Generic Diovan Valsartan

1.DIOVAN HISTORY
How was Diovan discovered?

Diovan is a product of Novartis Pharmaceuticals.

FDA approved Diovan capsules in January 1997 and the tablet form of Diovanwas approved in July 2001.

Novartis Pharmaceuticals Corporation is the U.S. affiliate of Novartis AG, a world leader in healthcare.

Novartis has core businesses in pharmaceuticals, consumer health, generics, eye care, and animal health.

In the U.S., Novartis has quickly achieved a reputation as an industry leader.

Note: World-drugs.net sells generic version of Diovan


2.DIOVAN FACTS

Diovan is the number 1 prescribed brand in the newest class of high blood pressure medications.

Diovan (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. Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects including vasocantstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.


3. ABOUT DIOVAN MEDICATION
What is High Blood Pressure (Hypertension)?

High blood pressure, also known as hypertension, is a serious disease affecting your heart and blood vessels. It occurs when the blood exerts too much pressure against the walls of the blood vessels. In fact, that is what the term hypertension means: "too much" (hyper) "pressure" (tension). It affects upwards of 58 million people nationwide.

High blood pressure is serious because it places you at risk for certain life threatening and disabling conditions. If left untreated, High blood pressure could lead to heart attack, kidney disease, and/or stroke.

This happens because as your blood continuously exerts too much pressure against the walls of the blood vessels, it places extra stress on the heart and blood vessels.

Blood pressure is measured in two numbers, systolic (top or higher number) and diastolic (lower number). The higher number is the maximum pressure, which occurs when the heart beats (systole), and the lower number is the lowest pressure measured when the heart relaxes between beats (diastole), just before the next contraction. A systolic reading of 140 or greater and a diastolic reading of 90 or greater is considered high.

The normal blood pressure is less than 120/80. In fact, for every 20/10 increase in blood pressure, your risk of cardiovascular events, such as heart attack or stroke, is DOUBLED.

Symptoms of High Blood Pressure

High blood pressure is sometimes called the "silent killer" because the symptoms are rarely seen or felt. So, even though it might be upsetting to be told that you have High blood pressure, it's good that your doctor has discovered it. Treatment can help avoid the serious, long-term effects of High blood pressure

What are antihypertensives?

Antihypertensives are medications used to treat high blood pressure (hypertension). Although some patients do not need to take medication to control their high blood pressure, anyone who is prescribed medication needs to take it exactly as prescribed to avoid the serious medical problems associated with the condition. People taking antihypertensives are also encouraged to make healthy lifestyle changes, such as quitting smoking, losing weight and getting regular exercise. Furthermore, they are encouraged to speak with their physician before taking any prescription medications, such as narcotics, or over-the-counter medications, such as diet pills.

Finally, people with high blood pressure are urged to be patient as the type and level of their medication are adjusted for optimal results. This is especially important because the vast majority of patients have no symptoms, making hypertension the silent killer.

There are a wide variety of antihypertensives and combinations of different medications that are available, and it may take some time before the ideal treatment has been found and finely tuned to the patients needs.

Antihypertensives include:

Diuretics ("water pills")

Diuretics are sometimes called "water pills" because they work in the kidney and flush excess water and sodium from the body.

Beta Blockers

Beta-blockers reduce nerve impulses to the heart and blood vessels. This makes the heart beat slower and with less force. Blood pressure drops and the heart works less hard.

Alpha Blockers

Alpha-blockers reduce nerve impulses to blood vessels, which allows blood to pass more easily, causing the blood pressure to go down.

Alpha-Beta Blockers

Alpha-beta-blockers work the same way as alpha-blockers but also slow the heartbeat, as Beta-blockers do. As a result, less blood is pumped through the vessels and the blood pressure goes down.

Nervous System Inhibitors

Nervous system inhibitors relax blood vessels by controlling nerve impulses. This causes the blood vessels to become wider and the blood pressure to go down.

Angiotensin Converting Enzyme (ACE) Inhibitors

Angiotensin converting enzyme (ACE) inhibitors prevent the formation of a hormone called angiotensin II, which normally causes blood vessels to narrow. The ACE inhibitors cause the vessels to relax and blood pressure goes down.

Calcium Channel Blockers

CCBs keep calcium from entering the muscle cells of the heart and blood vessels. This causes the blood vessels to relax and pressure goes down.

Angiotensin Receptor Blockers (formal medical name angiotensin-2-receptor antagonists, known as "sartans" for short). Angiotensin antagonists shield blood vessels from angiotensin II. As a result, the vessels become wider and blood pressure goes down.

Common Angiotensin Receptor blockers include:

  • Candesartan
  • Valsartan
  • Eprosartan
  • Irbesartan
  • Losartan
  • Telmisartan

4.DIOVAN EFFECTIVENESS
When is Diovan best taken?

Diovan peak plasma concentration is reached 2 to 4 hours after dosing.

Diovan shows bi-exponential decay kinetics following intravenous administration, with an average elimination half-life of about 6 hours. Absolute bioavailability for Diovan is about 25% (range 10%-35%).

Food decreases the exposure to Diovan by about 40% and peak plasma concentration by about 50%. Hence, Diovan should not be taken with food.

Concentration of Diovan increases approximately linearly with increasing dose over the clinical dosing range. Diovan does not accumulate appreciably in plasma following repeated administration.

Metabolism and Elimination : Diovan is primarily recovered in feces (about 83% of dose) and urine (about 13% of dose). The recovery is mainly as unchanged drug, with only about 20% of dose recovered as metabolites. The primary metabolite, accounting for about 9% of dose, is valeryl 4-hydroxy valsartan. The enzyme responsible for Diovan metabolism has not been identified.

5.DIOVAN EFFECTS ON SPECIAL POPULATION
How do different people react to Diovan?

Pediatrics : The pharmacokinetics of Diovan has not been investigated in patients below 18 years of age. Safety and effectiveness of Diovan in pediatric patients has therefore not been established.

Geriatrics : Exposure to Diovan is higher by 70% and the half-life is longer by 35% in the elderly than in the young. No dosage adjustment is necessary.

Gender : Pharmacokinetics of Diovan does not differ significantly between males and females.

Nursing Mothers : It is not known whether Diovan is excreted in human milk, but Diovan was excreted in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue Diovan, taking into account the importance of the drug to the mother.

6.DIOVAN EFFECTS ON MEDICAL CONDITIONS
How does Diovan affect your existing condition/ailment?

Heart Failure : The average time to peak concentration and elimination half-life of Diovan in heart failure patients are similar to that observed in healthy volunteers. The maximum concentration of Diovan increases linearly and is almost proportional with increasing dose over the clinical dosing range (40 to 160 mg twice a day). The average accumulation factor is about 1.7. The apparent clearance of Diovan following oral administration is approximately 4.5 L/h. Age does not affect the apparent clearance in heart failure patients.

Renal Insufficiency : There is no apparent correlation between renal function and exposure to Diovan in patients with different degrees of renal impairment. Consequently, dose adjustment is not required in patients with mild-to-moderate renal dysfunction. No studies have been performed in patients with severe impairment of renal function. Diovan is not removed from the plasma by hemodialysis. In the case of severe renal disease, take utmost care with dosing of Diovan is suggested.

Hepatic Insufficiency : On average, patients with mild-to-moderate chronic liver disease have twice the exposure to Diovan of healthy volunteers. In general, no dosage adjustment is needed in patients with mild-to-moderate liver disease. Care should be exercised in patients with liver disease.


7.OTHER/ALTERNATE USES OF DIOVAN
What else does Diovan treat?

Diovan may be used for other purposes if prescribed by your physician.

8.ADVERSE/SIDE EFFECTS of DIOVAN
What are the side effects of Diovan?

Diovan has been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.

Headache, dizziness, upper respiratory infection, cough, diarrhea, rhinitis, sinusitis, nausea, pharyngitis, edema, and arthralgia occurred at a more than 1% rate but at about the same incidence in placebo and Diovan patients.

Other adverse experiences that occurred in controlled clinical trials of patients treated with Diovan are listed below.

Body as a Whole : Allergic reaction and asthenia

Cardiovascular: Palpitations

Dermatologic : Pruritus and rash

Digestive : Constipation, dry mouth, dyspepsia, and flatulence

Musculoskeletal : Back pain, muscle cramps, and myalgia

Neurological and Psychiatric : Anxiety, insomnia, paresthesia, and somnolence

Respiratory : Dyspnea

Special Senses : Vertigo

Urogenital : Impotence

Other reported events seen less frequently in clinical trials included chest pain, anorexia, vomiting, and angioedema.