Product Overview
Drug Name
Trade Name: Maikoning
Generic Name: Indapamide Sustained-Release Tablets
English Name: Indapamide Sustained-Release Tablets
Indications
This product is indicated for essential hypertension.
Main Ingredients
The main ingredient of this product is indapamide.
Specifications
1.5mg*30 tablets
Drug Interactions
Incompatible Drugs: 1. Lithium: During a sodium-free diet (which reduces urinary lithium excretion), indapamide increases blood lithium concentrations and can lead to symptoms of lithium overdose. However, if a diuretic is used concomitantly, blood lithium levels should be carefully monitored and the dosage adjusted. 2. Non-antiarrhythmic Drugs Inducing Torsades De pointes (including astemizole, bepridil, intravenous erythromycin, halofantrine, pentamidine, sultopride, terfenadine, and vincamine): Torsades de pointes (hypokalemia, bradycardia, and QT prolongation are precipitating factors). If hypokalemia occurs, avoid using medications that can trigger torsades de pointes. Coadministration requires caution. 3. Nonsteroidal anti-inflammatory drugs (systemic), high-dose sodium salicylate: May reduce the antihypertensive effect of indapamide. Acute renal failure (decreased glomerular filtration) in dehydrated patients. When initiating treatment, administer fluids and monitor renal function. 4. Other potassium-lowering compounds: Amphotericin B (intravenous), glucocorticoids and mineralocorticoids (systemic), tecocorticoids, stimulant laxatives: Increase the risk of hypokalemia (synergistic effect). Monitor serum potassium and correct if necessary. Exercise particular caution when using digitalis. Use non-stimulant laxatives. 5. Baclofen: Potentiates the hypotensive effect. Administer fluids; monitor renal function at the start of treatment. 6. Digitalis: Hypokalemia can predispose to toxic effects of digitalis. Monitor serum potassium and electrocardiogram as needed, and readjust treatment if necessary. Coadministration requires careful consideration. 7. Potassium-sparing diuretics (amiloride, spironolactone, triamterene): This combination of medication is beneficial for some patients, but the possibility of hypokalemia or hyperkalemia cannot be ruled out, especially for patients with renal failure and diabetes, who are more prone to hyperkalemia. Monitor blood potassium and electrocardiogram as needed, and readjust treatment if necessary. 8. Angiotensin-converting enzyme (ACE) inhibitors: In the case of pre-existing sodium deficiency (especially in renal artery stenosis), the combination of indapamide and ACE inhibitors carries the risk of sudden hypotension and/or acute renal failure. In patients with essential hypertension, previous diuretic treatment may lead to sodium deficiency, and it is important to note: (1) Stop diuretics for 3 days before using ACE inhibitors; potassium-wasting diuretics can be restarted if necessary. (2) Or when giving ACE inhibitors, use a low starting dose and gradually increase the dose. In patients with congestive heart failure, the initial dose of ACE inhibitors should be very small, and can be started after reducing the dose of potassium-wasting diuretics. For all patients taking angiotensin-converting enzyme inhibitors, renal function (serum creatinine) should be monitored during the first week. 9. Antiarrhythmic drugs that can cause torsades de pointes: Class Ia antiarrhythmic drugs (quinidine, dihydroquinidine, disopyramide), amiodarone, bretylium, and sotalol: Torsades de pointes (hypokalemia, bradycardia, and preexisting QT interval prolongation are precipitating factors). Prevent hypokalemia and correct it if necessary; monitor the QT interval. During a torsades de pointes episode, do not use antiarrhythmic drugs (pacemaker therapy is recommended). 10. Metformin: Diuretic-induced functional renal insufficiency (particularly loop diuretics) can exacerbate metformin-induced lactic acidosis. Do not use metformin if the serum creatinine level exceeds 15 mg/L (135 μmol/L) in men and 12 mg/L (110 μmol/L) in women. 11. Iodinated contrast media: In the setting of diuretic-induced dehydration, iodinated contrast media increase the risk of acute renal failure, especially when used in high doses. Fluid rehydration should be initiated before administering iodinated compounds. 12. Imipramine antidepressants (tricyclic antidepressants) and neuroleptics: Potentiate antihypertensive effects and increase the risk of orthostatic hypotension (synergistic effect). 13. Calcium salts: Reduced urinary calcium excretion leads to the risk of hypercalcemia. 14. Cyclosporine: Without increasing circulation, corticosteroids, and teicosin (systemic route): Reduced antihypertensive efficacy of indapamide (due to water/sodium retention caused by corticosteroids).
Adverse Reactions
Most clinical and laboratory adverse reactions are dose-dependent. Thiazide and related diuretics including indapamide may cause the following: 1. Laboratory parameters: (1) Potassium depletion and hypokalemia, which may be more severe in certain high-risk groups (see Precautions). In clinical trials, 10% of patients developed hypokalemia (blood potassium <3.4 mmol/L) after 4-6 weeks of treatment; 4% of patients had blood potassium <3.2 mmol/L. After 12 weeks of treatment, the average decrease in blood potassium was 0.23 mmol/L. (2) Hyponatremia with hypovolemia causing dehydration and orthostatic hypotension. Concomitant chloride depletion can lead to secondary compensatory metabolic alkalosis: this condition is rare and mild. (3) During treatment, plasma uric acid and blood glucose increase: when these diuretics are used in patients with gout and diabetes, their indications must be considered very carefully. (4) Hematological disorders, very rare: thrombocytopenia, leukopenia, agranulocytosis, nutritional anemia, hemolytic anemia. (5) Hypercalcemia: Very rare. 2. Clinical parameters: (1) In the case of liver dysfunction, hepatic encephalopathy may occur. (2) Allergic reactions, mainly skin allergies, seen in patients with previous allergies or asthma. (3) Maculopapular rash, purpura, may aggravate existing acute systemic lupus erythematosus. (4) Nausea, constipation, dry mouth, dizziness, fatigue, paresthesia, headache and other symptoms rarely occur, and most of them are relieved with drug reduction. (5) Pancreatitis is very rare.
Contraindications
1. Hypersensitivity to sulfonamides. 2. Severe renal failure. 3. Hepatic encephalopathy or severe liver failure. 4. Hypokalemia.
Precautions
1. Warning: When liver function is impaired, thiazide and related diuretics may cause hepatic encephalopathy. If this disease occurs, the diuretic should be stopped immediately. Water and electrolyte balance. 2. Blood sodium: Blood sodium must be measured before treatment and should be monitored regularly thereafter. Any diuretic therapy may cause hyponatremia, sometimes with serious consequences. Hyponatremia may initially be asymptomatic, so regular monitoring of serum sodium is essential; monitoring should be more frequent in the elderly and patients with cirrhosis (see Adverse Reactions and Overdosage). 3. Potassium: Hypokalemia and potassium depletion are the major risks of thiazide and related diuretics. Hypokalemia (<3-4 mmol/L) must be prevented in certain high-risk groups, such as the elderly, those who are malnourished and/or taking multiple medications, and patients with cirrhosis, edema, ascites, coronary artery disease, and heart failure. In these cases, hypokalemia can increase the cardiotoxicity of digitalis and the risk of arrhythmias. Patients with a prolonged QT interval, whether congenital or iatrogenic, are also at high risk. Hypokalemia and bradycardia can subsequently precipitate serious arrhythmias, particularly fatal ones. In all of these cases, frequent potassium monitoring is essential. The first serum potassium measurement should be performed within 1 week of starting treatment. If hypokalemia is detected, appropriate correction should be made. 4. Serum Calcium: Thiazides and related diuretics may reduce urinary calcium excretion, causing a transient, mild increase in serum calcium. Overt hypercalcemia may be due to previously undetected hyperparathyroidism. Treatment should be discontinued before parathyroid function is tested. 5. Blood Glucose: Monitoring blood glucose is important in patients with diabetes, especially if hypokalemia is present. 6. Uric Acid: Patients with hyperuricemia may have an increased risk of gout attacks. 7. Renal and Urinary Function: Thiazides and related diuretics are fully effective only when renal function is normal or mildly impaired (serum creatinine less than 25 mg/L (220 μmol/L) in adults). In the elderly, serum creatinine values must be adjusted for age, weight, and sex. During the initial stages of diuretic treatment, hypovolemia caused by water and sodium loss reduces glomerular filtration, potentially leading to increased blood urea and creatinine. This transient renal impairment is not serious in patients with previously normal renal function, but it can worsen renal function in those with pre-existing renal insufficiency. 8. Athletes: The active ingredients in this medication may cause a positive test result for anti-doping agents; athletes should exercise caution. 9. Effects on Ability to Drive a Motor Vehicle and Operate Machinery: Naturopathic sustained-release tablets do not impair alertness, but some patients may experience decreased reactivity due to lowered blood pressure, particularly at the start of treatment and when taking other antihypertensive medications. This may result in decreased ability to drive a motor vehicle and operate machinery.
Storage: Store below 30°C.
Approval Number: National Medicine Standard H20070262
Manufacturer: Huangshan Zhonghuang Pharmaceutical Co., Ltd.
