Indapamide Tablets
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Indapamide Tablets
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Product Details
Date of approval: 3 August 2007 Date of revision: 1 December 2019
Date of approval: 3 August 2007 Date of revision: 1 December 2019
Date modified: 01 October 2010 Date modified: 30 December 2020
Date modified: 01 October 2010 Date modified: 30 December 2020
Date modified: December 1, 2015
Indapamide Tablets Instructions
Please read the instructions carefully and use under the guidance of a physician
[Drug Name]
Generic name: Indapamide Tablets
English name: Indapamide Tablets
Pinyin: Yindapa'an pian
[Ingredients]
The active ingredient of this product is indapamide, with the chemical name: N-(2-methyl-2,3-dihydro-1H-indolyl)-3-aminosulfonamide-4-chlorobenzamide. The structural formula is:
Molecular formula: C16H16ClN3O3S
Molecular weight: 365.83
[Properties]
This product is a sugar-coated tablet, appearing white after removal of the coating.
[Indications]
For the treatment of hypertension.
[Specification]
2.5 mg.
[Dosage and Administration]
For adults, the usual dosage is oral administration. 2.5mg (1 tablet) once daily.
Adverse reactions were mild and transient, with dose-related patterns.
(1) Less common adverse reactions include: diarrhea, headache, decreased appetite, insomnia, nausea, and orthostatic hypotension.
(2) Rare adverse reactions include: allergic reactions such as rash and pruritus; hyponatremia, hypokalemia, and hypochloremic alkalosis.
[Contraindications]
Sulfonamide allergy, severe renal insufficiency, hepatic encephalopathy or severe hepatic insufficiency, hypokalemia.
[Matters Need Attention]
①To reduce the risk of electrolyte imbalance, a lower effective dose should be used, and regular monitoring of serum potassium, sodium, and uric acid levels is recommended. It is essential to maintain water and electrolyte balance and ensure timely potassium supplementation.
② For diuretic use, it is recommended to administer the medication once daily in the morning to avoid nocturnal voiding.
③Anuria or severe renal insufficiency may induce azotemia.
④Gout or hyperuricemia, in which case serum uric acid levels may further increase.
⑤ Hepatic insufficiency may trigger hepatic coma after diuresis.
⑥After sympathectomy, the antihypertensive effect is enhanced.
⑦If surgery is required due to the use of this product, the medication should not be discontinued, but the anesthesiologist must be informed.
⑧ Athletes should use with caution.
[Medication Use in Pregnant and Lactating Women]
The impact on pregnancy has not been studied in humans, and no issues have been identified in animal studies. Whether this product is excreted in breast milk remains unknown, but no problems have occurred in human applications.
[Pediatric Medication]
This experiment has not been conducted and there are no reliable references available.
[Geriatric Medication]
Elderly patients are more sensitive to antihypertensive effects and electrolyte changes, and often exhibit renal function alterations. Caution is required when using this product.
[Drug Interaction]
①The diuretic and natriuretic effects of this product are reduced when used concomitantly with adrenal corticosteroids;
②Concomitant use of this product with amiodarone may easily induce arrhythmias due to hypokalemia;
③Concomitant use with oral anticoagulants may reduce the anticoagulant effect;
④When co-administered with nonsteroidal anti-inflammatory analgesics (NSAIDs), the natriuretic effect of this product is attenuated;
⑤Concomitant use with dopamine enhances the diuretic effect;
⑥Concomitant use with other antihypertensive agents enhances the hypotensive effect;
⑦The antihypertensive effect of this product is weakened when used concomitantly with sympathomimetic drugs;
⑧Concomitant use of this product with lithium preparations may increase serum lithium concentrations and lead to signs of overdose;
⑨When used in combination with high-dose salicylates, dehydrated patients may develop acute renal failure;
⑩Concomitant use with metformin may easily lead to lactic acidosis.
[Overdose]
No toxic effects were observed when the dose reached 16 times the therapeutic dose of 40 mg. The primary symptoms of acute poisoning include water and electrolyte disturbances (hypotension and hypokalemia). Clinically, symptoms may manifest as nausea, vomiting, hypotension, convulsions, drowsiness, confusion, polyuria or oliguria, and even anuria (due to hypovolemia). The initial measures should involve rapid elimination of the ingested drug, which may include gastric lavage and/or activated charcoal administration. Subsequently, water and electrolyte imbalances should be corrected to normal levels at a specialized center.
[Pharmacology and Toxicology]
Pharmacological action: This is a sulfonamide diuretic that exerts its effects by inhibiting the reabsorption of water and electrolytes in the distal renal tubular cortical dilution segment. The antihypertensive effect is unclear, and its diuretic action cannot explain the antihypertensive effect, as the dose required for antihypertension is significantly lower than that for diuresis. Possible mechanisms include the following aspects: regulation of calcium influx into vascular smooth muscle cells; stimulation of the synthesis of prostaglandins PGE2 and PGI2; reduction of vascular hypersensitivity to vasoconstrictive amines, thereby inhibiting vasoconstriction. This drug has minimal or no effect on cardiac output, heart rate, or rhythm during antihypertensive action. Long-term use of this drug rarely affects glomerular filtration rate or renal blood flow. This drug does not affect lipid or carbohydrate metabolism.
Toxicology study: Not performed and no reliable references available.
[Pharmacokinetics]
The drug is rapidly and completely absorbed orally, with a bioavailability of 93%, unaffected by food. Its plasma binding affinity ranges from 71% to 79%, and it also binds to elastin in vascular smooth muscle. Peak plasma concentration is achieved 1–2 hours after oral administration. The antihypertensive effect peaks approximately 24 hours after a single oral dose; repeated dosing achieves peak efficacy in about 8–12 weeks, with the effect lasting for 8 weeks. The half-life is 14–18 hours. It is metabolized in the liver, producing 19 metabolites. Approximately 70% is excreted renally, of which 7% is unchanged and 23% is excreted via the gastrointestinal tract. Pharmacokinetic parameters remain unchanged in patients with renal failure.
Storage: Protect from light and store in a tightly sealed container.
[Packaging]
Pharmaceutical aluminum foil/Polyvinyl chloride (PVC) solid tablet packaging, 15 tablets/plate × 2 plates/box; 20 tablets/plate × 3 plates/box. Pharmaceutical packaging composite film, 6 tablets/plate × 2 plates/box.
[Validity]
24 months
[Implementation Standard]
China Pharmacopoeia 2020 Edition Part II
[Approval Number]
National Drug Approval Number H20003270
[Marketing Authorization Holder]
Company Name: Henan Zhongjie Pharmaceutical Co., Ltd.
Registered address: South Railway Station, Xinxiang City, Henan Province
[Manufacturing Enterprise]
Company Name: Henan Zhongjie Pharmaceutical Co., Ltd.
Production address: South Railway Station, Xinxiang City, Henan Province
Postal Code: 453003
Phone Number: +86-373-5071333
Fax: +86-373-5071222
Website: http://www.xxzjyy.com.cn
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