Valsartan

(val sar' tan)

PCI / LCIContraindication for pregnancy & lactation (breast feeding)

Molecule Info

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WARNING

FETAL TOXICITY

  • When pregnancy is detected, discontinue Valsartan as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Recent major changes

Recent major changes with US FDA:

 

  • Boxed Warning: Fetal Toxicity..................................................................................     01/2012
  • Indications and Usage: Benefits of lowering blood pressure (1).....................       12/2011
  • Dosage and Administration: Pediatric Hypertension 6-16 years of age (2.2)      02/2012
  • Contraindications: Known hypersensitivity (4)......................................................     07/2012
  • Contraindications: Dual RAS Blockade in Diabetics (4).....................................     10/2012
  • Warnings and Precautions: Fetal Toxicity (5.1)....................................................      01/2012
  • Drug Interactions: Dual Blockade of the Renin-Angiotensin System (7)........       10/2012

See Brand Manufacturer's Prescribing Information for detailed information.

Indication(s)

Valsartan is an angiotensin II receptor blocker (ARB) indicated for:

  • Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions
  • Treatment of heart failure (NYHA class II-IV); Valsartan significantly reduced hospitalization for heart failure
  • Reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction

Dosage & Administration

Valsartan recommended dosage & administration:

Indication Starting Dose Dose Range Target Maintenance Dose*
Adult Hypertension 80 or 160 mg once daily 80-320 mg once daily ---
Pediatric Hypertension (6-16 years) 1.3 mg/kg once daily (up to 40 mg total) 1.3-2.7 mg/kg once daily (up to 40-160 mg total) ---
Heart Failure 40 mg twice daily 40-160 mg twice daily 160 mg twice daily
Post-Myocardial Infarction 20 mg twice daily 20-160 mg twice daily 160 mg twice daily
* as tolerated by patient

May be taken with or without food.

Overdosage

Symptoms: Hypotension, tachycardia or bradycardia, depressed level of consciousness, circulatory collapse and shock. Management: Treatment is mainly supportive. Haemodialysis is not likely to be useful.

Contraindications

Hypersensitivity; severe hepatic impairment, cirrhosis or biliary obstruction; primary hyperaldosteronism. Pregnancy  and lactation.

Warning & Precautions

  • Observe for signs and symptoms of hypotension
  • Monitor renal function and potassium in susceptible patients

Volume depletion; renal artery stenosis; mild to moderate hepatic impairment, elderly individual.

Adverse Drug Reaction(s)

Hypertension: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain.

Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia .

Post-Myocardial Infarction: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine.

Drug Interactions

  • Potassium sparing diuretics, potassium supplements or salt substitutes may lead to increases in serum potassium, and in heart failure patients, increases in serum creatinine.
  • NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect.
  • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia.

Pregnancy Category (FDA)

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk.

Nursing Mothers:  Nursing or drug should be discontinued.

Pediatrics: Efficacy and safety data support use in 6-16 year old patients; use is not recommended in patients <6 years old.

Storage

Store between 15-30°C .

Pharmacology

Valsartan, an angiotensin II receptor antagonist, produces its BP lowering effects by antagonizing angiotensin II-induced vasoconstriction, aldosterone release and renal reabsorption of sodium. Onset: 2 hr. Duration: >24 hr. Absorption: Rapidly absorbed with oral bioavailability 23%. Peak plasma concentrations: 2-4 hr. Food may decrease the rate and extent. Distribution: Protein binding: 94-97% to serum albumin. Volume of distribution after IV admin: 17 L. Metabolism: Not significantly metabolised. Excretion: Excreted via bile in faeces  and urine, mainly as unchanged drug and some as metabolites . Terminal elimination half life: 5-9 hr.

mph Class

Angiotensin II Antagonists

ATC Classification

C09CA03 - valsartan; Belongs to the class of angiotensin II antagonists. Used in the treatment of cardiovascular disease.

Brand/Product Info


Total Products : 12            
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
AROVAN-80 Aristopharma Ltd. Valsartan INN 80mg Capsule 80mg x 30's: 300.00 MRP
CARDIVAL Drug International Ltd Valsartan INN 80mg Capsule 80mg x 30's: 210.00 MRP
DIOVAN Novartis (Bangladesh) Ltd. Valsartan 40mg, 80mg & 160mg Tablet 28's each: 952, 1344 & 1848.00 MRP
DISYS 160 Healthcare Pharmacuticals Ltd. Valsartan INN 160mg Tablet 30's MRP 540 Tk
DISYS 80 Healthcare Pharmacuticals Ltd. Valsartan INN 80mg Tablet 30's MRP 300 Tk
REOVAN R A K Pharmaceuticals Pvt. Ltd. Valsartan INN 80mg Tablet 30's: 300.00 MRP
VALPRESS 80 Silva Pharmaceuticals Limited Valsartan INN 80mg Capsule 30's: 240.90 MRP
VALSAN 80 Mystic Pharmaceuticals Limited Valsartan INN 80mg Capsule 20's: 500.00 MRP
Valsartil 160 Incepta Pharmaceuticals Limited Valsartan INN 160mg Tablet 10x3's:MRP 480 Tk
Valsartil 40 Incepta Pharmaceuticals Limited Valsartan INN 40 mg Tablet 10x3's:MRP 150 Tk
Valsartil 80 Incepta Pharmaceuticals Limited Valsartan INN 80mg Tablet 10x3's:MRP 270 Tk
VALSET 80 Orion Pharma Ltd. Valsartan INN 80mg Capsule 30's: 180.60 MRP

Gen. MedInfo

IMPORTANT WARNING:

Share your doctor if you are pregnant or plan to become pregnant. Do not take valsartan if you are pregnant. If you become pregnant while you are taking valsartan, stop taking valsartan and consult your doctor immediately. Valsartan may cause death or serious injury to the fetus when taken in the last 6 months of pregnancy. 

Why is this medication prescribed?

Valsartan is used alone or in combination with other medications to treat high blood pressure. It is also used to treat congestive heart failure (condition in which the heart is unable to pump enough blood to the rest of the body) and to improve survival after a heart attack. Valsartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.

How should this medicine be used?

Valsartan comes as a tablet to take by mouth. For the treatment of high blood pressure, it is usually taken once a day with or without food. For the treatment of heart failure or heart attack, it is usually taken twice a day with or without food. To help you remember to take valsartan, take it at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take valsartan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of valsartan and gradually increase your dose.

Valsartan controls high blood pressure and heart failure but does not cure them. Your blood pressure may decrease during the first 2 weeks of your treatment, but it may take 4 weeks for you to notice the full benefit of valsartan. Continue to take valsartan even if you feel well. Do not stop taking valsartan without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine

Valsartan is also sometimes used to treat diabetic nephropathy (kidney disease in people with diabetes and high blood pressure). Talk to your doctor about the risks of using this medication for your condition. This medication may be prescribed for other uses; ask your doctor for more information.

What special precautions should I follow?

Before taking valsartan,

  • tell your doctor if you are allergic to valsartan,any other medications, or any of the ingredients in valsartan tablets.
  • tell your doctor if you have diabetes  and you are taking aliskiren . Your doctor will probably tell you not to take valsartan if you have diabetes and you are also taking aliskiren.
  • tell your doctor what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the following: aspirin and other nonsteroidal anti-inflammatory medications  such as ibuprofen  and naproxen  and selective COX-2 inhibitors such as celecoxib ;cyclosporine; diuretics, including potassium-sparing diuretics such as amiloride, spironolactone, and triamterene; other medications to treat high blood pressure or a heart problem; potassium supplements; rifampin; and ritonavir. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had blockage of the bile duct; heart, kidney, or liver disease.
  • tell your doctor if you are breast-feeding.
  • you should know that valsartan may cause dizziness, light-headedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking valsartan. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
  • you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause light-headedness and fainting. Share your doctor if you have any of these problems or develop them during your treatment.

What special dietary instructions should I follow?

Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Valsartan may cause side effects. Share your doctor if any of these symptoms are severe or do not go away:

-   dizziness

-   headache

-   excessive tiredness

-   nausea

-   diarrhea

-   stomach pain

-   back pain

-   joint pain

-   blurry vision

-   cough

-   rash

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, consult your doctor immediately:

-   swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

-   hoarseness

-   difficulty breathing or swallowing

-   unexplained weight gain

Valsartan may cause other side effects. Consult your doctor if you have any unusual problems while taking this medication.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Ref: U.S. Natl. Library of Medicine


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

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