Product Overview
[Drug Name]
Generic Name: Losartan Potassium Hydrochlorothiazide Tablets
Trade Name: BeiZuo Losartan Potassium Hydrochlorothiazide Tablets 50mg: 12.5mg*14 tablets
Pinyin Full Code: BeiZuo LvShaTanJiaQingLvZuoZuoPian 50mg: 12.5mg*14 tablets
[Main Ingredients]
This product is a combination preparation. Each tablet contains 50mg of losartan potassium and 12.5mg of hydrochlorothiazide. The chemical name of losartan potassium is 2-butyl-4-chloro-1-{[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol monopotassium salt. The chemical name of hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide-1,1-dioxide. Molecular formula: Losartan potassium: C22H22CIKN6O; hydrochlorothiazide: C7H8CIN3O4S2. Molecular weight: Losartan potassium: 461.01; hydrochlorothiazide: 297.74
[Properties]
This product is a yellow film-coated tablet that appears white to off-white after removal of the coating.
[Indications/Main Functions]
This product is used to treat hypertension and is suitable for patients taking combination medications.
[Specifications]
50mg: 12.5mg x 14 tablets
[Dosage and Administration]
The usual starting and maintenance dose of this product is one tablet once daily. For patients with an inadequate response, the dose can be increased to two tablets once daily, and this is the maximum daily dose. Antihypertensive effects are generally achieved within three weeks of starting treatment. This product should not be used in patients with hypovolemia (such as those taking high-dose diuretics). This product is not recommended for patients with severe renal insufficiency (creatinine clearance <30 ml/min) or hepatic insufficiency. Elderly hypertensive patients do not require initial dose adjustment, but losartan potassium and hydrochlorothiazide tablets (100mg + 25mg) should not be used as initial treatment. This product can be taken in combination with other antihypertensive medications. This product can be taken with or without food.
[Adverse Reactions]
No adverse reactions specific to losartan potassium-hydrochlorothiazide were observed in clinical trials of this combination. These adverse reactions were limited to previously reported adverse reactions with losartan potassium and/or hydrochlorothiazide. The overall incidence of adverse reactions with this combination was similar to that with placebo. The percentage of treatment discontinuations was also similar to that with placebo. Losartan potassium-hydrochlorothiazide was generally well tolerated. The vast majority of adverse reactions were mild and transient, not requiring treatment interruption. In controlled clinical trials of losartan potassium-hydrochlorothiazide for the treatment of essential hypertension, dizziness was the only adverse reaction reported as drug-related with an incidence greater than 1% and greater than that with placebo. In controlled clinical trials of hypertensive patients with left ventricular hypertrophy, losartan (usually used in combination with hydrochlorothiazide) was well tolerated. The most common drug-related adverse reactions were dizziness, weakness/fatigue, and vertigo. Other adverse reactions reported postmarketing with this product and/or with losartan and hydrochlorothiazide alone in clinical trials or postmarketing include: Neoplasms, benign, malignant, and unspecified (including cysts and polyps); Non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma). Blood and lymphatic system disorders: Thrombocytopenia, anemia, aplastic anemia, hemolytic anemia, leukopenia, and agranulocytosis. Immune system disorders: Angioedema (including laryngeal and glottic edema 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). Metabolic and nutritional disorders: Anorexia, hyperglycemia, hyperuricemia, and electrolyte imbalances including hyponatremia and hypokalemia. Psychiatric disorders: Insomnia and restlessness. Neurological disorders: Dysgeusia, headache, migraine, and paresthesia. Ocular disorders: Xanthoopia and transient blurred vision. Cardiac Disorders: Palpitations, tachycardia. Vascular Disorders: Dose-related orthostatic hypotension, necrotizing vasculitis (angiitis) (cutaneous vasculitis). Gastrointestinal Disorders: Dyspepsia, abdominal pain, gastrointestinal irritation, cramps, diarrhea, constipation, nausea, vomiting, pancreatitis, sialadenitis. Respiratory Tract, Thoracic, and Mediastinal Disorders: Cough, nasal congestion, pharyngitis, sinus disorders, upper respiratory tract infection, respiratory distress (including pneumonia and pulmonary edema). Hepatobiliary Disorders: Hepatitis, jaundice (jaundice due to intrahepatic bile accumulation). Skin and Subcutaneous Tissue Disorders: Rash, pruritus, purpura (including Henoch-Schönlein purpura), toxic epidermal necrolysis, urticaria, erythroderma, photosensitivity, cutaneous lupus erythematosus. Musculoskeletal and Connective Tissue Disorders: Back pain, muscle cramps, muscle spasms, myalgia, arthralgia. Renal and Urinary Disorders: Diabetes mellitus, renal dysfunction, interstitial nephritis, renal failure. Reproductive System and Breast Disorders: Erectile dysfunction/impotence. General Disorders and Administration Site Abnormalities: Chest pain, edema/swelling, malaise, fever, asthenia. Investigational: Liver dysfunction. Description of Selected Adverse Reactions: Non-melanoma Skin Cancer (Basal Cell Carcinoma, Squamous Cell Carcinoma): Based on available data from epidemiological studies, a cumulative dose-dependent relationship between hydrochlorothiazide and non-melanoma skin cancer (BCC and SCC) has been identified. The largest study included 71,533 patients with basal cell carcinoma (BCC) and 8,629 patients with squamous cell carcinoma (SCC), who were matched to 1,430,833 and 172,462 controls, respectively. For basal cell carcinoma (BCC), the adjusted odds ratio (OR) for those who used a high cumulative dose of hydrochlorothiazide (≥50,000 mg) was 1.29 (95% CI: 1.23-1.35); for squamous cell carcinoma (SCC), the adjusted OR for those who used a high cumulative dose of hydrochlorothiazide (>50,000 mg) was 3.98 (95% CI: 3.68-4.31). A cumulative dose-response relationship was observed in both BCC and SCC populations. Another study that included 633 cases of lip cancer and 63,067 controls evaluated the relationship between lip cancer (SCC) and hydrochlorothiazide exposure. There was a cumulative dose-response relationship between lip cancer (SCC) and hydrochlorothiazide exposure: the adjusted odds ratio (OR) was 2.1 (95% CI: 1.7-2.6) for ever users of hydrochlorothiazide; the OR increased to 3.9 (95% CI: 3.0-4.9) for high-dose users (≥25,000 mg); and the OR increased to 7.7 (95% CI: 5.7-10.5) for the highest cumulative dose (≥100,000 mg). Laboratory Findings: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with the use of hydrochlorothiazide. Hyperkalemia (serum potassium >5.5 mEq/L) occurred in 0.7% of patients, but in these trials, discontinuation of hydrochlorothiazide was not necessary. ALT elevations occurred rarely and generally resolved after discontinuation of hydrochlorothiazide.
[Contraindications]
- Patients allergic to any component of this product.
- Patients with anuria.
- Patients allergic to other sulfonamides.
- Diabetic patients should not use this product concomitantly with aliskiren (see [Drug Interactions]).
[Precautions]
Losartan-Hydrochlorothiazide Embryotoxicity: During the second and third trimesters of pregnancy, the use of drugs that affect the renin-angiotensin system can reduce fetal renal function and increase fetal and neonatal morbidity and mortality. The resulting oligohydramnios may be associated with fetal lung hypoplasia and skeletal deformities. Potential neonatal adverse reactions include craniosynostosis, anuria, hypotension, renal failure, and death. Upon discovery of pregnancy, this product should be discontinued as soon as possible. See [Use in Pregnant and Lactating Women]. Hypersensitivity reaction: Angioedema. (See [Adverse Reactions]). Hepatic and Renal Impairment: This product is not recommended for patients with hepatic or severe renal impairment (creatinine clearance <30 mL/min) (see [Dosage and Administration]). Losartan's inhibition of the renin-angiotensin system in patients with renal insufficiency can lead to changes in renal function. Renal failure has been reported in some susceptible patients (particularly in patients with conditions where renal function is dependent on the renin-angiotensin-aldosterone system, such as those with severe cardiac insufficiency or renal dysfunction). Some changes in renal function are reversible after discontinuation of treatment. Anemia has been reported in some patients with severe renal disease or renal transplant recipients treated with losartan potassium. In patients with bilateral or unilateral renal artery stenosis or renal artery stenosis of a single kidney, the use of other drugs that affect the renin-angiotensin system can cause elevations in plasma urea and creatinine; similar effects have been reported with losartan. These changes in renal function are reversible with discontinuation of the drug. Elevated serum potassium may lead to hyperkalemia when used concomitantly with other drugs that may increase serum potassium (see [Drug Interactions]). Hypotension and electrolyte imbalances with hydrochlorothiazide: As with all antihypertensive treatments, symptomatic hypotension may occur in some patients. If diarrhea or vomiting occurs, patients should be observed for clinical signs of fluid or electrolyte imbalance, such as volume depletion, hyponatremia, hypochloremic alkalosis, hypomagnesemia, or hypokalemia. Serum electrolytes should be monitored regularly. Metabolic and endocrine effects: Thiazide therapy can impair glucose tolerance. Doses of antidiabetic medications, including insulin, may require adjustment (see Drug Interactions). Thiazides can decrease urinary calcium excretion and cause intermittent, mild elevations in serum calcium. Significant hypercalcemia may be a manifestation of latent hyperparathyroidism. Therefore, thiazide therapy should be discontinued before parathyroid function testing. Elevated cholesterol and triglycerides may be associated with thiazide diuretic therapy. Thiazide therapy may precipitate hyperuricemia and/or gout in some patients. Because losartan lowers uric acid, the combined use of losartan potassium and hydrochlorothiazide can mitigate diuretic-induced hyperuricemia. Non-melanoma skin cancer: Epidemiological studies have shown that the risk of non-melanoma skin cancer (basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]) increases with increasing cumulative doses of hydrochlorothiazide. The photosensitizing effect of hydrochlorothiazide may be a pathogenic mechanism for non-melanoma skin cancer. Patients taking hydrochlorothiazide should be informed of the risk of non-melanoma skin cancer and advised to take precautions to reduce exposure to sunlight and artificial ultraviolet light. Patients should regularly examine their skin for new lesions and promptly report suspicious skin lesions to their physician for evaluation. For patients with a prior history of non-melanoma skin cancer, the use of hydrochlorothiazide may require reconsideration (see Adverse Reactions). Allergic reactions may occur with thiazide use, regardless of a history of allergies or bronchial asthma. Cases of systemic lupus erythematosus exacerbated or induced by thiazide use have been reported. Anti-doping control: This product contains hydrochlorothiazide, which can result in positive anti-doping control test results. Athletes should use this product with caution.
