valsartan


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valsartan

 [val-sahr´tan]
an angiotensin II antagonist used as an antihypertensive, administered orally.

valsartan

Diovan

Pharmacologic class: Angiotensin II receptor antagonist

Therapeutic class: Antihypertensive

Pregnancy risk category C (first trimester), D (second and third trimesters)

Action

Blocks the vasoconstrictive and aldosterone-producing effects of angiotensin II at various receptor sites, including vascular smooth muscle and adrenal glands

Availability

Tablets: 40 mg, 80 mg, 160 mg, 320 mg

Indications and dosages

Hypertension

Adults: Initially, 80 to 160 mg P.O. daily. May increase as needed to a maximum of 320 mg P.O. daily, or a diuretic may be added.

Children ages 6 to 16: Initially, 1.3 mg/kg (up to 40 mg total) P.O. once daily; dosage range is 1.3 to 2.7 mg/kg (40 to 160 mg total).

Heart failure

Adults: 40 mg P.O. b.i.d., titrated to 80 mg or 160 mg P.O. b.i.d., as tolerated

Reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction

Adults: 20 mg P.O. b.i.d., followed by titration to 40 mg P.O. b.i.d., with subsequent titration to a target maintenance dosage of 160 mg P.O. b.i.d., as tolerated

Dosage adjustment

• Symptomatic hypotension

• Renal dysfunction

Off-label uses

• Left ventricular hypertrophy

• Diabetic nephropathy

Contraindications

• None

Precautions

Use cautiously in:

• severe heart failure; volume or sodium depletion; hepatic or renal impairment; obstructive biliary disorders; angioedema; aortic, mitral valve, or renal artery stenosis; hyperkalemia, hypotension

• pregnant or breastfeeding patients

• children younger than age 6 (safety not established).

Administration

• Give with or without food.

• For children who can't swallow tablets or children for whom calculated dosage doesn't correspond to available tablet strength, use a suspension but be aware that exposure to the suspension is 1.6 times greater than the tablet.

• To prepare 160 ml of a 4-mg/ml suspension, add 80 ml of Ora-Plus to bottle containing eight valsartan 80-mg tablets and shake for at least 2 minutes. Allow suspension to stand for at least 1 hour. Then shake for at least 1 additional minute. Add 80 ml of Ora-Sweet to bottle and shake for at least 10 seconds before giving appropriate dose. May store suspension for 30 days at room temperature or up to 75 days if refrigerated.

Be aware that drug isn't recommended for children with glomerular filtration rate of less than 30 ml/minute/1.732.

Adverse reactions

CNS: dizziness, fatigue, headache

CV: hypotension, palpitations

EENT: sinus disorders, rhinitis, pharyngitis

GI: nausea, diarrhea, constipation, abdominal pain, dry mouth

GU: albuminuria, renal impairment

Hematologic: neutropenia

Metabolic: hyperkalemia

Musculoskeletal: back pain, joint pain, muscle cramps

Respiratory: cough, upper respiratory tract infection

Skin: alopecia, angioedema

Other: dental pain, fever, viral infection, edema

Interactions

Drug-drug. Nonsteroidal anti-inflammatory drugs including selective cyclooxygenase-2 inhibitors: increased risk of renal impairment including acute renal failure in elderly patients, volume-depleted patients, or those with compromised renal function; loss of valsartan antihypertensive effect

Other antihypertensives: increased risk of hypotension

Potassium-sparing diuretics, potassium supplements: increased risk of hyperkalemia

Drug-diagnostic tests. Serum creatinine, serum and urine albumin, urine potassium: increased levels

Drug-food. Salt substitutes containing potassium: increased risk of hyperkalemia

Drug-herbs. Ephedra (ma huang): reduced hypotensive effect of valsartan

Drug-behaviors. Alcohol use: increased CNS depression

Patient monitoring

• Monitor blood pressure closely, especially during initial therapy and dosage adjustments.

• Assess potassium level. Stay alert for hyperkalemia.

• Be aware that in black patients, drug may be ineffective when used alone. Additional agents may be required.

Patient teaching

• Tell patient he may take with or without food.

• For children who can't swallow tablets or children for whom calculated dosage doesn't correspond to available tablet strength, show caregiver how to prepare a suspension.

Instruct female of childbearing age to report pregnancy immediately.

• Advise breastfeeding patient to avoid breastfeeding while taking drug.

• Advise patient to avoid potassium-containing salt substitutes.

• Caution patient to avoid alcohol.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.

valsartan

(văl-sär′tn)
n.
An angiotensin II receptor blocker drug, C24H29N5O3, used to treat hypertension and heart failure.

valsartan

A drug that interferes with the action of ANGIOTENSIN II and is used to treat high blood pressure (HYPERTENSION). A brand name is Diovan.
References in periodicals archive ?
Sacubitril/valsartan was associated with more hypotension, but less hyperkalaemia and less renal dysfunction compared with valsartan, findings similar to those seen in the PARADIGM-HF trial.
PARAGON-HF follows the only positive Phase II trial in HFpEF, PARAMOUNT-HF, which demonstrated that sacubitril/valsartan reduced NT-proBNP (a biomarker of cardiac strain) to a greater extent than valsartan at 12 weeks and was associated with improvement in NYHA class at 36 weeks[16][17].
A separate study in Denmark also found no evidence of valsartan causing cancer after long-term use.
"The only time we tell someone not to take the medication is if, say, warfarin [Coumadin[R]] was put into a valsartan bottle and valsartan was put into a warfarin bottle," she explains.
Valisure found DMF in valsartan that is still on the market in the U.S., including in medicines the FDA had highlighted as alternatives to recalled drugs.
In connection with the approval, the US FDA prioritised the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities.
Both the United States and the European Union launched recalls of drugs against high blood pressure which contained Valsartan produced in China or India.
"Nous recommandons aux patients traites par les medicaments a base de valsartan de ne pas arreter par eux-memes le traitement mais de consulter leurs medecins ou pharmaciens pour les remplacer par des medicaments equivalents provenant d'autres fournisseurs", a-t-elle insiste.
The statement was issued following a recall notice by the United States Food and Drug Administration (USFDA) of products containing active valsartan and losartan ingredients due to the presence of NDEA.
Prexxartan (valsartan oral solution) is indicated for treatment of hypertension in adults and children six years and older.
"In addition to NDMA, EMA is assessing the impact of a related substance, N-nitrosodiethylamine (NDEA), which has been detected in valsartan made by Zhejiang Huahai using its previous manufacturing process before changes were introduced in 2012," it said in a statement.
Valsartan, which had previously been described as an effective treatment with regard to high blood pressure, and heart pain, was recalled by the FDA and subsequently, by the Drug Regulatory Authority of Pakistan.