Names and pronunciation
(nye-fed′i-peen) Adalat , Adalat CC, Adalat XL , Afeditab CR, Procardia, Procardia XL
Source page 950
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Individual generic drug information
Extracted information for NIFEdipine only.
(nye-fed′i-peen) Adalat , Adalat CC, Adalat XL , Afeditab CR, Procardia, Procardia XL
Source page 950
Func. class.: Calcium channel blocker, antianginal, antihypertensive
Source page 950
Chem. class.: Dihydropyridine
Source page 950
Do not confuse: NIFEdipine/niCARdipine/niMODipine
Source page 950
ACTION: Inhibits calcium ion influx across cell membrane during cardiac depolarization; relaxes coronary vascular smooth muscle; dilates coronary arteries; increases myocardial oxygen delivery in patients with vasospastic angina; dilates peripheral arteries
Source page 950
USES: Chronic stable angina pectoris, variant angina, hypertension
Source page 950
Extracted information for NIFEdipine only.
CONTRAINDICATIONS: Hyper- sensitivity to this product or dihydropyri- dine; cardiogenic shock Precautions: Pregnancy, breastfeeding, children, hypotension, sick sinus syndrome, 2nd-/3rd-degree heart block, hypotension <90 mm Hg systolic, hepatic injury, renal disease, acute MI, aortic stenosis, GERD, heart failure
Source page 950
SIDE EFFECTS CNS: Headache, fatigue, drowsiness, dizziness, anxiety, depression, weak- ness, insomnia, light-headedness, pares- thesia, tinnitus, blurred vision, nervous- ness, tremor, flushing CV: Dysrhythmias, edema, hypotension, palpitations, tachycardia GI: Nausea, vomiting, diarrhea, gastric upset, constipation, increased LFTs, dry mouth, flatulence, gingival hyperplasia GU: Nocturia, polyuria HEMA: Bruising, bleeding, petechiae INTEG: Rash, pruritus, flushing, hair loss, Stevens-Johnson syndrome, toxic epider- mal necrolysis, exfoliative dermatitis MISC: Sexual difficulties, cough, fever, chills
Source pages 950, 951
INTERACTIONS • Contraindicated with strong CYP3A4 inducers Increase: level of digoxin, phenytoin, cycloSPORINE, prazosin, carBAMazepine β-blockers, antihypertensives, vincris- tine, warfarin, diuretics Increase: nifedipine effect—ACE inhibi- tors, alpha blockers, cimetidine, antiret- rovirals, verapamil, CYP3A4 inhibitors azole antifungals, diltiazem Increase: hypotension, PDE5 inhibitors, monitor B/P Increase: NIFEdipine, toxicity—cimeti- dine, raNITIdine Drug/Food Increase: NIFEdipine level—grapefruit juice Drug/Lab Test Increase: CPK, LDH, AST Positive: ANA, direct Coombs’ test
Source page 951
TREATMENT OF OVERDOSE: Defibrillation, atropine for AV block, vasopressor for hypotension HIGH ALERT
Source pages 951, 952
Extracted information for NIFEdipine only.
DOSAGE AND ROUTES Angina • Adult: PO Immediate release 10 mg tid, increase in 10-mg increments q7- 14days, max 180 mg/24 hr or single dose of 30 mg; EXTENDED RELEASE 30-60 mg/day, may increase q7-14days, max 120 mg/day Hypertension • Adult: PO EXTENDED RELEASE 30-60 mg daily, titrate upward as needed, max 90 mg/day (Adalat CC), 120 mg/day (Procardia XL) • Child/adolescent (unlabeled): PO EXT REL 0.25-0.5 mg/kg/day in 1-2 divided doses, max 3 mg/kg/day or 120 mg, whichever is less
Source page 950
Available forms: Caps 10, 20 mg; ext rel tabs (XL) 30, 60, 90 mg; extended- release tablet 30, 60, 90 mg
Source page 950
Administer: • Do not break, crush, or chew ext rel tabs, do not use immediate-release caps within 7 days of MI, coronary syndrome; do not use caps (SL) to reduce severe hypertension, may cause death • Without regard to meals; avoid grape- fruit juice • Give ext rel (Adalat CC) on empty stomach • Protect caps from direct light, keep in dry area, do not freeze
Source page 950
Extracted information for NIFEdipine only.
Assess: • Anginal pain: location, intensity, dura- tion, character, alleviating, aggravating factors • HF: peripheral edema, dyspnea, weight gain >5 lb, jugular venous distention, rales; monitor I&O ratios, daily weight • Cardiac status: B/P, pulse, respiration, ECG at baseline and periodically, in those taking antihypertensives, β-blockers, monitor B/P often • Potassium, renal, hepatic studies peri- odically during treatment • For bruising, petechiae, bleeding • GI obstruction: ext rel products have been associated with rare reports of ob- struction in those with strictures and no known GI disease • Serious skin disorders: rash that starts suddenly, fever, cutaneous lesions that may have pustules present; discontinue product if fever present or if rash is severe • Beers: avoid in older adults; poten- tial for hypotension, myocardial isch- emia • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk; avoid breast- feeding
Source page 951
Evaluate: • Therapeutic response: decreased angi- nal pain, B/P, activity tolerance
Source page 951
CLINICAL CONSIDERATIONS
Source page 951
Patient and caregiver information: • To avoid hazardous activities until sta- bilized on product, dizziness is no longer a problem • To limit caffeine consumption; to avoid alcohol products • To avoid OTC products unless directed by N prescriber; give without regard to meals, not to use with grapefruit juice • That empty tab shells may appear in stools and are not significant • To prevent direct light on ext rel product • To swallow ext rel product whole • Hypertension: to comply with all areas of medical regimen: diet, exercise, stress reduction, product therapy • To change position slowly because or- thostatic hypotension is common • To notify prescriber of dyspnea, edema of extremities, nausea, vomiting, severe ataxia, severe rash; changes in pattern, frequency, severity of angina • To increase fluid intake and fiber to prevent constipation • To check for gingival hyperplasia and report promptly • Not to discontinue abruptly; to gradu- ally taper, may cause increased angina • About fall risk for older adults
Source page 951
Extracted information for NIFEdipine only.
PHARMACOKINETICS Metabolized by liver; excreted in urine 60%-80% (metabolites), feces 15%; pro- tein binding 92%-98%, half-life 2-7 hr, well absorbed PO: Onset 20 min, duration 6-8 hr PO-ER: Onset 20 min, duration 24 hr
Source page 951
Filter the extracted dose blocks for this individual drug.
Angina
• Adult: PO Immediate release 10 mg tid, increase in 10-mg increments q7- 14days, max 180 mg/24 hr or single dose of 30 mg; EXTENDED RELEASE 30-60 mg/day, may increase q7-14days, max 120 mg/day Hypertension
Candidate age grouping · source page 950
Angina
• Adult: PO EXTENDED RELEASE 30-60 mg daily, titrate upward as needed, max 90 mg/day (Adalat CC), 120 mg/day (Procardia XL)
Candidate age grouping · source page 950