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Amlodipine, valsartan & hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure.
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of Angiotensin II by selectively blocking the binding of Angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for Angiotensin II synthesis. Amlodipine and Valsartan have been shown to be effective in lowering blood pressure. Both Amlodipine and Valsartan lower blood pressure by reducing peripheral resistance, but calcium influx blockade and reduction of Angiotensin II vasoconstriction are complementary mechanisms.
Hydrochlorothiazide inhibits the reabsorption of Na in the distal tubules causing increased excretion of Na and water including K and hydrogen ions. Hydrochlorothiazide is a novel diuretic which affects the distal renal tubular mechanism of electrolyte reabsorption. The mechanism of the antihypertensive effect of thiazides is unknown. Hydrochlorothiazide does not usually affect normal blood pressure.
General Considerations: Dose once-daily. The dosage may be increased after two weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Amlodipine, valsartan & hydrochlorothiazide. The maximum recommended dose is Amlodipine 10 mg, valsartan 320 mg & hydrochlorothiazide 25 mg
Add-on or Switch Therapy: Amlodipine, valsartan & hydrochlorothiazide may be used for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.
A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Amlodipine, valsartan & hydrochlorothiazide may be switched to Amlodipine, valsartan & hydrochlorothiazide containing a lower dose of that component to achieve similar blood pressure reductions.
Replacement Therapy: Amlodipine, valsartan & hydrochlorothiazide may be substituted for the individually titrated components.
Use with Other Antihypertensive Drugs: Amlodipine, valsartan & hydrochlorothiazide may be administered with other antihypertensive agents.
No drug interaction studies have been conducted with Amlodipine, valsartan & hydrochlorothiazide and other drugs, although studies have been conducted with the individual components. A pharmacokinetic drug-drug interaction study has been conducted to address the potential for pharmacokinetic interaction between the triple combination, Amlodipine, valsartan & hydrochlorothiazide, and the corresponding three double combinations. No clinically relevant interaction was observed.
Do not use in patients with anuria, hypersensitivity to other sulfonamide-derived drugs, or hypersensitivity to any component of this product. Do not coadminister aliskiren with amlodipine, valsartan & hydrochlorothiazide in patients with diabetes
Common side effects are Dizziness, Edema, Headache, Dyspepsia, Fatigue, Muscle spasms, Back pain, Nausea, Nasopharyngitis
Pregnancy: Category D. 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. When pregnancy is detected, discontinue amlodipine, valsartan & hydrochlorothiazide as soon as possible.
Nursing Mothers: It is not known whether amlodipine and valsartan are excreted in human milk, but thiazides are excreted in human milk and valsartan is excreted in rat milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Store at 20° to 25°C. Keep amlodipine, valsartan & hydrochlorothiazide dry (protect it from moisture).
Valvas HCT Tablet contains Amlodipine + Valsartan + Hydrochlorothiazide (10 mg+160 mg+25 mg)