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Author: Admin | 2025-04-28
On any of the components (valsartan or HCTZ) (2) • May be substituted for titrated components (2.3) 2.1 General Considerations The usual starting dose is valsartan and hydrochlorothiazide tablets 160/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose. 2.2 Add-On Therapy A patient whose blood pressure is not adequately controlled with valsartan (or another ARB) alone or hydrochlorothiazide alone may be switched to combination therapy with valsartan and hydrochlorothiazide tablets. A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 320/25 mg.2.3 Replacement Therapy Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components. 2.4 Initial Therapy Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)]. 2.5 Use with Other Antihypertensive Drugs Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents. 3 Dosage Forms And Strengths 80/12.5 mg tablets, imprinted 345/HH (Side 1/Side 2) 160/12.5 mg tablets, imprinted 347/HH 160/25 mg tablets, imprinted 346/HH 320/12.5 mg tablets, imprinted 351/HH 320/25 mg tablets, imprinted 349/HH Tablets (valsartan/HCTZ mg): 80/12.5, 160/12.5, 160/25, 320/12.5, 320/25 (3) 4 Contraindications Valsartan and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not coadminister aliskiren with valsartan and hydrochlorothiazide tablets in patients with diabetes [see Drug Interactions (7)]. Anuria; Hypersensitivity to any sulfonamide-derived drugs or any component; Do not coadminister aliskiren with valsartan and hydrochlorothiazide tablets in patients with diabetes (4) 5 Warnings And Precautions • Hypotension: Correct volume depletion prior to initiation (5.2) • Observe for signs of fluid or electrolyte imbalance (5.9) • Monitor renal function and potassium in susceptible patients (5.3, 5.7) • Exacerbation or activation of systemic lupus erythematosus (5.5) • Acute angle-closure glaucoma (5.8) 5.1 Fetal Toxicity Valsartan and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. Thiazides cross the placenta, and use of thiazides during pregnancy is associated with fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse
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