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Name /bks_53161_deglins_md_disk/hydralazineisosorbidedin 02/14/2014 02:23PM Plate # 0-Composite pg 1 # 1 TIME/ACTION PROFILE (effect on BP) 1 ROUTE ONSET PEAK DURATION (hye-dral-a-zeen eye-so-sor-bide di-ni-trate) hydralazine isosorbide 45 min 15–40 min 2 hr unknown 2–4 hr 4 hr BiDil Classification Therapeutic: vasodilators Pharmacologic: vasodilators, nitrates Pregnancy Category C Contraindications/Precautions Contraindicated in: Hypersensitivity to either component. Use Cautiously in: Lactation: Pedi: Safety not established in children ⬍18 yr or hydralazine/isosorbide dinitrate breast-fed infants; Cardiovascular or cerebrovascular disease; Severe renal/hepatic disease (dose modification may be necessary); OB: Has been used safely during pregnancy; Lactation: Usually compatible with breast feeding (AAP); Head trauma or cerebral hemorrhage; Geriatric patients (start with lower doses); OB: May compromise maternal/fetal circulation; Lactation: Safety not established. Indications Management of heart failure in black patients. Action BiDil is a fixed-dose combination of isosorbide dinitrate, a vasodilator with effects on both arteries and veins, and hydralazine, a predominantly arterial vasodilator. Therapeutic Effects: Improved survival, increased time to hospitalization and decreased symptoms of heart failure in black patients. Pharmacokinetics See pharmacokinetic sections in hydralazine and isosorbide dinitrate monographs of Davis’s Drug Guide for Nurses for more information. Absorption: Hydralazine— 10– 26% absorbed in HF patients, absorption can be saturated leading to large increases in absorption with higher doses; isosorbide dinitrate— variable absorbed (10– 90%) reflecting first-pass hepatic metabolism. Distribution: Hydralazine— widely distributed, crosses the placenta, minimal amounts in breast milk; isosorbide dinitrate— accumulates in muscle and venous wall. Metabolism and Excretion: Hydralazine— mostly metabolized by GI mucosa and liver; isosorbide dinitrate— undergoes extensive first-pass metabolism in the liver mostly metabolized by the liver, some metabolites are vasodilators. Half-life: Hydralazine— 4 hr; isosorbide dinitrate— 2 hr. ⫽ Canadian drug name. ⫽ Genetic Implication. Adverse Reactions/Side Effects Hydralazine CNS: dizziness, drowsiness, headache. CV: tachycardia, angina, arrhythmias, edema, orthostatic hypotension. GI: diarrhea, nausea, vomiting. Derm: rashes. F and E: sodium retention. MS: arthralgias, arthritis. Neuro: peripheral neuropathy. Misc: drug-induced lupus syndrome. Isosorbide Dinitrate CNS: dizziness, headache, apprehension, weakness. CV: hypotension, tachycardia, paradoxic bradycardia, syncope. GI: abdominal pain, nausea, vomiting. Misc: cross-tolerance, flushing, tolerance. Interactions Drug-Drug:qrisk of hypotension with phosphodiesterase inhibitors (sildenafil, vardenafil, or tadalafil) other antihypertensives, acute ingestion of alcohol, beta blockers, calcium channel blockers, and phenothiazines. MAO inhibitors may exaggerate hypotension. May reduce the pressor response to epinephrine. Beta blockersptachycardia from hydralazine (therapy may be combined for this reason). Metoprolol and propranolol increase hydralazine levels. Hydralazineqblood levels of metoprolol and propranolol. Route/Dosage PO (Adults): 1 tablet 3 times daily, may be increased to 2 tablets 3 times daily. CAPITALS indicate life-threatening, underlines indicate most frequent. Strikethrough ⫽ Discontinued. PDF Page #1 Name /bks_53161_deglins_md_disk/hydralazineisosorbidedin 02/14/2014 02:23PM Plate # 0-Composite pg 2 # 2 Evaluation/Desired Outcomes 2 NURSING IMPLICATIONS Assessment ● Monitor BP and pulse routinely during period of dosage adjustment. Symptomatic ● Improved survival, increased time to hospitalization and decreased symptoms of heart failure in black patients. Why was this drug prescribed for your patient? hypotension may occur even with small doses. Use caution with patients who are volume depleted or hypotensive. ● Lab Test Considerations: If symptoms of systemic lupus erythematosus (SLE) occur obtain a CBC and ANA titer. If positive for SLE, carefully weigh risks/benefits of continued therapy. Potential Nursing Diagnoses Ineffective tissue perfusion (Indications) Activity intolerance (Indications) Implementation ● Dose may be titrated rapidly over 3– 5 days, but may need to decrease if side ef- fects occur. May decrease to one-half tablet 3 times daily if intolerable side effects occur. Titrate up as soon as side effects subside. Patient/Family Teaching ● Instruct patient to take medication as directed on a regular schedule. ● Caution patient to make position changes slowly to minimize orthostatic hypoten- sion. ● May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known. ● Advise patient to avoid concurrent use of alcohol or medications for erectile dys- function with this medication. Patient should also consult health care professional before taking Rx, OTC, or herbal products while taking this medication. ● Caution patient that inadequate fluid intake or excessive fluid loss from perspiration, diarrhea or vomiting may lead to a fall in BP, dizziness or syncope. If syncope occurs, discontinue medication and notify health care professional promptly. ● Inform patient that headache is a common side effect that should decrease with continuing therapy. Aspirin or acetaminophen may be ordered to treat headache. Notify health care professional if headache is persistent or severe. Do not alter dose to avoid headache. ● Advise patient to notify health care professional if symptoms of systemic lupus erythematosus occur (arthralgia, fever, chest pain, prolonged malaise or other unexplained symptoms). 䉷 2015 F.A. Davis Company PDF Page #2