Amlodipine valsartan and hydrochlorothiazide

What is Amlodipine valsartan and hydrochlorothiazide?

• Amlodipine valsartan and hydrochlorothiazide tablets are a combination of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), valsartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a thiazide diuretic used to for the treatment of hypertension to lower blood pressure.

Amlodipine

Valsartan

Hydrochlorothiazide

What are the uses of this medicine?

Amlodipine, valsartan and hydrochlorothiazide tablets contain 3 prescription medicines:

• amlodipine, a calcium channel blocker
• valsartan, an angiotensin receptor blocker, and
• hydrochlorothiazide, a diuretic (water pill)

• Amlodipine, valsartan and hydrochlorothiazide tablets may be used to lower blood pressure in adults when 2 medicines to lower your high blood pressure are not enough.

How does this medicine work?

• The active ingredients of amlodipine, valsartan and hydrochlorothiazide target 3 separate mechanisms involved in blood pressure regulation.
• Amlodipine blocks the contractile effects of calcium on cardiac and vascular smooth muscle cells.
• Valsartan blocks the vasoconstriction and sodium retaining effects of angiotensin II on cardiac, vascular smooth muscle, adrenal and renal. cells
• Hydrochlorothiazide directly promotes the excretion of sodium and chloride in the kidney leading to reductions in intravascular volume.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• anuria, hypersensitivity to other sulfonamide-derived drugs, or hypersensitivity to any component of this product.
• diabetes who use aliskiren.

What drug interactions can this medicine cause?

• Some of your other medicines and amlodipine, valsartan and hydrochlorothiazide tablets could affect each other, causing serious side effects.

Especially tell your doctor if you take:

• simvastatin or other cholesterol-lowering medicine
• other medicines for high blood pressure or a heart problem
• water pills (“diuretics”)
• potassium supplements. Your doctor may check the amount of potassium in your blood periodically.
• salt substitute containing potassium. Your doctor may check the amount of potassium in your blood periodically.
• diabetes medicine, including insulin
• narcotic pain medicines
• sleeping pills and antiseizure medicines called barbiturates
• lithium, a medicine used to treat some types of depression
• aspirin or other medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen or naproxen
• steroids
• alcohol
• digoxin or other digitalis glycosides (a heart medicine)
• muscle relaxants (medicines used during operations)
• certain cancer medicines, like cyclophosphamide or methotrexate
• medicines used to prevent and treat fungal infections (such as ketoconazole, itraconazole)
• medicines used to treat bacterial infections (such as clarithromycin, telithromycin)
• certain antibiotics (rifamycin group), a drug used to protect against transplant rejection (cyclosporine) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of valsartan.

Is this medicine FDA approved?

• Initial U.S. Approval: 2009

How should this medicine be used?

Recommended dosage:

• Dose once-daily. The dosage may be increased after 2 weeks of therapy.
• The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of amlodipine, valsartan and hydrochlorothiazide tablets.
• The maximum recommended dose of amlodipine, valsartan and hydrochlorothiazide tablets is 10 mg/320 mg/25 mg.

• Amlodipine, valsartan and hydrochlorothiazide tablets may be used as add-on/switch therapy for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.
• Amlodipine, valsartan and hydrochlorothiazide tablets may be substituted for its individually titrated components.

Administration:

• Take amlodipine, valsartan and hydrochlorothiazide tablets one time each day.
• Amlodipine, valsartan and hydrochlorothiazide tablets can be taken with or without food.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at the regular time.
• If you take too much amlodipine, valsartan and hydrochlorothiazide, call your doctor or Poison Control Center, or go to the emergency room.
• Tell all your doctors and dentist you are taking amlodipine, valsartan and hydrochlorothiazide tablets. This is especially important if you:
• are going to have surgery
• go for kidney dialysis

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: (amlodipine/valsartan/hydrochlorothiazide) 5 mg/160 mg/12.5 mg, 10 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/25 mg and 10 mg/320 mg/25 mg

This medicine is available in fallowing brand namesː

• Exforge HCT

What side effects can this medication cause?

The most common side effects of this medicine include:

• dizziness
• swelling (edema) of the hands, ankles, or feet
• headache
• indigestion
• tiredness
• muscle spasms
• back pain
• nausea

This medicine may cause serious side effects, including:

• cause harm or death to an unborn baby
• hypotension
• kidney problems
• laboratory blood test changes in people with heart failure
• allergic reactions
• skin rash
• eye problems

What special precautions should I follow?

• In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur in patients receiving angiotensin receptor blockers. Correct volume depletion prior to initiation.
• Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
• Changes in renal function, including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Monitor renal function and potassium in susceptible patients.
• Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
• In the controlled trial of amlodipine, valsartan and hydrochlorothiazide in moderate to severe hypertensive patients, the incidence of hypokalemia. If hypokalemia is accompanied by clinical signs (e.g., muscular weakness, paresis, or ECG alterations), amlodipine, valsartan and hydrochlorothiazide should be discontinued. Correction of hypokalemia and any coexisting hypomagnesemia is recommended prior to the initiation of thiazides.
• Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
• Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.
• Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.
• Monitor calcium levels in patients with hypercalcemia receiving amlodipine, valsartan and hydrochlorothiazide.
• Amlodipine, valsartan and hydrochlorothiazide can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue amlodipine, valsartan and hydrochlorothiazide as soon as possible.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypotension
• tachycardia
• bradycardia
• Depressed level of consciousness
• circulatory collapse
• shock
• hypokalemia
• hypochloremia
• hyponatremia
• dehydration resulting from excessive diuresis

Management of overdosage:

• If symptomatic hypotension should occur, institute supportive treatment.
• As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit. Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption.
• Valsartan is not removed from the plasma by hemodialysis.
• The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.

Can this medicine be used in pregnancy?

• Amlodipine, valsartan and hydrochlorothiazide can cause fetal harm when administered to a pregnant woman.
• When pregnancy is detected, discontinue amlodipine, valsartan and hydrochlorothiazide as soon as possible.

Can this medicine be used in children?

• The safety and effectiveness of amlodipine, valsartan and hydrochlorothiazide in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients: amlodipine besylate, valsartan, and hydrochlorothiazide
• The inactive ingredients of all strengths of the tablets are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), sodium starch glycolate, talc, and titanium dioxide. Additionally, the 10 mg/160 mg/12.5 mg strength contains red iron oxide and yellow iron oxide; the 5 mg/160 mg/25 mg, 10 mg/160 mg/25 mg and 10 mg/320 mg/25 mg strengths contain yellow iron oxide.

Who manufactures and distributes this medicine?

• Distributed by:

Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ

• Manufactured by:
• Aurobindo Pharma Limited
• Hyderabad-500 032, India

What should I know about storage and disposal of this medication?

• Store amlodipine, valsartan and hydrochlorothiazide tablets at room temperature between 20° to 25°C (68° to 77°F).
• Keep amlodipine, valsartan and hydrochlorothiazide tablets dry (protect them from moisture).

• Dailymed label info on Amlodipine valsartan and hydrochlorothiazide
• FDA Amlodipine valsartan and hydrochlorothiazide

Amlodipine valsartan and hydrochlorothiazide Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski

‎