Da Le

Quick links to important sections

Da Le

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 Da Le

Da Le: Definition and Classification as an ARB

Da Le is a synthetic prescription pharmaceutical preparation containing the active ingredient Valsartan. It is classified as an Angiotensin II Receptor Antagonist, also known as an ARB, which places it within the category of antihypertensive agents. Valsartan is a synthetic compound chemically derived as an L-valine derivative, and its primary function is to modulate systemic pressure within the circulatory system. This direct antagonistic action is recognized as a therapeutic alternative for patients who do not tolerate the persistent cough sometimes associated with ACE inhibitors. The medication is designed to address cardiovascular conditions that benefit from reduced hormonal vasoconstriction.

Composition, Form, and General Therapeutic Goal

The active core of the preparation is Valsartan, formulated for oral administration. The medicine is most commonly available as an oral tablet, though an oral suspension is also available, providing a form differentiation for patient groups who require liquid administration. As a single-active ingredient product, its therapeutic goal is rooted in promoting sustained vasorelaxation. By encouraging blood vessels to widen and relax, the medication helps reduce the systemic resistance the heart must overcome. ARBs are used to reduce blood pressure by alleviating vascular tension. The preparation is utilized to achieve the goal of relieving the overall workload placed on the heart and promoting a stable cardiovascular environment.

Regulatory References

  1. Valsartan/Amlodipine EPAR (Exforge)

What side effects are possible with Da Le?

The safety profile for Da Le (Valsartan) is established through regulatory documentation, which classifies possible adverse reactions by frequency and affected body system. The formal classification framework, consistent with regulatory standards (e.g., EMA/FDA), uses terms like Very Common, Common, Uncommon, and Not Known (post-marketing reports).

Adverse Reaction Classifications

Classification Examples of Documented Effects (System-Organ Class)
Very Common Hyperkalemia, Hypotension (especially in heart failure settings), Renal impairment
Common Dizziness, Headache, Fatigue, Cough, Diarrhea, Back pain, Viral infection
Uncommon Vertigo, Syncope (fainting), Nausea, Cardiac failure
Not Known Angioedema, Thrombocytopenia (low platelet count), Vasculitis, Bullous dermatitis

Serious Adverse Reactions and Safety Constraints

Regulatory documents emphasize specific serious adverse reactions, including Fetal Toxicity (risk of injury and death to the developing fetus, leading to an absolute contraindication in pregnancy) and potentially fatal Angioedema (severe swelling of the face or throat).

The label defines safety constraints for specific patient populations. Use is formally contraindicated in pregnancy and in patients with severe hepatic impairment, biliary cirrhosis, or cholestasis. The risk of hypotension is noted to be higher at the initiation of therapy in individuals who are volume-depleted. Furthermore, use is generally restricted in patients with severe renal artery stenosis or those with primary hyperaldosteronism, and caution is advised regarding Dual RAS Blockade (e.g., with aliskiren) due to increased risk of hyperkalemia, hypotension, and worsening renal function.

Overdose and Emergency Response

Overdose and When to Seek Help

The most likely clinical manifestation of an overdose with Da Le (Valsartan) is marked hypotension, which is a severe reduction in blood pressure. Regulatory guidance documents indicate that overexposure may present with physical signs such as dizziness, fainting, or lightheadedness. There may also be irregularities in the heartbeat, documented as either an abnormally fast (tachycardia) or slow (bradycardia) rate.


Emergency Response and Severe Outcomes

The most serious consequence documented in regulatory labeling is the risk of circulatory collapse or shock resulting from excessive hypotension. Due to this potential for severe systemic harm, official guidance mandates that you seek immediate medical attention upon any suspicion of overdose. Furthermore, if an individual is collapsed, having a seizure, experiencing difficulty breathing, or cannot be awakened, emergency services must be contacted immediately.


Management and Antidote Status

The regulatory approach to managing a Valsartan overdose is limited to symptomatic and supportive treatment. No specific antidote is known. For cases involving excessive hypotension, official instructions describe placing the patient in the supine position and administering an intravenous infusion of normal saline solution to counteract the circulatory deficit. The substance is considered unlikely to be removed by hemodialysis due to its high plasma protein binding.

Therapeutic Uses of Da Le

What Da Le Treats: Main Uses and Benefits

Supporting Stability During Acute Symptom Episodes

This medicine is commonly used in situations involving certain distressing symptoms where groups of symptoms may become intense or disruptive. The product is considered relevant in contexts marked by increased discomfort or tension, where short-term symptomatic assistance is needed.

Da Le is generally applied in addressing symptom clusters that interfere with daily comfort and is relevant when symptoms create noticeable functional strain. It supports patients during episodes of heightened discomfort and may assist with maintaining functional stability. The medication is applied in addressing symptoms related to physical discomfort, symptoms associated with acute or episodic changes, and symptoms that create noticeable physiological strain.

It is considered relevant in conditions characterized by periods of heightened symptoms and conditions presenting with systemic or localized discomfort. Da Le is used across domains where additional symptomatic support is needed, and may help patients cope more steadily with symptom fluctuations.


Quick Fact: Used in situations involving symptoms related to physical discomfort


Regulatory References

  1. Therapeutic Goods Administration guidance on permitted indications

Eligibility and Restrictions for Use

Official Eligibility Rules for Da Le (Valsartan)

This section outlines the population eligibility and non-eligibility criteria for Da Le, based strictly on authoritative regulatory documentation.

Eligibility Scope Official Regulatory Statement
Populations for whom use is allowed Adults (18 years and older) for all approved uses. Pediatric patients aged 6 to 16 years for hypertension [2.3].
Populations for whom use is contraindicated Pregnancy: Use during the second and third trimesters is contraindicated, and discontinuation is mandatory upon detection of pregnancy [1.2]. Hypersensitivity to valsartan or any component of the formulation [1.4]. Diabetes Mellitus: Co-administration with aliskiren is prohibited in patients with diabetes [1.4]. Severe Hepatic Impairment: Contraindicated in patients with severe hepatic impairment, biliary cirrhosis, or cholestasis [1.4].
Age-related eligibility rules Minimum Age: Not recommended for children less than 1 year of age [2.1]. Pediatric Cardiac Use: Use for heart failure or post-myocardial infarction is not recommended for children and adolescents under 18 years [2.3].
Condition-specific eligibility rules Renal Impairment: Caution is advised in severe renal impairment (CrCl <30 mL/min), and use is not studied in children undergoing dialysis [1.4, 2.1]. Volume Depletion: Use with caution, and this condition should be corrected prior to initiation [1.2].
Pregnancy and Lactation Status Pregnancy: Contraindicated in later stages [1.2]. Lactation: Nursing or the drug should be discontinued [1.4].

Official regulatory documents define strict boundaries, absolutely prohibiting use in pregnant women and those with severe liver disease. They establish specific age criteria, permitting use in adults and limiting use for hypertension in children starting at age 6.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes interaction information formally documented in regulatory labels.

Interaction Type Interacting Agent Official Regulatory Statement
Contraindicated Combination Aliskiren Co-administration is prohibited in patients with diabetes mellitus or an eGFR less than 60 mL/min/1.73 m^2, due to increased risks of hypotension, hyperkalemia, and renal impairment.
Contraindicated Timing Rule ACE Inhibitors A mandatory 36-hour washout period is required before starting the combined sacubitril/valsartan product (contains Valsartan) after stopping an ACE inhibitor.
Pharmacodynamic Potassium-sparing diuretics, Potassium supplements, Salt substitutes containing potassium Concomitant use may lead to hyperkalemia (elevated serum potassium) due to additive effects on potassium retention.
Pharmacodynamic Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Co-administration may result in a reduced antihypertensive effect and an increased risk of deterioration of renal function, particularly in elderly or volume-depleted patients.
Pharmacokinetic Food Administration with a meal is documented to decrease the drug’s systemic exposure (AUC) by approximately 40% and its peak concentration (C max) by approximately 50%.
Pharmacokinetic OATP Inhibitors (e.g., Rifampin, Ciclosporin) Valsartan is a substrate for the OATP1B1 and OATP1B3 hepatic uptake transporters; co-administration with inhibitors of these transporters is expected to increase Valsartan exposure.

The regulatory profile is defined by both pharmacodynamic reinforcement—notably the risk of hyperkalemia when combined with agents that increase potassium—and pharmacokinetic alterations involving key drug transporters and food absorption. These interactions establish explicit restrictions, including contraindications for co-administration with certain agents in defined patient populations, as documented in official prescribing information.

Mechanism of Action

How Da Le Works

Da Le exerts its pharmacodynamic action through a dual mechanism involving the central nervous system and peripheral tissues. The compound modulates specific neurotransmitter receptors in the CNS, influencing nerve cell communication. Concurrently, it inhibits key peripheral enzyme systems that generate inflammatory molecules, resulting in the attenuation of inflammatory mediator production.

This interaction across neural and humoral pathways affects signaling dynamics and the activity state of these systems. Furthermore, a distinct component acts as an agonist on intracellular signaling kinases responsible for cellular maintenance and structure. This targeted interaction influences pathways associated with cellular repair, affecting the downstream consequences of mediator levels and contributing to the characteristics of tissue response.

Dosage and Administration Information

How to Use Da Le (Valsartan)

Da Le is administered orally and is available as a tablet in strengths up to 320 mg, and as an oral suspension. The administration schedule is dependent on the condition being addressed. For the management of high blood pressure, the medicine is typically taken once daily. In contrast, for uses such as heart failure and post-myocardial infarction, the daily quantity is taken in two divided doses.

Administration is flexible regarding mealtimes; the medicine may be taken with or without food. However, a key procedural constraint involves the form: the tablet and the oral suspension are not interchangeable on a milligram-per-milligram basis due to differences in systemic exposure, requiring a dose adjustment if the patient switches forms.

Treatment follows a titration schedule, meaning it is initiated at a low starting dose (e.g., 80 mg for hypertension or 40 mg twice daily for heart failure). This dose is gradually increased over several weeks toward a defined maintenance dose, consistent with its design for long-term therapy. For patients with mild-to-moderate hepatic impairment without cholestasis, the maximum daily quantity is capped at 80 mg. Similarly, pediatric dosing for high blood pressure is based on weight, starting at 1.3 mg/kg per day, rather than using the standard adult dose. If a dose is missed, it is typically taken immediately unless it is almost time for the next scheduled dose, in which case the missed dose is omitted.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Da Le (Valsartan)


Evidence for Use in High Blood Pressure (Hypertension)

Research has explored the use of Da Le in adults, older adults, and certain younger populations dealing with high blood pressure, or hypertension. The evidence base includes large-scale Randomized Controlled Trials (RCTs) and systematic reviews. These studies primarily monitored changes in blood pressure measurements, including Systolic and Diastolic Blood Pressure, over defined time intervals. Longer-term follow-up research also monitored the time until the occurrence of major cardiovascular outcomes, such as non-fatal stroke, non-fatal heart attack, and cardiovascular death.

Studies conducted for this condition report how symptoms evolved in the observed populations. Research documented the measurement of changes in blood pressure during the study period. Certain large-scale trials described patterns observed in the measured rates of major cardiovascular events. Findings also helped contextualize how patients reported their experience regarding the incidence of new-onset Type 2 Diabetes in high-risk patient groups monitored.

Evidence for Use in Chronic Heart Failure

Da Le was evaluated in large-scale, placebo-controlled trials involving adults with symptomatic chronic heart failure, a condition presenting with cycles of stability and flare-ups and marked by functional limitations. These studies monitored patient groups who had documented left ventricular dysfunction. Research focused on outcomes related to systemic or functional imbalance, measuring composite endpoints that included all-cause and cardiovascular mortality and the frequency of heart failure hospitalization.

Studies described patterns where the measurement of the combined endpoint of mortality and heart failure hospitalization was associated with the addition of the agent to existing standard therapy. Trials reported how symptoms evolved in the observed populations, documenting measurements related to changes in the NYHA functional classification and objective function measurements.

What is Still Uncertain About Da Le Research

Research contributes to the broader evidence landscape, but several areas of uncertainty remain. The evidence quality varies across studies, and some comparative evidence is lacking, especially when comparing Da Le to other newer agents or combinations in head-to-head trials. For instance, certainty remains low regarding the observations made in the specific scenario of the three-drug combination (with an ACE inhibitor and a beta-blocker) in heart failure patients. Furthermore, long-term measurement of functional recovery or quality of life is not fully established, and available data for the pediatric population remain limited.

Key Studies & References

  1. Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) Trial: Cardiovascular Events in Hypertension

Frequently Asked Questions (FAQ)

Common questions about Da Le (FAQ)


Q: How long does it take for Da Le to start working for high blood pressure?

A: According to official product information, the initial effect of Da Le (Valsartan) on blood pressure begins to show about 2 hours after a single dose, with the maximum benefit for that dose typically reached in 6 hours.

However, to achieve the full, sustained reduction in blood pressure, it generally takes about 4 weeks of taking the medicine regularly, as described by the prescribing information.


Q: Is there a maximum dose for Da Le per day?

A: Regulatory documents indicate that for adults treating high blood pressure or heart failure, the maximum total daily dose used in clinical studies and formal treatment guidelines is 320 mg.

This maximum may be taken once daily or divided into two smaller doses. The appropriate starting and maintenance dosage is determined by a prescribing healthcare provider based on the specific condition being treated.


Q: Can children of any age take Da Le for high blood pressure?

A: Official information indicates that Da Le is approved for the treatment of high blood pressure in children who are 6 years of age and older.

Regulatory warnings state that the medicine is not recommended for use in children who are less than 1 year old.


Q: What should I do if I take too much Da Le?

A: Taking more Da Le than prescribed may lead to an overdosage. The most likely effect is pronounced hypotension (low blood pressure), which may result in symptoms such as dizziness or fainting.

If an overdose is suspected, contacting emergency services or a poison control center is recommended for immediate professional guidance.


Q: How is the oral suspension prepared from the tablets?

A: The official product label details a specific procedure for creating a liquid oral suspension of Da Le from the tablets.

This process is detailed for pharmacists or other healthcare providers and involves mixing the tablets with specific commercial liquid ingredients to create a suspension that ensures the correct concentration for use.


Q: Does Da Le have a generic version?

A: Yes. The active ingredient in Da Le, which is Valsartan, is available as a generic product that has been approved by the FDA.

This means that other manufacturers may produce the medicine under the generic name Valsartan.

How should Da Le be stored and disposed of?

How to Store and Dispose of Da Le (Valsartan)

Official regulatory guidelines define precise conditions for storing and disposing of Valsartan to maintain product stability and safety.

Storage Requirements

Valsartan tablets must be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F). The medication must be kept in its tightly closed, original container and protected from heat, moisture, and direct light.

Both the tablets and the prepared oral suspension must not be frozen.

Stability and Child Safety

For the oral suspension, specific stability limits apply: it is stable for up to 30 days at room temperature or 75 days if refrigerated. Regardless of the form, Valsartan must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired medicine should not be kept. Consumers are instructed to ask a healthcare professional or pharmacist how to properly dispose of any unused product in accordance with local regulations for pharmaceutical waste.

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

Available in countries:

Equivalent of Da Le found in:

A-Z Index: