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Indapamide Tablets Instructions
Please read the instructions carefully and use under the guidance of your physician.
[Drug Name]
Generic Name: Indapamide Tablets Indapamide Tablets. Paracetamol Tablets
English Name: Indapamide Tablets
Hanyu Pinyin: Yindapa’an Pian
[Ingredients]
The main ingredient of this product is indapamide.
Chemical name:N-(2-methyl-2,3-dihydro-1H-indole-1-based)-3-aminosulfonyl -4-chloro-Benzamide.
Chemical structure formula:
Molecular Formula:C16H16ClN3O3S
Molecular weight:365.83
[Properties]This product is a film-coated tablet, which appears white after removing the coating.
[Indications] Primary hypertension.
[Specification]2.5 mg
[dosage]
Orally: every 24hours One tablet, preferably taken in the morning.
The daily dose should not exceed2.5 mg(increasing the dose will not improve the efficacy but will increase the side effects).
[Adverse Reactions]
Summary of Security Features
The most frequently reported adverse reaction was hypersensitivity reactions (skin predominant), primarily in patients with an allergic tendency, susceptibility to asthmatic reactions or maculopapular rash. During the course of clinical trials, treatment4to6weeks later, after 25%patients hypokalemia (blood potassium <3.4 mmol/l) was observed,10% of patients with blood potassium levels< 3.2 mmol/l. After 12weeks of treatment, the mean decrease in blood potassium 0.41 mmol/l.
Most laboratory test abnormalities and clinically relevant adverse reactions are dose-dependent.
Tabular Adverse Reaction Summary
The following adverse reactions were observed during indapamide treatment and are listed in the following order of frequency:
very common (≥1/10); common (≥1/100 to 1/10); uncommon (≥1/1000 to 1/100); rare (≥1/10,000to 1/1000); very rare (≥1/100,000to 1/10,000), unknown(cannot be inferred from known data).
MedDRA
Systematic Organ ClassificationAdverse effectsFrequencyDiseases of the blood and lymphatic systemGranulocyte deficiencyExtremely rare Aplastic anemiaextremely rareHemolytic anemiaExtremely rareLeukopeniaextremely rareThrombocytopeniaextremely rareMetabolic and nutritional disordershypercalcemiaextremely rarePotassium deficiency with hypokalemia, particularly severe in certain high-risk groups (see [Caution])unknownHyponatremia (see [Precautions])unknown Neurological DisordersGlarerareFatiguerareHeadacherareFeeling abnormalrareSwoonunknownEye DiseaseMyopiaunknownBlurred visionunknownVisual impairmentunknownHeart diseaseCardiac Arrhythmiaextremely rareTip-twisting ventricular tachycardia (which may be fatal) (see [Precautions] and [Drug Interactions])unknownVascular diseaseLow blood pressureextremely rareGastrointestinal DisordersVomiting
unusualNauseousRareConstipationrareDry mouthrarePancreatitisextremely rareHepatobiliary DiseaseAbnormal liver functionextremely rareHepatic encephalopathy may occur in hepatic insufficiency (see [Contraindications] and [Precautions])unknownHepatitisunknownDermatologic and subcutaneous tissue disordershypersensitivity reactionCommonPemphigusCommonPurpuraUnusualAngiogenic edemaextremely rareHivesextremely rareToxic epidermal necrolysis looseningextremely rareStevens-JohnsonSyndromeextremely raremay exacerbate existing acute disseminated lupus erythematosusunknownPhotosensitive reaction (see [Precautions])unknownRenal and urinary tract disordersRenal Failure “padding-left: 5px; padding-right: 5px; border-top: none; border-left: none; border-bottom: solid 0.5pt; border-right: solid 0.5pt”>extremely rareLab TestsElectrocardiogram Prolonged QT interval (see [Precautions] and [Drug Interactions])unknownGlucose increase (see [Precautions])unknownIncreased blood uric acid (see [Precautions])unknownElevated liver enzyme levelsunknown[Taboo]
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Hypersensitivity to the active ingredient or to other sulfonamides or to any excipients
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Severe renal failure
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Hepatic encephalopathy or severe hepatic impairment
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Hypokalemia
This product is not usually recommended in combination with lithium and non-antiarrhythmic agents that can trigger tip-twisting ventricular tachycardia (see [Drug Interactions]).
[Precautions]
Warning
Thiazide-related diuretics may cause hepatic encephalopathy when liver function is impaired, especially in the presence of electrolyte disturbances. If this occurs, diuretics must be discontinued immediately.
Photosensitivity
Photosensitivity reactions have been reported with thiazide and thiazide-related diuretics (see [Adverse Reactions]). If photosensitivity reactions occur during treatment, discontinuation of the drug is recommended. If diuretics must be used again, it is recommended to protect areas exposed to sunlight or unnaturalUVA.
Accessories
This product contains lactose. Patients with rare genetic problems such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medication
Precautions
Water and electrolyte balance
Blood sodium
Blood sodium must be measured prior to treatment and should be monitored regularly thereafter. Lower blood sodium can be asymptomatic at first, so regular monitoring is essential; in high-risk groups, i.e., older and cirrhotic patients, monitoring should be more frequent (see [Adverse Reactions] and [Drug Overdose]). Any diuretic therapy can lead to hyponatremia, sometimes with very serious consequences. Hyponatremia with hypovolemia may lead to dehydration and upright hypotension. Combined loss of chloride may lead to secondary compensatory metabolic alkalosis: the incidence of this effect is low and mild.
Blood potassium
Potassium deficiency and hypokalemia are a major risk associated with thiazides and their related diuretics. In certain high-risk patients, namely the elderly and/or malnourished and family:Times New Roman”>/or patients taking multiple medications, patients with cirrhosis with edema and ascites, patients with coronary artery disease and heart failure, etc., must prevent hypokalemia (). family:Times New Roman”>3.4mmol/l) risk. Because hypokalemia increases the risk of cardiotoxicity and arrhythmias with digitalis preparations in these conditions.
LongQT in ECG Patients with interval, either congenital or medical in origin, are at risk with this drug. Hypokalemia (and bradycardia) are both triggers of severe arrhythmias, especially potentially lethal tip-twisting ventricular tachycardia.
All of the above require frequent testing of potassium levels.
The first measurement of blood potassium must be obtained within the first week when the medication is started.
Hypokalemia should be corrected when detected.
Blood calcium
Thiazides and related diuretics may decrease urinary calcium excretion, resulting in a slight and transient increase in blood calcium levels. Significantly elevated blood calcium may be due to pre-existing undetected hyperparathyroidism. Treatment should be discontinued until parathyroid function is checked.
Glucose
Patients with diabetes should monitor their blood glucose levels, especially in the presence of hypokalemia.
Uric acid
Relief between renal function and diuretic potency
In the initial phase of diuretic therapy, the glomerular filtration rate decreases due to the loss of water and sodium, which also causes a decrease in blood volume. This may cause increased levels of urea and creatinine in the blood. This temporary functional renal insufficiency does not have serious consequences in those with previously normal renal function, but may lead to further deterioration of pre-existing renal insufficiency.
Athletes
Effects on driving and mechanical handling ability
This product does not affect alertness, but in individual cases a different response associated with a decrease in blood pressure may occur, particularly at the beginning of treatment or with the addition of another antihypertensive medication.
As a result, the ability to drive a vehicle or operate a machine may be impaired.
[For Pregnant and Lactating Women]
Pregnancy
There are limited data on the use of indapamide in pregnant women (less than300 cases of pregnancy outcome). Prolonged exposure to thiazides at the end of pregnancy may reduce maternal plasma volume and uteroplacental blood flow, which in turn may lead to fetal-placental ischemia and growth retardation.
Animal studies have not suggested direct or indirect adverse effects in terms of reproductive toxicity (see [Pharmacology and Toxicology]).
As a precaution, indapamide is best avoided during pregnancy. Such drugs should not be used to treat physiologic edema that occurs during pregnancy.
Lactation
About indapamide// “font-family:Arial”>Insufficient information on the secretion of metabolites via human milk. Hypersensitivity to sulfonamide-derived drugs and hypokalemia may occur. Risk to neonatal/infants cannot be excluded.
Indapamide is structurally very similar to thiazide diuretics, which have been associated with reduced milk production and even suppression of lactation during breastfeeding.
Indapamide should not be used during breastfeeding.
Fertility
Reproductive toxicity studies showed no effect on fertility in female and male rats (see [Pharmacology and Toxicology]). No effect on human fertility is expected.
[Pediatric Use] The safety and efficacy of pediatric use have not been established.
See under Other, or as directed by your physician.
Not Recommended Combinations
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Lithium
In a salt-free diet (where urinary excretion of lithium is reduced), indapamide increases blood lithium and leads to the manifestation of lithium overload. However, if diuretics must be applied, blood lithium should be carefully monitored and the dose adjusted as needed.
Co-medications to Watch
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Drugs that induce tip-twisting ventricular tachycardia
-Iaclass of antiarrhythmic agents (quinidine, hydroquinidine diisoproterenol).
-IIIclass antiarrhythmic agents (amiodarone, sotalol, dofetilide, ibupril). Ibudilate).
-Some antipsychotics: =”font-family:Times New Roman”>
-Phen Thiazides (chlorpromazine, cyromazine, levomepromazine, thioridazine, trifluoperazine).
-Benzene Aminoglutethimide (amisulpride, sulpiride, sutropilide, tepilide).
– Butyrylbenzenes (haloperidol, haloperidol).
-Other: Bepridil, Cisapride, Dibenzomanil, ErythromycinIV, halofantrine, imipramine, pentazocine, sparfloxacin, moxifloxacin, vincristineIV.
Increased risk of ventricular arrhythmias, especially tip-twist arrhythmias (hypokalemia is a risk factor).
Monitor hypokalemia and correct as needed before introducing such combinations. Perform clinical, plasma electrolyte, and electrocardiographic monitoring.
In the presence of hypokalemia, use a drug that does not have the disadvantage of causing tip-twist arrhythmias.
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Nonsteroidal anti-inflammatory drugs (N.S.A.I.Ds family:Arial”>, systemic), includingCOX-2selective inhibitors, high doses of salicylic acid (≥3g/day)
may reduce the antihypertensive effect of indapamide.
At risk of acute renal failure (reduced glomerular filtration) in dehydrated patients.
Patients should be hydrated and renal function should be monitored from the start of treatment.
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Angiotensin-converting enzyme (A.C.E.) inhibitors
Coadministration of A.C.E.in the presence of pre-existing sodium deficiencyinhibitors, there is a risk of sudden hypotension and/or acute renal failure (especially in patients with renal artery stenosis), so care must be taken in patients with essential hypertension, where prior diuretics may lead to sodium deficiency:
-should be started three days after discontinuation of diureticsA.C.E.. family:Arial”>inhibitors and, if necessary, revert to potassium-depleting diuretics,
-or start on a low dose ofA.C.E. family:Arial”>inhibitors, slowly increasing the dose of the drug.
In patients with congestive heart failure, after decreasing the dose of potassium-removal diuretics, a very small dose of A.C.E. span style=”font-family:Arial”>inhibitors to start treatment.
For patients takingA.C.E.Inhibitors are tested for renal function (blood creatinine level) in the first few weeks of administration in all patients.
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Other compounds causing hypokalemia: amphotericinBB family:Arial”>(sedative), glucocorticoids and salt corticosteroids (systemic), ticlopidine, stimulant laxatives
Increases the risk of hypokalemia (superimposed effect).
Monitor blood potassium levels and correct hypokalemia if necessary; more so when co-administered with digitalis preparations. Use non-stimulant laxatives.
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Baclofen
Increase the effectiveness of antihypertensive therapy. Rehydrate the patient; monitor renal function at the start of therapy.
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Cyanodine preparations
Hypokalemia predisposes to the toxic effects of digitalis analogues. Monitoring of blood potassium and electrocardiogram should be monitored, and therapy should be readjusted if necessary.
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Allopurinol:
Increased allopurinol hypersensitivity reactions when used in combination with indapamide.
Co-administration should take into account
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Potassium-preserving diuretics (amiloride, ambrisentin, aminopterin)
This rational combination is beneficial in some patients, but hypokalemia or hyperkalemia may still occur (especially in patients with renal failure and diabetes mellitus). Care should be taken to monitor blood potassium levels, ECG, and readjust therapy if necessary.
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Metformin
Functional renal failure that may be induced by diuretics, including medullary diuretics, can increase the risk of metformin-induced lactic acidosis.
Men with blood creatinine levels above15 mg/L(135μmol/L), women with blood creatinine levels above12 mg/L (110 μmol/L), and women with blood creatinine levels above, metformin should not be used.
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Iodine contrast agent
In patients who are dehydrated from the use of diuretics, the combination of iodine contrast agents often increases the risk of acute renal failure, and the risk is even greater with high doses of iodine contrast agents.
Patients must be hydrated prior to the administration of iodine compounds.
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Promethazine antidepressants (tricyclic antidepressants), psychostimulants
Enhances antihypertensive efficacy and also increases the risk of upright hypotension (superimposed effect).
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Calcium (salt)
Increases the risk of hypercalcemia due to reduced urinary calcium excretion.
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Cyclosporine, Tacrolimus
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Corticosteroids, Ticoglutide (systemic)
Reduced indapamide antihypertensive efficacy (water due to corticosteroids/sodium retention).
[Drug overdose]
Symptoms
Indapamide with up to40mgand no toxicity was seen, which is 16fold of the conventional therapeutic dose.
Acute toxicity is mainly manifested by water/electrolyte disturbances (hyponatremia, hypokalemia). Clinical manifestations include nausea, vomiting, hypotension, painful cramps, dizziness, drowsiness, confusion, polyuria or oliguria or even anuria (due to decreased blood volume).
Treatment
The initial treatment used at specialized medical centers was by gastric lavage and/ or administration of activated charcoal to remove the ingested drug as soon as possible. Thereafter, water and electrolytes should be replenished to restore water and electrolyte balance.
[Pharmacology and Toxicology]
Indapamide is a sulfonamide diuretic that increases urinary excretion by inhibiting sodium reabsorption in the dilute segment of the renal cortex and increases urinary sodium and chloride excretion, thereby increasing urinary output and exerting a hypotensive effect in mild Diuresis exerts a hypotensive effect.
[Pharmacokinetics]
Absorption
The bioavailability of indapamide is high (93%)
Take2.5mg After the dose, the time to peak blood concentration (Tmax) is1to2hours.
Distribution
binding to plasma proteins is greater than75%.
clearance half-life of 14-24hours (average18hours).
Steady-state blood concentrations (plateau) were higher with repeated dosing compared to single dosing, and the plateau was maintained stable, indicating no drug accumulation.
Excretion
Renal clearance accounts for 60%-80% of total clearance.
The amount of unmetabolized breakdown of the drug observed in urine was 5%, and indapamide is mostly excreted as metabolites.
Renal failure
For patients with renal failure, the above pharmacokinetic parameters remain unchanged.
[Storage]Store under shade and seal.
[Packaging]Pharmaceutical aluminum foil with polyvinyl chloride/polyvinylidene chloride solid pharmaceutical laminated rigid tablets packaged in a box of10tablets×1plate or10pieces×3×3plate or10piecespieces×6panels.
[Expiry date]18months
[Executive Standard]
[Approval number]State Drug CertificateH10880019
[Drug Marketing Licensee]
Name
Name: Tianjin Lisheng Pharmaceutical Co.
Registered office: Saeda North Road, Xiqing Economic Development Zone, Tianjin16 =”font-family:Arial”>No.
[Manufacturer]
Company Name: Tianjin Lixin Pharmaceutical Co.
Manufacturing Address: Saeda North Road, Xiqing Economic Development Zone, Tianjin16 =”font-family:Arial”>No.
Postal Code:300385
Tel:022-27366012
Fax Number:022-27364239
Website:http://www.lishengpharma.com Roman”>www.lishengpharma.com
Toll Free Consultation:4006490098