Monopril


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fosinopril sodium

APO-Fosinopril (CA), Gen-Fosinopril (CA), Lin-Fosinopril (CA), Monopril, Novo-Fosinopril (CA), PMS-Fosinopril (CA), Ran-Fosinopril (CA), Ratio-Fosinopril (CA), Riva-Fosinopril (CA), Staril (UK)

Pharmacologic class: Angiotensin-converting enzyme (ACE) inhibitor

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

Prevents conversion of angiotensin I to the vasoconstrictor angiotensin II, thereby reducing sodium and water retention and enhancing blood flow in circulatory system

Availability

Tablets: 10 mg, 20 mg, 40 mg

Indications and dosages

Hypertension

Adults: 10 mg P.O. daily. May increase as required up to 80 mg/day; typical range is 20 to 40 mg P.O. daily.

Heart failure

Adults: 10 mg P.O. daily. May increase over several weeks up to 40 mg/day; typical range is 20 to 40 mg/day.

Dosage adjustment

• Renal impairment

Off-label uses

• Adjunct in myocardial infarction
• Nephropathy

Contraindications

• Hypersensitivity to drug or other ACE inhibitors
• Angioedema (hereditary or idiopathic)
• Pregnancy

Precautions

Use cautiously in:
• aortic stenosis, cardiomyopathy, cerebrovascular or cardiac insufficiency, renal or hepatic impairment, hyponatremia, hypovolemia
• black patients with hypertension
• patients receiving diuretics concurrently
• elderly patients
• breastfeeding patients (safety not established)
• children (safety not established).

Administration

• Don't administer within 2 hours of antacids.
• Give with or without food, but avoid giving with high-potassium foods or potassium supplements.

Adverse reactions

CNS: dizziness, drowsiness, fatigue, headache, insomnia, weakness, vertigo

CV: hypotension, angina pectoris, tachycardia

EENT: sinusitis

GI: nausea, vomiting, diarrhea, anorexia

GU: proteinuria, erectile dysfunction, decreased libido, renal failure

Hematologic: agranulocytosis, bone marrow depression

Metabolic: hyperkalemia

Respiratory: cough, bronchitis, dyspnea, asthma, eosinophilic pneumonitis

Skin: rash, angioedema

Other: altered taste, fever, hypersensitivity reactions including anaphylaxis

Interactions

Drug-drug.Allopurinol: increased risk of hypersensitivity reaction

Antacids: decreased fosinopril absorption

Antihypertensives, diuretics, general anesthetics, nitrates, phenothiazines: additive hypotension

Cyclosporine, indomethacin, potassium-sparing diuretics, potassium supplements: hyperkalemia

Digoxin, lithium: increased blood levels of these drugs, greater risk of toxicity

Indomethacin: decreased hypotensive effects

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

Antinuclear antibody titer: false-positive result

Sodium: decreased level

Drug-food.Salt substitutes containing potassium: hyperkalemia

Drug-herbs.Capsaicin: increased incidence of cough

Drug-behaviors.Acute alcohol ingestion: additive hypotension

Patient monitoring

• Monitor cardiovascular, respiratory, and neurologic status.
• Monitor CBC and liver and kidney function tests.
• Measure blood pressure to assess drug efficacy and detect hypotension.
• Assess patient's potassium intake; monitor serum potassium level.

Monitor for signs and symptoms of angioedema and anaphylaxis. If these occur, withdraw drug and contact prescriber immediately.

Patient teaching

Instruct patient to immediately report rash or difficulty breathing.
• Tell patient to report dizziness, fainting, bleeding tendency, change in urination pattern, swelling, or persistent cough.
• Encourage patient to drink enough fluids to stay well hydrated.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Instruct female patient to notify prescriber if she suspects she is pregnant.
• Tell patient that he will undergo regular blood testing during therapy.
• 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.

fosinopril

(foe-sin-oh-pril) ,

Monopril

(trade name)

Classification

Therapeutic: antihypertensives
Pharmacologic: ace inhibitors
Pregnancy Category: D

Indications

Alone or with other agents in the management of hypertension.Management of heart failure.

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 patients with hypertension.
Decreased afterload and symptoms in patients with heart failure.

Pharmacokinetics

Absorption: 36% absorbed following oral administration.
Distribution: Crosses the placenta; enters breast milk in small amounts.
Protein Binding: 99.4%.
Metabolism and Excretion: Converted by the liver and GI mucosa to fosinoprilat, the active metabolite: 50% excreted in urine, 50% in feces.
Half-life: 12 hr.

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

ROUTEONSETPEAKDURATION
POWithin 1 hr2–6 hr24 hr
†Full effects may not be noted for several weeks

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Bilateral renal artery stenosis; History of angioedema with previous use of ACE inhibitors; Obstetric: Can cause injury or death of fetus – if pregnancy occurs, discontinue immediately..Concurrent use with aliskiren in patients with diabetes or moderate-to-severe renal impairment (CCr <60 mL/min) Lactation: Discontinue drug or use formula.
Use Cautiously in: Patients with renal impairment, hypovolemia, hyponatremia, and concurrent diuretic therapy; 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; Pediatric: Children <6 yr (safety not established); Geriatric: Initial dose ↓ recommended.
Exercise Extreme Caution in: Family history of angioedema.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness (most frequent)
  • fatigue
  • headache
  • insomnia
  • weakness

Respiratory

  • cough (most frequent)

Cardiovascular

  • hypotension (most frequent)
  • chest pain
  • edema

Gastrointestinal

  • abdominal pain
  • diarrhea
  • nausea
  • vomiting

Genitourinary

  • erectile dysfunction
  • impaired renal function

Dermatologic

  • rash

Fluid and Electrolyte

  • hyperkalemia

Musculoskeletal

  • muscle cramps

Respiratory

  • dyspnea

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.Absorption may be ↓ by antacids (separate administration by 1–2 hr).↑ levels and may ↑ the risk of lithium toxicity.

Route/Dosage

Oral (Adults) Hypertension—10 mg once daily, may be ↑ as required up to 80 mg/day. Heart failure—10 mg once daily (5 mg once daily in patients who have been vigorously diuresed), may be ↑ over several weeks up to 40 mg/day.
Oral (Children ≥6 yr and >50 kg) Hypertension—5–10 mg once daily.

Availability (generic available)

Tablets: 10 mg, 20 mg, 40 mg
In combination with: hydrochlorothiazide. See combination drugs.

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 ↑ in 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 slight ↓ in hemoglobin and hematocrit as well as neutropenia and eosinophilia.
    • May cause ↑ AST, ALT, alkaline phosphatase, and serum bilirubin.

Potential Nursing Diagnoses

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

Implementation

  • Correct volume depletion, if possible, before initiation of therapy due to possible precipitous drop in BP during first 1–3 hr following first dose. Risk of hypotension may be decreased by discontinuing diuretics or cautiously increasing salt intake 2–3 days prior to beginning fosinopril. Monitor BP closely. Resume diuretics if BP is not controlled.

Patient/Family Teaching

  • Instruct patient 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 dose. 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.
    • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially OTC cough, cold, or allergy remedies.
    • 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 before treatment or surgery.
    • Instruct patient to notify health care professional if rash; mouth sores; sore throat; fever; swelling of hands or feet; irregular heart beat; 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 of pregnancy is planned or suspected.
    • 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 excessive side effects.
  • Decrease in signs and symptoms of heart failure.

Monopril

a trademark for an angiotensin-converting enzyme inhibitor (fosinopril).
References in periodicals archive ?
ACE Inhibitors: benazepril, lisinopril, monopril, quinapril, ramipril, trandolapril
Accupril - Agrylin - Axid - Biaxin - Celexa - Cipro - Difl ucan - Duragesic - Effexor - Flonase - Floxin/Occufl ox - Glucophage XR - Glucotrol XL - Glucovance - Lotensin - Metaglip - Mobic - Monopril - Novantrone - Paraplatin - Paxil - Pravachol - Proscar - Retrovir - Rocephin - Romazicon - Tambocor - Ultram - Zaditor - Zestril/Prinivil - Zithromax - Zocor - Zofran - Zoloft
Other cardiovascular products include Pravachol, which lowers cholesterol; Avapro/Avalide, an angiotensin II receptor blocker for hypertension; Coumadin, a bloodthinning agent; and Monopril, an antihypertensive.
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
Fosinopril sodium and Andrx Pharmaceuticals Monopril HCT
It has received approval for fosinopril tablets in the same strengths (10-, 20- and 40-mg) as those for Monopril, made by Bristol-Myers Squibb.
For example, the ACE inhibitor Monopril and the cancer drug Nolvadex are among brand name medications slated for patent expiration this year.
Pan has held senior level management posts in three of the world's major healthcare companies and has been involved in the development of a number of significant drugs including Captopril, Cardiolite, Coumadin, Monopril, Neurolite, Pravachol, ReVia and Sustiva.
pharmaceutical sales should be strong, led by Pravachol, Taxol, Glucophage and Monopril, whose gains should more than offset a sharp decline in Capoten sales.