Nursing Implications for Vardenafil Hydrochloride Tablets

VARDENAFIL HYDROCHLORIDE

(var-den′a-fil hy-dro-chlo′ride)

Levitra, Staxyn

Classifications: IMPOTENCE AGENT; PHOSPHODIESTERASE (PDE) INHIBITOR; VASODILATOR

Therapeutic: IMPOTENCE; PDE TYPE 5 INHIBITOR

Prototype: Sildenafil

Pregnancy Category: B

AVAILABILITY

Tablet; orally disintegrating tablet

ACTION & THERAPEUTIC EFFECT

Phosphodiesterases-5 (PDE5) is an enzyme that speeds up the degradation of cyclic guanosine monophosphate (cGMP), an enzyme needed to cause and maintain increased blood flow into the penis necessary for an erection. Vardenafil is a PDE5 inhibitor. It enhances erectile function by increasing the amount of cGMP in the penis.

USES

Treatment of erectile dysfunction.

CONTRAINDICATIONS

Hypersensitivity to vardenafil or sildenafil; coadministration of nitrates; QT prolongation, renal failure, severe renal impairment; retinitis pigmentosa. Levitra: Severe hepatic impairment (Child-Pugh class C); Staxyn: Moderate or severe hepatic impairment  (Child-Pugh B and C); lactation.

CAUTIOUS USE

CAD, MI, or stroke within 6 mo; hypotension, or hypertension; risk factors for CVA; anatomic deformity of the penis; subaortic stenosis; sickle cell anemia, leukemia; multiple myeloma; leukemia; coagulopathy; active bleeding or a peptic ulcer; coagulopathy; GERD; hepatitis, cirrhosis; older adults; pregnancy (category B).

ROUTE & DOSAGE

Erectile Dysfunction

Adult: PO 10 mg approximately 60 min before sexual activity. May increase to max 20 mg/day if needed. If taking ritonavir, max dose is 2.5 mg/72 h. If taking erythromycin, indinavir, itraconazole, ketoconazole, max dose is 2.5–5 mg/24 h.

Geriatric: PO Start with 5 mg 60 min before sexual activity (max: 20 mg/day)

Hepatic Impairment Dosage Adjustment

Moderate impairment: For Levitra reduce dose to 5 mg (max: 10 mg/ day). For Staxyn dosing do not use in patients with moderate or severe (class B or C) hepatic impairment.

ADMINISTRATION

Oral

• Take approximately 1 h before expected intercourse, but preferably not after a heavy or high-fat meal.
• Store at 15°–30° C (59°–86° F).

Nursing Implications for Vardenafil Hydrochloride Tablets

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ADVERSE EFFECTS (≥1%)

Body as a Whole: Flushing, flu-like syndrome, back pain, anaphylactoid reactions, asthenia, facial edema, pain, paresthesias. CNS: Headache, dizziness, insomnia, somnolence, vertigo.

CV: Angina, hypertension, hypotension, MI, orthostatic hypotension, palpitations, syncope, sinus tachycardia. GI: Dyspepsia, nausea, vomiting, abdominal pain, abnormal liver function tests, diarrhea, dysphagia, esophagitis, gastritis, GERD, xerostomia. Metabolic: Increased creatine kinase. Musculoskeletal: Arthralgia, myalgia, hypertonia, hyperesthesia. Respiratory: Rhinitis, sinusitis, dyspnea, epistaxis, pharyngitis. Skin: Photosensitivity, rash, pruritus, sweating. Special Senses: Tinnitus, sudden vision loss, blurred vision, changes in color vision. Urogenital: Ejaculation dysfunction.

INTERACTIONS

Drug: May potentiate hypotensive effects of NITRATES, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin; amiodarone, dofetilide, procainamide, quinidine, sotalol may increase QTc interval leading to arrhythmias; erythromycin (and other MACROLIDES), indinavir, itraconazole, ketoconazole, PROTEASE INHIBITORS, ritonavir, voriconazole may increase level and toxicity of vardenafil.

PHARMACOKINETICS

Absorption: Rapidly absorbed, 15% reaches systemic circulation. Onset:Within 1 h. Peak: 0.5–2 h. Metabolism: In liver by CYP3A4. Elimination: Primarily in feces (90–95%). Half-Life: 4–5 h.

NURSING IMPLICATIONS

Assessment & Drug Effects

• Monitor CV status and report angina or other S&S of cardiac dysfunction.
• Montior lab tests: Baseline and periodic LFTs.

Patient & Family Education

• Do not take more than once a day and never take more than the prescribed dose.
• Do not take this drug without consulting prescriber if you are taking drugs called “alpha-blockers” or “nitrates” or any other drugs for high blood pressure, chest pain, or enlarged prostate.
• Report promptly any of the following: Palpitations, chest pain, back pain, difficulty breathing, or shortness of breath; dizziness or fainting; changes in vision; dizziness; swollen eyelids; muscle aches; painful or prolonged erection (lasting longer than 4 h); skin rash, or itching.

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Ditulis oleh Unknown pada tanggal Tuesday, August 4, 2015