Diovan


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valsartan

Diovan

Pharmacologic class: Angiotensin II receptor antagonist

Therapeutic class: Antihypertensive

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

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

(val-sar-tan) ,

Diovan

(trade name)

Classification

Therapeutic: antihypertensives
Pharmacologic: angiotensin ii receptor antagonists
Pregnancy Category: D

Indications

Alone or with other agents in the management of hypertension.Treatment of heart failure (New York Heart Association class II-IV).Reduction of risk of death from cardiovascular causes in patients with left ventricular systolic dysfunction following myocardial infarction.

Action

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

Therapeutic effects

Lowering of BP in patients with hypertension.
Decreased risk of heart-failure-related hospitalizations in patients with heart failure.
Decreased risk of death from cardiovascular causes in patients with left ventricular systolic dysfunction following myocardial infarction.

Pharmacokinetics

Absorption: 10–35% absorbed following oral administration.
Distribution: Crosses the placenta.
Protein Binding: 95%.
Metabolism and Excretion: Minor metabolism by the liver; 13% excreted in urine; 83% in feces.
Half-life: 6 hr.

Time/action profile (antihypertensive effect)

ROUTEONSETPEAKDURATION
POwithin 2 hr*4 wks†24 hr†
*After single dose†Chronic dosing

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Concurrent use with aliskiren in patients with diabetes or moderate-to-severe renal impairment (CCr <60 mL/min) Obstetric: Can cause injury or death of fetus – if pregnancy occurs, discontinue immediately. Lactation: Discontinue drug or use formula.
Use Cautiously in: Volume- or salt-depleted patients or patients receiving large doses of diuretics (correct deficits before initiating therapy or initiate at lower doses); Black patients (may not be as effective); Impaired renal function due to primary renal disease or HF (may worsen renal function); Hepatic impairment; Women of childbearing potential; Pediatric: Children <6 yr (safety not established).

Adverse Reactions/Side Effects

Central nervous system

  • dizziness (most frequent)
  • fatigue
  • headache

Cardiovascular

  • edema
  • hypotension

Ear, Eye, Nose, Throat

  • pharyngitis
  • rhinitis
  • sinusitis

Fluid and Electrolyte

  • hyperkalemia

Gastrointestinal

  • abdominal pain
  • diarrhea
  • nausea

Genitourinary

  • impaired renal function

Musculoskeletal

  • arthralgia
  • back pain

Miscellaneous

  • angioedema (life-threatening)

Interactions

Drug-Drug interaction

Additive hypotension with other antihypertensives.Excessive hypotension may occur with concurrent use of diuretics.↑ risk of hyperkalemia with concurrent use of potassium supplements, potassium-containing salt substitutes, or potassium-sparing diuretics.↑ risk of hyperkalemia, renal dysfunction, hypotension, and syncope with concurrent use of ACE inhibitors or aliskiren ; avoid concurrent use with aliskiren in patients with diabetes or CCr <60 mL/minNSAIDs and selective COX-2 inhibitors may blunt the antihypertensive effect and ↑ the risk of renal dysfunction.

Route/Dosage

Hypertension

Oral (Adults) 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume depleted; may be ↑ up to 320 mg once daily.
Oral (Children 6–16 yr) 1.3 mg/kg once daily (maximum dose = 40 mg/day); may be ↑ up to 2.7 mg/kg once daily (maximum dose = 160 mg/day)

Heart Failure

Oral (Adults) 40 mg twice daily, dose may be titrated up to target dose of 160 mg twice daily, as tolerated.

Post-Myocardial Infarction

Oral (Adults) 20 mg twice daily (may be initiated ≥ 12 hours after myocardial infarction), dose may be titrated up to target dose of 160 mg twice daily, as tolerated.

Availability

Tablets: 40 mg, 80 mg, 160 mg, 320 mg
In combination with: hydrochlorothiazide (Diovan HCT), amlodipine (Exforge), and amlodipine/hydrochlorothiazide (Exforge HCT); see combination drugs).

Nursing implications

Nursing assessment

  • Assess BP (lying, sitting, standing) and pulse frequently during initial dosage adjustment and periodically throughout therapy. Notify health care professional of significant changes.
  • Monitor frequency of prescription refills to determine compliance.
  • Assess patients for signs of angioedema (dyspnea, facial swelling).
  • HF: Monitor daily weight and assess patient routinely for resolution of fluid overload (peripheral edema, rales/crackles, dyspnea, weight gain, jugular venous distention).
  • Lab Test Considerations: Monitor renal function. May cause increase in BUN and serum creatinine.
    • May cause hyperkalemia.
    • May cause ↑ AST and ALT.
    • May cause slight ↓ in hemoglobin and hematocrit, or neutropenia.

Potential Nursing Diagnoses

Risk for injury (Adverse Reactions)
Noncompliance (Patient/Family Teaching)

Implementation

  • Do not confuse Diovan with Zyban.
  • Volume depletion should be corrected, if possible, before initiation of therapy.
  • Oral: May be taken without regard to food.

Patient/Family Teaching

  • Emphasize the importance of continuing to take as directed, at the same time each day, even if feeling well. Take missed doses as soon as remembered if not almost time for next dose; do not double doses. Warn patient not to discontinue therapy unless directed by health care professional.
  • Caution patient to avoid salt substitutes containing potassium or foods containing high levels of potassium or sodium unless directed by health care professional. See.
  • Caution patient to avoid sudden position changes to decrease orthostatic hypotension. Use of alcohol, standing for long periods, exercising, and hot weather may increase orthostatic hypotension.
  • May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products, especially NSAIDs and cough, cold, or allergy medications, without consulting health care professional.
  • Instruct patient to notify health care professional of medication regimen before treatment or surgery.
  • Instruct patient to notify health care professional if swelling of face, eyes, lips, or tongue or if difficulty swallowing or breathing occur.
  • Advise women of childbearing age to use contraception and notify health care professional if pregnancy is planned or suspected, or if breastfeeding. Valsartan should be discontinued as soon as possible when pregnancy is detected.
  • Emphasize the importance of follow-up exams to evaluate effectiveness of medication.
  • Hypertension: Encourage patient to comply with additional interventions for hypertension (weight reduction, low-sodium diet, discontinuation of smoking, moderation of alcohol consumption, regular exercise, stress management). Medication controls but does not cure hypertension.
    • Instruct patient and family on proper technique for monitoring BP. Advise them to check BP at least weekly and to report significant changes.

Evaluation/Desired Outcomes

  • Decrease in BP without appearance of excessive side effects. Effects are usually seen within 2 wks, with maximum effect in 4 wks.
  • Decreased heart-failure-related hospitalizations in patients with heart failure.
  • Decreased risk of death from cardiovascular causes in patients with left ventricular systolic dysfunction following myocardial infarction.

Diovan

(dī′ə-văn′)
A trademark for the drug valsartan.

Diovan

A brand name for VALSARTAN.
References in periodicals archive ?
The reason for the difference between two Diovan containing tests with the VC6000 is apparent when studying the data plots from the trials, shown in Figure 2a and 2b.
Lisinopril is an ACE-inhibitor and Diovan is an ARB.
The contract of this time has been made possible because Novartis Pharma, which aims to further increase growth of Diovan with a superior effect in the ARB market where competition is intensifying, and Mochida Pharmaceutical, which desires to provide additional strengths to its business foundation in the cardiovascular area that is a focused area of the company, had a common purpose.
Diovan is now the only agent in its class across the world indicated to treat high blood pressure, high risk heart attack survivors and people with heart failure.
For Diovan specifically, the plus is that it reduces the risk of developing diabetes.
In these patients, Diovan therapy was associated with a 49% reduction in morbidity, a 41% reduction in all-cause mortality, and a 57% reduction in first hospitalization for heart failure, said Dr.
Lupin's Valsartan Tablets 40 mg, 80 mg, 160 mg and 320 mg are the AB rated generic equivalent of Novartis's Diovan Tablets and is indicated for the treatment of hypertension and heart failure.
In the US, UK and Australia, valsartan is marketed by Novartis under the trade name Diovan.
11) A possible reason is that Diovan is the only ARB approved for three cardiovascular indications.
Sales of Novartis products, which include the hypertension drug Diovan and anticancer drug Glivec--known as Gleevec in the United States--rose 28% to $12.
Preliminary analysis of products from these companies intercepted on their way to the United States identified counterfeit versions of these prescription drugs: the cholesterol-lowering agents Lipitor (atorvastatin), Crestor (rosuvastatin), and Zetia (ezetimibe); the antihypertensives Diovan (valsartan) and Hyzaar (losartan-hydrochlorothiazide); Actonel (risedronate), a bisphosphonate for osteoporosis; Nexium (esomeprazole) for gastroesophageal reflux disease; Celebrex (celecoxib) for arthritis-related pain; Arimidex (anastrozole) for breast cancer; and Propecia (finasteride), for male pattern baldness.
But now a massive study across 24-countries - run by Enniskillen-born Professor John McMurray - has found that another medicine called Diovan is just as good.