Product Overview
[Drug Name] Generic Name: Losartan Potassium Hydrochlorothiazide Tablets
Trade Name: Hyzaar
English Name: Hydrochlorothiazide
Chinese Pinyin: Lvshatanjiaqinglvsaiqin Pian
[Ingredients]
Losartan Potassium Hydrochlorothiazide.
[Appearance]
This 50mg tablet is a white, oval film-coated tablet. The core appears white or off-white after the film is removed.
[Indications]
Losartan Potassium Hydrochlorothiazide is used to treat hypertension and is suitable for patients receiving combination medications.
[Dosage and Administration]
The typical starting and maintenance dose of losartan potassium hydrochlorothiazide is one tablet of losartan potassium hydrochlorothiazide 50-12.5mg (losartan potassium 50mg/hydrochlorothiazide 12.5mg) once daily. For patients who have an inadequate response to losartan potassium hydrochlorothiazide 50-12.5mg, the dose can be increased to two tablets of Hyzaar 50-12.5mg once daily. The maximum dose is two tablets of Hyzaar 50-12.5 once daily. Antihypertensive efficacy is typically achieved within three weeks of starting treatment.
[Adverse Reactions]
In clinical trials of losartan potassium-hydrochlorothiazide, no adverse reactions specific to this combination were observed, limited to those previously reported for losartan potassium and/or hydrochlorothiazide. The overall incidence of adverse reactions with this combination was similar to that with placebo, as was the percentage of treatment discontinuations. In general, treatment with losartan potassium-hydrochlorothiazide was well tolerated, with most adverse reactions being mild and transient and not requiring treatment discontinuation. In controlled clinical trials of losartan-hydrochlorothiazide for the treatment of essential hypertension, dizziness was the only adverse reaction reported at a rate of 1% or greater compared to placebo. Other adverse reactions identified post-marketing: Hypersensitivity: Angioedema (including swelling of the larynx and glottis leading to airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue) has been reported rarely in patients treated with losartan. Some of these patients have previously experienced angioedema with other medications (e.g., ACE inhibitors). Gastrointestinal: Hepatitis (rarely reported in patients taking losartan); diarrhea. Laboratory Test Results: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with losartan potassium/hydrochlorothiazide use. Hyperkalemia (5.5 mEq/L) occurred in 0.7% of patients, but this did not require discontinuation of losartan potassium/hydrochlorothiazide. Elevated alanine aminotransferase levels rarely occur and generally resolve with discontinuation of the drug.
[Contraindications]
1. Patients with hypersensitivity to any component of this product; 2. Patients with anuria; 3. Patients with hypersensitivity to other sulfonamides. 4. Pregnancy: Losartan potassium and hydrochlorothiazide use during the second or third trimester can directly affect the renin-angiotensin system and cause fetal harm or even death. Therefore, the drug should be discontinued as soon as pregnancy is confirmed.
[Precautions]
1. Losartan potassium and hydrochlorothiazide should not be used in patients with reduced blood volume (such as those taking high-dose diuretics). 2. Losartan potassium and hydrochlorothiazide are not recommended for patients with severe renal insufficiency (creatinine clearance <30 ml/min) or abnormal liver function. 3. No initial dose adjustment is required for elderly patients. 4. Losartan potassium and hydrochlorothiazide can be used in combination with other antihypertensive medications. 5. Losartan potassium and hydrochlorothiazide can be taken with or without food.
[Use in Special Populations]
Precautions for Children:
Safety and efficacy in children have not been established. Precautions for Pregnancy and Breastfeeding:
Pregnancy: Losartan potassium and hydrochlorothiazide use during the second or third trimester directly affects the renin-angiotensin system, potentially causing fetal harm or even death. Therefore, discontinue use as soon as possible after pregnancy is confirmed.
Precautions for Elderly Patients:
Clinical studies have shown no clinically significant differences in the efficacy and safety of losartan potassium and hydrochlorothiazide between elderly patients (≥65 years) and younger patients (<65 years).
[Drug Interactions]
Drug interactions may occur if used concurrently with other medications. Please consult your physician or pharmacist for details.
[Pharmacological Actions]
Losartan potassium and hydrochlorothiazide is the first combination preparation of an angiotensin II receptor (AT1) antagonist and a diuretic.
[Storage] Store in a dark, sealed container.
[Strength] 50 mg/12.5 mg
[Packaging Size] 7 tablets
[Expiry Date] 36 months.
[Manufacturer] Company Name: Hangzhou Merck Pharmaceuticals Co., Ltd.
