Product Overview
[Generic Name]
Losartan Potassium-Hydrochlorothiazide Tablets
[Drug Name]
Yuanstan Losartan Potassium-Hydrochlorothiazide Tablets
[Main Ingredients]
This product is a recurrent formulation. Each tablet contains losartan potassium and hydrochlorothiazide.
[Indications]
This product is used to treat hypertension and is suitable for patients receiving combination medication.
[Dosage and Administration]
The usual starting and maintenance dose of this product is once daily (see package insert for details).
[Adverse Reactions]
1. In clinical trials of losartan potassium-hydrochlorothiazide, no adverse reactions specific to this combination were observed. These 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. 2. In general, losartan potassium-hydrochlorothiazide was well tolerated. The vast majority of adverse reactions were mild and transient and did not require treatment interruption. 3. In controlled clinical trials of losartan potassium-hydrochlorothiazide for the treatment of essential hypertension, dizziness was the only adverse reaction reported to be drug-related with an incidence greater than 1% or higher than placebo. 4. 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. 5. Other adverse reactions found with post-marketing use of this product, and/or with losartan and hydrochlorothiazide used alone in clinical trials or post-marketing are as follows: (1) Blood and lymphatic system disorders: thrombocytopenia, anemia, aplastic anemia, hemolytic anemia, leukopenia, agranulocytosis. (2) Immune system disorders: Angioedema (including laryngeal and glottis edema leading to airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue) has rarely been reported in patients treated with losartan: some of these patients had experienced angioedema from taking other medications (such as ACE inhibitors). (3) Metabolic and nutritional disorders: anorexia, hyperglycemia, hyperuricemia, electrolyte imbalance including hyponatremia and hypokalemia. (4) Psychiatric disorders: insomnia, restlessness. (5) Nervous system disorders: taste disturbance, headache, migraine, paresthesia. (6) Eye disorders: xanthoopia, transient visual impairment. (7) Cardiac disorders: palpitations, tachycardia. (8) Vascular disorders: dose-related postural hypotension, necrotizing vasculitis (vasculitis) (skin vasculitis). (9) Gastrointestinal disorders: indigestion, abdominal pain, gastrointestinal irritation, cramps, diarrhea, constipation, nausea, vomiting, pancreatitis, sialadenitis. (10) Respiratory, thoracic and mediastinal disorders: cough, nasal congestion, pharyngitis, sinus disorders, upper respiratory tract infection, respiratory distress (including pneumonia and pulmonary edema). (11) Hepatobiliary disorders: hepatitis, jaundice (jaundice due to intrahepatic bile accumulation). (12) Skin and subcutaneous tissue disorders: rash, pruritus, purpura (including Henoch-Schönlein purpura), toxic epidermal necrolysis, urticaria, erythroderma, photosensitivity, cutaneous lupus erythematosus. (13) Musculoskeletal and connective tissue disorders: back pain, muscle cramps, muscle spasms, myalgia, arthralgia. (14) Kidney and urinary system disorders: diabetes, renal dysfunction, interstitial nephritis, renal failure. (15) Reproductive system and breast disorders: erectile dysfunction/impotence. (16) General discomfort and administration site abnormalities: chest pain, edema/swelling, discomfort, fever, weakness. 5. Investigations: Abnormal liver function. 6. Laboratory findings: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with the use of this product. Hyperkalemia (serum potassium > 505 mEp/l) occurred in 0.7% of patients, but in these trials, this did not require discontinuation of this product. Elevated ALT levels rarely occur and usually resolve after discontinuation of this drug.
[Precautions]
1. Losartan-Hydrochlorothiazide: Hypersensitivity reaction: Angioedema. (See [Adverse Reactions]). Hepatic and Renal Impairment: This drug is not recommended for patients with hepatic impairment or severe renal impairment (creatinine clearance ≤ 30 ml/min) (see [Dosage and Administration]). 2. Losartan: Renal Impairment: Inhibition of the renin-angiotensin system can lead to changes in renal function. Renal failure has been reported in some susceptible patients (particularly in some diseases where renal function depends on the renin-angiotensin-aldosterone system, such as those with severe heart failure or renal abnormalities). In some patients, changes in renal function can be reversed 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, 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 upon discontinuation of the drug. 3. Hydrochlorothiazide: Hypotension and Electrolyte Imbalance: As with all antihypertensive therapies, some patients may experience symptomatic hypotension. In the event of concurrent diarrhea or vomiting, patients should be observed for clinical signs of fluid or electrolyte imbalance, such as volume depletion, hyponatremia, hypochloremic alkalosis, hypomagnesemia, or hypokalemia. Serum electrolyte levels should be monitored regularly. Metabolic and Endocrine Effects: Thiazide therapy can impair glucose tolerance. Adjustments in the dose of antidiabetic medications, including insulin, may be necessary (see [Drug Interactions]). Thiazides can reduce urinary calcium excretion and cause intermittent, mild elevations in serum calcium. Significant hypercalcemia may be a manifestation of latent hyperparathyroidism. Therefore, thiazide use 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. Other: Allergic reactions may occur with thiazide use, regardless of a history of allergies or bronchial asthma. Cases of systemic lupus erythematosus exacerbated or precipitated by thiazide use have been reported. 4. Anti-doping Control: This product contains hydrochlorothiazide, which can result in positive anti-doping control test results. 5. Athletes should use this product with caution.
[Interactions]
1. Losartan (1) In clinical pharmacokinetic studies, no clinically significant drug interactions with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital (see below for hydrochlorothiazide: alcohol, barbiturates or anesthetics), ketoconazole, and erythromycin have been found. Rifampicin and fluconazole have been reported to reduce the levels of active metabolites. The clinical significance of these interactions has not been evaluated. (2) As with other drugs that block angiotensin II and its effects, the concomitant use of losartan potassium with potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes may lead to increased serum potassium. (3) When used concomitantly with other drugs that affect sodium excretion, lithium excretion may be reduced. Therefore, if lithium salts are to be used in combination with angiotensin II receptor antagonists, serum lithium levels should be carefully monitored. (2) Nonsteroidal anti-inflammatory drugs (NSADs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), may reduce the effects of diuretics or other antihypertensive drugs. Therefore, the effects of angiotensin II receptor antagonists or angiotensin converting enzyme inhibitors may also be weakened by NSAIDs, including selective COX-2 inhibitors. In some patients with renal insufficiency who are taking nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors (such as elderly patients or patients with insufficient volume, including patients receiving diuretic therapy), the concomitant use of angiotensin II receptor antagonists or angiotensin converting enzyme inhibitors may lead to further deterioration of renal function, including the possibility of acute renal failure, which is usually reversible. Therefore, caution should be exercised when co-administering drugs to patients with renal insufficiency. 2. Hydrochlorothiazide When used concomitantly, the following drugs may interact with thiazide diuretics: Alcohol, barbiturates or anesthetics - may precipitate orthostatic hypotension. Antidiabetic drugs (oral anesthetics and insulin) - the dose of antidiabetic drugs may need to be adjusted. Other antihypertensive drugs—Additive effects. Cholestyramine and colestipol resins—The presence of anion exchange resins impairs the absorption of hydrochlorothiazide. Single doses of cholestyramine or colestipol resin bind to hydrochlorothiazide, reducing thiazide absorption from the gastrointestinal tract by up to 85% and 43%, respectively. Corticosteroids, ACTH—Exacerbate electrolyte depletion, particularly leading to hypokalemia. Vasopressors (e.g., epinephrine)—May decrease the response to vasopressors, but not sufficiently to preclude their use. Skeletal muscle relaxants, nondepolarizing (e.g., curarene)—May enhance the response to muscle relaxants. Lithium—Diuretics decrease the renal clearance of lithium, significantly increasing the risk of lithium toxicity; concomitant use is not recommended. Consult the label for lithium preparations before use. Nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors—Use of nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors, may reduce the diuretic, natriuretic, and antihypertensive effects of diuretics. In some patients with renal impairment (e.g., elderly or volume-depleted patients, including those receiving diuretics) taking nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors, concomitant use of angiotensin II receptor antagonists or angiotensin-converting enzyme inhibitors may lead to further deterioration of renal function, including the development of acute renal failure; this effect is generally reversible. Therefore, caution should be exercised when administering these drugs together in patients with renal impairment. Drug/Laboratory Test Interactions - Due to their effects on calcium metabolism, thiazides may interfere with parathyroid function tests (see [Precautions]).
[Specifications]
7 tablets/box
[Approval Number]
National Medicine Standard H20123367
[Manufacturer]
Lepu Pharmaceutical Technology Co., Ltd.
