Product Overview
[Drug Name]
Generic Name: Irbesartan and Hydrochlorothiazide Dispersible Tablets
Trade Name: Lipei Irbesartan and Hydrochlorothiazide Dispersible Tablets (150mg:12.5mg)*7 Tablets
Pinyin Full Code: LiPei EBeiShaTanQingLvZuoZuoFenSanPian (150mg:12.5mg)*7 Tablets
[Main Ingredients]
The main ingredients of this product are irbesartan and hydrochlorothiazide.
[Properties]
This product is a white or off-white tablet.
[Indications/Main Functions]
For the treatment of essential hypertension. This fixed-dose combination is used to treat patients whose blood pressure cannot be effectively controlled with irbesartan or hydrochlorothiazide alone.
[Precautions]
See the package insert for details.
[Drug Interactions]
During the 4th to 9th month of pregnancy (see [Use in Pregnant and Lactating Women]). Lactating women (see Pregnant and Lactating Women Use); Known hypersensitivity to the active ingredient or any of the excipients in this product, or to other sulfonamide derivatives (hydrochlorothiazide is a sulfonamide derivative). Severe renal impairment (creatinine clearance <30 ml/min); Refractory hypokalemia, hypercalcemia; Severe hepatic impairment, biliary cirrhosis, and cholestasis.
[Pediatric Use]
No safety data are available for patients under 18 years of age.
[Elderly Use]
Unknown.
[Pregnant and Lactating Women Use]
Contraindicated in pregnant and lactating women.
[Specifications]
(150 mg:12.5 mg)*7 tablets
[Dosage and Administration]
Oral, on an empty stomach or with food. The usual initial and maintenance dose is one tablet once daily, which can be increased to two tablets once daily depending on the condition.
[Adverse Reactions]
Adverse reactions in patients treated with this product were generally mild and transient. In placebo-controlled clinical trials of irbesartan and hydrochlorothiazide combined, treatment discontinuation due to any clinical or laboratory abnormality was less frequent in the irbesartan and hydrochlorothiazide combined group than in the placebo group. The incidence of adverse reactions was not associated with sex, age, race, or dose. In pooled placebo-controlled clinical trials of patients with dry blood pressure treated with various doses (ranging from 37.5 mg/6.25 mg to 300 mg/25 mg of irbesartan/hydrochlorothiazide), adverse events that were possibly, probably, or unknown to be related to treatment, as well as those occurring at an incidence of 1% or greater, are detailed in the package insert.
Contraindications:
During the fourth to ninth month of pregnancy (see [Use During Pregnancy and Lactation]). During lactation (see [Use During Pregnancy and Lactation]). Patients with known hypersensitivity to the active ingredient or any of the excipients of this product, or to other sulfonamide derivatives (hydrochlorothiazide is a sulfonamide derivative). Severe renal impairment (creatinine clearance <30 ml/min), refractory hypokalemia, hypercalcemia; severe hepatic impairment, biliary cirrhosis, and cholestasis.
[Overdose]
Unknown.
[Pharmacology and Toxicology]
Unknown.
[Pharmacokinetics]
Unknown.
