Univasc

moexipril hydrochloride

Perdix (UK), Univasc

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)

FDA Box Warning

• When used during second or third trimester of pregnancy, drug may cause fetal harm or death. Discontinue drug as soon as possible when pregnancy is detected.

Action

Inhibits conversion of angiotensin I to the vasoconstrictor angiotensin II, inactivates bradykinin and other vasodilatory prostaglandins, increases plasma renin levels, and reduces aldosterone levels. Net effect is systemic vasodilation.

Availability

Tablets: 7.5 mg, 15 mg

Indications and dosages

Hypertension

Adults: 7.5 mg P.O. daily 1 hour before a meal; may increase if blood pressure control is inadequate. Range is 7.5 mg to 30 mg/day in one or two divided doses given 1 hour before a meal.

Dosage adjustment

• Renal impairment
• Concurrent diuretic therapy

Contraindications

• Hypersensitivity to drug
• Angioedema secondary to ACE inhibitor use

Precautions

Use cautiously in:
• renal or hepatic impairment, hypovolemia, hyponatremia, aortic stenosis or hypertrophic cardiomyopathy, cardiac or cerebrovascular insufficiency
• family history of angioedema
• concurrent diuretic therapy
• black patients
• elderly patients
• pregnant or breastfeeding patients
• children (safety not established).

Administration

• Give 1 hour before meals (food reduces drug absorption).
• Adjust dosage, as ordered, according to blood pressure response.

Adverse reactions

CNS: dizziness, fatigue

CV: chest pain, peripheral edema

EENT: pharyngitis, sinusitis

GI: nausea, diarrhea

GU: urinary frequency

Metabolic: hyperkalemia

Musculoskeletal: myalgia

Respiratory: upper respiratory infection, increased cough

Skin: rash, flushing, angioedema

Other: fever, flulike symptoms, hypersensitivity reaction

Interactions

Drug-drug.Allopurinol: increased risk of hypersensitivity reaction

Antacids: decreased moexipril absorption

Antihypertensives, general anesthetics, nitrates, phenothiazines: additive hypotension

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

Digoxin, lithium: increased blood levels of these drugs

Diuretics: excessive hypotension

Nonsteroidal anti-inflammatory drugs: blunted antihypertensive response

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

Antinuclear antibody: positive titer

Sodium: decreased level

Drug-food.Salt substitutes containing potassium: hyperkalemia

Drug-behaviors.Acute alcohol ingestion: additive hypotension

Patient monitoring

• Monitor vital signs and neurologic and cardiovascular status.
• Assess respiratory status, staying alert for persistent dry cough.
• Evaluate for allergic reactions and angioedema.
• Know that moexipril monotherapy is less effective in black patients, who may need additional concurrent antihypertensives.

Patient teaching

• Instruct patient to take 1 hour before a meal.
• Tell patient to report persistent dry cough and signs or symptoms of infection (especially upper respiratory infection).
• Advise patient to change position slowly (especially during first few days of therapy), to minimize hypotension and dizziness.
• Instruct patient to limit foods high in potassium and avoid salt substitutes containing potassium.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and behaviors mentioned above.

moexipril

(moe-eks-i-pril) ,

Univasc

(trade name)

Classification

Therapeutic: antihypertensives
Pharmacologic: ace inhibitors
Pregnancy Category: D

Indications

Alone or with other agents in the management of hypertension.

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.

Pharmacokinetics

Absorption: 13% bioavailability as moexiprilat following oral administration (↓ by food).
Distribution: Crosses the placenta.
Protein Binding: Moexipril—90%; Moexiprilat—50–70%.
Metabolism and Excretion: Converted by liver and GI mucosa to moexiprilat, the active metabolite; 13% excreted in urine, 53% excreted in feces.
Half-life: Moexipril—1 hr; Moexiprilat—2–9 hr (↑ in renal impairment).

Time/action profile (antihypertensive effect with chronic dosing)

ROUTEONSETPEAKDURATION
POwithin 1 hr4 wksup to 24 hr

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: 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; Geriatric: Initial dose ↓ recommended; Pediatric: Safety not established
Exercise Extreme Caution in: Family history of angioedema.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • fatigue
  • headache

Respiratory

  • cough (most frequent)

Cardiovascular

  • hypotension (most frequent)
  • chest pain
  • edema

Gastrointestinal

  • diarrhea
  • dyspepsia

Genitourinary

  • impaired renal function

Dermatologic

  • flushing
  • rash

Fluid and Electrolyte

  • hyperkalemia

Musculoskeletal

  • myalgia

Miscellaneous

  • angioedema (life-threatening)
  • flu-like symptoms

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-sharing 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. Food significantly ↓ absorption. Administer moexipril 1 hr before meals.

Route/Dosage

Oral (Adults) 7.5 mg once daily, may be ↑ up to 30 mg/day in 1–2 divided doses; (initiate therapy with 3.75 mg/day in patients receiving diuretics).

Renal Impairment

Oral (Adults) CCr ≤40 mL/min—Initiate therapy at 3.75 mg once daily, may be titrated upward carefully to 15 mg/day.

Availability (generic available)

Tablets: 7.5 mg, 15 mg
In combination with: hydrochlorothiazide (Uniretic). See combination drugs.

Nursing implications

Nursing assessment

  • Monitor BP 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 patient for signs of angioedema (dyspnea, facial swelling).
  • 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 agranulocytosis.
    • May cause ↑ AST, ALT, alkaline phosphatase, serum bilirubin, and uric acid.

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.
  • Oral: Administer moexipril on an empty stomach, 1 hr before a meal.

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 doses. Warn patient not to discontinue ACE inhibitor therapy unless directed by health care professional.
  • 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.
  • 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 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.

Evaluation/Desired Outcomes

  • Decrease in BP without appearance of excessive side effects.

Univasc

a trademark for an angiotensin-converting enzyme inhibitor (moexipril).

moexipril

An ACE inhibitor used for managing hypertension, either as a monotherapy or in combination with thiazide diuretics.

Adverse effects
Cough, dizziness, diarrhoea, flu syndrome, fatigue, flushing, myalgia.
References in periodicals archive ?
Moexipril hydrochloride is the generic equivalent of Univasc tablets, marketed by Schwarz Pharma.
ACE inhibitors include Lotensin, captopril, enalapril, Monopril, Prinivil/Zestril, Univasc, Aceon, Accupril, Altace and Mavik.
Nasdaq: TEVA) announced today that further to its press release dated January 31, 2004, the Company has entered into an agreement with Schwarz Pharma regarding Moexipril HCl Tablets, the AB-rated generic equivalents of Schwarz's antihypertensive agent Univasc (R) Tablets.
Moexipril HCl Tablets are the AB-rated generic equivalents of Schwarz Pharma's antihypertensive agent Univasc (R) Tablets.