Altace


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ramipril

Altace, Apo-Ramipril (CA), Co Ramipril (CA), Lopace (CA), Novo-Ramipril*, Ratio-Ramipril (CA), Sandoz Ramipril (CA), Tritace (UK)

Pharmacologic class: Angiotensinconverting enzyme (ACE) inhibitor

Therapeutic class: Antihypertensive

Pregnancy risk category D

Action

Inhibits conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. Increases plasma renin levels and reduces aldosterone levels, causing systemic vasodilation and decreased cardiac output.

Availability

Capsules: 1.25 mg, 2.5 mg, 5 mg, 10 mg

Indications and dosages

Hypertension

Adults: Initially, 2.5 mg P.O. daily in patients not receiving diuretics; may increase dosage slowly p.r.n. according to response. For maintenance, 2.5 to 20 mg/day P.O. as a single dose or in two equally divided doses. If ramipril alone doesn't control blood pressure, a diuretic may be added.

To reduce the risk of myocardial infarction (MI), cerebrovascular accident, or death from cardiovascular causes

Adults: Initially, 2.5 mg P.O. daily for 1 week, followed by 5 mg P.O. daily for the next 3 weeks, then increased as tolerated to a maintenance dosage of 10 mg P.O. daily. In hypertensive patients and those who've had a recent MI, may divide maintenance dose.

Heart failure after MI

Adults: Initially, 2.5 mg P.O. b.i.d.; may decrease to 1.25 mg b.i.d. if higher dosage causes hypotension. Titrate toward target dosage of 5 mg b.i.d. at 3-week intervals.

Dosage adjustment

• Renal impairment
• Concurrent diuretic use

Off-label uses

• Angina associated with syndrome X
• Atherosclerosis
• Mitral insufficiency
• Renovascular hypertension
• Diabetic or nondiabetic nephropathy
• Erythrocytosis

Contraindications

• Hypersensitivity to drug or other ACE inhibitors
• Angioedema with previous ACE inhibitor use or history of hereditary or idiopathic angioedema

Precautions

Use cautiously in:
• autoimmune diseases, aortic stenosis, hypertrophic cardiomyopathy, cerebrovascular or cardiac insufficiency, collagen vascular disease, febrile illness, hepatic or renal impairment, hypotension, neutropenia, chronic cough, proteinuria, renal artery stenosis
• risk factors for development of hyperkalemia (including renal insufficiency, diabetes mellitus, concurrent use of potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes)
• family history of angioedema
• concurrent immunosuppressant or diuretic therapy
• black patients
• elderly patients
• pregnant patients
• breastfeeding patients (avoid use)
• children (safety not established).

Administration

• If possible, discontinue diuretics 2 to 3 days before ramipril therapy begins to prevent severe hypotension.
• If patient can't swallow capsule, open it and mix contents in water or apple juice or sprinkle in small amount of applesauce.
• Know that drug may be used alone or with other antihypertensives.

Adverse reactions

CNS: dizziness, light-headedness, fatigue, headache, vertigo, asthenia

CV: hypotension, orthostatic hypotension, angina pectoris, tachycardia, MI, heart failure

EENT: blurred vision, sinusitis

GI: nausea, vomiting, diarrhea

Hematologic: purpura, agranulocytosis

Metabolic: hyperkalemia

Musculoskeletal: muscle cramps

Respiratory: cough, asthma, upper respiratory tract infection, bronchospasm

Skin: rash, pruritus, urticaria, photosensitivity, angioedema, anaphylactoid reactions

Other: fever

Interactions

Drug-drug.Diuretics, other antihypertensives: increased hypotension

Gold (sodium aurothiomalate): increased risk of rare nitritoid reactions (including facial flushing, nausea, vomiting, and hypotension)

Lithium: increased lithium blood level and risk of toxicity

Nonsteroidal anti-inflammatory drugs: may result in deterioration of renal function, including acute renal failure and attenuated ACE inhibitor antihypertensive effect

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

Drug-diagnostic tests.Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, potassium: increased levels

Drug-food.Any food: decreased rate (but not extent) of drug absorption Salt substitutes containing potassium: increased risk of hyperkalemia

Patient monitoring

• Assess vital signs and cardiovascular status. Ask patient if he's experiencing angina.
• Monitor CBC and liver function tests.
• Closely monitor potassium level. Watch for signs and symptoms of hyperkalemia.

Stay alert for signs and symptoms of hypersensitivity reactions (including angioedema), especially in black patients after first dose
• Evaluate for dry, nonproductive cough.

Patient teaching

• Tell patient he may take with or without food.

Instruct patient to immediately report swelling of tongue or face or difficulty breathing.
• Teach patient how to monitor and record blood pressure.
• Tell patient drug may cause dry, nonproductive cough. Instruct him to report this problem if it becomes bothersome.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Advise patient to move slowly when sitting up or standing, to avoid dizziness from sudden blood pressure decrease.
• Inform patient that excessive fluid loss (as from sweating, vomiting, or diarrhea) and inadequate fluid intake increase risk of light-headedness (especially in hot weather).
• Tell patient to avoid salt substitutes containing potassium.
• Advise female patient to tell prescriber if she is pregnant. Caution her not to take drug during third trimester or when breastfeeding.
• 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.

ramipril

(ra-mi-pril) ,

Altace

(trade name)

Classification

Therapeutic: antihypertensives
Pharmacologic: ace inhibitors
Pregnancy Category: D

Indications

Alone or with other agents in the management of hypertension.Reduction of risk of myocardial infarction, stroke, or death from cardiovascular causes in patients at least 55 years of age who are at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor.Reduction of risk of death, heart-failure–related hospitalizations, and progression of heart failure in patients with signs of heart failure following myocardial infarction.

Action

Angiotensin-converting enzyme (ACE) inhibitors block the conversion of angiotensin I to the vasoconstrictor angiotensin II. ACE inhibitors also prevent the degradation of bradykinin and other vasodilatory prostaglandins. ACE inhibitors also ↑ plasma renin levels and ↓ aldosterone levels. Net result is systemic vasodilation.

Therapeutic effects

Lowering of BP in hypertensive patients.
Decreased risk of myocardial infarction, stroke, or death from cardiovascular causes in high-risk patients.
Increased survival and decreased heart failure progression after myocardial infarction.

Pharmacokinetics

Absorption: 50–60% absorbed following oral administration.
Distribution: Crosses the placenta; may enter breast milk.
Metabolism and Excretion: Converted by the liver to ramiprilat, the active metabolite; 60% excreted in urine; 40% in feces.
Half-life: Ramiprilat:13–17 hr (↑ in renal impairment).

Time/action profile (effect on BP—single dose†)

ROUTEONSETPEAKDURATION
POwithin 1–2 hr3–6 hr24 hr
†Full effects may not be noted for several wk.

Contraindications/Precautions

Contraindicated in: Hypersensitivity; History of angioedema with previous use of ACE inhibitors; 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: genetic implication Black patients (monotherapy for hypertension less effective, may require additional therapy; higher risk of angioedema); Surgery/anesthesia (hypotension may be exaggerated); Women of childbearing potential; Renal impairment (especially renal artery stenosis), hypovolemia, hyponatremia, concurrent diuretic therapy–initial dose ↓ recommended; Pediatric: Safety not established; Geriatric: Initial dose ↓ recommended.
Exercise Extreme Caution in: Family history of angioedema.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • fatigue
  • headache
  • vertigo
  • weakness

Respiratory

  • cough (most frequent)

Cardiovascular

  • hypotension (most frequent)
  • chest pain

Gastrointestinal

  • diarrhea
  • nausea
  • vomiting

Genitourinary

  • impaired renal function

Dermatologic

  • rashes

Fluid and Electrolyte

  • hyperkalemia

Miscellaneous

  • angioedema (life-threatening)

Interactions

Drug-Drug interaction

Excessive hypotension may occur with concurrent use of diuretics.Additive hypotension with other antihypertensive agents.↑ risk of hyperkalemia with concurrent use of potassium supplements,potassium-sparing diuretics, or potassium-containing salt substitutes.↑ risk of hyperkalemia, renal dysfunction, hypotension, and syncope with concurrent use of angiotensin II receptor antagonists 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.↑ levels and may ↑ the risk of lithium toxicity.↑ risk of renal dysfunction when used with telmisartan ; concurrent use not recommended.↑ risk of angioedema with temsirolimus or everolimus

Route/Dosage

Hypertension

Oral (Adults) 2.5 mg once daily, slowly may be ↑ up to 20 mg/day in 1–2 divided doses (initiate therapy at 1.25 mg/day in patients receiving diuretics).

Heart Failure Post-Myocardial Infarction

Oral (Adults) 1.25–2.5 mg twice daily initially, may be ↑ slowly up to 5 mg twice daily.

Reduction in Risk of MI, Stroke, and Death from Cardiovascular Causes

Oral (Adults) 2.5 mg once daily for 1 wk, then 5 mg once daily for 3 wk, then ↑ as tolerated to 10 mg once daily (can also be given in 2 divided doses).

Renal Impairment

Oral (Adults) CCr < 40 mL/min—Initiate therapy at 1.25 mg once daily, may be slowly titrated up to 5 mg/day in 1–2 divided doses.

Availability (generic available)

Capsules: 1.25 mg, 2.5 mg, 5 mg, 10 mg
Tablets: 1.25 mg, 2.5 mg, 5 mg, 10 mg, 15 mg

Nursing implications

Nursing assessment

  • Hypertension: Monitor BP and pulse frequently during initial dose adjustment and periodically during therapy. Notify health care professional of significant changes.
    • Monitor frequency of prescription refills to determine compliance.
    • Assess patient for signs of angioedema (dyspnea, facial swelling).
  • Heart Failure: Monitor 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 ↑ BUN and serum creatinine.
    • May cause hyperkalemia.
    • Monitor CBC periodically during therapy in patients with collagen vascular disease and/or renal disease. May rarely cause ↓ in hemoglobin and hematocrit as well as neutropenia and eosinophilia.
    • May cause ↑ AST, ALT, alkaline phosphatase, serum bilirubin, uric acid, and glucose.

Potential Nursing Diagnoses

Decreased cardiac output (Indications,  Side Effects)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)
Noncompliance (Patient/Family Teaching)

Implementation

  • Correct volume depletion, if possible, before initiation of therapy. Precipitous drop in BP during first 1–3 hr following first dose may require volume expansion with normal saline. Discontinuing diuretic therapy or cautiously increasing salt intake 2–3 days prior to initiation may decrease risk. Monitor closely for at least 1 hr after BP has stabilized. Resume diuretics if BP is not controlled.
  • Oral: Capsules may be opened and sprinkled on applesauce, or dissolved in 4 oz water or apple juice for patients with difficulty swallowing. Effectiveness is same as capsule. Pre-prepared mixtures can be stored for up to 24 hr at room temperature or up to 48 hr if refrigerated.

Patient/Family Teaching

  • Emphasize the importance of continuing to take medication as directed at the same time each day, even if feeling well. Take missed doses as soon as remembered but not if almost time for next dose. Do not double doses. Warn patient not to discontinue ACE inhibitor 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 change positions slowly to minimize orthostatic hypotension. Use of alcohol, standing for long periods, exercising, and hot weather may increase orthostatic hypotension.
    • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications especially cough, cold, or allergy medications.
    • May cause dizziness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
    • Advise patient to inform health care professional of medication regimen prior to treatment or surgery.
    • Instruct patient to notify health care professional if rash; mouth sores; sore throat; fever; swelling of hands or feet; irregular heartbeat; chest pain; dry cough; hoarseness; swelling of face, eyes, lips, or tongue; or if difficulty swallowing or breathing occurs. Persistent dry cough may occur and may not subside until medication is discontinued. Consult health care professional if cough becomes bothersome. Also notify health care professional if nausea, vomiting, or diarrhea occurs and continues.
    • Advise women of childbearing age to use contraception and notify health care professional if pregnancy is planned or suspected or if breastfeeding. If pregnancy is detected, discontinue medication as soon as possible.
    • Emphasize the importance of follow-up examinations 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, and stress management). Medication controls but does not cure hypertension.
    • Instruct patient and family on correct technique for monitoring BP. Advise them to check BP at least weekly and to report significant changes to health care professional.

Evaluation/Desired Outcomes

  • Decrease in BP without appearance of side effects.
  • Reduction in risk of myocardial infarction, stroke, or death from cardiovascular causes in patients at high-risk for these events.
  • Reduction of risk of death, progression of heart failure, or heart failure-related hospitalizations following myocardial infarction.

Altace®

Ramipil Vascular disease An ACE inhibitor antihypertensive Adverse effects Headache, fatigue, dizziness, dry cough, angioedema Contraindications Hx of angioedema. See ACE inhibitor.
References in periodicals archive ?
The specific Geomatrix technology planned for use in the development of a modified-release formulation of Altace should provide the product with extended duration of action and improved bioavailability.
5 years of follow-up, 14% of those on Altace reached the combined end point of MI, stroke, or death from cardiovascular causes vs.
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the highest proportion of surveyed managed care organizations' (MCO) pharmacy directors select King Pharmaceuticals' Altace and Novartis's Diovan as the safest, most tolerable and most conveniently delivered agents for the treatment of diabetic nephropathy.
Bristol TN), the company whose top-selling heart pill Altace has gone generic, lost as much as a fifth of its market value last week after second-quarter revenue and profit missed analysts' estimates.
Included on the list are Norvasc, Zoloft, Altace, Ambien, Zocor, and Pravachol.
DRUG BRAND NAMES Acarbose Prandase, Precose Amlodipine Norvasc Atenolol Tenoretic; Tenormin Captopril Capoten Enalapril Vasotec Fosinopril Monopril Irbesartan Avapro Losartan Cozaar Lovastatin Mevacor Metformin Glucophage Nisoldipine Sular Orlistat Xenical Pravastatin Pravachol Ramipril Altace Simvastatin Zocor
Amlodipine * Norvasc Amoxicillin * Amoxil, Biomox, Polymox, Trimox, Wymox Azithromycin * Zithromax Cefaclor * Ceclor Cephalexin * Biocef, Keflex Clarithromycin * Biaxin Clindamycin * Cleocin, Dalacin Irbesartan * Avapro Losartan * Cozaar Ramipril * Altace Vancomycin * Vancocin Warfarin * Coumadin Xylometazoline * Otrivin
A court found that patent claims behind its top-selling drug, the blood pressure medication Altace, were invalid.
Ramipril, marketed by King Pharmaceuticals under the trade name Altace, was previously approved for treating hypertension, with or without thiazide diuretics, and for treating heart failure after MI.
Although generic versions of Altace continued to impact the top-line, products like Skelaxin, Thrombin-JMI and Flector Patch -- as well as the Meridian Auto-Injector and Animal Health segments -- posted better-than-expected sales.
HOPE was funded chiefly by the Medical Research Council of Canada, Altace manufacturer Hoechst Marion Roussel, Astra, and the Natural Source Vitamin E Association.
Mylan maintains that a significant component of the transaction's value to that company is King's experienced cardiovascular sales force, which currently concentrates on Altace, a leading ACE inhibitor for hypertension and cardiovascular protection.