Product Overview
[Drug Name]
Generic Name: Olmesartan Medoxomil Hydrochlorothiazide Tablets
Trade Name: Fuaotan Olmesartan Medoxomil Hydrochlorothiazide Tablets 20mg x 7 tablets
[Main Ingredients]
This product is a combination preparation, consisting of: Olmesartan Medoxomil 20mg and Hydrochlorothiazide 12.5mg per tablet.
[Properties]
This product is a film-coated tablet that appears white after removal of the coating.
[Indications/Main Functions]
This product is indicated for the treatment of hypertension. This product is a fixed-dose combination preparation and is not indicated for the initial treatment of hypertension.
[Specifications]
20mg: 12.5mg x 7 tablets (Fuaotan)
[Dosage and Administration]
For normovolemic patients, the recommended starting dose of Olmesartan Medoxomil as monotherapy is 20mg once daily. For patients who require further blood pressure lowering after two weeks of treatment, the dose can be increased to 40mg. Doses greater than 40mg have not demonstrated a greater antihypertensive effect. When the daily dose is the same, twice-daily dosing has not demonstrated superiority compared to once-daily dosing. No initial dose adjustment is required for elderly patients, patients with moderate to significant renal impairment (creatinine clearance <40 m/min), or patients with moderate to significant hepatic impairment (see Special Populations in Pharmacokinetics). For patients with potential volume depletion (e.g., those receiving diuretics, particularly those with renal impairment), initiation of fusantane therapy must be conducted under close medical supervision, and a lower initial dose may be considered (see Precautions for Hypotension in Patients with Volume Depletion or Hyponatremia). The effective dose of hydrochlorothiazide is 12.5-50 mg once daily. Combination therapy is typically initiated after unsatisfactory efficacy has been achieved with monotherapy with olmesartan medoxomil or hydrochlorothiazide. Fusantane is administered orally, one tablet once daily. The dose of fusantane should be individualized. The dose may be adjusted at 2-4 week intervals based on the antihypertensive effect. The antihypertensive effect of valproate is dose-dependent within the dose range of 10mg/12.5mg to 40mg/25mg. Olmesartan medoxomil/hydrochlorothiazide tablets have an onset of antihypertensive effect within one week and reach maximum antihypertensive effect at four weeks. Valproate can be used in combination with other antihypertensive medications. For patients with creatinine clearance >30mL/min, standard Valproate doses can be used. For patients with more severe renal impairment, myeloid diuretics are preferred over thiazide diuretics; therefore, Valproate is not recommended. No dose adjustment is required for patients with hepatic impairment (see Special Populations under Pharmacokinetics).
[Adverse Reactions]
1. Olmesartan medoxomil/hydrochlorothiazide: The safety of olmesartan medoxomil/hydrochlorothiazide was evaluated in 1243 hypertensive patients. Valproate was well tolerated, with a similar incidence of adverse events and a similar rate of clinical trial withdrawal due to adverse events as placebo. Adverse events were generally mild and transient and were not associated with dose, gender, age, or race. In a placebo-controlled clinical trial, adverse events occurring at an incidence greater than 2% and greater than placebo, regardless of whether they were related to drug therapy, included nausea, hyperuricemia, dizziness, and upper respiratory tract infection. Adverse events occurring at an incidence greater than 2% but similar to or less than placebo included headache and urinary tract infection. Other adverse events reported at an incidence greater than 1.0% in over 1200 hypertensive patients receiving olmesartan medoxomil-hydrochlorothiazide in controlled or open-label trials, regardless of whether they were attributable to drug therapy, included chest pain, back pain, peripheral edema, dizziness, abdominal pain, dyspepsia, gastroenteritis, diarrhea, increased SGOT, increased GGT, increased SGPT, hyperlipidemia, increased creatine phosphokinase, hyperglycemia, arthritis, arthralgia, myalgia, cough, rash, and hematuria. Facial edema was reported in two of 1243 patients receiving olmesartan medoxomil-hydrochlorothiazide. Angioedema has been reported with the use of angiotensin I receptor antagonists. 2 Olmesartan medoxomil: Other adverse events reported with an incidence greater than 0.5% in more than 3,100 hypertensive patients receiving olmesartan medoxomil monotherapy in controlled or open trials, regardless of whether they were related to drug treatment, included: tachycardia and hypercholesterolemia. 3. Hydrochlorothiazide: Other adverse events associated with hydrochlorothiazide, whether or not related to drug therapy, include asthenia, pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, abdominal cramps, gastric irritability, aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia, purpura, photosensitivity, urticaria, necrotizing vasculitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonia and pulmonary edema, allergic reactions, hyperglycemia, glycosuria, hyperuricemia, muscle cramps, restlessness, renal failure, decreased renal function, interstitial nephritis, erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, transient visual impairment, and xanthoopia. Laboratory Test Results: In controlled clinical trials, changes in clinically important laboratory parameters were rarely associated with treatment with olmesartan medoxomil-hydrochlorothiazide. Creatinine and Blood Urea Nitrogen: Increases of blood urea nitrogen and creatinine greater than 50% were observed in 1.3% of patients. No patient in the Olmesartan Medoxomil/Hydrochlorothiazide clinical trials withdrew due to increases in creatinine or blood urea nitrogen. Hemoglobin and Hematocrit: Decreases of hemoglobin and hematocrit greater than 20% occurred in 0.0% and 0.4% (1 patient) of patients receiving Olmesartan Medoxomil/Hydrochlorothiazide, respectively, compared with 0.0% and 0.0% of patients receiving placebo, respectively. No patient discontinued treatment due to anemia. Postmarketing Experience: The following adverse reactions have been reported with Fuotan: Systemic: Asthenia, Angioedema; Gastrointestinal: Vomiting; Metabolic and Nutritional: Hyperkalemia; Musculoskeletal: Rhabdomyolysis; Genitourinary: Acute renal failure, increased blood creatinine; Skin and Appendages: Alopecia, pruritus, urticaria.
[Contraindications] Fuotan is contraindicated in patients with hypersensitivity to its ingredients. Because it contains hydrochlorothiazide, it is contraindicated in patients with anuria or allergies to other sulfonamides.
[Drug Interactions]
Olmesartan medoxomil is not metabolized by the hepatic cytochrome P450 system and has no effect on P450 enzymes. Therefore, drug interactions related to the inhibition, induction, or metabolism of these enzymes are unlikely. Concomitant use of hydrochlorothiazide, digoxin, or warfarin did not significantly alter the bioavailability of olmesartan in healthy subjects. Concomitant use of antacids [A(OH3/Mg(OH)2] did not significantly alter the bioavailability of olmesartan. Concomitant use of hydrochlorothiazide with the following medications may interact with purine diuretics: alcohol, barbiturates, or anesthetics. Orthostatic hypotension may be precipitated. Antidiabetic medications (oral preparations and insulin) may require dose adjustment. Other antihypertensive medications – additive or synergistic effects. Effects. Cholestyramine and colestipol resins · The presence of anion exchange resins impairs the absorption of hydrochlorothiazide. A single dose of cholestyramine or colestipol resin binds to hydrochlorothiazide, reducing the absorption of hydrochlorothiazide drugs from the gastrointestinal tract by 85% and 43%, respectively. Corticosteroids, ACTH - exacerbate electrolyte loss, especially leading to hypokalemia. Pressor amines (such as epinephrine) · May reduce the response to pressor amines, but not enough to prevent their use. Non-depolarizing skeletal muscle relaxants (such as tubocurarine) - May enhance muscle relaxants reaction. Lithium - usually cannot be administered at the same time as diuretics. Diuretics reduce the renal clearance of lithium and greatly increase the risk of lithium poisoning. Before using Olmesartan Medoxomil·Hydrochlorothiazine combination preparations, you should refer to the instructions for lithium preparations. Nonsteroidal anti-inflammatory drugs - Some patients use nonsteroidal anti-inflammatory drugs, which may reduce the diuretic, natriuretic and antihypertensive effects of myeloid diuretics, potassium-sparing diuretics and thiazide diuretics. Therefore, when Olmesartan Medoxomil·Hydrochlorothiazine tablets are used with nonsteroidal anti-inflammatory drugs, patients should pay close attention to monitor whether the diuretic is achieving the expected effect. Effect.
[Precautions]
See package insert for details.
[Pharmacology and Toxicology]
1. Concomitant use with salicylates, sulfonamides, phenylbutazone, anti-tuberculosis drugs, tetracyclines, monoamine oxidase inhibitors, beta-blockers, aerotoxins, dicoumarols, and cyclophosphamide may enhance the effects of this drug. 2. Fenpromazine, sympathomimetics, corticosteroids, thyroid hormones, oral contraceptives, and niacin preparations may reduce the hypoglycemic effect of this drug. This drug may also reduce the patient's tolerance to alcohol, which may also enhance the drug's hypoglycemic effect.
