side effects such as dizziness or lightheadedness.

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Q: How do I get a prescription for Losartankalium Teva?

Losartankalium Teva is formally classified by regulatory authorities as a prescription-only medicine in most countries. It can only be dispensed by a pharmacist upon presentation of a valid prescription issued by a licensed healthcare provider.

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Q: What happens if I stop taking Losartankalium Teva suddenly?

Abruptly stopping Losartan is not recommended in official product information, as this may lead to a rebound increase in blood pressure. Treatment discontinuation or dosage changes should always be supervised by a healthcare provider.

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Q: What are the most important warning signs that I should contact my doctor right away?

Official safety information highlights that any severe adverse reaction should be immediately reported to a healthcare provider. This includes the sudden swelling of the face, lips, or tongue (angioedema), symptoms of severe low blood pressure (like fainting), or signs suggesting high potassium (such as an irregular heartbeat).

Official Storage and Disposal Requirements

Losartankalium Teva tablets must be stored at controlled room temperature, generally 25 C (77 F), with permitted variations up to 30 C. The product must be protected from freezing, heat, moisture, and direct light to maintain its stability.

Regulatory instructions require the tablets to be kept in the original container, which must be tightly closed. For safety, the medicine must always be stored out of the reach and sight of children.

Disposal of unused or expired tablets must follow local authority regulations. Medicines should not be placed in household waste or wastewater without specific preparation. Users are advised to utilize official drug take-back programs or consult a pharmacist for guidance on proper disposal methods.