Plendil


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Related to Plendil: Plavix, Felodipine, Amlodipine, Coversyl, Concor

felodipine

Cardioplen (UK), Felotens (UK), Keloc (UK), Neofel (UK), Plendil, Renedil (CA), Vascalpha (UK)

Pharmacologic class: Calcium channel blocker

Therapeutic class: Antihypertensive, antianginal

Pregnancy risk category C

Action

Impedes extracellular calcium ion movement across membranes of myocardial muscle cells, depressing myocardial contractility and impulse formation; slows impulse conduction velocity and dilates coronary arteries and peripheral arterioles. Net effect is reduced cardiac workload and lower blood pressure.

Availability

Tablets (extended-release): 2.5 mg, 5 mg, 10 mg

Indications and dosages

Hypertension

Adults: Initially, 5 mg P.O. daily. Depending on response, may decrease to 2.5 mg or increase to a maximum of 10 mg P.O. daily at 2-week intervals.

Dosage adjustment

• Hepatic impairment
• Elderly patients

Off-label uses

• Heart failure
• Angina pectoris or vasospastic (Prinzmetal's) angina

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:
• cardiac disease, arrhythmias, severe hepatic or renal impairment
• elderly patients
• pregnant or breastfeeding patients
• children (safety not established).

Administration

• Give without regard to meals.
• Make sure patient swallows tablet whole without crushing or chewing.

Adverse reactions

CNS: headache, drowsiness, dizziness, syncope, nervousness, anxiety, psychiatric disturbances, paresthesia, insomnia, asthenia, confusion, irritability

CV: chest pain, peripheral edema, hypotension, palpitations, tachycardia, angina, arrhythmias, myocardial infarction, atrioventricular block

EENT: rhinorrhea, sneezing, pharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal discomfort, dyspepsia, abdominal cramps, flatulence, dry mouth

Hematologic: anemia

Musculoskeletal: back pain

Respiratory: bronchitis

Skin: dermatitis, rash, pruritus, urticaria, erythema

Other: dysgeusia, gingival hyperplasia, facial edema, thirst, warm sensation

Interactions

Drug-drug.Antifungals, cimetidine, erythromycin, propranolol, ranitidine: increased felodipine blood level, increased risk of toxicity

Barbiturates, hydantoins: decreased felodipine blood level

Beta-adrenergic blockers, digoxin, disopyramide, phenytoin: bradycardia, conduction defects, heart failure

Fentanyl, nitrates, other antihypertensives, quinidine: additive hypotension

Nonsteroidal anti-inflammatory drugs: decreased antihypertensive effects

Drug-food.Grapefruit juice: increased felodipine blood level and effects

Drug-behaviors.Acute alcohol ingestion: additive hypotension

Patient monitoring

Don't give to patient with heart block unless he has a pacemaker.

Use extreme caution when administering to patients with pulmonary hypertension, renal insufficiency, heart failure, or compromised ventricular function (especially those receiving beta-adrenergic blockers concurrently).
• Monitor fluid intake and output, and weigh patient daily.
• Monitor ECG and vital signs. Assess for signs and symptoms of heart block.
• Assess for reflex tachycardia, angina, and sustained hypotension.
• Check hepatic profile and alkaline phosphatase level in patients with hepatic impairment.

Patient teaching

• Tell patient drug controls but doesn't cure high blood pressure, so he should keep taking it even if he feels well.
• Instruct patient to move slowly when rising, to avoid light-headedness or dizziness from sudden blood pressure decrease.
• Explain that exercise and hot weather may increase drug's hypotensive effects.
• Tell patient to report peripheral edema, persistent headache, or flushing.
• Advise patient to use hard candy or gum if dry mouth or thirst occurs.
• Tell female patient to inform prescriber if she is pregnant or breastfeeding.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, foods, and behaviors mentioned above.

felodipine

(fe-loe-di-peen) ,

Plendil

(trade name),

Renedil

(trade name)

Classification

Therapeutic: antianginals
Pharmacologic: calcium channel blockers
Pregnancy Category: C

Indications

Management of hypertension, angina pectoris, and vasospastic (Prinzmetal’s) angina.

Action

Inhibits the transport of calcium into myocardial and vascular smooth muscle cells, resulting in inhibition of excitation-contraction coupling and subsequent contraction.

Therapeutic effects

Systemic vasodilation resulting in decreased BP.
Coronary vasodilation resulting in decreased frequency and severity of attacks of angina.

Pharmacokinetics

Absorption: Well absorbed after oral administration, but extensively metabolized, resulting in ↓ bioavailability.
Distribution: Unknown.
Protein Binding: >99%.
Metabolism and Excretion: Mostly metabolized; minimal amounts excreted unchanged by kidneys.
Half-life: 11–16 hr.

Time/action profile (antihypertensive effect)

ROUTEONSETPEAKDURATION
PO 1 hr 2–4 hrup to 24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity (cross-sensitivity may occur);Sick sinus syndrome;2nd- or 3rd-degree AV block (unless an artificial pacemaker is in place);Systolic BP <90 mm Hg.
Use Cautiously in: Severe hepatic impairment (dose ↓ recommended); Geriatric: Dose ↓ recommended; ↑ risk of hypotension;Severe renal impairment;History of serious ventricular arrhythmias or HF; Obstetric / Lactation / Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • abnormal dreams
  • anxiety
  • confusion
  • dizziness
  • drowsiness
  • nervousness
  • psychiatric disturbances
  • weakness

Ear, Eye, Nose, Throat

  • blurred vision
  • disturbed equilibrium
  • epistaxis
  • tinnitus

Respiratory

  • cough
  • dyspnea

Cardiovascular

  • arrhythmias (life-threatening)
  • HF (life-threatening)
  • peripheral edema (most frequent)
  • chest pain
  • hypotension
  • palpitations
  • syncope
  • tachycardia

Gastrointestinal

  • anorexia
  • constipation
  • diarrhea
  • dry mouth
  • dysgeusia
  • dyspepsia
  • ↑ liver enzymes
  • nausea
  • vomiting

Genitourinary

  • dysuria
  • nocturia
  • polyuria
  • sexual dysfunction
  • urinary frequency

Dermatologic

  • dermatitis
  • erythema multiforme
  • flushing
  • ↑ sweating
  • photosensitivity
  • pruritus/urticaria
  • rash

Endocrinologic

  • gynecomastia
  • hyperglycemia

Hematologic

  • anemia
  • leukopenia
  • thrombocytopenia

Metabolic

  • weight gain

Musculoskeletal

  • joint stiffness
  • muscle cramps

Neurologic

  • paresthesia
  • tremor

Miscellaneous

  • stevens-johnson syndrome (life-threatening)
  • gingival hyperplasia

Interactions

Drug-Drug interaction

Additive hypotension may occur when used concurrently with fentanyl, other antihypertensives, nitrates, acute ingestion of alcohol, or quinidine.Antihypertensive effects may be ↓ by concurrent use of NSAIDs.Ketoconazole, itraconazole, propranolol, and erythromycin ↓ metabolism and ↑ blood levels and the risk of toxicity (dose ↓ may be necessary).Grapefruit juice ↑ serum levels and effect.

Route/Dosage

Oral (Adults) 5 mg/day (2.5 mg/day in geriatric patients); may ↑ q 2 wk (range 5–10 mg/day; not to exceed 10 mg/day).

Availability (generic available)

Extended-release tablets: 2.5 mg, 5 mg, 10 mg

Nursing implications

Nursing assessment

  • Monitor BP and pulse before therapy, during dosage titration, and periodically during therapy. Monitor ECG periodically during prolonged therapy.
    • Monitor intake and output ratios and daily weight. Assess for signs of HF (peripheral edema, rales/crackles, dyspnea, weight gain, jugular venous distention).
  • Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia.
  • Angina: Assess location, duration, intensity, and precipitating factors of patient’s anginal pain.
  • Hypertension: Check frequency of refills to monitor adherence.
  • Lab Test Considerations: Total serum calcium concentrations are not affected by calcium channel blockers.
    • Monitor serum potassium periodically. Hypokalemia ↑ risk of arrhythmias and should be corrected.
    • Monitor renal and hepatic functions periodically during long-term therapy. May cause ↑ in hepatic enzymes after several days of therapy, which return to normal upon discontinuation of therapy.

Potential Nursing Diagnoses

Ineffective tissue perfusion (Indications)
Acute pain (Indications)

Implementation

  • Do not confuse Plendil with Isordil.
  • Oral: May be administered without regard to meals. May be administered with meals if GI irritation becomes a problem.
  • Swallow tablets whole; do not break, crush, or chew. Empty tablets that appear in stool are not significant.

Patient/Family Teaching

  • Advise patient to take medication as directed, even if feeling well. If a dose is missed, take as soon as possible unless almost time for next dose; do not double doses. May need to be discontinued gradually.
    • Instruct patient on correct technique for monitoring pulse. Instruct patient to contact health care professional if heart rate is <50 bpm.
    • Advise patient to avoid grapefruit or grapefruit juice during therapy.
    • Caution patient to change positions slowly to minimize orthostatic hypotension.
    • May cause drowsiness or dizziness. Advise patient to avoid driving or other activities requiring alertness until response to the medication is known.
    • Instruct patient on importance of maintaining good dental hygiene and seeing dentist frequently for teeth cleaning to prevent tenderness, bleeding, and gingival hyperplasia (gum enlargement).
    • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of alcohol or OTC medications and herbal products, especially cold preparations, without consulting health care professional.
    • Advise patient to notify health care professional if rash, irregular heartbeat, dyspnea, swelling of hands and feet, pronounced dizziness, nausea, constipation, rash, or hypotension occurs or if headache is severe or persistent.
    • Caution patient to wear protective clothing and to use sunscreen to prevent photosensitivity reactions.
    • Advise patient to inform health care professional of medication regimen before treatment or surgery.
  • Angina: Instruct patient on concurrent nitrate or beta-blocker therapy to continue taking both medications as directed and to use SL nitroglycerin as needed for anginal attacks.
    • Advise patient to contact health care professional if chest pain does not improve or worsens after therapy; occurs with diaphoresis or shortness of breath; or if severe, persistent headache occurs.
    • Caution patient to discuss exercise restrictions with health care professional before exertion.
  • Hypertension: Encourage patient to comply with other interventions for hypertension (weight reduction, low-sodium diet, smoking cessation, moderation of alcohol consumption, regular exercise, and stress management). Medication controls but does not cure hypertension.
    • Instruct patient and family in proper technique for monitoring BP. Advise patient to take BP weekly and to report significant changes.

Evaluation/Desired Outcomes

  • Decrease in BP.
  • Decrease in frequency and severity of anginal attacks.
    • Decrease in need for nitrate therapy.
    • Increase in activity tolerance and sense of well-being.

Plendil

A brand name for FELOPIDINE.
References in periodicals archive ?
Grapefruit and grapefruit juice are also known to interact with Plendil Extended-Release tablets and Procardia (calcium channel blockers), Premarin (a hormone preparation), and Xanax (for anxiety and panic), according to the 2004 Physicians' Desk Reference Companion Guide.
Calcium-Channel Blocking Agents Classification/Drug Trade Names Starting Dosage Amlodipine Norvasc 5 mg QD Diltiazem Cardizem, 30 mg QID or Tiamate, 60-120 mg BID (SR) Cardizem SR, or 180-240 mg QD Cardizem CD, (CD and XR) Dilacor XR, Tiazac Felodipine Plendil 5 mg QD Isradipine DyanaCirc, 2.
As a result of the restructuring, the Company will record, in its revenue line, sales reflecting its share of the proceeds from PRILOSEC, PLENDIL and future Astra products that would have been sold by the joint venture.
It markets the antisecretory medication, Prilosec, and the cardiovascular drugs, Plendil and Tonocard.
Felodipine is the generic name for the brand Plendil [sup.
is 50% owned by Astra and presently primarily markets Prilosec (Losec), the antipeptic ulcer agent, and Plendil, a vasodilating agent.
In addition to Prilosec, the company markets the cardiovascular drugs Plendil (felodipine) and Tonocard (tocainide HCL) -0- For a copy of the package insert, please call 610/695-1230.
5mg, 5mg and 10mg ER Tablets (AB-rated to Astra-Zeneca's Plendil ER Tablets), which the Company launched in late October 2004.
5mg, 5mg and 10mg ER tablets (AB-rated to Plendil ER, Astra Zeneca), Clonidine HCl 0.
As Mutual prepares to initiate its validation of Felodipine ER in anticipation of receiving FDA's final approval of its ANDA, it is also reviewing its options regarding product launch, which include a possible launch of its Felodipine ER as a branded alternative to AstraZeneca's Plendil ER.
Felodipine Hydrochloride ER Tablets (reference Plendil ER(R) Tablets, AstraZeneca): On August 5, 2004, the Federal Court of Appeal heard oral arguments concerning Mutual's Paragraph IV litigation against AstraZeneca in respect to AstraZeneca's U.