Losartan Potassium and Hydrochlorothiazide Tablets

This product is the first combination preparation of angiotensin II receptor (AT1 receptor) antagonist and diuretic. Losartan-Hydrochlorothiazide The components of this product have an additive effect on lowering blood pressure, and this product reduces blood pressure to a greater extent than the use of any of the components alone. This is because the two components have a synergistic effect. Moreover, as a result of the diuretic effect, hydrochlorothiazide increases plasma renin activity, increases aldosterone secretion, reduces blood potassium, and increases angiotensin II levels. Taking losartan can block all physiological effects related to angiotensin II and reduce potassium loss associated with diuretics by inhibiting aldosterone. Losartan has a mild and transient uricosuric effect. Hydrochlorothiazide can cause a moderate increase in uric acid, and the combined use of losartan and hydrochlorothiazide can reduce diuretic-induced hyperuricemia. The antihypertensive effects of losartan and hydrochlorothiazide are additive when used together. The antihypertensive effect of this product can last for 24 hours. In clinical studies lasting at least one year, the antihypertensive effect of this product remained unchanged when it was taken continuously. Although this product can significantly reduce blood pressure, it has no clinically significant effect on heart rate. In clinical trials, 12 weeks of treatment with losartan 50mg/hydrochlorothiazide 12.5mg reduced the average sitting diastolic blood pressure by 13.2mmHg. A study of 131 patients with severe hypertension showed that this product was equally effective as an initial treatment and in combination with other antihypertensive drugs for 12 weeks. Losartan Losartan is an oral angiotensin II receptor (AT1 receptor) antagonist. Angiotensin II binds to AT1 receptors in many tissues (such as vascular smooth muscle, adrenal glands, kidneys and heart), causing several important biological effects, including vasoconstriction and aldosterone release. Angiotensin II also stimulates smooth muscle cell proliferation. According to binding and pharmacological bioassays, angiotensin II selectively binds to AT1 receptors. In in vitro and in vivo tests, losartan and its pharmacologically active hydroxy acid metabolite (E-3174) can block all physiological effects associated with angiotensin II, regardless of the source or synthesis pathway of angiotensin II. During the application of losartan, the elimination of the negative feedback effect of angiotensin II on renin secretion leads to an increase in plasma renin activity. However, the increase in plasma renin activity only leads to an increase in angiotensin II in plasma. Even so, its antihypertensive activity and the effect of suppressing plasma aldosterone concentration can still be maintained, suggesting effective angiotensin II receptor blocking effect. Losartan selectively binds to the AT1 receptor, but does not bind to or block other hormone receptors or ion channels that have important regulatory effects on the cardiovascular system. Moreover, losartan does not inhibit angiotensin converting enzyme (kininase II), which degrades bradykinin. Therefore, losartan does not produce effects unrelated to AT1 blockade, such as enhancing bradykinin-mediated effects or producing edema (losartan potassium 1.7%, placebo 1.9%). Losartan can block the response to angiotensin I and angiotensin II without affecting the response to bradykinin, which is consistent with the unique mechanism of action of losartan. In contrast, ACE inhibitors can block the response to angiotensin I and enhance the response to bradykinin, but have no effect on the action of angiotensin II, which is the difference in pharmacodynamics between losartan potassium and ACE inhibitors. For hypertensive patients with proteinuria but no diabetes, losartan potassium can significantly reduce proteinuria and reduce the partial excretion of albumin and IgG. Losartan maintains the glomerular filtration rate and reduces the filtration fraction. In general, losartan can reduce serum uric acid (usually in patients with left ventricular failure. Losartan 25mg and 50mg have positive effects on hemodynamics and neurohormones, characterized by increased cardiac index, decreased pulmonary capillary wedge pressure, decreased systemic vascular resistance, decreased mean arterial pressure, decreased heart rate, and decreased levels of aldosterone and norepinephrine in the circulation. In patients with heart failure, the occurrence of hypotension is dose-related. In clinical trials, once-daily losartan significantly reduced systolic and diastolic blood pressure in patients with mild to moderate essential hypertension; several clinical trials lasting up to one year have shown that the antihypertensive effect of losartan potassium remains unchanged. Trough blood pressure (24 hours after taking the drug) and peak blood pressure (5-6 hours after taking the drug) measurements show that losartan potassium can be relatively effective in 24 hours. Steady reduction of blood pressure. The antihypertensive effect of losartan potassium is consistent with the natural daily circadian rhythm. The antihypertensive effect at the end of the dosing interval is 70-80% of the effect 5-6 hours after dosing. Discontinuation of losartan treatment in hypertensive patients does not result in a sudden rebound in blood pressure. Although losartan significantly reduces blood pressure, it has no clinically significant effect on heart rate. Hydrochlorothiazide The mechanism of action of thiazides in the antihypertensive role is unclear. Thiazides do not usually affect normal blood pressure. Hydrochlorothiazide has diuretic and antihypertensive effects. It affects the reabsorption of electrolytes by the distal renal tubule. Hydrochlorothiazide increases sodium and chloride excretion to an almost equal degree. Urinary sodium excretion may be accompanied by some potassium and bicarbonate losses. After oral administration, the diuretic effect begins within 2 hours, peaks at about 4 hours, and lasts for 6 to 12 hours.

This product is a compound preparation, and its components are: each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

This product is a film-coated tablet, which appears white to off-white after removing the film coating.

This product is used to treat hypertension and is suitable for patients receiving combination medication.

The commonly used starting dose and maintenance dose of this product is once a day, one tablet of losartan potassium hydrochlorothiazide tablet (50mg + 12.5mg) each time. For patients with insufficient response, the dose can be increased to once a day, two tablets of losartan potassium hydrochlorothiazide tablets (50mg + 12.5mg) or one tablet of losartan potassium hydrochlorothiazide tablet (100mg + 25mg) each time, and this dose is the maximum daily dose. Usually, the antihypertensive effect is obtained within 3 weeks of starting treatment. This product cannot be used in patients with insufficient blood volume (such as patients taking high-dose diuretics) and is not recommended for patients with severe renal insufficiency (creatinine clearance le; 30mL/min) or hepatic insufficiency. For elderly hypertensive patients, there is no need to adjust the starting dose, but losartan potassium hydrochlorothiazide tablets (100mg + 25mg) should not be used as the starting treatment for elderly patients. This product can be taken in combination with other antihypertensive drugs. This product can be taken with food or alone.

In clinical trials of losartan potassium-hydrochlorothiazide, no adverse reactions specific to this combination were observed. They were limited to previously reported adverse reactions of losartan potassium and/or hydrochlorothiazide. The overall incidence of adverse reactions for this combination was similar to that of placebo. The percentage of discontinuations was also similar to that of placebo. In general, losartan potassium-hydrochlorothiazide was well tolerated. The vast majority of adverse reactions were mild and transient and did not require discontinuation of treatment. In clinical controlled 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. Other adverse reactions discovered after marketing: Allergy: 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 had experienced angioedema due to taking other drugs (such as ACE inhibitors). Vasculitis, including Henoch-Schönlein purpura, has also been reported rarely with losartan. Gastrointestinal: Hepatitis has been reported rarely in patients treated with losartan, diarrhea. Respiratory: Losartan has been reported to cause cough. Skin: Urticaria. Laboratory Findings: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with the use of losartan. Hyperkalemia (serum potassium 5.5 mEq/L) occurred in 0.7% of patients, but in these trials, it was not necessary to discontinue losartan. ALT elevations occurred rarely and usually recovered after discontinuation of losartan. The following are adverse reactions when losartan and hydrochlorothiazide are used alone, and therefore may also be potential adverse reactions of this product: losartan rash, dose-related orthostatic hypotension, abdominal pain, weakness/fatigue, chest pain, edema/swelling, palpitations, tachycardia, dyspepsia, nausea, back pain, muscle cramps, headache, insomnia, cough, nasal congestion, pharyngitis, sinus disorders, upper respiratory tract infection, migraine, abnormal liver function, anemia, thrombocytopenia, myalgia, arthralgia, and pruritus. Hydrochlorothiazide may cause anorexia, gastrointestinal irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic biliary jaundice), pancreatitis, sialadenitis, vertigo, paresthesia, headache, xanthoopia, leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, purpura, photosensitivity, fever, necrotizing vasculitis (angiitis) (skin vasculitis), respiratory distress (including pneumonia and pulmonary edema), toxic epidermal necrolysis, hyperglycemia, glycosuria, hyperuricemia, electrolyte imbalance including hyponatremia and hyperkalemia, renal dysfunction, interstitial nephritis, renal failure, muscle cramps, weakness, restlessness, and transient visual impairment.

Patients who are allergic to any component of this product. Patients with anuria. Patients who are allergic to other sulfonamide drugs.

Precautions for children: The safety and effectiveness in children have not been determined. Precautions for pregnancy and lactation: Pregnant women are prohibited from using this product. Precautions for the elderly: In clinical studies, there was no clinically significant difference in the efficacy and safety of this product in elderly (≥65 years old) and young (<65 years old) patients.

In clinical pharmacokinetic studies, no clinically significant drug interactions were found with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital (see Hydrochlorothiazide: Alcohol, Barbiturates or Narcotics below), ketoconazole, and erythromycin. Rifampicin and fluconazole have been reported to reduce the levels of the active metabolite. The clinical significance of these interactions has not been evaluated. As with other drugs that block angiotensin II and its effects, coadministration of losartan potassium with potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes may result in elevated serum potassium. Nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), may reduce the effect of diuretics or other antihypertensive drugs. Therefore, the effects of angiotensin II receptor antagonists may also be attenuated by NSAIDs, including selective COX-2 inhibitors. In some patients with renal impairment who are taking nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors, the concomitant use of angiotensin II receptor antagonists may lead to further deterioration of renal function and possible acute renal failure, an effect that is usually reversible. The following drugs may interact with thiazide diuretics when hydrochlorothiazide is taken concomitantly: Alcohol, barbiturates, or anesthetics - may precipitate orthostatic hypotension. Antidiabetic agents (oral agents and insulin) - dose adjustment of antidiabetic agents may be required. Other antihypertensive agents - 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 and reduce the absorption of thiazides from the gastrointestinal tract by up to 85% and 43%, respectively. Corticosteroids, ACTH - exacerbate electrolyte losses, particularly leading to hypokalemia. Vasopressors (e.g., epinephrine) - may reduce the response to vasopressors, but not enough to preclude their use. Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine) - May enhance the response to muscle relaxants. Lithium - Diuretics reduce the renal clearance of lithium, greatly increasing the risk of lithium toxicity, and concomitant use is not recommended. Consult the instructions for lithium preparations before use. Nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors - The use of nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors, in some patients may reduce the diuretic, natriuretic, and antihypertensive effects of diuretics. Drug/Laboratory Test Interactions Due to their effects on calcium metabolism, thiazides may interfere with parathyroid function tests (see PRECAUTIONS).

Store at room temperature 15-30℃. Keep the package tightly sealed.

Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide

36 months.

Beijing Foyou Pharma Co., Ltd.

• Founded in:

  1999-02-03

• Address:

  No. 8 Guangyuan East Street, Tongzhou Industrial Development Zone, Tongzhou District, Beijing

• Tax NO.:

  91110112700216160K

• Registered Funds:

  480 million yuan

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