Cardovan Plus160 mg+12.5 mg

Valsartan and hydrochlorothiazide combination tablets are used for the treatment of hypertension (high blood pressure), to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and heart attacks. This combination is used:

• As initial therapy in patients likely to need multiple medicines to reach their blood pressure goal
• As add-on or switch therapy in patients not adequately controlled on either valsartan or hydrochlorothiazide alone

This combination is not recommended as initial therapy in patients who are not likely to need more than one medicine to reach their blood pressure goal.

Contains valsartan (an angiotensin II receptor blocker) and hydrochlorothiazide (a thiazide diuretic) as active ingredients, marketed in several fixed-dose strengths, commonly including 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg (valsartan/hydrochlorothiazide).

Valsartan and hydrochlorothiazide is a combination tablet that pairs two different classes of blood pressure medicine: valsartan, an angiotensin II receptor blocker (ARB) that relaxes blood vessels, and hydrochlorothiazide, a thiazide diuretic ("water pill") that helps the kidneys remove excess salt and water from the body. Together, they lower blood pressure through two complementary mechanisms. This combination carries a boxed warning regarding serious, potentially fatal harm to a developing fetus if used during pregnancy, and must be stopped as soon as pregnancy is detected.

Therapeutic Class: Antihypertensive Combination (ARB + Thiazide Diuretic)

Valsartan selectively blocks the angiotensin II type 1 (AT1) receptor, preventing the blood-vessel-constricting and sodium-retaining effects of angiotensin II. Hydrochlorothiazide inhibits sodium reabsorption in the distal renal tubule, increasing excretion of sodium and water, which reduces blood volume and contributes to lower blood pressure. Valsartan is primarily eliminated by the liver, so caution is advised when using higher doses in patients with liver disease; hydrochlorothiazide requires adequate kidney filtration to reach its site of action and is not recommended when creatinine clearance is below 30 mL/min.

• Taken orally, once daily, with or without food
• Take at approximately the same time each day
• Swallow the tablet whole with water
• Maintain adequate fluid intake, particularly in hot weather or during illness, given the diuretic effect of the hydrochlorothiazide component

The following should be assessed by a healthcare professional before combining with valsartan and hydrochlorothiazide:

• Aliskiren (in patients with diabetes): concomitant use is not recommended, given an increased risk of hyperkalemia, hypotension, and reduced kidney function.
• Other drugs that affect the renin-angiotensin system (ACE inhibitors, other ARBs): combining increases the risk of hypotension, hyperkalemia, and reduced kidney function; dual blockade is generally avoided.
• Potassium supplements, potassium-sparing diuretics, and salt substitutes containing potassium: may increase the risk of hyperkalemia when combined with valsartan.
• Lithium: both valsartan and hydrochlorothiazide can increase lithium blood levels, increasing toxicity risk; monitor lithium levels closely if combined.
• NSAIDs: may reduce the antihypertensive effect and increase the risk of kidney impairment, particularly in patients who are elderly, volume-depleted, or have pre-existing kidney disease.
• Other antihypertensive medicines and alcohol: may increase the blood-pressure-lowering and diuretic effects.
• Cholestyramine and colestipol: can reduce hydrochlorothiazide absorption.
• Corticosteroids and ACTH: may intensify electrolyte depletion (particularly potassium) caused by hydrochlorothiazide.

Common side effects

• Dizziness
• Headache
• Nasopharyngitis (common cold-type symptoms)
• Increased urination

Serious side effects (seek urgent medical attention)

• Symptomatic low blood pressure, particularly with volume or salt depletion: dizziness or fainting, especially on standing.
• Signs of significantly reduced kidney function: decreased urination, swelling.
• Signs of hyperkalemia (from valsartan) or hypokalemia (from hydrochlorothiazide): muscle weakness, irregular heartbeat.
• Signs of a severe allergic reaction, or a sulfa-drug allergic reaction, given the hydrochlorothiazide component: rash, hives, swelling, difficulty breathing.
• Acute angle-closure glaucoma (rare, associated with the hydrochlorothiazide component): sudden decreased vision or eye pain, typically within hours to weeks of starting the medicine - discontinue promptly and seek medical attention if this occurs.
• Signs of pancreatitis (rare, associated with the hydrochlorothiazide component): severe abdominal pain.

Pregnancy

Boxed warning: valsartan and hydrochlorothiazide can cause fetal harm when used during the second and third trimesters of pregnancy, including reduced fetal kidney function, oligohydramnios (low amniotic fluid), fetal lung underdevelopment, and skeletal deformities; potential neonatal effects include skull underdevelopment, absent urine output, low blood pressure, kidney failure, and death. Thiazides also cross the placenta and are associated with fetal or neonatal jaundice and low platelet counts. When pregnancy is detected, this medicine should be discontinued as soon as possible.

Breastfeeding

There is limited information on valsartan in human milk; hydrochlorothiazide is present in human breast milk. Use during breastfeeding should be discussed with a healthcare professional, weighing the mother's treatment needs against potential infant exposure.

• Pregnancy (boxed warning): discontinue as soon as pregnancy is detected, given the serious risk of fetal harm, particularly in the second and third trimesters.
• Symptomatic hypotension: can occur, particularly in volume- or salt-depleted patients (such as those on high-dose diuretics); correct volume depletion before starting, or start under close medical supervision.
• Renal function: monitor periodically, particularly in patients with pre-existing kidney impairment or those on other medicines affecting the renin-angiotensin system.
• Electrolyte monitoring: periodic monitoring of serum potassium and sodium is advisable, given the opposing effects of the two components on potassium and the sodium-depleting effect of the thiazide component.
• Acute angle-closure glaucoma and acute myopia: a rare but serious reaction associated with the hydrochlorothiazide component; discontinue promptly and seek medical attention if sudden vision changes or eye pain occur.
• Not recommended in severe renal impairment (creatinine clearance below 30 mL/min).

Overdose is likely to cause pronounced hypotension, along with electrolyte disturbances (particularly low potassium or sodium) and dehydration from the hydrochlorothiazide component. Suspected significant overdose requires prompt medical evaluation; treatment is generally supportive, including fluid and electrolyte correction and monitoring of blood pressure and kidney function, provided in a medical facility.

Store at controlled room temperature (generally 15-30°C), protected from moisture, in the original container.

• Severe renal impairment (CrCl below 30 mL/min): Not recommended, given the hydrochlorothiazide component's reduced effectiveness at low kidney function.
• Hepatic impairment: Caution advised when advancing to higher doses, given valsartan's hepatic elimination and theoretically increased side-effect risk in this population.
• Elderly: Generally used with the same dosing approach; monitor for hypotension and electrolyte changes, given increased susceptibility in this population.
• Women of childbearing potential: Should be counselled on the risk of fetal harm and the need to discontinue promptly if pregnancy occurs.

This combination is generally used as ongoing, long-term therapy for hypertension, for as long as it provides adequate blood pressure control and is well tolerated, with periodic monitoring of blood pressure, kidney function, and electrolytes, as directed by the treating physician.

Drug Class: Angiotensin II receptor blocker (valsartan) combined with a thiazide diuretic (hydrochlorothiazide)

Valsartan blocks the receptor that angiotensin II (a hormone that narrows blood vessels and promotes salt and water retention) would otherwise activate, causing blood vessels to relax and blood pressure to fall. Hydrochlorothiazide works in the kidney to increase the excretion of sodium and water, reducing the total volume of fluid in the bloodstream, which further lowers blood pressure. Combining these two complementary mechanisms provides more effective blood pressure control than either medicine alone.

Safety and effectiveness of this combination have not been established in patients younger than 18 years, and it is not recommended for use in children.