Norvasc


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amlodipine besylate

Norvasc

Pharmacologic class: Calcium channel blocker

Therapeutic class: Antihypertensive

Pregnancy risk category C

Action

Inhibits influx of extracellular calcium ions, thereby decreasing myocardial contractility, relaxing coronary and vascular muscles, and decreasing peripheral resistance

Availability

Tablets: 2.5 mg, 5 mg, 10 mg

Indications and dosages

Essential hypertension, chronic stable angina pectoris, and vasospastic angina (Prinzmetal's angina)

Adults: 5 to 10 mg P.O. once daily

Dosage adjustment

• Hepatic impairment
• Elderly patients

Off-label uses

• Pulmonary hypertension
• Raynaud's disease

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:
• aortic stenosis, severe hepatic impairment, heart failure
• elderly patients
• pregnant or breastfeeding patients
• children.

Administration

• Be aware that this drug may be given alone or with other drugs to relieve hypertension or angina.

Adverse reactions

CNS: headache, dizziness, drowsiness, light-headedness, fatigue, weakness, lethargy

CV: peripheral edema, angina, bradycardia, hypotension, palpitations

GI: nausea, abdominal discomfort

Musculoskeletal: muscle cramps, muscle pain or inflammation

Respiratory: shortness of breath, dyspnea, wheezing

Skin: rash, pruritus, urticaria, flushing

Interactions

Drug-drug.Beta-adrenergic blockers: increased risk of adverse effects

Fentanyl, nitrates, other antihypertensives, quinidine: additive hypotension

Drug-behaviors.Acute alcohol ingestion: additive hypotension

Patient monitoring

Monitor patient for worsening angina.
• Monitor heart rate and rhythm and blood pressure, especially at start of therapy.

Assess for heart failure; report signs and symptoms (peripheral edema, dyspnea) to prescriber promptly.

Give sublingual nitroglycerin, as prescribed, if patient has signs or symptoms of acute myocardial infarction (especially when dosage is increased).

Patient teaching

• If patient also uses sublingual nitroglycerin, tell him he can take nitroglycerin as needed for acute angina.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant adverse reactions, especially those related to the drugs and behaviors mentioned above.

amLODIPine

(am-loe-di-peen) ,

Norvasc

(trade name)

Classification

Therapeutic: antihypertensives
Pharmacologic: calcium channel blockers
Pregnancy Category: C

Indications

Alone or with other agents in the management of hypertension, angina pectoris, and vasospastic (Prinzmetal’s) angina.

Action

Inhibits the transport of calcium into myocardial and vascular smooth muscle cells, resulting in inhibition of excitation-contraction coupling and subsequent contraction.

Therapeutic effects

Systemic vasodilation resulting in decreased BP.
Coronary vasodilation resulting in decreased frequency and severity of attacks of angina.

Pharmacokinetics

Absorption: Well absorbed after oral administration (64–90%).
Distribution: Probably crosses the placenta.
Protein Binding: 95–98%.
Metabolism and Excretion: Mostly metabolized by the liver.
Half-life: 30–50 hr (↑ in geriatric patients and patients with hepatic impairment).

Time/action profile (cardiovascular effects)

ROUTEONSETPEAKDURATION
POunknown6–924 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Systolic BP <90 mm Hg.
Use Cautiously in: Severe hepatic impairment (dosage reduction recommended);Aortic stenosis;History of HF; Obstetric / Lactation / Pediatric: Children <6 yr (safety not established); Geriatric: Dose reduction recommended; ↑ risk of hypotension.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • fatigue

Cardiovascular

  • peripheral edema (most frequent)
  • angina
  • bradycardia
  • hypotension
  • palpitations

Gastrointestinal

  • gingival hyperplasia
  • nausea

Dermatologic

  • flushing

Interactions

Drug-Drug interaction

Strong CYP3A4 inhibitors, including ketoconazole, itraconazole, and ritonavir may ↑ levels.Additive hypotension may occur when used concurrently with fentanyl, other antihypertensives, nitrates, acute ingestion of alcohol, or quinidine.Antihypertensive effects may be ↓ by concurrent use of nonsteroidal anti-inflammatory agents.May ↑ risk of neurotoxicity with lithium.↑ risk of myopathy with simvastatin (do not exceed 20 mg/day of simvastatin).May ↑ cyclosporine levelsGrapefruit juice ↑ serum levels and effect.

Route/Dosage

Oral (Adults) 5–10 mg once daily; antihypertensive in fragile or small patients or patients already receiving other antihypertensives—initiate at 2.5 mg/day, ↑ as required/tolerated (up to 10 mg/day) as an antihypertensive therapy with 2.5 mg/day in patients with hepatic insufficiency.
Oral (Geriatric Patients) Antihypertensive—Initiate therapy at 2.5 mg/day, ↑ as required/tolerated (up to 10 mg/day); antianginal—initiate therapy at 5 mg/day, ↑ as required/tolerated (up to 10 mg/day).
Oral (Children 6–17 yr) 2.5–5 mg once daily

Hepatic Impairment

Oral (Adults) Antihypertensive—Initiate therapy at 2.5 mg/day, ↑ as required/tolerated (up to 10 mg/day); antianginal—initiate therapy at 5 mg/day, ↑ as required/tolerated (up to 10 mg/day).

Availability (generic available)

Tablets: 2.5 mg, 5 mg, 10 mg Cost: Generic — 2.5 mg $11.35 / 100, 5 mg $12.86 / 100, 10 mg $8.42 / 100
In combination with: aliskiren (Tekamlo), aliskiren/hydrochlorothiazide (Amturnide), atorvastatin (Caduet), benazepril (Lotrel), olmesartan (Azor), telmisartan (Twynsta), valsartan (Exforge), olmesartan/hydrochlorothiazide (Tribenzor), and valsartan/hydrochlorothiazide (Exforge HCT). See combination drugs.

Nursing implications

Nursing assessment

  • Monitor BP and pulse before therapy, during dose titration, and periodically during therapy. Monitor ECG periodically during prolonged therapy.
    • Monitor intake and output ratios and daily weight. Assess for signs of HF (peripheral edema, rales/crackles, dyspnea, weight gain, jugular venous distention).
  • Angina: Assess location, duration, intensity, and precipitating factors of patient’s anginal pain.
  • Lab Test Considerations: Total serum calcium concentrations are not affected by calcium channel blockers.

Potential Nursing Diagnoses

Ineffective tissue perfusion (Indications)
Acute pain (Indications)

Implementation

  • Do not confuse amlodipine with amiloride. Do not confuse Norvasc with Navane.
  • Oral: May be administered without regard to meals.

Patient/Family Teaching

  • Advise patient to take medication as directed, even if feeling well. Take missed doses as soon as possible unless almost time for next dose; do not double doses. May need to be discontinued gradually.
    • Advise patient to avoid large amounts (6–8 glasses of grapefruit juice/day) during therapy.
    • Instruct patient on correct technique for monitoring pulse. Instruct patient to contact health care professional if heart rate is <50 bpm.
    • Caution patient to change positions slowly to minimize orthostatic hypotension.
    • May cause drowsiness or dizziness. Advise patient to avoid driving or other activities requiring alertness until response to the medication is known.
    • Instruct patient on importance of maintaining good dental hygiene and seeing dentist frequently for teeth cleaning to prevent tenderness, bleeding, and gingival hyperplasia (gum enlargement).
    • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken, to avoid alcohol, and to consult health care professional before taking any new medications, especially cold preparations.
    • Advise patient to notify health care professional if irregular heartbeats, dyspnea, swelling of hands and feet, pronounced dizziness, nausea, constipation, or hypotension occurs or if headache is severe or persistent.
    • Caution patient to wear protective clothing and use sunscreen to prevent photosensitivity reactions.
    • Advise patient to inform health care professional of medication regimen before treatment or surgery.
  • Angina: Instruct patient on concurrent nitrate or beta-blocker therapy to continue taking both medications as directed and to use SL nitroglycerin as needed for anginal attacks.
    • Advise patient to contact health care professional if chest pain does not improve or worsens after therapy, if it occurs with diaphoresis, if shortness of breath occurs, or if severe, persistent headache occurs.
    • Caution patient to discuss exercise restrictions with health care professional before exertion.
  • Hypertension: Encourage patient to comply with other interventions for hypertension (weight reduction, low-sodium diet, smoking cessation, moderation of alcohol consumption, regular exercise, and stress management). Medication controls but does not cure hypertension.
    • Instruct patient and family in proper technique for monitoring BP. Advise patient to take BP weekly and to report significant changes to health care professional.

Evaluation/Desired Outcomes

  • Decrease in BP.
  • Decrease in frequency and severity of anginal attacks.
    • Decrease in need for nitrate therapy.
    • Increase in activity tolerance and sense of well-being.

Norvasc

(nôr′văsk′)
A trademark for the drug amlodipine besylate.

Norvasc®

Amlodepine besylate, see there.
References in periodicals archive ?
PRECAUTIONS: General: Since the vasodilation induced by NORVASC is gradual in onset, acute hypotension has rarely been reported after oral administration of NORVASC.
Synthon had asserted that Pfizer's process for manufacturing Norvasc -- a
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amlodipine besylate, the active ingredient in Norvasc, the world's most-prescribed
A calcium antagonist initially released in the UK in 1991, Norvasc has been available in Japan since 1993.
1 percent of patients on Norvasc and less than one percent of those taking Cozaar.
In clinical trials, the most common side effects for Norvasc versus
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However, the expiries of some key patents, particularly Pfizer's Norvasc and Merck's Cozaar, will restrain market growth.
The drug behemoth had asked the court to overturn an appeals court ruling earlier this year, which determined that Pfizer's Norvasc patent is invalid.
Patients Taking A Regimen Based On Pfizer's Norvasc Experienced Significant
based on its calcium channel blocker Norvasc (amlodipine besylate) experienced