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valsartan

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Overview

What is Diovan?

Diovan (valsartan) is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT receptor subtype.

Valsartan is chemically described as -(1-oxopentyl)--[[2′-(1-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is CHNO, its molecular weight is 435.5, and its structural formula is

Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water.

Diovan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides (yellow, black and/or red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, and titanium dioxide.



What does Diovan look like?



What are the available doses of Diovan?

Tablets (mg): 40 (scored), 80, 160, 320

What should I talk to my health care provider before I take Diovan?

Nursing Mothers:

Pediatrics

Geriatrics

How should I use Diovan?

Diovan (valsartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

The recommended starting dose of Diovan (valsartan) is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Diovan may be used over a dose range of 80 mg to 320 mg daily, administered once a day.

The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg.

No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of Diovan in patients with hepatic or severe renal impairment.

Diovan may be administered with other antihypertensive agents.

Diovan may be administered with or without food.


What interacts with Diovan?

Sorry No Records found


What are the warnings of Diovan?

Sorry No Records found


What are the precautions of Diovan?

Sorry No Records found


What are the side effects of Diovan?

Sorry No records found


What should I look out for while using Diovan?

None

When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

When pregnancy is detected, Diovan should be discontinued as soon as possible.

See WARNINGS:

Fetal/Neonatal Morbidity and Mortality

(5.1)


What might happen if I take too much Diovan?

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. If symptomatic hypotension should occur, supportive treatment should be instituted.

Diovan (valsartan) is not removed from the plasma by hemodialysis.

Valsartan was without grossly observable adverse effects at single oral doses up to 2000 mg/kg in rats and up to 1000 mg/kg in marmosets, except for salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 31 times, respectively, the maximum recommended human dose on a mg/m basis). (Calculations assume an oral dose of 320 mg/day and a 60-kg patient.)


How should I store and handle Diovan?

Diovan (valsartan) is available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles and unit dose blister packages (10 strips of 10 tablets) as described below.40 mg tablets are scored on one side and ovaloid with bevelled edges. 80 mg, 160 mg, and 320 mg tablets are unscored and almond-shaped with bevelled edges. Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature].Protect from moisture. Dispense in tight container (USP).Diovan (valsartan) is available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles and unit dose blister packages (10 strips of 10 tablets) as described below.40 mg tablets are scored on one side and ovaloid with bevelled edges. 80 mg, 160 mg, and 320 mg tablets are unscored and almond-shaped with bevelled edges. Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature].Protect from moisture. Dispense in tight container (USP).Diovan (valsartan) is available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles and unit dose blister packages (10 strips of 10 tablets) as described below.40 mg tablets are scored on one side and ovaloid with bevelled edges. 80 mg, 160 mg, and 320 mg tablets are unscored and almond-shaped with bevelled edges. Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature].Protect from moisture. Dispense in tight container (USP).Diovan (valsartan) is available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles and unit dose blister packages (10 strips of 10 tablets) as described below.40 mg tablets are scored on one side and ovaloid with bevelled edges. 80 mg, 160 mg, and 320 mg tablets are unscored and almond-shaped with bevelled edges. Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature].Protect from moisture. Dispense in tight container (USP).Diovan (valsartan) is available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles and unit dose blister packages (10 strips of 10 tablets) as described below.40 mg tablets are scored on one side and ovaloid with bevelled edges. 80 mg, 160 mg, and 320 mg tablets are unscored and almond-shaped with bevelled edges. Store at 25°C (77°F); excursions permitted to 15-30°C (59 - 86°F) [see USP Controlled Room Temperature].Protect from moisture. Dispense in tight container (USP).


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Diovan (valsartan) blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 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.

There is also an AT receptor found in many tissues, but AT is not known to be associated with cardiovascular homeostasis. Valsartan has much greater affinity (about 20,000-fold) for the AT receptor than for the AT receptor. The increased plasma levels of angiotensin II following AT receptor blockade with valsartan may stimulate the unblocked AT receptor. The primary metabolite of valsartan is essentially inactive with an affinity for the AT receptor about one-200th that of valsartan itself.

Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because valsartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known. Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of valsartan on blood pressure.

Non-Clinical Toxicology
None

When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

When pregnancy is detected, Diovan should be discontinued as soon as possible.

See WARNINGS:

Fetal/Neonatal Morbidity and Mortality

(5.1)

Diovan can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus

Drugs that act on the renin angiotensin system can cause fetal and neonatal morbidity and mortality when used in pregnancy. In several dozen published cases, ACE inhibitor use during the second and third trimesters of pregnancy was associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

Tips

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Interactions

Interactions

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