Индапамид-OBL

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Индапамид-OBL

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Treatment option: Hypertension

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Overview of Индапамид-OBL

Quick Facts

Property Description
Active ingredient Indapamide
Form Film-coated tablets
Pharmacological class Diuretic (Thiazide-like)
Common use Essential Hypertension
Origin Synthetic, Chemical

Индапамид-OBL: Identity and Drug Type

Индапамид-OBL is an orally administered medication containing the single active ingredient Indapamide, which is the drug's International Nonproprietary Name (INN). This medication is a synthetic, chemical-based compound, not derived from natural sources, and is provided as film-coated tablets for convenient oral intake. The product name with the "OBL" suffix identifies it as a generic version manufactured by Obolenskoye Pharmaceutical Enterprise.

Indapamide is consistently classified as a thiazide-like diuretic in major pharmacopoeias. This classification is clinically recognized for its long-standing efficacy in managing chronic cardiovascular conditions.

What is the Active Ingredient in Индапамид-OBL? (Composition and Class)

The active substance responsible for the therapeutic effect of this medication is Indapamide. It formally belongs to the pharmacological class of diuretics—often colloquially known as "water pills." Diuretics generally function by increasing the rate at which salt (sodium) and water are removed from the body via the kidneys.

This simple principle leads to a reduction in the overall fluid volume in the blood vessels, which is critical to its role as an antihypertensive agent. Indapamide's classification is rooted in its unique structure, providing a powerful and sustained diuretic action.

What is Индапамид-OBL Prescribed For? (Therapeutic Purpose)

Индапамид-OBL is principally prescribed for the long-term management of essential hypertension (chronically high blood pressure). Its primary goal is to lower and maintain blood pressure within a healthy range, which is essential for reducing the patient's risk of major cardiovascular events. It is also sometimes utilized to manage edema (fluid retention) associated with certain chronic health conditions, such as mild to moderate heart failure.

Regulatory References

  1. USP Monograph: Indapamide Tablets
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What side effects are possible with Индапамид-OBL?

Possible Side Effects and Safety Information

The most clinically significant safety considerations for Indapamide-OBL involve electrolyte and metabolic disturbances, which require regular monitoring during treatment.

Serious Adverse Reactions (Rare):

  • Cardiac Events: Risk of developing serious heart rhythm abnormalities, including Torsade de pointes, particularly when associated with hypokalemia (low potassium).
  • Hypersensitivity: Severe, potentially life-threatening allergic reactions, such as Angioedema and severe skin conditions like Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN).
  • Ocular Effects: Acute onset of decreased visual acuity or ocular pain that may signal acute angle-closure glaucoma.

Common Adverse Reactions (Frequency >1 in 100):

System-Organ Class Common Reactions
Nervous System Headache, dizziness, fatigue
Metabolism Hypokalemia (low potassium), Hyponatremia (low sodium), Hyperuricemia (high uric acid)
Gastrointestinal Nausea, vomiting
Skin Rash, photosensitivity reactions

Safety Restrictions and Monitoring

Treatment is contraindicated in cases of known hypersensitivity to sulfonamide derivatives and in severe renal or hepatic impairment. Caution is required in patients with pre-existing electrolyte imbalances or a history of gout or diabetes, as the drug may alter glucose and uric acid levels. Elderly patients are at an increased risk of severe hyponatremia. Monitoring of serum electrolytes (potassium, sodium) and renal function is essential for all patients throughout therapy, especially at the start of treatment.

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Overdose and Emergency Response

Overdose: When to Seek Help

Overdoses of Индапамид-OBL (Indapamide) are primarily associated with the pharmacological consequences of its action, leading to severe disturbances in fluid and electrolyte balance.

Documented Overdose Presentations

The most commonly documented clinical manifestations include:

  • Severe Hypotension: Markedly low blood pressure.
  • Electrolyte Imbalance: Critical depletion of minerals, specifically hyponatremia (low sodium) and hypokalemia (low potassium).
  • CNS Depression: Symptoms such as drowsiness, lethargy, and general weakness.
  • Gastrointestinal Symptoms: Nausea and vomiting.

In patients with pre-existing severe hepatic impairment, an overdose may precipitate hepatic encephalopathy or coma.

Emergency Action Requirements

If an overdose is suspected, immediate medical attention is required due to the potential for life-threatening consequences and the lack of a specific antidote. It is essential to:

  1. Stop taking the medication immediately.
  2. Contact emergency services or a Poison Control Center, or go to the nearest hospital emergency department, even if symptoms are not yet present.

Official management focuses on supportive care, including gastric emptying (if appropriate) and the rigorous monitoring and correction of the fluid and electrolyte imbalances that occur. Close observation of vital signs and laboratory values is necessary.

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Therapeutic Uses of Индапамид-OBL

What Индапамид-OBL Treats: Main Uses and Benefits

The core therapeutic domains of Индапамид-OBL relate to the management of systemic and physiological factors, primarily used in situations involving certain distressing symptoms.


Supporting Cardiovascular Comfort and Stability

The medication is commonly used to help with the management of hypertension (high blood pressure), which is a condition where functional stability becomes affected. This domain involves supporting the patient during conditions where symptoms are related to heightened physiological activity. It is applied in scenarios where additional management of discomfort is required. The therapeutic benefit is that it provides support that helps ease the overall symptom burden by contributing to easing the overall symptom load and supports general well-being during symptomatic phases.


Managing Fluid and Symptomatic Discomfort

This area of use is relevant in situations involving certain distressing symptoms. The medication is commonly used across conditions presenting with episodic or fluctuating manifestations, assisting with maintaining a sense of stability when symptoms create noticeable physiological strain and become more noticeable. It is relevant when supportive symptom management is appropriate for conditions presenting with systemic or localized discomfort.


Quick Fact: Relief for Physiological Strain

Regulatory References

  1. NIH MedlinePlus overview on Indapamide
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Eligibility and Restrictions for Use

Eligibility and Contraindications for Индапамид-OBL

Индапамид-OBL is generally intended for use in adults to manage essential hypertension.

Populations that Must Not Use the Medicine (Contraindications)

Official regulatory information strictly prohibits the use of Индапамид-OBL in the following populations:

  • Patients with known hypersensitivity to indapamide, to any other sulfonamide-derived drugs, or to the product's excipients.
  • Individuals with severe renal failure, specifically when creatinine clearance is below 30 ml/min.
  • Patients who have hepatic encephalopathy or documented severe impairment of liver function.
  • Those with hypokalaemia (abnormally low blood potassium levels).

Restricted or Not Recommended Populations

Use is not recommended or requires special consideration in several groups due to lack of established data or potential risks:

Population Category Eligibility Status (Regulatory)
Children and Adolescents Use is not recommended; safety and efficacy are not established.
Pregnancy and Lactation Use is not recommended due to insufficient safety data.
Elderly Patients Requires special caution; dosage may need adjustment due to potential age-related organ impairment.
Metabolic Disorders Not recommended for patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption (due to excipients).
Impaired Liver Function Use requires immediate cessation if signs of hepatic encephalopathy occur.

All patients should be fully evaluated by a healthcare professional against the official criteria before starting treatment.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information documents critical interaction patterns for Indapamide-OBL, primarily categorized by effects on electrolytes, exposure modification, and combined cardiovascular effects. All documented interactions are based on label information from government health authorities.

Pharmacodynamic and Pharmacokinetic Restrictions

Category Documented Interaction Statement Restriction Type
Contraindicated Combinations Co-administration with Lithium results in reduced renal clearance, increasing the risk of plasma concentration and toxicity. High-Risk/Restricted
Agents Prolonging QTc Interval (e.g., Amiodarone, Sotalol) are restricted due to the severe, additive risk of Hypokalemia leading to Torsade de Pointes. Highly Restricted
The combination with Aliskiren is officially contraindicated in patients with diabetes. Contraindicated
Exposure Modification Co-administration with Simvastatin requires a mandatory dosage restriction, not to exceed 20 mg daily. Procedural Constraint
Pharmacodynamic Effects Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) may lead to a loss of the antihypertensive effect and increased risk of acute renal failure. Use with Caution

Population-Specific Cautions

Regulatory labels contain specific warnings for certain populations: severe hyponatremia has been reported in elderly females, and the presence of hepatic impairment may increase the risk of precipitating hepatic encephalopathy. These statements define critical constraints for safe co-administration, based strictly on official regulatory classification.

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Mechanism of Action

Индапамид-OBL acts through a dual mechanism of action, targeting both the renal system and the peripheral vasculature to exert its physiological actions.

Regulation of Peripheral Vascular Tone

This mechanistic domain involves the drug's direct action on vascular smooth muscle cells. Индапамид-OBL modulates ion channels, particularly by altering the transmembrane flux of calcium ions (Ca^2+). This activity leads to reduced cellular hyper-responsiveness and results in the relaxation and widening of blood vessels, producing a decrease in systemic peripheral resistance.

Modulation of Renal Fluid and Electrolyte Excretion

This domain centers on the kidney, specifically the distal convoluted tubule of the nephron. The drug functions as an inhibitor of the sodium-chloride cotransporter (NCC), a membrane protein responsible for ion reabsorption. This mechanism increases the excretion of sodium and chloride (natriuresis) and, consequently, water, leading to a reduction in circulating intravascular volume.

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Dosage and Administration Information

Индапамид-OBL is supplied as an oral tablet and is administered as a single dose once daily. To adhere to procedural instructions and minimize disruption from the diuretic effect, the daily dose is typically taken in the morning, without specific dependence on food. Tablets must be swallowed whole with water and should not be crushed, chewed, or split, especially if using a controlled-release formulation.

Instruction Detail
Route of administration Oral (by mouth) only.
Dosing schedule (Hypertension) Initial adult dose is 1.25 mg once daily. The dose is generally maintained at the lowest effective level, typically not exceeding 2.5 mg once daily.
Dosing schedule (Edema) Initial adult dose is typically 2.5 mg once daily, with a maximum dose of 5 mg once daily.
Dose Titration Period Dose adjustments for hypertension are evaluated after approximately 4 weeks of continuous use to assess the full therapeutic response.

Population-Specific Rules

Administration instructions define starting at the low end of the dosing range (e.g., 1.25 mg) for older adults. Official use in the pediatric population is not established. The drug is generally constrained or potentially discontinued in cases of severe renal or hepatic impairment, as reduced function may diminish efficacy.

Missed-Dose Protocol

If a morning dose is missed, it should be taken as soon as it is remembered. If it is remembered late in the day, the missed dose is typically skipped to maintain the morning-only schedule and prevent double dosing, with the next dose taken at the usual time.

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Recent Clinical Evidence

Индапамид-OBL: Recent Clinical Evidence

The research base for Indapamide has been extensively developed, primarily through large-scale clinical studies and systematic reviews. The available evidence focuses on two core therapeutic areas: the management of high blood pressure and the management of fluid retention.


Evidence for Use in Essential Hypertension (Chronically High Blood Pressure)

Research examining Indapamide for high blood pressure has been conducted extensively, primarily using large-scale, randomized controlled trials (RCTs). Research examined changes in blood pressure readings and outcomes related to the incidence of major cardiovascular events, such as strokes and heart attacks, and instances of hospitalization for heart failure. Studies also monitored outcomes capturing phases of heightened symptom activity, such as tracking changes in the Left Ventricular Mass Index.

Findings describe patterns observed in these studies related to blood pressure changes over intermediate to long-term follow-up periods, which may last up to several years (e.g., a mean of 3.9 years in some key studies). Research does not determine whether an individual will respond similarly; the results apply only to the populations studied.


Evidence for Use in Edema (Fluid Retention)

Indapamide was studied for its use in managing fluid retention, known as edema. This research includes early clinical trials that measured the drug's fundamental properties. Research explored outcomes related to physical discomfort, such as changes in the degree of visible swelling and total body weight.

However, the evidence is limited when compared to the large-scale outcomes research available for high blood pressure. Comparative evidence is lacking against certain other diuretics, and certainty remains low for its use in conditions presenting with cycles of stability and flare-ups, such as the most severe cases of edema.


What is Still Uncertain About Indapamide Research

Research always contains gaps and limitations. Evidence is limited regarding long-term effects in young, low-risk people with uncomplicated high blood pressure, as the focus of the largest trials was on higher-risk groups. Additionally, evidence quality varies across studies, meaning findings may be mixed or harder to rely on with high certainty. Research provides context but not individual predictions; findings describe group patterns, not personal outcomes.

Key Studies & References

  1. Indapamide - MedlinePlus Drug Information
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Frequently Asked Questions (FAQ)

Common questions about Индапамид-OBL (FAQ)

Q: How quickly does Индапамид-OBL start to have an effect on blood pressure?

The drug's active substance is generally observed to reach peak concentration in the blood within approximately 1 to 2 hours of administration. However, achieving the full benefit in lowering high blood pressure is a gradual process. Official studies indicate that the maximum therapeutic effect may take several months, such as three to four months, to fully develop.

Q: Is Индапамид-OBL suitable for people who also have kidney impairment?

Regulatory documents state that the medicine is contraindicated (must not be used) in patients experiencing severe renal failure, specifically when creatinine clearance is below 30 ml/min. Thiazide-related diuretics are described as generally less effective or less predictable when kidney function is significantly impaired. Suitability for use in cases of mild or moderate kidney impairment is a determination made by a healthcare professional.

Q: Is Индапамид-OBL generally considered appropriate for elderly patients?

Studies and official information indicate that Indapamide has been observed to be effective and is described as generally tolerated in studies involving older adult populations with hypertension. However, regulatory warnings note that special caution is required in this group. This is primarily due to an increased risk of certain side effects, such as severe hyponatremia (abnormally low sodium levels).

Q: How long does the therapeutic effect of one dose of Индапамид-OBL last?

The active component of this medicine is associated with a long elimination half-life, which is generally reported as being between 15 to 18 hours. Regulatory guidance specifies that dosing is typically done once daily. This dosing schedule is intended to provide sustained coverage of the drug's effects over a full 24-hour period.

Q: Are changes in blood sugar levels a commonly reported side effect of Индапамид-OBL?

According to clinical data, at the recommended dose for high blood pressure, Indapamide generally does not appear to significantly alter glucose (blood sugar) metabolism. This finding applies even to patients who have been diagnosed with diabetes. The product label contains a notation for patients with pre-existing metabolic disorders, but the available evidence does not suggest that blood sugar changes are a commonly reported side effect.

Q: What are general warning signs related to electrolyte changes while using this medicine?

Official safety information states that common symptoms which could signal an electrolyte imbalance (like low potassium or sodium) include several physical changes. These may involve feeling dry mouth or unusually thirsty, experiencing muscle pains or cramps, or noticing an irregular heartbeat. Also, excessive tiredness or weakness can be a signal of a possible imbalance.

Q: Is it generally acceptable to consume alcohol in moderation while on Индапамид-OBL?

Regulatory documents caution that the consumption of alcohol may potentiate (increase the risk of) a side effect known as orthostatic hypotension. This condition involves feeling dizzy or lightheaded when moving quickly from a sitting or lying position to a standing position. Regulatory warnings describe this potential interaction for patients who consume alcohol.

Q: What types of supplements or herbal products are described as potentially interacting with Индапамид-OBL?

Specific regulatory warnings exist regarding certain mineral supplements because they can directly alter electrolyte levels and interfere with the drug’s action. Cautions are noted for the use of potassium supplements and, in some official documentation, calcium supplements. For all concurrent medications and supplements, a review of official safety literature is typically necessary.

Q: Is dry mouth or excessive thirst a known side effect of Индапамид-OBL?

Official safety literature lists dry mouth as a reported side effect of the medicine. Increased or excessive thirst, however, is often noted in drug safety literature as a general symptom. This symptom is sometimes linked to a possible electrolyte imbalance, such as low sodium or potassium.

Q: Are mood changes, like depression or anxiety, described as potential side effects?

The comprehensive safety literature reports that mood changes, including feelings consistent with sadness, emptiness, or depression, have been observed in clinical settings. These types of effects are noted in the safety profile as less common side effects that have been reported.

Q: Is there a link between the use of Индапамид-OBL and changes in cholesterol levels?

Clinical evidence from official sources indicates that Indapamide, when administered at the recommended therapeutic dose, does not appear to cause alterations in lipid metabolism. This means that changes in triglycerides, LDL-cholesterol, and HDL-cholesterol levels are not typically expected as a result of using the medication.

Q: Does the leaflet mention anything about sudden discontinuation of Индапамид-OBL?

Official patient information leaflets clearly advise that a person should not stop taking this medicine or make any changes to the prescribed dosage on their own. This general caution is included to help prevent potential complications and encourages that any decision to stop the medicine be managed by a healthcare professional.

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How should Индапамид-OBL be stored and disposed of?

How to Store and Dispose of Индапамид-OBL?

The official storage and disposal guidelines for Индапамид-OBL tablets are defined by regulatory agencies to ensure product stability and safety.

Storage Requirement Official Classification
Temperature Do not store above 25 C (77 F); keep from freezing.
Environment Store away from excess heat, moisture, and direct light.
Packaging Keep in the original container, which must be tightly closed.
Protection Store out of the sight and reach of children.

Official disposal protocols require that the unused or expired medication be disposed of via a drug take-back program or, alternatively, prepared for household trash by mixing the tablets with an undesirable substance. The product must not be flushed down the toilet or disposed of in wastewater.

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

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