Индапамид-Тева

Indapamid

Advertisements

Treatment option: Hypertension

Advertisements

Overview of Индапамид-Тева

What is Индапамид-Тева? Defining the Medicinal Entity

Property	Description
Active Ingredient	Indapamide
Form	Oral Tablet (including SR)
Pharmacological Class	Thiazide-like Diuretic, Antihypertensive Agent
General Purpose	Management of high blood pressure
Origin	Synthetic (Sulfonamide derivative)

Индапамид-Тева is a pharmaceutical product containing the active substance Indapamide, a synthetic compound structurally classified as a sulfonamide derivative and formally defined as a thiazide-like diuretic and a core antihypertensive agent. This compound is specifically designed for the foundational, sustained management of conditions involving elevated circulatory pressure.

The classification as 'thiazide-like' indicates that the drug’s function is similar to conventional thiazides but possesses a differentiated action that includes direct vasodilatory properties. This dual mechanism—combining salt and water excretion with blood vessel relaxation—contributes to the compound's overall efficacy in chronic pressure reduction. This distinction of Indapamide's mechanism is a key feature that differentiates it from agents focused solely on volume reduction.

Composition, Presentation, and General Purpose

The medication is a single-ingredient product delivered via the oral route of administration as a tablet. Formulations often include a sustained-release (SR) design, ensuring the consistent delivery of Indapamide over a prolonged period. The specific presentation of Индапамид-Тева, often manufactured by the company Teva, makes this well-established compound available in a readily accessible form.

The general purpose of administering the Indapamide tablet is to achieve a stable and sustained reduction in vascular pressure. By facilitating selective salt and water removal while simultaneously exerting vasodilatory properties, the medication effectively lessens the structural workload on the heart and arteries, which is the foundational benefit in managing hypertension in adult patients. The drug is used to help the body get rid of extra water and salt, which helps lower blood pressure. This dual mechanism provides a comprehensive approach to circulatory management.

Advertisements

What side effects are possible with Индапамид-Тева?

This section outlines the possible adverse reactions and safety characteristics of Indapamide (the active ingredient in Индапамид-Тева) based on official government regulatory documents.

Adverse Reaction Scope

The most significant and common safety profile element is the effect on Metabolism and Nutrition Disorders, specifically electrolyte imbalance. Hypokalaemia (low potassium) is classified as a common adverse reaction, and Hyponatraemia (low sodium) is uncommon, both requiring monitoring as they are integral to the drug's mechanism. Less frequent effects are categorized under Nervous System Disorders (e.g., headache, dizziness) and Gastrointestinal Disorders (e.g., nausea, constipation).

Serious Adverse Reactions officially documented include the risk of developing Torsades de pointes (a potentially fatal heart rhythm disturbance) secondary to severe Hypokalaemia. The drug also carries a documented risk of severe skin reactions (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) and serious ocular events, such as Acute angle-closure glaucoma.

Safety Classifications and Restrictions

The regulatory documentation provides specific safety constraints. Indapamide is contraindicated in patients with known Hypersensitivity to sulfonamides, severe Hypokalaemia, severe Renal Failure (creatinine clearance below 30 mL/ min), or Hepatic Encephalopathy / severe impairment of liver function. Use is not established or recommended for the paediatric population.

Time-Related Safety Patterns are also noted; for instance, effects like dizziness and fatigue are more likely to occur upon the initiation of treatment or following dose increases. Ocular symptoms like acute angle-closure glaucoma typically manifest within hours to weeks of starting therapy.

This official safety information structures the drug’s risk profile by detailing the frequent, expected metabolic changes alongside rare, clinically significant events, establishing the constraints for its regulatory use.

Advertisements

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — official regulatory information for Индапамид-Тева

Overdose scope
Documented overdose presentations:	Symptoms of Indapamide overexposure are consistent with an exaggerated diuretic effect, primarily presenting as severe hypotension (low blood pressure) and profound fluid and electrolyte imbalance. Clinical signs documented in regulatory sources include nausea, vomiting, weakness, muscle cramps, lethargy, and confusion. Laboratory findings frequently show severe hyponatremia and hypokalemia (low sodium and potassium).
Physiological systems affected (as stated in label):	Systems affected include the cardiovascular (hypotension, tachycardia), neurological (drowsiness, confusion, seizure), and renal systems (oliguria, acute renal failure).
Dose-related or exposure-related factors (if applicable):	The overdose risk is primarily defined by the resulting physiological derangements from excessive fluid and salt loss.
Population-specific overdose notes (if applicable):	Regulatory sources note an increased risk for severe hyponatremia and hypokalemia in elderly female patients. Patients with impaired hepatic function are at risk for developing hepatic encephalopathy and potentially coma as a severe outcome.
Emergency-response statements (as written in official documents):	Seek immediate medical attention upon confirmed or suspected overdose. Immediate contact with a poison control center, hospital emergency department, or emergency services is mandated.
When immediate medical help is required (label-derived phrasing only):	Immediate medical help is required in all suspected cases, and urgently if the person has collapsed, had a seizure, has trouble breathing, or cannot be awakened.

Overdose classifications (high-level)
Severity classification (as defined in official documents):	The potential for Severe and Life-Threatening outcomes is documented, related to circulatory collapse and severe electrolyte imbalance.
Regulatory basis (EMA / FDA / etc.):	Information is based on official prescribing documents (e.g., SmPC and FDA labeling).
Overdose-context constraints (as defined in official documents):	No specific antidote is documented. Treatment must be symptomatic and supportive, focusing on correcting severe volume and electrolyte deficits, often requiring close hospital monitoring.

Resulting Overdose Structure

Official overdose statements:

Overdose may present with exaggerated effects of the drug, including severe hypotension and disturbances of fluid and electrolyte balance (e.g., hyponatremia, hypokalemia).
Life-threatening complications documented in regulatory sources include respiratory depression, seizure, and hepatic encephalopathy progressing to coma in vulnerable patients.
Treatment involves symptomatic and supportive measures directed at correcting electrolyte abnormalities and volume depletion, often requiring close monitoring in a hospital setting.

Connection to the overall overdose profile (3 sentences): Regulatory documents define the Indapamide overdose profile through the physiological consequences of excessive volume and salt depletion. This leads to a primary focus on the risk of severe cardiovascular instability and metabolic derangement, which directly informs the mandatory requirement for immediate emergency contact. The structured official information dictates that management is limited to supportive care due to the lack of a documented specific antidote.

Therapeutic Uses of Индапамид-Тева

Индапамид-Тева is commonly used in contexts involving high blood pressure and issues of systemic imbalance. The medication is generally used for conditions presenting with sustained pressure, supporting the management of symptoms related to Essential Hypertension and easing the manifestations of volume overload and fluid retention (edema). This ongoing therapeutic support contributes to easing the overall symptom load and supports the cardiac system.

“It is considered relevant for supporting the patient’s maintenance of stability and contributes to improved day-to-day comfort when symptoms are more noticeable.”

Quick Fact: Relief for Elevated Circulatory Pressure

This medication is relevant for managing symptoms that create noticeable physiological strain and interfere with daily functioning. Its use in scenarios involving chronic pressure elevation supports the patient’s maintenance of cardiovascular functional stability and may assist with easing associated swelling.

Regulatory References

NIH MedlinePlus overview

Advertisements

Eligibility and Restrictions for Use

The official regulatory profile for Индапамид-Тева (Indapamide) defines specific population rules for its use. The medicine is primarily intended for Adults aged 18 and over.

Contraindicated Populations

Use is absolutely contraindicated for several populations, based on official labeling. This includes individuals with a known hypersensitivity to indapamide or any other sulfonamide-derived medicine. It must not be used by patients diagnosed with severe hepatic impairment (including hepatic encephalopathy), severe renal impairment (creatinine clearance below 30 ml/min), anuria (absence of urine production), or pre-existing hypokalaemia (abnormally low blood potassium).

Age and Condition Restrictions

Regarding age, the medicine is not recommended for children and adolescents under 18 years due to a lack of established data on safety and efficacy. Older adults may require careful monitoring of electrolytes.

In terms of physiological states, routine use during pregnancy is inappropriate and is generally not recommended. Similarly, use is not recommended while breastfeeding.

Caution is explicitly required for eligible patients with comorbidities such as Diabetes Mellitus, Gout/Hyperuricemia, or Systemic Lupus Erythematosus (SLE), as described in regulatory documents.

Advertisements

What should I know about interactions with other medicines?

The official regulatory documentation for Indapamide identifies specific interaction patterns and co-administration restrictions primarily based on pharmacodynamic effects and the potential for severe adverse outcomes.

Interaction Severity	Interacting Entity	Official Interaction Description
Contraindicated	Lithium	Reduced renal clearance, leading to the risk of increased plasma concentrations and toxicity.
Contraindicated	Non-Antiarrhythmic Torsadogenic Drugs	Formal prohibition due to the increased risk of developing Torsades de pointes.
High-Risk	ACE Inhibitors	Risk of sudden, severe hypotension and acute renal failure when co-administration is initiated in volume-depleted states.
High-Risk	NSAIDs (including high-dose Aspirin)	Potential for reduction of the antihypertensive effect and risk of acute renal function impairment.

Interactions concerning electrolyte balance are a primary focus. Co-administration with Cardiac Glycosides increases the official risk of digitalis toxicity due to hypokalaemia. Similarly, concurrent use with Potassium-Sparing Diuretics requires careful monitoring due to the documented risk of both hypokalaemia and hyperkalaemia. Alcohol is noted to potentiate the effect of orthostatic hypotension. Specific population-dependent cautions exist: interaction risks are deemed more significant in elderly females and patients with hepatic impairment, where electrolyte disturbance may officially precipitate hepatic encephalopathy.

Advertisements

Mechanism of Action

The mechanism of action for Indapamide is defined by a dual set of biological effects targeting the circulatory system's regulatory components. The primary action is within the kidney, where the molecule acts as an inhibitor of the Sodium-Chloride Co-transporter (NCC) in the distal convoluted tubules. This inhibition prevents the reabsorption of sodium ( Na^+) and chloride ( Cl^-) back into the bloodstream, initiating a signaling sequence that increases water excretion. This process modifies early molecular steps, causing a subsequent decrease in total intravascular fluid volume. Independent of the kidney mechanism, the drug also modulates activity within peripheral vascular pathways. It modulates the movement of calcium ions ( Ca^2+) in the smooth muscle cells of the arterial walls, which are responsible for vessel contraction. This interference establishes a decrease in contractile tension within the targeted pathways, leading to a decrease in the stiffness and resistance of the blood vessels.

Advertisements

Dosage and Administration Information

Official Administration Guidelines

Индапамид-Тева (Indapamide) is administered exclusively via the oral route as a tablet. The usage protocol is typically structured around once-daily administration.

Category	Administration Instructions
Route & Form	Oral tablet; available in standard and sustained-release (SR) forms.
Frequency & Timing	Taken once daily, typically in the morning to prevent nighttime urination. The medication can be taken with or without food.
Standard Dosing	The initial dose for hypertension is 1.25 mg once daily (or 1.5 mg for the SR form). The dose for edema may start at 2.5 mg once daily.
Dose Adjustments	Doses should be increased incrementally only after sufficient observation; for hypertension, this interval is a minimum of 4 weeks between adjustments. The maximum daily dose for any indication is 5 mg.
Handling	Sustained-release tablets must be swallowed whole and must not be cut, crushed, or chewed, as this compromises the intended controlled release.

Population-Specific Usage Rules

Usage is not recommended for children and adolescents under 18 years due to a lack of established safety and efficacy data in this age group. Indapamide is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min) and in cases of severe hepatic impairment, restrictions tied to the drug's metabolism and function.

Missed Dose Protocol

If a dose is missed, it should only be taken if the next scheduled dose is more than 6 hours away. If the next dose is imminent, the missed dose must be skipped entirely to avoid double-dosing. This protocol ensures the maintenance of a consistent daily dosing pattern.

Advertisements

Recent Clinical Evidence

Indapamide-Teva: Recent Clinical Evidence

Summary of Clinical Trials

Clinical research has explored the mechanism of indapamide, which is classified as a thiazide-like diuretic. These studies were designed to evaluate the drug's influence on specific cardiovascular outcomes and blood pressure measurements in participants. Data from long-term studies involving use in adult participants were collected and analyzed.

Trials have investigated whether indapamide monotherapy was associated with an influence on cardiovascular risk factors. Research has also compared outcomes observed when indapamide was used as part of a combination therapy versus single-agent treatment.

Efficacy and Study Findings

Blood Pressure and Cardiovascular Events

Studies consistently evaluated whether indapamide influenced both systolic and diastolic blood pressure. Trial results documented findings across various dosing schedules, with a primary focus on individuals with essential hypertension.

Major research, including large-scale randomized controlled trials, examined the drug's effect on the risk of experiencing major cardiovascular events, such as stroke and myocardial infarction (heart attack), in hypertensive adults. These investigations tracked participants for multiple years. The study results observed in the participants were documented to assess sustained effects over time.

Population Studied

The primary studies included participants across a range of ages and documented findings in those with and without other pre-existing conditions. Research focused on adults, and participants with certain severe co-morbidities were often excluded from initial trials to ensure data consistency.

Key Studies & References

View of Combination of perindopril/indapamide in secondary prevention of stroke and other vascular events: A combined analysis of ADVANCE, PROGRESS and HYVET trials

Advertisements

Frequently Asked Questions (FAQ)

Common questions about Индапамид-Тева (FAQ)

Q: Can I use Indapamide while also taking vitamins and supplements?

A: Official product information describes the importance of a patient discussing all medicines, vitamins, minerals, and natural supplements they use with a healthcare professional. This is because certain supplements, such as calcium, are mentioned in regulatory documents as having a potential for interaction with indapamide.

Q: Can taking Indapamide affect my blood sugar levels?

A: Official documents indicate that indapamide may cause an increase in blood sugar levels. For patients with diabetes, this medication may alter insulin requirements. The official product information states that monitoring of blood glucose levels is a necessary precaution for patients with diabetes while this medicine is being used.

Q: Is there a risk of dehydration when taking this medication?

A: According to regulatory documents, indapamide can cause imbalances in the body's fluid or electrolytes (salts and minerals). While the medication is described as increasing water excretion, these imbalances may lead to symptoms such as thirst, dry mouth, or weakness. Official guidance indicates that patients should be monitored for these specific symptoms.

Q: How often do muscle cramps or weakness occur as a side effect?

A: Muscle cramps or general weakness can be a possible sign of an electrolyte disturbance, such as low potassium. Low potassium (hypokalaemia) is classified as a common adverse reaction in the official safety profile of indapamide. Regulatory guidance states that patients using this medicine require monitoring for changes in their electrolyte levels.

Q: Does Indapamide affect my ability to drive or operate machinery?

A: Official consumer information advises that caution is warranted when driving or operating machinery. This is due to the potential for dizziness or weakness, which may result from low blood pressure in some patients. Regulatory guidance suggests that a person should assess how the medicine affects them before engaging in activities that require alertness.

Q: What is the half-life of Indapamide and what does it mean?

A: The half-life of indapamide is typically stated in regulatory documents to be between 14 to 24 hours. The half-life is a pharmacokinetic concept that refers to the duration required for half of the active drug to be eliminated from the body.

Q: Will Indapamide change my cholesterol levels?

A: Official product information notes that indapamide can be associated with adverse changes in specific laboratory values. The impact of the medicine on lipid metabolism, which includes cholesterol, is a factor that is specified in regulatory documents for healthcare professionals to consider during follow-up testing.

Q: Are mood changes a possible side effect?

A: Official regulatory documents list a range of central nervous system effects as reported adverse reactions. These effects include feelings such as agitation, nervousness, irritability, and anxiety. Drowsiness is also listed as a possible reaction.

Q: Can Indapamide cause sleep problems or insomnia?

A: Official safety data describes that clinical signs of fluid or electrolyte imbalance, which the drug can cause, may manifest as symptoms such as drowsiness and restlessness. These symptoms are related to changes in the central nervous system.

Q: Does salt intake affect the effectiveness of Indapamide?

A: Indapamide is used to control high blood pressure. Regulatory information mentions that non-pharmacological measures, such as following a low-salt or low-sodium diet, can complement the medicinal treatment.

Q: How should I change my diet or lifestyle when taking Indapamide?

A: Official product information states that indapamide is often part of a broader treatment plan. This plan may include non-medicinal recommendations such as a daily exercise program, following a low-sodium or low-salt diet, and possibly changes related to the intake of potassium-rich foods or supplements.

Advertisements

How should Индапамид-Тева be stored and disposed of?

How to Store and Dispose of Индапамид-Тева

To ensure the stability and safety of this medication, follow the official regulatory storage and disposal guidelines.

Storage Conditions

Requirement	Official Instruction
Temperature	Store below 30 C (86°F).
Protection	Keep in the original package and keep the blister in the outer carton to protect from light and moisture.
Child Safety	Keep out of the reach and sight of children.

Disposal Instructions

Proper disposal is required to protect the environment. Do not dispose of Индапамид-Тева or any other medicines via wastewater (e.g., flushing down the toilet or sink) or with household waste.

Consult your pharmacist for guidance on how to dispose of medicines that are no longer required or have expired. These measures help prevent environmental contamination.

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

Available in countries:

Russia

A-Z Index:

A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z